SQCIIIETYS

     

Social and Ethical Decision
Making in Biomedicine

Ruth Ellen Bulger, Elizabeth Meyer Bobby,
and Harvey V. Fineberg, Editors

Committee on the Social and Ethical Impacts of
Developments in Biomedicine
Division of Health Sciences Policy

INSTITUTE OF MEDICINE

NATIONAL ACADEMY PRESS
Washington, DC. 1995

f: D (f, L

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Library of CongreS Catalogingvin-Publication Data

Society’s choices : social and ethical decision making in biomedicine
/ Ruth Ellen Bulger, Elimbeth Meyer Bobby, and Harvey V. Fineberg,
editors ; Committee on the Social and Ethical Impacts of
Developments in Biomedicine, Division of Health Sciences Policy,
Institute of Medicine.
. cm.
Includes bibliographical references and index.
ISBN 0309051320
1. Medical ethics. 2. Bioethics. I. Bulger, Ruth Ellen.
[1. Bobby, Elizabeth Meyer. III. Fineberg, Harvey V. IV. Institute
of Medicine (U.S.). Committee on the Social and Ethical Impacts of
Developments in Biomedicine.
R724.8598 1995
174‘. 2—dc20 94-39354
CIP

Copyright 1995 by the National Academy of Sciences. All rights reserved.

Printed in the United Smtes of America.

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type by the Institute of Medicine is based on a relief carving from ancient Greece, now held
by the Staalichemuseen in Berlin.

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V $7 8
4 , ,...
COMMITTEE ON THE SOCIAL AND ETHICAL IMPACTS A, . " .
0F DEVELOPMENTS IN BIOMEDICINE #4. s’ 1;. L,

HARVEY V. FINEBERG, M.D., Ph.D.,* Chair, Dean, Harvard School of
Public Health, Boston

W. FRENCH ANDERSON, M.D., Director, USC Gene Therapy Lab,
University of Southern California, School of Medicine, Noris Cancer
Center, Los Angeles

JOHN ARRAS, Ph.D., Associate Professor of Bioethics, Albert Einstein
College of Medicine, Monteﬁore Medical Center, Bronx, NY.

ALEXANDER CAPRON, LL.B.,* University Professor of Law and
Medicine, The Law Center, University of Southern California,
Los Angeles

TROY DUSTER, Ph.D., Director, Institute for the Study of Social
Change, University of California, Berkeley

ALFRED P. FISHMAN, M.D.,* Chairman, Department of Rehabilitation
Medicine, Hospital of the University of Pennsylvania, Philadelphia

THEODORE FRIEDMANN, M.D., Professor of Pediatrics and Bioethics,
Department of Pediatrics, Center for Molecular Genetics, University
of California, San Diego

WILLIAM D. FULLERTON,* Consultant to “Health Policy Alternatives,”
Crystal River, Fla.

WALTER HARRELSON, Professor Emeritus, The Divinity School,
Vanderbilt University

SHEIIAJASANOFF,].D., Ph.D., Professor and Chair, Department of
Science and Technology Studies, Cornell University

ALBERT R. JONSEN, M.D.,* Chairman, Department of Medical
History/Ethics, School of Medicine, University of Washington

PATRICIA KING,‘].D.,* Professor of Law, Georgetown University
Law Center

JOANNE LYNN, M.D., Center for the Evaluative Clinical Sciences,
Dartmouth Medical School

JAMES A. MORONE, Ph.D., Associate Professor, Department of Political
Science, Brown University

STANLEY REISER, M.D., Ph.D., Director, Program on Humanities and
Technology in Health Care, University of Texas Health Sciences
Center, Houston

DANIEL WIKLER, Ph.D., Professor, Departments of Medical Ethics and
Philosophy, University of Wisconsin, Madison

 

 

 

*Member, Institute of Medicine

iii

Staff

RUTH ELLEN BULGER, Ph.D., Study Director and Division Director
(until August 1993)

VALERIE P. SETLOW, Ph.D., Division Director (from August 1993)

ELIZABETH MEYER BOBBY, Research Associate

PHILOMINA MAMMEN, Study Assistant and Administrative Assistant

NANCY DIENER, Budget Analyst

iv

Preface

So often, new developments in biomedicine are hailed as panaceas, as
answers to problems, as hopes of ﬁnally having conquered an adversary.
Even when a discovery may lead to a valuable treatment or even a cure for
disease, it can also bring with it troublesome social and ethical issues. This
report illustrates—through examples like genetic technology, with its power
to alter human nature, and health care reform, with its emphasis on cost
control—how developments in biomedicine can affect the fabric of society
in significant and lasting ways. The report explores mechanisms for con—
fronting these challenges and describes the strengths and weaknesses of
various approaches to social and ethical deliberation. Appreciating the
subjective nature of their own judgments, members of the committee en-
deavored to synthesize the available literature, the judgments of its consult-
ants, and the relevant experiences ofits members into a thoughtful analysis
of mechanisms for bioethics deliberation. The result is a report that differs
from many lnstitute of Medicine reports in that it constitutes an interpre-
tive essay rather than a predominantly data-based analysis.

The development of renal dialysis and transplantation technologies is
a salient example. Dialysis and transplantation were (and are today) tre-
mendous advantages for patients with permanent kidney failure, because
the procedures gave them many more years of life than they would have
had prior to the advent of these technologies, when a diagnosis of end-
stage renal disease meant certain death. When more patients needed the
technology than could be treated, however, society was faced with a trouble-
some question: How do we decide who should beneﬁt from these life-

'0

vi PREFACE

saving technologies, and who should die? This question stimulated phi-
losophers and theologians to study the criteria for fair allocation of a life-
saving resource. Is it ethical, they asked, to choose persons on the basis of
their social worth or by a lottery? At the same time, a political response to
the problem began to build momentum to cover aﬁected patients under
Medicare. Congress passed such legislation in 1972. In so doing, it re-
moved the ﬁnancial barrier to access yet left untouched the remaining
social and ethical quandaries. The arguments of the philosophers and
theologians were set aside as no longer relevant. Society continues today to
struggle with many of the questions related to allocation of scarce life-
saving technologies.

Often individuals making biomedical decisions must contend with per-
sonal moral dilemmas: a woman who is pregnant with a desired child learns
that the fetus she carries is afﬂicted with a serious genetic or congenital
disorder and agonizes over whether she should have an abortion; parents
agonize about discontinuing life support for a child who the doctors say
has permanently lost all brain function. These are deeply personal dilem-
mas, and, as a rule, American society has given latitude to such private
choices. We have made our own the dictum of the British philosopher,
John Stuart Mill, who wrote a century ago,

The individual is not accountable to society for his actions, insofar as
these concern the interests of no person but himself.

(Mill, On Liberty, 1859)

However, the qualifying clause, “insofar as these concern the interests of
no person but himself” may loom large. Indeed, even when individual
choices may benefit another, we may hesitate to endorse them. Thus, the
prospect that some person ill with a neurological or metabolic disorder
might be cured by transplantation of tissue from an aborted fetus, or that
the organs of a brain-dead child might save the life of another, immediately
raises ethical questions that go beyond the personal and private. They
become matters of public policy because other parties now enter into the
range of those who can be harmed or can benefit. Examples such as these
suggest that ethical decisions that are exclusively matters for personal de—
liberation may be exceptional in modern biomedicine.

Despite the difﬁculty of resolving ethical dilemmas in the public sphere,
society has made notable progress in the past two decades in confronting
the social and ethical impacts of developments in biomedicine, partly to
the credit of a number of “ethics” bodies. The work of many of these
bodies, including the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research (National Commission),
the President’s Commission for the Study of Ethical Problems in Medicine
and Biomedical and Behavioral Research (President’s Commission), and

PREM (‘1; vii

the Human Genome Project’s Ethical, Legal, and Social Implications
(ELSI) Working Group, among others, is described in this report. While
the contributions of these groups have been signiﬁcant, their work is not
complete. Technologies and practices in biomedicine continue to evolve,
and as they do, novel social and ethical quandaries will undoubtedly take
shape. Moreover, many of the social and ethical dilemmas that arose in the
past are still in need of resolution. In fact, a principal motivating factor
behind this report was indeed the fact that little public bioethics activity
took place in the 19805 when the country was sharply divided on several
ethical issues. After the closing of the President’s Commission, no mecha-
nisms for public discussion and consensus building were being employed
effectively.

The charge to this committee had two parts, the ﬁrst of which was to
assess the mechanisms employed by our society to deliberate social and
ethical issues stemming from developments in biomedicine. The com-
mittee’s ﬁrst step in addressing this charge was to come to an understand-
ing of the circumstances deﬁning such issues. The committee recognized
early in its deliberations that not all ethical dilemmas related to biomedical
developments have resulted from a new discovery or novel technology.
Some scientiﬁc developments diffuse into medical practice quickly, and
ethical issues related to these developments get overlooked. The develop-
ment becomes part of accepted practice and, while not novel, ethical quan-
daries about the application of the development remain and may eventu-
ally assert themselves. Techniques of assisted reproduction, such as in vitro
fertilization, provide an example.

Social and ethical quandaries can also be raised when numerous small
developments accumulate to present a novel situation. An example lies in
this country’s growing population of elderly persons. Immunization and
antibiotics have reduced the risk of death due to infectious disease; surgical
advances save more and more people from early death due to cardiovascu-
lar disease and cancer. The aggregate effect of these and other medical
advances has been the prolongation of life, which in turn raises social and
ethical concerns about quality of life and end—of-life care.

Lastly, social and ethical dilemmas can arise from organizational inno-
vation and change. As our society restructures its health care system, for
example, ethical issues related to allocation and rationing of health re—
sources will undoubtedly surface.

The second part of the committee’s charge was to provide guidance to
professionals, institutions, and the general public about utilizing and im-
proving existing mechanisms for deliberation and, where applicable, creat-
ing new mechanisms. The value of such mechanisms was clear to this
committee from the outset, as was the idea that the more our society can
recognize and effectively deal with the social and ethical impacts of devel-

vz‘z‘z‘ PREFA (m:

opments—through whatever mechanism—the greater the likelihood that
these developments will affect society positively.

One of the key steps in the committee’s work was to identify and review
the groups that have functioned in this capacity in the past. Several groups
convened during the past two decades to deliberate ethical issues in bio-
medicine have been widely recognized as having made important contribu-
tions. The impact of these groups is evident in, for example, the enduring
nature of their guidance on the protection of human research subjects
(National Commission) and the continued citation of their arguments in
legal cases pertaining to termination of life-sustaining treatment (Pres-
ident’s Commission). In addition to reviewing the work of these well-
known groups, the committee explored the efforts of a number of other
bioethics institutions whose impact has been less conspicuous. It did so
with the recognition that bioethics deliberation takes place at many levels:
national, state, community, institutional, and individual. The committee
found that there were lessons to be learned at each level about the integra-
tion of moral reasoning into decisions in medicine and health.

The committee apprehended thatjust as there are various forms and
styles of bioethics deliberation, so are there various deﬁnitions of success.
Success may be the fulﬁllment of a group’s intended function, which may
take numerous different forms; it may be the citation of a group’s work in
courts and classrooms; it may be the translation ofa group’s recommenda—
tions into legislation; it may be the mere stimulation of thought among
others. Success may also be in the eye of the observer; a group may be
perceived as successful by one person or faction and not by another, de-
pending upon what each expected the group to achieve.

The members of the committee brought to their task a wide range of
expertise. Several had served as members or staff of ethics bodies of the
past, such as the National Commission and the President’s Commission.
Several were active members of ethics bodies such as the ELSI Working
Group and the New York State Task Force on Life and Law. Their ﬁelds of
expertise covered public health, basic science research, bioethics, law, so-
cial science, medicine, theology, medical history, clinical sciences research,
political science, and science and technology studies.

The committee also beneﬁtted from the expertise of other profession-
als not on the committee. Papers were commissioned on a variety of topics,
including the implications oflabeling an issue an ethical issue, the value of
consensus, and the dynamics ofmoral reasoning in public. The committee
discussions stimulated by these papers were unfailingly enlightening and
helped shape the orientation of the report. The 12 papers commissioned
by the committee are compiled in Part [I of this report. In an attempt to
understand the current environment in which policy—making in science
and health takes place, the committee also invited the contributions of

PREFACE ix

several people from federal health and science agencies who balance scien-
tiﬁc and ethical concerns on a daily basis. Their insights into the kinds of
guidance needed by the scientiﬁc community were especially valuable.

In sum, what is presented in this volume is a historical and social
analysis of public moral reasoning in medicine and health, from which this
committee has drawn conclusions, principles, and recommendations based
on its shared judgments. The report is intended to serve as a source of
ideas for those wishing to utilize or redeﬁne mechanisms for considering
the social and ethical impacts of developments in biomedicine. It sheds
new light on criteria that contribute to the success of such mechanisms at a
variety of levels and with a variety of intended functions. It speaks to the
critical importance of forethought and communication in turning develop-
ments into “advances.” It is the committee’s sincere hope that policy-
makers, scientists, health care providers, patients and their families, stu-
dents, and others concerned with the social and ethical impacts of
biomedical developments will find the report valuable.

Harvey V. Fineberg, M.D., Ph.D., Chair

Acknowledgments

The committee wishes to express its gratitude to many individuals who
helped during the course of this study. They included the authors of the
background papers published with this volume, those who wrote drafts of
materials used in the text, including Beth Kosiak, Katherine Taylor, and
Roger Bulger, and the many individuals who shared their insights with the
committee, particularly Michael Yesley, Eric juengst, Jay Moskowitz, and
Sandy Chamblee.

The committee would like to thank Philomina Mammen, study assis—
tant, for her unfailing help in planning and logistics, materials distribu-
tion, manuscript and report preparation, and general support to the com-
mittee.

The committee members also appreciated the many letters we received
from scientists concerning the issue and the processes that are currently
being followed in their areas of science. These individuals included Alan
R. Fleischman, M.D.; Fred Rosner, M.D., F.A.C.P.; Neil A. Hotzman, M.D.,
M.P.H.; Beverly Torok—Storb, Ph.D.; David W. Martin, Jr., M.D.; Alvin H.
Moss, M.D.; Norman C. Levinsky, M.D.; Arnold S. Relman, M.D.; Nancy
Boucot Cummings, M.D.; Robert S. Balaban, Ph.D.; Robert G. Shulman,
Ph.D.; Gary Nabel, M.D.; and Ralph Crawshaw, M.D. Thanks also to
Enriqueta Bond for her support and advice during the study process, Paul
Phelps for his improvements and editing of the report, Mike Edington for
his help with the publication of the manuscript, Claudia Carl for coordina-
tion of the review process, and Nancy Diener for budget oversight.

The committee expresses its special appreciation to Elizabeth Meyer

xi

xii ACKNOWLEDGMENTS
Bobby and Ruth Bulger for their excellent and constant support. Their
contributions permeate this report, which would have been a different and
much diminished product without their participation.

Finally I would like to thank the members of the committee for their
generous sharing of time and knowledge and their stimulating insights
expressed during what were very productive meetings of the group.

Harvey V. Fineberg, M.D., Ph.D., Chair

Contents

EXECUTIVE SUMMARY 1

PART I

1 INTRODUCTION 27
Deﬁning “Ethical” Issues, 27
Sources of Ethical Issues in Biomedicine, 30

2 THE SOCIAL CONTEXT OF BIOETHICAL
PROBLEM SOLVING 43
The American Character, 43
Actors Shaping the Social Context for Bioethics, 48
Health Care and Science: Shaping the Social Context
for Bioethics, 53

3 SYSTEMATIC APPROACHES TO BIOETHICS 67
Academic Bioethics, 67
Scientists and Other Technical Experts, 75
Health Care Professional Education, 80

4 THE SPECTRUM OF SOCIETAL RESPONSES 87
Political and Legal Mechanisms, 89
Professional and Institutional Mechanisms, 115
Individual and Community Responses, 136

xiii

xiv

5 CRITERIA FOR SUCCESS
Intellectual Integrity, 153
Sensitivity to Democratic Values, 155
Effectiveness, 159

6 CONCLUSIONS AND RECOMMENDATIONS
Interpreting the Committee’s Charge, 168
Criteria for Evaluation, 171
A Multilevel Approach to Bioethics Deliberation, 174
Recommendations, 176

PART II COMMISSIONED PAPERS

Moral Epistemology
Thomas Nagel

Public Moral Discourse
Dan W. Brock

The Value of Consensus
Martin Benjamin

Bioethics Commissions: What Can We Learn from
Past Successes and Failures?
Bradford H. Gray

Limiting Life-Prolonging Medical Treatment:
A Comparative Analysis of the President's Commission
and the New York State Task Force
Baruch A. Brody

The Formulation of Health Policy by the
Three Branches of Government
Lawrence Gostin

The Role of Religious Participation and Religious Belief
in Biomedical Decision Making
Charles M. Swaey

Trust, Honesty, and the Authority of Science
Steven Shapin

Institutional Ethics Committees: Local Perspectives on
Ethical Issues in Medicine
Elizabeth Heitman

CONTENTS

150

168

201

215

241

261

307

335

358

388

409

CONTENTS

The Ethical, Legal, and Social Implications
Program of the National Center for Human
Genome Research: A Missed Opportunity?

Kathi E. Hanna

AIDS, Ethics, and Activism: Institutional Encounters
in the Epidemic’s First Decade
Ronald Bayer

“La Pénible Valse I-Iésitation”: Fetal Tissue Research
Review and the Use of Bioethics Commissions in
France and the United States

R. Alta Charo

APPENDIX PAST COMMISSIONS AND ADVISORY BOARDS

INDEX

xv

432

458

477

503

521

SQCIIIETY S
CHONCIES

Slocia and Ethical Decision
Ma king In Bieom dic ine

Executive Summary

During the past 30 years, social and ethical issues in biomedicine have
vaulted to prominence, prompting public debate and deep reflection by
governmental commissions, professional societies, and community organi-
zations. The issues have at times demanded immediate public attention, as
in the case of abuse of human research subjects, and, at other times, more
gradually raised public concern, as have the possibilities provided by ad-
vances in genetic technology. More and more, the ethical implications of
such issues as health care delivery and commercialization of biotechnology
are being examined in a public fashion. Despite the increasing activity in
this area, however, there has been little systematic study of the various
social processes through which we subject the ethical and social issues in
medicine and biotechnology to debate and analysis.

In an attempt to delineate these processes as they are manifested in
this country, the committee considered those characteristics that make an
issue an ethical issue and the circumstances under which it is determined
that an ethical issue should be publicly deliberated. The word “ethical”
typically connotes human values and ethicaljudgments—that is,judgments
grounded in values. These issues arise during the deliberation and resolu-
tion of nearly every public issue. Some public issues especially prompt
reference to the kinds of ethical ideas—dignity, freedom, rights, fairness,
respect, equality, solidarity, and integrity—that are evoked in efforts to
distinguish right from wrong. These are the sorts of issues that come
within the purview of public ethics bodies, including congressionally or
presidentially appointed bodies, community—centered bodies, institutional

I

2 SOCIETY’S CHOICES

bodies, and the like. This report explores how these bodies approach the
task of deliberating ethical issues, and how their approaches reﬂect the
character of our society.

SOURCES OF ETHICAL ISSUES IN BIOMEDICINE

The tasks of ethics bodies convened to address issues in biomedicine
have originated from clashes of values, norms, principles, and practices
that have occurred in a number of arenas, especially: biomedical research
involving human subjects; health care decision making, delivery, and ﬁ-
nancing; advances in medical diagnostics and therapeutics; and academic-
industry relationships in biotechnology. From these arenas have come new
technologies, the proper use of which is controversial; crises in resource
allocation and perplexing questions of distributivejustice; changes in the
organization and delivery of health care and related concerns about the
appropriate role of physicians; and ﬁnancing challenges that have spawned
new relationships ofquestionable appropriateness between researchers and
their sponsors. It was in the arena of human studies research that the
ethical dimensions of biomedicine and the need for public involvement in
such ethical matters were ﬁrst recognized.

Abuses of human research subjects by the Nazis during World War II
outraged the public and stimulated formal inquiry into the inherent con—
ﬂict in biomedical investigation between beneﬁt to the subject and beneﬁt
to science and society. The Nuremberg Code of 1948, designed to be used
as a standard by which tojudge the actions of Nazi scientists, was the ﬁrst
formal enunciation of ethical standards that proscribed scientiﬁc zealotry
and disregard for human consent and dignity. In the 19605 and 19705,
following revelations in the United States ofsuch incidents as the Tuskegee
syphilis study, federal regulations were issued to protect human research
subjects. The National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research (National Commission), which
operated between 1974 and 1978 and became one of the most well—known
public ethics bodies, was inﬂuential in developing these regulations and in
stimulating the design of localized bodies, known as institutional review
boards (IRBs), for the protection of human research subjects.

Changes in health care delivery and ﬁnancing have also raised ethical
concerns that have been subject to public deliberation. Informed consent,
the linchpin of regulations for research on human subjects, was at the
heart of a movement during the 1960s and 1970s toward greater patient
autonomy. At issue were questions of information disclosure, decisional
authority, and patient self—determination. At the same time, specialized
medical technology began to ﬂourish, health insurance companies grew
and began to exert inﬂuence on health care decisions, and health care

EXECUTIVE SUMMARY 3

began its transformation into the business-like enterprise it is today. Ethi-
cal aspects of the resulting specialization, fragmentation, depersonalization,
and variable accessibility of health care became the topics put before such
public ethics bodies as the President’s Commission for the Study of Ethical
Issues in Medicine and Biomedical and Behavioral Research (President’s
Commission), which operated between 1980 and 1983; institutional ethics
bodies known as hospital ethics committees; and community-based groups
of health care consumers.

Developments in the area of biotechnology have also raised publicly
debated ethical quandaries. Some of these quandaries have reflected genu-
ine societal uncertainty about the use of novel technologies; others have
related to the propriety of ﬁnancial relationships between scientists and
biotechnology companies. Developments in genetic research illustrate the
promise and hazard of scientiﬁc discoveries—at the same time that they
offer the potential of an end to suffering from gene-linked disease, they
also threaten our identity as humans. One product of this apprehension
has been the creation of the Ethical, Legal, and Social Implications (ELSI)
Program at the National Center for Human Genome Research. Illustrative
of the ethical issues raised by the commercialization of scientific discover-
ies are the pricing and distribution of products developed with public
funds and the degree to which they serve the public interest. Also of
concern are the ethical issues raised by the increasing tendency of univer-
sities and government laboratories to establish closer ties with industry.

Our society’s capacity for dealing humanely and wisely with the impact
of technological and scientiﬁc innovation, in each of the above areas and
in others, is enhanced by the creation of forums in which ethical delibera—
tion can be carried out. The deliberation may draw on many resources:
experience in the use of these technologies and in the practice of medi-
cine; the personal values and life experiences of participants; bodies of
thought, such as economics and the law, which reﬂect and systematize
value-ladenjudgments; and the intellectual and scholarly resources of the
ﬁeld of ethics. Its character and form are inevitably inﬂuenced by the
distinctive history and culture of our society.

THE SOCIETAL CONTEXT OF BIOETHICAL PROBLEM SOLVING

American history is replete with examples of stirring ethical debates
that have mobilized huge numbers of citizens. Debates about child labor
laws, women’s suffrage, prohibition, and the abolition of slavery are illus-
trative. What stimulated these public deliberations in large part was what
characterized this country at its founding: a strong will to reject tyranny, to
self-govern, and to preserve individual liberty. The American penchant for
celebrating the individual and the private fostered the growth and diversity

4 SOCIE’I‘Y’S (.‘HOICES

that has characterized this country. At the same time, these values exist in
tension with concerns about responsibility for the community and public
well-being. Such tension becomes particularly visible when an ethical issue
is at stake.

Our society’s capacity for deliberation about social and ethical issues in
biomedicine has expanded and matured signiﬁcantly within the past few
decades. In the mid-19605, ambivalence about authority and tension be—
tween public and private life combined to produce a wave of social move-
ments in civil rights, feminism, and consumer activism. In biomedicine as
in the whole of society, new voices began to gather volume, particularly
those of patients and their families demanding to have a say in medical
decision making. As medical technology ﬂourished and new treatment
options (e.g., life support) challenged long-held ideas about life and death,
religious representatives began to voice their opinions. And as health care
costs skyrocketed, additional factions—insurers, employers, and hospitals—
organized to represent their interests.

SYSTEMATIC APPROACHES TO BIOETHICS

The events of the 19605 lent impetus to a growing interest in systematic
thinking about social and ethical issues in biomedicine. In the 19705,
scholars from several disciplines, principally moral philosophy, theological
ethics, medicine, and law, began to study and write about the social and
ethical issues of modern medical science and health care. A discipline
called bioethics began to emerge, with specialized faculty (usually located
in schools of medicine), courses, conferences, and journals. Today, aca-
demic bioethics has moved far beyond its beginnings. A number of aca-
demic programs prepare students for the field, teaching the foundation of
ethical reasoning and a variety of analytic methods. In addition, ethics
programs in health professional schools prepare care providers to apply
these methods in the practice setting.

Systematic thinking about social and ethical issues in biomedicine also
takes place in numerous religious communities. Clergy come into fre-
quent contact with the wrenching moral dilemmas of life and death, and
many clergy today have spent time in formal training programs in hospital
pastoral counseling. Theological seminaries offer courses on bioethics and
their faculty often contribute to the denominational literature on its topics.
In addition, several centers of theological and religious reﬂection on bio-
ethics exist with sponsorship from religious communities. Areas of tension
remain with respect to religious participation in bioethical decision mak-
ing for the entire community. Religious views, precisely because they are
religious, are likely to be held with great conﬁdence and tenacity, and
inconsistent views may be espoused by leaders of different religious com-

EXECUTIVE SUMMARY 5

munities. Many thoughtful religious specialists and leaders are willing to
participate in public ethics deliberation, and many of them are qualiﬁed by
temperament, knowledge, and experience to be valuable contributors.

Scientists and other technical experts also make unique contributions
to deliberation about the social and ethical impacts of developments in
biomedicine. Three arguments have been advanced to justify the impor—
tance of their participation in this deliberation. First, science, because of
its openness and critical tradition, can be thought to provide a useful way
of approaching ethical deliberation in a pluralist society. Second, scientists
and physicians, because of their closeness to the practice of medicine and
the use of technology, may have special insights into ethical issues arising
from their practice that would not as easily be apparent to other users or
consumers of technology. Third, science can be counted on to remove
certain issues from ethical debate because they are “facts” and hence are
no longer open to social negotiation. While there are limitations to each
of these arguments, they point to the value of scientiﬁc and technical input
in decisions made at the frontiers of medicine.

THE SPECTRUM OF SOCIETAL RESPONSES

With the growth in society’s interest in and understanding of social
and ethical issues in biomedicine has come the creation of a number of
mechanisms for deliberation and decision making in this area. Some of
these mechanisms entail the formation of a group of persons at a local
level, as in grassroots organizations, hospital ethics committees (HECs),
and institutional review boards (IRBs), while others relate to the activities
of long-established social institutions, such as the legal system. Still others
involve federally or state-sponsored groups convened to advise on public
policy regarding biomedical developments. Despite their variation in loca-
tion, sponsorship, and other characteristics, these mechanisms for public
deliberation of social and ethical issues can share a variety of functions.
Such functions include identiﬁcation of ethical issues at stake in areas of
societal controversy, analysis of an issue, development or documentation of
areas of consensus, exposure and documentation of areas of disagreement,
generation of public awareness and debate, development of factual bases
for public policy, and recommendation of new legislation or improvements
in existing public policy.

Political and Legal Mechanisms

Government responsibility to consider the ethical and social conse-
quences of biomedical research arises from its support and encourage—
ment of research as a means of advancing human welfare. Although the

6 S()( 21E TY’S CHOICES

timeliness of its initiatives in this area has been criticized, the Congress of
the United States has in the past two decades established the National
Commission, the President’s Commission, and the Biomedical Ethics Advi-
sory Committee (BEAC) to advise public policy on and illuminate issues
raised by biomedical research. None of these bodies is currently active,
and Congress is presently considering the creation ofa new national ethics
body that might echo the success of the National and President’s Commis-
sions.

Federally sponsored ethics bodies have also been situated within fed-
eral agencies that conduct biomedical research. Past examples include the
Ethics Advisory Board in the Department of Health, Education, and Wel-
fare, and the Human Fetal Tissue Transplantation Research Panel of the
National Institutes of Health (NIH). Current examples include the NIH
Recombinant DNA Advisory Committee and the Ethical, Legal, and Social
Implications (ELSI) Program of the Human Genome Project, both ofwhich
are housed within the NIH. Ethics bodies housed within federal agencies
generally consider issues that are speciﬁc to the work of their sponsoring
agency; they may also review protocols for proposed research to be con-
ducted or funded by that agency.

The governments of two states, New York and Newjersey, have estab-
lished ethics commissions to advise the states’ executive and legislative
branches on a range of bioethical topics, including surrogate parenting,
determination of death, the use of advance directives in medical care, and
distribution of organs for transplantation. Both the New jersey Bioethics
Commission (closed in 1991) and the New York State Task Force on Life
and Law issue(d) recommendations for changes in state policy related to
these areas of medicine.

Courts, regulation, and legislation are mechanisms used by govern-
ments and others to contend with social and ethical issues related to devel-
opments in biomedicine. In our litigious society, in fact, courts often are
the arena where ethical quandaries related to biomedicine ﬁrst make their
appearance and demand resolution. Dramatic cases like Quinlan or Cruzan
illustrate how courts provide a forum in which abstract ethical concerns are
made concrete.

While government-sponsored activity in bioethics has languished some-
what in this country since the closing of the President‘s Commission in
1983, several European countries—notably Denmark, France, and the
United Kingdom—have recently taken the initiative. Multinational organi-
zations also have begun to deal with bioethical issues. As the US. govern-
ment considers the possible reestablishment of a national bioethics com-
mission, the experiences of these foreign bioethics groups may hold useful
lessons.

EXECUTIVE SUMMARY 7

Professional and Institutional Mechanisms

Professional medical associations and specialty societies have re-
sponded individually and cooperatively to social and ethical questions
raised by developments in medical technology and medical care. Several
of these groups have formed ethics subcommittees or task forces to deal
speciﬁcally with these questions and, in several cases, to formulate practice
guidelines to assist health care providers in rendering appropriate care to
their patients. The guidance provided by professional societies is often the
best source of up-to-date scientiﬁc, legal, and practical information avail-
able to practitioners. Organizations like the American Medical Associa-
tion, American Academy of Pediatrics, American College of Obstetricians
and Gynecologists, American College of Physicians, American Thoracic
Society, and National Advisory Board on Ethics in Reproduction, along
with others, have taken the initiative to understand and advise on the
complex issues that confront practitioners every day.

Institutional review boards and hospital ethics committees are institu-
tion-based mechanisms for deliberation on ethical issues in biomedical
research and health care. IRBs review protocols for research involving
human subjects to ensure that the research does not violate ethical stan-
dards. HECs exist to ensure that difﬁcult ethical decisions about medical
treatment are made in a careful and impartial fashion. By federal law, IRBs
must exist in any institution that conducts or funds human subjects re-
search using federal funds; hospital accreditation standards specify that
accredited hospitals must have either a formal HEC or some other mecha—
nism for the consideration of ethical issues in the care of patients. As
mechanisms for ethical deliberation and decision making at a local level,
IRBs and HECs are uniquely positioned to make decisions that are sensitive
to local norms and values and to the particular circumstances of individual
patients or research subjects.

The Institute of Medicine (IOM) and the Ofﬁce of Technology Assess-
ment (OTA) have also from time to time engaged in bioethics delibera-
tion. An arm of the National Academy of Sciences (NAS) , IOM is a private,
nonproﬁt organization, associated with the government by virtue of the
1863 NAS congressional charter to advise the federal government on mat-
ters pertaining to science. OTA is a branch of the US. Congress, estab-
lished to advise congressional committees on technical issues in all areas of
science and technology. Both IOM and OTA have issued reports on a
variety of ethical issues over the past 20 years, including health care re-
source allocation, genetic research, life-sustaining technology, and the re-
sponsible conduct of research. Both organizations have been sought to
advise on complex ethical issues because of their ability to convene well-
informed and impartial study committees.

8 SOCIE’I‘Y’S CHOICES

Deliberation about ethical issues arising from developments in bio-
medicine also takes place at several research and educational centers
throughout the world devoted speciﬁcally to the study of ethics. Ethics
centers such as the Hastings Center and the Kennedy Institute of Ethics
inﬂuence policy development in the area of ethics through conferences,
publications, and educational programs. In addition, experts in ethics
from these centers are frequently called upon to serve on the boards of
academic institutions, research centers, professional societies, and non-
proﬁt organizations, as well as journal editorial boards. The Clinton
administration’s task force on health care reform provides a recent ex-
ample ofa public policy activity in which experts in ethics were called upon
to participate in national bioethics deliberation. Together, hundreds of
bioethics organizations around the world comprise a remarkable resource
for policy-making, analysis, consultation, and education in medicine and
the life sciences.

Religious bodies, including interfaith and ecumenical bodies, have also
examined the import for religion of developments in biomedicine. In
recent years, North American religious groups have produced some care—
fully researched reports on ethical issues in biomedicine; the Presbyterian
Church’s report on values and choices in health care is one example.
Professorships in religious ethics have been established at several universi—
ties and a number of centers have been created for the study of religious
ethics. The sheer number of indiw'duals and groups now working on these
issues offers some encouragement that useful modes of discourse may be
developed, and that a variety of religious perspectives will be a constructive
part of public deliberation on the ethical consequences of advances in
biomedicine.

Individual and Community Responses

Individuals, groups, and communities are often spurred to action in
the wake of changes brought about by developments in biomedicine. Their
efforts often begin as loosely structured, grassroots organizations. These
organizations frequently come into being as a result of a perceived crisis—
over abortion, over concerns about justice in clinical trials—as did the
National Abortion Rights Action League, the National Right to Life Com—
mittee, and the AIDS Coalition to Unleash Power (ACT-UP). Grassroots
organizations often inspire the loyal support of individuals who have little
else in common other than their interest in resolving the crisis. The broad-
based citizen-sponsored forums on health care that have taken place in
recent years in Vermont, Maine, California, and Oregon provide addi-
tional examples of community—based bioethics deliberation. The work of
grassroots bioethics organizations has had a particularly signiﬁcant impact

EXECUTIVE SUMMARY 9

on public awareness of social and ethical issues raised by biomedical devel-
opments, as well as on public policy.

CRITERIA FOR SUCCESS

The committee developed an approach to evaluating the outcomes of
public ethics bodies.l These criteria apply particularly to those delibera-
tions that lead to issuance of a document or report. While certain general
criteria can be articulated, their importance for evaluating a particular
public ethics body is crucially dependent upon context, including the na-
ture of the controversy, the specific tasks of the body, the social setting, the
legal environment, and the like. Notwithstanding this caveat, it is still
possible to develop a number of important criteria that could be used in
establishing, participating in, or judging the overall performance of public
ethics bodies. The following discussion divides these criteria into three
categories: intellectual integrity, sensitivity to democratic values, and effec—
tiveness. As we shall see, however, there is a considerable amount of over-
lap and interplay among these categories.

In offering a list and discussion of criteria for judging the success of
public ethics bodies, the committee does not mean to suggest that the
business of evaluating the performance of these bodies might be reducible
to some sort of perfunctory checklist. Often, public ethics bodies must
grapple with extremely controversial and contested issues that involve our
most fundamental individual and social values. The judgments that people
bring to bear on the work of these bodies will naturally reﬂect their differ-
ing views on these fundamental controversies concerning life, death, and
justice.

Intellectual Integrity: Logic, Scholarship, and Sound Judgment

Logic

Logic is the first prerequisite of a successful product from a public
ethics body. At issue here are the soundness of the reasoning and the
overall coherence of the document. Does it describe the topics and issues
clearly? Do the conclusions, including the policy recommendations, follow

1 The term “public ethics body” is used in the report to denote a group convened to
deliberate about social and ethical issues stemming from developments in biomedicine. Such
groups may exist at the level of the institution, professional society, community, state, federal
agency, or federal government. Generally, these groups address public policy issues that
involve moral ideas such as dignity, freedom, rights, fairness, respect, equality, solidarity,
responsibility,justice, and integrity.

10 SOCIETY 's CHOICES

logically from clearly stated premises, or are they simply announced on the
presumption that the authority or prestige of the body will carry over to its
conclusions? Does the document present coherent arguments and recom-
mendations, or is there unresolved contradiction between various parts of
the report?

A related function of public ethics bodies is to help clarify, through
logical analysis, the terms and nature of the debates covered in their re-
ports. These bodies can often help to fully distinguish the various disciplin-
ary perspectives on an issue, e.g., theological, ethical, economic, political,
legal, medical, biological, and epidemiological.

Scholarship

Scholarship is another important dimension of intellectual integrity.
The work of public ethics bodies must not only be coherent, it must also be
competent—that is, based upon the soundest available scholarship. This
means, ﬁrst, that the body‘s “findings” must be grounded upon solid, em-
pirical, state-of-the-art information about the relevant area of technological
innovation. Although it is reasonable to seek a broad range of cultural,
professional, ethnic, and ideological diversity for membership, it is vital
that the staff and members of these bodies possess the required expertise
in ethics, law, medicine, biology, or related ﬁelds. If the membership or
staff lacks this technical knowledge, it must consult with appropriate ex-
perts and seek out empirical studies bearing on the topic at hand.

Secondly, reports of public ethics bodies should reflect a thorough
knowledge of the interdisciplinary field of bioethics. In addition to being
factually accurate and well reasoned, such reports should be based upon an
equally state-of-the-art understanding of the public and professional “con—
versation" surrounding a particular issue. The reasoning and conclusions
of the report should reflect an awareness of“the best that has been thought"
in the bioethical literature,journals of opinion, newspapers, and the like.

Sound judgment

Soundjudgment is also an important element—albeit less tangible and
more controversial than logic and scholarship—of the intellectual integrity
of public ethics bodies. Because ethical consideration is often complicated
by uncertainty, lack of information, and conflicting values and principles,
soundjudgment in this area resides not so much in being able to apply a
single ethical theory or principle to a set of facts, as in the ability to discern
the unique particularities of the problem in its social setting, to creatively
reframe a question, to reason by analogy, to perceive and acknowledge the
interests of affected parties, and tojudiciously weigh and balance compet-

EXECUTIVE SUMMARY 1 1

ing principles and considerations. We call “judicious" those reports that
strike an appropriate and fruitful balance between the relevant rights and
interests, disciplinary perspectives, and cultural traditions of a given society.

Sensitivity to Democratic Values:
Respect, Representation, and Openness

Respect for Affected Parties

Public ethics bodies should be attentive to all the signiﬁcant contribu-
tors to the public conversation about an issue. Rather than focusing on
and advancing their own preferred approach to a problem, members and
staff should make an honest attempt to hear all plausible, responsible
views. Public ethics bodies should be particularly attentive to minority or
disenfranchised voices, not only because these voices can enrich public
discourse, but also because they may speak to concerns about religion,
culture, and individual rights that ought to be respected, so far as possible,
by public policy.

Representation of Diverse Views

Public ethics bodies’ consideration of the interests of affected parties
should manifest itself not only in the solicitation of input from these par-
ties, but also in the presence of representatives of (or advocates for) these
parties in the bodies’ membership. Representatives should be willing to
deliberate in an open-minded fashion and not merely to champion their
group’s initial position.

Open versus Closed Meetings

The holding of open meetings by public ethics bodies is intuitively
more consonant with democratic values than is the holding of private,
closed meetings. Open meetings do not allow for the crafting of secret
deals. Rather, they generally foster the effectiveness of public ethics bodies
by providing an open forum for exchange of ideas and information among
interested parties, all of whom are accountable for their positions.

On the other hand, those who argue that public ethics bodies should
operate in private, at least occasionally, note that confidentiality fosters
mutual trust and candor among members and staff. When people come
together to discuss complex issues, they often require a good deal of intel-
lectual elbow room in which to change their minds once confronted with
compelling counterarguments. Proponents of closed meetings argue that
it is easier to modify one’s position in private than in public, where flexibil-

12 SOCIETY’S CHOICES

ity and openness to new evidence might be wrongly interpreted as feckless-
ness and inconsistency. Many of the issues addressed by public ethics
bodies represent problems that have been generated in part by the pres-
ence of strongly held, conﬂicting views within society. If complete consen-
sus is not possible on an issue, resolution may require compromise, a pro-
cess that some believe can be more successful when undertaken in the
absence of publicity. If a public ethics body holds closed meetings, it
should make every effort to solicit the views of interested parties during the
process of data gathering.

Effectiveness: Communication, Authority

judgments about the effectiveness of a public ethics body must be
based upon a clear understanding of the group’s purpose, the public need
to which it responds, and the social context in which it deliberates. Not-
withstanding the importance of purpose and context, the committee notes
two preconditions of effectiveness for any group regardless of its speciﬁc
charge: communication and authority.

Communication

The reports of public ethics bodies must be clearly written, trenchantly
argued, and comprehensible to as wide an audience as possible. Reports
should also reﬂect a clear understanding of the makeup of their audiences;
reports that respect the sensibilities of their readers will be more persua-
sive, and hence more effective, than those that do not. Even the most
clearly written and persuasive reports can fail to be effective, however, if
they are not disseminated to as broad an audience as possible. Adequate
numbers of reports should be printed and made available at reasonable
prices to consumers, professional groups, and public libraries; newer meth—
ods of dissemination, such as computer networks and CD ROMS, should
also be explored. Members and staff should consider discussing ﬁndings
and recommendations through a wide variety of media, including newspa-
pers, editorial columns, book reviews, radio interviews, professional jour-
nals, and public and professional forums. If a public ethics body proposes
new legislation, its staff and members should attempt to educate members
of the legislature about the issues and about the body’s views.

Authority

The effectiveness of a public ethics body is enhanced when it is viewed
as an authoritative body—one whose recommendations carry weight with
policymakers, professionals, and the general public. Authority can be be-
stowed through sponsorship by an authoritative ﬁgure like the president.

EXECUTIVE SUMMARY 13

It can also be earned through, for example, the individual reputations of
members and staff or a successful history of accomplishment. Authority
can also be a function of democratic representation; the recommendations
of a public ethics body may be perceived as authoritative if it is clear that all
viewpoints have been heard.

Different Goals, Different Yardsticks of Success:
Achieving Consensus, Achieving Results

The primary function of many public ethics bodies is to achieve con-
sensus on issues that require some sort of public response. Thus, whatever
may be the speciﬁc goals of a particular body, achieving consensus will
usually be an explicit policy objective. Consensus can be instrumental in
obtaining external acceptance and implementation of a body’s recommen—
dations, especially (and, some may argue, only) when members of a public
ethics body bring to the deliberations an array of different viewpoints on
an issue. On the other hand, consensus can be used to obscure deep
philosophical issues. Excessive pressure to reach agreement may lead to
underestimation of risks and objections, ignoring of unpopular viewpoints,
or failure to consider alternatives or additional information.

Social and political circumstances play a signiﬁcant role in determin-
ing not only the value of consensus, but also the possibility of achieving
consensus in any form. A particularly salient factor in public ethics delib—
eration is the “ripeness” of the issue in question for public resolution. In
some cases, a body might merely have to place its imprimatur on a consen—
sus that has been gradually building and is now more or less in place. More
frequently, however, public ethics bodies are faced with the harder task of
forging a consensus that does not yet exist.

Apart from the ob'ective of forging consensus, public ethics bodies
may also seek to achieve more speciﬁc goals such as education, inﬂuencing (——
of public debate, and stimulation of various government actions, including
legislation. Public ethics bodies should successfully discharge the speciﬁc
mandates that they are given. If a body fails to do what is asked of it, it
cannot be judged a success. Depending on the circumstances, some spe-
ciﬁc objectives may be more difficult to achieve than others. Articulating
the contours of an emergent consensus for educational purposes, while a
demanding and important task, is not nearly as difficult as drafting legisla-
tion on controversial topics for a population divided by ideological and
religious differences. Assessments of a body’s accomplishments should
consider the difficulty as well as the nature of the project assigned to it.
Educational projects should be judged in part according to pedagogic
standards, while judgment of legislative efforts should reﬂect the quality of
the legal craft presented.

14 SOCIE'I‘Y’S CHOICES

Can Bioethics Be Disadvantageous?

Although there has been no systematic research on the downside of
public bioethics deliberation, the committee found it useful to identify two
potential risks of public bioethical deliberation, if only as a suggestion for
future research, evaluation, and monitoring. One such risk is diversion
and capture by advocacy or sectarian groups, or by ﬁnancially self—inter-
ested parties. To the extent that such factions could inﬂuence or capture
a body charged with the task of bioethical deliberation—a task that aims at
impartiality—they could undermine the public interest. While the energy
and knowledge of advocacy groups can be an important asset to bodies
engaged in bioethical deliberation, the possibility for capture, diversion,
and conflict of interest in bioethical deliberation must be carefully moni-
tored. This caution may be particularly important in deliberations regard-
ing health care reform, where ethical and ﬁnancial considerations are
inextricably linked.

Another possible risk associated with public bioethical deliberation is
that some might expect bioethics to deliver something—answers, certainty,
or the morally correct view—that it is not equipped to produce. It must be
clear that “ethical analysis” is not a single, straightforward method, like
algebra or geometry. Different ethicists favor different approaches and
methodologies and claim different philosophical antecedents. Moreover,
even if there existed a single logical formula for ethical argument, such a
formula could not account for the substantive elements of ethical argu-
ment that arise from individuals’ deeply held values and norms, which are
colored by culture, religion, heritage, personal history, preferences, and
tastes. Ethicists can often do little more than ask for clariﬁcation about the
meaning of these values and norms in the minds of those who hold them,
attempt to discover when the values and norms arise from misunderstand-
ing, and invite those who hold them to ﬁnd practical ways of living to
gether. The best conclusion of an ethical analysis may be the description :
of alternative views. Thus, while this committee believes that more good
than bad can come from public moral discourse, it also recommends pru—
dent caution whenever an ethical analysis ofa major problem is proposed.
Broad representation of distinct. opinions is probably the best antidote.

CONCLUSIONS AND RECOMMENDATIONS

In formulating its conclusions and recommendations, the committee
recognized that not all social and ethical quandaries that have confronted
society in the context of biomedicine have resulted from a single radical
change or the introduction of a unique new technology. While this is
certainly the case in some instances as in the recently reported cloning of

 

EXECUTIVE SUMMARY I 5

human embryos—social and ethical quandaries may also stem from devel—
opments that are rapidly integrated into medical practice before related
ethical issues can be resolved. In vitro fertilization (IVF) is an example;
many physicians employ the technology, which is no longer regarded as
new, despite the fact that IVF continues to challenge widely accepted un-
derstandings of parenthood and the legal status of the embryo and fetus.

Social and ethical quandaries may also arise when technological
changes or developments (that do not by themselves raise ethical ques-
tions) accumulate to present a novel circumstance that alters existing prac-
tices and beliefs. For example, the accumulation of several developments
in health care, such as immunizations and antibiotics that prevent or cure
infectious disease and arterial bypasses that avert death from heart disease,
have made it possible for people to live longer than ever before. Longer
life spans, however, have increased the incidence of chronic disease, which
in turn has provoked reflection on social and ethical issues related to death
and dying, the rationing of medical care, and the ends of medicine. Sig—
niﬁcant organizational changes—like the impending health care reform—
can also raise new ethical concerns. For example, it is likely that health
care reform will necessitate explicit ordering of priorities regarding health
resources as well as newjudgments about rationing of expensive medical
technologies.

A Multilevel Approach to Bioethics Deliberation

Ethical quandaries arise in the context of everyday interactions with
medicine as well as from vanguard research laboratories, and effective
mechanisms can be valuable at many levels to recognize and resolve social
and ethical quandaries in biomedicine. The committee therefore pro—
poses strengthening the multitiered system of public deliberation at local,
institutional, professional, community, state, and national levels and par-
ticularly recommends ﬁlling a key gap through reestablishing a supra-
agency ethics commission at the national level. The recommendation for a
multitiered system rests on the conviction that capacities for public ethical
deliberation (through academic experts, health professionals, religious
communities, secular agencies, and an increasingly informed and inter-
ested public) have blossomed in all regions of the country. At the same
time, certain contemporary ethical quandaries, including many ramifica—
tions of molecular genetic research, may best be considered for the nation
as a whole through a supra-agency national commission. The committee
presents two supra-agency models: a single national commission with a
broad mandate, and a set of national commissions, each with a more fo-
cused charge. The recommendations elaborate on the elements proposed
for the multitiered system and the features the committee deems desirable

1 6 SOCIETY’S CHOICES

for any new national commission. In general, the committee believes that
decisions about public policy should occur as closely as possible to the
levels at which relevant actions are taken, and should involve those likely to
be affected by the policy. The committee is not proposing a new focus of
policy-making authority, but a system, separate from existing political struc-
tures, for reﬂecting on and informing public policy decisions at all levels.

Nongovernmental Organizations and Individuals

Based on letters solicited by the committee from scientists and practi—
tioners in a variety of medical areas, the committee noted that those who
discover, develop, or apply new technologies in biomedicine are often well
positioned to recognize the potential for adverse social and ethical conse-
quences of these technologies. One of the most efﬁcient ways to initiate
deliberation of and responses to such consequences may therefore be to
call upon researchers, developers of technologies, and medical providers
who use new technologies to share their special knowledge of these tech-
nologies in ways that could facilitate awareness. Such avenues might in—
clude publications and professional presentations; perhaps inquiry about
such consequences could even be made part of grant applications. The
more that it becomes the norm for consideration of these issues to be part
of scientiﬁc investigation, the greater would be our society’s capacity to
catch problems in their early stages and address them more effectively.

The committee recommends that the people or organizations that con-
duct, fund, and commercialize research, as well as those medical pro-
viders who apply new technologies, establish a formal capacity whereby
they can participate in public moral discourse about the ethical impli-
cations of developments in their field. They should attempt to antici-
pate how these developments may affect society for better or worse
and to prepare ways in which adverse effects on social values can be
prevented.

The committee recommends that the National Institutes of Health
provide funding mechanisms to support (1) the exploration by indi-
vidual investigators of social and ethical aspects of biomedical tech-
nologies as they are developed and (2) the creation of a social and
ethical knowledge base for all of biomedical science (e.g., extend the
ELSI program to other institutes and other programs within the NIH).

Professions exist as part of a societal contract that grants learned ex-
perts a certain latitude of discretion and self-control in return for the
expectation of service to the public. In addition, the resources used to
support biomedical innovation and development are generated by the com-

EXECUTIVE SUMMARY 1 7

munity, largely through governmental support of research. These eco-
nomic considerations support a role for professional organizations in bio-
ethics deliberations.

The committee recommends that organizations of biomedical profes-
sionals establish ethics committees that can be easily mobilized to re-
spond to social and ethical issues as they are identiﬁed. Collaboration
among professional associations dealing with related issues is to be
encouraged.

The committee recommends that professional associations, including
those for health care providers and biomedical scientists, recognize
their special obligation to investigate the ethical implications of bio-
medical developments and advocate for the interests of the public and
of patients, especially when those adversely affected by change are
unable to advocate for themselves.

The committee believes that hospital ethics committees or similar com-
mittees operating across health plans could help patients and health care
professionals deal with social and ethical quandaries arising from develop-
ments in biomedicine. However, little is known about the range and char-
acteristics of effectiveness of HECs. This knowledge needs to be expanded
so that it can be applied in the design and evaluation of similar ethics
committees that may accompany health care reform.

Preliminary evidence indicates that hospital ethics committees provide
many useful support functions for staff, patients, and their families
relating to the handling of social and ethical issues that arise from
developments in biomedicine. The committee nevertheless recom-
mends that formal studies of the optimum roles, use, and outcomes of
HECs be undertaken by such groups as the Office of Technology As-
sessment, Institute of Medicine, and foundations interested in health
care issues.

Like HECs, institutional review boards have played a signiﬁcant role in
the democratization of social and ethical decision making in biomedicine.
Given the continuing importance of IRBs, the committee believes that the
present structure and role of these bodies should be evaluated and, if
necessary, modiﬁed.

The committee believes that the NIH, in conjunction with other fed-
eral agencies (such as the Food and Drug Administration) to which
IRBs relate, need to carefully examine the IRB system and assess
whether it is functioning well. Some questions that could be assessed
include:

1 8 SOCIETY 13‘ CHOICES

1. Are IRBs successfully representing the interests of human sub-
jects in research and not merely those of their sponsoring institution?

2. Do IRBs generally fulﬁll their goals?

3. What lessons can be learned about effective IRB function from
the wide variation in actual IRB practices, and should greater unifor-
mity be encouraged?

4. Would communication among different IRBs facilitate effective
functioning?

5. Are there adequate forums for the appeal of institutional rulings
or for resolution of issues that an individual IRB cannot easily address?

6. How do freestanding IRBs operate, especially with respect to
conflict-of-interest considerations?

The committee believes that improved integration of social and ethical
concepts into health professional education is needed, particularly in the
training of students in basic and clinical research. The committee believes
that it is important for health care providers and research scientists to be
part of the process of examining the social and ethical dimensions of
science and technology because: (1) the tradition of openness and internal
criticism found in science could fruitfully be extended to the deliberation
of ethical issues; (2) biomedical scientists and medical practitioners, due to
their understanding of the use of technology as part of the practice of
medicine, might have special insight into related ethical issues; and (3)
scientists may facilitate the discrimination between factual and value—laden
components ofscientiﬁc belief.

The committee recommends that an evaluation be undertaken of the
process of education for graduate students in the health sciences on
the social and ethical implications of technology as part of the current
educational efforts on scientific responsibility. The committee also
urges increased efforts to integrate social and ethical issues in bio-
medicine into the curriculum of undergraduate and graduate health
professional programs.

States

The committee believes that states must play an active role in deﬁning
a capacity for ethical deliberation, particularly in a reformed health care
system. State governments might facilitate public ethical deliberation
through their oversight of professional certiﬁcation, medical practice,
health care ﬁnancing, and legal liability. Examples of issues that might be
addressed at the state level include the use of reproductive technologies;
laws and regulations concerning the “definition” of death and forgoing
life-sustaining treatments; the practice of assisted suicide and active eutha-

EXECUTIVE SUMMARY 1 9

nasia; public health measures involving screening, contact tracing, and
quarantining for infectious diseases; screening programs to detect either
the presence of genetic disease or susceptibility to diseases such as cancer
or heart disease; and the procurement and allocation of organs for trans-
plantation. State mechanisms may be effective at shaping a consensus into
the particular legislative form that is appropriate for and acceptable to
citizens of a particular state (i.e., one that reﬂects local conditions, con—
stituencies, historical traditions, and legal requirements).

The committee does not recommend a single specific mechanism for
public deliberation of ethical issues at the state level, nor does it recom-
mend a formal institutionalized response in each of the 50 states. Some
states may want to establish their own ethics commissions, as has New York.
Other states lacking the resources or breadth of representation for such
undertakings may wish to cooperate with neighboring states to form re-
gional ethics commissions or information exchange programs.

The committee recommends that states foster or participate in a pub-
lic deliberative process for responding to social and ethical quandaries
stemming from technological and organizational developments in bio-
medicine and health care.

Advisory Bodies in Federal Agencies

The committee perceives a need for a permanent ethics staff within
governmental agencies. Ethics panels located within, and related to, spe—
cific agencies have provided valuable advice to these agencies in the past.
The committee strongly supports the reestablishment of a body similar to
the Ethics Advisory Board because the tasks assigned to it in its originating
regulation are not being accomplished at present and constitute a national
need and a missed opportunity for leadership in this area.

The committee recommends the establishment of a deliberative capac-
ity within relevant government agencies and departments to provide
advice on issues relating to biomedical research and applications of
biomedical technology. The committee strongly recommends that as a
ﬁrst step, the Ethics Advisory Board or a similar body within the De-
partment of Health and Human Services be reestablished.

A Supra-agency Commission

For certain issues of broad national interest the committee finds it
highly desirable to have a supra-agency national commission to address
these issues as they concern the broad public interest and span multiple
governmental agencies. At the present time there are several issues that

20 SOCIETY'S CHOICES

might be incorporated into the mandates of one or more national commis—
sions, including: (1) issues related to scientiﬁc advances in genetics, includ—
ing new possibilities for shaping future generations and the impact of
genetic knowledge on peoples’ insurability and employability; (2) issues
related to conﬁdentiality and privacy of medical information, especially in
light of health care reform; (3) the interplay of serious disability and life-
sustaining treatment, as well as discrimination on the basis of disability; (4)
the integration of cost and social and ethical considerations into clinical
and allocation policy decisions; and (5) issues related to reproductive tech-
nology and research and medical treatment of embryos and fetuses.

A high-level commission has several institutional advantages over lower-
level bodies, including greater visibility, prestige, and independence, as
well as greater capacity to address a broad mandate. A national body is also
in a better position to formulate and represent distinctively American views
on bioethics at a time when issues relating to biomedical research and
applications are becoming increasingly internationalized.

The committee recommends that the federal government establish a
public deliberative body (or bodies, depending on the breadth of the
mandate to be addressed) for a limited term at the supra-agency level
to consider social and ethical issues stemming from technological and
organizational developments in biomedicine that are of concern simul-
taneously to several governmental agencies or are nationwide in scope.

In the event that one or more national ethics commissions are estab-
lished, the committee recommends that each have the following at-
tributes:

Mandate. The body must have a broad yet clearly deﬁned and coher-
ent mandate, as well as the ability to add additional related topics as
they become salient.

The committee was unable to reach consensus regarding the appropri-
ate breadth ofa national commission’s mandate. The majority of commit-
tee members believe that it is no longer feasible for any single national
commission to address all aspects of social and ethical issues in biomedi—
cine, since the expertise and experience that such a broad mandate would
require could not be encompassed in a membership of reasonable size.
These committee members propose that a national commission’s mandate
include a set of related social and ethical issues. Commissions with a
mandate to address interrelated issues will ordinarily have an easier time
studying and resolving subsequent issues after they have reached conclu-
sions in one area. Ifa national commission were to have a mandate limited
to a deﬁned set of related issues, it is possible that more than one national
commission would be necessary at any one time.

EXECUTIVE SUMMARY 21

A second group of committee members believed that a single national
commission with a broad mandate was preferable if sufﬁcient time and
funding were available to hire staff and commission background papers to
encompass all of the appropriate expertise needed. In this case, commis-
sion members could be generalists, and background papers and staff re-
search would play a far more critical role than in a commission with a
thematic mandate.

Sponsorship. National commissions could be appointed by the presi-
dent or Congress. Wherever located, each national commission should
operate autonomously.

Both the perception and reality of independence are important to the
credibility of a commission’s recommendations. In spite of appointment
by the president or Congress, a national commission needs insulation from
short-term political interests at the same time as it needs strong ties to
affected or vulnerable groups, consumers, and public interest groups.

Membership. Each national commission should have a diverse member-
ship in order to represent the points of view of all those concerned
with or affected by the social and ethical issues to be considered. The
composition of the body should enhance the qualities of impartiality.

Public media coverage can help to educate the public about the delib-
erations ofa national commission. Public meetings can also facilitate broad
public involvement.

Public Access. To the extent possible, a national commission should
deliberate in public. The committee recognizes that if such public
deliberation is not possible, means need to be found to gain input
from all persons and groups with interests in the deliberations. A
national commission must reach out to segments of the population
whose voices are less regularly heard.

Commissions at all levels should take speciﬁc steps to assure that the
results of their deliberations are made accessible to the public. In addition
to the use of newspaper and radio, thought needs to be given to how newer
methods of information transmission (e.g., electronic means) might be
utilized to communicate commission conclusions.

Advisory Role. A national commission should provide advice not only to
its authorizing body but to all concerned parties, including the bio-
medical community; federal, state, and local governmental bodies; and
the public.

Action-Forcing Powers. Although a national commission should be advi-
sory, its recommendations should be published, and relevant federal
agencies should be required to respond to the recommendations within

22 SOCIETYIS‘ CHOICES

a defined “comment period” (e.g., 180 days), either by adopting the
recommendations or by explaining why they are not being adopted.

Funding and Staff. A national commission should be given adequate
resources and staff to accomplish its task. It should be funded by
direct appropriation to ensure its independence. It should have au-
thority over its own budget and the hiring and firing of its staff.

Duration. The commission should have a defined term that is adequate
to allow for achievement of assigned tasks.

In determining the duration of a national commission’s term, consid-
erations of timeliness, as well as commission members’ abilities to maintain
energy and concentration of focus come into play. Committee members
favored two different possibilities: (I) the term of the commission could be
approximately three years, with commissioners serving for the entire term,
or (2) the commission could have a longer term, with rotating appoint-
ments that replace one-third of the membership every two years. Propo-
nents of shorter—term commissions noted that the existence of a date by
which work must be completed can result in a high level of productivity
and that shorter-term commissions are less likely to become overly bureau-
cratic in their work approaches. Those who argued for longer-term com—
missions pointed to considerations ofefficiency of group interaction, con-
sistency, and credibility.

The majority of committee members favored commissions with ﬁxed
lifetimes. The majority also believed that a mechanism should be created
for initiation of new commissions to consider future issues as they arise.
Some committee members favored the idea of a fixed-term national com—
mission with a “sunset clause," which sets an initial date for termination but
permits extensions of the commission’s term if the issues it is addressing
merit further attention.

Ifa national commission has a fixed term, then the value of continuity
and the “learning curve" favor a fixed membership. If a national commis-
sion has a sunset clause, then a rotating membership with staggered terms
seems advisable, in part as a means to ensure diversity of views and avoid
bureaucratic narrowing of the group’s collective vision.

If a term-limited national commission is appointed, the committee
recommends that responsibility be located within some existing gov-
ernment locus for ongoing monitoring/ reporting on social and ethical
issues in biomedicine and for recommending the appointment of new
commissions as serious issues of national scope emerge. This respon-
sibility could be located in the Office of Science and Technology
Policy, the Office of the Secretary of Health and Human Services, or
at some other location chosen by the president or Congress.

EXECUTIVE SUMMARY 23

The committee believes that, during times when no national commis—
sion is functioning or when issues arise at an agency level but remain
unaddressed, a continuing surveillance mechanism should be in place to
identify developing unsolved problems that require more focused atten-
tion. A governmental locus for such monitoring could provide several
speciﬁc functions: it could commission or prepare a biennial report to be
published in the Federal Register on social and ethical issues emerging from
biomedical technology; it could serve as a receptor for the input ofcommu-
nities, individuals, institutions, and states that identify issues that need to
be addressed in a broad fashion; it could facilitate networking among the
various groups addressing social and ethical issues; and it could advise the
executive branch about special social and ethical issues that need immedi-
ate attention. Most of the committee members felt that this function could
be accomplished in an existing governmental office without increasing the
bureaucracy by creating a new ofﬁce. A few of the committee members
favored having an external advisory committee, related to the governmen-
tal locus, that is charged with identifying issues to be dealt with at a depart-
mental or across-departmental level, developing mandates, and nominat-
ing commissioners.

PART I

Introduction

During the past 30 years, the study of ethical issues in the life sciences
has become a public concern, debated in the press and, increasingly,
guided by governmental commissions, professional societies, and commu-
nity organizations. The issues have sometimes demanded public attention,
as have cases of the abuse of human research subjects, and, at other times,
more gradually raised public concern, as have the possibilities provided by
advances in genetic technology. More and more, the ethical implications
of such issues as health care delivery and commercialization of biotechnol-
ogy are being pursued in a public fashion. The recent Clinton administra-
tion task force on health care reform involved ethicists as consultants; the
ethical aspects of academic-industry relationships in the biotechnology in—
dustry was the subject of recent congressional hearings. Despite the in—
creasing activity in this area, however, there has been little systematic study
of the various collective processes through which we subject these ethical
and social issues to debate and analysis. In an attempt to delineate the
elements of these processes as they are practiced in this country, the com-
mittee found it useful to define more clearly one of the central notions of
this discussion—namely, ethical issues or dilemmas.

DEFINING “ETHICAL” ISSUES

The word “ethical" is often used interchangeably with the word “moral,”
although both words also have narrower and more speciﬁc meanings (e.g.,
“ethical” may refer to an issue such as conﬂict of interest in political set—

27

28 SOCIETY’S CHOICES

tings; “moral” may refer to an issue such as sexual conduct as well as very
broad and undeﬁned meanings referring to human values in general). It is
difﬁcult, perhaps impossible, to deﬁne precisely what these words mean.
Often the deﬁnitions one ﬁnds in the ethics literature deﬁne ethics and
morality in terms of values, moral principles, virtues, and the like, terms
that are in turn deﬁned in terms of ethics and morality. Even if we assume
that we share a common, intuitive understanding of these terms, moreover,
it is not clear how we come to view a given issue or question as an ethical
one. For example, cloning a human being is viewed as an ethical issue
whereas international trade agreements typically are not—even though
both involve moral choices and affect the vital interests of Americans.

Nearly every public issue requires moral judgments in its resolution.
These judgments may be visible or invisible, explicit or implicit, addressed
as such or ignored. Thus it is not particularly helpful to decide which
public issues are inherently “ethical.” However, we can usefully distinguish
between issues that are discussed and resolved with reference to the ethical
questions they pose and issues debated on other grounds. The former are
those discussed in terms of moral ideas, such as dignity, freedom, rights,
fairness, respect, equality, solidarity, responsibility, justice, and integrity.
Some of these are personal virtues, others are features of social life; some
are powers, others ideals. What they have in common is that they are
mentioned when one tries to speak of right and wrong, and that they are
invoked in discussions that go beyond assertions about facts and descrip-
tions of events to claims about why things ought to be done in certain ways
or what ought to be done.

Perhaps there exist (or once existed) societies in which a single code of
morality is so universal and so comprehensive that its members know right
from wrong in every situation without need of debate and deliberation.
Ours is certainly not such a society. Americans often disagree about stan—
dards ofjustice, conceptions of fairness, and the requirements of integrity;
and even when they agree they may still not apply these concepts in the
same way to a given subject. Moreover, they may disagree over the facts of
the case to which moral standards are to be applied. The discussions and
debates that ensue are “ethics” discussions and debates. They form an
important subset of the social choices that we routinely confront.

Some “ethical issues” consist in deciding how to react to a moral out-
rage or scandal. In these cases there is virtual unanimity on the wrongness
of what has occurred and no moral argument is needed. Other “ethical
issues,” however, represent genuine quandaries. With these issues the
answers are unclear; they provoke moral disagreement, whether between
people or in the form of ambivalence or uncertainty in the mind of indi-
viduals. The creation of the Ethical, Legal, and Social Implications (ELSI)
Program of the Human Genome Project, for example, was stimulated by

INTRODUCTION 29

genuine uncertainty about the possibilities brought about by new capabili—
ties in genetics. While some perceived new genetic technologies to be
encroaching on sacred territory—our identity as humans—many others
focused on the potential of these same developments to end suffering from
gene-linked diseases and disabilities.

People who disagree over ethical issues can attempt to ignore their
differences or to outﬂank or overpower their opponents. Or they can seek
to expand their understanding and perhaps reach agreement or compro-
mise through open discussion and rational moral deliberation, investiga-
tion, and argument. This is the potential role of bioethics debates, whether
undertaken between neighbors concerned over a personal experience in
medicine, or between clinicians perplexed by the moral dimensions of a
case, or among presidential appointees to a bioethics commission.

One hallmark of moral deliberation is its ideal of impartiality. Ethical
deliberation should be distinct from the pursuit of self-interest; it should
also be different from advocacy. Each person, when he or she takes the
moral point of View, is supposed to put aside self-interest and the emotions
of the moment. Though our cultural, psychological, and religious differ-
ences may create some barriers to common agreement, each of us expects
the considerations and arguments that lead us to our positions on moral
issues to be plausible to other reasonable people who deliberate on these
same issues. For example, when we oppose experiments on unconsenting
human subjects, we argue that the subjects” right of self-determination is
violated, and we expect others to agree that these rights exist. If not, we
marshall arguments in support of that proposition, and again appeal to
considerations that we expect to be persuasive to those who disagree with
us. There is no guarantee that unanimity will be reached, nor even that any
consensus that emerges will be well advised and without error. Yet there is
widespread agreement on the rules of procedure in ethical argument. Few
would be persuaded by a person who backed up a claim about right and
wrong by an appeal to personal tastes, feelings, or preferences, for none of
these have the essential quality of impartiality.

Our society’s capacity for dealing humanely and wisely with the impact
of technological and scientiﬁc innovation is enhanced by the creation of
forums in which this kind of impartial deliberation can be carried out.
This deliberation may draw on many resources: actual experience in the
use of these technologies and in the practice of medicine; the personal
values and life experiences of participants; bodies of formal analysis, such
as economics and the law, which reﬂect and systematize moral judgments;
and, not least, the intellectual and scholarly resources of the ﬁeld of ethics.
This report emphasizes the wide variety of settings in which these delibera-
tions are occurring and the diversity of intellectual resources that can be
brought to bear on public moral discourse.

30 soelr'rys CHOICES

SOURCES OF ETHICAL ISSUES IN BIOMEDICINE

The tasks of ethics bodies convened to address issues in biomedicine
have originated from clashes of values, norms, principles, and practices
that have occurred in a number of arenas, especially: biomedical research
involving human subjects; health care decision making, delivery, and fi-
nancing; advances in medical diagnostics and therapeutics; and academic-
industry relationships in biotechnology. From these spheres have come
new technologies, the proper use ofwhich is controversial; allocation crises
and perplexing questions of distributivejustice; changes in the organiza-
tion and delivery ol‘health care and concerns about the appropriate role of
physicians; and financial and policy incentives that have spawned new rela-
tionships of questionable appropriateness between researchers and their
sponsors. It was in the sphere of human studies research that the ethical
dimensions of biomedicine and the need for public involvement in defin-
ing these dimensions was first recognized.

Biomedical Research Involving Human Subjects

The use of human beings as research subjects has ancient roots. The
Hippocratic tradition recognizes the uncertainty of medical practice. In
the famous Hippocratic aphorism, “Life is short, the art long, experience
ﬂeeting, experiment perilous,judgment uncertain,” there is an awareness
that innovative practice carries dangers. Yet no explicit discussion of the
ethical dimension of experimental medicine is found in this literature;
little more is found in the literature of subsequent centuries.

Speciﬁc attention to this issue flowered in the mid—nineteenth century
through the work of Claude Bernard, who introduced techniques for com-
paring different treatment methods. In An Introdurlion to the Study ofExpeﬁ—
mental Medicine (1865), Bernard declared:

It is our duty and our right to perform an experiment on man whenever
it can save his life, cure him or gain him some personal beneﬁt. The
principle of medical and surgical morality, therefore, consists in never
performing an experiment which might be harmful to him to any extent,
even though the result might be highly advantageous to science, i.e., to
the health of others. But performing experiments and operations exclu-
sively from the point of view of the patient‘s own advantage does not
prevent their turning out proﬁtably to science.

This linkage of practice and science became crucial in the early twenti-
eth century as medical innovations made possible the noninvasive monitor-
ing of human functions. Inventions such as the blood pressure cuff, elec—
trocardiograph, X—ray, and blood chemistry using small quantities of blood,

INTRODUCTION 31

allowed scientists to monitor physiological functions without the required
invasive techniques that previously dictated the use of animals. Also, math-
ematical models and statistical techniques made possible discriminating
analysis of differences between treatments. In the 19205 and 1930s, it was
seen as appropriate for patient care to become a venue of scientiﬁc team-
ing, and for the line between treatment and experimentation to be erased.
At that time, Alfred Schwitalla, regent of the medical school at St. Louis
University, wrote: “The sick human being, it is true, is not a laboratory
animal, but neither is he so isolated in his human glory that he must
consider himself outside the possibilities of some, carefully controlled,
watchfully supervised experimentation” (Schwitalla, 1929).

The need to assert a clear distinction between practice and research
became apparent at the end of World War II. The heinous experiments
carried out during the war led to the enunciation of ethical standards that
proscribed scientiﬁc zealotry and the desire for social benefit at the ex—
pense of human consent and dignity. The Nuremberg Code of 1948 is
probably the most widely recognized of such declarations. Designed as a
standard by which to judge the actions of the perpetrators of the wartime
experiments, including the physicians involved, the code ﬁlled an impor-
tant void in the existing medical standards.

Consent of the subject is the linchpin of the Nuremberg Code. The
first principle of the code states: “The voluntary consent of the human
subject is absolutely essential” (Nuremberg Code, 1949). The code’s ten
principles establish a wall of protection for the subject and place indepen-
dent responsibility for avoiding harm to the subject on the shoulders of
investigators. The ethical principles enunciated in the Nuremberg Code
remain important guides for human experimentation today.

The Nuremberg Code stimulated additional inﬂuential statements on
the ethical use of human subjects in research. One such statement was
issued in 1953 by the Clinical Center at NIH. Titled “Group Consider-
ations for Clinical Research Procedures Deviating from Accepted Medical
Practice or Involving Universal Hazards,” these were the first federal guide-
lines for human studies research and the first ofﬁcial statement requiring
committee review of human studies protocols.

The Declaration of Helsinki, adopted in 1964 by the 18th World Medi-
cal Assembly in Helsinki, Finland, was another such statement. The decla—
ration speciﬁed that experimental protocols for clinical research should be
sent to a “specially appointed committee for consideration, comment, and
guidance,” making it the first international research guideline to address
the concept of independent review (Levine, 1986). The Declaration of
Helsinki included no mechanisms for enforcement of its guidelines, how-
ever, except for a recommendation that the results of research not comply-
ing with the declaration be rejected for publication. The ultimate duty to

32 SOCIETY’S CHOICES

serve as protector of human subjects of biomedical research remained the
physician’s.

Many observers assumed that these proclamations would be sufficient
to assure ethical behavior by physician investigators, but revelations in the
1960s of further abuses of human subjects made it clear that this was not
true. In 1966 came the news that researchers at the Brooklyn jewish
Chronic Disease Hospital had injected live cancer cells under the skin of
elderly patients to test immune competence. The patients had not given,
and in some cases could not give, adequate consent to participate in the
investigation.

Also in 1966, physician Henry Beecher gave a lecture (and later wrote
an article) that presented 22 research studies in which there were serious
problems related to the use of vulnerable, disadvantaged, and unaware
human subjects. In some of the studies the risks were not adequately
explained to the subjects; in others, subjects were not even made aware
that they were participating in an experiment. Beecher concluded, “It
must be apparent that they would not have been available if they had been
truly aware of the uses that would be made of them” (Beecher, 1966).

The controversy stimulated by these and other revelations led to a 1966
surgeon general’s ruling that required all medical institutions funded by
the Public Health Service to empanel human studies committees made up
ofscientists, clinicians, and lay members of the community. These commit-
tees had two major functions: (1) to evaluate whether the consent form to
be signed by subjects was complete and clear; and (2) to decide whether
the experiment could be conducted in a manner safer for the subjects, or
whether it was safe enough to be conducted at all. Human studies commit-
tees declared by their presence that biomedical research was a public en-
terprise, and that members of the public had important views to offer
about its ethical dimensions. The tasks of human study committees later
became further reﬁned with the promulgation of federal guidelines. In
1971, the Department of Health, Education, and Welfare (DHEW) issued a
publication entitled “Institutional Guide to the DHEW Policy on Protec-
tion of Human Subjects,” which contained detailed considerations ofinsti-
tutional review and informed consent requirements.

While the creation of research review committees raised public and
investigator consciousness about the ethical dimensions of biomedical re-
search, the revelation in 1972 of the Tuskegee Syphilis Study, an observa-
tional study of untreated syphilis in black men, begun in 1932, revealed the
need for even clearer guidelines and more forceful measures for compli-
ance. A now-infamous litany of ethical abuses characterized the study: no
informed consent was obtained from the participants, the men were steered
away from treatment even after the discovery in the 19408 that penicillin
could effectively treat the disease, and they were deceived into believing

INTRODUCTION 33

that they were receiving treatment when they were not. Congress con-
vened an independent panel that concluded that the Tuskegee Study was
highly unethical and should be immediately halted. The panel also de—
clared the protection of human subjects to be a widespread problem and
expressed concern that no uniform policy existed for the protection of
human subjects of federally funded biomedical research. Among other
recommendations, the Tuskegee panel advocated the strengthening of
guidelines regarding the review of research protocols by independent com-
mittees. These recommendations were reﬂected in formal policies pro-
mulgated in 1971 in the DHEW publication entitled “Institutional Guide to
the DHEW Policy on Protection of Human Subjects,” mentioned above.

In 1973, the Senate Committee on Labor and Public Welfare held a
series of hearings regarding human experimentation that included discus-
sion of such issues as research on human fetuses, sterilization of the men—
tally retarded, and use of prisoners (Senate Committee on Labor and Pub—
lic Welfare, 1973). The hearings received extensive television coverage
and further increased public awareness of and concern about ethical prob-
lems in biomedical research. There was considerable public outrage over
reports of fetal research, particularly over a research project that had been
conducted in Finland using the perfused heads of aborted fetuses. This
study, together with the Tuskegee study, was the stimulus for congressional
action on research ethics in the form of the National Research Act of 1974
(PL. 93-348).

The National Research Act established The National Commission for
the Protection of Human Subjects of Biomedical and Behavioral Research
(see Chapter 4 for more information on this commission). The National
Commission was charged to identify ethical principles that would guide
research on human subjects and to develop relevant guidelines for re—
searchers and institutions. The Act also formally established the require-
ment that research institutions must have an institutional review board
(IRB) as a mechanism for the protection of human research subjects (see
Chapter 3 for more information on IRBs).

Thus, during the 19705 and 19805, serious efforts were made to distin-
guish biomedical research from medical practice. The inherent possibility
of conﬂict between beneﬁt to the patient and beneﬁt to knowledge and
society has been acknowledged, and, groups like IRBs and commissions
have been entrusted to help investigators, research subjects, and society
decide how best to judge the trade-offs.

Recently, President Clinton appointed a 15—member Advisory Commit-
tee on Human Radiation Experiments to provide advice and recommenda-
tions on the ethical and scientiﬁc standards applicable to human radiation
experiments carried out or sponsored by the United States government
between 1946 and 1974. The group has been charged with reviewing

34 socm'rys CHOICES

several speciﬁc experiments about which questions have been raised con-
cerning whether subjects were treated properly. Composed of experts in
medicine, science, ethics, and law, the advisory committee will submit its
report in 1995. The rapid establishment of the advisory committee in
response to reports of potential past abuses demonstrates the capacity of
the federal government to respond to ethical issues.

Changes in Health Care

The seed that was planted in the public consciousness by abuses of
human research subjects would later sprout in other areas. The doctrine of
informed consent, central to the ethics of clinical research, was at the heart
of the movement in the 19605 and 19705 toward greater patient autonomy.
At the same time, medical technology began to ﬂourish and health care
began its transformation into the business-like enterprise it is today. The
resulting specialization, fragmentation, and depersonalization of health
care became sources of social and ethical quandaries of great concern to
individuals and the public.

Making Decisions About Health Care

Revelations that persons had been subjected to medical experimenta-
tion without their knowledge or consent led to great concern that similar
situations not occur in the context of medical practice. This concern was
directed not only at the potential for the recurrence of blatant abuse, but
also at routine questions of disclosure and decisional authority. The new-
found interest in greater patient autonomy posed a serious challenge to
the historical authority of physicians, who had previously seen patient par—
ticipation in medical decision making as largely discretionary. joseph
Fletcher‘s pioneering Morals and Medicine (1954) had urged physicians to
afford patients freedom of choice and “the fullest possible knowledge” of
the medical facts and available alternatives, but the true focus of Fletcher’s
book was on the dying patient’s “right to know the truth" (Faden and
Beauchamp, 1986). Physicians continued to consider it their professional
responsibility to make treatment decisions for patients, and even to employ
what has been called “benevolent deception” when communicating with
patients. An excellent account of the history of ethics in medical decision
making can be found in David Rothman’s Strangers at the Bedside (1991).

A cluster of legal cases in 1972 explored the issue of disclosure of
information by physicians to their patients and the implications of this
disclosure for patient self-determination. While traditional practice stan-
dards had permitted professional discretion to dictate what physicians told
patients, Canterbury v. Spence, Cobbs 1;. Grant, and Wilkinson 1/. Vesey chal-

INTRODUCTION 35

lenged these standards, claiming that even when a medical procedure is
skillfully performed, physicians may nevertheless be liable for adverse con-
sequences about which the patient was not adequately informed. The
decisions in these cases combined features of negligence and battery theo-
ries into a new approach to informed consent in the medical setting that
attempted a fairer balance between patients’ rights to self-determination
and the demands and complexities of both the physician—patient relation-
ship and the legal setting (Faden and Beauchamp, 1986). Partly as a result
of these decisions, the traditional model of medical practice, characterized
by paternalism and authoritarianism, eventually gave way to a new model of
informed consent, where the competent patient’s decision-making author—
ity became primary.

Ironically, the triumph of patient autonomy raised a new set of ethical
quandaries. Many clinicians fear that strict observance of patient autonomy
may override good medical judgment, encourage moral detachment on
the part of the physician, and even work against the patient’s best interests
(Brock, 1991; Pellegrino, 1993). Patient autonomy also raises questions
about increased public costs for expensive but not necessarily beneﬁcial
technologies, as well as about prolonging the quantity of life at the expense
of quality oflife. Empirical research in this area would enhance our under-
standing of the attendant ethical quandaries.

In addition to the changes in patient care engendered by a new em-
phasis on patient autonomy, the continuing technological revolution in
medical diagnosis and treatment has further altered the delivery of health
care and the relationship between patient and provider. Where the physi—
cian had once been viewed as omniscient, new medical technologies demy-
thologized the individual physician’s role. People began to View physicians
less as personal therapeutic forces than as accomplished wielders of tech-
nology.

Coincident with the growth of new medical technologies has been an
increase in specialization in the health establishment and the proliferation
of health care delivery “teams" to administer specialized care. It is not
always the physician who leads the team or has the initial or greatest con—
tact with the patient or client. For example, health maintenance organiza-
tions (HMOs) might assign a nurse practitioner or physician assistant as a
primary care provider or gatekeeper to specialized care, instead of a family
physician. A cardiac surgeon may lead both the preoperative and operative
teams, while a cardiologist and a cardiac nurse intensivist might lead the
postoperative aspects of care. All of these caregivers share in the responsi-
bilities for care ofa patient, but each may be distant from total accountabil-
ity for the patient’s welfare.

This arrangement has contributed to a sense of isolation on the part of
the patient. Sometimes, it seems that no one is in charge; that no one is

36 SOCIETY’S CHOICES

there to take overall responsibility; that everyone can, with some justiﬁca-
tion, feel that almost anything should be taken care of by someone else on
the extended team. Advanced technology and the increasingly complex
organizational styles it has engendered tend to isolate patients as human
beings atjust the time when and in the settings where their confrontation
with suffering and death may be most intense. The impersonal tone of
medical care and the surge in the medical expert industry spurred a grow-
ing discontent among patients as health care consumers (Reiser, 1993).

These developments, along with physician paternalism, set the stage
for the emergence ofa distinct patient rights movement in the early 19705,
a movement that primarily addressed patient rights in hospital care. In
1970, several consumer groups successfully petitioned the joint Commis-
sion on the Accreditation of Hospitals (ICAH) to redraft its standards to
address patients’ concerns. In 1973, the American Hospital Association
published the Patient Bill of Rights, the first explicit statement of the rights
of patients and the responsibilities of physicians and medical institutions.
Considered by many to be a landmark in the quest for patient autonomy,
the bill acknowledged patients’ rights to complete and current informa-
tion in terms that they can understand, to informed consent prior to treat-
ment, to refusal of treatment, and to be advised of and refuse to participate
in experimental treatments (American Hospital Association, 1973).

Other developments in the 19705 and 19805 further facilitated a grow-
ing acceptance of patient autonomy as the hallmark in both clinical deci-
sion making and research. The National Commission’s Belmont Repon
(1978) emphasized the need for informed consent and protections for
research patients in research trials. The commission’s work on informed
consent was later continued and applied more to the clinical treatment
context by the President’s Commission, two of whose reports dealt speciﬁ-
cally with the patient's right to informed consent and m‘th the right to
refuse life-sustaining treatment (President’s Commission, 1982, 1983).

In the last decade, the rights and concerns of patients have held a
central place in ethical and health policy discourse. Patient advocates are
now employed in many hospitals. State court decisions concerning the
right to refuse medical treatment have continued, culminating with a Su-
preme Court decision recognizing a competent refusal of treatment as a
constitutionally protected liberty (Cruzan 1). Director, Missouri Department of
Health, 1990). Physician-assisted suicide and euthanasia continue to stir
divisive national debate. The recent focus on outcomes research, and calls
for increased participation of consumer consultants and advocates in
health-care decision making and policy, are just a few examples of a grow-
ing trend to involve patient consumers in all levels of health care policy
(Reiser, 1993). Finally, the national debate on health care reform has
focused signiﬁcant attention on patient concerns and needs.

INTRODUCTION 37

The Health Care System: Financing and Structure

Over the past 50 years, the structure and ﬁnancing of health care has
changed in many ways: medical care once rendered by a personal physician
is now parcelled out among many specialists and often takes place in vast,
impersonal institutions. Its costs, once paid out of pocket by the patient or
even provided gratuitously by the physician, are now paid by insurers or by
government. In many respects, these changes are beneficial: specialists
may provide more skilled care, institutions may supply more sophisticated
technology, insurers may pay what the individual could not. At the same
time, these changes pose threats to the features of human life that we have
designated as ethical, such as individual rights, dignity, liberty, and fair-
ness.

The American hospital began as a charitable institution for the sick
poor and evolved into an institution that, relying on community support,
made its facilities available to those who could pay and those who could not
on a nonproﬁt basis. This was accomplished by philanthropy and the
widely accepted practice of cost-shifting, by which those able to pay subsi-
dized those unable to do so. However, by the 19705, the need to control
rising health care costs and pressure from third—party payers to do so forced
hospitals to assume an increasingly business-like mentality. One important
third-party payer was the government, which administered Medicare. As
hospital costs escalated, payers and providers resisted the ﬁnancial burden
of those who could not afford to pay or had inadequate or no insurance.
Determinants of hospital economic viability, like occupancy and proper
payer mix (i.e., the proper percentage of patients covered by third-party
payers), set the stage for concerns about fair access and about conﬂicts of
interest between hospitals‘ economic health and patients’ physical health.

Financial and organizational systems also vary greatly among institu-
tions: some are wealthier than others, resulting in differential availability of
care. Sometimes institutions located in the same city, and staffed by the
same specialty teams, operate according to widely variant standards of care.
For example, a major county hospital in an urban center might offer dialy-
sis to patients only when symptomatic uremia has progressed to a critical
stage, because the hospital cannot afford more dialysis capacity. At a major
private teaching hospital in the same city, patients may be dialyzed at lower
symptomatic levels (perhaps even before they feel ill from renal failure),
since reimbursement and private resources allow it.

Insurance companies have adjusted to the changing environment by
segmenting the market, leaving more and more of those outside the work
force without insurance and health care. Insurers have also attempted to
cut costs by excluding innovative, expensive therapies from coverage on
the grounds that they are experimental. This means that those with the

38 SOCIE’I‘Y’S CHOICES

means to pay for treatment when an insurance claim is rejected have access
to care that is closed to persons who are less afﬂuent. In addition, the
practice of denying coverage for treatment of preexisting conditions can
severely limit many people’s freedom to change employers and can cause
enormous out—of-pocket expenses even for those with insurance.

As insurance companies try to manage their risks, so too do physicians.
In our increasingly litigious society, malpractice suits against physicians are
commonplace, especially as the personal physician is replaced by the more
remote specialist. Operating under the threat of malpractice, physicians
sometimes perform procedures that are medically unnecessary or marginal
in order to protect themselves from the accusation that they did not do
everything possible. Inappropriate use of tests and technology carries its
own risks to patient health and raises the overall costs of health care, as do
the large amounts of money paid by physicians for malpractice premiums.

Thus, these changes in the structure and financing of health care put
persons in need of health care into a system that may ignore their dignity as
individuals, impose on them or on society as a whole costs that are unfair,
and distribute services in an inequitable fashion.

New Diagnostic and Therapeutic Capabilities in Medicine

There are many engines driving technological advance in the biomedi-
cal sciences, but it is not entirely clear that maximal stoking of those en-
gines is necessarily the route to equitable distribution of the good that new
knowledge can bring. Congressman George Brown,jr., Chairman of the
Committee on Science, Space, and Technology of the U.S. House of Repre-
sentatives, has argued that the free-market drive to technology, based on
the notion of sustained economic growth, may not be the most direct path
to improved quality of life for all. He observes, on the contrary, that
freewheeling market forces and the drive for high-technology solutions to
our society’s problems may in fact displace nontechnological, readily dis-
tributed preventive solutions in favor of inequitable, expensive, and some—
times even less effective solutions (Brown, 1993). Implied in his argument
is the notion that high—technology solutions to biotechnological problems
are more likely to produce ethically contorted and difficult situations than
are the simpler, low—technology solutions that are driven by concern for the
fair and equitable access for all to elemental human needs. Our country’s
experience with biomedical technology lends some credence to this idea.

During the latter half of the twentieth century, federal investment in
research and development has fueled a steady stream of advances in sci-
ence and technology in general and in biomedicine in particular. The
federal government, through NIH, is the principal supporter of biomedi-
cal research in US. universities and research institutes. But despite the

INTRODUCTION 39

effectiveness of this massive technological effort in ﬁelds from physics to
material science, as well as the development of biomedical procedures,
there have been increasing calls to examine the potential harm that might
ﬂow from advances in science and technology.

The biomedical advance that perhaps most effectively illustrates the
sometimes troubling consequences of technology was the development of
kidney dialysis techniques to save the lives of patients with terminal renal
disease. The technology was effective but expensive, and therefore not
universally accessible. In the early 19605, a kidney dialysis team in Seattle,
recognizing that it would not be able to treat all medically deserving pa-
tients, established a selection committee to choose patients who would
receive the treatment (Jensen, 1993). The committee came to be called
the “God Committee,” and the well-publicized pain of its dilemma and its
choices was relieved only by the passage of legislation that provided fund-
ing for treatment of all kidney patients. This experience served to alert
both the general public and the medical community to the problems cre-
ated by limited resources and the desperate need to anticipate such situa-
tions and institute equitable solutions.

More recently, advances in molecular genetics have delivered the prom-
ise of both technical benefits and ethical problems. Large collaborative
efforts have already succeeded in isolating and characterizing some of the
genes responsible for a number of our society’s most burdensome genetic
disorders, including cystic ﬁbrosis, Huntington’s disease, fragile X syn-
drome, and certain forms of common cancers (breast, colon, and pros-
tatic). Population—wide screening tests for these and many more disorders
may be within reach. The Human Genome Project, well on the road
toward its objective of producing a detailed map of the entire human
genome, promises to identify many additional targets for genetic screening
tests and gene therapy. Yet, it is likely that social and ethical concerns
about employment and insurance discrimination and about the value of
knowledge about one’s future health will develop in concert.

Academic-Industry Relationships in Biotechnology

Recent dramatic changes in the research and development relation-
ships between industry and academia threaten to upset the time-honored
traditions of the biomedical sciences. In the past, academic scientists pro-
vided a constant stream of basic biomedical research and a cadre of new
investigators as a source of renewed talent. Their activities were generously
funded by NIH. Industry would center its attention on the development of
their ideas into marketable products. Today, however, the process is un-
dergoing radical change as commercial interests seek to direct scientiﬁc
discovery.

40 SOCIETY'S CHOICES

The ethical issues raised by the tendency of universities and govern-
ment laboratories to establish closer ties with industry through Cooperative
Research and Development Agreements (CRADAs) need to be carefully
examined. This need is starkly illustrated by a controversial proposed
agreement between Sandoz Pharmaceutical Corporation and Scripps Re-
search Institute, which is being renegotiated under pressure from both the
NIH and Congress. The agreement would have given Scripps more than
$300 million over 10 years, starting in 1997, in exchange for worldwide
license to all Scripps medical or manufacturing inventions (excluding ex-
isting research agreements). Ajoint scientific council (with a Sandoz ma-
jority in members) would have been able to inﬂuence the direction of
research by the Scripps scientists. Under the proposed agreement, Sandoz
would have reviewed invention disclosures before they could be ﬁled with
the government, and even ongoing Scripps research projects could be
transferred to Sandoz facilities for further research and development
(Anderson, 1993).

A variety of changes in law and science policy have caused scientists to
seek such business-related agreements. Although Congress has steadily
increased the funding for NIH-supported biomedical research each year,
these increases have been inadequate to meet all increased needs and costs
of research. The number of scientists working in biomedical research, the
number ofindividual investigator (R01) grant applications, the proportion
of each grant that goes to cover indirect costs, and the average size of each
grant have all increased steadily over the years. Such factors underlie the
declining success rates of applications for NIH support, from a peak of 45.3
percent in 1975 (Institute of Medicine, 1990) to only 29.3 percent in 1991
(NIH, 1992) , and the prospects point to continued decline. The emphasis on
obtaining funding and producing publications as measures of success for
academic promotion and tenure confounds the problem, causing scientists
to seek other sources of research funding. Industry is one obvious source.

Additionally, the insights associated with the genetic revolution have
been more readily transferable to industry than previous technologies. As
a result, many leading molecular biologists in the academic world have
established complex ties with the biotechnology industry. Such relation-
ships have become so prevalent that public agencies such as the US Food
and Drug Administration that need unbiased advice from knowledgeable
scientists have encountered increasing problems avoiding conﬂicts of in-
terest when empaneling advisory groups. Finally, both Congress and the
executive branch have issued laws, regulations, and executive orders that
encourage commercial development of government-funded science (e.g.,
the Patent and Trademark Amendments of 1980; the Stevenson—Wydler
Act of 1980; the Small Business Patent Procedure Act of 1980; and the
Federal Technology Transfer Act of 1986).

INTRODUCTION 4]

The types of social and ethical issues that arise from these develop-
ments include the availability and cost of new DNA—based products, delay
in or reduced numbers of academic research publications due to consider-
ations of commercial proﬁt, “pipelining” of information or inventions to
preferred companies, diversion of faculty from other university responsi-
bilities such as teaching, delays of beneﬁt to society, and shifts in the focus
of research programs in order to optimize proﬁtability, not scientiﬁc ad-
vance. The implications for the university of university-industry research
relationships in biotechnology have been explored in depth by Blumenthal
and his colleagues (1986). These issues demonstrate how social changes
can have ethical implications. The issues have attracted public attention,
and will do so increasingly, because of concern on the public’s part that
scientists maintain their honesty and integrity (so that the innovations can
be reliably beneﬁcial), their openness and cooperation (so that biomedical
science can progress as rapidly as possible), and their commitment to pub-
lic, not personal, gain (so that all will beneﬁt from publicly supported
research).

REFERENCES

American Hospital Association. 1973. Statement on a Patient’s Bill of Rights. journal of the
American Medical Association 47:41.

Anderson, C. 1993. Scripps backs down on controversial Sandor. deal. Science 260:1872—1873.

Beecher, H.K 1966. Ethics and clinical research. New England journal of Medicine 27421354—
1360.

Bernard, C. 1865. An Introduction to the Study of Experimental Medicine. New York: Abelard-
Schuman.

Blumenthal, D., Gluck, M., Louis, K8,, Stoto, M.A.. and Wise, D. 1986. University-industry
research relationships in biotechnology: Implications for the university. Science 23221361—
1366.

Brock, D.W. 1991. The idea of shared decision making between physicians and patients.
Kennedy Institute of Ethics journal 1 (l):‘28~47.

Brown, G.E.,Jr. 1993. The mother of necessity: Technology policy and social equity. Pre-
sentation given at the American Association for the Advancement of Science (AAAS)
Science and Technology Policy Colloquium. April 16, Washington, DC.

Cruzan v. Director, Missouri Department of Health, 110 S.Ct. 2841 (1990).

Faden, R.R., and Beauchamp, TL. 1986. A History and Theory ofInformed Consent. New York:
Oxford University Press.

Fletcher, J. 1954. Morals and Medicine: The Moral Problems of: The Patient’s Right to Know the
Truth, Contraception, Artificial Insemination, Sterilization, and Euthanasia. Princeton, NJ:
Princeton University Press.

Institute of Medicine (IOM). 1990. Funding Health Sciences Research: A Strategy to Restore Bal-
ance. Washington, DC: National Academy Press, p. 37.

Jonsen, AR. 1993. The birth of bioethics. Hastings Center Report (special supplement) 23(6):]—
15.

Levine, R.J. 1986. Ethics and the Regulation of Clinical Research. New Haven, CT: Yale University
Press.

42 SOCIETY’S CHOICES

National Commission (National Commission for the Protection of Human Subjects of Bio-
medical and Behavioral Research), 1978. The Belmont Report: Ethical Principles and Guide—
lines for the Protection of Human Subjects of Research. Washington, DC: U.S. Government
Printing Ofﬁce.

NIH (National Institutes of Health). 1992. NIH Data Book 1992: Basic Data Relating to the
National Institutes of Health. Bethesda, MD.

Nuremberg Code. 1949. Trials of War Criminals Before the Nuremberg Military Tribunals
Under Control Council Law No. 10. Vol. 2. Washington, DC: U.S. Government Print-
ing Ofﬁce, pp. 181—182.

Pellegrino, ED. 1993. The metamorphosis of medical ethics: A 30-year retrospective.]oumal
of the American Medical Association 269:1 158—1162.

President's Commission (President’s Commission for the Study of Ethical Problems in Medi-
cine and Biomedical and Behaw'oral Research). 1982. Making Health Care Decisions: The
Ethical and Legal Implications of Informed Consent in the Patient—Practitioner Relationship.
Washington, DC: U.S. Government Printing Ofﬁce.

President's Commission. 1983. Deciding to Forego Life-Sustaining Treatment. Washington, DC:
U.S. Government Printing Ofﬁce.

Reiser, S. 1993. The era of the patient: Using the experience of illness in shaping the mis-
sions of health care.j0mnal ofthe American Medical Association 269(8):1012—1017.

Rothman, David J. 1991. Strangers at the Bedside: A History of How Law and Bioethics Transformed
Medical Decisionmaking. New York: Basic Books.

Schwitalla, A.M. 1929. The Real Meaning of Research and Why It Should Be Encouraged.
Modern Hospital 33:77—80.

Senate Committee on Labor and Public Welfare. 1973. Quality ofHealth Care—Human Experi-
mentation: Hearings Before the Subcommittee on Health, 93rd Congress, lst Sess. (February
21—23, March 6-8, April 30,June 28—29,July 10). Washington, DC: U.S. Government
Printing Ofﬁce.

2

The Social Context of
Bioethical Problem Solving

THE AMERICAN CHARACTER

The distinctive history and culture of our society shapes the range,
character, and form of social and ethical responses to developments in
biomedical technology. US. history is replete vn'th examples of stirring
moral debates that have mobilized the entire country; current debates over
developments in biomedicine are shaped by some of the same forces that
molded the great controversies of the past.

Our nation was born in rebellion against tyranny to preserve individual
liberty; tension between the powers of the state and the rights of the indi-
vidual has persisted, and it colors the public debate and resolution of major
moral issues. In addition, our culture is suffused with an optimistic expec-
tation of progress and Change for the better, best exempliﬁed in an unwa-
vering beliefin the myth of upward social mobility. Ambivalence about the
proper role of government, together with a fervent belief in the power and
ultimate triumph of individual efforts, is manifested in a pluralistic ap-
proach to political, social, and ethical issues, involving the active participa-
tion of numerous and diverse groups and individuals in public discourse.
The religious commitments of many of this country’s early inhabitants
both fostered skepticism about the range of governmental authority and
favored governmental sanctions on morality. While moral issues in public
policy are often settled at the national level, intense debate may occur at
both local and state levels and within scientiﬁc, religious, and other com-
munities long before the national debate takes definite shape.

43

44 SOCIETY’S CHOICES

Cases illustrative of this multifaceted approach are found in the history
of child labor laws, women’s suffrage, prohibition, and the abolition of
slavery. For example, in the latter case, citizens engaged in heated debates
and formed antislavery societies, newspapers editorialized, churches issued
proclamations, and local political bodies took stands, all of which led up to
the Civil War and culminated in a national solution. Thus, intense debate
at the local and state levels contributed to the formation and acceptance of
a central governmental response.

The capacities for public debate of ethical issues in our society have
expanded and matured within the past few decades. Discussed in this
chapter is the overall social and institutional context in which ethical quan-
daries arise, get debated, and, sometimes, get resolved. We see, for ex-
ample, that government performs a dual role: on the one hand it formu-
lates policy responses to nationally debated moral quandaries; on the other,
it fuels these quandaries through its funding of the research that produces
problematic developments.

Over time, and in many contexts, Americans have managed to main—
tain a tenuous balance between the celebration of the individual and re-
sponsibility for the community, between market striving and civic sharing,
between the private sphere and the public good. Populist political mobili-
zations have offered one mode for restoring the balance; religious move-
ments have proved to be another potent mechanism for doing the same.
The structure, function, and dominant ideologies of the political and reli-
gious spheres have been central in shaping public discourse on important
moral issues—both spheres reﬂect key aspects of the American character.

The struggle between pluralistic diversity and universal standards has
been vivid in both secular and religious American thought. In the political
realm, the early colonists demanded to participate in governing their soci-
ety. The chaos of early participatory politics would echo throughout US.
history as future generations fought new battles over their place in the
political realm. Along with demands for participation came sharp limits to
the legitimacy of central authority. A very similar dynamic could be seen in
the religious sphere. In contrast to the fixed religious establishments of
the old world, Americans witnessed an extraordinary sectarianism, driven
by the waves of populist revivalism. Generations of American fundamental-
ists have, ironically, only added to the multiplicity of sects (Butler, 1990).

Ambivalence About Government

Given that public power has long been viewed as a threat to individual
liberty, the state occupies an unusually ambiguous place in US. society. As
a result, political discourse has been preoccupied with limiting state au-
thority (Morone, 1990). Even as the modern administrative state began to

SOCIAL CONTEXT OF BIOETHICAL PROBLEM SOL VING 45

take its contemporary form, somewhere between the two Roosevelt admin—
istrations, ambivalence remained. For example, Americans developed their
social insurance programs far more reluctantly and obliquely than did
their European counterparts (Skocpol, 1992). Throughout the twentieth
century, new social welfare proposals were greeted with state bashing,
threats of looming socialism, and concerns about the erosion of the work
ethic. Hartz (1955), in a classic formulation of this ideology, described the
result as “American exceptionalism”:

. . opposition to the state that weakens every move toward government
programs, let alone a class-based politics. New forms of government au-
thority evoke the charge that an overreaching state threatens the people’s
liberty.

Observers of U.S. health care are familiar with this theme. Ambiva-
lence about government has been offered as an explanation for why Ameri-
cans refused national health insurance long after the rest of the industrial-
ized world had secured it. While this inconsistent reaction to government
runs deep in U.S. politics, however, it is often overstated. Other legacies in
U.S. political history have offered now familiar visions of a radically differ—
ent nature—a strong and active state. American distrust of government
matters, but it is only part of the story.

The Political Process

Caution around centralized government is built into U.S. political in-
stitutions and celebrated as “checks and balances.” Political programs
must often pass through the executive branch, both houses of Congress,
and other points in the federal bureaucracy; then they must negotiate the
various layers of federalism—regions, states, substate bodies, counties,
municipalities—each with its own government, each itself fragmented in a
number of ways. Legal matters must also be addressed at nearly every
stage. To pass through this gauntlet, proposed programs are typically
oversold by their supporters, who promise all kinds of benefits to all kinds
of constituencies at the same time that they heavily compromise their
propositions. The combination, while often succeeding in ﬁnding com-
mon ground among many competing interests, is also a well-tested recipe
for disappointment.

This tangled system of checks and balances is rooted in the Constitu-
tion and has been further complicated by succeeding generations of re-
form. In the vain hope of getting beyond politics, wave after wave of
American reformers have organized new agencies designed to be indepen-
dent, expert, apolitical. Each new “apolitical” reform is quickly bogged
down in precisely the politics it was designed to avoid (McConnell, 1966;

46 SOCIETY’S CHOICES

Morone, 1992). The result is a political framework that is geared toward
narrow incremental changes and best negotiated by individual agencies
with narrowjurisdictions and parochial interests. The system is especially
resistant to broad policy changes that require coordination from the politi-
cal center.

In this institutional context, US. politics is characterized by broad and
persistent participation at every point in the political process. Political
scientists once celebrated the resulting play of interest groups as a bulwark
for democratic participation. Today, they call it “hyperpluralism” and,
generally, lament the resulting stalemate. In sum, an activist interest group
culture operates within a sprawling, fragmented state that is always vulner-
able to challenges of illegitimacy (Greenstone, 1975; Morone, 1992).

One result is that organized interesm can influence policies at multiple
points in the political process. The broader consequence is that ideology,
institutional design, and the politics of both interests and groups all rein—
force the same biases in US. politics. Change is difﬁcult to introduce, and
the broader the change, the more difficult the task. The overwhelming
bias is toward incremental adjustments in the status quo.

How, then, do Americans change their politics and their society? One
answer lies in the recurring impulse to organize great democratic move—
ments—a populist urge to remake government, organize direct participa-
tion, foster a renewed sense of community. This “democratic wish” has
been pursued in a wide variety of contexts across the generations: Anti-
Federalists resisting the Constitution, jacksonians remaking the federal
government, abolitionists redeﬁning citizenship, New Left students seek-
ing a more democratic society, and African American activists demanding
civil rights.

Broad participatory movements have had a powerful inﬂuence
throughout US. history. It may be difficult to dent the political status quo,
but great gusts of democratic sentiment regularly break the impasse. Popu-
lar mobilizations create new coalitions, new political rules, new institutions,
an entirely new status quo. Precisely when US. politics grows most conten-
tious, Americans look beyond their adversary pluralism for direct participa-
tion in a shared communal fate.

The Religious Sphere

Religious values permeate U.S. culture. This is the case even for those
who are little involved with religious practice, for the substance of religious
thought is spread throughout arts, literature, popular culture, and all of
the media. Indeed, one can speak ofa “civil religion” that throughout the
centuries of U.S. history has held the nation together and helped deﬁne its
character (Bellah, 1985). The question is how this rich fund of human

SOCIAL CONTEXT ()l"l§l01:"I‘HICAI. PROBLEM SOLVING 47

thought and experience can appropriately contribute to public debate and
decision making in a democratic society, in which religion is neither to be
favored nor curtailed.

The separation of church and state has worked to prevent the domi-
nance of any sectarian theology or religious ideology within US. society.
As both secularism and religious pluralism have grown with great rapidity
during recent decades, some religious groups that had rarely been politi-
cally active in former times have developed coalitions that have become a
political factor. Some of these groups have mastered the use of the mass
media (radio and television, advertising, mass mailings, and political action
committees). They have been enlisted by politicians and political parties to
further general, national programs, and they have themselves enrolled
politicians in their own causes. This public activity by some religious groups
has, on the whole, contributed positively to the clarification ofissues in the
field of biomedicine (Bishop and (loutts, 1994). Religious zeal can, how-
ever, lead politically active groups to insist that their religiously derived
norms must be accepted by the society at large. Out of such religious zeal,
some individuals have resorted to violence against their opponents.

Naturally enough, virtually all religious groups have given major atten-
tion to fundamental moral questions raised in the fields of medical science
and medical technology. Some of these issues divide the religious commu-
nities sharply; issues related to the inception and end oflife are particularly
divisive. This division is not unique to religious communities, nor is the
division merely between the more conservative and the more liberal por-
tions of the religious community, as the issue of abortion makes clear.
Persons committed to a traditional or conservative theology may neverthe-
less be forceful advocates of a more liberal social, economic, and political
agenda (see background paper by Swezey in this volume).

At the same time, much religious thought and activity has been di-
rected toward more effective ways of presenting commonly held religious
values, such as respect for the views ofothers, honesty in individual, group,
and public life, and the overcoming of racial, ethnic, and sexual biases.
Representatives of many religions, including Islam, Buddhism, Hinduism,
Judaism, and Christianity often have joined in this effort. Note, for ex-
ample, the effort by the World Parliament of‘ Religions to articulate a set of
common moral commitments and understandings.

Religious organizations are not the only groups that have actively de-
bated and responded to major moral issues, including those brought on by
developments in biomedical technology; many other groups are notable
for their participation in such debates. Moreover, in addition to the re-
sponse of diverse social groups, institutions (e.g., the scientific research
community and biotechnology industry) also react to and change in accor-
dance with developments in biomedicine. Both specific actors (e.g., mi-

48 SOCIETY 'S CHOICES

norities, women) and arenas (government, industry, hospitals) shape pub—
lic ethical discourse on biomedical developments.

ACTORS SHAPING THE SOCIAL
CONTEXT FOR BIOETHICS

Advances in biomedicine do not occur in a vacuum—they are applied
within a rich and varied cultural context, with different impacts on diverse
social groups. Over the past three decades, the empowerment of certain
groups within U.S. society, from minorities to women, from gays and lesbi-
ans to health care consumers and patients, has contributed new and dis-
tinct voices to the debate surrounding advances in medicine and health
policy. While the emergence of these groups occurred roughly contempo-
raneously and in a somewhat interrelated fashion, each group is treated
separately below in order to highlight its own unique perspective.

Minorities: A History of Distrust

The civil rights movement born in the 1960s brought institutional
racism and entrenched social inequalities to the forefront of national at-
tention. From the 1959 bus boycotts to the March on Washington in 1963,
from the Freedom Riders to the Black Panthers, the movement chipped
away at discrimination and instilled a collective consciousness and pride
that coalesced African Americans into a powerful interest group (Branch,
1988; Garrow, 1989). While health care was not at the top of the move-
ment’s agenda, issues of distributive justice were; the 1963 March on Wash-
ington was not only about race discrimination, but also about poverty and
economic opportunity. The movement provided impetus for President
Johnson’s “war on poverty," declared in 1964, which led to passage of
Medicaid and other antipoverty programs; data show that after passage of
Medicaid, utilization of medical services by the poor increased sharply
(Starr, 1983).

Two events in the early 19705 highlighted the racism endemic to the
U.S. health establishment and further entrenched the African American
community’s distrust of medicine: the Tuskegee Syphilis Study (see Chap—
ter 1) and the African American community’s experience with sickle cell
anemia screening programs. The Tuskegee Syphilis Study has become the
most potent symbol to African Americans and other minorities of racist
exploitation by the public health community (Jones, 1993). Public outrage
over the study was enormous and provided the impetus for the eventual
crafting of federal regulations protecting human subjects. However, the
study left another legacy that can still be felt today: a profound suspicion
and distrust by the minority community of the motives of the U.S. medical

SOCIAL CONTEXT OF BIOETHICAL PROBLEM SOLVING 4 9

establishment (Iones, 1992; Lex and Norris, 1994). Writes jones (1992)
about the exposure of the study in 1972,

Confronted with the experiment’s moral bankruptcy, many blacks lost
faith in the government and no longer believed health ofﬁcials who spoke
on matters of public concern.

Ironically, the desire to respond to the historical neglect of the minor-
ity community led to another deﬁning event that only reafﬁrmed this dis-
trust: racial discrimination and stigmatization resulting from sickle cell
anemia screening programs. These programs were spurred in the early
19705 by a perception that the disease, more prevalent in African Ameri-
cans than in others, had been neglected, and by a desire to remedy the
racial inequities brought to light by the civil rights movement. However,
screening programs were undertaken with little public education, little
counseling for those identiﬁed as carriers, and insufﬁcient attention to
clariﬁcation of the distinction between sickle cell traits and sickle cell dis-
ease (Fost and Kaback, 1972). Many of the 12 states that passed sickle cell
screening laws required mandatory screening of infants and children, even
though at the time the only valid scientiﬁc objective of the screening was to
provide carriers with information concerning whether or not to have a
child, since no treatment was available.

Fears that these laws would result in racial discrimination were borne
out, with disastrous results for some in the African American community.
Children with the disease were stigmatized; insurance carriers raised insur-
ance premiums for sickle cell carriers; some corporations initiated screen-
ing programs; and most major airlines grounded or ﬁred employees with
sickle cell trait (Bowman and Murray, 1981; Duster, 1990). Indeed, the
US. Air Force Academy decided to exclude candidates with sickle cell trait
from 1973 until 1979 (when the policy was ended after a lawsuit), based on
a National Research Council report that characterized its own evidence as
inadequate (Duster, 1990). Such reactions to sickle cell disease tended to
reinforce both racial discrimination and the suspicions of minorities that
medical advances would be used to their detriment.

The legacy of distrust left by Tuskegee and sickle cell screening contin-
ues to shape the attitudes of minorities toward organized medicine. Fears
of medical exploitation and racial discrimination have led some in the
African American community to charge that AIDS was engineered as a
program ofgenocide (Jones, 1993). Suspicions in the minority community
have made it difﬁcult to enroll minorities in AIDS and other clinical trials,
despite a high level of infection among those populations (El—Sadr, 1992).
Concerns remain that any racial differences found in the course of AIDS
and other diseases will be used to justify discrimination against minority
groups (King, 1992).

50 SOCIETY’S CHOICES

This persistent distrust of public health ofﬁcials could thwart efforts to
reverse the current decline in the health of minority groups. Indeed, the
documented disparity between the health status of Americans based on
race and class reinforces the View that current health policies are not re-
sponsive to the speciﬁc needs of these groups. These and other health
inequalities likely reflect differences in access to and quality of health care
services for minority and poor populations. While recent initiatives have
been established to improve the health of minority groups (National Insti—
tutes of Health, 1991), the sad history of medical racism and the suspicion
it engendered remains to be addressed.

Women: A Struggle for Control

The women’s movement began to take shape in the late 1950s and
early 19605, on the heels of early successes in the civil rights movement.
The ﬁrst mainstream women’s organization, the National Organization for
Women (NOW), was organized in 1966 to focus on attainment of women’s
legal rights; other groups followed with a less traditional agenda. By the
early 19705, the “women’s liberation movement” emerged full force, com-
posed of both the more traditional groups and a younger, more radical,
cohort. A slogan of the movement, “the personal is political," highlighted
its concern not only with discriminatory legal barriers to women, but also
with more subtle, pervasive cultural sexism (McGlen and O’Connor, 1983;
Rosenberg, 1992).

The women’s movement was unique in its concern, from the outset,
with health—related issues—namely, the need for women to control their
reproductive lives as a prerequisite for individual autonomy. Reproductive
politics surrounding both abortion and contraception engaged feminists
early on. Women exerted enormous pressure toward the repeal of restric—
tive abortion laws from 1968 to 1973. Women’s groups were also instru-
mental in facilitating access to illegal abortions; one group in Chicago
organized an underground abortion clinic where abortions were per-
formed by self—trained women (Petchesky, 1990). Access to contraception,
previously the purview of the population control movement, arose as an-
other leading demand of the women’s movement, centering on theories of
self-determination, sexual discovery, or “sexual liberation” (Gordon, 1976).

These reproductive issues became the catalyst for the formation of a
distinct women’s health movement in the early 19705. As restrictions on
reproductive freedom came to be seen as an issue of male domination over
women’s sexuality and autonomy, the movement expanded to encompass a
broader challenge to the male-dominated medical profession’s authority
to dictate women’s health in many other areas. With the ﬁrst publication
of Our Bodies, Ourselves by the Boston Women’s Health Book Collective in

SOCIAL CONTEXT OF BIOETHICAL PROBLEM SOLVING 51

1973, the women’s health movement expanded throughout the country as
a campaign by women to reappropriate control over their own medical
experience, particularly by means of medical self-help and self-awareness
training groups and women’s medical clinics. The movement focused on
issues such as demedicalizing women‘s routine health care and childbirth
practices, sterilization and surgical abuses, and self-help gynecology (Ruzek,
1978).

In addition to its objections to and concerns with traditional medical
practice, the women’s health movement also grew distrustful of the drug
and device industry over what it perceived to be inadequate drug and
device safety measures for drugs marketed to women. Women became
concerned over the dangers of the birth control pill, which frequently were
not relayed to them by physicians; a book on this subject geared toward the
lay reader set off a series of events that ﬁnally led the Food and Drug
Administration (FDA) to require warning labels for oral contraceptives
(Seaman, 1969). Women’s suspicion of the drug industry was heightened
further by revelations that diethylstilbestrol (DES), a synthetic estrogen
prescribed to millions of women between 1945 and 1970 to prevent early
miscarriages, caused vaginal cancer in some of their daughters. When
concerns were raised about the health complications of IUDs, women’s
health advocates were instrumental in pressuring the FDA to recall Cop—
per-7 IUDs and halt the manufacture of the Dalkon Shield; further protests
eventually led to the regulation of such devices by the FDA (Ruzek, 1978).

More recent developments illustrate women’s continued concern with
the safety of drugs and devices prescribed for them, and a perceived lack of
responsiveness to women’s unique health needs by the medical establish-
ment. The recent scandal over the safety of silicone breast implants sparked
outcries by some feminists that women’s health was being exploited for
profit (Wolf, 1992). Allegations that there has been a historical lack of
research attention to breast cancer, as well as cardiovascular disease and
AIDS in women, has also sparked a wealth of efforts by a wide range of
women’s organizations to ensure that these areas of investigation are ad-
equately addressed.

Despite increasing numbers of women entering careers in medicine,
women continue to be underrepresented in the medical profession, and
some within it have observed an entrenched bias against women
(Komaromy et al., 1993). Women’s health advocates were also instrumen—
tal in calling for the review and revision of existing NIH and FDA policies
that routinely excluded women of childbearing age from research trials.
This had led to revised policies at both agencies, reﬂected in the NIH
Revitalization Act of 1993 (P.L. 103-43), which requires promulgation of
guidelines to ensure that women and minorities are included in NIH-
funded research.

52 SOCIETY’S CHOICES

A myriad of pressing issues continues to confront women in health
care, including a renewed battle over abortion rights and access to RU-486
(Charo, 1991), disparate treatment of women in medical management of
illness (Steingart et al., 1991), violence against women as a public health
threat (American Medical Association, 1992), the growing population of
women infected with HIV (United Nations Development Programme,
1993), and complex questions surrounding the maternal—fetal relation-
ship, fetal diagnosis, and the control of pregnant women (Rothman, 1987;
Mattingly, 1992). Despite these continuing concerns and problems, how-
ever, there is no doubt that women have become a viable, forceful interest
group, challenging sexism in medical practice and research and calling
attention to medical problems unique to women.

Gays and Lesbians: A New Activism

Gay rights, like minority and women’s rights, have long been a part of
US. political debate, but gays and lesbians emerged as a powerful, distinct
interest group in the 19705. The Stonewall riots in New York City in 1969,
following a police raid on a gay bar in Greenwich Village, led to a decade of
organizing, fundraising, and consciousness-raising among gays and lesbi-
ans throughout the country, modeled on the civil rights and feminist move-
ments. The late 19705 saw renewed efforts in reaction to a backlash that
resulted in the repeal of gay rights ordinances in Dade County, Florida,
and other cities. In 1978, riots broke out in San Francisco after Dan White,
the killer of gay supervisor Harvey Milk and mayor George Moscone, re-
ceived a sentence of only seven years in prison (D'Emilio, 1983; Cruikshank,
1992).

As with minorities and women, the history of the gay community’s
relation with the US medical establishment is characterized by suspicion
and distrust (see background paper by Bayer). A decade before the AIDS
epidemic, gay men began to form their own health clinics in response to
perceived discriminatory treatment for sexually transmitted diseases. The
American Psychiatric Association classiﬁed homosexuality as a mental ill-
ness until 1976; but even until 1990, the Public Health Service was respon-
sible for enforcing a ban on immigration by homosexuals based on that
mental classification (Levi, 1991). But as with other rights movements, the
gay liberation movement focused its initial energies not on health issues,
but on legal and social stigmatization and discrimination in housing,jobs,
and other areas.

In the early 1980s, the general public’s erroneous perception that AIDS
was a disease affecting only gay men lent momentum to gay activism. The
labeling of AIDS as a “gay" disease transformed what should have been a
mass mobilization of public health resources to combat a critical health

SOCIAL CONTEXT OF BIOETHICAL PROBLEM SOLVING 53

problem into the politicization of public health agencies. Former Surgeon
General C. Everett Koop notes in his 1991 autobiography that “the Reagan
revolution brought into positions of power and influence Americans whose
politics and personal beliefs predisposed them to antipathy toward the
homosexual community.” Conservative politics, Koop adds, both slowed
the understanding of AIDS and thwarted his attempts to educate the public
about the disease. In the face of an establishment that failed to rise to the
challenge of the AIDS epidemic, gays began to organize their own commu—
nity health clinics and treatment networks, seeking to redeﬁne the notion
of AIDS as a disease rather than divine retribution (Shilts, 1987; Padgug
and Oppenheimer, 1992).

Gay health advocates introduced a new level of activism and self-help
to the previous endeavors of health interest groups. For example, in re-
sponse to what was perceived as a sluggish federal drug approval process,
gays organized an “AIDS underground,” a network of illegal drug buyer
clubs. In 1987, the AIDS Coalition to Unleash Power (ACT-UP) was orga-
nized in New York City as a more activist alternative to existing gay health
groups. ACT-UP repeatedly caught the attention of federal and state
policymakers by relying on dramatic modes of civil protest and disobedi-
ence borrowed from the civil rights movement (Arno and Feiden, 1992).

The development of a parallel track policy at the FDA, arising from the
introduction of dideoxyinosine (ddI) as a potential AIDS therapy, exempli-
ﬁes an unprecedented involvement by gays and other consumer groups in
federal health policy-making, even though the outcome of this policy has
yet to be evaluated. Extending the basic tenets of the patients’ rights
movement concerning participation in treatment decisions, gay activists
succeeded in negotiating with federal ofﬁcials and drug manufacturers to
speed the availability of unapproved but possibly effective treatments for
AIDS (Levi, 1991).

The activism of gays in response to the AIDS epidemic marks a signifi-
cant turning point in the history of health interest organizations and their
relations with the medical and research establishments. This activism may
well inform the future efforts of other groups as well, perhaps changing the
power dynamics between the medical community and patient groups.

HEALTH CARE AND SCIENCE: SHAPING THE
SOCIAL CONTEXT FOR BIOETHICS

Patients, Employers, and Insurance Companies:
Health Care Consumers

Substantial changes in the delivery of health care have transformed
patients from trusting, relatively passive recipients of health care to a more

54 SOCIETY’S CHOICES

skeptical and active group of informed consumers, voicing their concerns
and challenging the previously unquestioned authority of physicians and
other health care practitioners. In the past, a patient who wished to learn
about advances in medicine would ask for information and guidance from
a trusted health care provider and conﬁdant, with whom a long-term rela-
tionship had been established. But as more Americans receive medical
care in managed care settings from a series of specialists, and as patients/
consumers must assume major responsibility for decisions about their per-
sonal health care, such close relationships no longer exist for many people.
Health care consumers now express concern at the number of procedures
to which they are exposed, and question whether these procedures are
really necessaly for the diagnosis or treatment of their illness. They are
troubled by the apparent inability of the health care system to control
spiraling costs for medical insurance and medical treatment, and wonder
what type and level of basic research will provide relevant advances in
medical care at an affordable cost to the public.

In considering patients‘ relationships to the health care system, em—
ployment-based health benefits and the role of employers have to be taken
into account. The system of employer-based health beneﬁts began in the
early 19305. It is a voluntary system, required by neither federal nor state
law. The offering of health benefits to workers and their families is now
almost universal in organizations with 100 or more employees. In contrast,
only about one-half of employees in organizations employing less than 25
employees receive health benefits directly from their employer. At present,
about two-thirds of all Americans under age 65 (about 140 million people)
receive health benefits through the workplace. However, 35 million Ameri-
cans are uninsured. and many other millions have inadequate or precari-
ous coverage (Field and Shapiro, 1993).

just as proﬁt-making health conglomerates are concerned about health
care costs, so too are increasing numbers ofemployers, who are alert to risk
selection as a strategy to reduce the costs of their insurance. They may
favor the hiring of individuals who are least, apt to draw upon costly health
benefits. They realize that any health plan that avoids providing coverage
to high risk groups will have a competitive advantage. Thus, consumers
and patients, particularly those with preexisting conditions or genetic dis-
eases, may find that their problematic health status makes them less desir—
able as employees and, as a consequence, less able to secure adequate
health beneﬁts.

The government has provided some protection of health care beneﬁts
for vulnerable populations. In 1965, the federal government introduced
Medicare for workers who were over 65 or disabled. Medicare separated
coverage for hospitalization from that for the physician, in accordance with
the pattern set by Blue (lross. For workers over 65 who are entitled to both

SOCIAL CONTEXT ()I’BIOE'I'III(JAI. PROBLEM SOLWNG 55

Medicare and employment-based health benefits. arrangements are gener-
ally made between employer and insurance company to charge Medicare
ﬁrst and leave the balance to the insurance company. This arrangement
faces restructuring as the federal government moves to curtail Medicare
benefits.

Until recently, insurance companies made profits by underwriting the
cost of employer-based health plans. However, anticipating the advent of
managed competition, they are now moving further into management as
well as financing for a profit. Like hospitals, they are actively engaged in
setting up networks, buying hospitals, and establishing a variety of diagnos-
tic and therapeutic facilities and thus may be a powerful part of any future
health care system.

Public discourse surrounding biomedical developments is affected not
only by the activities of specific social groups, but also by the institutional
landscape of hospitals, government and industrial research communities,
and academic activities in bioethics. The interaction of public policies and
structural changes has produced a vastly altered institutional setting for
biomedical innovation, with major social and ethical ramiﬁcations.

Hospitals

Largely because of the resistance ofphysicians to national health insur-
ance, the United States has a “system ofprivate insurance for those who can
afford it, and public welfare services for the poor” (Starr, 1983). The
present system evolved gradually over 200 years, modified in large part by
the changing role of the physician in the delivery of health care. Before
the mid-nineteenth century, the public had little confidence in physicians.
Health care was generally provided at home, by relatives and friends, often
in consultation with professional healers. The practice of medicine was
limited because physicians had few effective therapeutic interventions.

The tide turned for physicians in the mid to late 1800s, not only in
their own practices but also in their relationships to hospitals. Five broad
forces were responsible for this change: (1) urbanization, which concen—
trated patients in smaller areas; (2) improved transportation (the advent of
the automobile in the 1890s); (3) growth in the application of science
(e.g., bacteriology) to medical practice; (4) organization of physicians to
resist competition from other health practitioners and to resist intrusions
by government; and (5) educational and licensing reform. By the 19205,
the medical profession was a highly respected profession that controlled
hospitals by controlling the flow of patients into these institutions. Increas-
ingly, health care shifted from home to hospital.

Not until the 19703 did this costly, physician-dominated health system
face serious challenge, when national health insurance was seriously de-

5 6 SOCIETY’S CHOICES

bated as a desirable alternative. Thereafter, medical domination of hospi-
tals began to yield to professional administrators (Starr, 1983). Increas-
ingly, physicians offer the hospital professional skills, technology, and in-
come; but in many hospitals their dominance was diminished with the
increased control gained by administrators. Along with the change in
control came a greater focus on the ﬁnancial aspects of running a hospital.

Between 1850 and 1920, the American hospital was transformed from
an asylum for the indigent—noisy, dirty, and in disarray—to a scientiﬁcally
oriented institution for medical management and nursing care. The dra-
matic change was prompted largely by a combination of industrialization,
urbanization, and immigration, as well as by advances in sanitation and
medical treatment (Rosenberg, 1987). Not only did the hospital become
clean and efﬁcient, it became increasingly technological and intervention-
ist (Stevens, 1989). It also assumed a dominant role in the training of
physicians, shaping their interests, attitudes, behavior, values, and practice.
In the process, it also became increasingly sensitive to political and societal
pressures, cultural rewards, and economic incentives and disincentives,
changing its scope, priorities, and structure as it accommodated to these
inﬂuences. In this evolutionary process, the physician became less of a
healer than an expert who provided access to the necessary technology;
often, the nurse was charged with ministering to the patient‘s care and
well—being.

For most of the nineteenth and early twentieth century, the health care
system centered around the hospital and its inpatient activities. Surgery
became its mainstay. More and more, its success and visibility depended on
its ability to deliver up—to—date acute and specialized care. As the hospital’s
primary role as a charitable institution faded, however, it began to assume
a more corporate mentality, and low occupancy became a major detriment
to economic viability. In the 19605 and 19705, with the advent of Medicare
and employer-sponsored health insurance programs, admissions to hospi-
tals rose; in the 19905, due to AIDS and the rise in chronic diseases, they
are increasing again.

At the same time, a growing emphasis on specialty medicine led to a
decline of primary care medicine. Along with greater reliance on science
and technological sophistication, specialists assumed a central role in the
business of medicine. Some showed entrepreneurial instincts that verged
on conﬂicts of interest. Physicians also became targets for those with prod-
ucts to sell (e.g., drugs) and for malpractice suits by those with failed
expectations. All of these factors contributed to the rising cost of practic-
ing medicine and of running hospitals. The term “hospital” refers today to
short-term, acute care, general hospitals that include both medicine and
surgery. Most are voluntary, not—for-proﬁt organizations; these provide 70
percent of short-term beds in the United States.

SOCIAL CONTEXT OF BIOETHICAL PROBLEM SOLVING 5 7

Voluntary hospitals handled the ﬁnancial pressures by becoming more
aggressive, competitive, expansionary, proﬁt-oriented, and income-maxi-
mizing. Access to health care became increasingly dependent on ability to
pay. Some hospitals, faced with prospects of ﬁnancial doom, merged with
others; others ﬂed to the suburbs where the payer mix was more favorable.
This contributed to the growing problem of limited access to health care
for the uninsured: the poor, the part-time worker without beneﬁts, and the
unemployed.

Currently, the voluntary hospital is a central part of the changing scene
in health care delivery. The idea of “managed competition" is driving
hospitals into health care networks. The tempo of competition among
urban hospitals has become ﬁerce as they strive to set up networks for
managed competition. Insurance companies are prominently engaged in
the struggle for a piece of the pie. Drug companies are resorting to novel
strategies in order to maintain prized relationships with physicians and
hospitals while the restructuring is under way.

A variety of inﬂuences is diminishing our society’s traditional reliance
on hospitals as independent entities:

0 increased dissatisfaction of the public and of major political ﬁgures
with the high cost of health care and the major role played by hospitals and
their administrative costs in the genesis of this difﬁcult burden;

0 growing ability of and ﬁnancial incentive for outpatient care to sub-
stitute for in-hospital care due to advances in medical management and
technology (e.g., cardiac catheterization, renal dialysis);

0 less need for hospitalization because of the development of non-
invasive technologies for diagnosis and treatment (e.g., CAT scanning,
MRI, or ultrasound);

0 restructuring of health care (e.g., through HMOs, which discourage
referrals to hospital-based specialists, and greater strictures on reimburse-
ment by third-party payers);

0 development of new effective therapeutic agents (e.g., antibiotics
for cystic ﬁbrosis);

0 expanded use of living wills advance directives, which may limit
interventions and expenditures for terminal disease; and

0 greater effectiveness of preventive measures (e.g., education for
AIDS, vaccines).

As the United States prepares itself for health care reform, it is impor—
tant to recognize that in addition to unmet needs (e.g., preventive medi-
cine), the aging of the population will introduce additional needs and
related ethical questions. For example, disability from dementia, includ-
ing Alzheimer’s disease and stroke, will require research into etiology,
medications, devices, and suitable treatment environments. The major

58 SOCIETYS CHOICES

causes of death have shifted from acute infectious diseases (e.g., inﬂuenza)
to chronic diseases (e.g., heart disease and cancer), and death by these
causes occurs later in life, after a period that includes limited functional
capacity and impaired quality of life. In the course of a patient’s dying,
hospitals often provide a variety of expensive life—prolonging measures,
even though the effect on survival time and quality of life is often small.
Decisions have to be made concerning the availability of such measures.

The Health Care Industry

Health care is a big business with several components that are germane
to our considerations of social and ethical issues: primary among them are
health care services and the research, development, and use of drugs and
devices. Health care costs include the money paid to physicians in man-
aged care or private practice, to hospitals, laboratories, and other health
care workers. Costs also include the money spent on the products of
pharmaceutical and biotechnology companies as well as the money spent
on health—related research to develop and produce these drugs and tech-
nologies. Some basic statistics illustrate the size and scope of this business
and, hence, the stakes involved in changing any aspect through public
policy. In 1991, according to Letsch and colleagues (1992), the United
States spent a total of $751.8 billion for health care, or $2,868 per person.
Approximately 88 percent of the health care expenditures paid for medical
services or products such as hospital services, physician services, drugs, and
nursing home care. Inpatient and outpatient hospital care comprised 43.7
percent of the total personal health care expenditures, but only 3.4 per-
cent of this was paid directly by the patient, while private health insurance
paid for 35.2 percent and public health insurance paid for 56.3 percent of
the charges. Another $23.1 billion was spent on biomedical research and
development, about half of it in federal funds.

Biomedical Research: The Federal Government and Private Industry

Since the end of World War II, a growing function of government has
been sponsorship of biomedical research, primarily through the National
Institutes of Health and the National Science Foundation (NSF). The idea
that public investments in biomedical science should play a major role in
improving the economic status of the country has become a recurrent
theme and is prominently featured in the Clinton economic policy. A
frequently cited analysis estimated 28 percent rate of return to society from
funds invested in academic research (Mansﬁeld, 1991).

Beginning in 1980, a series of laws and regulations have sought to
benefit the economy through the commercial development of government-
funded science. These laws have fundamentally altered the role of re-

SOCIAL CONTEXT OF BIOETHICAL PROBLEM SOLVING 5 9

search scientists in relation to their discoveries. The Stevenson-Wydler Act
(P.L. 96—480) of 1980 required that 0.5 percent of the R&D budgets of
federal agencies be used for technology transfer activities. The Bayh-Dole
Patent and Trademark Laws Amendment Act of 1980 (P.L. 96—517) as-
signed intellectual property rights to the institutions carrying out the gov-
ernment-funded research, allowing grantee institutions to patent and li-
cense their developments and collect and retain royalties. Also in 1980, the
Small Business Patent Procedure Act (P.L. 96-517) reversed the federal
policy of nonexclusive licensing by assigning patent rights to small busi-
nesses, universities, and some nonproﬁt organizations that were involved
with government contracts. The Federal Technology Transfer Act of 1986
(P.L. 99-502), authorized government-operated laboratories to establish
Cooperative Research and Development Agreements (CRADAs) with other
federal agencies, state or local governments, and industrial and nonproﬁt
organizations for the licensing of government-owned inventions, with in-
ventors and their laboratories keeping part of the royalties received from
these licenses. As a result of all of these actions, biomedical scientists
began to beneﬁt ﬁnancially from their ideas by forming relationships with
industry and by starting small biotechnology companies of their own.

The development of recombinant DNA technology, in combination
with the change in government policies with respect to technology trans-
fer, underlay the biotechnology industry that was created de novo during
the 19805. The number of new biotechnology companies soared during
the 1980s, making the United States a world leader in the commercializa—
tion of biotechnology products. Ajune 1993 fact sheet from the Biotech-
nology Industry Organization (BIO) reports that there are 1,231 biotech-
nology companies in the United States, an 11 percent increase since 1991.
Thirty-eight percent of US. biotechnology companies are involved in prod-
uct development in therapeutic agents, while 28 percent are producing
human diagnostics. Other companies are involved in agricultural, chemi—
cal, environmental, or service areas. The industry presently employs 79,000
individuals (BIO, 1993). By 1993, 21 approved drugs or vaccines and over
600 diagnostic agents had reached the market; another 16 agents are await-
ing FDA approval, and 132 agents are in clinical trials. The biotechnology
industry is predicted to grow to a $50 billion industry by the year 2000
(President’s Council on Competitiveness, 1991). As was the case in the
past decade, new technologies that alter existing practices and challenge
traditional values and beliefs promise to accompany this growth.

Another site of biomedical innovation from which ethical and social
quandaries are likely to arise is the pharmaceutical industry. The vast
majority of new drugs have been developed by this industry, which has
doubled its investment in R&D every 5 years since 1970. In 1993, the
industry was expected to invest $12.6 billion in R&D—a 13.5 percent in—

60 SOCIETY’S CHOICES

crease over 1992. This investment amounts to 16.7 percent of the industry’s
expected sales in 1993, four times the average of R&D investment for all
US. industries that conduct research (Beary, 1993). Since 1988, the mem-
ber companies of the Pharmaceutical Manufacturers Association (PMA)
have supported more R&D than the NIH, with industry spending totalling
$9.2 billion in 1991 (PMA, 1991). Although it is difﬁcult to accurately
estimate the costs of developing any single drug, DiMasi et al. (1991) esti—
mated that the average cost of developing a single drug was $231 million. A
more recent report by the OTA (1993) estimates that the average cost to a
company for moving a single new medicine from laboratory to practice is
presently $359 million.

The high cost of drug development is partly a result of the rigorous
testing process that a new drug undergoes. It takes an average of 12 years
for a new drug to reach the market, and for every 5,000 compounds that
are evaluated, only 5 enter clinical trials in humans and only 1 is approved
(Wierenga and Eaton, 1993). In spite of the huge investments of time and
money required to produce a single drug, the pharmaceutical industry has
been highly productive, commercially successful, and highly proﬁtable to
its investors. Kaitin et al. (1993) studied 196 new chemical entities that had
been approved by the FDA between 1981 and 1990, and found that 181
drugs (92.4 percent) were developed by the pharmaceutical industry, 7 by
academia, 2 by the government, and 2 by individuals.

As the biotechnology and pharmaceutical industries play an increasing
role in the economic competitiveness of our society, industry needs new
resources from various sectors of society. From the regulatory agencies, it
needs clear guidance on what is expected in terms of safety and efﬁcacy
regarding the testing process, as well as an efﬁcient approval process. The
success of industry also depends on basic biomedical research in academic
and government laboratories, a vital academic research enterprise that
generates new scientiﬁc insights. Industry also looks to the academic re-
search community for new skills and techniques, speciﬁc assays and re—
agents, personnel to conduct clinical trials, consultants and collaborators,
individuals to provide expertise to regulatory agencies, and highly skilled
scientists and technicians to work in industry. To facilitate cooperation
between academia and industry, value questions related to ownership of
intellectual property rights and conﬂicts of interest must be resolved.

A 1990 National Academy of Sciences (NAS) report on industrial per—
spectives on innovation and interactions with universities concluded that,
in the early stages of large scientiﬁc breakthroughs, industry needs interac-
tion with university scientists, who are at the forefront of scientiﬁc knowl-
edge. As a breakthrough matures, however, incremental improvements
(product— and process-oriented technical changes that are related to com-
petitiveness) occur most often within industry only. Thus, primary roles

SOCIAL CONTEXT OF BIOETHICAL PROBLEM $01. VING 61

for universities in academic-industry partnerships lie not in product devel—
opment but in providing in-depth education about new and emerging
concepts.

A cautious analyst of “technology transfer” from the university or the
national laboratories to industry is john A. Armstrong, retired vice presi-
dent for science and technology at IBM (1993). He holds industry respon-
sible for poor management decisions, lack of attention to quality and cost
in manufacturing, past high interest rates, and poorly trained workers.
“The most effective technology transfer from universities in the short term
is well-trained technical and scientiﬁc workers at many levels of sophistica-
tion and knowledge," he concludes. If universities become focused on
technology transfer and economic competitiveness, he anticipates a variety
of problems, including a shift in the amount and priorities of available
funding, a distortion of the role of universities, and an increase in ethical
issues such as potential conflicts of interest of research faculty. Universities
could improve the rate of return on society’s investment in basic research
through the following actions:

' improve the training of scientists and engineers to make them more
effective and enthusiastic participants in R&D exploitation with height-
ened interest in the challenges of manufacturing;

0 make innovations in how universities and industry interact;

0 rationalize university policy with respect to intellectual property
rights;

0 reexamine university conﬂicts of interest policies.

Harold Shapiro, president of Princeton University, echoes these con—
cerns (Shapiro, 1992). He notes that technologic progress depends not
only on new science and technology but also on cultural and social factors
such as political stability, life expectancy, nutrition, attitudes toward risk,
natural resources, property rights, religious values, demographics, and
openness to change. The critical contributions from the university sector
are education and advanced training, quasi-independent scientiﬁc agen-
das, and exploration of the human condition, through a broad set of his-
torical, cultural, political, and value questions. In the ﬁnal analysis, “[i]t is
a society that is full of hope rather than fear, full of trust rather than
alienation, full of knowledge rather than ignorance, full of honesty rather
than cynicism, full of conﬁdence rather than helplessness that will survive
and progress."

Funding of Scientific Research

Since 1950, the federal government has been the main source of ﬁ-
nancing for scientiﬁc research and a principal shaper of the research

62 soclE’I‘Y‘s CHOICES

agenda. One reason for growing public interest in scientific expenditures
is the sheer size of the government-funded program of biomedical re-
search. The NIH budget alone grew from $26 million in 1945 to over $10
billion in 1993. and the Clinton administration’s budget request for FY
1994 is $10.668 billion. Almost 90 percent of the funding goes to extramu-
ral research. Additional matching funds are applied to the construction of
biomedical research facilities. For its part, NSF has a FY 1994 budget
request of $3.182 billion to fulfill its scientific mission.

The establishment and success of these premier scientific research
agencies resulted partly from the early insights of Vannevar Bush, head of
the wartime Office of Scientific Research and Development, who pointed
out in his book, Science—The Endless frontier, the importance of the uninter-
rupted flow of new scientific knowledge for both health and defense. To
accomplish these purposes, Bush proposed a permanent governmental
structure receiving funds from Congress to support basic research in the
colleges, universities, and research institutes, as well as scholarships and
fellowships for training. Bush specified that this proposed agency should
recognize the importance of freedom of inquiry on the part of the indi-
vidual scientist.

Today, it is precisely this unfettered freedom of the individual scientist
to determine research priorities that is being questioned. Yet, who should
be setting the priorities for science? Congress must respond to a variety of
pressures from constituents, resulting in academic earmarks to fund “pork
barrel,” non—peer-reviewed science at levels that have grown from about
$10 million in 1980 to almost $800 million in 1993 (Washington Fax, 1993).
Congress also responds to the voices ofspecial interest groups by specifying
funding levels for specific diseases. Scientists as a group have not devel-
oped a way to effectively establish research priorities across the various
ﬁelds of scientific endeavor. Unfortunately, Congress also seems to lack a
mechanism for obtaining objective data to help to weigh scientific priori—
ties across the spectrum of important diseases.

At the same time that the public demands greater accountability in the
funding of biomedical science, it is generally optimistic about the ultimate
outcome of its investments. A l990 survey by the National Science Board
showed that most Americans trust the motives of scientists; 80 percent of
respondents agreed that most scientists want to make life better for the
average person (National Science Board, 1991). The survey also showed
that between 1979 and I990, decreasing proportions of respondents agreed
with the statement that “Science makes our way of life change too fast.”
Most respondents indicated that they believe that the benefits of scientiﬁc
research had outweighed the harmful results; a majority perceived a strong
link between advances in science and technology and improvements in
their own daily lives.

SOCIAL CONTEXT OF BIOE'I‘HICAL PROBLEM SOLVING 63

How the public responds to developments in biomedicine is often
inﬂuenced by the way such developments are presented in the media. In
general, the media provide a valuable service by informing the public of
developments in health—related research and biotechnology, not only the
scientific advances but also the social, legal, or ethical impacts of these
advances on the lives of all Americans. However, as the media strive to
create a newsworthy story, the value of this service can be diminished. The
30-second soundbite conveys partial information but ignores crucial de-
tails. The limited success of an animal experiment can be reported in a
manner that suggests an imminent breakthrough in human therapy; when
the expected results do not immediately materialize, such stories can lead
to public disillusionment.

These tendencies in the media compound the problems caused when
politicians or scientists overpromise about expected breakthroughs. A sa-
lient example was the so—called “War Against Cancer” during the 19505 and
19605 (IOM, 1973). The funds that were expended under that program
have contributed to advances in the diagnosis and treatment of cancer
(and to the understanding ofHIV disease), but the idea that cancer would
be defeated by this program caused unfounded expectations on the part of
the public, and resulting disappointment.

Research on the human genome is an area in which the media’s inﬂu-
ence has been more positive, however. There has been a concerted effort
to deal with ethical, social, and legal issues related to the uses of new
genetic technologies (see background paper by Hanna). Nobel laureate
james Watson has been a central ﬁgure in expanding our understanding of
the molecular structure of DNA and of the relationship between viruses
and cancer. As head of the NIH Ofﬁce of Genome Research (now the
National Center for Human Genome Research), he responded to public
and congressional concern by proposing to use part of the money allocated
to the Human Genome Project to study the ethical, social, and legal issues
that are raised by the information this research generates. Media coverage
highlighted this effort and was partially responsible for encouraging public
support for this initiative.

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Systematic Approaches to Bioethics

ACADEMIC BIOETHICS

Definitions

During the 1970s, scholars from several disciplines, principally moral
philosophy, theological ethics, medicine, and law, began to study and write
about the ethical issues of modern medical science and health care. Gradu-
ally, a discipline called bioethics began to emerge, with specialized faculty
(usually located in schools of medicine), courses, conferences, and jour-
nals. What contribution can academic bioethics make toward public moral
discourse about the biomedical sciences and health care practices and
policies?

Academic bioethics is easier to describe than to deﬁne. Descriptively,
the term refers to the scholarly activities of individuals, usually trained in
an academic discipline that deals with ethics, such as theology, moral phi-
losophy, or law, and usually working within institutions dedicated to teach-
ing and research. These persons study a range of issues loosely arranged
around the biomedical sciences and health care, apply the methods of
their disciplines, and publish their conclusions in scholarly and semi-
scholarlyjournals. In the 19805, graduate programs in bioethics appeared;
there are now about a dozen such programs offering higher degrees. Aca—
demic bioethicists, then, have scholarly and practical training that enables
them to work in various settings: as faculty in medical and nursing schools
or university departments, as hospital or organizational consultants, as gov-

67

68 SOCIETY’S CHOICES

ernment employees in policy or regulatory positions, and as members of
public committees and commissions dealing with ethical issues.

Academic bioethics should be distinguished from what might be called
professional bioethics, whose practitioners (such as physicians, nurses, and
scientists) undertake to learn about the ethical standards and issues in
their professional practices. They may utilize the work of academic bioeth-
ics and invite scholars to join their discussions as consultants, but their
engagement tends to reﬂect the exigencies of their work more strongly
than the theoretical and analytic features of academic bioethics. This is
practical bioethics in the most commendable sense: individuals become
competent—sometimes quite competent—in a subject, but work at it pri-
marily as an adjunct to their primary occupation.

Academic bioethics can also be distinguished from popular bioethics,
popular moral discourse that concentrates on issues in medicine, health
care, and the biomedical sciences. Thus, public debate over genetic engi-
neering or assisted suicide, carried out in many different forums and mani-
fested in the media, constitutes popular bioethics. In this format, it is the
story rather than the analysis that prevails. Participants in this “amateur”
bioethics may become interested enough to learn something about ethical
analysis, but do so casually and often without rigorous scholarship or argu-
ment. Sometimes, popular bioethics may be drafted into the service of
strongly held ideologies and become quite sophisticated, although no
longer impartial.

If public moral discourse is taken in the strictest sense, as the deliber—
ately organized effort to marshall evidence and considered opinion m‘th
the purpose of formulating a broadly acceptable analysis or policy about an
issue, then there must be an attempt to integrate these three sources, using
each according to its appropriate contribution to the debate. What then is
the proportionate contribution of academic bioethics, in relation to profes-
sional and popular bioethics, and indeed in relation to other fonns of dis-
course in a democratic society, such as legal, economic, political, and reli—
gious? The primary task of any public body charged with providing a forum
for public moral discourse is to orchestrate these various perspectives.

Origins

Academic bioethics came into being when persons other than physi-
cians started to scrutinize the moral dimensions of the practices of medi-
cine. There is a long history of physicians doing so, but only rarely did
nonphysicians comment in a scholarly manner on the work of physicians.
If a date is to be found for the earliest suggestion of an academic bioethics,
it might be 1927. In that year, Chauncey Leake, a distinguished pharma-
cologist, but not a physician, published the ﬁrst modern edition of Thomas

S YSTEMA TIC APPROACHES TO BIOETHICS 69

Percival’s Medical Ethics, which originally appeared in England in 1803 and
served as the model for the American Medical Association’s Code of Ethics
in 1847. In the preface, he noted that Percival, while using the term
“ethics,” had in effect written a book on medical “etiquette,” describing the
ways in which physicians dealt with each other and their patients. Leake
suggested that a proper “ethics” would employ methods of moral philoso-
phy, and he called on philosophers to examine modern medicine from the
viewpoints of pragmatism, utilitarianism, and other ethical theories.

Leake’s call was not heeded until 1953, when joseph Fletcher, profes-
sor of moral theology at Episcopal School of Theology in Cambridge, pro—
duced Morals and Medicine, the ﬁrst serious effort by a nonphysician aca-
demic to examine certain medical mores, such as euthanasia, truth-telling,
abortion, and contraception. Fletcher, though a theologian, utilized the
philosophical approaches of pragmatism and utilitarianism. Several years
earlier, Williard Sperry, dean of the Harvard Divinity School, had pub—
lished his reﬂections on similar questions, but without a discernable meth-
odology or philosophical foundation.

In the mid-1960s, various academicians noted that the discoveries of
modern medical science posed interesting moral problems. European
theologians such as Karl Rahner and Helmut Thielicke ruminated about
creative forces being put into the hands of fallible humans, either extolling
their possibilities or warning about their misuse. In the United States,
theologiansjames Gustafson and Leroy Augenstein and philosophers Hans
Jonas and Martin Golding published reflective commentaries on similar
themes.

These, however, were occasional essays, raising questions and testing
approaches, rather than subjecting the world of biomedical science and
practice to focused moral analysis. In response to the proliferation of
ethical issues arising from developments in biomedicine, two centers for
research were created almost simultaneously, the Institute for Society, Eth-
ics, and the Life Sciences (now known as the Hastings Center) in 1969 and
the Joseph and Rose Kennedy Center for Bioethics in 1970. These two
centers can be seen as the principal source and stimulus for academic
bioethics in the United States and they have, in the past two decades, been
replicated in many forms and many places.

In the late 19608 and early 19705, US. medical schools began to ap—
point faculty in medical ethics. These persons, surprisingly, were not phy-
sicians but philosophers and theologians. Gradually, these faculty posi-
tions generated scholarly work that, more often than not, was published in
medical journals rather than in publications devoted to philosophy and
theology. This required a change in style, moving away from the vocabu—
lary and idioms common to those scholarly disciplines toward language
and arguments used by health professionals.

70 SOCIETY’S CHOICES

The most important stimulus to the development of academic bioeth—
ics was the establishment by Congress of the National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research.
Because of the nature of its mandate, the National Commission was re-
quired to carry on moral discourse in a way that satisﬁed the criteria for
formal ethics, met the exigencies of public policy and law, and responded
to popular concern about the abuse of research subjects. Two of its eleven
members were trained in theological ethics and a reputable philosopher
was immediately hired as a consultant. During its four years of existence,
the Commission asked a great number of philosophers and theologians to
contribute essays on specific topics, and the preparation ofits statement of
the ethical principles that should govern research with human subjects was
carried out with the advice of many scholars. The commission’s work
enlisted into the emerging field of bioethics many scholars who otherwise
would have remained in the more speculative world of academic philoso-
phy and theology. The subsequent President’s Commission continued this
endeavor.

Contributions

What did the early bioethicists, immigrants from other scholarly disci—
plines, contribute to the formation of this new field? Moral philosophy in
the United States had been attracted, since World War II, to the methods
of analytic and linguistic philosophy cultivated in British universities. This
style emphasized the logic of moral discourse, attending to deﬁnition of
terms and rigor of argument, and almost entirely ignored substantive moral
questions. A new subtopic of moral philosophy called metaethics became
the center of attention: it asked not what actions are right and good, but
what do “right” and “good” mean.

The philosophers who did reﬂect on substantive moral problems did
so in a remote manner, devoting their attention to the construction and
defense of theories that could provide a moral foundation for particular
moral claims. Thus, anyone trained in philosophy during the years after
World War II was likely to have acquired skills in the analysis of moral
language and the ability to defend or criticize utilitarian theory and its
alternatives. R.M. Hare, one of the most prominent moral philosophers of
the era, was asked to speak to the topic: Can the moral philosopher help in
doing philosophical medical ethics? He responded:

The main—perhaps the only—contribution of the philosopher to solu-
tion of these problems is the clariﬁcation of the logical properties of
tricky words like wrong, and the establishment of canons of valid argu-
ment. It is my belief that once issues are thoroughly clarified in this way,
the problems will not seem so perplexing . . . and, the philosophical

S YSTEMA TIC APPROACHES TO BIOETHICS 7]

difﬁculties having been removed, we can get on with discussing the prac—
tical difﬁculties, which are likely to remain serious. (Hare, 1977)

Professor Hare‘s comment implies that those adept at clarifying “philo-
sophical difﬁculties," which are mainly linguistic confusions, must bow out
of the discussion when the serious “practical difﬁculties" are addressed.
Or, at best, they enter this discussion with no more competence than any
other person. This View leaves little place for academic bioethics in public
moral discourse. At that time, the few philosphers interested in normative
ethics were concerned to ﬁnd ways in which moral views and arguments
could be defended as objective, that is, based on some grounds other than
the subjective personal attitudes and emotions of those expresssing the
views. For example, one among many such efforts was R. Firth’s theory
called the “Ideal Observer,” in which he proposed that thejudgment “x is
right” means “any person who is fully informed, impartial, and in a calm
frame of mind would approve of x.” This theory, and others like it, set a
tone for the work of moral philosophers that gave them a larger place in
public moral discourse than did Hare’s clariﬁcation of tricky words. The
Ideal Observer theory and its counterparts in the moral philosophy of that
era deﬁned the quality of mind and attitude that a moral philosopher
should bring to public moral discourse.

This is not to claim that all moral philosophers employed Firth’s Ideal
Observer theory, or its variants, in the solution of moral problems. Rather,
the theory implies that if public moral discourse is composed of popular
moral concern and professional moral pronouncements, as suggested
above, then the moral philosopher should approach the problem with an
attitude that can correct the defects of both of these contributions. As
noted in Chapter 1, the ideal of impartiality counters the pursuit of self-
interest as well as the militancy of advocacy and contributes to the revela-
tion of common interests and understandings. Popular moral concern is
often not fully informed and is often not calm: it is the emotional response
to what some perceive as a violation of rights. Professional moral pro-
nouncements are likewise not necessarily impartial, since the professional
group will advocate, often covertly and even unintentionally, for its own
interests. Full information, impartiality, and a calm frame of mind must
constantly be brought to bear on the discussion of contentious issues in
public moral discourse. The experience of the National Commission, in
which ethical analysis had to maneuver between public moral outrage over
abuses and the values of scientiﬁc progress, provides a vivid example.

In addition, moral philosophy attends to one particular feature of
moral discourse that is often neglected in popular and professional discus-
sions, namely, the justiﬁcation of ethical claims. Again, normative moral
philosophy had provided the theories that provided ultimate justiﬁcation,
but at the same time it emphasized certain general features ofjustjﬁcation

72 SOCIE'I'Y’S CHOICES

that should be present, regardless of the preferred theory, namely consis-
tency and generality. A good moral philosopher will be sensitive to incon—
sistency between positions or to the limited applicability of principles.
These are signiﬁcant virtues in public moral discourse, which is often highly
particularist.

The moral philosophers of the 19603 were pulled out of their concern
with the speculative questions of moral judgment into the world of practi-
cal concern over the rights and wrongs of such burning questions as civil
rights and the justiﬁcation of the war in Southeast Asia. Many serious
moral philosophers initiated courses dealing directly with these questions,
and a journal, Philosophy and Public Aﬂairs, was founded to pursue these
questions at the most rigorous intellectual level. just as the questions of
bioethics were emerging, moral philosophers were discovering the world
of practical moral problems.

The moral philosophers who initiated bioethics brought to this new
ﬁeld certain virtues of intellect and attitude that improved the quality of
discourse. They less commonly brought substantive moral positions. The
moral theologians, on the other hand, often did speak from such substan-
tive positions formulated within the ecclesiastical traditions from which
they came. Many moral theologians, especially those from the Roman
Catholic tradition, also utilized philosophical theory and method in their
analysis of moral problems. Many others, however, were more skeptical of
philosophy and relied on scriptural themes that they felt could be applied
to contemporary problems. Thus, the theological concept of covenant was
used tojustify and reﬁne the medical and research doctrine of informed
consent. In addition, moral theology in that era had something of a pro-
phetic mood: it was compelled to offer radical criticism of common life
and accepted norms. Hence, the advances of biomedical science were to
be viewed critically rather than accepted enthusiastically. Were these star—
tling advances manifestations of God’s creative power or examples of hu-
man hubris? Theologians who took this tone provided a cutting edge to
public moral discourse.

Among the many theologians who discussed the issues, Paul Ramsey of
Princeton University became the most prominent. Taking a stand ﬁrmly
situated on biblical ethics of covenant and the faithfulness of God toward
humankind, he trenchantly analyzed the new issues of the day—death by
brain criteria, transplantation, research with human subjects—in ways that
exposed their moral ambiguity and their threats to human dignity and
freedom. His book, Patient as Person (1970), was a monumental contribu-
tion to the ethical analysis of biomedicine and, while written from a theo—
logical viewpoint, has been influential on all subsequent work in the ﬁeld.

Neither philosophers nor theologians have been particularly success-
ful at one feature of public moral discourse. Whenever ethical discussion

S YSTEMA 'I‘IC APPROA CHES T0 BI 0E THI CS 7 3

rises to the level of public moral discourse, a variety of facts surround the
topic under discussion. As philosopher Dan W. Brock (this volume) writes,
“the consideration of economic costs, political feasibility, legal constraints,
potentials for abuse, and so forth, all bear on and must be considered as
part of the ethical case for a particular policy.” Even though bioethics is
remarkable for the concreteness with which it discusses its subjects, it re-
mains unclear how these factual features “must be considered as part of the
ethical case.” In the experience of the President’s Commission, philo-
sophical arguments about the claims of individual research subjects that
supported their compensation were countered by considerations of cost
and feasibility. It was never made clear how all these facts ﬁtted into a
coherent philosophical argument (President’s Commission, 1982). Cur—
rently, bioethics scholars are debating vigorously the relationship between
principles and facts, a debate that is essential to the role of academic
bioethics in public moral discourse.

Academic bioethics today has moved far beyond its beginnings. A
number of academic programs prepare students for the ﬁeld. These pro-
grams present students with a canon of topics and a variety of analytic
methodologies. As the ﬁeld grows, it incorporates the current trends in
philosophy and theology. Feminist philosophy in particular is making its
mark on bioethics and cross-cultural studies exert strong inﬂuence on
younger scholars. Philosophers trained in these emerging approaches may
be quite different from those in the earlier era: they may come with more
substantive views, as did the earlier theologians, rather than with the Ideal
Observer stance of moral philosophers trained after World War II. They
will most likely be more sensitive to the distortions of argument due to
differences in power or bias in the social construction of reality. They may
be more deconstructionist than analytic. They are more skeptical of theory.
Also, they are less likely than their predecessors to be uncritical heirs of the
Western liberal tradition. The same can be said of students coming into
bioethics from religious studies and theology. They too are now inﬂu—
enced by feminist, communitarian, and cross-cultural approaches; their
theological commitments may be less doctrinal and ecclesiastical than in
the past. The new generation of bioethicists, which is certainly more ex-
plicitly trained to deal with the complexities of the ﬁeld, will probably
bring different qualities to the public moral discourse about bioethics than
did the early scholars in the ﬁeld.

Contributions of Religious Ethicists to Biomedical Questions

Outside the ﬁeld of academic bioethics, in which theologians have
cooperated with philosophers, religious ethicists of many denominations
have contributed to public moral discourse about developments in bio—

74 SOCIETY 'S CHOICES

medicine. Clergy come into frequent contact with the wrenching moral
dilemmas of life and death. Many clergy today have spent time in formal
training programs in hospital pastoral counseling. Theological seminaries
offer courses on bioethics and their faculty often contribute to the denomi-
national literature on its topics. Several centers of theological and reli-
gious reﬂection on bioethics exist with church sponsorship, among them
The Park Ridge Center for the Study of Health, Faith, and Ethics, sup-
ported by the Lutheran Hospital Association; the Loma Linda Center for
Christian Bioethics, affiliated with the Seventh Day Adventist Church; and
the Popejohn XII Medico—Moral Research Center, operated under Catho-
lic auspices. A research center that focuses on religious and theological
aspects of the Human Genome Project has been funded by the ELSI pro—
gram at the Graduate Theological Union in Berkeley. Many denomina—
tions have established committees and commissions to report on bioethical
issues of relevance to their faith and doctrines. In these ways, theological
insights enter into public discourse about bioethics.

Dangerous Ways to Present Religious Ethics

Even so, certain ways of presenting religious beliefs do not contribute
to clear and sound ethical decision making. Many members of religious
communities consider their ethical positions to be rooted in the divine will
and religiously demanded. The problem comes when persons insist that
these revealed positions must be accepted by everyone else. To refuse to
allow others to see matters otherwise, and thus to be wrong, may be appro—
priate for one’s coreligionists, but it is a dangerous position to take as a
citizen. This impulse often arises when persons or groups locate evil in
some distinct part of the world—certain groups, certain practices, certain
ideas (see the background papers by Swezey).

Hopeful Developments

The rapid growth of multidisciplinary work on ethics is an immensely
hopeful development. This development has its counterpart in religion, as
in the production of periodicals like the journal of Religious Ethics and the
many institutes, commissions, and committees that confront questions of
ethics. And in no area is this more the case than in the field of biomedicine
and ethics. The essays produced for this study illustrate the point: such
essays would hardly have been taken seriously by medical scientists and
practitioners at an earlier time, but they are of much interest to many
individuals and institutions of the medical world today.

Areas of tension remain and are probably inevitable. Religious views,
precisely because they are religious, are likely to be held with great confi-

SYSTEMATIC APPROACHES TO BIOETHICS 75

dence and tenacity. But one should not suppose that the religious and
ethical positions of any religious group are unchanging. One holds fast to
what is central in one’s religion, but the view of what is in fact central may
and does change over time. American society faces many strains today,
apart from those directly related to religion, and each of us lives within that
ferment. The ferment demands attention, and urgently, and from many
quarters. One thing is unmistakable: religious specialists and leaders want
to be a part of the discussions, and many of them are qualiﬁed by tempera-
ment, learning, and experience to be valuable partners.

SCIENTISTS AND OTHER TECHNICAL EXPERTS

Do scientists as a community have any special contributions to make in
decisions involving the social and ethical impacts of biomedicine? If so,
what is the basis for their special status? Are there circumstances in which
society inappropriately relies on science or scientists for help in making
ethical decisions relating to biomedicine?

The American sociologist Robert Merton (1973) described science as a
ﬁeld of inquiry marked by unique ethical commitments (he called them
“norms") that enhance its trustworthiness. The idealized view of science
stresses its openness, its universality, its institutionalized procedures for
self-criticism and self-correction. These attributes might be taken to sup-
port the argument that scientists as a group are more virtuous than other
communities; their ethicaljudgments accordingly may be considered wor—
thy of special deference.

Historical and sociological writing about science, however, undermines
the notion of scientists as a community possessed of unique wisdom or
virtue, even with respect to the social consequences of their own inven-
tions. As Steven Shapin’s background paper points out, we cannot deduce
from the “truthfulness" of scientiﬁc claims that scientists themselves are
virtuous. If anything, individual virtue and mutual trust have historically
been preconditions for the production of scientiﬁc “truths” that are ac-
knowledged as such within a community of researchers.

Apart from questionable claims about scientists’ special virtue, there
are three additional grounds that might be advanced for why scientists
should be accorded a privileged place in ethical decision making:

0 First, science, because of its openness and critical tradition, can be
thought to provide a particularly appropriate discursive model for making
ethical decisions in a pluralist society.

0 Second, scientists, because of their closeness to the practice of medi-
cine and the use of technology, may be expected to have special insights
into ethical issues arising from their practice that would not as easily be
apparent to other users or consumers of technology.

76 SOCIETY 'S CHOICES

0 Third, science can be counted on to remove certain issues from
ethical debate because they are “facts” and hence are no longer open to
social negotiation: there is only one correct way to see them. The possibili—
ties and limitations of these arguments are discussed below.

Science as a Discursive Model

Arguably, US. political institutions have already incorporated some
important aspects of science's discursive style into procedures for ethical
deliberation. Openness and rational criticism, for example, are prized and
deeply embedded features of our political discourse. Openness in particu-
lar is a feature that distinguishes our political culture from that of closely
related polities like Britain’s (Brickman et al., 1985; Vogel, 1986).

Science, however, shares the stage with law as one of the two dominant
discursive traditions in America. These two traditions—the scientiﬁc and
the legal—have consistently drawn on each other for legitimation and have
in fact become closely intertwined over time. judge David Bazelon of the
DC. Circuit Court, for example, defended the (ultimately ill-fated) notion
of judicially imposed administrative procedures in the 1970s on the grounds
that these would open up agency decisions to “peer review” (Bazelon,
1977). The Supreme Court in its recent decision in Daubm v. Mmell Dow
cites peer review as a pertinent factor that courts should weigh in admitting
scientiﬁc testimony (61 U.S.L.W. 4805,]une 28, 1993). Equally, however,
scientiﬁc bodies from the National Academy of Sciences to more special-
ized expert groups have adopted features of legal procedure—ideas of
representation and due process, in particular—to give their opinions
greater weight. Examples range from consensus development panels at
NIH to the (successful) attempt by the California Medical Association to
declare clinical ecology an “unscientiﬁc” theory (Iasanoff, 1991).

It may not be farfetched to argue that our public moral discourse is
uniquely shaped by the conﬂuence of scientiﬁc and legal norms of criti-
cism. Science has supplied the authoritative model for determining what
kinds of arguments may be advanced in public life, whereas the law has
deeply inﬂuenced our thinking about who should be allowed to make
these arguments and through what procedures. This marriage of technical
rationality and political diversity sometimes produces authoritative results.
Other times, however, rationality frays under critical attack from divergent
viewpoints. Institutional design is the primary variable that can sway out-
comes in one or the other of these two directions.

Some of the most robust institutions for addressing the ethical dimen-
sions of biomedicine in the United States may be ones that combine the
scientiﬁc tradition of rational criticism with the legal tradition of opening
up expertise to scrutiny by non-experts or differently qualiﬁed experts.

SYSTEMATIC APPROACHES TO BIOETHICS 77

“Successful" exercises in clarifying moral questions or establishing a moral
consensus around biomedicine often reﬂect a deeper success in combining
the critical resources of science and law. For instance, a hospital ethics
committee may work because it opens up previously closed medicaljudg-
ments to additional lay and expert viewpoints: those of nurses, administra-
tors, religious counselors, and, of course, family members. The committee
thus is an institution that democratizes expertise. At the same time, it is a
forum that exposes lay values and assumptions that might otherwise have
remained unexamined to questioning from other perspectives and frames
of reference, including those of medical experts. Finally, it is a forum in
which the speciﬁcity of the decision and the procedural rules of the game
push parties toward making negotiated compromises.

Controversies about the work of ethics commissions (and public com—
missions more broadly) reﬂect our adherence to the ideals of due process
as well as rationality. Thus, challenges to commissions often center on
perceived violations of process values, such as inadequate representation of
affected interests. As a recent reminder of the strength of these percep-
tions, we may recall that James Watt, former Secretary of the Interior, was
forced from ofﬁce because of disparaging remarks about the composition of
an investigative commission. The legitimacy of commissions, in other words,
seems to require the incorporation of recognized forms of political bias; to
exclude relevant viewpoints—or to contest their inclusion, as Watt did—is
to court public repudiation. Yet intellectual bias (with economic affiliations
often taken as a convenient indicator of such bias) damages the credibility
of commissions, perhaps because it negates the institutional commitment
of such bodies to impartial discourse. Disqualiﬁcation on grounds of intel-
lectual bias may be the best way to describe the “voluntary” withdrawal of a
member of the NAS committee on DNA fingerprinting who was felt to have
inappropriately close ties to the biotechnology industry (Roberts, 1992).

The values ofwide representation and technically grounded rationality
are most likely to conﬂict in forums that employ overly formal processes of
criticism. For instance, the structured, adversarial format of litigation has
been shown to be considerably more effective in breaking down the bases
for scientiﬁc claims than in reconstructing a set of shared factual beliefs.
Accordingly, institutions that promote informal negotiation among com-
peting viewpoints are more likely to produce consensus, or at least an
unbiased airing of divergent positions, than are institutions that put their
primary emphasis on conceptual clarification.

Scientists’ Ethical Intuition

It is worth noting that scientists themselves have generally been eager
to disavow any special sensitivity or predictive power with respect to new

78 SOCIETY’S CHOICES

technologies or their social impacts. The idea that technologies are neu—
tral at the time of their creation has many adherents in science and engi-
neering. The corollary is the belief that it is society—not science—that
imbues technology with moral overtones by deciding how inventions will
be used. These beliefs may explain why suggestions by scientists like Rob-
ert Sinsheimer (1979) that certain lines of biological research may be in-
trinsically dangerous and should not be pursued were generally repudiated
by fellow scientists.

Similarly, many geneticists and molecular biologists, including James
Watson, have come to believe that the scientiﬁc community made a mistake at
the 1975 Asilomar conference by seeking to prejudge the risks of recombi-
nant DNA research. More politically sophisticated observers praise Asilomar
as an important moment of self-examination but one that also happened to
beneﬁt science. The exercise was immensely effective in forestalling exter-
nal regulation because it satisfied Congress for at least two decades that
scientists can and do take responsibility for the consequences of their re-
search. Yet, while many agree that Asilomar overstated the physical risks of
laboratory-based recombinant DNA research, the realization has also grown
that moral, social, and even environmental risks were underappreciated,
possibly because of the relatively closed technical nature of the debate.

Recent scholarly writing in history, sociology, and politics has done
much to dispel the notion of the neutrality of scientiﬁc discoveries and
technological artifacts, In particular, we have grown used to the idea that
technologies should be seen as products of social negotiation that neces-
sarily incorporate trade-offs among competing values (Bijker et al., 1990).
Technologies, particularly large and complex ones, are said to “have poli-
tics” in the sense that they presume the existence of particular social and
cultural organizations for their management and control (Winner, 1986).
Far from being rigidly bounded inanimate objects, modern technologies
are regarded as systems in which things, people, skills, practices, institu-
tions, and so forth are united in “networks" or “seamless webs” (Hughes,
1983; Latour, 1988). Technologies also have a ﬂuid and changeable di-
mension, since they can be altered by the practices of their users. A simple
example is the use of a drug that has been approved for one indication to
treat another unapproved indication.

These new perspectives provide a basis for thinking that scientists may
after all have special moral insights into the products of their ingenuity. By
stressing features of social and cultural embeddedness, recent scholarly
accounts help to read values back into science and technology. As central
participants in the project of creating and applying expert knowledge,
scientists necessarily participate in shaping the moral and political character
of technological products. Participation in public moral discourse may help
them to make their value commitments explicit, and then integrate these

SYSTEMATIC APPROACHES TO BIOETHICS 79

values into decision making. By contrast, preserving the ﬁction of scientific
neutrality, and thus excluding scientists from full participation in ethical
debate, may deprive society of an important avenue of moral criticism.

The difﬁculty, of course, is that the research community seems often
not to be aware of the social and ethical judgments that are embedded in
the practice of science or the design of technology. This is an area where
feminist critiques of science have opened a discussion of the preconcep-
tions of science (Keller, 1985; Haraway, 1989). For example, there is now
general agreement that women’s health issues have received dispropor-
tionately little attention in biomedical research and that study designs have
often been insensitive to questions of gender and culture. One illustration
is the case of clinical trials of contraceptives that assumed, inappropriately,
that the characteristics of user populations in the developing countries
would be the same as those in industrialized countries. Examples such as
this suggest that, in order to play an effective part in public moral dis-
course, scientists may first need to develop a more reﬂective understanding
of the ways in which they do science.

Facts and Values

Social and political institutions continue in hard cases to delegate to
science the power to make binding ethical judgments. Such delegation
often takes place in the guise of seeking a consensus on facts and then
allowing these facts to dictate rules of action. Thus, medical expertise has
variously been called upon to deﬁne “viability" for purposes of distinguish-
ing lawful from unlawful abortions; to deﬁne “death” so as to guide the use
of life-prolonging technologies; and to define “pre-embryos” in order to
establish the limits of permissible research with the human conceptus.
Building a scientific consensus around such morally loaded concepts can
be a convenient way of ending disputes. Science then appears to draw a
bright line that neatly separates permissible from impermissible social ac-
tion. The facts provided by science constitute a seemingly objective basis
for distinguishing right from wrong behavior.

Although this strategy of delegation may work well in terms of produc-
ing social harmony, we should keep in mind one or two caveats. First, as
noted above, Americans are not in general given to unquestioning accep-
tance of the authority of science. Indeed, our legal system has been a
powerful instrument for holding scientiﬁc experts accountable to lay mem-
bers of the public. In part, the law accomplishes this result by making
scientists speak in language that is accessible to nonexperts; this require-
ment has been particularly emphasized in the judicial review of agency
decisions. Further, the adversarial processes of the law very effectively
probe the basis for scientiﬁc claims and expose the assumptions and judg-

80 SOCIETY’S CHOICES

ments that have gone into the production of alleged facts. Finally, our
courts have in most cases refused to let legal outcomes be decided by
technical consensus alone. Witness, for example, the judicial insistence
that the expert’s role in court is to assist the factﬁnder, not to make the
ultimate factual assessment (see Daubm v. Merrell Dow, cited above).

Second, many studies of scientiﬁc controversies have called attention
to the point that what passes for “fact” on either side is often a construct
that incorporates clear elements of subjective judgment. The factual char-
acter of such “mixed” assertions can nevertheless be upheld through suc-
cessful boundary drawing. For example, scientiﬁc advisory committees
often effectively represent their Views as “science” or as “fact” simply on the
strength of their institutional role—which is to give factual or scientiﬁc
advice Gasanoff, 1990). If the boundaries are drawn tightly enough (e.g.,
when the experts are especially prestigious or closely knit), then others do
not think of questioning the epistemological status of the claims advanced
as “science.” Accepting the boundaries that scientists draw in such in-
stances, however, abdicates some degree of moral authority to experts.
This insight has repeatedly caused U.S. policymakers to insist that impor-
tant advisory bodies include lay opinions or, at the very least, a wide spec-
trum of scientific viewpoints.

Outlook

Summing up the three points discussed above, it is fair to say that
scientists do have a special role in making ethical decisions at the frontiers
of biomedicine. This role derives from their close involvement in the
processes of discovery and technological innovation and their subsequent
experience in monitoring and utilizing technologies in a health care con-
text. Yet for scientists to play their ethical part most effectively, they need
to be involved in forums that open up their perspectives and underlying
assumptions to critical evaluation. Scientiﬁc advice will tend to be least
ethically sensitive when it is offered as unexamined “fact.” It may advance
social decisions most in a context that forces scientists to become aware of
their own value commitments. For such reﬂexivity to become routine
among scientists working in changing areas of biomedicine, it may be
necessary to broaden scientists’ training to include formal work on the
social and ethical foundations of scientiﬁc knowledge and practice.

HEALTH CARE PROFESSIONAL EDUCATION
Origins
Many of the improvements that make modern medicine so powerful in
treating patients have resulted directly from the advances in our under-

SYSTEMATIC APPROACHES TO BIOETHICS 81

standing of disease processes made possible by biomedical research efforts.
These advances are rapidly incorporated into the education of health care
professionals in science-intensive curricula. The pressure of the ever-in-
creasing scientiﬁc content of the medical school curriculum, as well as the
emphasis on a mechanistic, reductionist model of disease, important for
the students’ understanding of modern diseases, threatens to force the
teachings about caring for the emotional and psychological stresses on the
patients with the diseases into a back seat.

Although many health care professionals believed that the formal
teaching of ethics was unnecessary, progress was being made to include
ethics courses in the curriculum, frequently as an elective. The Society for
Health and Human Values, founded in 1968, established a program
through which consultations were provided to medical schools interested
in initiating courses aimed at exploring the ethical and human values di-
mensions of the health care enterprise. Throughout the following decade,
faculty trained in the humanities began to appear in gradually increasing
numbers on medical school faculties.

In 1984, the Association of American Medical Colleges (AAMC) re-
leased a Report on the General Professional Education of the Physician and College
Preparation for Medicine (GPEP), in response to what was perceived as a
continuing and even accelerating erosion of the general education for
physicians (Muller, 1984). This forward-looking report was aimed at help-
ing the profession (and ultimately the patient) accommodate to the rapid
advances that were occurring in biomedical science and technology, in—
cluding the more complex and potentially more onerous treatments that
were emerging. It also called attention to social, environmental, and life-
style determinants of poor health status and increasing burdens of illness—
issues that in the previous two decades had been overshadowed by
medicine’s focus on technology (Muller, 1984). GPEP’s ethical dimension
is captured in the introduction, written by chair Steven Muller:

We believe that every physician should be caring, compassionate, and
dedicated to patients—to keeping them well and to helping them when
they are ill. Each should be committed to work, to learning, to rationali-
ty, to science, and to serving the greater society. Ethical sensitivity and
moral integrity, combined with equanimity, humility, and self-knowledge,
are quite essential qualities of all physicians.

It comes as no surprise that the ﬁrst recommendation of the report was
for a general professional education of the physician in which medical
faculties emphasize the acquisition and development of social skills, per-
sonal values, and attitudes by students at least to the same extent as they
emphasize the acquisition of technical knowledge. Unfortunately, the re-
port had little early detectable effect on the medical curriculum.

82 SOCIETY’S CHOICES

Sociologist Renee Fox has noted the repeated, unsuccessful calls for
such changes in medical education. In a penetrating article (1990), Fox
explored the origins and possible remedies for the lack of broader social
awareness among physicians. A highly analytic, logico—rational way of think-
ing and viewing the world, which produces a chain of dichotomies (mind
versus body, thought versus feeling, objective versus subjective, self versus
other, and individual versus social), is evident in the medical curriculum
in, for example, considerations of biomedical versus psychosocial compo-
nents. A second source of difficulty in developing caring competence in
physicians is the “dehumanizing” and “brutalizing” effect of medical educa-
tion on students. Medical students may experience these effects when they
confront human suffering without sufﬁcient mentoring, on exhausting
schedules, and in the face of the scientific determinism and reductionism
that characterizes molecular biology. Fox suggested several strategies for
making medical education and, ultimately, medical care, more humanistic:

0 more awareness of how biomedicine is imprinted with dichotomies
that split competence from caring;

0 more attention to the cognitive content of medicine;

0 more attention to the defense mechanisms developed during train—
ing and their implications for humane competence;

0 more effort to ensuring felicitous timing for training experiences;
and

0 a return by teachers to ﬁrsthand teaching.

As medical education has evolved to encompass ethics, a similar pro-
cess has occurred in the other health professions. In 1983, for example,
the American Dental Association (ADA) established a number of guide—
lines to serve as the ethical basis of the profession. The ADA Committee on
the Future of Dentistry recommended that methods be designed to assess
attitudes and interpersonal skills of dental school applicants and to identify
values, preferences, and goals of recent dental graduates (ADA, 1983). In
response to these two efforts, dental educator Muriel Bebeau designed a
curriculum based on real—life ethical problems to help dental students
identify, reason about, and adequately resolve ethical problems in the
dental profession. Other schools have modeled programs using her
insights.

Nursing schools have also developed educational programs in ethics.
A 1986 report of the American Association of Colleges of Nursing (AACN)
identiﬁed “essential” values to be addressed in the curriculum of nursing
ethics: these are altruism, equality, aesthetics, freedom, human dignity,
justice, and truth (AACN, 1986).

While some of the social and ethical issues facing doctors, dentists, and
nurses are unique to their speciﬁc medical disciplines, the health profes-

SYSTEMA TIC APPROACHES TO BIOETHICS 83

sions share many of the same concerns. Possible goals of ethics education
programs reﬂect those common issues:

0 To promote understanding of one’s own moral positions as well
as understanding and tolerance toward views of others in our pluralistic
society.

0 To recognize ethical issues in medical practice and biomedical re—
search, to improve skills for critical reasoning and analysis, and to inﬂu-
ence in a positive manner the health care professional’s moral maturity
(Self, 1988; Bickel, 1991, 1993; Culver et al., 1985).

0 To promote health care professionals’ social responsibilities to pa-
tients and the public, in other words, to aid the individual professional in
understanding his/her role within the rest of the society, thus encouraging
individual professional activity within the legitimate constraints of social
institutions and community values.

0 To understand the relationship between ill health and the social
context of disease (Tarlov, 1992; Maheux et al., 1990).

A 1987 AAMC survey of the medical ethics curricula, “Integrating Hu-
man Values Teaching Programs Into Medical Students’ Clinical Educa-
tion,” examined 113 course descriptions from the 1984—1985 school year
and 99 completed surveys from the 126 medical schools contacted. Ninety—
ﬁve schools (84 percent) required students to complete a human values
course in the ﬁrst two years, while 38 schools (34 percent) required such a
course in the last two years. Developments since 1980 included a reinforce—
ment or addition of human values emphasis during clerkships, addition of
one or more required human values courses into year one or two, enhance-
ment of human values emphasis in existing preclinical courses, and im—
proved integration of human values programs. The report ﬁnds that ethics
education often becomes integrated into the traditional curriculum in de-
ﬁnable stages, moving from preclinical courses given by humanities and/
or social sciences faculty, to subspecialty conferences and ethic rounds, to
more formal presentations and participation by the faculty in clinical edu-
cation of clerks and residents, to more formal commitments from clinical
departments and school administration. Barriers to integration of ethics
education into the curriculum include funding constraints, emphasis on
memorizing material rather than reflecting on it, competing faculty priori-
ties, departmental segregation, nonoptimal inpatient teaching environ-
ment (e.g., shorter hospital stays), lack of role models, and the dehumaniz-
ing aspects of medical education. The report also notes the need to develop
further mechanisms to improve human values education for residents.

More recent studies have attempted to define goals and basic curricula
in medical ethics for medical students (Culver et al., 1985), for clinicians
and ethics committee members (Thornton et al., 1993), and for internists

84 SOCIETY’S CHOICES

(ABIM, 1983). The Kennedy Institute has published a survey of the litera-
ture in this area (Coutts, 1991).

Contributions

Table 3—1 demonstrates the great number of medical schools that are
teaching courses related to ethical and social concerns, as well as the diver-
sity of curricular approaches to ethics—related topics. The variation in
approaches may be related to the resources available at each school, as well
as to the diversiﬁed subject matter, goals, and interests of the faculty.

Do such curricular additions have any impact on the individuals in
training? The work of Lawrence Kohlberg (1980, 1984) supports the idea
that moral reasoning ability is facilitated by exposing individuals to dilem-
mas that challenge one’s current level of moral reasoning skills. Other
studies reveal that moral development continues throughout formal edu—
cation and can be dramatic in early adulthood (the time of professional
training), and that well-developed educational interventions can enhance
ethical consciousness and commitment (Rest, 1988; Blasi, 1980;]osephson,
1988; Leming, 1981).

TABLE 3-1 Number of U.S. and Canadian Medical Schools Teaching
Selected Topics as Required Course Material (n = 139“)

 

 

Part of

Existing Separate

Course, Course, Do Not Data Not
Topics Required Required Offer Available
Computer applications in medicine 92 7 18 15
Cost containment 117 2 9
Death and dying 127 4 1 4
Domestic violence 95 0 23 18
History of medicine 53 10 38 25
Law and medicine

(medicaljurisprudence) 85 17 21 21

Literature and medicine 40 2 52 37
Long-term health care 105 7 9 17
Medical ethics 83 56 0 3
Physician—patient relationship 117 15 0 4
Termination of pregnancy 106 l 21 9

 

”Data for the four University of Illinois schools (Chicago, Peoria, Rockford, and Urbana-
Champaign) were tallied individually. Six of the 145 (126 U.S., 16 Canadian, and 3 Puerto
Rican) medical schools did not respond and are not included in this table.

SOURCE: Adapted from Association of American Medical Colleges (AAMC) Curriculum
Directory, 1992—93 (2lst Edition). Washington, DC: AAMC.

SYSTEMATIC APPROACHES TO BIOETHICS 85

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Bazelon, D. 1977. Coping with technology through the legal process. Cornell Law Review
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Bebeau, MJ. 1985. Teaching ethics in dentistry. journal ofDental Education 49: 236-243.

Bickel,]. 199]. Medical students’ professional ethics: Deﬁning the problems and developing
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Bicke1,j. 1993. Promoting Medical Students’ Ethical Development: A Resource Guide. Washington,
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Bijker, W.E., Hughes, T.P., and Pinch, T., eds. 1990. The Social Construction of Technological
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Blasi, A. 1980. Bridging moral cognition and moral action: A critical review of the literature.
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Brickman, R.,_]asanoff, S., and Ilgen, T. 1985. Controlling Chemicals: The Politics of Regulation in
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Coutts, M.C. 1991. Teaching Ethics in the Health Care Setting (Scope Note 16). Washington, DC:
National Reference Center for Bioethics Literature, Kennedy Institute of Ethics,
Georgetown University.

Culver, C.M., Clouser, KD., Gert, 13., Brody, H., Fletcher,].,_]onsen, A., Kopelman, L., Lynn,
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Fletcher, ]. 1954. Morals and Medicine: The Moral Problems of the Patients Right to Know the
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Fox, RC. 1990. Training in Caring and Competence. In: Educating Competent and Humane
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Thornton, B.C., Callahan, D., and Nelson, _].L. 1993. Bioethics education: Expanding the
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Winner, L. 1986. Do Artifacts Have Politics? In: The Whale and the Reactor. Chicago: University
of Chicago Press.

The Spectrum of Societal Responses

Public moral discourse on bioethics has been fostered in a variety of
ways in the United States. Some of the mechanisms described in this
chapter entail the formation ofa group of persons, as in grassroots organi-
zations, while others relate to the activities oflong-established social institu—
tions, such as the legal system. Each mechanism offers distinctive capaci-
ties and limitations, and together they shed light from many perspectives
on the complicated process of public deliberation of ethical issues. This
chapter summarizes salient features and activities of some of the more
prominent of these institutions.

Past social responses to ethical quandaries in biomedicine have suc-
ceeded in a variety of ways. For example, many public commissions, at the
minimum, have enlisted outstanding scholars to contribute their insights
on the issue of concern. Many of the products of these commissions have
been viewed as authoritative and have had a substantial impacg on policy
decisions, as for example occurred in the cases of deﬁning brain death and
establishing standards for human experimentation. These and other simi-
lar examples are described later in this chapter.

Commissions and other deliberative bodies operate in a world where
deadlines, personalities, and special interests converge. The necessity for
compromise is unavoidable. Many products of these commissions have
stood the test of time and continue to have a prominent role in education
for health professionals and ethicists. Hospital ethics committees, for ex-
ample, are often able to soften advocacy of patient interest in order to gain
the willing participation of health care providers (Hoffman, 1991). While

87

88 SOCIETY s CHOICES

the committee does not attempt in this report to perform a comprehensive
assessment of the performance of every social mechanism for deliberation
of ethical issues, one of the background papers in this volume by Gray does
assess some of the accomplishments, determinants of success, and views of
participants in the National Commission and President's Commission. The
accomplishments of other deliberative bodies described in this chapter are
outlined in greater detail in Appendix A.

The social and institutional context within which bioethics delibera-
tion takes place was described in Chapter 2. In this chapter, we are con-
cerned with the vast array of speciﬁc responses and mechanisms that facili-
tate the public deliberation of ethical issues in biomedicine. Whether, and
to what extent, the activities of these various groups and institutions have
been effective is a separate question that receives attention in Chapter 5,
where criteria for evaluating the effectiveness of the work of these bodies
are set forth.

For organizational purposes, this Chapter categorizes ethics bodies ac—
cording to their source of sponsorship or authority: political and legal
(e.g., federal commissions), professional and institutional (e.g., institu-
tional review boards), or grassroots (e.g., individual and community initia-
tives). It will become obvious, however, that there is signiﬁcant overlap in
the functions served by the different mechanisms, an overlap that deﬁes
neat categorization. In some cases, there are functional similarities be-
tween mechanisms that have signiﬁcant structural differences and operate
in separate societal spheres. The mechanisms have been created to fulﬁll
numerous functions—some very general, some quite speciﬁc, many inter-
related—including the following:

' to bring to the larger public the opportunity and the responsibility
(that previously belonged to elite groups) to deﬁne ethical issues;
0 to identify ethical issues at stake in areas of societal controversy;
to undertake a careful analysis of an issue;
to develop and/ or document areas of consensus;
to expose and document areas of disagreement;
to Lfnify the expertise of authorities from a wide variety of relevant

ﬁelds;

to represent competing interests;

to generate public awareness and debate;

to be a lightning rod for public concern;

to educate;

to correct misunderstandings and errors in reasoning;
to develop factual bases for public policy;

to offer guidance for decision making;

to develop recommendations for action;

SPECTRUM 0F SOCIETAL RESPONSES 89

0 to recommend new legislation or changes or improvements in exist-
ing public policy;

0 to sanction delays or recommend unpopular policies;

0 to dignify and legitimize ofﬁcial action;

0 to overcome bureaucratic obstacles; and

0 to justify the expenditure of money.

The functions served by a particular mechanism or group may be dic-
tated by a sponsor‘s mandate, or, as is frequently the case, be simply inci-
dental. For example, a group convened to recommend legislation on a
controversial issue may be unable to reach agreement on a plan of legisla-
tive action but, in the course of its work, may succeed at educating mem-
bers of society and perhaps even at reducing controversy by clarifying vari-
ous Viewpoints. Finally, experience has shown that what is ultimately
achieved through public deliberation often depends more on the particu—
lar issue and on societal circumstances than on the intended outcome of
the deliberation.

POLITICAL AND LEGAL MECHANISMS

It is not surprising—at least in democratic societies—that governments
should look for means to address the ethical and social consequences of
biomedical research, since research is heavily supported and encouraged
by government as a means of advancing human welfare. Yet during the 20
years following the Nuremburg tribunal, neither governments nor profes-
sional bodies paid more than glancing attention to the actual or potential
problems inherent in the activities and discoveries of biomedical scientists.
During this period, no framework existed forjudging when, how, and for
what reasons the government should get involved, nor was there a means
for determining which developments in the life sciences might pose signiﬁ-
cant problems.

Beginning in the late 1960s, however, the ﬁrst steps were taken toward
sustained examination of the ethical and social effects of the processes and
products of biomedical research. In 1966, for example, Surgeon General
William H. Stewart promulgated rules for peer examination of the ethics of
research protocols at Public Health Service grantee institutions (U.S. Pub-
lic Health Service, 1966). In 1968, the Government Research Subcommit-
tee of the Senate Committee on Government Operations held hearings on
a joint resolution sponsored by Senator Walter Mondale to establish a
National Advisory Commission on Health Science and Society (National
Commission on Health Science and Society, 1968). After the Ad Hoc Task
Force on Cardiac Replacement of the National Heart Institute acknowl-
edged that this new technology had ethical and social implications that

90 SOCIETY’S CHOICES

should be explored (1969), Dr. Theodore Cooper, then Director of the
National Heart Institute, appointed the Artiﬁcial Heart Assessment Panel,
which issued the ﬁrst major government report on the ethical implications
of new technologies (1973).

Commissions Established by Congress

When Senator Mondale initially proposed a commission, the first hu-
man-to—human heart transplants had just been performed, and his inten-
tion was for the commission to address ethical issues in biomedical devel-
opments and human subjects research. Over the next several years, further
developments in human reproduction (such as in vitro fertilization), neu—
roscience, behavioral medicine, and control of lethal diseases underscored
the need for a commission. Yet it was scandal in the research process
rather than the worrisome products of research that apparently convinced
the US. Congress to establish the first national commission on bioethics.
In the wake of the revelation in 1972 of the Tuskegee Syphilis Study, the
Senate Committee on Labor and Public Welfare held further hearings into
research abuses in state mental facilities and prisons (Senate Committee
on Labor and Public Welfare, 1973). The hearings were chaired by Sena-
tor Edward Kennedy, whose family has long been interested in issues affect-
ing retarded persons and whose family foundation had recently established
one of the ﬁrst “bioethics" centers at Georgetown University.

National Commission

As a result of these hearings, provisions were included in the National
Research Act of 1974 (PL. 93-348) to create the National Commission for
the Protection of Human Subjects of Biomedical and Behavioral Research
(National Commission), as well as to require that Public Health Service
(PHS) grantee institutions establish institutional review boards (IRBs) to
review the ethics of research projects carried out by their employees. Al-
though Senator Mondale‘s proposed examination of the ethical and social
implications of medical developments was incorporated as a special study
for the National Commission, the body’s primary mandate was to make
recommendations for the ethical conduct of research, including research
that involved various vulnerable populations.

The National Commission, which functioned from 1974 to 1978, was
appointed by the Secretary of Health, Education, and Welfare and oper-
ated within that department (DHEW). It was made up of 11 members, all
from outside the federal government: three physicians (one of whom was
elected chair of the body), two psychologists, three lawyers, two professors
of ethics, and one civic leader. Their work was aided by a professional and

SPECTRUM 0F SOCIETAL RESPONSES 91

support staff of 12 and further assisted by a number of consultants from
medicine, philosophy, law, and the social and natural sciences. The public
was allowed access to the commission’s deliberations, as well as to draft
papers; the commission also held several public hearings and made site
visits. During its four years, the National Commission issued ten reports:
five dealt with special groups of subjects (fetuses, prisoners, children, pa-
tients undergoing psychosurgery, and the institutionalized mentally in-
firm); two dealt with research review (reports on IRBs and on disclosure of
information under the Freedom of Information Act); one provided ethical
guidelines for delivery of health services by DHEW; and one reported the
results of the “special study” (the implications of research advances, the
topic inherited from the Mondale bill).

The best—known of the National Commission’s reports was the Belmont
Repoﬁ (1978a), which abstracted the general principles for protection of
research subjects that lay behind its other reports on particular aspects of
biomedical and behavioral research. It set forth three comprehensive
principles to “serve as a basic justification for the many practical ethical
prescriptions and evaluation of human actions”: (I) respect for persons,
(2) beneficence, and (3) justice. Respect for persons requires that indi-
viduals be treated as autonomous agents, while persons with diminished
autonomy are entitled to protection. Beneficence calls not only for pro-
tecting individuals from harm, but also for making efforts to secure their
well—being.1 justice relates to fairness in distribution of the beneﬁts and
burdens of research. The commission‘s provision of these explicit prin-
ciples for the analysis of ethical issues in language that was clear and acces-
sible to a lay audience enabled the general public to engage in informed
and effective discussion of such issues, and opened up a whole new field for
public discourse.

The recommendations in the commission’s report on fetal research
were made in May 1975 and were quickly translated into proposed federal
regulations. In that instance, DHEW’s need for regulations was at least as
important in provoking a rapid response as was the commission’s statutory
“action-forcing power" (i.e., the secretary had to either accept the com-
mission’s recommendations or make public the reasons for rejection). Not
all of the commission’s recommendations were as inﬂuential, however, and
while its core points provided the basis for what are now government-wide
regulations on human subjects research, several of the reports had little
inﬂuence. For example, DHEW did not respond to the commission’s
report on the institutionalized mentally infirm (1978c). But in light of the
novel nature of this enterprise, the work of the commission was impressive:

1 While the Belmont Report did not employ the term “non-maleﬁcence” (to do no harm), the
language it employed makes it clear that it encompasses this notion in the discussion of
beneficence.

 

92 SOCIETY’S CHOICES

its products met high standards of intellectual rigor, and the papers it
commissioned from major scholarly ﬁgures catalyzed the study of bioethics
as noted scholars became actively involved in addressing these issues.

President ’5 Commission

The statute establishing the National Commission suggested that, at
the conclusion of its term, a standing National Council for the Protection
of Human Subjects would be established to carry its work forward. Instead,
in 1978 the Congress authorized the President’s Commission for the Study
of Ethical Problems in Medicine and Biomedical and Behavioral Research
(President's Commission), thereby combining Senator Kennedy’s interest
in elevating the National Commission above the departmental level with
the desire of Representative Paul Rogers and his colleagues on the House
Health Subcommittee that the successor body take on topics beyond re-
search with human subjects (P.L. 95-622). In addition to requiring bien-
nial reports on the latter topic, Congress mandated that the President’s
Commission also report on the ethical and legal aspects of determining
death, informed consent, conﬁdentiality and privacy, genetic issues, and
disparities in access to health care.

While the National Commission had been quickly appointed, the Pres-
ident’s Commission was not sworn in for 14 months after the passage ofits
authorizing statute. Like the National Commission, membership in the
President’s Commission was divided into several categories: three from
biomedical or behavioral research (initially a professor of human genetics,
a professor of psychiatry, and a molecular biologist), three from the prac-
tice of medicine (a general internist, a cardiologist, and a pediatrician),
and ﬁve from other ﬁelds (a medical economist, a medical sociologist, a
professor of law, a professor of ethics, and a lawyer who was appointed by
the president to chair the commission). Two commissioners (the profes-
sors of ethics and law) had served on the National Commission, although
one had to resign almost immediately when she was appointed to a high
position in the federal government. Two other commissioners resigned
later, and seven others were replaced as their terms expired, so that 21
people in total served on the President's Commission. The staff usually
numbered about 20 (including 6 in support positions), but several of the
professional staff (a total of 23 individuals over the life of the commission)
served for only a year while on leave from academic positions. Addition-
ally, 16 students (primarily from medicine, law, and philosophy) served as
Congressional Fellows and interns.

Part of the delay in appointing the original commissioners apparently
resulted from political friction between the White House and Congress.
The executive branch was slow to choose the commissioners, and even

SPECTRUM 0F SOCIETAL RESPONSES 93

after they had been named in the summer of 1979, the commission could
not begin its work because no funds had been requested (or appropriated)
for it in the FY 1980 budget. When pressed to “reprogram” monies from
other activities, the leadership of DHEW eventually complied, but only
after deciding that it would end operation of its Ethics Advisory Board
(EAB) on the grounds that the President's Commission made the EAB
redundant (see below) and then transferred the funds originally allocated
for the EAB to the President’s Commission (1983d).

The commission’s statute included a “sunset" clause with a termination
date of December 31, 1982. In 1982, Senator Kennedy proposed that the
date be changed to 1984, but a provision of the December 1982 Continu—
ing Resolution (PL. 97-377) extended the commission only through March
31, 1983.

During its 39 months, the President’s Commission issued 17 volumes,
consisting of 10 reports (several with one or more appendix volumes), the
proceedings of a workshop on policies and procedures for responding to
reports of scientiﬁc misconduct (Whistleblowing in Biomedical Research, 1981 ) ,
and a loose—leaf book (The Ofﬁcial [RB Guidebook). Five of the reports dealt
with health care issues; four of these responded to the commission’s statu-
tory mandate: Deﬁning Death (1981), Making Health Care Decisions (1982a),
Screening and Counseling for Genetic Conditions (1983b), and Securing Access to
Health Care (1983c). The ﬁfth, Deciding to Forego Life—Sustaining Treatment
(1983a), grew out of the studies on determining death, informed consent,
and access to care. Four reports dealt with biomedical and behavioral
research, including the subject of human genetic engineering (at the re-
quest of the president’s science advisor) and compensation for research
injuries (at the request of the EAB, shortly before its demise). Finally, on
March 31, 1983, as it closed its doors, the commission issued a last report,
entitled Summing Up, that provided an overview of its work and that ad-
dressed the one topic (privacy and conﬁdentiality) in its original statutory
mandate that had not been the subject of a separate report (1983d).

Biomedical Ethics Board

The third major congressionally chartered bioethics effort was less
fortunate than its predecessors. Following 1982 hearings on the President’s
Commission report, Splicing Life (1982b), then—Representative Albert Gore,
jr., proposed the establishment of a presidential commission on genetic
engineering, a proposal that was later broadened to include other bioethi—
cal issues. Because of differences in viewpoint between Senate conserva-
tives and House liberals over what would result if another presidential
bioethics panel were authorized (Cook-Deegan, 1994), Congress in 1985
chose to locate the successor within the legislative branch. A Biomedical

94 SOCIETY’S CHOICES

Ethics Board (BEB) was authorized through September 30, 1988, to be
composed of six Senators and six Representatives (equally divided between
the two major parties) (P.L. 99—158). The BEB was responsible for appoint-
ing a l4—member Biomedical Ethics Advisory Committee (BEAC) made up
of experts from law, medicine, research, and ethics, as well as members of
the general public. The BEAC was instructed to begin its work by studying
three topics: human genetic engineering, fetal research, and food and ﬂuids
for dying patients (see Appendix A for a further description of the BEAC).

From the outset, politics—especially the sharp division in Congress
over the abortion issue—complicated the operation of the BEB and the
BEAC. It took nearly a year to choose the l2-member BEB and another 30
months of internal wrangling before BEB members could agree on 14
people for the BEAC; one of the 14 died before the BEAC could even hold
its ﬁrst meeting. Congress passed a two-year extension and an appropria-
tion for FY 1989, but withheld authority to meet or to expend funds until
the BEB agreed upon a new chair (which with the start of the 101$t Con-
gress had shifted from the House back to the Senate) and named a replace-
ment for the BEAC member who had died. The BEB was unable to do so,
and the BEAC had no further sessions after its second meeting in February
1989. It issued no reports, its staff departed by the end of FY 1989, and its
mandate expired on September 30, 1990.

Ethics Bodies in the Executive Branch

Ethics Advisory Board, DHE W

Among the recommendations of the National Commission was the
establishment ofa group within DHEW to provide ethical advice regarding
proposals that involved particularly sensitive types of research. This recom-
mendation became a part of the department’s regulations (45 CPR. 46),
and in September 1977 Secretaryjoseph Califano appointed a l4—member
Ethics Advisory Board to review problematic protocols that required spe-
cial scrutiny under the human subjects regulations (c.g., problematic pro-
tocols having to do with more than minimal risk for nonconsenting sub-
jects). The group had a distinguished interdisciplinary membership (see
Appendix A for further description of the EAB).

Between 1978 and 1980, the EAB’s principal work was to produce a
major report on stearrh Involving Human In Vitro Fertilization and Embryo
Transfer (May 4, 1979) , which came in response to an approved application
for NIH support of research that would have used in vitro fertilization
(IVF) in basic research. The EAB also conducted two inquiries in response
to requests from NIH and the Centers for Disease Control for legislative
recommendations that would provide for limited exemptions from the

SPECTRUM OF SOCIETAL RESPONSES 95

Freedom of Information Act. At the time it was disbanded in 1980, it had
also embarked on a study of another policy topic—compensation for re-
search injuries—that had previously been examined by a DHEW task force
(U.S. Department of Health, Education, and Welfare, 1977).

The EAB did creditable work, but for several reasons it remains at best
a footnote in the history of public bioethics. First, its report on IVF was
delivered to Dr. Califano’s successor, Patricia Harris, who had little interest
in the ﬁeld. Neither she nor any of her successors have ofﬁcially accepted
or rejected the EAB’s recommendations. Second, although the depart-
ment’s regulations continue to provide for the existence of an EAB, Secre-
tary Harris disbanded the existing body due to what was perceived as dupli-
cation with the President’s Commission, even though the EAB focused on
intra—agency issues and the commission on broad, national issues. Finally,
the lack of an EAB allowed the Reagan and Bush administrations to avoid
approving any research with human embryos or tissues between 1981 and
1992, during some of which time explicit moratoria on such research were
written into various congressional bills.

Recombinant DNA Advisory Committee, NIH

In 1975, the Director of NIH established a Recombinant DNA Advisory
Committee (RAC). This committee and its implementing regulations were
a response to the conclusions reached at a meeting held at the Asilomar
Conference Center in California under the sponsorship of the National
Academy of Sciences. The meeting addressed the concerns that had led
several leading molecular biologists to call for an international morato-
rium on certain classes of laboratory research using newly developed meth-
ods of cutting and splicing DNA. As a result of the meeting, the scientists
in attendance voted to lift the moratorium and adopted certain procedures
for their research, including developing means to carry it out more safely.
Since some members of Congress seemed to believe that these methods of
self-regulation by scientists might be too self—interested, NIH Director
Donald Fredrickson broadened the membership of the RAC to include
nonscientists.

The primary concern of the RAC in its ﬁrst years was laboratory safety;
thereafter, it began to confront issues involved with commercial develop-
ment of recombinant techniques and release of altered organisms into the
environment. While ethical issues were inherent in such deliberations, the
major focus was on technical concerns about the relative riskiness of par-
ticular microorganisms, with or without genetic alteration. In response to
the 1982 report of the President’s Commission, Splicing Life, the RAC de-
cided to address ethical issues more intensely by appointing a task force on
human gene therapy, subsequently modiﬁed into a standing Subcommit-

96 SOCIETY’S CHOICES

tee on Human Gene Therapy. This body eventually established the bench-
marks for review and approval of protocols to apply the techniques of gene
transfer to human beings in a set of “Points to Consider," which was ﬁrst
issued in 1988 and subsequently modiﬁed on a number of occasions. For
several years, protocols were reviewed ﬁrst by the subcommittee and then
by the RAC; by 1992, it was decided that, since the RAC was devoting most
of its own time to human gene protocols, the subcommittee’s work was
redundant and all proposals would come directly to RAG. On all matters,
the RAC is advisory to the Director of NIH, who publishes the committee’s
recommendations in the course of announcing which studies have been
approved for NIH funding or sponsorship.

The RAG is a multidisciplinary committee, a majority of whose mem—
bers are physicians and scientists who work in some aspect of molecular
biology or genetics. The committee also includes lawyers, social scientists,
ethicists, and members of the general public with an interest in genetic
disease. Although traditionally chaired by one of its scientiﬁc members,
the current chair is an ethicist with long involvement in genetic engineer-
ing issues. As a federal advisory committee, its meetings are announced in
the Federal Register and are open to the public; when important new scien-
tiﬁc projects are before the committee for review, media attention is often
intense and the group’s recommendations are given extensive coverage.

At the present time, the protocols that come before the RAC usually
involve the transfer of genes to serve as markers on cells being adminis-
tered in experimental therapies or to enhance the effectiveness of various
immunological methods of ﬁghting diseases like cancer and AIDS; in addi-
tion, some studies involving gene transfer to treat single-gene diseases have
been approved. Beyond such somatic cell gene therapy, the “Points to
Consider” state that the RAC will not now entertain proposals for gene
transfers that would affect germ-line cells. In light of developments in
molecular genetics, it may soon become necessary to consider when (if
ever), under what conditions, and for what reasons it would be appropriate
to broaden gene therapy to germ—line cells, or for purposes of genetic
enhancement. No attention has been given to such issues because RAG
meetings for several years have been absorbed with protocols under the
existing guidelines. At its September 1993 meeting, however, the RAC
placed these issues on its agenda for the coming year (see Appendix for
further description of the RAC).

Ethical, Legal, and Social Implications (ELSI) Working Group,
NCHGR and DOE

The Ethical, Legal, and Social Implications (ELSI) Working Group was
founded in 1988 at the National Center for Human Genome Research

SPECTRUM 0F SOCIETAL RESPONSES 97

(NCHGR) ofNIH. The US. Department ofEnergy (DOE)joined in support
of the ELSI Working Group in 1989. Having recognized that the capabili-
ties arising out of the Human Genome Initiative are likely to have a pro-
found impact on individuals and society, NIH created the ELSI Working
Group to explore such issues as fairness in the use of genetic information
with respect to insurance, employment, and the criminal justice system;
privacy of genetic information; and the inﬂuence of genetic information
on reproductive decisions (see Appendix A and the background paper by
Hanna in this volume for further descriptions of the ELSI Working Group).

Today, a sizable portion of the budgets for both NCHGR and DOE
(from 3 to 5 percent) is formally designated to support studies on the
identiﬁcation and examination of these broader impacts of genetic sci-
ence. This seems to be the ﬁrst instance in which a portion of a science
budget has been devoted speciﬁcally to the study of the ethical, legal, and
social impacts of science. In all other instances, we have allowed the tech—
nology to develop and to be applied, and the resulting ethical, legal, and
social dilemmas to arise, and then attempted to resolve them largely in
retrospect.

The impact of the ELSI program is not yet clear. Arguments that it is
overly academic and not adequately representative of society merit consid-
eration (see Hanna, this volume). At the same time, however, many ob-
servers and even some critics seem to agree that the ELSI program is
indeed stimulating effective ethical inquiries into genetic technologies and
encouraging the molecular biology community to design their technologi-
cal studies accordingly. Such an effect would be of great benefit to the
genome project, and the success of this earmarked ELSI funding program
could serve as a very useful model for other areas of science.

Human Fetal Tissue Transplantation Research Panel, DHHS

The NIH Human Fetal Tissue Transplantation Research Panel was
convened in 1988 at the request of Assistant Secretary for Health Robert
Windom. Following discussions with NIH Director James Wyngaarden
about proposed research that involved the transplantation of human fetal
neural tissue into patients with Parkinson’s disease, Dr. Windom requested
that a panel be formed to investigate the issue and formulated ten ques-
tions the panel was to address. Wyngaarden believed that the research was
extremely important, but that it also had the potential to stir controversy
and perhaps even to send a message to the public that NIH encouraged
abortions (Childress, 1991). Windom responded to Wyngaarden’s con—
cerns by issuing a moratorium on the use of fetal tissue in federally funded
transplantation research until NIH could convene a panel to deliberate the
issue and offer recommendations.

 

98 SOCIETY’S CHOICES

In the summer of 1988, the 21-member Human Fetal Tissue Trans-
plantation Research Panel was appointed. Nominations were submitted by
members of Congress and the executive branch, and by other interested
parties; categories for nominations included ethicists, lawyers, biomedical
researchers, physicians, public policy experts, and clergy. The panel selec-
tion process was closely watched by outsiders on both sides of the abortion
debate. Retired federal judge Arlin Adams, appointed as chairman of the
panel by an internal NIH committee, was a Republican who was opposed to
abortion.

When the panel met for the ﬁrst time in September 1988, it was asked
to respond to ten questions pertaining to the ethical implications of fetal
tissue transplantation research. Concerns about the source of the tissue to
be used in such research—elective abortions—ﬁgured heavily in these ques-
tions. For example:

0 Is it morally relevant whether the source of tissue is from an induced
or spontaneous abortion?

0 Does the use of the fetal tissue in research encourage women to
have an abortion that they might not otherwise undertake?

0 Should there be and could there be a prohibition on the donation
of fetal tissue between family members, or friends and acquaintances?
(NIH, 1988).

In the course of this three-day meeting it became apparent that a
single meeting did not allow sufﬁcient time to address such complex and
controversial issues. The panel had also intended to meet in executive
session, but amidst vigorous public outcry it was decided that panel delib-
erations would be open to the public. At the September meeting, the
panel heard from more than 50 invited speakers, as well as from represen—
tatives of various interest groups. The panel held a second meeting in
October and a third in December, at which it prepared its ﬁnal report to
the assistant secretary. Volume 1 contained responses to the ten questions,
along with panel members’ votes on each question; a summary of the
current scientiﬁc literature relevant to human fetal tissues transplantation
research; three concurring statements; two dissenting statements; and a
ﬁnal dissenting letter. Volume 2 of the report contained text of the testi-
mony submitted to the panel.

The majority of panel members (17 out of 21) voted in favor of permit-
ting fetal tissue transplantation research, provided that a woman’s decision
to abort be kept carefully separated from research. The panel’s report was
unanimously approved by the Advisory Committee to the NIH Director,
which urged acceptance of its recommendations, including the lifting of
the moratorium on federal funding of fetal tissue transplantation research
utilizing tissue from induced abortions, and the development of additional

SPECTRUM 0F SOCIETAL RESPONSES 99

policy guidance by NIH as needed. The recommendations of the panel
were not accepted, however, and the moratorium that had been declared
prior to their meeting continued.

State Commissions

New York State Task Force on Life and the Law

Following a public outcry over apparent abuses of “do not resuscitate”
orders in health care facilities, Governor Mario Cuomo of New York de-
cided to appoint a multidisciplinary panel under the leadership of his
Commissioner of Health, Dr. David Axelrod, to advise the executive and
legislative branches on a range of bioethical topics. Because of the strongly
held views of several religious communities in the state on some of these
issues, the New York State Task Force on Life and the Law has had (in
addition to the usual mixture of researchers, physicians, lawyers, and phi-
losophers) a larger representation of religious leaders than the equivalent
federal advisory commissions (see Appendix A and the background paper
by Brody for further descriptions of the New York State Task Force).

In other ways, however, the New York group is quite similar to its
federal counterparts. By 1993 it had issued eight reports on topics ranging
from surrogate parenting to the determination of death, from health care
proxies for incompetent patients to procuring and distributing organs for
transplantation. Although the task force has attempted to develop a con-
sensus position on the issues it addresses, its reports have sometimes con-
tained dissenting positions. By holding its meetings in private, it does not
use the meeting process itself to foster a consensus within the general
community or to test its tentative conclusions by airing them before the
community. Its reports are usually oriented toward practical recommenda-
tions for changes in state policy and hence are subject to public examina-
tion during the hearings held on any legislation proposed as a result. The
task force operates with annual appropriations, and its small staff is supple-
mented by the volunteered services of consultants.

New jersey Bioethics Commission

Beginning in 1983, an active grassroots group emerged in Newjersey
to involve lay people and health care professionals alike in responding to
the medical and legal developments reﬂected in such landmark cases as In
re Quinlan. This group, the Citizens’ Committee on Biomedical Ethics,
encouraged the legislature to establish an ofﬁcial body in 1985 in the wake
of the Conroy case regarding the withdrawal of artiﬁcial nutrition and by-
dration from an incompetent, dying patient. The State of New jersey

1 00 SOCIETY’S CHOICES

Commission on Legal and Ethical Problems in the Delivery of Health
Care—known informally as the New jersey Bioethics Commission—was
mandated to “provide a comprehensive and scholarly examination of the
impact of advancing technology on health care decisions” and speciﬁcally
to recommend policies to the governor, the legislature, and the citizens of
New Jersey (NJ. Public Law 1985, Ch. 363). The group was large (27
members) and included 4 legislators and 9 members designated from ex-
ecutive agencies and major statewide professional and health care organi-
zations. Its membership, which included representatives from law, medi-
cine, nursing, science, humanities, theology, health care administration,
and the Newjersey Citizen’s Committee, was appointed by the governor,
the Senate president, and the speaker of the General Assembly (see Appen—
dix A for further description of the Newjersey Bioethics Commission).

Within its broad mandate, the commission chose to focus its half—dozen
reports on three areas: surrogate motherhood (in light of the landmark
Baby Mcase) , decision making about medical treatment (especially the use
of advance directives), and the determination of death. The commission
also established ad hoc task forces on other topics (ethics, AIDS, protection
of vulnerable subjects); these groups, which included noncommissioners,
made recommendations to the parent body. Besides obtaining consult-
ants’ advice and supporting research (to supplement the work of its small
staff of two to ﬁve professionals), the commission took testimony at public
hearings. Its work resulted in considerable public and professional educa—
tion on its topics in Newjersey and in the adoption of two statutes (on the
determination of death and on advance directives for health care). How-
ever, conﬂicts within the commission and between the staff and commis-
sioners (particularly the legislator members) brought its work to an end in
1991 after six years.

Analysis of Governmental Bodies

Experience with ofﬁcially established and supported efforts to exam—
ine bioethical issues is too limited tojustify deﬁnitive conclusions, but it is
sufﬁcient to support some general ﬁndings. Since the broadest and best-
documented experience involved the National Commission and the
President’s Commission, our analysis begins with them and then widens to
encompass other federal and state panels.

Comparing the Commissions

The two national commissions had several features in common: both
were made up of 11 people from a variety of ﬁelds (about half from medi-
cine or research); they came from outside government; they met regularly

SPECTRUM 0F SOCIETAL RESPONSES I 01

(on average, for two days nearly once a month) and in public; their work
was carried out by a multidisciplinary staff; and they had “action-forcing
power” (that is, although the commissions could not issue regulations, any
federal agency to which they made recommendations was required to pub-
lish the recommendations and then respond within a specified time, either
adopting the recommendations or explaining why they had been rejected).

There were also some marked differences between the two commis—
sions: the mandate of the President’s Commission was considerably
broader, and it operated independently of any department or agency; no
new members were added to the National Commission during its four-year
life, whereas only three of the original members served throughout the life
of the President’s Commission; and the staff of the President’s Commis-
sion—which began with much greater expertise in bioethics than the Na-
tional Commission staff—was divided into working groups for the various
reports, meaning that many worked only on speciﬁed topics with no in—
volvement in other reports that concerned unrelated topics.

The President’s Commission mandate was broader, more responsive to
varied public concerns, and thus more publicly visible. Its ﬁrst publication,
Defining Death (1981), was eagerly awaited by various professional groups
and legislators who had been involved in ongoing debate over policies that
differed in only minor respects. The report presented a proposed resolu-
tion of the policy issues, and it also presented two very important consensus
documents: (1) a new model statute that was endorsed by key professional
groups (the American Bar Association, the American Medical Association,
and the National Conference of Commissions on Uniform State Laws) and
(2) a comprehensive statement of the criteria for the determination of
death, which was endorsed by 56 coauthors, including virtually all of the
physicians who had written about the subject in the United States. Thus,
this publication eliminated the perception that the relevant professionals
could not agree as to who should count as having died and what should
count as a good statute, factors that had posed barriers to adoption of
legislation in many states. The criteria for determination of death were
also published shortly thereafter (AMA, 1981), which led to widespread
awareness of the report itself.

Many of the later reports were awaited by engaged and eager audi-
ences, although these concerned publics were smaller or less visible than
the audience that welcomed Deﬁning Death. In the last month of its term,
the President’s Commission published two reports that had broader appeal
and receptive audiences: Deciding to Forego Life-Sustaining Treatment and Se-
curing Access to Health Care. The former document had been circulated to
hundreds of concerned citizens in draft and it included not only clear
recommendations about practice but also extensive appendices outlining
palliative care, statutes on advance directives, and policies on foregoing

1 02 SOCIETY‘S CHOICES

treatments. The Deciding report speciﬁcally addressed a series of troubling
dichotomies (e.g., withholding and withdrawing, killing and letting die)
and a series of troubling clinical settings (e.g., seriously ill newborns, or-
ders to withhold attempts at resuscitation, decisions for adults who do not
have decision-making capacity, treatment for patients who have perma-
nently lost consciousness). Also, its prose and presentation was specifically
designed to be accessible to any health care professional. By chance, the
report was released just as the “Baby Doe” case and the federal response to
it was unfolding, and it took a much more temperate tone than the ofﬁcial
federal response. For these reasons, Deciding was one of the “best sellers”
printed by the Government Printing Ofﬁce, which made it available at cost.
It remains a classic reference used in court cases, professional literature,
and education.

Securing also had an eager public, since allocation and equity were at
least as central to public concern in 1983 as now. However, this report
underwent many changes as the commission gained new members in its
ﬁnal months. The central ethical argument stayed largely intact, but many
examples and much strong language were excised. The report thus ended
up being an academic discourse on the role and function of commissions,
rather than affecting the public issue of access to health care.

The National Commission spoke primarily to federal ofﬁcials respon-
sible for human subjects regulations and to the biomedical research com-
munity (including members ofIRBs). The President's Commission, on the
other hand, chose to address many constituencies (which varied depend-
ing upon the topic). As a result, its reports on some subjects were virtually
unknown to readers who were concerned solely with other topics, although
specialists in bioethics generally kept abreast of—and commented on—the
commission’s work across the board,just as they had the work of the Na—
tional Commission. Both commissions considered some reports more im—
portant than others, and these same reports were usually regarded as more
inﬂuential and important by outsiders as well (see background paper by
Gray in this volume).

The central characteristics of both commissions were that they under—
took to study complex and sometimes quite highly charged topics; they
were able to do so in a thoughtful way because they operated outside the
usual political channels; and they were inﬂuential both because they oper-
ated with an ofﬁcial mandate and because they produced reports that were
accessible to the intelligent lay person as well as the scientiﬁc or ethical
expert. The ideal of impartiality, one of the primary characteristics of
ethical discourse, may not have been met completely, but the work of these
commissions was a serious approximation. They both attempted to exam—
ine all sides of the issues and to move beyond the limits of self-interest and
advocacy to ﬁnd broad grounds of agreement on controversial positions.

SPECTRUM 019 SOCIETA I. RESPONSES 103

Location and Autonomy

Two other influential characteristics of these commissions also stand
out: (1) national scope and (2) independence from political or ideological
control. Ethics committees appointed by professional organizations and
study groups established by bioethics centers have much to contribute, but
the public and its representatives do not place any particular weight on the
recommendations of these groups, which are neither accountable to the
public nor burdened with obligations toward the broad and unbiased in-
quiry that is incumbent upon public panels.

Further, while state and local ethics committees (both those appointed
by governmental entities and those established by institutions and profes-
sional groups) can play important roles, many of the most troublesome
issues do not stop at state borders, and some process for national delibera-
tion and formulation is needed. Not all states or localities have the re-
sources (or interest) to mount an effective effort, but they may still be able
to beneﬁt from the conclusions and recommendations of a national com—
mission. Many of the issues being studied are of greatest concern to the
federal government, such as the ethics of various types of research sup-
ported by federal agencies. And even when the issues involve matters of
state law and policy (such as the regulation of health care professionals and
institutions or the rules offamily law), a national inquiry avoids duplication
and may have the added advantage of leading to uniformity among the
states on issues where differences in policy or regulation can produce un-
desirable results.

The greater the visibility of a panel, however, the greater the danger
that its work will be encumbered by bureaucratic, ideological, or political
interference. In this sense, the sort of independence that the National
Commission and especially the President’s Commission enjoyed was criti-
cal to the work of these groups. The movement from departmental to
presidential status and the freedom from the polarizing issue of abortion
made the latter more independent and gave it greater visibility, higher
prestige, and better access to sources of information and advice, both in-
side and outside the government.

The close relationship between an ethics panel and its appointing
officer can also have beneficial results in terms of having its recommenda-
tions implemented. But there are other means of ensuring that the panel
will be listened to; in the end, it is more likely to be widely influential
because of the thoroughness of its inquiries and the soundness of its rec-
ommendations than because of its political connections. Moreover, the
danger of too much entanglement with the political process (particularly
when appointments are made by the legislative branch or involve legisla-
tors) is clearly evident in the experience of the Biomedical Ethics Advisory
Committee and the Newjersey Bioethics Commission.

 

I 04 SOCIETY’S CHOICES

Courts, Regulation, and Legislation

Society can also handle the ethical issues related to developments in
biomedicine through legal mechanisms such as courts, regulation, and
legislation. Ethics commissions and other consensual mechanisms can be
useful, but since these issues reﬂect choices among competing values, as
well as assessments of available data, even groups composed of highly ex-
pert and well-intentioned professionals can produce markedly different
decisions about bioethical questions. (See background paper by Gostin for
further description of the ways in which courts, regulation, and legislation
can impact such decisions).

Courts as Ethical Decision Makers

In our litigious society, courts often are the forum where ethical quan-
daries related to biomedicine ﬁrst make their appearance and demand
resolution. Courts therefore are necessary participants in the bioethics
debate, although their special institutional features both facilitate and de-
tract from their effectiveness in making health policy.

On the positive side, common law courts have developed for centuries
a tradition of ethically relevant decision making that places a high value on
reasoned explanation of judicial holdings. The practice ofjustiﬁcation by
precedent obliges courts to draw on settled legal principles, thereby reduc-
ing the likelihood of ill—considered or arbitraryjudgments. Courts deter-
mine ethical issues in the context of speciﬁc cases; this heightens the im-
mediacy of the questions, but, especially in the case of lower court decisions,
also usefully limits the negative impact of poorly reasoned opinions. A
dramatic case, such as Quinlan or Cruzan, provides a gripping narrative
through which abstract ethical concerns are made concrete for varied pub—
lics. At the same time, the tiered structure of the court system, the exist-
ence of multiplejurisdictions, and the practice of writing dissenting opin-
ions all serve to open up judicial reasoning to public criticism and
improvement.

On the negative side, courts employ an adversarial process that is not
necessarily conducive to dispassionate analysis or fact ﬁnding. Unlike leg—
islatures, courts are compelled to resolve the issues related to speciﬁc cases
and individuals that come before them, even if the basis for a principled
decision has not been fully laid. Yet courts are fundamentally reactive, in
that they cannot make policy unless decisions are put to them. This lack of
capacity may be especially evident when courts are confronted with con-
ﬂicts arising out of developments in biomedical science and technology.
Finally, the decentralized nature of the court system leads to contradictory
and confusing ethical pronouncements that may take years to sort out
through legislation or an authoritative higher court ruling.

SPECTRUM ()F SOCIETAL RESPONSES 105

The institutional strengths and weaknesses of courts have been re-
vealed in instances where new treatments raised ethical questions that were
submitted to the courts. For example, judicial leadership on questions
concerning the use of life-supporting technologies began with the New
jersey Supreme Court’s decision about Karen Ann Quinlan’s right to be
disconnected from a life support system. Since then, a series of decisions
by federal and state courts on refusing or withholding care have guided the
nation’s policy on these issues. Most signiﬁcant was the Supreme Court’s
decision in szan, which held that competent patients had a “liberty inter-
est” in refusing treatment and provided an impetus for state legislation.
Many state courts have extended this right of refusal to people who are
incapable of making a decision by respecting the decisions of surrogates,
particularly family members (see the background paper by Gostin in this
volume).

In some cases, courts have turned to other bodies for guidance in
deﬁning the circumstances under which treatment can be terminated. The
President’s Commission report on foregoing treatment was instrumental
in leading most courts to reject the distinction between withholding and
withdrawing treatment, between ordinary and extraordinary treatments,
and between terminal and nonterminal cases. In other cases, courts have
acted independently to set out procedures and criteria for decision mak-
ing, ranging from second opinions to the use of ethics committees or
ombudsmen.

Many times state legislatures became involved in these issues; they
acted only some time after court decisions and usually followed policies
implicit in those decisions. The most recent national actions in this area
came about when Congress passed the Patient Self-Determination Act,
which was implemented on December 1, 1991. The law requires health
care providers to inform their patients of the right to accept or refuse
medical care, including the right to give advance directives on the use of
medical means of sustaining life. Other times, state legislative action has
preceded court decisions and set policy in this area, most notably in natu-
ral death acts, determination of death (which many states enacted before
any court action as well), surrogacy, and, in recent times, reproductive
decisions. An example is the California Natural Death Act of 1976, which
preceded all court decisions, including Quinlan.

Courts have also been involved in a major way in the ﬁeld of reproduc-
tive rights. Beginning with the landmark cases of Griswold v. Connecticut
and Roe v. Wade, the courts for nearly two decades deﬁned the reproductive
rights of women. In the early cases, the Supreme Court found a constitu-
tional right of “privacy” even though no mention of the concept appears in
the Bill of Rights. In Griswold the Court used the newly identiﬁed right to
privacy to prevent states from interfering with the sale and distribution of

106 SOCIETY’S CHOICES

contraceptives. The Court explained that contraception concerns “the
most intimate of human activities and relationships.”

In Roe the Supreme Court stated that the constitutional promise of
privacy protects not only the right to use contraceptives but also the right
to decide whether to carry a fetus to term and the privacy of a woman’s
relationship with her physician (see the background paper by Gostin in
this volume). In recent years, there has been a signiﬁcant erosion of
privacy rights. The Court has upheld the authority of the state to restrict
the use of public employees and facilities for the use of nontherapeutic
abortions (see Gostin). The Court also upheld a regulation prohibiting
federally funded family planning clinics from counseling or referring
women to abortions (the so—called “gag rule”) (see Gostin). In Planned
Parenthood of Southeastern Pennsylvania 1/. Casey (see Gostin), the Court
changed the legal standard by which to evaluate restrictions on abortion.
This rule may allow states to place new restrictions on access, timing, and
information provision in abortion decisions.

In spite of these retrenchments, it has been argued that the extension
of the right to privacy since 1965 has had profound and positive effects on
reproductive policy (see Gostin). Prior to the Supreme Court’s entry into
the area, neither the legislative nor executive branch produced policies
that adequately recognized the need to balance the interests of pregnant
women against those of the state or the fetus. Current efforts to protect
reproductive privacy use the same “fundamental rights” analysis that the
Supreme Court employed in Roe v. Wade. State legislatures are also emulat-
ing thoughtful court rulings on related reproductive issues such as surro-
gate motherhood and artiﬁcial reproduction.

Courts will continue to play an important role in the deliberation of
emotionally charged issues in health care and biomedical innovation where
no formal policy is in place and where there is a fundamental claim of human
rights by individuals and groups. If, as has frequently occurred in certain
states, legislators have not proactively addressed issues of this character that
ﬂow from biomedical advances, the courts have been and will be required to
take the lead in resolving the legal and ethical issues that arise in particular
cases. For, while legislatures may choose not to act, courts cannot avoid this
burden once a case is before them. For example, courts have been involved
in such issues as the right to die and the ownership of sperm in a sperm bank.
If no statute provides a deﬁnite answer, courts must decide which precedents
seem most helpful, whether the scientiﬁc aspects are supported by sound
data, whether the common law provides guidance, and so on. Many court
decisions in these areas read like laws—some even set up speciﬁc adminis-
trative procedures to handle future cases—and they provide a blueprint for
subsequent legislation. Courts will also continue to play a signiﬁcant sec-
ondary role through their power to review federal regulations.

SPECTRUM 0F SOCIETAL RESPONSES 107

Regulations can take several forms—instructions, ﬁndings, deﬁnitions
of terms, and so on—but a prescribed set of actions, including solicitation
of public comment, must take place before federal regulations become
effective. It has become common for interested parties to pose legal chal-
lenges to regulations (in either their proposed or ﬁnal form). These chal-
lenges may be made on several grounds—the law does not authorize them,
they do not follow the law, the issuing process was faulty, and so on. Some
of these issues also have strong ethical elements. For example, the Su-
preme Court has rejected challenges against several regulations issued by
the Secretary of Health and Human Services that limited women’s rights to
abortion as established by Roe v. Wade.

Courts have to take the limited view imposed upon them by the case as
presented and by precedent; legislatures are buffered by special interests
and any legislation is inevitably marked by compromises. Public bioethical
deliberation can provide the broader view that the courts, which are set up
to focus on individual cases and circumstances, cannot easily provide and
can attempt an impartiality that legislation cannot always achieve. The
existence of bioethical opinion may inform the courts, as did the President’s
Commission opinion on foregoing life support in the Herbert case (Cali-
fornia Court of Appeals, Barber 1). Superior Coun, 1983), and may inﬂuence
the legislatures, as did the New York State Task Force on Life and Law.

International Perspectives2

Bioethics is generally regarded as a subject ﬁrst developed in the United
States. Until recently, a clear majority of books and articles in the ﬁeld was
published here, and the number of academic departments, courses, and
conferences was far greater in the United States than abroad. Similarly,
the U.S. government took the lead in investigating bioethical issues and in
issuing regulations when it established the National Commission and Pres-
ident’s Commission in the 19705. In the past few years, however, bioethics
has rapidly internationalized. Hospitals the world over have sprouted eth-
ics committees, new journals are appearing in foreign languages, and re-
gional and international bioethics societies have been formed.

While the United States has been notable for launching new initiatives
and sponsoring numerous activities on bioethics in the academic world, it
has not been as active in the support of governmental bioethics activity.
Since the demise of the President’s Commission in 1983, the United States
has had no national bioethics commission, despite the still-increasing pub-
lic and academic fascination with bioethical issues. In Europe, govern-

2 This section is based on research by committee member Daniel Wikler while he worked
as a consultant to the Ofﬁce of Technology Assessment.

I 08 SOCIETY’S CHOICES

ments have taken the initiative in this area; elsewhere, development of
bioethics is often prodded by governmental organizations. Multinational
organizations also have begun to deal with bioethical issues. As the U.S.
government considers the possible reestablishment of a bioethics agency
or commission, these foreign bioethics groups are available as positive and
negative models. A brief examination of the structure and agendas of
some of these bodies may prow’de valuable guidance for future govern-
ment-sponsored efforts in our own country.

A number of international organizations have been active in the ﬁeld
of bioethics. The Council for International Organizations of Medical Sci-
ence (CIOMS) was established in 1949 by two United Nations agencies:
the World Health Organization and UNESCO. In 1985, it constituted a
steering committee on bioethics representing a variety of professional back-
grounds and geographical areas, which in turn organized “international
dialogues” on ethical issues arising in such subjects as battered children,
human genome research, and family planning.

Over the years, CIOMS groups have offered international ethical guide-
lines on a number of topics, ranging from protection of human subjects of
medical experimentation (1982 and 1993) to ethical review of epidemio-
logical studies (1991). In addition, the Ofﬁce of Health Legislation of the
World Health Organization keeps track of bioethics actions of govern-
ments and multinational bodies, some of which are reported in its quar-
terly International Digest of Health Legislation. In 1993, UNESCO formed an
International Bioethics Committee with 46 members, chaired by Mme.
Noelle Lenoir, an attorney and member of France’s Conseil Constitu—
tionnel. Thus far this committee has held one meeting; another is planned.

The Council of Europe (CE), an organization created by European
governments in part for cooperation in cultural and scientiﬁc affairs, has
also become active in bioethics. Following a resolution presented by the
French Minister of Justice to the European Ministerial Conference on
Human Rights in Vienna in 1985, the CE created an Ad Hoc Committee of
Experts on Bioethics (CAHBI) to further the interests of member states in
bioethical issues. CAHBI’s aim is “to ﬁll the political and legal gaps that
may result from the rapid development of biomedical sciences,” but it must
achieve the voluntary consensus of member states. In 1992, the CE el-
evated the group to full legal status and gave it a new acronym: CDBI, for
Cornité Directeur de Bioethique Internationale.

CAHBI/CDBI was given a proposal in 1989 to create a European Bio-
ethics Committee; in 1992, itjudged such a step premature. However, the
committee recently held a Framework Convention for Bioethics, designed
to present norms on a variety of issues for consideration by the European
members of CE. The convention, which was open to nonmember states,

SPECTRUM 0F SOCIETAI. RESPONSES 109

considered general ethical principles related to organ transplantation,
medical research on humans, including embryos, and the use of genetic
information for nonmedical purposes.

Representatives of national bioethics committees, primarily but not
exclusively European, have met three times under CAHBI/CDBI auspices.
The council also empaneled a commission on ethical issues in reproduc-
tive technology, known as the Glover Commission after its chairman, Ox—
ford philosopher and bioethicistjonathan Glover.

The government of the European Community (EC), which is distinct
both in members and in function from the CE, has not yet sought to
establish a general European bioethics commission. In three instances,
however, the EC has initiated working groups on speciﬁc topics: one on
human embryos and research; a second on ethical, social, and legal as—
pects of human genome analysis; and a third on ethical issues in biotech-
nology. A fourth initiative involves the establishment of a research pro-
gram in bioethics, offering grants to scholars on a competitive basis. This
appears to be the world’s sole general fund for investigator—initiated bio-
ethics research. In addition, the European Parliament looks for technical
advice to its Scientiﬁc and Technological Options Assessment (STOA)
Programme,just as the US. Congress relies on its Office of Technology
Assessment.

In the Americas, the Pan American Health Organization (PAHO, a
regional ofﬁce of the World Health Organization) has fostered the devel-
opment of bioethics in Central and South America. PAHO’s general coun-
sel sits on the board of directors of the International Association of Bioeth-
ics, an international bioethics group founded in 1992. Planning is currently
under way to establish a Pan American Institute of Bioethics, to be located
at the University of Chile in Santiago. The institute, slated to begin its work
in 1994, is charged to provide a “permanent place for . . . discussion of
bioethical subjects.” However, its chief mission will be support of research
and training in bioethics for the region. Given the novelty of bioethics
research and policy in Latin America, its prospectus does not suggest the
kind of intergovernmental authority vested in the European organizations
(PAHO, 1992).

Other international organizations dealing with bioethics include inter-
national medical specialty societies and international bioethics societies.
The International Association of Bioethics (IAB) held its inaugural con-
gress in 1992, hosted by the National Health Council of the Netherlands
with the support of the EC. The IAB, headquartered in Australia, provides
a forum for diverse views on bioethical issues but does not itself take posi-
tions on any of them. None of the other organizations has yet attempted to
form an international bioethics commission.

 

I I 0 SOCIE'I‘Y'S CHOICES

Models of National Deliberation on Bioethics

Bioethics commissions have been widely used in other English-speak-
ing countries. A number of federal and state bioethics commissions have
contributed to health policy development in Australia, including the Law
Reform Commission on Human Tissue Transplant, the Medical Research
Ethics Committee, and the new Australian Health Ethics Committee
(AHEC), a committee of the National Health and Medical Research Coun-
cil (approximately analogous to the U.S. National Institutes of Health).
Bioethical issues have been discussed in regard to potential legislation by
Law Reform Commissions of both the Canadian government and the vari-
ous provinces. A Human Subjects Research Ethics Committee advises
Canada’s National Research Council on issues arising in experimentation
on human subjects.

Canada’s Royal Commission on New Reproductive Technologies is a
notably well—funded initiative that has only partially escaped the kind of
political heat generated by abortion politics that doomed the Biomedical
Ethics Advisory Committee in our Congress. It is charged with performing
a comprehensive and authoritative review of Canadian laws and practices
on present and forthcoming reproductive technologies. The commission
has a large professional staff, has sponsored considerable research, and
held hearings and open meetings around the country. Its reports were
recently published in 1993.

Latin American countries arejust beginning to establish bioethics com-
missions. In Mexico, a Commission Nacional de Bioetica, sponsored by the
federal government and reporting to the Ministry of Health, was created in
1992. The commission’s broad mandate includes oversight on environ-
mental as well as medical issues. In December 1992, Argentina’s National
Ministry of Health and Social Welfare established a National Bioethics
Commission for that country.

Despite the growing number of national bioethics commissions, few
commissions make a visible and signiﬁcant impact on national debate and
policy. There is considerable diversity of approach among the well-estab-
lished commissions, and the United States can learn from the experience
of each of them. Three models of national deliberation on bioethics merit
particular attention: the Danish commission, which stresses public educa-
tion and participation; the French commission, distilling the considered
judgment of an elite; and the current British approach, in which a private
commission takes on a public function.

Denmark, A Populist ModeL Denmark’s national bioethics committee is no-
table for at least two reasons. First, the country has not one but two national
bioethics commissions, with overlapping areas of interest. Second, one of
these commissions has a uniquely active program of public education.

SPEC'I‘RI ’M or S()(.'ll:"l}11. RESPONSES I I 1

The Central Scientiﬁc—Ethical Committee (CSEC) has been in opera-
tion since the late 19705. It was created in the wake of the Helsinki II
declaration on human experimentation and has been chaired by one ofits
drafters. CSEC originally played its role through a voluntary arrangement
of professional groups, but in 1992 it was given statutory authority. CSEC is
at the apex of a system of human subjects review boards that covers the
whole of Denmark; it acts on disputed proposals and in cases in which a
matter of principle must be decided.

In 1988, Parliament created a second council, the Danish Council of
Ethics, with a mandate to consider a broader range of bioethical issues.
The council’s 17 members are predominantly laypersons. Though the
reports are written by the members of the council, it has a slightly larger
staff than is common in Europe: three professionals, including a physician,
as well as administrative support; it also takes on academics for short peri-
ods of service.

The council’s public education efforts go beyond anything attempted
by US. bioethics commissions. In considering the deﬁnition of death, for
example, the council held public hearings and financed local debates. It
produced a film that was shown not only on national television but also in
movie theaters. The council produced booklets and brochures explaining
the basic facts about the deﬁnitions of death and distributed them at public
libraries. The council reportedly gathered the editors of 20 newspapers
and induced them to carry articles and exchanges on the subject; 1,000
articles and editorials were published over three years, drawing hundreds
of letters to editors. A competition for young people invited art works on
the concept of death; the winner of a poster contest won the privilege of
display as the cover of the council’s annual report.

For the report Protection of Human Gametes, Fertilized Ova, Embryos and
Fetuses, the council focused on schools (1990). It gathered educational
materials and prepared teaching material for education on these ethical
issues in the context of 17 subjects, ranging from biology and philosophy to
drama, music, and literature. These were sent to every high school in the
country. The council held a short—story contest, in cooperation with a
newspaper, which drew hundreds of entries. Its ﬁlm “Onskebarn”
(“Wished-for Child”) won a medal at the International Film and Television
Festival in New York.

The Danish Council of Ethics appears to be closer to the grass roots
than any other foreign commission, but it is not without its critics. Its
findings on the definition of death rejected the current global consensus,
which favors a brain death formulation, a step that drew criticism from
members of the other Danish group, the CSEC. The two commissions also
disagreed on the propriety of preserving brain tissue for research and
teaching purposes. Moreover, the council’s own surveys revealed wide-

 

I 12 SOCIETY‘S CHOICES

spread misunderstanding about brain death, not only before but also after
the massive public education campaigns.

France, An Elite Model. A Comité Consultatif National d’Ethique Pour les
Sciences de la Vie et de la Santé (National Consultative Ethics Committee
on Life and Medical Sciences) (CCNE) was created by the President of the
Republic in 1983. CCNE has over 40 members, drawn not only from
scholarly specialties and professional groups but also representative of
philosophical currents in France. The chair is appointed by the president,
and half of the membership is renewed every two years. Members are not
paid, and several have publicly complained about the lack of staff.

CCNE has issued over 30 reports thus far on topics ranging from the
testing of drug addicts in employment to genetic ﬁngerprints to reproduc-
tive technology. The committee also issues statements on topical ques-
tions, such as the introduction of RU-486 (the so—called abortion pill) and
sex-determination procedures in the Olympics. The committee is housed
at INSERM, which is analogous to NIH. Meetings are closed, and minutes,
which are released to the public, do not reﬂect the identity of those making
the remarks. However, a two-day public symposium is held each year (see
the background paper by Charo for a further description of the CCNE).

Questions can be brought to the committee by members of the govern-
ment, presidents of the two houses of parliament, or by public institutions
involved in research. CCNE also takes up topics of its own choosing. The
committee typically creates a subcommittee for each question or topic,
which eventually reports to CCNE as a whole. The latter has occasionally
rejected a subcommittee’s report.

CCNE aims to play a central role in the country’s deliberations over
bioethical issues. Its unusually large size permits wider representation of
views and interests. It attempts to enunciate general principles for the
whole of French society (e.g., that body parts must not be traded in com—
merce). The committee not only carries out studies of the chief bioethical
issues of the day, but also involves itself in day-to—day controversies arising
in the hospitals and courts. High in visibility and prestige, its meetings
have been addressed on several occasions by the President of the Republic.
Its outgoing chairman has been venerated as a public sage, the more-or—less
ofﬁcial national voice on bioethics. Its deliberations and ﬁndings are cov—
ered extensively by the press; the newspaper Le Monde covers the commis-
sion closely, providing reportage and commentary even on its philosophi-
cal deliberations. Thus, the French model, as opposed to the Danish one,
might be characterized as prescriptive, elite, and centralized.

United Kingdom, A Private Model. Bioethics policy is developed in many ways
and in many bodies in the United Kingdom. Its research councils, particu-
larly the Medical Research Council, publish an ethics series that focuses

SPECTRUM 0F SOCIETAL RESPONSES I I 3

primarily on human subjects issues. The British Medical Association has a
medical ethics committee, and the Royal Colleges (e.g., of Psychiatrists)
have issued numerous guidelines and position papers. Most prominent
among the bioethics councils was the recent Warnock Commission on
embryos and reproductive technology. Closely studied by academics as
well as patients and physicians, its recommendations were largely embod—
ied in new legislation.

However, the government has rejected suggestions that it create a na-
tional bioethics commission with a broader mandate. Explanations for this
reticence vary; one reason seems to be the past prime minister’s wish to
avoid placing undue restrictions on scientists. In this respect, as in others,
the United Kingdom is out of step with its fellow European states; promi-
nent bioethicists have complained that without a national commission they
are not able to identify and pursue the “British position" on these issues in
pan—European councils and conferences.

With an interest in a national commission rising in the face of govern-
mental refusal to go along, a private solution has been attempted. The
Nufﬁeld Foundation, an educational and charitable trust, was asked to
consider the organization of a private body that would function like the
governmental bioethics bodies in other European states. The new Nuﬂield
Council on Bioethics was founded after elaborate soundings of profes—
sional, scientific, legal, and consumer groups. Its 15 members do not
represent constituencies but are chosen for diversity. The council aims to
stimulate coordination between the diverse groups now contributing to
bioethics policy; to anticipate new problems, and to increase the public’s
awareness of the issues and of their importance. Several working groups
have already been set up. The staff consists of an executive director and
two administrative assistants.

The Nufﬁeld Council on Bioethics, as a private advisory body, will have
no regulatory role. Nevertheless, the foundation’s initiative was welcomed
by the government, and one ofits staff is government salaried. The council
seems to be fixed in the minds of British bioethicists as the national body.
Indeed, in its makeup and procedures, the council is conducting itselfjust
as it would if it were a creation of the national government. Whether it
will achieve the same inﬂuence and authority in national deliberations
over bioethical issues as its governmental counterparts abroad remains
uncertain.

Dimensions of Bioethics Commissions

This brief survey of bioethics commissions abroad permits no firm
judgments on relative successes and failures. However, the differences
between national approaches suggest a number of questions that might be

I I 4 SOCIETY'S CHOICES

considered by the United States in designing its own mechanisms for delib—
eration on bioethics.

Scope. Until recently, most bioethics commissions abroad have been topi-
cal—i.e., devoted to one or a small number of issues—and temporary.
Topics have been selected in advance by the sponsor. The French commis—
sion, however, is wide ranging and seemingly permanent, with the power to
investigate topics of its own choosing. Other commissions established in
Europe since the founding of the French commission, and perhaps in
imitation of it, have also been general, self-generating, and open ended.
Among the most inﬂuential commissions have been some single-topic ef-
forts, such as the Warnock Commission in the United Kingdom.

Sponsorship. The independence of ethics commissions abroad has been
regarded by most observers as essential to its moral authority. Whether
based in the legislature or in the executive branch, all commissions but the
U.K’s are public. Most answer to, and are located within, the ministries of
health. The US. President's Commission, which was administratively lo-
cated outside the departmental structure of the executive branch, has not
been seen as a precedent.

Public Access. Most of the commissions allow only limited public access.
Meetings are generally closed. In some cases, members of the public may
offer their views. Some commissions hold periodic public symposia. One
reason offered for the lack of public access is that some commissions rule
on particular cases and therefore require conﬁdentiality.

Professional Dominance. All governments have striven to ensure lay member—
ship on their commissions; in some cases, physicians and scientists are in a
clear minority. No survey data exist regarding public perceptions of the
commissions as independent or as “captured.” Unsystematic opinion sam-
pling suggests that, where separate boards or committees exist to oversee
human subjects research, these tend to be perceived as protective of the
interests of physicians and scientists, lay membership or majorities notwith-
standing.

Evaluation and Soundness. Bioethics commissions may be evaluated in many
dimensions such as productivity, influence, and soundness. Very little
evaluation has been done in any country to date. In this sense, all countries
are ﬂying blind. Soundness is the most difﬁcult of the criteria to assess, but
it is among the most important. In responses to a survey conducted by
OTA, the ﬁrmer the commentator’s credentials in academic bioethics, the
lower his or her opinion of the soundness of the bioethics commission
reports. Complaints that commission’s ﬁndings are poorly argued, or even
not argued at all, are common. Only a few commissions have followed the

SPECTRUM 0F SOCIETAL RESPONSES I 15

US. example of rotating professional staff recruited via paid leaves from
academic departments.

A different perspective emerges in some of the solicited comments and
in the literature: some believe that there is no such thing as expertise in
ethics; the commissions’ role is to act as forum, broker, and mediator for
diverse points of view. Thus a ﬁnding that represents a compromise be—
tween conﬂicting commissioners representing diverse constituencies would
be regarded as a successful one, even if none of the commissioners could (or
would wish to) support the compromised conclusion with data or argument.

Role. National bioethics commissions differ in their basic purpose. In some
instances, they are directly advisory to parliaments; their existence isjusti-
ﬁed by the need to develop legislation on complex technological and sci-
entiﬁc issues that can go slower and deeper than the usual legislative pro-
cess permits. In other cases, the commission exists to stimulate and educate
the public. Still others take on the role of distilling and articulating the
national sensibility on these matters.

Structure. All the commissions have a chair and numerous commissioners,
though they vary in size by a factor of four. Large commissions can be
more representative, but sacriﬁce working efﬁciency. More striking is the
difference in the size of the staff. Most have hardly any, although in a few
cases the staff is larger and well trained. Only Canada has provided to its
bioethics commission a staff comparable to that of the National Commis—
sion or the President’s Commission in the United States. As noted above,
there is considerable complaining among commissioners over the lack of
staff.

A National Voice? Particularly in international councils, the national bio-
ethics committees are increasingly seen as deﬁning their nation’s position
on bioethics issues. To this extent, they act as national spokesperson, even
though few commissioners are elected to their posts. In the United States,
commissions have not been regarded as bioethics policymakers except and
until their recommendations have been adopted as law (e.g., the human
subjects regulations of the National Commission, or the statutory deﬁni-
tion of death of the President’s Commission). As new entities multiply
within and outside of government, the designation of a national voice will
become more difﬁcult, and the goal itself open to further question.

PROFESSIONAL AND INSTITUTIONAL MECHANISMS

When Americans are confronted with a change in the moral landscape
arising from a change in our capacities to affect the world (e.g., a develop-
ment in biomedicine), we often slip into an assumption that the relevant

I I6 SOCIETY’S CHOICES

moral discourse need only address two questions: What should I do? And
what should our government do? For example, when we worry about
environmental degradation, we think of what each individual should re-
cycle and what action the federal government should take with regard to
environmental pollutants. When we worry about mapping the humane
genome, we focus on the opportunities and risks for individuals afﬂicted
with undesirable genotypes, and on the government‘s role in regulating
the use and abuse of this information.

Between the isolated individual and the impersonal actions of govern-
ment, however, lie numerous social institutions composed of deeply in-
grained, patterned sets of behaviors that shape our expectations and op-
portunities (Bellah et al., 1991). Social institutions include both large-scale
entities, such as the economy, the polity, religion, and the educational
system, and small-scale entities such as the family and professional and
voluntary associations. Voluntary and professional associations in particu-
lar often play active roles in changing policies and practices. For example,
local citizens’ groups, homeowners’ associations, architects’ and urban
planners’ professional associations actively participate in environmental
decision making. Similarly, groups interested in possible effects upon the
family, insurance pools and disability insuring, and the uses and abuses of
genetic testing become active in shaping the ethical discourse and formu-
lating guidelines and policies pertinent to genetic mapping.

Professional Societies and Voluntary Organizations

Professional medical associations and specialty societies [e.g., Ameri-
can Medical Association (AMA)], research institutes (e.g., RAND, the
Hastings Center), and even individual health maintenance organizations
(HMOs) (e.g., Group Health of Puget Sound, Harvard Community Health
Plan) have responded individually and cooperatively to the changes intro-
duced into the medical, legal, and ethical communities by biomedical tech-
nology. Medical associations in particular have long been involved in the
formulation of clinical practice guidelines and ethical policies in an at-
tempt to assist clinicians in the rendering of proper and appropriate care
to their patients.

An impetus to these guidance efforts has been the frequent abdication
by the federal government of responsibility for providing ethical guidance
to clinicians in many of the fastest-growing areas of biomedical technology.
In some cases, the guidance provided by professional societies is the sole
source of up—to-date scientiﬁc, legal, and practical information available to
practitioners. For example, the federal refusal to fund research on in vitro
fertilization left both researchers and clinicians with no organized forum
to consider practical and ethical issues presented by this technique. In

SPECTRUM OF SOCIETAI. RESPONSES 11 7

response to this neglect, many medical associations have stepped up their
efforts to provide ethical and practical guidelines to their members, and
several associations have established subcommittees to explore the un-
charted areas of biomedical technology and delineate practice options.

Medical associations have been in the forefront of the movement to
guide physicians through the legal and ethical quagmire produced by the
dual developments of greater technological advancement and government
inaction. Four that have been inﬂuential, active, and proliﬁc are the AMA,
the American College of Obstetricians and Gynecologists (ACOG), the
National Advisory Board on Ethics in Reproduction (NABER), and the
American College of Physicians (ACP).

AMA

The American Medical Association has taken a lead in the attempt to
guide its members through the ethical and legal dilemmas that surround
medical treatment decisions and the use of new technologies. It has a long
history of such guidance, beginning in 1847 with the establishment of a
code of ethics. The nine-member Council on Ethical and judicial Affairs
addresses the moral and legal concerns that attend clinical practice, prima-
rily through the issuance of regular reports containing opinions, guide-
lines, and relevant case law regarding a vast array of ethical and legal issues
presented by the rapid advancement of biomedical technology. Periodic
updates ensure that guidance provided to practitioners is based on the
most current scientiﬁc and legal information.

Recent reports address a wide range of concerns and provide detailed
advice to clinicians on topics such as:

0 conﬁdential care for minors, particularly those minors who may
seek contraceptive information and/ or abortions without parental knowl-
edge or consent;

0 the difﬁcult issues to be resolved if a patient’s AIDS status is to be
kept conﬁdential on autopsy reports; and

0 complexities of treatment decisions for seriously ill newborns (AMA,
1992b).

Two groups within the AMA issue recommendations for clinical practice
on speciﬁc technologies: the Council on Scientiﬁc Affairs and the Diagnos-
tic and Therapeutic Technology Assessment Program. The AMA also pro-
mulgates guidelines and recommendations through the widely read journal
of the American Medical Association.

In addition, the AMA has been instrumental in fostering cooperation
among specialized medical societies in order to provide professional guid—
ance and forums for discussion of biomedical technology and clinical prac-

1 1 8 SOCIE’I‘Y'S CHOICES

tice issues. The Practice Parameters Forum (PPF) is composed of nearly 50
volunteer specialty and state medical societies that attempt to devise crite-
ria forjudging the soundness of processes for developing practice param—
eters, deﬁne minimum standards of care, and set priorities for insurance
coverage.

ACOG

The American College of Obstetricians and Gynecologists exempliﬁes
the critical role that a medical specialty society can play in providing guid-
ance to physicians. ACOG produces detailed reports and guidelines for a
number of procedures that pose highly sensitive ethical and practical di—
lemmas for practitioners. Recent publications cover a wide range of issues,
including the following:

' sterilization, and in particular the use of this procedure among the
mentally retarded;

0 multifetal pregnancy reduction, selective fetal termination, and the
distinction between these procedures and abortion;

0 surrogate motherhood;

0 withholding or withdrawing life-sustaining medical therapy, which
carefully explored the tension between the obligation to alleviate pain and
suffering and prolong life;

0 the potential for industry’s ﬁnancial and educational support of
physicians to lead to conﬂict of interest and how best to avoid it; and

¢ the conﬂicts that arise when providing expert testimony in a trial
and the need to distinguish between maloccurrence and malpractice when
evaluating another physician’s actions (ACOG, 1992).

NABER

Fetal tissue research is governed by state law and federal regulation.
Department of Health and Human Services (DHHS) regulations, for ex—
ample, require that all funding of in vitro fertilization research involving
humans be reviewed by an ofﬁcially constituted board that—with the dis-
banding of the EAB in 1980—no longer exists. Since 1980, the country has
been without an ofﬁcially constituted group to provide analysis and advice
on ethically and socially controversial biomedical research protocols, and
clinicians and investigators have been without much—needed guidance.
Created in 1991 through thejoint efforts of the American Fertility Society
(AFS) and ACOG, the National Advisory Board on Ethics and Reproduc-
tion deals exclusively with the rapid growth in reproductive technology.
NABER has two stated purposes:

SPECTRUM ()F SOCIETA]. RESPONSES I I 9

1. To prow'de a public forum for informed and nonpartisan national
debate over the ethical issues raised by modern reproductive sciences and
technology.

2. To offer to the public, professionals, and policymakers sound, well
researched, and nonpartisan counsel on the ethics of research and clinical
practice involving reproductive services and technology (NABER, 1991).

The 12 members of NABER represent a variety of disciplines, includ-
ing theology, pediatrics, biomedical ethics, law, public policy, and obstet-
rics and gynecology. NABER offers itself as an independent body for re-
view of research protocols that have raised ethical problems difﬁcult for
local IRBs to resolve. It also conducted the initial work on the implications
of fetal cell sorting and oocyte donation.

A CP

The American College of Physicians publishes the American College of
Physicians Ethics Manual, now in its third edition (1992), which provides
guidance to physicians in clinical and research settings. The newly revised
manual treats a wide range of issues, including:

0 end—of-life care;

0 physician-assisted suicide;

0 HIV and physician/patient susceptibility to infection;

0 sexual contact between physicians and patients; and

0 physician/pharmaceutical industry relations and potential conﬂict
of interest.

The ACP also has an Ethics Committee that disseminates guidelines
through the publication of background papers and policy statements in
the Annals oflnlcmal Medicine. ACP also has established a Clinical Efﬁcacy
Assessment Project that carefully evaluates the merits of medical interven-
tions such as cardiac rehabilitation and certain diagnostic tests.

Other Medical Associations

A number of other medical societies has been actively engaged in
providing ethical guidance to their members. The American Academy of
Pediatrics (AAP) has developed influential guidelines for establishing hos-
pital ethics committees and authored many papers on bioethical subjects
such as informed consent, forced maternal treatment, research involving
children, Baby Doe issues, religious exemption from child abuse laws, and
organ procurement from anencephalic infants. The American Thoracic
Society has developed guidelines on foregoing life-sustaining treatment
(ATS, 1991) and on allocation within intensive care units.

120 SOCIETY’S CHOICES

A recently created organization called the American Association of
Bioethics (AAB) aims to provide a forum for collaboration among varied
professional societies in addressing ethical issues confronted in health sci-
ence and health care. The AAB board is composed of representatives from
the AMA, ACP, AHA, American Bar Association, and other professional
organizations, as well as several bioethicists.

Health Maintenance Organizations

In addition to the efforts of medical associations, individual HMOs,
motivated primarily by desires to reduce costs and simultaneously preserve
a reasonable standard of care, have made several efforts to guide physicians
and patients in their use of biomedical technology. Group Health of Puget
Sound (GHPS) developed a preventive care manual for its primary care
practitioners and has attempted to involve subscribers to the health plan in
decisions about the allocation of resources. The manual includes, for
example, risk—based guidelines for preventive services such as mammo—
grams. Harvard Community Health Plan (HCHP) has also developed sci-
entiﬁcally based clinical algorithms.

Challenges Presented by the Creation of Guidelines

All of these efforts to provide physicians with up-to—date information
and guidance are welcome, particularly in light of limited governmental
action in many areas. However, such efforts have not been without prob-
lems. Guidelines are devised by a variety of groups for a variety of pur-
poses, and the resulting welter of guidelines can often be inconsistent and
thus confusing. First, guidelines are sometimes not based on universally
accepted scientiﬁc evidence. Second, they are sometimes haphazardly and
inefﬁciently disseminated to their intended users. Third, they are some—
times offensive to physicians, who may not be receptive to guidelines that
do not mesh well with their practice and experience. Fourth, the various
guidelines may offer competing and contradictory advice, presenting prac-
titioners with additional ethical problems (IOM, 1992). For example, AMA
and ACOG offer conﬂicting guidance on the handling of surrogate moth-
erhood: AMA disapproves of the practice and advises against involvement
in it (AMA, 1992a), while ACOG regards it as a difﬁcult but potentially
acceptable pregnancy option (ACOG, 1990). Fifth, such guidelines often
do not incorporate patient preferences. Finally, the professional self-inter—
est of some groups may inadvertently inform and bias their speciﬁc recom-
mendations.

IOM examined many of these issues in a 1992 report on the difﬁculties
encountered by the Agency for Health Care Policy and Research (AHCPR)

SPECTRUM 0F SOCIETAL RESPONSES 121

in its attempt to comply with the congressional mandate to facilitate the
creation of clinical practice guidelines. As the importance of such guide-
lines becomes more apparent, however, greater care and increased atten-
tion are being devoted to rectifying these problems. As a result of such
attention, more systematic, consistent, and scientiﬁcally grounded guide-
lines may be formulated by individual societies as well. Two speciﬁc cases
illustrate the ways in which professional associations have dealt effectively
with the challenges presented by technological change.

Seriously Ill Newborns. Between the mid-19605 and the early 19805, an array
of devices and interventions greatly improved our ability to sustain the lives
of very small or seriously ill newborns. Lives were saved by these new
interventions, but often at the cost of severe physical and developmental
disabilities. Also, many lives were prolonged only to be lost after great
suffering. Thus, neonatal intensive care became a laboratory for the ethi-
cal questions: should life always be saved, and at what cost? (see jonsen,
1974).

In 1982, for example, a child was born in Bloomington, Indiana with
treatable physical defects that threatened its life and with an untreatable
genetic defect that predicted limited mental development. The parents
chose not to correct the physical defect. Reports of this event reached
President Reagan, who ordered DHHS to establish regulations to prevent
such events in the future. The department ordered neonatal intensive care
units to post conspicuous signs warning that children might be neglected
and giving a hotline number to report alleged neglect. This crude effort
was successfully challenged in court. Further efforts were made to regulate
clinical practice, ﬁnally resulting in legislation passed by Congress. How-
ever, in a most unusual move, the American Academy of Pediatrics and the
American College of Obstetricians and Gynecologists were invited to par-
ticipate in drafting the language of the statute, allowing them to bring up
considerations that reﬂected the bioethical discussions on such cases. The
subsequent “Baby Doe Rules," issued in 1982, were far from perfect, but
they were much improved by this contribution.

Artiﬁcial Nutrition and Hydration. Only a few decades ago, an elderly per-
son with serious disabilities who lost the ability to eat would die. During
the 19605, advances in the use of feeding tubes allowed doctors to alter the
timing and manner of death for these patients. Practitioners and scholars
were among the ﬁrst groups to question the advisability of such a proce-
dure (Micetich et al., 1983; Lynn and Childress, 1983; Zerwekh, 1983).
This new technology arrived without fanfare, without evaluation, and with-
out signiﬁcant direct cost (at least until the advent of total parenteral
nutrition).

When the inevitable court cases arose, they were met with a surprising

122 socuarys CHOICES

array of amici from professional societies. Briefs ﬁled on behalf of the
American Geriatrics Society (Lynn, 1984) and the members of the Pres-
ident’s Commission (which had disbanded) were referenced in the Conroy
opinion (1985). Throughout the discourse, various multidisciplinary and
specialty groups, including the Hastings Center, American Nurses Associa-
tion, and American Dietetic Association, issued guidelines designed to shape
practice and public opinion. In the szan case, for example, 19 health
care provider associations supported the removal of the feeding tube.
These examples demonstrate that professional and voluntary societies,
including HMOs, insurers, and research institutes, as well as medical asso-
ciations, can play an impressive and central role in the response to bio-
medical advances. Without the intervention of these groups, practitioners
would have little guidance in the proper employment of many new tech-
nologies and the ethical problems that their usage prompts. It seems
reasonable to conclude that these associations can also influence the fu—
ture course of policy and practice in the realm of biomedical technology.

Institutional Review Boards and Institutional Guidelines

The National Research Act of 1974 (PL. 93—348), which mandated the
establishment of institutional review boards in all research organizations
receiving federal funds to support research using human subjects, also
directed the National Commission to identify ethical principles relevant to
human subjects research, develop guidelines for the conduct of such re—
search, and examine IRB mechanisms for rew'ew of applications for human
subjects research, particularly in the case of research involving vulnerable
subjects. The National Commission described the purpose of an IRB as the
balancing of the interests of society in protecting the rights of individual
subjects with the developing of knowledge that can beneﬁt not only spe-
ciﬁc subjects but society as a whole (National Commission, 1978b).

The commission recommended that IRBs include persons who are
independent from the research process, so that objectivity is enhanced. It
also recommended that IRBs be situated at the local level, since local com-
mittees would be more familiar with the conditions surrounding human
studies research at particular institutions. The IRB protects the rights and
the welfare of individuals who participate in research protocols at the insti-
tution that establishes the board. In reviewing human subjects research
protocols, the IRB can approve or disapprove the proposed activity, or it
can require modiﬁcations that will make the proposed research accept—
able. Each IRB must have a minimum of five members with varying exper-
tise, attitudes, and backgrounds, including racial and cultural heritage.
Areas of expertise would include professional competence as well as under-
standings of institutional commitments, regulations, and law. The IRB is

SPECTRUM 0F SOCIETAL RESPONSES 123

required to keep detailed records of its actions. Prior to conducting re-
search on human beings, the institution must provide assurances to the
funding agencies that it will comply with policy requirements. These re-
quirements, the so-called Common Federal Policy, were adopted in 1991
by 16 federal agencies (not including the FDA, which has maintained its
own regulations) that conduct, support, or regulate research utilizing hu-
man subjects.

Before endorsing a proposed protocol, the IRB reviews six basic areas
of the protocol: the risks, informed consent procedures, equity, privacy,
vulnerable subjects, and undesirable incentives.

1. Risk. The risks (deﬁned in terms of probabilities or magnitude of
harm or discomfort) and beneﬁts (either providing new knowledge or
improving the health of the individual) to subjects. These risks can be
classified as physical, psychological, social, and economic (Levine, 1986).

2. Informed consent procedures. The human subject must clearly under-
stand the proposed research, have the capacity to give consent, and volun-
tarily decide whether to participate. The kinds ofinformation that must be
presented include the nature, purpose, and length of the experiments;
foreseeable risks and discomforts; potential beneﬁts to the subject or to
society; alternative procedures; the degree of conﬁdentiality for the re-
search records; whether compensation or medical treatments will be pro-
vided in the case of research-related injury; and a statement that the re-
search is voluntary and refusal to participate will not result in any penalty.

3. Equity. The IRB must also consider whether the selection of subjects
will be equitable so that burdens and beneﬁts are fairly distributed.

4. Privacy. Will the proposed research assure that the subject cannot
be identiﬁed in the research results and that the conﬁdentiality of the
information about the indiw'dual that is obtained will not be improperly
divulged?

5. Vulnerable subjects and undue inﬂuences. Subjects classiﬁed as vulner-
able include children, pregnant women, mentally disabled persons, prison-
ers, and economically or educationally disadvantaged persons. Distinct
limitations on the use of research on fetuses, research on human in vitro
fertilization, children, and prisoners are provided in the 1981 DHHS Com-
mon Federal Policy (45 C.F.R. 46).

6. Incentives. Finally the IRB considers whether the presence and kind
of incentives provided to the patient present undue pressure limiting the
voluntary nature of the participation decision. Payments can involve
money, free health care, free contraception, or a variety of other beneﬁts.

IRBs are an example of an innovative public mechanism for addressing
social and ethical issues related to research involving human subjects. IRBs
have been able to function with some efﬁciency because they have the

124 SOCIETY’S CHOICES

guidance of the federal regulations that resulted from the work of the
National Commission, especially from the principles established in the
Belmont Report. In addition, the constant stream of bioethical literature on
the ethics of research can provide insights about special problems that
arise.

Although the presence of IRB review has seemingly avoided any new
sensational transgressions in human investigation, at least three major prob-
lems remain to be addressed: (1) there has been little systematic study of
the adequacy of the decision-making process; (2) uncertainty exists about
the adequacy of balancing risks and beneﬁts as used in IRES; and (3) claims
have been made that the IRB protects the interests of institutions and
investigators over those of subjects (Levine, 1986). Another criticism is
that, although IRBs are effective at using rights-based criteria that protect
certain values such as autonomy, privacy, and justice, they are unsuccessful
at protecting the welfare of subjects as deﬁned in the federal regulations
that call for the balancing of the risks and beneﬁts of research (Williams,
1984). The reasons for this problem relate to the bias for approval in the
DHHS guidelines, the composition of the committee, and the operation of
committees (e.g., unwillingness to truly evaluate an investigator’s compe-
tence, the unappealing dilemma of either having to reject or redesign the
research, and the collective decision making that leads to greater willing-
ness to countenance risks (Veatch, 1987).

An additional problem with which IRBS must contend is that patients
may not adequately understand the scientiﬁc methodology used in a ran-
domized clinical trial (Appelbaum et al., 1987). In spite of acceptable
informed consent procedures, patients often distort or misinterpret the
research so that the research is seen to beneﬁt the person directly. This has
been labeled the “therapeutic misconception.” These concerns were also
raised in an article concerning the deaths of participants in the NIH drug
trial of Fialuridine, which raised questions not only about whether the
consent form gave the volunteers enough information, but whether des—
perately ill patients involved in a study can truly be informed (Altman,
1993).

Another problem is the time, space, and effort required to deal with
the paperwork generated by IRB review and monitoring. In the case of
large-scale, multicentered clinical trials, the logistics of separate review by
IRBs at all involved institutions, and responding to the concerns raised by
each, are also problematic. Lynn et al. (1994) describe the many differ—
ences that arose in the proposed informed consent procedures in 50 appli-
cations for a health services research project sponsored by the Robert
Woodjohnson Foundation. A similar diversity of institutional approaches
to consent requirements and risk determination was found by Kavanaugh
et al. (1979) when surveying genetic counseling centers.

SPECTRUM 0F SOCIETAL RESPONSES I 25

Because of problems with the IRB system of review, NIH awarded a
contract in 1992 to assess the status of the IRB system, in order to ensure
that the criteria for the protection of human subjects is still adequate in
light of the many changes that have occurred in biomedical, behavioral,
and social science research in recent years. This study is designed to
examine the costs and burdens borne by IRBs, and to make recommenda-
tions to improve the review process.

Hospital Ethics Committees and Physicians

Historical Development of Hospital Ethics Committees

In the last two decades many hospitals have instituted ethics commit-
tees charged with providing the institution and its staff with ethical guid-
ance in policy and practice. The development of the hospital ethics com-
mittee (HEC) parallels the history of medical ethics and, more particularly,
its rise as a clinical discipline (see the background paper by Heitman in this
volume). HECs evolved as physicians and other health care professionals,
hospital administrators, legal authorities, clergy, and patients and their
families struggled to make good decisions about applying resuscitative and
life-sustaining technologies. Hospital ethics committees constitute an evolv—
ing mechanism for sharing power that traditionally has belonged to physi—
cians. The existence of HECs conﬁrms that others also have the standing
to deﬁne, discuss, and intervene when signiﬁcant ethical problems inter-
rupt the continuum of patient care. While most of the work on and by
HECs has reﬂected developments in academic medical ethics, the con-
straints and practical nature of clinical ethics and institutional policy have
sometimes led to signiﬁcant divergence from theoretical ideals.

In 1990, the Joint Commission on Accreditation of the Health Care
Organizations (ICAHO, formerlyJCAH) proposed new accreditation stan—
dards on patient rights that included a requirement for “mechanism(s) for
the consideration of ethical issues in the care of patients and to provide
education to caregivers and patients on ethical issues in health care”
(ICAHO, 1992). These standards took effect on January 1, 1992, making
the existence of an ethics committee (or a similar body or process) a
requirement for accreditation and eligibility for Medicare payments for all
hospitals in the United States.

The actual prevalence of HECs has been difﬁcult to determine, al-
though there has clearly been remarkable growth in the last decade. The
President’s Commission survey of 602 hospitals found that in 1982 only 3
percent had an HEC or similar structure, all of them in hospitals with over
200 beds (President’s Commission, 1983a). In 1983, 26 percent of hospi-
tals responding to a national survey conducted by AHA’s National Society

126 SOCIETY 's CHOICES

for Patient Representatives reported having an HEC; in a repeat survey in
1985, that number had risen to 60 percent (Hospitals, 1985). Large teach-
ing hospitals were much more likely than others to have an HEC, and the
proportion of nonteaching hospitals with an ethics committee dropped
almost 10 percent in the two years between the surveys.

Despite the fact that over three years have passed since JCAHO’S pa-
tient rights standards were proposed, some hospitals—particularly small
private hospitals and those in rural areas—still do not have formal mecha-
nisms in place, and many are scrambling to determine what is required of
them. Even in many hospitals that have established HECs, committee
members remain uncertain about their roles, true purpose, and the ad-
equacy of their knowledge in ethics, law, or medicine (Hoffman, 1991;
Ross, 1991; and Cohen et al., 1992).

Roles of the HEC

As described in the extensive literature on clinical ethics, the HEC has
three typical roles:

1. the creation or recommendation of policy on ethical issues in pa-
tient care;

2. the education of hospital staff, patients, family members, and the
community on ethical issues and the institution’s policies; and

3. deliberation and consultation on speciﬁc questions in the treatment
of identiﬁed patients.

Not all HECs engage in all three activities, and some have additional re—
sponsibilities. jCAHO standards call only for committees to provide educa-
tion on ethical issues and to provide a forum for the discussion of those
issues. However, these three aspects of clinical ethics are complementary
and mutually sustaining.

The membership of the HECs ultimately reﬂects the question of who
the committee is intended to serve: the hospital, the physician, the staff,
the patient and family, or some other entity. Diversity of discipline and
professional expertise expands the HEC’s ability to recognize and under-
stand the medical and medically related problems and options that particu-
lar issues and cases may entail; the need for such diversity is widely appreci-
ated and addressed in practice. Less well addressed in practice is the need
for diversity of age, race, gender, ethnicity, and socioeconomic status.

In the past ﬁve years, networks of HECs have appeared across the United
States as individual committees consult with one another in an effort to
improve themselves (Kushner, 1988). Typically, members of networks
share institutional policies and general advice with newly developing com-
mittees, coordinate educational efforts, and review the handling of particu-

SPECTRUM ()F SOCIE'I‘AL RESPONSES 12 7

larly troublesome cases, real or ﬁctional. Such administrative umbrellas
may become increasingly important with the implementation of health
care reform, both to facilitate the integration of allied HECs and to ensure
that managed competition does not compromise the ethical quality of care.

As some HECS enter their second decade, many others arejust getting
started. A tremendous amount remains unknown about the future of
ethics committees. A few issues on the horizon include the development of
HECs in nursing homes and other long-term care facilities, the liability of
HECs and their members for advisory opinions, the role of HECs in cost
containment, and the need for careful evaluation of HECs in their many
capacities.

In the more than 10 years that professional organizations and licensing
and accrediting bodies have recommended or required the establishment
of HECs, there have been many calls for substantive evaluation of their
effects (Levine, 1977; President’s Commission, 1983a; Rosner, 1985; Craig
et a1., 1986; Hosford, 1986; Ross et al., 1986; Lo, 1987; van Allen et al., 1989;
McCloskey, 1991; West and Gibson, 1992). To date, assessment has been
limited to a few academic articles (primarily on their effects on do-not—
resuscitate orders and limiting intervention), workshops at professional
meetings, and the informal shoptalk of clinical ethicists.

IOM and OTA

The Institute of Medicine (IOM) and the Ofﬁce of Technology Assess-
ment (OTA) have also from time to time engaged in bioethics delibera-
tion. An arm of the National Academy of Sciences (NAS), IOM is a private,
nonprofit organization, associated with the government by virtue of the
1863 NAS congressional charter to advise the federal government on mat-
ters pertaining to science. OTA is a branch of the US. Congress, estab-
lished to advise congressional committees on technical issues in all areas of
science and technology. Both IOM and OTA have issued reports on a
variety of ethical issues over the past 20 years.

Institute of Medicine

IOM was chartered by NAS in 1970 to enlist distinguished members of
the medical and other professions in the study ofissues and problems that
affect human health. IOM’s principal resource for carrying out its mission
is its elected membership of nearly 1,000 professionals from the ﬁelds of
basic science, clinical science, behavioral and social science, and health
care. As mandated, at least 20 percent of IOM members are drawn from
fields outside of medicine, including law, economics, engineering, and the
physical sciences, lending to the membership a diversity that ensures a

I 28 SOCIETY’S CHOICES

breadth of perspective and multidisciplinary approach to IOM activities.
Other distinguished professionals who are not IOM members also contrib-
ute greatly to the work of IOM through service on committees and advisory
boards and through scholarly review of IOM reports.

IOM addresses health issues through a variety of mechanisms, includ—
ing workshops, roundtable sessions, forums, and symposia. Most fre-
quently, however, IOM convenes committees of persons with relevant ex-
pertise to conduct comprehensive studies of speciﬁc issues. Conducted in
response to requests from the federal government and other public and
private agencies, these studies usually last between 6 and 24 months and
result in independently reviewed, published reports with policy recom-
mendations. A large majority of the studies are funded by governmental
agencies; a smaller proportion are funded by foundations, voluntary orga—
nizations, and industry representatives. In some cases, ideas about issues
that merit study are generated within IOM and funded either from outside
sources or from lOM/NAS internal sources. Reports and other products
of IOM are disseminated to sponsoring agencies, interested professionals,
and the public.

IOM has a long-standing interest in bioethics, which was a new disci—
pline when IOM was founded. It seems evident from the wording of the
IOM charter and from some ofits initial activities that its establishment was
prompted by some of the same concerns that pushed bioethics into the
limelight as a discipline in its own right in the late 19605 and early 19705.
At that time, medicine was struggling (as it continues to do today) with new
dilemmas brought on in large part by the development of new and expen-
sive medical technologies. How should health care resources be allocated?
When is it appropriate or inappropriate to use medical technologies to
delay the end of life? These were some of the ﬁrst questions that IOM
attempted to answer in a 1973 conference on Health Care and Changing
Values. The report that resulted from this conference, Ethics of Health Care
(1974), examined such issues as the preciousness of life, the consumer’s
perception of health as a value, ethical problems in treating the chronically
ill and aged, and the origin of professional values.

Throughout the 19705, “ethical and legal aspects of health care deliv-
ery” remained an IOM program priority. A Division of Legal, Ethical, and
Educational Aspects of Health was established in 1977 and subsequently
published several reports, including The Elderly and Functional Dependency
(1977) and Beyond Malpractice: Compensation for Medical Injuries (1978a), as
well as commissioned papers such as The Rights of Physicians: A Philosophical
Essay (1978c) and Ethical Issues in Governmental Eﬂoﬁs to Promote Health
(1978b). Only one year after its establishment, a funding crisis stemming
from changes in federal policy regarding indirect costs challenged the
division’s core funding and it was eliminated. Although several ongoing

SPECTRUM 0F SOCIETAL RESPONSES 129

and newly initiated projects were shifted to other divisions and completed,
the division itself—and IOM’s only focused program on ethics—was not
preserved.

IOM nevertheless continues to address social and ethical issues in the
context of its reports. IOM has half a dozen of the leading bioethicists
among its elected members. Other ethicists have been sought to serve as
committee members and report reviewers, and social and ethical issues
have been made the focus of report chapters in some cases, and integrated
throughout reports in others (IOM, 1986, 1991a, 1991b, 1993). More
recently, IOM’s Division of Health Sciences Policy has taken on studies that
explicitly address social and ethical issues. In 1989, the division published
The Responsible Conduct of Research in the Health Sciences, a report that pro-
posed ways to encourage high ethical standards in the conduct of research
without harming the freedom and creativity that have traditionally charac-
terized U.S. research institutions. In 1990, NIH’s and Department of
Energy’s Ethical, Legal, and Social Implications Program commissioned an
IOM study of the issues raised by new capacities in genetic testing. The
report of this study committee, entitled, Assessing Genetic Risks, was recently
published (IOM, 1994). In 1992, NIH also provided funding for an IOM
committee to explore the legal and ethical issues relating to the inclusion
of women in clinical studies. While both studies addressed some scientiﬁc
issues, their primary focus was on ethical, legal, and social considerations.

How best to study ethical issues in medicine and health policy has been
another recurrent concern. Injune 1983, IOM convened a conference on
strategies for deliberation of ethical issues at the national level. The Pres-
ident’s Commission had expired at the end of March 1983, and the IOM
conference was intended for discussion of the need for a new group to
replace the President’s Commission and of the role, ifany, that IOM should
play. Conference participants were unanimous in their belief that a new
bioethics body was needed, but not in their opinions about whether IOM
should have a role. In their debate about the role of IOM in national bio—
ethics deliberation, they noted several advantages and disadvantages of IOM
as a professional/ institutional mechanism for deliberation of ethical issues.

Characteristics that enhance IOM’s ability to address ethical issues care-
fully and credibly include the fact that IOM is a private organization and
therefore less subject than a government agency or federal body to chang-
ing political winds. Its membership is large and diverse, and it frequently
draws on the expertise of nonmember professionals when needed. Signifi-
cant care is taken in the composition of IOM committees to ensure that
diverse viewpoints on an issue are represented, that biases are disclosed,
and that individuals with potential conﬂicts ofinterest do not participate in
the development of recommendations in the area of conﬂict.

Other characteristics could be said to detract from IOM’s ability to

I 30 SOCIETY’S CHOICES

address ethical issues credibly. IOM has little stable funding and therefore
has limited ability to direct its attention to issues that it deems important
but for which funding might not be available from government or private
sources. In addition, administrative complications arising from multiple
sources of funding can delay the initiation of projects considerably, limit—
ing IOM’s ability to take on ethical issues or dilemmas requiring a prompt
response. Recently, administrative reforms have enhanced IOM’s capacity
to conduct rapid studies on focused issues, once funding is secured.

IOM’s effectiveness could also be called into question because it con—
ducts the majority of its work in private. [OM is not subject to the Federal
Advisory Committee Act of 1972, which requires federal advisory bodies to
permit public access to their deliberations. Particularly in the American
cultural context, people may be reluctant to embrace conclusions on value-
laden ethical issues when they are reached behind closed doors.

Ofﬁce of Technology Assessment

OTA was established by Congress in 1972 to respond to requests by
congressional committees for analyses of emerging and complex technical
issues in a wide range of ﬁelds. Governed by a 12-member Technology
Assessment Board composed of six Senators and six Representatives, OTA
organizes brieﬁngs, provides testimony, and conducts extensive studies,
some requiring more than two years to complete. Participants include
OTA staff, professionals from the private sector and the academic commu-
nity, representatives from public interest groups and state and local gov-
ernments, and citizens at large. Through these activities, OTA assists
Congress in clarifying uncertainties, resolving conﬂicting claims, and expli-
cating options in the vast arena of science and technology policy. As its
name implies, one of OTA’s foremost responsibilities is to assess the impact
of new developments on future federal policy. While OTA frequently
identiﬁes the pros and cons of proposed policies or actions, however, it
does not make policy recommendations.

OTA began to address ethical issues explicitly in the early 19805, begin—
ning with a 1983 report on the role of genetic testing in the prevention of
occupational disease (OTA, 1983). The following year, OTA published a
report on human gene therapy that speciﬁcally addressed the ethical ac—
ceptability of different kinds of gene therapy and their implications for
society (OTA, 1984a). A series of reports followed that included chapters
on ethical considerations or extensive discussions of ethical issues (OTA,
1984b; 1985a; 1986; 1987c; 1988b,c). Bioethicists were increasingly sought
to consult on OTA projects related to health policy and biomedical re—
search. At one point, each OTA report generally contained an ethics
chapter, and, at times, OTA employed a resident bioethicist.

SPECTRUM 0F SOCIETA L RESPONSES 131

In the late 19805 and early 1990s, several more reports that gave pri-
mary emphasis to ethical considerations were issued by OTA: Technology
and Aging in America (1985b), Ownership of Human Tissues and Cells (1987b),
LifeSustaining Technologies and the Elderly (1987a), Infertility: Medical and
Social Choices (1988a), Parenting Life (1989), Neural Grafting: Repairing the
Brain and Spinal Cord (1990), and Summary: Evaluation of the Oregon Medicaid
Proposal (1992b). OTA continues to be involved in ethics today, having
recently conducted studies of cystic ﬁbrosis and health insurers (1992a)
and ethics in US. public policy (1993).

Thus, while OTA has never had an explicit mandate to address bioethi-
cal issues, its efforts to assess the impacts of emerging technologies on
society have forced it to confront complex ethical dilemmas on several
occasions. Like IOM, OTA has inherent strengths and weaknesses as a
deliberator of ethical issues in medicine and health policy. One of OTA's
strengths is its ability to enlist the expertise of a wide range of persons
representing different social and ethical perspectives to participate in work-
ing groups or to provide testimony. In addition, OTA has an informal
policy that all of its activities are accessible to the public, a policy that
enhances its ability to gather information as well as its credibility. Another
strength is stable funding: OTA need not raise funds from outside sources
to conduct its activities; all funding is provided by congressional allocation.
This allows OTA to activate studies quickly and deliver reports in a timely
fashion.

One of OTA’s weaknesses as a deliberator of value—laden ethical issues
is that, by virtue of its attachment to Congress, it is perceived as a highly
political entity. When the President’s Commission expired in 1983, OTA
(like IOM) was considered as a possible locus for a replacement ethics
body. Claims that an OTA-based ethics body would be “bureaucratized and
inadequately buffered from the political process” and that “elected ofﬁcials
would retain direct control over OTA policy” in part kept this from coming
to fruition (Abram and Wolf, 1984). Finally, while OTA is able to respond
rapidly to direct congressional requests for studies, it is not well situated to
respond quickly to needs that arise outside of Congress, whether in federal
agencies or elsewhere. Federal agencies hoping to initiate an OTA study
must work with Congress to have the study commissioned. In the case of
ethical dilemmas requiring prompt resolution, delays in the commission-
ing of a study pose serious disadvantages.

Ethics Centers

Deliberation about ethical issues arising from developments in bio—
medicine also takes place at several research and educational centers
throughout the world devoted speciﬁcally to the study of ethics. Described

132 SOCIETY’S CHOICES

here are the Hastings Center and the Kennedy Institute of Ethics, two of
the best-known ethics centers in this country. However, they are only two
of a cadre of centers devoted to bioethics research and education that have
experienced tremendous growth in the past two decades. Together, hun-
dreds of bioethics organizations around the world comprise a remarkable
new resource for policymaking, analysis, consultation, and education in
medicine and the life sciences. Ethics centers such as Hastings and
Kennedy inﬂuence policy development in the area of ethics through
conferences, publications, and educational programs. In addition, staff
from these centers are frequently called upon to serve on the boards of
academic institutions, research centers, professional societies, and non-
proﬁt organizations, as well as journal editorial boards. The Clinton admin-
istration’s task force on health care reform provides a recent example
of a public policy activity in which experts in ethics were called upon to
participate.

Hastings Center

Founded in 1969, the Hastings Center is an independent, nonprofit,
and nonpartisan research and educational institute for the examination of
ethical and social issues in medicine, the life sciences, and the professions.
The center is located in Briarcliff Manor, New York, and employs a profes-
sional staff of 13 persons with special interest and expertise in biomedical
ethics. The center has three primary goals:

1. to raise the level of competence and research in the examination of
the ethical and social problems arising out of advances in the life, behav-
ioral, and social sciences;

2. to assist educational institutions in the development of programs
designed to make a consideration of ethical problems an integral part of
higher education; and

3. to bring the importance of the ethical and social problems to the
attention of professional and policymaking bodies and to assist them, when
requested, by supplying technical advice and by making available results of
analysis, study, and research (Nolen and Coutts, 1993).

The Hastings Center strives to achieve these goals through sponsorship
of conferences on topics in biomedical ethics and support of educational
opportunities such as student internships, a Visiting scholars program, and
international fellowships. The center publishes the Hastings Center Repon, a
bimonthly publication that features articles, commentary, literature reviews,
and announcements of conferences and educational and employment op-
portunities throughout the country and abroad. The center also publishes

SPECTRUM 0F SOCIETAL RESPONSES I33

IRB: A Review of Human Subjects, a bimonthly journal featuring articles of
relevance to the work of institutional review boards.

Kennedy Institute of Ethics

The Joseph and Rose Kennedy Institute of Ethics was established in
1971 at Georgetown University in Washington, DC, as a research and
teaching center to offer moral and ethical perspectives on public policy
issues (Nolen and Coutts, 1993). With 12 senior research scholars, 2 inter—
national scholars, and 29 senior research fellows, the Kennedy Institute
represents the largest university-based group of scholars in the world de-
voted to research and teaching in biomedical ethics and other ﬁelds of
applied ethics. Faculty members bring expertise from such disciplines as
philosophy, religion, medicine, social science, and law. Bioethical issues
such as in vitro fertilization, abortion, health resource allocation, use of
life-sustaining technologies, organ transplantation, euthanasia, and gene
therapy have been the focus of research.

In addition to activities in this country, the Kennedy Institute conducts
an “Asian Bioethics Program” that, together with the Waseda University’s
Center for Human Sciences in Tokyo, has been organizing a series of U.S.-
japan Bioethics Conferences since 1985. These conferences have focused
on cross-cultural aspects of both biomedical ethics and business ethics.
The institute’s European Program in Bioethics was established with the
aim of developing and enriching moral awareness in the ﬁelds of business,
environment, regulation, engineering, and medicine. Courses and sympo-
sia for this program are initially developed in Germany and subsequently in
other European countries.

The Kennedy Institute also houses the National Reference Center for
Bioethics Literature, the world‘s largest collection of books and articles
related to ethical issues in health care and biomedical research. The refer-
ence center has several special collections, including collections on Jewish
ethics, Christian ethics, and federal bioethics commissions. It also main-
tains and administers an online database of bioethics literature that is part
of the National Library of Medicine’s database system, which is accessible
worldwide.

The Kennedy Institute produces several publications, including the
quarterly Kennedy Institute of Ethics journal, which contains essays and re-
views; the Bibliography of Bioethics, an annual collection of citations to books,
journals, court decisions, government documents, and other materials re-
lated to bioethics; and the Encyclopedia of Bioethics, a basic reference work
containing information about ethical issues in the life sciences. A new
edition of the Encyclopedia of Bioethics, first published in 1976, is currently
being prepared.

134 SOC/Hrs CHOICES

Religious Groups

The connection between religion and health is as old as human cul-
ture. While conﬂicts have appeared along the way (traditional versus scien-
tific medical practice, and the refusal of some religious groups to accept
certain medical procedures, etc.), religion and medicine have developed a
productive partnership over the past 100 years in most parts of the world.
That partnership has been greatly enriched in recent decades.

Religion has made noteworthy contributions to medicine, especially in
the area of patient care and in helping patients to understand and deal
with disease and catastrophes. At the same time, religious beliefs have
proved to be a formidable stimulus to the evaluation of some developments
in biomedicine—especially contraception, birth control, and other aspects
of human sexuality, as well as end—of-life issues.

Roman Catholic theologians have examined certain central questions
about the ethical aspects of medical care for several centuries. They have
written treatises in which they applied their principal ethical theory, natu-
ral law, to subjects such as abortion, sterilization, and the obligation to
accept life-saving treatments. Similarly, jewish law has for centuries at-
tended to similar questions about life, death, health, and illness, and the
acute analyses of the rabbinical scholars has become familiar to the ortho—
dox. Thus, as the new issues of bioethics began to appear, two major
religious traditions already had a stock of concepts and opinions on certain
of these issues and scholars in those traditions began to apply them to the
new questions.

In recent years, North American religious groups have produced some
excellent, carefully researched reports for their national or regional bod—
ies; the Presbyterian report on health care is a good example (Presbyterian
Church, U.S.A., 1988). These documents have sometimes failed to gain
full endorsement of the groups for which they were prepared, but as work-
ing documents available for study and reﬂection in the life of the religious
communities, such documents have exercised great inﬂuence. And some
of these documents produced by and for religious groups (churches, syna—
gogues, religious societies) have become valued literature in the field.

As noted in Chapter 2, some twentieth century theologians and phi-
losophers of religion were pioneers in reﬂecting on the import of religion
for biomedical developments and in giving an entirely new character to the
area in medicine called medical ethics. Theologians and clergy have contin—
ued to be important contributors to bioethics. The establishment of pro-
fessorships at Georgetown University, the University of Notre Dame, and
Vanderbilt University charged to deal directly with the relations of religion,
law, and philosophy to medical sciences and practice has followed, giving
further standing to the place of religion in biomedicine. Such work has

SPECTRUM 0F SOCIE'I‘AL RESPONSES 135

been greatly furthered by separate institutions dealing with medical ethics
described above. Work of this sort has also taken place in Great Britain and
Commonwealth countries and is gaining ground in European nations.

Interfaith and ecumenical bodies have also begun to study the import
for religion of developments in biomedicine. The World Council of
Churches and the National Council of Churches have worked to develop
guidelines dealing with such issues as population control, access to medical
treatment, and ways to face life’s end. Studies of this sort are particularly
timely and valuable in light of today’s widespread religious pluralism. Con—
sensus is difficult on many of the issues in medical ethics that religious
groups discuss, but religious pluralism itself may require of the leaders of
religious groups not only more civility in dealing with opponents of their
views but also greater understanding of positions different from their own.
Some rapprochement may have developed in the summer of 1993 as the
World Parliament of Religions sought common understanding on moral
questions at its Chicago gathering.

On _]une ‘20, 1980, the General Secretaries of the National Council of
Churches, the Synagogue Council ofAmerica, and the United States Catho-
lic Conference addressed a letter to President Carter expressing concern
over the ethical implications of genetic engineering. Their letter stated,
“We are rapidly moving into a new era of fundamental danger triggered by
the rapid growth of genetic engineering, albeit there may be opportunity
for doing good; the term suggests the danger” and called upon President
Carter to remedy the lack of “adequate oversight or control . . . by provid—
ing a way for representatives ofa broad spectrum of our society to consider
these matters and advise the government of its necessary role” (President's
Commission, 1982b). President Carter passed the letter to his science
advisor, who requested the President’s Commission to consider it. The
commission decided to undertake a special study, not included in its con-
gressional mandate, that explored the questions raised by the religious
leaders. This study, entitled Splicing Life, reviewed the religious and moral
questions in light of the scientiﬁc possibilities and attempted to delineate
with care the precise areas of concern to which public attention should be
directed. Many of these areas now fall within the mandate of the ELSI
Program of the National Center for Human Genome Research.

Religious groups often ﬁnd it difficult to affirm their own stance and
values without ruling out alternative views and visions. Intolerance is not,
of course, restricted to persons of religious faith. But the sheer number of
individuals and groups working on these issues offers some encourage-
ment that more useful modes of discourse will be developed, and that
religious controversies in the ﬁeld of biomedicine will become more pro-
ductive. Such a development would be a boon to religion, to medical
science and practice, and to the public good.

136 SOCIETY’S CHOICES

INDIVIDUAL AND COMMUNITY RESPONSES

The widespread American tendency to initiate and develop voluntary
associations around a whole range of social, moral, and political purposes
has a long history. In the early nineteenth century (1835), visiting French
social theorist Alexis de Tocqueville commented on the tendency for self-
help groups to emerge in American communities. Indeed, Tocqueville
appropriately characterized the proliferation of voluntary associations as a
distinctly American phenomenon:

In no country in the world has the principle of association been more
successfully used or applied to a greater multitude of objects than in
America. . . . The citizen of the United States is taught from infancy to
rely upon his own exertions in order to resist the evils and the difficulties
of life. . . .

While voluntary associations are hardly new to the American cultural
scene, the self-conscious application of voluntarism and wider public par-
ticipation in the medical sphere emerged most strongly out of the con-
sumer and community organizing movements of the 19605. For example,
although self-care has always been an unacknowledged part of the informal
health care system, the practice of self-care has increased dramatically in
the past 20 years. Some have argued that the current embrace of self-help
and health support groups, particularly by HMOs, reﬂects the transforma-
tion of a movement of consumers organized for themselves into an incor-
porated and co-opted component of the American medical establishment
(DeFriese, 1989). Patient advocacy groups, family support groups, and
disease-speciﬁc self-help groups, once considered radical for their aim of
increasing individual control and responsibility over health, have become
integral to the nation’s dominant public health policy (Crawford, 1977;
Stone, 1989; Taylor, 1986; Tesh, 1988). Such lifestyle changes and the
public discussions they inspire touch the boundaries of important ethical
issues concerning individual autonomy. Thus, activities that initially ap-
pear to be political and social in nature frequently have relevance to cen-
tral ethical problems in biomedicine.

Grassroots Efforts

Individuals, groups, and communities are often spurred to action in
the wake of changes wrought by developments in biomedicine. We have
already seen the critical role that professional associations have played,
primarily by providing ethical and practical guidance to physicians in the
use of these technologies. Yet voluntary efforts are not conﬁned to organi-
zations with preexisting structures and stable numbers of professionally
educated members. Some voluntary organizations are more loosely struc-

SPECTRUM 0F SOCIETAL RESPONSES 13 7

tured and come into being as a result of a perceived crisis, as did the
National Abortion Rights League (NARAL) or in response to a particular
condition or disease as did the AIDS Coalition to Unleash Power (ACT-
UP). They often inspire the loyal support of individuals who have little else
in common than their interest in resolving the crisis or managing the
treatment for the disease. Others, such as the broad—based citizen—spon-
sored forums on health care that took place in Vermont, Maine, California,
and Oregon, have devoted long hours to the examination of a wide variety
of challenging issues in health care, attempting to provide both policy and
personal guidance to legislators and fellow citizens.

Increasingly, patients actively participate in the delivery of health ser—
vices, disease prevention practices, and health education. Contemporary
“self-care” movements include participation in a variety of self—help groups
from postoperative recovery groups, cancer support groups, support groups
for those with a family member who has a chronic disease, and the various
permutations in twelve-step recovery programs (from alcohol or drug prob-
lems to obesity). Practitioners, scholars, and ethicists justify the shift of
responsibility to individuals on the grounds that it increases both patient
control and the efﬁciency of care. Others argue that incorporating self—
care improves health outcomes while increasing the experience of self-
control and enhancing quality of life.

Such efforts and groups are best characterized as “grassroots,” and,
depending on their structure and purpose, sometimes are also known as
community-based organizations (CBOs) (National Research Council,
1993). There are so many grassroots efforts and CBOs that it would be
impractical to discuss all of them here; hence, the groups described in this
section merely illustrate the wide variety of groups that exist. Some of
these groups have had a signiﬁcant impact on the research into and use of
biomedical technologies, as well as public discussion of these issues. The
impact of grassroots organizations has been particularly notable in the
ﬁeld of AIDS research and treatment, as well as in the areas of contracep-
tive technology and fetal tissue transplantation research.

AIDS Grassroots Organizations

Grassroots organizations have proliferated in direct response to the
AIDS epidemic. It is estimated that more than 600 such organizations
formed in the last decade alone (National Research Council, 1993). Many
of these organizations had their roots in the gay community, which had
created a network of medical self-help groups years earlier in response to
perceived discrimination by the medical establishment. Such groups were
flexible and quick to adapt to the needs of AIDS sufferers and their fami—
lies. Their initial aims were to provide appropriate medical care and social

138 SOCIETY’S CHOICES

support, but some extended their efforts into the political arena, challeng-
ing the way in which both the government and the medical community
were responding to the AIDS crisis.

The AIDS Coalition to Unleash Power is one of the most visible and
proactive of these groups, combining public protest, acts of civil disobedi-
ence, and media events with the more traditional political methods of
lobbying and education to raise public awareness and change policies.
ACT-UP is notable for its unprecedented success in changing federal drug
development procedures to allow the early release of a promising new
AIDS drug. Through careful organization, sustained contact with sympa—
thetic elected representatives, and the acquisition of a well-deserved repu-
tation for being knowledgeable and articulate on medical developments in
AIDS, members of its Treatment and Data Committee gained standing to
participate in pivotal discussions in NIH, FDA, and other forums. Their
views inﬂuenced critical policy decisions concerning the research process
for experimental drugs and set the stage for greater citizen involvement in
the future in such decisions (Levi, 1991).

Abortion Grassroots Organizations

The National Abortion Rights Action League supports a woman’s right
to choose and has been vocal in its opposition to efforts to restrict that
right. Although other women’s organizations actively support the availabil-
ity of abortion (e.g., National Organization of Women and the National
Women’s Health Network), no other has abortion as its raison d’étre.
NARAL publishes newsletters, rallies its supporters to public protests, lob-
bies representatives, and sponsors forums in which scientiﬁc, legal, and
ethical scholars and legislators sympathetic to this cause present compel—
ling arguments for policies that guarantee women’s reproductive auton-
omy, including the continued availability of abortion and research into
contraceptive technologies that make abortion less necessary. In 1991,
NARAL sponsored a symposium on the federal ban on fetal tissue trans-
plantation research at which participants decried both the policy itself and
the tenuous linkage that DHHS had made between such research and a
hypothetical increase in abortions (NARAL, 1991).

NARAL’s antiabortion counterpart is found in the National Right to
Life Committee (NRLC), a pro-life organization that opposes abortion,
euthanasia, and infanticide. NRLC supports abortion alternative programs
involving counseling and adoption, provides ongoing public education
programs, lobbies before congressional committees, and conducts research.
The NRLC was instrumental in preventing RU—486, a highly effective aborti-
facient, from being introduced into this country. Pharmaceutical compa—
nies have been very reluctant to conduct research on contraception, not

SPECTRUM 0F SOCIETA I, RESPONSES 139

only because of weak governmental support for such research but also
because of the willingness of NRLC and other antiabortion groups to en-
gage in public protests and threaten boycotts if they do proceed with such
research. The history of the development and distribution of RU-486 in
France conﬁrms that these fears of reprisal are well founded. Because
many drug companies are unwilling to become the target of controversial
protests, they will avoid areas of research that may provoke such action. In
the case of RU-486, and in the development of contraceptive technology in
general, the grassroots antiabortion movement thus far has been largely
successful in its goal (Charo, 1991).

Community Prevention

Sometimes entire communities (whether geographic, ethnic, or cul-
tural) respond to the changes brought about by technological advances.
The response of communities has been variable: weaker for general health
initiatives, but often stronger for speciﬁc initiatives such as screening for
genetic disease. Success in the latter enterprise has also varied widely
depending on the particular community and the strategies of the agencies
that initiate and organize the screening. In general, however, large-scale
community-based health education and intervention programs—in such
areas as heart disease, nutrition, smoking, and drugs—have either not
worked or worked only within certain limited class, educational, cultural,
and racially or ethnically distinct community segments. Few have suc-
ceeded in effecting lasting changes in health behavior (Mechanic, 1990,
1992). Their failure is increasingly recognized as a function of treating
health behavior as an individual rather than a social and cultural phenom—
enon (Mechanic, 1990; Syme and Alcalay, 1982). One notable exception is
the recent series of efforts to curb smoking by stepping up public educa-
tion and by banning smoking in public places; these initiatives seem to
have reduced smoking behavior in many sectors of society. A growing body
of research shows that cultural factors are critical to understanding
and modifying health-related behavior, including preventive action
(Cruickshank and Beevers, 1989; Graham, 1984; Mascie-Taylor, 1993;
Strauss, 1991; Helman, 1990; Biersecker et al., 1987; Armstrong, 1989).

Assessing Genetic Risks

Cultural issues are particularly salient in understanding responses to
new genetic knowledge and screening possibilities, in part because genetic
disorders, to a greater extent than other health problems, coincide with
“risk populations” that are ethnically and racially demarcated. Thus, each
disorder may exist in a different cultural context: Americans of African

140 SOCIETY’S CHOICES

descent are at greater risk for sickle cell anemia; Americans of European
descent are at greater risk for cystic ﬁbrosis; Americans of Ashkenazijewish
descent are at greater risk for Tay—Sachs disease; Americans of Southern
Italian descent are at greater risk for beta—thalassemia (McKusick, 1988).
Because genetic disorders are typically located in subsets of populations at
greater risk due to ethnic and racial endogamy, because transmission is
limited to offspring, and because there are no cures for any of these ge—
netic disorders, the question of who screens whom and for what purpose is
potentially charged and culturally loaded.

Genetic disorders are experienced not only by individuals and their
families, but also simultaneously by risk populations that are culturally
distinct, and these populations will have highly variable responses to “their
disease.” The variability will be linked to their social attributes, including
the meaning of a genetic disorder in their respective cultural, racial, or
ethnic groups. In the past, many community health interventions have not
worked because they have not been articulated with the cultural meanings
and constructions which are at the center of people’s everyday life priori-
ties (Syme and Alcalay, 1982). For example, important elements of genetic
knowledge do penetrate into the popular culture, and people do use ge-
netic explanations to account for maladies and odd traits in their families,
but in most cases they do not use genetic information (through testing,
screening, counseling) to guide their health-related behaviors. The excep-
tions to this pattern occur when the larger social context of a genetic
disorder becomes either highly politicized, as with sickle cell anemia in the
late 19605, or when a community “takes over and possesses its own genetic
disorder," as with Tay-Sachs disease during the early 19705.

With respect to the latter, a community-based carrier screening pro-
gram was initiated in the greater Baltimore/Washington area in the early
19705. The program had the support of leading rabbis, and worked with a
committee of committed lay people. Brochures from supportive physi-
cians blanketed the jewish community. Mass mailings and television and
radio announcements were also used, all in support of a community-rati-
ﬁed voluntary screening program. Before the program, 98 percent of the
Jews in the area that were surveyed had never heard of Tay-Sachs. Within a
year, not only were 95 percent of those surveyed aware of the disorder, but
thousands volunteered for screening (Stine, 1977). In the ﬁrst year of the
program, 7,000 adults, approximately 10 percent of the total eligible popu—
lation, were screened (NAS, 1975). One of the key architects of this pro-
gram, Michael Kaback, perhaps the world‘s leading specialist on the topic,
had this to say about the issue of voluntary versus mandatory screening:

An alternative approach, mandatory (or legislated) screening, although
easier to implement perhaps, was regarded as unwarranted, unnecessary
and ethically unacceptable (Kaback et al., 1974).

SPECTRUM 01" S OCIE TAL RESPONSES 14]

The estimated cost of the program was $65,000 to provide equipment,
supplies, and personnel. All those screened were asked to contribute $5,
and most did so. At—risk couples received counseling, and reports indicate
that it was direct, careful, and sensitive (Stine, 1977). The success of the
initial Baltimore/Washington project was such that scores of jewish com-
munities around the United States followed suit and were laterjoined by
Jewish communities in ﬁve other countries. By the early 19805, over 310,000
jews around the world had been screened voluntan'ly, leading to the identi-
ﬁcation of 268 couples in which both partners were carriers. In New York
city, Hasidic jews developed a program, the Chevra Dor Yeshorim pro-
gram, to deter the marriage of partners who were both carriers of the Tay-
Sachs gene (Merz, 1987).

The history of screening for sickle cell was very different. Perhaps most
signiﬁcantly, many of the screening programs were developed without ad-
equate consultation and education of the affected communities (IOM,
1994). Little could be offered to high-risk couples once they were identi-
ﬁed and safe prenatal diagnosis of sickle cell disease was not possible at the
time (as it was for Tay-Sachs). The failure of the Black Panthers (who were
among the ﬁrst to start and favor sickle cell screening) as well as the politi-
cally motivated whites, to recognize the technological limitations made the
experience of sickle cell screening a very negative one for the African
American community. Some have also suggested that, while many of those
who were managing or recruiting for these screening programs were doing
so for health and medical reasons, a sizeable proportion came from com-
munity-based organizations that had a political agenda, including urban
poverty programs and methadone clinics (Duster, 1990).

Raﬁonalizing Health Care Priorities

One of the side effects of advances in biomedicine has been skyrocket—
ing health care costs, particularly of the elderly, premature infants, and
those with rare disorders. In contrast, preventive medicine has sometimes
gotten short shrift, despite the demonstrable cost savings to society. This
situation has led to several attempts around the nation to “rationalize” the
allocation of health care. The most famous case has been the work of the
Oregon Health Services Commission, which expanded the notion of com—
munity responses to include well-organized, focused, volunteer-led group
discussion of vital health care issues. The higher-level initiative brought
together citizens from different geographical, socioeconomic, and cultural
communities.

In the mid-19805, Oregon was faced with a series of very difﬁcult deci-
sions about the provision of transplants for poor children. The cost for
one liver transplant was so high that the same amount of money could

I 42 socua'ry’s CHOICES

provide prenatal care for poor women in the state for almost a year. As a
result, Oregon ended funding for soft-tissue transplants. The rationale was
simple enough: that it would be more cost-effective to transfer a projected
$1.1 million per year from the transplants to prenatal care (Daniels, 1991).
This action initiated ﬁerce debate, but the debate itself provided neither
the criteria for ranking health care procedures nor the process that would
establish such criteria. It was not clear whether such a project should be
entrusted to a group of medical experts, elected ofﬁcials, the general pub-
lic, or some combination thereof.

The solution was a major, statewide grassroots effort. Oregon Health
Decisions, a private, nonproﬁt community educational group, sponsored
citizen meetings throughout the state, encouraging serious thought about
the proper allocation of Medicaid dollars through carefully led group dis-
cussions centering on speciﬁc difﬁcult medical cases (Crawshaw et al., 1985;
Garland, 1992; OTA, 1992b). The values undergirding a desirable health
care system were enumerated by citizens, and included equity, quality of
life, cost, functional independence, and community compassion (Garland
and Hasnain, 1990). A summary document set forth these and other
principles, one of which was that the poor should be guaranteed access to
basic health care services, even if it meant that the range of services avail-
able to that same group had to be restricted. Thus, citizens favored the
breadth of service provision (minimal services to many) over the depth of
service provision (extensive services to a few). Because these fundamental
principles were arrived at through an open and democratic process, they
achieved a certain legitimacy that might not have been earned by alterna-
tive approaches (Welch and Dixon, 1991). The information provided by
these discussions and the results of a parliamentary debate and vote taken
by citizens chosen from these statewide discussion groups was part of the
information used by the 11-member Oregon Health Services Commission
to guide the ranking of health care seivices (Klevit et al., 1991).

In early May of 1990, the commission published a list of health care
services, with each assigned a different level of priority; coverage would be
restricted to those conditions assigned a high priority (Hadorn, 1991).
The Oregon experience has generated considerable debate and contro-
versy, in part because of particular rankings but primarily because it high-
lights the essential and enduring conﬂict between individual and collective
interests. As health care is increasingly Viewed as an issue in the public
domain, this conﬂict—between expensive procedures to save the lives of a
few and inexpensive preventive measures to save the lives (or improve the
quality of life) of the many—will increase. Another set of issues raised by
citizen—sponsored health forums in Oregon and other states and regions
(e.g., California’s Orange County, Hawaii, Maine, Washington, Idaho) is
that of participatory democracy and its role in the allocation of scarce

SPECTRUM 0F SOCIETAL RESPONSES 1 43

health resources, including the use and/or restriction of biomedical tech-
nologies (Jennings, 1988).

While political scientists have long argued that apathy pervades the
democratic political arena (at least in the United States), this indifference
has not been evident in the citizen-sponsored health forums (Iennings,
1993). On the contrary, citizens have been energized and active in these
efforts, with minimal outside encouragement and no apparent rewards for
their involvement other than the intrinsic satisfaction of participation.
There was much variation among the states in their approach to these
forums, but their successes had several critical elements in common:

0 building a base of community support by utilizing existing commu-
nity groups and recognized leaders;

0 holding forums carefully structured to allow open discussion of com-
peting views;

0 relying on motivated, trained volunteers; and

0 channeling the enthusiasm surrounding the discussions into con-
structive action (Iennings, 1988).

The success of these efforts suggests that true participatory democracy
may play a unique and vibrant role in health care reform and practice. Not
only does the process itself provide satisfaction to participants, it also con-
fers legitimacy upon the decisions reached. Moreover, because biomedical
advances are an integral part of the discussions concerning the allocation
of health care, these forums set the stage for greater citizen monitoring of
and inﬂuence in the development and use of biomedical technologies.

It is critical to note that these citizen efforts, while fruitful, are not
without their limitations. Those who participated in these community
discussions were more likely to be white, affluent, and better-educated than
most Oregon residents. In some instances more than 50 percent of partici-
pants were health professionals. Only 9.4 percent of participants were
persons without insurance. Given that the uninsured constitute 16 percent
of Oregon’s population, it is clear that this group was underrepresented.
Medicaid recipients, too, were seriously underrepresented (Daniels, 1991).
Thus, those least likely to attend these meetings—the poor, underem—
ployed, elderly, minorities, and Medicaid recipients—were those most likely
to be seriously affected by any rationing plan developed as part of health
care reform. Without the input of these groups, the ultimate validity of
such citizen proposals is seriously undermined.

Nearly every public issue requires moral judgment in its resolution.
For some issues, however, consideration of moral ideas such as dignity,
freedom, rights,justice, respect, and equality are especially critical to reso-
lution. Scientific and social changes stemming from developments in bio-
medicine have raised such issues. These changes have exerted particular

144 SOCIETY’S CHOICES

pressure on deep-rooted moral ideas acquired through experiences with
one’s family, church, and country, and have thus presented society with
complex social and ethical quandaries. As we have seen in this chapter,
debate about these quandaries is occurring in many places and in many
ways throughout our society. Some of the debate has been conducted in an
undisciplined fashion, in which the interests of particular interests groups
have dominated. More constructively, however, the debate has involved
open, informed, and impartial discussion, mutual respect, and rational
moral deliberation. Given the impending changes in health care and the
promise of continued scientific development, it will be important to ensure
that there are places where this sort of deliberation can continue to take
place so that the storm of debate can be picked up, channelled, made
comprehensible, and perhaps even brought to bear on long-term solutions
like the restructuring of institutions and laws.

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Criteria for Success

How to evaluate the products and outcomes of public ethics bodiesl
using objective criteria has been a continuing question, not resolved by the
work of this committee. For example, should they be evaluated relative to
the speciﬁc mandate of each group or report or the particular public needs
that the group or report addresses? Although certain general criteria can
be articulated, their importance for evaluating a particular public ethics
body may depend in large measure on the specific mission of that body.
This is true notjust for single-issue bodies, such as the Human Fetal Tissue
Transplantation Research Panel, but also for bodies with a broader man-
date, such as the President’s Commission. The background paper written
by Gray, who attempts to compare the “success” of the National Commis-
sion and the President’s Commission, highlights many of the problems
inherent in the evaluation and comparison of even two commissions, espe-
cially when the groups each have multiple functions and operated at differ-
ent periods of time. Given the multiplicity of functions that public ethics
bodies can serve (as noted early in Chapter 4) and the power of the societal
context in which they operate to inﬂuence their outcomes (as described in
Chapter 2), the committee did not believe that a complete, critical evalua-

1 The term “public ethics body" is used in this chapter and in Chapter 6 to denote a group
convened to deliberate about social and ethical issues stemming from developments in bio-
medicine. Such groups may exist at the level of the institution, community, state, federal
agency, or federal government. Generally, these groups address public policy issues that
involve moral ideas such as dignity, freedom, rights, fairness, respect, equality, solidarity,
responsibility,justice, and integrity.

I50

CRITERIA FOR sucaass I 5 1

tion of all of the public ethics bodies discussed in this report was feasible.
The committee instead sought to identify criteria that could be used as
hallmarks (together with more wide-ranging exploration of social contexts)
by individuals who are initiating or serving on such bodies, or attempting
to evaluate the impact of their deliberations or reports.

Past social responses to ethical quandaries in biomedicine have suc-
ceeded in a variety of ways. For example, many public ethics bodies have
enlisted outstanding scholars to contribute their insights on the issue of
concern. Many of the products of these bodies have been viewed as au-
thoritative and have had a substantial impact on policy decisions, as for
example occurred in the cases of deﬁning brain death and establishing
standards for human experimentation. Many products of these bodies
have stood the test of time and continue to have a prominent role in
education for health professionals and ethicists. Hospital ethics commit-
tees, for example, are often able to soften advocacy of patient interest in
order to gain the willing participation of health care providers (Hoffman,
1991). These and other similar examples are described later in this
chapter.

Commissions and other public ethics bodies operate in a world where
deadlines, personalities, and special interests converge. The need for con—
sensus development and sometimes compromise is unavoidable. While the
committee does not attempt in this report to perform a comprehensive
assessment of the performance of every mechanism for public deliberation
of social and ethical issues, it does explore some of the speciﬁc outcomes of
this deliberation according to a set of criteria it identified as measures of
“success.”

Applying the criteria, the committee found, did not produce unquali-
ﬁed results. Among the criteria used for evaluation of public ethics bodies
are items bearing on integrity of the reasoning process, public education (i.e.,
how well a report articulates the nature of a controversy, competing values,
and alternative solutions, as well as how effectively the report is dissemi-
nated), and effectiveness (i.e., getting laws passed, forging a public consen—
sus, etc.). Different reports of the same body, being aimed at different
kinds of tasks, might well satisfy these criteria in different ways and to
different degrees (see the background paper by Gray).

The President’s Commission report on Deﬁning Death (1981), for ex-
ample, was intended to provide definitive resolution of a public policy
problem. Viewed from this perspective, the report was a smashing success.
Its recommendations regarding the Uniform Determination of Death Act
were quickly accepted by the vast majority of states. The commission’s
reasoning in defense ofits policy proposal has been a source of continuing
controversy and even disparagement in the scholarly literature (Wikler,
1993; Veatch, 1993), and this might lead us to give the report a lower score

152 SOCIETY 15‘ CHOICES

on integrity and public education. But these scales may not be the most
appropriate criteria, given this view of the primary mission of that particu—
lar report.

Conversely, the President’s Commission report on Splicing Life (1982b)
is most appropriately judged as an educational document. Seen as an
attempt to calm the fears of religious leaders, and to separate morally
positive work in somatic cell gene therapy from the unsavory specter of
eugenics and germ-line manipulation, it would bejudged a success. The
report was clearly written; it deftly separated issues of genuine moral con-
cern from ill-founded fears about “genetic engineering" and provided an
excellent framework for future public discussion of the issue. The fact that
this particular report did not generate new laws (as did Deﬁning Death) or
inﬂuence court decisions (as did Deciding to Forego Life-Sustaining Treatments
[1983a]) would be relatively unimportant in its overall evaluation, given its
predominantly educational mission. Another way of expressing this is to
say that it was effective in educating the public, but not effective in pushing
a regulatory or policy agenda because it was not meant to do so.

Few thorough evaluations have been done on the success of various
other bodies covened to deliberate social and ethical issues in biomedi-
cine—bodies such as HECS, IRBs, professional societies, grassroots organi—
zations, or special interest groups.

In short, evaluative criteria and their speciﬁc weights depend crucially
upon context, including the nature of the controversy, the speciﬁc tasks of
the body, the social setting, legal environment, etc. (see the background
paper by Brody in this volume). Notwithstanding this caveat, it is still
possible to develop a number of important criteria that could be used in
establishing, participating in, orjudging the overall performance of public
ethics bodies. The following discussion divides these criteria into three
categories: intellectual integrity, sensitivity to democratic values, and effec-
tiveness. As we shall see, however, there is a considerable amount of over-
lap and interplay among these categories.

One ﬁnal caveat is in order before proceeding. In offering a list and
discussion of criteria forjudging the success of public ethics bodies, we do
not mean to suggest that the business of evaluating their performance
might be reducible to some sort of perfunctory checklist. As Aristotle
wisely reminds us in Nieomaehean Ethics (Book 1), we must not expect more
precision than the subject matter permits. There is no scoring system that
will yield objective assessments that command universal assent. Often,
public ethics bodies must grapple with extremely controversial and con-
tested issues that implicate our most fundamental individual and social
values. The judgments that we all bring to bear on the work of these bodies
will naturally reﬂect our differing views on these fundamental controver-
sies concerning life, death, and justice. Like evaluations of works of litera-

CRITERIA FOR SUCCESS I53

ture, art, or philosophy, our critical assessments of public ethics bodies and
their products ultimately rest upon nothing more, and nothing less, than
the quality of our reasoning and the soundness of our judgments. Consen-
sus is possible, but controversy is to be expected.

INTELLECTUAL INTEGRITY

Logic

Logic is the ﬁrst prerequisite ofa successful report from a public ethics
body. At issue here are the soundness of the reasoning and the overall
coherence of the document. Does it describe the topics and issues clearly?
Do the conclusions, including the policy recommendations, follow logi-
cally from clearly stated premises, or are they simply announced on the
presumption that the authority or prestige of the body will carry over to its
conclusions? Is the report characterized by consistency in standards, or is
one standard used in one place and another used elsewhere in the report?
Does the document present itself as a seamless web of argument and rec-
ommendations, all heading in the same direction, or is there a tension or
perhaps outright contradiction between various parts of the report? Recall
in this connection the President’s Commission’s Securing Access to Health
Care (1983b): several commentators have noted the disparity between the
report’s liberal philosophical and factual premises, written by staff schol-
ars, and the conclusion, dictated by the conservative moral and political
stance of certain commissioners.

A related function of these bodies is to help clarify, through logical
analysis, the terms and nature of the debates addressed in their reports.
Frequently ethical decision making at all levels, from the bedside to legisla—
tive chambers, is confused by pervasive fuzziness in terminology and rea-
soning. For example, clinicians,journalists,judges, and ordinary people
alike have tended to overlook important distinctions (e.g., between so-
matic and germ-line genetic therapies) or have based decisions and poli—
cies on distinctions of dubious merit (e.g., between so-called “ordinary”
and “extraordinary" means).

Likewise, some debates are muddled by failure to attend to disciplinary
distinctions and the resulting confusion of categories. The Ad Hoc Com-
mittee of the Harvard Medical School to Examine the Definition of Brain
Death (1968), for example, mistook the medical criterion of “permanent
coma” for an ethical and policy statement about the deﬁnition of death.
Public ethics bodies should take care to identify separately the various
disciplinary perspectives on an issue—e.g., theological, ethical, economic,
political, legal, medical, biological, epidemiological—and to give each its
due without mistaking one for another.

1 5 4 SOCIETY 's CHOICES

An important criterion for evaluating the efforts of a public ethics
body, then, is the body’s ability to advance the ethical discussion by means
of logical analysis, including rigorous critique of deﬁnitions, arguments,
and distinctions—what one committee member has labeled “logic polic—
mg.

Scholarship

Scholarship is another important dimension of intellectual integrity.
The work of public ethics bodies must not only be coherent, it must also be
competent—that is, based upon the soundest available scholarship. This
means, ﬁrst, that the body’s “ﬁndings” must be grounded upon solid em-
pirical facts pertaining to the relevant area of technological innovation. A
report on fetal tissue transplants, brain death, or genetic screening and
therapy must be premised upon state-of-the-art information regarding the
current practice and future prospects of relevant technologies. If the mem-
bership of a public ethics body lacks this technical knowledge, it must
consult with appropriate experts. Members and staff of public ethics bod—
ies should be aware of empirical studies bearing on their topic.

Secondly, reports should reﬂect a thorough knowledge of the interdis-
ciplinary ﬁeld of bioethics. In addition to being factually accurate and well
reasoned, such reports should be based upon an equally state—of—the—art
understanding of the public and professional “conversation” surrounding
a particular issue. The reasoning and conclusions of the report should
reﬂect an awareness of “the best that has been thought" in the bioethical
literature, journals of opinion, newspapers, etc.

When policy analysts, scholars, and teachers read an ethics body report
that is scientiﬁcally and ethically “competent” in this sense, they are much
more likely to credit its conclusions as being reasonable, thorough, and
fair. In this way, the perception of competency helps to generate the moral
authority of a commission. Those responsible for forming public ethics
bodies must keep this point in mind as they select members and staff.
Although it is reasonable to seek a broad range of cultural, professional,
ethnic, and ideological diversity for membership, it is absolutely vital that
all of the staff and many of the members of these bodies possess the re-
quired expertise in ethics, law, medicine, biology, and related ﬁelds.

Sound Judgment

Sound judgment complements logical analysis and scholarship in an
overall assessment of intellectual integrity. Reports should be based not
only on good facts, scholarship, and reasoning, but also on the less tangible
(and more controversial) factor ofjudgment. Unlike logic or mathemat—

CR1 TERIA FOR SUCCESS 155

ics, ethics is not primarily driven by deductive reasoning. Ethical consider-
ation is often “messy,” complicated by uncertainty, lack of information, and
conﬂicting values and principles. Ethical “skill” resides not so much in
being able to apply a single ethical theory or principle to a set of facts as in
the ability to discern the unique particularities of the problem in its social
setting, to creatively reframe a question, to reason by analogy, to perceive
and acknowledge the interests of affected parties, and to judiciously
weigh and balance competing principles and considerations Gonsen and
Toulmin, 1988; Arras, in press).

These activities, while loosely connected to deductive logic, are crucial
for the successful framing, debate, and resolution of moral problems. Just
as individuals must display these skills in concrete moral reasoning, so
too must public ethics bodies exhibit them in their reports (Ionsen and
Toulmin, 1988). The sorts ofjudgments called for here can be exceedingly
difﬁcult and delicate, and thus very controversial. How heavily should
economic efﬁciency weigh vis-a-vis equality of opportunity in structuring a
health care policy? What will be the impact of the new reproductive tech-
nologies on women’s identity and role in society, and how should this
consideration be measured against the rights of women to do with their
bodies as they wish?

Any group that comes to terms with such difﬁcult questions, as any
serious public ethics body must, will engage conﬂicting values and inter-
ests, and attempt to reach sound judgments. We call “judicious" those
reports that strike an appropriate and fruitful balance between the relevant
rights and interests, disciplinary perspectives, and cultural traditions of a
given society. Unfortunately, there is no known algorithm for producing
reports of this kind. In the ﬁnal analysis, it is a matter of goodjudgment
honed through years of experience.

SENSITIVITY TO DEMOCRATIC VALUES

Respect for Affected Parties

In addition to “the best that has been thought” on an issue, public
ethics bodies should also be attentive to all the signiﬁcant contributors to
the public conversation about an issue. Rather than simply ﬁxing on and
advancing their own preferred approach to a problem, members and staff
should make an honest attempt to hear all plausible, responsible views.
This process is vital for two reasons. First, as John Stuart Mill wisely noted
long ago (1859) , seemingly marginal ideas may be true, or at least partially
true; and even if they are false, the process of having tojustify a received
view in the face of dissenting arguments will usually strengthen and invigo-
rate it.

156 SOCIETY’S CHOICES

Second, public ethics bodies should be attentive to minority or disen—
franchised voices, not only because they can enrich our public discourse,
but also because sometimes they may be attached to important individual
rights or serious religious or cultural concerns that ought to be respected,
so far as possible, by public policy. The Newjersey Bioethics Commission,
for example, grappled creatively with the problem of Orthodox jewish
concerns over the deﬁnition of death.

Third, failure to attend to significant minority concerns in the process
of policy formation may render implementation of a policy more difﬁcult
or even impossible if it requires the cooperation of the affected minority
group. The experience of the city of Baltimore in distributing the long-
term contraceptive, N0rplant®, in the city’s predominantly African Ameri-
can public schools is illustrative. Although the facts are in dispute, a num-
ber of vocal African American clergymen protested that the planned
distribution of Norplant was decided upon without adequate consultation
with the African American community, and that it violated the ethical and
religious norms of that community.

Representation of Diverse Views

Concern for affected parties, including minorities, the disenfranchised,
consumers, and public interest groups, should manifest itself not only in
listening to the experiences and concerns of a wide variety of people, but
also in the presence of representatives of such groups within the composi-
tion of the public ethics body itself. Some affected parties are difﬁcult to
recruit for membership on these bodies (e.g., psychotic individuals, drug
users, and various persons suffering from serious addictions), so the bodies
should seek not the affected parties themselves, but those who are known
to be their dedicated advocates. Also, a seat at the table is sometimes
demanded by persons who intend to champion a position and sway a delib-
erative body to accept it. This is undesirable for a public ethics body, which
must be committed to impartiality and willingness to deliberate, yet the
views of such parties deserve to be heard. Thus, advocacy should not have
a seat, but appreciation and understanding of the advocates should, so as
to guarantee that their interests and values will count in the body’s delib-
erations (see the background paper by Bayer in this volume).

Open Versus Closed Meetings

An important question bearing on the process ofa public ethics body’s
deliberations, as opposed to the substance of its recommendations, con-
cerns the conditions under which meetings will be held. Speciﬁcally, the
issue is whether these groups should operate in the “sunshine”—that is, in

CRITERIA FOR sucarss 15 7

open public sessions with everything on the record—or in the privacy and
conﬁdentiality of closed sessions. Important national-level bodies, includ-
ing the National Commission and President’s Commission, and one state—
level commission (New jersey) provide examples of open process, while
the ethics work group of the recent Clinton administration health care
reform task force and the New York State Task Force on Life and the Law
have operated behind closed doors before disclosing their ﬁndings to the
public. What are the implications for democratic values of these alterna-
tive approaches to process?

At ﬁrst glance, it would appear that openness best reflects democratic
values. The group is a public body, and its deliberations should be open
for all to see and hear. Anyone with a stake in an issue under discussion
may attend and, at appropriate times and places, speak his or her mind.
journalists may attend and write about what they see and hear, so that the
public will know how the body it is funding conducts its business. Since the
body deliberates before an attentive public, the members and staff must
eschew the arcane jargon of their respective professions and speak in plain
English. And with everything on the record, there will be no “smoke—ﬁlled
rooms" and no secret deals that cannot be explained to an inquisitive
public. The open meeting model is thus especially well-suited to the values
of a democratic society.

In addition to expressing and reinforcing democratic values, the model
of openness may also foster the effectiveness of public ethics bodies, which
provide an open forum for all interested parties to witness the delibera-
tions leading to public policy recommendations. Since the members’ evolv-
ing views could be reported to the public in the print and electronic media,
those with differing opinions will have a chance to be heard during this
process and, in any case, will not be surprised by the resulting reports.
Policy recommendations that pass through this crucible of publicity may be
accepted more readily once they are ﬁnally published.

The virtues of the closed meeting model have more to do with collegi-
ality and efﬁciency within a deliberative group than m'th democracy and
public education. Perhaps the most common argument for privacy and con-
ﬁdentiality has to do with the fostering of mutual trust and openness among
the commissioners and staff. Since these people come together to discuss
and decide upon policy questions of great moment and difﬁculty, they need
to keep an open mind. Indeed, they often require a good deal of intellectual
elbow room in which to change their minds once confronted with compel-
ling evidence and argument. Arguably, it is easier to do this in private than
in public, where the virtues of flexibility and openness to new evidence
might be wrongly interpreted as simple fecklessness and inconsistency.

Equally important, however, some members of public ethics bodies
might be chosen in part because of their ability, not merely to think clearly

I 58 sonny/vs CHOICES

about the issues, but also to represent various religious or secular view—
points. A strong argument can be made that representatives from the
clergy, labor, or civil liberties constituencies, for example, will have an
easier time crafting inevitable, difficult, and highly sensitive compromises
in private than in public. Thus, for example, a Catholic priest might be
able to say things in private that he might not be able to say in public. (“As
a Catholic and a priest I cannot countenance this kind of reproductive
liberty, but as a citizen I will tolerate it") Instead of spending much of
their time “playing to the home audience," members can speak with one
another in full candor, concentrating on the task at hand, and setting aside
advocacy for calm impartiality.

The greatest disadvantage of closed meetings, still speaking on the
level of efﬁciency and effectiveness, is that the public ethics body must do a
thorough job of testing the waters with other groups most likely to be
affected by or feel strongly about a policy, lest the public be surprised by
the body’s ﬁndings. Groups that feel excluded from the policy process are
more likely to react in a spirit of opposition rather than mutual accommo-
dation. Thus, if a body opts for closed meetings, it should make every
effort to solicit the views of affected parties during the process of data
gathering and policy formation.

In sum, it should be noted that closed meetings, while they do not
directly advance democratic values, are not necessarily incompatible with
them. When public ethics bodies do hold closed meetings, it is important
that they also use mechanisms such as open hearings and public release of
preliminary ﬁndings and recommendations. Conversely, the open meet-
ing, while conforming outwardly to democratic norms, may in practice
work around them. Recall that public ethics bodies, whether or not they
hold open meetings, are not usually making the decisions; they are usually
advisory in nature. In order for their recommendations to go into effect,
they often must be acted upon by some publicly responsive and responsible
body, like a state or federal legislature. Even if decisions are crafted in
private, they remain recommendations that representatives of the people may
still accept or reject as they see ﬁt, following public discussion and debate.

The open meeting model, on the other hand, may outwardly conform
to democratic norms of openness and publicity while deviating from them
in private. Many of the issues dealt with by public ethics bodies pose
problems of exquisite difficulty, problems generated in part by the pres-
ence of strongly held, conflicting views within society. Supposing that
consensus is possible on a given question, it will often be achieved by virtue
of the willingness of those on opposite sides to make reasonable but pain-
ful compromises. This delicate process of ﬁnding common ground through
moral consensus building is much more likely to succeed in privacy and
conﬁdentiality than under the harsh glare of publicity. It may well be,

CRITERIA FOR sucaiss I 5 9

then, that even within a model built upon the democratic value of open—
ness, much of the real work of compromise and consensus-building takes
place away from the public stage.

EFFECTIVENESS

Preconditions of Effectiveness

As noted above, judgments about the effectiveness of any particular
public ethics body must be based upon a clear understanding of the group’s
purpose, the public need to which it responds, and the social context in
which it deliberates. Notwithstanding the importance of purpose and con-
text, we can note two preconditions of effectiveness for any group, no
matter what its specific charge: communication and authority.

Communication

First, the body must communicate well with its audience. Its reports
and recommendations must be clearly written, trenchantly argued, and
comprehensible to as wide an audience as possible. Accordingly, drafters
should be self-conscious about their writing style, avoiding wherever pos-
sible arcane jargon and academic prose. Since reports are all written in
order to effect some change in the reader—either to change beliefs or to
encourage alternative actions or policies—they should be written with the
specific characteristics of their audience in mind. In a state with a very
active and vocal religious presence, for example, drafters of reports should be
sensitive, not only to the representation of religious views within the group’s
process, but also to the way these documents speak to members of religious
communities. Reports that respect the sensibilities of their readers will be
more persuasive, and hence more effective, than those that do not.

Even the most clearly written and persuasive reports can fail to be
effective, however, if they are not disseminated to as broad an audience as
possible. This means, ﬁrst, that the reports themselves must be easily
accessible to professionals and the general public alike. An adequate num-
ber should be printed and made available at reasonable prices to consum-
ers, professional groups, and public libraries. In the future, public ethics
bodies should take advantage of new information technologies, such as
making documents available through computer networks and on CD ROM.

In addition to the documents themselves, members and staff of public
ethics bodies should attempt to disseminate the main ideas behind their
ﬁndings through a wide variety of media, including newspapers, editorial
columns, book reviews, radio interviews, professionaljournals, and public
and professional issue forums. If the body is proposing new legislation, its

I 60 SOCIETY’S CHOICES

staff and members should attempt to educate members of the legislature
about the issues and about the body’s views.

Authority

The effectiveness or inﬂuence of a report is also in part a function of
the extent to which the group itself is viewed as an authoritative body, i.e.,
a group whose recommendations carry weight with policymakers, profes-
sionals, and the general public. This kind of authority sometimes derives
from the sponsoring body. A public ethics body appointed by the Presi—
dent of the United States or the Governor of New York, for example,
automatically assumes a certain stature in the eyes of the community; this
might, in turn, lend needed credibility to its recommendations. Authority
can also be earned rather than bestowed, either through the individual
reputations of members and staff, or through a successful track record of
substantive accomplishment. The selection of well-known and respected
academicians, community activists, and professionals can lend “clout” to a
commission’s ﬁndings, as can a succession of well-crafted reports, each
building on the success of its predecessors.

Authority can also be a function of democratic representation. Not
every group with a position on a particular controversial issue can be equally
satisfied by a body’s report, but its recommendations will nevertheless be
perceived as authoritative to the extent that all sides have been heard and,
ideally, represented in the body’s deliberations. Conversely, groups whose
voices have been excluded from the process will tend to View the result as a
mere power play and, thus, as lacking legitimacy.

Different Goals, Different Yardsticks of Success

Achieving Consensus

The primary function of many public ethics bodies is to achieve con-
sensus on issues that require some sort of public response. Thus, whatever
may be the specific goals of a particular body, achieving consensus will
usually be an explicit policy objective.

As Martin Benjamin explains in his background paper, consensus in
public ethics bodies make take a number of forms. One such form is what
Benjamin labels “complete” consensus, a term describing the situation in
which members ofa body agree unanimously on recommendations and on
the reasoning behind these recommendations. Not surprisingly, complete
consensus is an uncommon outcome for public ethics bodies because ques-
tions directed at these bodies are typically controversial and because the
membership of these bodies tends to be broadly constituted so as to repre-

CRI'I ‘ERJA FOR SUCCESS I 61

sent all points of view. A more common outcome for these bodies is
“overlapping consensus,” a term coined by political philosopherjohn Rawls
to characterize a situation in which there is agreement on basic principles
among individuals embracing different, and sometimes conﬂicting, out-
looks. In the case of overlapping consensus, people appealing to different
principles may agree on a recommendation and at the same time disagree
about why they agree. Overlapping consensus is understandably more
likely than complete consensus given a population as pluralistic as that in
the United States.

Compromise, explains Benjamin, is another form of agreement that
can occur in public ethics bodies. Central to the idea of compromise is
mutual concession for mutual gain; people with opposing positions relin-
quish aspects of their positions to find some middle ground that is mutu-
ally satisfying. Compromise typically occurs in public ethics bodies when
members value the body’s speaking with one voice more than they value
the body’s endorsing of the view ofa given individual at the price of contin-
ued impasse. Compromise is similar to consensus in that it entails a unani-
mous agreement that the collective body should recommend something
rather than nothing. Another form of agreement that can also occur in
such a situation is “majority rule.” Majority rule represents “procedural”
(as opposed to “substantive”) consensus in that people have agreed to put
forward the recommendation that most members agree on.

In all forms, consensus can be valuable to public ethics bodies. Most
notably, consensus can be instrumental in obtaining external acceptance
and implementation ofa body’s recommendations, especially (and, some
may argue, only) when members ofa public ethics body bring to the delib-
erations an array of different viewpoints on an issue. Observers with differ-
ent viewpoints may be more likely to agree that a group’s recommendation
is valid if they perceive that their varied interests have been considered.

Consensus in all forms also presents dangers. For example, consensus
can be used to obscure deep philosophical issues, in which case the public
would be better served by discussion and reﬂection than by the false resolu-
tion provided by a consensus statement. Excessive pressure to reach agree-
ment may also lead to underestimation of risks and objections, ignoring of
unpopular viewpoints, failure to consider alternatives or to seek additional
information, uncritical acceptance of secondhand information, or failure
to exercise sufficient imagination or ingenuity in building consensus or
devising compromise (Lo, 1987).

Social and political circumstances play a significant role in determin-
ing not only the value of consensus, but also the possibility of achieving
consensus in any form. A particularly salient factor in public ethics delib-
eration is the “ripeness” of the issue in question for public resolution. In
some cases, a body might merely have to place its imprimatur on a consen-

I 62 SOCIETY’S CHOICES

sus that has been gradually building and is now more or less in place. A
good example of this kind of “consensus articulation” might be the Pres—
ident’s Commission report on informed consent and truth telling in Mak-
ing Health Care Decisions (1982).

More frequently, however, public ethics bodies are faced with the
harder task of actually forging a consensus that does not yet exist. In some
instances, a report can help create a societal consensus in spite of some
lingering opposition. A good example of this is provided by the New York
State Task Force report on Surrogate Parenting (1988). The task force mem—
bers were initially deeply divided on this issue, but through a process of
intense and thorough discussion and debate, they eventually reached a
unanimous decision to void surrogacy contracts in New York, Eventually,
legislation premised on the task force’s recommendations was passed, al-
beit over the objections of civil libertarians, the surrogacy industry, and
some couples and prospective surrogates who wished to engage in this
practice. It would probably be accurate to say that a consensus now exists
in New York on this issue, although on many such issues consensus is
subject to changes in public opinion over time.

Consensus has been more difﬁcult to achieve on other issues, such as
federal funding for research on fetal tissue transplants. The NIH panel
that addressed this question achieved a clear majority in favor of funding
such research, but it could not reach consensus. Try as they might to
separate the question of fetal tissue research from the ethics and politics of
abortion, the panel was ultimately divided on the question, reproducing
within itself the divisions haunting the larger society.

Likewise, the President’s Commission report on SecuringAccess to Health
Care (1983b) faced the daunting task of attempting to create societal con—
sensus on an issue that had divided Americans for decades. Forging ahead
in spite of conflicting interest groups (doctors, hospitals, pharmaceutical
companies, consumers, etc.), the commission was able to achieve internal
consensus on the ethical principles that should govern the process of health
care delivery and reform. The problem, according to some critics, was that
this consensus was achieved by divorcing health care ethics from health
care politics; the resulting consensus was, they claim, too abstract to be
compatible with any live option for health care reform. The critics con-
clude that, in contrast to many of its other distinguished reports, this vol-
ume of the President’s Commission has had virtually no impact on the
public debate over health care reform (Bayer, 1984).

Achieving Speciﬁc Results

Apart from the global objective of forging a consensus on difficult
bioethical controversies, public ethics bodies also seek to achieve more

CRITERIA FOR SUCCESS I63

speciﬁc goals such as education, inﬂuencing of public debate, and stimula-
tion of various government actions, including legislation. These disparate
efforts, which may be pursued separately or in concert, must be evaluated
according to a variety of different standards.

Starting with the obvious, public ethics bodies should successfully dis—
charge the speciﬁc mandates that they are given. Ifa body fails to do what
is asked ofit, either because of political paralysis (e.g., the BEAC) or inad-
equate leadership and stafﬁng, it cannot bejudged a success.

Mandate is relevant to the overall assessment ofa public ethics body in
another way. Depending on the circumstances, some speciﬁc objectives
may be more difﬁcult to achieve than others. For example, articulating the
contours of an emergent consensus for educational purposes, while a de-
manding and important task, is not nearly as difﬁcult as drafting legislation
on controversial topics for a population divided by ﬁerce ideological and
religious differences. Assessments of a body‘s accomplishments should
thus resemble the scoring ofa divingjudge: assuming comparable quality,
a greater number of points should go to the more ambitious and difﬁcult
projects. Neither public criticism of a work nor political opposition to its
agenda are reliably reﬂective of inadequacies in its process or product;
rather, they may simply represent the cost of doing very difﬁcult business
under contentious circumstances (see the background paper by Brody).

Assessing the effectiveness ofa public ethics body’s efforts at educating
the public, inﬂuencing public opinion, or stimulating government action is
a complex task. In large measure, judgments can be made based on criteria
discussed above—e.g., intellectual integrity, respect for democratic values,
and so forth—but they should also depend on criteria that reﬂect the
nature of speciﬁc activities of the body. Thus, educational projects should
be judged in part according to pedagogic standards, while judgment of
legislative efforts should reﬂect the quality of the legal craft presented.

Examples of highly successful educational ventures include the Danish
Council of Ethics, described in Chapter 4, and several of the President's
Commission documents, including Splicing Life, Making Health Care Deci—
sions, and Deciding to Farego Life-Sustaining Treatments. Successful legislative
and regulatory efforts include the work of the National Commission and
the respective reports of the New York State Task Force on Life and the
Law and the New jersey Bioethics Commission on the issue of advance
directives. An example of a problematic legislative effort is the New York
State Task Force’s proposal for a statute on “do not resuscitate" (DNR)
orders. While the task force’s recommendations and the ensuing legisla—
tion can be credited with fostering greater dialogue among patients, fami-
lies, and physicians, the law’s apparent insistence upon emergency car-
diopulmonary resuscitation (CPR) in the absence of a documented DNR
order has given rise to unanticipated and vexing problems related to the

1 64 SOCIE’I'Y’S CHOICES

demands of some families for seemingly futile medical treatment. Like-
wise, many believe the President’s Commission report on Deﬁning Death
succeeded for the most part on the legislative front, but failed to advance a
cogent rationale for whole-brain death, thereby falling short in its efforts to
educate the public and shape public and professional opinion (Gervais,
1989).

Can Bioethics Be Disadvantageous?

Along with the advantages and beneﬁts of public bioethical delibera-
tion in many settings and at many levels, there are several potential risks.
Thus far, these are largely theoretical. No systematic research has looked
for the downside of bioethics, and this IOM study committee did not ﬁnd
tangible evidence of their realization. Nevertheless, even hypothetical risks
deserve mention, if only as a suggestion for future research, evaluation,
and monitoring. We call attention to two concerns: the possibility of diver-
sion and capture of bioethical deliberation by special interests and the lack
of proven methodologies and objective standards of evaluation.

Diversion and Capture

Bioethical deliberation could be useful to special interests in a number
of ways. Advocacy groups, for example, are usually perceived as partisan,
but, as mentioned at the outset of this report, bioethical deliberation aims
at impartiality. To the extent that an advocacy group could inﬂuence or
capture a body charged with the task of bioethical deliberation, it could
increase its inﬂuence by lowering the guard of the public. The same is true
for sectarian groups, religious or otherwise.

Financially self-interested parties are a particular cause for concern. In
the new era of health care reform the distinction between ﬁnancing and
provision of care is likely to be further blurred. One result is that the
outcome of ethical disputes over clinical medicine affects the bottom line.
The current debate over the term “futile,” which partly defines the author—
ity of physicians to discontinue life-sustaining care, is a pressing example of
how an ethical definition impacts on the cost of medical care.

Special interests can subvert the process of bioethical deliberation at
every level described in this report. National and state commissions can be
lobbied by advocacy and sectarian groups, who can also exert pressure
when commission and staff are appointed. The ethics committees of pro-
fessional societies have evident conﬂicts of interest when the interests of
their members hang in the balance; this presents a credibility problem, but
most importantly presents a danger that the ethical problems will be dis—
cussed ﬂrst in terms of the management of risks to the members of the

CRITERIA FOR SUCCESS 1 65

society. Even at the grassroots level, there are risks of capture. Creation of
seemingly-authentic grassroots organizations for the purpose of inﬂuenc-
ing legislators has become a new tactic in the public relations industry, and
there are reports that this is occurring in the health care reform debate. It
could also extend to bioethics.

The deﬁnition of “special interest” is itself a contentious issue. Are
advocates for AIDS victims or the mentally ill, or defenders of civil liberties
or human life, special interests? How about ethicists themselves, who re—
ceive public attention and even employment where bioethics is done? And
what of the government itself? When the government is ﬁnancially impli—
cated, as with the use of “experimental therapies” in entitlement health
care programs or in past research abuses where compensation may be due,
the government is not a neutral party. Even when the state turns to
grassroots bioethics for advice, there are risks: participation may serve a
paciﬁcation function if the government controls the agenda and partici-
pants are conﬁned to debating issues the outcomes of which are un-
threatening to the government’s interests. A state, for example, might set
a low ceiling on health care expenditures and then involve grassroots bio-
ethics groups in deciding how to ration within that budget.

None of these considerations demonstrates that the intimate involve-
ment of “special interests" with bioethical deliberation is inherently unde-
sirable or even suspect. Advocates and those with strongly held, sectarian
views will be among the closest observers of groups engaged in bioethical
deliberation. Their energy and knowledge can be an important asset to
these groups and in any case can help to make up the public to whom these
groups are accountable. Nevertheless, the need to avoid capture, diver-
sion, and conﬂict of interest in bioethical deliberation will increase as these
deliberations continue to increase in impact.

Methods and Evaluation

As the United States and other countries turn to applied ethics for
enlightenment, a realistic appreciation of what academic ethics can con-
tribute must be fostered. It is possible that some might expect bioethics to
deliver something—answers, certainty, the morally correct view, etc—that
it is not equipped to produce. It must be clear that “ethical analysis” is not
a single, straightforward method, like algebra or geometry. Different ethi-
cists favor different approaches and methods and claim different philo-
sophical antecedents. No school of thought, such as utilitarianism or
contractualism, dominates the discipline. New views, such as feminist and
narrative ethics, emerge constantly and even inﬂuence many who may not
wholly endorse them. Thus, it is unwise to expect from ethicists a method
all people would choose to use to unravel any ethical quandaries.

I 66 SOCIE’I‘Y'S CHOICES

When academic ethicists have moved into the world of public moral
discourse, they have often found that one of their skills as philosophers,
seeking clarity of meaning in commonly used terms and logic in argumen-
tation, has served better than their ability to explain ethical theory. They
disavow the claim to provide answers and offer to help in identifying the
assumptions underlying arguments and to point out inconsistencies in rea-
soning. These skills are often found useful by those struggling to make
sense of an ethical problem. Even more useful is the ethicists’ insistence
that difﬁcult and obscure terms, such as “dignity," “rights," and “justice,"
that are used constantly in ethical discourse be examined with care. If an
ethical analysis is one that refers in signiﬁcant ways to these concepts, as we
have said, the ability to construct an argument in which they ﬁgure mean-
ingfully and forcefully should be prized.

However, even if these skills are useful, an ethical argument is not
merely logical; it is also substantive, arising from values and norms that are
deeply held by individuals. These values and norms are colored by culture,
religion, heritage, personal history, preferences, and tastes. Ethicists can
often do little more than ask for clarification about the meaning of these
values and norms in the minds of those who hold them and ask them to
examine the consistency and consequences of holding them. Academic
ethics cannot dissolve the differences that might exist between persons and
groups at this level. At best, moral discourse can bring such differences to
the surface, attempt to discover when they arise from misunderstanding,
and invite those who hold them to ﬁnd practical ways of living together.
The best conclusion of an ethical analysis may be the description of alter-
native views. It may, in some cases, be folly to expect more. At the same
time, in the process of examining alternative positions, many consider-
ations are brought to light that illuminate and expand understanding of
the moral problem. This, in public moral discourse, is an invaluable by-
product of the bioethicist's presence.

It may not be possible to measure the success of this sort of activity with
any indisputable standard. Nor is it possible to demonstrate that an ethics
commission or committee has produced an analysis that meets some pre-
determined criteria for sound ethical argumentation. At best, we will rely
on such imprecise indicators of success as those mentioned in Chapter 5.
Thus, no one can prove that the public has gotten its money’s worth out of
such an enterprise. Given these difﬁculties, it may happen that ethics
becomes the cover for ideology (as has often happened in history). The
current favor in which ethics is held may make it possible, as we said above,
for persons and groups with quite sectarian views to disguise their interests
under the title “ethics”, and it may be difﬁcult for others to discern the
difference, until the results are viewed. Even then, clever argumentation
may persuade persons to accept a position that they would repudiate, had

CRITERIA FOR SUCCESS I 6 7

they been exposed to alternative reasoning. Thus, while this committee
believes that more good than bad can come from public moral discourse, it
also recommends prudent caution whenever an ethical analysis ofa major
problem is proposed. Broad representation of distinct opinions is prob-
ably the best antidote.

REFERENCES

Ad Hoc Committee of the Harvard Medical School to Examine the Deﬁnition of'Brain Death.
1968. A definition ofirreversible coma.]oumal ofthe American Medical Association 2052337.

Arras, ]. In press. Principles and particularity: The roles of cases in bioethics. Indiana Law
journal.

Bayer. R. 1984. Ethics, politics, and access to health care: A critical analysis of the President’s
Commission for the Study of Ethical Problems in Medicine and Biomedical and Behav-
ioral Research. Cardozo Law Review 6(2):303—320.

Gervais, KG. 1989. Advancing the definition of death: A philosophical essay. Medical Humani-
ties Review 3(2):7—19.

Hoffman, DE. 1991. Does legislating hospital ethics committees make a difference? A study
of hospital ethics committees in Maryland, the District of Columbia, and Virginia. Law,
Medicine, and Health Care 19:105—119.

Alonsen, A.R.. and Toulmin, S. 1988. The Abuse of Casuistry: A History ofMoml Reasoning Berke-
ley, (IA: University ofCalifornia Press.

Lo, B. 1987. Behind closed doors: Promises and pitfalls of ethics committees. New England
journal of Medicine 317:46—50.

Mi11,_].S. 1859. On Liberty. New York: W.W. Norton.

New York State Task Force on Life and the Law. 1988. Surrogate Parenting: Analysis and Recom»
mendations for Public Policy. New York, NY: New York State Task Force on Life and the
Law.

President's Commission (President’s Commission for the Study of Ethical Problems in Medi—
cine and Biomedical and Behavioral Research). 1981. Inﬁning Death. Washington, DC:
U.S. Government Printing Office.

President‘s Commission. 19823. Making Health Care Decisions. Washington, DC: U.S. Govern-
ment Printing Oflice.

President's Commission. 1982b. Splicing Life. Washington, DC: U.S. Government Printing
Office.

President‘s Commission. 1983a. Deciding to Forego Life-Sustaining Treatment. Washington, DC:
U.S. Government Printing Ofﬁce.

President's Commission. 1983b. Securing Access to Health Care. Washington, DC: U.S. Govern-
ment Printing Office.

Veatch, R.M. 1993. From forgoing life support to aid—in-dying. Hastings Center Repmt 23(6):S7—
SS.

Wikler, D. 1993. Brain death: A durable consensus? Bioethics 7(2/3):239—246.

Conclusions and Recommendations

INTERPRETING THE COMMITI'EE’S CHARGE

One motivating factor behind this report was the fact that little public
bioethics activity took place in the 1980s when the country was sharply
divided on several ethical issues. After the closing of the President’s Com-
mission, no mechanisms for public discussion and consensus building have
been employed effectively. Ethical issues that have been left unresolved
include: the nation's public health response to AIDS, research on fetuses
and embryos, research involving RU-486, research on the sexual practices
of teenagers and adults and their link to sexually transmitted diseases, and
the wide range of implications by findings by the Human Genome Project.

The committee’s initial charge was to analyze the nation‘s current
capacity to anticipate, recognize, and respond to social and ethical issues
arising from advances in biomedical science and technology. Part of this
analysis was a survey and evaluation of the mechanisms that have been used
in the past—at national, state, and local levels—to resolve such issues.
Where such mechanisms are needed but no historical models exist, it was
the committee’s task to make recommendations regarding processes and
structures by which the functions of anticipation, recognition, and response
could be established.

During its discussions, however, the committee decided that “anticipat—
ing” social, legal, and ethical problems associated with as yet unknown
discoveries was not practical, given the difﬁculty of accurately foreseeing
the future. In retrospect, most of the ethical dilemmas generated by inno-
vative technologies in the past would have been impossible to predict.

168

CONCLUSIONS AND RECOMMEND/1 TIONS I 69

Furthermore, it seems impractical to spend time and energy imagining
potential dilemmas when we are already faced with so many. Hence, the
concepts of “anticipation” and “recognition" were merged into “early rec—
ognition" for the purpose of the committee’s deliberations.

Next, the committee was asked to propose processes and/ or structures
by which early recognition and response could be accomplished on an
ongoing basis; the committee was not asked to resolve any particular issue
or set of issues. This portion of the committee’s charge reﬂects the idea
that the need to anticipate new issues becomes less pressing if established
processes exist to address issues promptly as they arise.

The committee was apprehensive about the wording of its charge,
noting that not all scientiﬁc and technological “advances” are, in fact,
advances. The word “advances” implies positive impact, which is not always
the case for new technologies. With this in mind, the committee agreed
that it was actually addressing “developments” in biomedical science and
technology.

Spheres of Concern

Finally, the committee recognized that not all ethical quandaries that
have confronted society in the context of biomedicine have resulted from
a single radical change or the introduction of a unique new technology.
Limiting discussion to single radical changes or unique technologies did
not produce a useful boundary for the committee’s mandate. Rather, it
pointed to a need to deﬁne more carefully the variety of circumstances
under which troubling social and ethical issues can arise. The committee
identiﬁed four illustrative scenarios, which follow.

Novel Developments

Novel developments may raise unique ethical concerns that did not
exist prior to their introduction. The controversy provoked by the recently
reported cloning of human embryos is illustrative (Kolata, 1993). So too
are developments in genetics, which raise new questions about the inter-
play of free will and genetic determinism in generating behavior and about
the value of information about future health status.

Innovations Already Integrated into Practice

Innovations may diffuse into medical practice more rapidly than re-
lated ethical issues can be resolved. Last year’s innovations sometimes
become this year’s practices, with application far outpacing our capacity as
a society to cope with the ethical dimensions raised by these new practices.

I 70 SOCIETY’S CHOICES

When doctors routinely employ a procedure, and when insurance compa-
nies reimburse for that procedure, we tend to think that ethical quandaries
raised by that procedure have been resolved. This is not always the case.
For example, in vitro fertilization is no longer regarded as new in many
quarters, yet the ethical dilemmas it raises have never been satisfactorily
addressed in the United States. Along with other new reproductive meth-
ods (such as surrogate motherhood), in vitro fertilization continues to
challenge widely accepted understandings of parenthood and the legal
status of the embryo/ fetus.

Aggregate Effect

Some technical changes or developments, considered individually, may
not raise substantial ethical issues. Yet an accumulation of such develop-
ments can present a novel circumstance that alters existing practices and
beliefs, triggering a sense that the developments as a whole require deeper
examination because they raise unexamined ethical questions. For ex-
ample, the accumulation of developments in health care, such as immuni-
zations and antibiotics that prevent or cure infectious disease and arterial
bypasses that avert death from heart disease, have made it possible for
people to live longer than ever before. Longer life spans, however, have
increased the incidence of chronic disease, which in turn has provoked
reﬂection on social and ethical issues related to death and dying, the ra-
tioning of medical care, and the ends of medicine.

Organizational Innovation

Organizational changes can also raise new ethical concerns. Our soci-
ety is about to undergo significant change in the delivery of health care
services, including both established and new technologies. This raises new
ethical quandaries related to equity. It is likely that health care reform will
necessitate explicit ordering of priorities regarding health resources as well
as newjudgments about rationing of expensive medical technologies. The
empowerment of distinct social groups, discussed in Chapter 2, is also illustra-
tive of an organizational change that can engender new social and ethical
quandaries. For example, the success of women’s health advocates has
compelled NIH, the scientiﬁc community, and others to address questions
ofjustice and self-determination in health care and health care research.

Limitations in Scope

As illustrated in Chapter 4, the committee recognized that efforts to
address the sorts of social and ethical quandaries described above can take

CONCLUSIONS AND RECOMMENDA TI()NS I 71

a variety of shapes, from community groups to hospital ethics committees
to state and national ethics commissions. The committee also recognized
that the way in which our society responds to such quandaries is inﬂuenced
signiﬁcantly by actions that take place in the context of the legal system,
sometimes through individual landmark cases such as Roe v. Wade or In re
Quinlan, and sometimes through more subtle accumulations of legal deci-
sions. The role of the legal system in inﬂuencing the atmosphere for social
and ethical quandaries in biomedicine is fascinating and complex. Given
resource and time limitations, however, the committee chose not to ad—
dress the legal system in a comprehensive fashion. In order to introduce
readers to the role played by courts, legislatures, and other lawmaking
bodies in bioethics deliberation and policymaking, a background paper by
Lawrence Gostin is included in this volume.

CRITERIA FOR EVALUATION

Potential Yardsticks

The committee worked to develop a series of criteria by which past
efforts—public ethics bodies and the products of these bodies alike—could
be evaluated. These criteria were described in Chapter 5.

Other criteria can and frequently have been used. In his background
paper for this report, for example, Bradford Gray evaluated the President’s
Commission and the National Commission by examining the frequency
with which the work of these bodies has been cited in court cases, the
Federal Register, medical journals, and law reviews. He also solicited the
opinions of former commissioners and staff of the two groups. In a recent
publication entitled Biomedical Ethics in US. Public Policy (1993), the Office
of Technology Assessment (OTA) judged public ethics bodies and their
products as successful on the basis of prevailing sentiment among OTA
study participants and advisors, as well as on the basis ofwhether or not the
recommendations of a particular body stimulated legislation.

Several problems arose in attempting to apply the criteria identiﬁed by
the committee in a uniform, checklist fashion. First, although one can list
what might be valued about a public ethics body or its products, the com-
mittee recognized that such bodies operate in complex situations in which
some of these values necessarily come into conﬂict, or at least tension, with
other values. For example, the committee believes that the practice of
holding open meetings enhances the effectiveness of ethics bodies because
openness is consistent with the democratic orientation of our country. Yet
in some situations, as with the New York State Task Force on Life and Law,
closed meetings may enhance internal collegiality, efﬁciency, and consen-
sus building—also important considerations.

I 72 SOCIETY’S CHOICES

Another complexity arises from the fact that public ethics bodies oper—
ate in a pluralistic society where citizens’ values vary greatly. For example,
agreement on issues that involve abortion is extremely difﬁcult, if not im—
possible, due to the deep divisions in our society on this subject. In fact,
partisan adherence to strongly held opinions on abortion played a major
role in the failure of the Biomedical Ethics Board (BBB) and the Human
Fetal Tissue Transplantation Research Panel (HFI‘TRP), as well as the
failure of efforts to reestablish the Ethics Advisory Board (EAB).

The mandate given to a public ethics body will also affect the way in
which the success of that body or its products arejudged. One reason that
the National Commission has been judged a success by many observers is
that it led to revised regulations for human subjects research (OTA, 1993).
However, that success might have been impossible without the action-forc-
ing clause in the original law, which forced the Department of Health,
Education, and Welfare either to accept the commission’s recommenda-
tions or publicly state its reasons for not accepting them. Conversely, the
HFTTRP was charged to respond to ten speciﬁc questions—a charge that
stimulated the majority of panel members to develop responses to the
individual questions rather than to provide comprehensive and consistent
justiﬁcations for all ofits conclusions (King, 1991.) Some observers believe
that the report of this panel would have been more persuasive had it
developed an analytical framework for considering the issue that took ac-
count of existing norms, methodologies, and cultural perspectives (King,
1991).

Baruch Brody in his background paper in this volume maintains that
both context and mandate were important factors in the effectiveness of
the three New York State Task Force reports, Do Not Resuscitate Orders, Life—
Sustaining Treatment: Making Decisions and Appointing a Health Care Agent,
and When Others Must Choose, as well as that of the President’s Commission
report, Deciding to Forego Life-Sustaining Treatment. The three reports of the
New York State Task Force on the topic of life-sustaining treatment occa-
sioned more controversy because they were focused on the development of
proposed legislation—an activity that is frequently accompanied by con-
ﬂict.

Finally, some public ethics bodies serve functions that they were not
speciﬁcally mandated to serve. For example, a body convened to draft
legislation may be unsuccessful in that regard but may increase public
awareness of an issue through its deliberations. Consequently, the evalua-
tion of the success ofa particular public ethics body may be more meaning-
ful if it also takes into account achievements that are incidental to or
unrelated to a group’s mandated function. It is also necessary to ask
whether public ethics bodies are to be judged on the basis of overall effect
or on the basis of their particular products. When evaluating the overall

CONCLUSIONS AND RECOMMENDATIONS 1 73

effect of an ethics body, factors such as the authority of the appointing
body, the esteem in which its members are held by society, the adequacy of
the staff and resources available, and the impact of previous products is-
sued by the group, in addition to the criteria outlined in Chapter 5, may be
inﬂuential.

Applying the Yardstick

Although the criteria for success cannot be reduced to a checklist, the
committee members believe that—with the appropriate scholarly analy-
sis—general agreement on the success of public ethics bodies often can be
obtained.

As noted in Chapter 4, the Ethics Advisory Board, established in 1978
by the Secretary of DHEW as a permanent advisory body, met frequently
for two years and produced four documents, marking a degree of success.
However, the EAB was disbanded in 1980 and the recommendations of its
principal report were never acted upon by DHHS. Moreover, since DHHS
regulations require that all research involving human in vitro fertilization
or embryo transfer be reviewed by such a board, work in this area has
virtually ceased. Disbanding the EAB might be considered a success by
individuals who wish to block controversial research. The committee dis-
agrees and considers the demise of the EAB to have left unmet a critical
need for bioethical deliberation and decision making. Without the EAB,
the country has had no officially constituted group of national scope to
provide analysis and advice on ethically and socially controversial biomedi-
cal research protocols or guidance to the research community. Human in
vitro fertilization has nevertheless become a standard accepted form of
medical practice, but without what many would consider sufﬁcient scien-
tific, social, and ethical underpinnings to optimize clinical practice (IOM,
1989; OTA, 1988).

The HFI‘TRP, also described in Chapter 4, was convened in 1988 by
the NIH and concluded that the use of human fetal tissue in transplanta-
tion research was acceptable public policy if certain guidelines were in
place (Childress, 1991). Although the panel's report lies within the range
of an international consensus (Walters, 1988), the Reagan and Bush ad—
ministrations did not accept the panel’s recommendations and the mora-
torium on the funding of research using fetal tissue from induced abor-
tions remained in effect until rescinded by the Clinton administration in
1993. Some analysts believe that the continuation of the moratorium
stemmed from the report's failure to make clear how persons holding
radically different views about abortion could nonetheless agree that use of
fetal tissue from induced abortion could be acceptable public policy under
speciﬁc conditions (King, 1991).

I 74 SOCIE'I'Y‘S CHOICES

The National Commission is an example of an advisory body that was
housed within the agency it advised and had an action-forcing mandate.
The commission published several effective reports on speciﬁc topics and
summarized its thinking in The Belmont Report (1978), which clearly enunci-
ated the underlying ethical principles that should guide research involving
human subjects. Whether or not due to National Commission reports, the
incidence of gross abuse of research subjects appears to have diminished
subsequent to their publication. The requirements that the commission’s
recommendations be published in the Federal Register and that DHEW re-
spond in writing within 180 days proved useful in the implementation of
the recommendations.

The President's Commission, on the other hand, is an example of a
commission convened to examine issues that spanned the concerns of
several agencies—not only human subjects research, but also aspects of
medical practice. With a prodigious output of reports, many of which
have inﬂuenced thought in ethics, law, and subsequent legislation, the
President’s Commission can be considered overall to have been an effec-
tive societal mechanism for deliberation about social and ethical issues in
biomedicine.

A MULTILEVEL APPROACH TO
BIOETHICS DELIBERATION

After considering all of these factors, the committee concluded that
the most effective method for dealing with complex ethical and social
quandaries would be a capacity for response at multiple levels of society.
The committee therefore proposes strengthening the multitiered system of
public deliberation at local, institutional, professional, community, state,
and national levels, and particularly recommends ﬁlling a key gap through
reestablishing a supra—agency ethics commission at the national level. The
recommendation for a multitiered system rests on the conviction that ca-
pacities for public ethical deliberation (through academic experts, health
professionals, religious communities, secular agencies, and an increasingly
informed and interested public) have blossomed in all regions of the coun-
try. At the same time, certain contemporary ethical quandaries, including
many ramiﬁcations of molecular genetic research, can best be considered
for the nation as a whole through a supra-agency national commission.
Two supra-agency models presented by the committee are a single national
commission with a broad mandate and a set of national commissions, each
with a more focused charge. The recommendations elaborate on the ele—
ments proposed for the multitiered system and the features the committee
deems desirable for any new national commission. In general, the commit-
tee believes that decisions about public policy should occur as closely as

CONCLUSIONS AND RECOMMENDATIONS I 75

possible to the levels at which relevant actions are taken, and must involve
those likely to be affected by the policy. The committee is not proposing a
new policymaking authority, but a system, separate from existing political
structures, for reflecting on and informing public policy decisions at all
levels.

In considering issues related to genetic technology, for example, some
questions will require resolution on the level of the individual, the family,
health care workers (such as physicians and counselors), and other trusted
advisors such as ministers. Many of these scientiﬁc, social, and ethical
issues will also require examination during the training of the professionals
who aid in the decision-making process. Professional societies will need to
provide their members with guidelines and educational materials to ensure
that patients receive accurate medical advice as well as appropriate and
empathetic treatment and guidance. As the process of genetic screening
moves out of the research laboratory and into the primary care arena, a
consensus must be developed on the kinds of information needed by phy-
sicians and patients (IOM, 1994).

At the level of the institution, hospital ethics committees will confront
issues relating to provider—patient interactions in the case of patients with
genetic conditions. Within institutions that conduct research on humans,
institutional review boards will have to determine the appropriate risks and
beneﬁts for research subjects as genetic testing and screening move into
wider use. Should research subjects involved in the development of ge—
netic tests be provided with preliminary diagnostic information, and if so,
when? When should such testing or screening procedures become part of
medical practice?

Social and ethical issues related to genetics must also be addressed at
the state level, States, which regulate many aspects of medical practice,
form the locus for legal decisions concerning not only what genetic screen-
ing should be done at various stages of life, but what information, counsel—
ing, and quality assessment will accompany each step of the processes.

Several federal agencies are also involved with research and practice
relating to human genetic disease. One example is the Health Care Fi-
nancing Agency, which is responsible for laboratory quality assurance in
genetic testing; it must assure that the information given to the individual
is accurate, since crucial decisions are often made on the basis of this
information. The NIH Recombinant DNA Advisory Committee assures
that present and future gene therapy research involving human subjects is
undertaken appropriately. The Ethical, Legal, and Social Implications
Working Group provides a funding mechanism for ethicists, social scien-
tists, lawyers, and health care professionals to describe, analyze, and edu-
cate professionals and the public concerning the many issues this new
technology raises (see the background paper by Hanna in this volume).

I 76 SOCIETY’S CHOICES

To date, however, the ELSI Working Group has not developed an effective
mechanism for translating the work being done in various professional
communities into public policy.

Governmental agencies have also solicited advice from groups such as
OTA (OTA, 1993) and IOM (IOM, 1994) on issues related to research in
human genetics. The issues raised by what has been called the “genetic
revolution" are so ubiquitous that it may be appropriate to appoint a com—
mission charged with oversight of issues related to human genetics and
situated so as to span the various agency concerns. Issues of individual
privacy and conﬁdentiality of medical information, employment and insur-
ance discrimination, and various eugenic implications are national in scope.

The recommendations made by the committee are divided into non-
governmental, state, and national levels for ease of description. The com-
mittee recognizes and applauds the growth that has occurred over the past
several decades in our nation’s capacity to deliberate social and ethical
issues. The committee envisions a strengthening of this capacity to fulﬁll
the broad array of functions (understanding, education, analysis, and de-
bate) necessary to facilitate the development of consensus in our pluralistic
society. In facing contemporary social and ethical quandaries stemming
from developments in biotechnology, society now has a richer capacity for
deliberation and a deeper pool of expertise than was available as few as 10
to 20 years ago. The modern bioethics movement is now in its fourth
decade. Since its origins in the 19605, it has grown and matured in several
ways. Paralleling the growth in bioethics, there has been a growing body of
literature in the social science arena. Academic experts, members of the
public, government ofﬁcials, and health care professionals with basic knowl-
edge and genuine interest in bioethics and social concerns can be found in
every region of the country.

RECOMMENDATIONS

Since much of the structure for dealing with the impacts of biomedical
developments is already in place at the local level (e.g., IRBs, HECs, and
professional organizations) many desirable actions might be taken at this
level. The committee addresses these recommendations to consumers of
biotechnology and biomedical research, as well as professional organiza-
tions at all levels, recognizing that their members and staffs have unique
capabilities for dealing with some of these impacts. In addition, hospitals
and IRBs have particular opportunities and responsibilities to confront
issues and problems presented by biomedical developments. Many of the
social and ethical impacts of developments in biomedicine are better ad-
dressed at the state or national level, for reasons indicated below. The
committee presents its recommendations for state or national response,

CONCLUSIONS AND RECOMMENDATIONS I 77

noting the advantages that state-level action can have. Finally, the commit-
tee describes the value that national advisory bodies would have and rec-
ommends establishing a national bioethics commission at the supra-agency
level.

A Multitiered Response

The committee envisions multitiered response to social and ethical
issues arising from developments in biomedicine, with deliberations and
decisions occurring as close as possible to the level at which relevant ac-
tions should be taken. These efforts should be democratic in nature, with
a capacity to combine individual and community preferences and values,
practical experience in biomedicine, the academic knowledge of bioethi-
cists, as well as the expertise of other disciplines in which ethical discourse
is prominent (e.g., law, philosophy, and religion), into its operational pro-
cedures. The committee envisions these efforts taking place at locations at
which social and ethical policy decisions related to health science and
health care are being made.

The matching of deliberation to the level at which the decisions are
made could be achieved through the creation of deliberative capacity* at
levels within the health care system where decisions arejointly made among
consumers, providers, payers, and policymakers. The committee is not
proposing a new focus of policy—making authority, but a deliberative capac-
ity, separate from political structures, for reﬂecting on and informing pub-
lic policy decisions at all levels.

Given the growth in the discipline of bioethics over the past 20 years,
and the growth in public interest in social and ethical issues in health and
health care, the “infrastructure” for such a diffuse capacity seems to be
already largely in place. This capacity can be further strengthened to
provide for greater consideration of the social and ethical issues that al—
most invariably accompany technologies and organizational developments
in biomedicine. The committee believes that many ethical decisions are
best made by the affected individuals and families, with the help of advisors
such as health care professionals and ministers. However, some issues will
require communal levels of decision making about quandaries that may
affect every citizen of the community.

Ongoing changes in the structure of the health care system, in combi-
nation with focused national efforts at health care reform, are creating new

*By “deliberative capacity" the committee means some formal assignment of persons and
resources that can make possible the gathering of persons to deliberate in an impartial and
informed way on speciﬁc ethical issues. This can be inside or outside of an agency, it can be
public or private, it can be an ofﬁce or committee.

I 78 SOCIETY’S CHOICES

opportunities to address social and ethical issues in public policy decision
making. The mechanisms for addressing these issues should be consistent
with the structure of health care in each state, and if health care reform
brings central authorities, they too should be supplemented by an ethics
deliberative capacity. If health alliances are established, an ethics capacity
should be built into the alliances at those points where major allocation
decisions are made. Some states might prefer a freestanding ethics com-
mission to advise on a broad range of bioethical issues. State committees,
in turn, could communicate with a national bioethics committee, one of
whose functions would be to help coordinate the activities of state commit-
tees and bring together individuals to deal with national issues that require
special attention.

Ethical deliberations will be particularly important in the case of deci-
sions about allocation of health care resources so that health care plans, at
whatever level, balance ethical and social considerations with consider-
ations of cost. Health care reform is entering unknown and uncharted
territory characterized by an explicit focus on health care costs and ﬁnanc-
ing. The system is presently in ﬂux and the future will bring major changes
in the way health care services are delivered. Traditional ways of making
decisions will also change.

It seems likely that a local ethical deliberative body can best balance
the competing interests of individual needs and desires for intervention
and the economic burdens borne by the institution or community. How-
ever, deliberations at the local level should not replace consideration of
related issues at higher levels.

The committee notes that there are large disparities among the citi-
zens of this country with respect to income, wealth, and power. Concerns
about socialjustice, which drive some of the present efforts to explore the
social and ethical impacts of developments in biomedicine, point to a need
for national deliberations. One advantage of a national deliberative capac-
ity is the authority and credibility with which it is imbued, and which make
it better able to reﬂect on and account for the interests of the disadvan—
taged in these deliberative efforts.

Nongovernmental Organizations and Individuals

The committee considered the current and potential roles of individu-
als and nongovernmental organizations—grassroots efforts, hospitals, insti-
tutional review boards, professional societies, and health professional edu—
cational institutions—in responding to social and ethical issues raised by
biomedical developments. The committee believes that those people who
play major roles in the generation and proliferation of new biomedical
capabilities bear an ongoing obligation to consider the potential impacts

CONCLUSIONS AND RECOMMENDA '1‘]()NS I 79

of their work on the general public and on the particular individuals and
groups to whom innovation is targeted.

The committee recommends that the people or organizations that con-
duct, fund, and commercialize research, as well as those medical pro-
viders who apply new technologies, establish a formal capacity whereby
they can participate in public moral discourse about the ethical impli-
cations of developments in their field. They should attempt to antici-
pate how these developments may affect society for better or worse
and to prepare ways in which adverse effects on social values can be
prevented.

The committee recommends that the National Institutes of Health
provide funding mechanisms to support (1) the exploration by indi-
vidual investigators of social and ethical aspects of biomedical tech-
nologies as they are developed and (2) the creation of a social and
ethical knowledge base for all of biomedical science (e.g., extend the
ELSI program to other institutes and programs within the NIH).

Based on letters solicited from scientists and practitioners in a variety
of ﬁelds, the committee noted that those who discover, develop, or apply
new technologies in biomedicine are often well positioned to recognize
the potential for adverse social and ethical consequences of these tech-
nologies (although sometimes they do not). One of the most efﬁcient ways
to initiate deliberation of and responses to such consequences may there-
fore be to call upon researchers, commercial developers of technologies,
and medical providers who use new technologies to share their special
knowledge of these technologies in ways that could facilitate awareness of
these consequences. Such avenues might include publications and profes—
sional presentations; perhaps inquiry about such consequences could even
be made part of grant applications. The more that it becomes the norm for
consideration of these issues to be part of scientiﬁc investigation, the
greater the likelihood that our society would identify problems in their
early stages and address them more effectively.

Professional Organizations

The committee believes that professional societies, such as organiza-
tions of health care providers or scientists within a ﬁeld, have an obligation
to provide professional guidelines for practitioners and patients dealing
with new technological or organizational developments.

The committee recommends that organizations of biomedical profes-
sionals establish ethics committees that can be easily mobilized to re-
spond to social and ethical issues as they are identiﬁed. Collaboration

I80 SOCIETY’S CHOICES

among professional associations dealing with related issues is to be
encouraged.

Professions exist as part of a societal contract that grants learned ex-
perts a certain latitude and self-control in return for the expectation of
service to the public. In addition, the resources used to support biomedi—
cal innovation and development are generated by the community, largely
through governmental support of research. These economic consider—
ations support a role for professional organizations in bioethics delibera-
tions; so too does the good track record of professional organizations in
advising on these issues. In the court cases adjudicating the foregoing of
life-sustaining treatment during the last 20 years, professional organiza-
tions have participated as amicz‘ (e.g., Cruzan and Conroy) and as parties
(Baby Doe cases involving the American Academy of Pediatrics and the
American College of Obstetricians and Gynecologists). More recently, the
American College of Obstetricians and Gynecologists and the American
Fertility Society, ﬁnding no publicly authorized forum for resolution of
some of the complex issues that repeatedly confront their practitioners,
established the National Advisory Board for Ethics and Reproduction, a
privately funded, and now separately incorporated, forum for discussion of
ethical issues in reproduction.

The committee recommends that professional associations, including
those for health care providers and biomedical scientists, recognize
their special obligation to investigate the ethical implications of bio-
medical developments and advocate for the interests of the public and
of patients, especially when those adversely affected by changes are
unable to advocate for themselves.

Professional organizations may often be among the ﬁrst to note the
potential for adverse effects for some patients or clients. Especially when
these adversely affected persons are already disadvantaged, they may lack
sufﬁcient resources to advocate for themselves. As part of the promise to
serve the public that is fundamental to professional standing, this circum-
stance creates an obligation to advocate on behalf of those at risk of even
greater disadvantage. This may well be a difﬁcult mandate, but the com—
mittee notes that professional societies, as representatives of professionals
themselves, have derivative obligations to speak out, and especially if devel-
opments that offer advantage to some actually worsen the lot of others who
are already seriously disadvantaged.

Hospital Ethics Committees

Preliminary evidence indicates that hospital ethics committees provide
many useful support functions for staff, patients, and their families

CONCLUSIONS AND RECOMMENDATIONS 181

relating to the handling of social and ethical issues that arise from
developments in biomedicine. The committee nevertheless recom-
mends that formal studies of the optimum roles, use, and outcomes of
HECs be undertaken by such groups as the Ofﬁce of Technology As-
sessment, Institute of Medicine, and foundations interested in health
care issues.

As has been described in this report, HECs were originally proposed as
a mechanism for sharing responsibility for morally charged treatment deci-
sions by hospital staff, patients, and their families. However, a tension
exists between the HEC as a forum for professionals and as a vehicle for
fostering the rights and interests of patients and their families (Wolf, 1991,
1992). HECS constitute one way in which medical decision making has
been democratized by being opened to input from nonphysicians (e.g.,
nurses, administrators, clergy, and family members).

The joint Commission on the Accreditation of Health Care Organiza-
tions (ICAHO) requires that hospitals have a HEC or a similar body or
process as a condition for US. hospital accreditation (which is tied, in turn,
to eligibility to receive Medicare payments). The JCAHO also requires
accredited hospitals to provide education on ethical issues to staff, patients,
and families. It has been suggested, but not required, that HECs assume
additional roles such as developing patient rights standards; formulating
and/or reviewing institutional policy and procedural guidelines on deci-
sion making for medical care; reviewing diagnoses, prognoses, and treat-
ment decisions made for speciﬁc patients by doctors and surrogates; and
mediating conﬂicts that might arise over treatment decisions. Although
HECS seem to be potentially useful bodies to help patients, families, surro-
gates, and other decision makers deal with ethical and social issues, it is
unclear at present how many HECs exist, how they function, and what the
outcomes are of the various ways in which they can operate.

The committee believes that HECs or similar committees operating
across health plans could help patients and health care professionals deal
with social and ethical issues that arise from developments in biomedicine.
Little is known about the range and characteristics of effectiveness of these
committees; this knowledge needs to be expanded. This sort of knowledge
will aid in the design and evaluation of similar ethics committees that may
accompany health care reform.

Institutional Review Boards

As discussed elsewhere in this report, the committee believes that past
experience with IRBS has been important and salutary, but that the present
structure and role of lRBs should be evaluated and, if necessary, modiﬁed.

I 82 socm’rys CHOICES

This includes IRBs that review research sponsored by all federal agencies as
well as that sponsored by industry. IRBs are known to be variable in their
application of federal rules and local prerogatives. Where one IRB might
approve a particular research proposal with little question, another might
question many components of the same proposal. Some IRBs uniformly
require written documentation ofconsent, irrespective of risk or feasibility;
others do not. Some irregularity among IRBs can be positive since it can
reﬂect appeal to local understandings and values. However, these irregulari-
ties also point to a need to understand the reasons for diversity and to correct
diversity that arises from bias. Moreover, since research is blocked by an lRB‘s
rejection, due process seems to require that IRBs develop some method for
appeal of their decisions and for identiﬁcation of error or prejudice.

The committee believes that the NIH, in conjunction with other fed-
eral agencies (such as the Food and Drug Administration) to which
IRBs relate, need to carefully examine the IRB system and assess
whether it is functioning well. Some questions that could be assessed
include:

1. Are IRBs successfully representing the interests of human sub-
jects in research and not merely those of their sponsoring institution?

2. Do IRBs generally fulfill their goals?

3. What lessons can be learned about effective IRB function from
the wide variation in actual IRB practices, and should greater unifor-
mity be encouraged?

4. Would communication among different IRBs facilitate effective
functioning?

5. Are there adequate forums for the appeal of institutional rulings
or for resolution of issues that an individual IRB cannot easily address?

6. How do freestanding IRBs operate, especially with respect to
conflict-of-interest considerations?

Health Professional Educational Institutions

As part of the remarkable growth in numbers ofindividuals trained in
academic bioethics, the curricula of health professional schools have be-
gun to reflect the critical role of social and ethical considerations in the
education of health professionals. The committee is convinced that con-
tinued integration of these concepts into health professional education
will ultimately help caregivers relate effectively to patients who are faced
with difﬁcult decisions stemming from technological developments. There
is a developing literature on the integration and evaluation of some of the
efforts to introduce social and ethical issues into the curriculum of health
professional students.

CONCLUSIONS AND RECOMMENDA TIONS I 83

The exposure of graduate students in basic and clinical sciences to
ethical and social issues has lagged behind the exposure of health profes—
sional students by 10 to 20 years. Since individual integrity and mutual
trust among scientists are preconditions for the production of scientiﬁc
truths (see the background paper by Shapin), it is necessary for students to
understand the importance of issues such as scientiﬁc responsibility and
the roles of conventions and consensus in modern science. The NIH
recently introduced a requirement that institutions applying for National
Research Service Award training grants demonstrate the presence of a
program for instruction on scientiﬁc integrity for all NIH-supported train-
ees. Since the requirement is new and still in the early stages ofimplemen-
tation, the degree to which this includes exposure to social and ethical
issues related to developments in biomedicine is unknown. The commit-
tee believes that it is important for biomedical scientists to be part of the
process of examining the social and ethical dimensions of science and
technology because: (1) the tradition of openness and internal criticism
found in science could fruitfully be extended to the deliberation of ethical
issues; (2) biomedical scientists and medical practitioners, due to their
understanding of the use of technology as part of the practice of medicine,
might have special insight into related ethical issues; and (3) scientists may
facilitate the discrimination between factual and value-laden components
of scientiﬁc belief.

The committee recommends that an evaluation be undertaken of the
process of education for graduate students in the health sciences on
the social and ethical implications of technology as part of the current
educational efforts on scientific responsibility. The committee also
urges increased efforts to integrate social and ethical issues in bio-
medicine into the curriculum of undergraduate and graduate health
professional programs.

The State Level

States need to play an active role in deﬁning a capacity for ethical
deliberation in biomedicine given their oversight of professional certiﬁca-
tion, medical practice, health care ﬁnancing, and legal liability. Due to the
number of roles that states play in the development and use of biomedical
technology, the committee believes that each state needs to shape the
method and scope of its commitment to ﬁnding these answers.

The committee recommends that states foster or participate in a pub-
lic deliberative process for responding to social and ethical quandaries
stemming from technological and organizational developments in bio-
medicine and health care.

1 84 SOCIETY’S CHOICES

In a democratic society such as ours, mechanisms should be in place
for participation of the public in decision making about public policy.
Such efforts may be designated as “public” either by virtue of their funding
or governmental sponsorship (e.g., state-sponsored commissions or pub—
licly supported “town meetings“), or merely by virtue of the fact that delib-
erations take place in open meetings. States should assume a special re-
sponsibility to establish or participate in such a process for several reasons,
one being that states are responsible for administering programs that inevi—
tably raise ethical issues (e.g., Medicaid, maternal and child health pro—
grams) and for developing health care regulations. For example, in re-
sponse to the Patient Self-Determination Act, a number of states did solicit
input from a wide variety of individuals and groups regarding how the Act
should be implemented (Teno et al., 1993).

Because states are also the primary locus for family law, public health
law, malpractice provisions, and criminal law, states should play an impor-
tant role in stimulating public discussion and resolution of such issues as
the use of reproductive technologies; laws and regulations concerning the
“deﬁnition” of death and foregoing life-sustaining treatments; the practice
of assisted suicide and active euthanasia; public health measures involving
screening, contact tracing, and quarantining for infectious diseases; screen-
ing programs to detect either the presence of genetic disease or susceptibil—
ity to diseases such as cancer or heart disease; the procurement and alloca-
tion of organs for transplantation; and so on. State mechanisms can also
channel consensus into the particular legislative form that is appropriate
for and acceptable to citizens of a particular state.

The committee does not recommend a single speciﬁc mechanism for
public deliberation of ethical issues at the state level, nor does it recom—
mend a formal institutionalized response in each of the 50 states. Some
states may want to establish their own ethics commissions, such as that
in New York. Other states lacking the resources or breadth of repre-
sentation for such undertakings may wish to cooperate with neighboring
states to form regional ethics commissions and information exchange pro—
grams.

There are several advantages of having a commission operating at the
state or regional level. State-level commissions, by virtue of their more
restricted geographic domain (compared to national-level commissions)
may be better able to target their deliberations to reﬂect local conditions,
constituencies, historical traditions, and legal requirements.

Second, with respect to some controversial issues regulated at the state
level, a state-level commission may be successful at achieving consensus. In
some instances, reports based on national-level deliberations may fail to
appear to a locally focused citizenry as being pertinent to meeting their
needs. For issues on which nationwide consensus is unlikely at present

CONCLUSIONS AND RECOMMENDATIONS I85

(e.g., rationing health care), some states have managed to confront the
issue in a more direct way. Oregon showed a willingness to deal with the
complexities of prioritizing health care services; the state was also able to
develop a public process that included grassroots input unlikely to be rep-
licated at this time at a national level.

Third, no matter how well a national commission might frame its policy
recommendations, these will in any case have to be implemented at the
state level. A state-level commission can serve as a helpful mediator be-
tween a nationally articulated consensus and the particular demographic
and legislative constraints of a given state or region. Particular religious
constituencies or interest groups may exercise little influence at the na-
tional level but play pivotal roles at the local or state level. By working
closely over time with a state legislature or by inviting the representatives of
particular groups to participate in its deliberations, a state- or regional-level
commission may ﬁnd it easier to implement a policy consensus that has
been forged at the national level.

Grassroots efforts may also be effective, as illustrated by efforts in Or-
egon, Vermont, and Colorado (Iennings, 1988). Assuming that some form
of health reform is enacted, states may also wish to recommend or perhaps
even require that each regional or corporate health alliance set up an
ethics committee charged with forging policy on access questions. Still
other states may wish to sponsor or encourage a wide variety of educational
efforts in schools, museums, and other forums and via print and electronic
media.

The committee acknowledges the possible objections to these recom—
mendations. For example, all this activity on the state level could be con-
strued as duplicative and different states could take different positions on
controversial issues, as they once did regarding the deﬁnition of death. In
addition, states may not choose to commit adequate funds for the kind of
stafﬁng and process that the committee recommends elsewhere in this
report. It should be noted, however, that states have the right and respon-
sibility to make these decisions. The fact that they will disagree, especially
on highly contested policy questions, can and should be regarded as an
advantage. The states provide a much—needed laboratory for social policy
experimentation.

The Newjersey Bioethics Commission, for example, acknowledged the
essentially philosophical and religious nature of the debate over brain
death; it then took the bold step of allowing members of certain religious
groups to deﬁne death for themselves, in accordance with their religious
beliefs. Newjersey’s experience with this legislation may provide the rest
of the nation with an interesting counterpoint to the proposition, endorsed
by the President’s Commission and the New York State Task Force, that
strict uniformity is a prerequisite of good public policy in this area.

I 86 SOCIETY’S CHOICES

The National Level

Agency-level Advisory Bodies

The committee recommends the establishment of a deliberative capac-
ity within relevant government agencies and departments to provide
advice on issues relating to biomedical research and applications of
biomedical technology. The committee strongly recommends that as a
first step, the Ethics Advisory Board or a similar body within the
Department of Health and Human Services be reestablished.

The committee perceives a need for a permanent ethics staff within
governmental agencies. Ethics panels located within, and related to, spe—
ciﬁc agencies have provided valuable advice to these agencies in the past.
Speciﬁc examples of advisory bodies located within agencies have been the
National Commission, the NIH Recombinant DNA Advisory Committee
with its Subcommittee on Human Gene Therapy, and the Ethics Advisory
Board. All three of these bodies provided advice to their sponsoring agen-
cies regarding research ethics. The committee strongly supports the rees—
tablishment of an EAB—like body, because the tasks assigned to it in its
originating regulation are not being accomplished at present and consti-
tute a national need and a missed opportunity for leadership in this area.
Comparable bodies, often located in ministries of health, have been estab—
lished in many countries in the past 10 years.

A Supra-agency Commission

For certain issues of broad national interest, the committee believes
that it would be highly desirable to have a national-level commission ad-
dress these issues as they concern multiple governmental agencies. Some
complex issues are better examined and analyzed in a disciplined fashion
at a national level, because they affect people throughout the country. In
addition, some issues may be ripe for a broad social consensus. The com-
mittee believes that at the present time there are several such issues that
might be incorporated into the mandates of one or more national commis-
mom:

1. issues related to scientiﬁc advances in genetics, including new possi-
bilities for shaping future generations in unusual and unexpected ways,
and the impact of genetic knowledge on peoples‘ insurability and employ-
ability;

2. issues related to confidentiality and privacy of medical information,
especially in light of health care reform;

3. the interplay of serious disability and life-sustaining treatment, as
well as discrimination on the basis of disability;

CONCLUSIONS AND RECOMMENDA TIONS 187

4. the principles to be used for allocation of medical services and inte-
gration of costs with social and ethical considerations into clinical and
allocation policy decisions; and

5. issues related to reproduction and research and medical treatment
of embryos and fetuses.

A high-level commission has several institutional advantages over ef-
forts at a lower level, including greater visibility, higher prestige, greater
capacity to address a broad mandate, and more independence. A centrally
situated body would be readily available to work on complex issues and give
coherent responses. A national body can more readily call upon the na-
tional and international expertise that is required for complicated and
difficult issues; experts can function as commissioners, staff, witnesses, and/
or authors of background papers. A national body is also in a better
position to formulate and represent distinctively American views on bio-
ethics, at a time when issues relating to biomedical research and applica-
tions are becoming increasingly internationalized.

National professional bodies may have the expertise to deal with social
and ethical issues, but may lack the authority and legitimacy that comes
from being authorized and appointed by the federal government. The
National Commission and President’s Commission demonstrated the ef-
fectiveness of federally appointed bodies in dealing with ethical issues.

The committee recommends that the federal government establish a
public deliberative body (or bodies, depending on the breadth of the
mandate to be addressed) for a limited term at the supra-agency level
to consider social and ethical issues stemming from technological and
organizational developments in biomedicine that are of concern simul-
taneously to several governmental agencies or are nationwide in scope.

The experience of BEAC should not be forgotten, however, in any
vision of a national-level commission and the sorts of issues it might ad—
dress. BEAC has been described as having “crashed on the shoals of abor-
tion politics,” an idea that raises the question of how another national-level
commission might navigate through some of the issues that BEAC was
convened to address. As Hanna and colleagues describe (1994), issues in
which abortion is a factor may be issues of which public bioethics delibera—
tion must simply steer clear. They suggest that abortion and issues involv-
ing abortion are issues that simply cannot be productively engaged at the
present time because they elicit “strongly held incompatible views that
rational people reach from different moral premises." Even if competing
biases were equally balanced on a commission, opinions about abortion
are usually so strongly held that it is unlikely that significant movement
toward a middle ground could occur. At some time in the future, bioethi-

I 88 SOCIETY’S CHOICES

cal issues that touch on such divisive issues as abortion may be ripe for
some form of useful explication or consensus, but they are decidedly un-
ripe now.

In the event that one or more national ethics commissions are estab-
lished, the committee recommends that each have the following at-
tributes:

Mandate. The body must have a broad yet clearly defined and coher-
ent mandate, as well as the ability to add additional related topics as
they become salient.

The committee was unable to reach consensus regarding the appropri-
ate breadth ofa national commission’s mandate. The majority of commit-
tee members believe that it is not feasible for a single national commission
to address all social and ethical issues in biomedicine, since the expertise
and experience required by such a broad mandate could not be encom-
passed in a membership of reasonable size. These committee members
propose that a national commission’s mandate include a set of related
social and ethical issues. This proposal reﬂects a perception that some of
the topics in the mandate of the National Commission were quite removed
from the central issues of that body and hence were less well handled by
the group. Examples of such topics include the study on Psychosurgery and
the Ethical Guidelines for Deli-(my of Health Services by DHEW Commissions
with a mandate to address interrelated issues will ordinarily have an easier
time studying and resolving subsequent issues after they have reached con-
clusions in one area.

A second group of committee members believed that a national com-
mission with a broad mandate was preferable, so long as it had sufﬁcient
time and funding to hire staff and commission background papers to en—
compass all of the appropriate expertise needed. In this case, commission
members—who could be generalists—would evaluate background papers
and staff research in order to reach conclusions. One advantage of a
commission with a broad and general mandate is that knowledge gained by
commissioners and staff in one area may be applied to the subsequent
study of other areas. Furthermore, if the group is effective in resolving
issues, the credibility of its conclusions on subsequent topics will—and
should—be enhanced.

When Congress or the president identiﬁes issues in special need of
attention, they could ask for a national commission’s advice on these top-
ics. Yet it is also desirable to permit the commission to add extra topics to
its mandate, as its time and resources allow and as dictated by the urgency
and importance of such additional topics. This prerogative was usefully
exercised by the President’s Commission in its reports on Deciding to Forego
Life-Sustaining Treatment and Splicing Life.

CONCL USIONS ANI) RECOMMEND/1 TIONS I 89

Sponsorship. National commissions could be appointed by the presi-
dent or Congress. Wherever located, each national commission should
operate autonomously.

Appointment by the president enhances a commission’s prestige and
may also increase its access to government and other information. In
addition, if the appointing power is vested in the president, it can be made
subject to certain categorical requirements that would ensure that mem-
bers reﬂect the range of views relevant to the topics under study. Congres-
sional power over appropriations may encourage responsiveness to statu-
tory expectations. Both the perception and reality of independence are
important to the credibility of a commission’s recommendations. In spite
of appointment by the president or Congress, a national commission needs
insulation from self—serving, narrow political interests at the same time as it
needs strong ties to affected or vulnerable groups.

Membership. Each national commission should have a diverse member-
ship in order to represent the points of view of all those concerned
with or affected by the social and ethical issues to be considered. The
composition of the body should enhance the qualities of impartiality.

All of the national-level public ethics bodies convened in the past have
been composed of experts in a range of relevant disciplines, including
academic bioethics, the health professions, biomedical science, social and
behavioral sciences, law, philosophy, and religion. Some have also in—
cluded members representing the general public. Given the logistical
desirability of limiting the group to a relatively small size (11 to 20 mem-
bers), care must be taken to ensure that the group reﬂect not only disci-
plinary expertise but also the diversity of views and personal characteristics
relevant to the topics under study. Members should be able to rise above
their representation of groups or constituencies.

The appointment procedure needs to strive for a delicate balance
among the needs of such a body. While the committee recommends that
the membership represent a diversity of interests, members should be cho-
sen in order that they may be free to consider issues independently, to
deliberate, argue, and reach conclusions based on the information pre-
sented, without fear of being removed from or disappointing any particu-
lar constituency. Efforts need to be made to include people with formal or
informal training in bioethics or who are willing to read and discuss the
literature of bioethics seriously.

Membership on federal ethics bodies has traditionally been restricted
to persons not employed by the federal government—a restriction that has
helped to ensure independence from political inﬂuences. There may be
reasons in some instances to deviate from this pattern through the appoint-

I 90 SOCIETY '3 (21101093

ment of executive or legislative branch personnel. Given the volatility of
some issues in bioethics, however, any arrangement that ties the appoint—
ment process directly to the president or Congress, or to a governor or
legislature, can engender a struggle over ideological “balance.” This can
result in a group that is potentially polarized, with at least some members
who regard themselves (and are regarded by others) as “representatives” of
the groups or organizations that lobbied for their appointment. Such a
group does not serve one of the most useful functions of a commission,
which is to remove sensitive topics from the political arena and consider
them in a more neutral atmosphere, allowing individuals who come with
differing views to discover common ground, as issues are ﬂeshed out and
relevant data are collected. Ideological polarization was responsible for
the failure of BEAC.

Public Access. To the extent possible, a national commission should
deliberate in public. If such public deliberation is not possible, means
need to be found to gain input from all persons and groups with inter-
ests in the deliberations. A national commission must reach out to
segments of the population whose voices are less regularly heard.

Public media coverage can help to educate the public about the delib—
erations ofa national commission. Public meetings can also facilitate broad
public involvement. The National Commission and President’s Commis—
sion did not find that public meetings interfered with full and frank ex-
change of views.

Advisory Rate. A national commission should provide advice not only to
its authorizing body but to all concerned parties, including the bio-
medical community; federal, state, and local governmental bodies; and
the public.

The commission could be required to report. to the president, to Con-
gress, and to any departments or agencies affected by its recommenda-
tions, but commission reports should also be disseminated to all interested
parties outside of the government. Some ﬁndings and recommendations
of a national commission may lead to federal legislation or regulation;
others may be of primary importance to indiﬁduals, as patients or profes-
sionals, or to state legislators,judges, and ofﬁcers of health care institu-
tions. A national commission might well address topics of interest to all
these groups. Local bodies (e.g., HECs and IRBS) can also beneﬁt from
national advice. The experience of the President’s Commission demon—
strates that conceiving of a commission’s audience broadly encourages
better communication and wider dissemination of ﬁndings. Commissions
at all levels should therefore take speciﬁc steps to assure that the results of
their deliberations are made accessible to the public. In addition to the

CONCLUSIONS AND RECOMMENDATIONS I 91

use of newspaper and radio, thought needs to be given to how newer
methods of information transmission (e.g., electronic means such as com-
puter bulletin boards) might be utilized to communicate commission con-
clusions.

Actionforcing Powm. Although a national commission should be advi-
sory, its recommendations should be published, and relevant federal
agencies should be required to respond to those recommendations
within a defined “comment period” (e.g., 180 days), either by adopting
the recommendations or by explaining why they are not being adopted.

For recommendations that are addressed to federal departments and
agencies, action-forcing authority is highly desirable, as the positive experi-
ences of both the National Commission and President’s Commission and
the negative experiences of the HFTTRP demonstrate. However, such
authority is not self-executing, and agency ofﬁcials who want neither to act
nor to explain their inaction may sometimes disregard the statutory re—
quirements. This is especially easy for them to do once the commission
goes out of existence.

Having action—forcing powers means that deliberations will be ap-
proached more thoughtfully by all, including members of the commission
itself. National commissions of the past have worked more effectively in
reaching their recommendations when they knew that the recommenda-
tions would be responded to by others and would potentially have a direct
regulatory impact.

Funding and Staff. A national commission should be given adequate
resources and staff to accomplish its task. It should be funded by
direct appropriation to ensure its independence. It should have au-
thority over its own budget and the hiring and firing of its staff.

The cost of running a national commission depends on the breadth of
the group’s mandate, the estimated number of commissioners and staff
needed, the number and location of the anticipated meetings, and the cost
of printing and disseminating the reports that will be produced. The
President’s Commission was authorized for $5 million per year for four
years; in operation, it expended under $5 million over its entire lifetime
(39 months), meeting 28 times (generally for 2 days) and publishing a total
of 17 volumes. The ability to bring highly qualiﬁed experts to the staff for
one- and two-year terms of service has several beneﬁcial results: it acceler-
ates a commission’s work, because of the experts’ knowledge of their ﬁelds;
it enhances the quality of the work, because such staff members want to
produce work they can be proud of when they return to their home institu-
tions; and it helps to avoid bureaucratization of the commission.

I 92 SOCIETY‘S CHOICES

Duration The commission should have a defined term that is adequate
to allow for achievement of assigned tasks.

There are important reasons to limit a national commission’s term,
one of which is that limited terms enhance members’ ability to maintain
energy, focus, and timeliness. The committee considered two possibilities:
(1) the term of the commission could be approximately 3 years, with com-
missioners serving for the entire term, or (2) the commission could have a
longer term, with rotating appointments so that one—third of the membership
would be replaced every 2 years. As the experience of both the National
and President's Commissions indicates, the existence of a date by which
work must be completed can result in a high level of productivity. Further-
more, time-limited commissions are less likely than standing commissions
to become overly bureaucratic in their approaches. Arguments for longer
terms (up to 6 years, with staggered terms for members) include consider-
ations of consistency, credibility, and efficiency of group interaction.

The majority of the committee favored a commission with a defined
lifetime as well as a mechanism for initiation of new commissions to con-
sider future issues as they arise (see next recommendation). Some com-
mittee members favored the idea ofa fixed—term national commission with
a “sunset clause,” which sets an initial date for termination while still mak—
ing it easy to extend the commission’s term if the issues it is addressing
merit further attention and if the quality of its workjustifles, in the eyes of
the Congress and the president, the commission’s continuation.

Ifa national commission has a limited term, then the value of continu-
ity and the “learning curve" favor a ﬁxed membership. If the group is
constituted as a longer-term body (subject to periodic review and renewal),
then a rotating membership with staggered terms seems advisable, both to
ensure diversity of views and to avoid bureaucratic narrowing of the group’s
collective vision.

If a term-limited national commission is appointed, the committee
recommends that responsibility be located within some existing gov-
ernment locus for ongoing monitoring/ reporting on social and ethical
issues in biomedicine and for recommending the appoinnnent of new
commissions as serious issues of national scope emerge. This respon-
sibility could be located in the Ofﬁce of Science and Technology
Policy, the Ofﬁce of the Secretary of Health and Human Services, or
at some other location chosen by the president or Congress.

The committee believes that, during times when no national commis-
sion is functioning or when issues arise at an agency level but remain
unaddressed, there should be a continuing surveillance mechanism to iden-

CONCLUSIONS AND RECOMMENDATIONS I 93

tify developing unsolved problems that require more focused attention. A
governmental locus for such monitoring could provide several speciﬁc
functions: it could initiate/prepare a biennial report to be published in
the Federal Register on social and ethical issues emerging from biomedical
technology; it could serve as a receptor for the input of local communities,
individuals, institutions, and states that identify issues that need to be ad—
dressed in a broad fashion; it could facilitate networking among the various
groups addressing social and ethical issues; and it could advise the execu-
tive branch about special social and ethical issues that need immediate
attention. At the same time, by virtue of its location, it would allow the
solution to be part of the political process.

Most of the committee members felt that this function could be accom-
plished in an existing governmental ofﬁce, without increasing the bureau-
cracy by creating a new ofﬁce. A few of the committee members favored
having an external advisory committee, related to the governmental locus,
that is charged with identifying issues to be dealt with at a departmental or
interdepartmental level, developing mandates, and nominating commis-
smners.

REFERENCES

Childress,].A. 1991. Deliberations of the Human Fetal Tissue Transplantation Research Panel.
In: Biomedical Politics, Institute of Medicine. Washington, D.C.: National Academy Press.

Hanna, KE, Cook-Deegan, R.M., and Nishimi, R. 1994. Finding a forum for bioethics in
public policy. Politics and the Life Sciences 12:205—219.

Institute of Medicine. 1989. Medically Assisted Conception: An Agenda for Research. Washington,
DC: National Academy Press.

Institute of Medicine. 1994. Assessing Genetic Risks: Implications for Health and Social Policy.
Washington, DC: National Academy Press.

jennings, B. 1988. A grassroots movement in bioethics. Hastings Center Report 18 Gune/
July):Supplement S.1—S.16.

King, P. 1991. Commentary (on Human Fetal Tissue Transplantation Research Panel article
by ].A. Childress) In: Biomedical Politics, Institute of Medicine. Washington, DC: Na-
tional Academy Press.

Kolata, G. 1993. Cloning human embryos: Debate erupts over ethics; some see nightmare,
but others hope to begin. New York Times (October 26):A1.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral
Research. 1978. The Belmont Report. Ethical Principles and Guidelines for the Protection of
Human Subjects in Research. Washington, DC: U.S. Government Printing Office.

Ofﬁce of Technology Assessment (OTA). 1988. Infertility: Medical and Social Choices. Washing-
ton, D.C.: U.S. Government Printing Ofﬁce.

OTA. 1993. Biomedical Ethics in U.S. Public Policy. Washington, DC: U.S. Government Printing
Ofﬁce.

President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and
Behavioral Research. 1983. Deciding to Forego Life-Sustaining Treatment. Washington, DC:
U.S. Government Printing Ofﬁce.

1 94 SOCIETY’S CHOICES

Teno,J.M., Sabatino, C., Pariser, L, Rouse, F., and]. Lynn. 1993. The impact of the Patient
Self-Determination Act’s requirement that states describe law concerning patients’
rights. journal ofI.aw, Medicine, and Ethics 21 (1 )z102-108.

Walters, L. 1988. Statement. In: Human Fetal Tissue Transplantation Research Advisory Committee
to the Director. Bethesda, Maryland.

Wolf, S.M. 1991. Ethics committees and due process. Maryland Law Review 50(3):798—858.

Wolf, S.M. 1992. Toward a theory of process. Law, Medicine, and Health Care 20:278—290.

PART II
COMMISSIONED PAPERS

he second part of this report presents a series of essays commissioned

by the committee on various aspects of the social and ethical dimen-
sions of decision making in biomedicine. Altogether there are 12 essays;
they are ordered according to the scope of the issues they address. The
ﬁrst several essays explore broad questions while the later essays are more
narrowly focused on a specific aspect of decision making or a particular
bioethics effort.

Moral Epistemology

Thomas Nagel provides a definition of moral knowledge, examines mecha-
nisms for acquiring such knowledge, and considers the possibility of arriv-
ing at moral knowledge through some kind of intellectually defensible
process. He relates these issues to the challenges faced by public ethics
bodies in contemporary, pluralistic America as they seek to explain and
justify their views to their fellow citizens.

Public Moral Discourse

Dan W. Brock describes some of the features of the nature of public ethics
bodies—the different goals they pursue, their typical charge and composi-
tion, and the role in public policy that they typically play. He argues that
the method by which ethics bodies have tended to address and reason
about moral issues is fundamentally similar to the methods of moral phi-
losophy, and explains why the substantive conclusions that public ethics
bodies reach by this process are justiﬁed.

The Value of Consensus

Martin Benjamin examines the nature, value, and limits of consensus in
bioethical deliberation. He describes various types of consensus, as well as
notions such as compromise and majority rule, and raises normative and
methodological issues to be explored by ethics bodies as they consider
what role consensus should play in their deliberations.

Bioethics Commissions: What Can We Learn from
Past Successes and Failures?

Bradford H. Gray provides an analysis of the lessons to be learned from the
experiences of two earlier ethics commissions—the National Commission
and the President’s Commission—both of which are generally cited as suc-
cesses. From a survey of the members and staff of these commissions, he
draws conclusions about the senses in which these two commissions were
successful and the reasons behind their successes and failures.

197

1 98 SOCIETY ’S CHOICES

Limiting Life-Prolonging Medical Treatment: A Comparative Analysis of
the President’s Commission and the New York State Task Force

Baruch A. Brody compares the accomplishments of these two ethics bodies,
one at a national level and one at a state level, in their different approaches
to one issue: limiting life—prolonging medical treatment. He explains why
the nature of their successes differed and explores the important connec-
tions between the role of an ethics body and the context in which it oper-
ates, and the structure and process of that body.

The Formulation of Health Policy by the Three Branches of Government

Lawrence Gostin explores the role of government in formulating health
policy. He considers the kinds of health policy questions that different
government bodies are best equipped to solve, the data that they need to
do so, and the mechanisms for making that data available to decision
makers.

The Role of Religious Participation and Religious
Belief in Biomedical Decision Making

Charles M. Swezey provides a framework for understanding the complex
relationship between religion and bioethical decision making. He identi—
ﬁes signiﬁcant dimensions of religious belief, sketches the elements of
decision making, and traces the interactions between the two to illuminate
the impact of religious belief on the practice of modern medicine.

Trust, Honesty, and the Authority of Science

Steven Shapin explores the moral authority of scientists by way of an histori—
cal inquiry into their credibility. He describes how the credibility of scien—
tiﬁc claims and the moral standing of those who make the claims have been
intertwined in the past. He points to the modern disengagement ofvirtue
and expertise—the weakening of trust relationships in science—as prob-
lematic to science.

Institutional Ethics Committees: Local Perspectives on
Ethical Issues in Medicine

Elizabeth Heitman examines the historical development of institutional eth-
ics committees and describes the roles of these committees in policymaking,
education, and consultation on ethical issues in medical care. She provides
a comprehensive account of the administrative aspects ofinstitutional eth-

(.‘(hUMISS‘ION/il) m PERS‘ I 99

ics committees and identiﬁes issues that these committees will confront in
the future. such as cost—containment, liability, and long—term care.

The Ethical, Legal, and Social Implications Program of the National
Center for Human Genome Research: A Missed Opportunity?

Kathi E. Hanna provides a comprehensive history and description of the
Ethical, Legal, and Social Implications Program of the National Center for
Human Genome Research. She explores the program’s role in policy
debate about genetic technology, analyzes its strengths and weaknesses,
and considers strategies for reshaping the program so that it can more
effectively achieve its intended goals.

AIDS, Ethics, and Activism: Institutional Encounters
in the Epidemic’s First Decade

Ronald Bayer examines the role of consultation between ethicists and those
at risk oleV in the confrontation of critical policy questions raised by the
HIV epidemic. He explores how the distinctive political context of this
consultation—the intensity of the discussion, the political forces called
into play, and the demands made and solutions sought by activists—have
fostered an unusual series of institutional efforts to engage activists in the
process of establishing guidelines for AIDS policy.

“La Pénible Valse Hésitation”: Fetal Tissue Research Review and the
Use of Bioethics Commissions in France and the United States

R. Alta Charo compares and contrasts the roles and experiences of bioeth—
ics commissions in France and the United States, focusing on both coun-
tries’ efforts in the area of fetal tissue research. She explores the political
and historical context for bioethical deliberation in the two countries and
points to significant social conditions to which commissions may have to be
responsive in order to succeed.

Moral Epistemology

THOMAS NAGEL, Ph.D.
Professor of Philosophy and Law, New York University

If our interest is the public evaluation and control of advances in bio—
medicine or other technologies, the problem of moral knowledge has to be
closely connected with the conditions of political legitimacy. The issue is
not just, “What are the grounds and methods of moral thought in general?”
but “What methods can be used to justify conclusions that are ﬁt to serve as
the basis for public policy and public restraint?” There may be grounds of
moral belief which can serve legitimately as a basis for personal conduct,
but which it would be inappropriate to rely on in justifying the actions of
ofﬁcial bodies, taken in the name of a public which comprises a wide range
of conviction.

I shall return to this point later. But for most of this discussion I won’t
distinguish between the morality of public and of private choice, but will
talk about the foundations of moral judgment in general. Because of the
essentially public concerns which prompt the discussion, however, I shall
leave aside the morality of individual virtue, which may have some bearing
on the conduct of particular public ofﬁcials but has little to do with tech-
nology assessment.

Epistemology, or the theory of knowledge, is a function of the subject
matter. How to arrive at conclusions, how to justify 0r criticize them, and
the pitfalls along the way, all depend on what kind of thing you are trying
to make up your mind about. So the ﬁrst question to answer is: What is
morality about—what kind of thing is a moral belief? What is it, in other
words, that moral epistemology must investigate our knowledge of?

The minimal answer has two elements: (1) Moral conclusions are

201

202 SOCIETY’S CHOICES

practical, which means that they are about what to do rather than about
what is the case (even though they may be based partly on what is the case);
(2) they are not merely individual but represent a possible area of interper-
sonal agreement. The most general concept of morality, shared by those
who may differ widely about its substantive content or foundation, refers to
standards of individual or collective conduct which permit people to agree
in the determination of what ought to be done in a given case or under
given circumstances.

There is difference of opinion over how wide the range of possible
agreement should be—whether morality should seek answers that permit
convergence only among members of a particular community or culture,
or among all human beings or even all rational beings (a class which could
in principle include nonhumans). But however we answer that question,
the main point is that such standards, if they exist, are supposed to give the
same result whoever in the moral community is trying to answer the ques—
tion. If you are trying to decide what to do, and if there is a moral answer
to the question of what you ought to do, that answer should be available
notjust to you but to anyone else informed about your situation. It should
be independent of the point of view of the individual making the judg-
ment, and in that sense objective. If such an answer is available, it should
permit you tojustify your conduct not only to yourself but to others.

So the search for moral knowledge is the search for a basis for objective
judgments about what people ought to do—judgments on which they can
agree and which allow them to offer justiﬁcations to one another for their
conduct. Such justiﬁcations will have to appeal to something independent
of the differences in point of View that ordinarily divide us, and that are
generally so important in motivating our actions—something we can rely
on in common. What this is, or whether such a thing can be found at all, is
the central issue of ethical theory. But most theorists would recognize, as
characteristic of morality, the aim of convergence by individuals with di—
verse and conﬂicting points of view on standards of conduct and choice
which all can see asjustiﬁed. Morality, if there is such a thing, requires us
to transcend in the practical domain our individual perspectives, and by
means of this collective transcendence to converge on a common stand-
point of evaluation. It aims to supply a framework of potential agreement
or harmony within which the remaining differences can operate without
doing harm.

There is in this sense a loose analogy between the aims of moral and of
factual knowledge: Both are concerned with convergence on results all
parties can recognize as correct, and both require transcendence of a purely
personal point of view to one that is more shareable and objective. But the
convergence sought by moral thought is practical and motivational,
whereas the convergence sought by factual and scientific thought is conver—

MORAL EPISTEMOLOG Y 2 03

gence of belief—convergence on a true account of how things are, or a
common picture of the world. The pursuit of moral knowledge, therefore,
must proceed by the development of our motives and practices, not of our
beliefs and descriptions.

Because our personal desires are so individual and conﬂicts of interest
and attitude are often so severe, the question whether moral objectivity is
possible is more serious than the comparable question about other ﬁelds.
Nonevaluative subjects like mathematics, science, and history don’t pro-
vide models for a conception of moral knowledge: In trying to determine
how to live together, we are not talking about abstract timeless structures
or about the observable external world. To reach a common standpoint
that is practical rather than merely theoretical, as morality requires, we
must modify our motives and attitudes by some process of coordination
that is suited for the purpose.

The ﬁrst step, common to many moral theories, is to put yourself in
other people’s shoes, with sufﬁcient imagination to be fairly sure that you
understand their point of view and their preferences, experiences, and
interests. An appreciation of the antecedent divergence that creates the
conﬂicts to which morality seeks a solution is essential in pursuing conver-
gence. The other effect of putting yourself in other people’s shoes is to
induce the sort of impartiality and escape from egocentricity which is
needed to reach a common standpoint. Whatever the moral solution, it
should have an appeal that is the same for everyone, even if it also impinges
unequally on their nonmoral interests.

But to get further, we have to decide what to do with all these points of
view, how to generate some kind of unity out of them. And to say any more
than this about moral epistemology, we must move to the level of substan-
tive moral argument. The methods of thought in this ﬁeld, as in others, are
revealed in the way one thinks about particular hypotheses. It is no more
possible here than elsewhere to specify a pure, content-free method that
can be used mechanically to produce results. If we look instead at the
disagreements among leading theories of moraljustiﬁcation, and the way
in which criticism of general principles can emerge from particular counter-
instances or counterarguments, we will get a better picture of the process.

I am going to begin by tracing the disagreements among several repre-
sentative theories of how this is to be done—theories which have made an
enduring contribution to our understanding of moral knowledge, even if
none of them captures the whole truth about it. Each of them offers a
different account of the basis of convergence, as follows: collective self-
interest (Hobbes), natural rights (Locke), general benevolence (Hume),
and universalizability (Kant).l Though they are associated with classic
authors, each of these approaches has its contemporary representatives.

The Hobbesian approach to moral argument is motivationally the sim-

204 SOCIETY’S CHOICES

plest. It assumes that the motives which produce conﬂict, notably self-
interest and the desire to survive, must also be relied on to resolve those
conﬂicts, because no other motives of comparable power are available to
override them. Hobbes therefore identiﬁed the content of morality with
those rules of conduct that it would be in everyone’s interest for everyone
to follow. He also recognized, however, that this by itself was not sufﬁcient
to give any individual a self-interested reason to follow those rules himself.
(In effect, Hobbes was the first thinker to describe the prisoner’s dilemma.)
To bring collective self-interest into accord with individual self-interest,
thereby making its achievement motivationally possible, it was necessary to
change the external circumstances by setting up an enforcer of the moral
rules, the sovereign. Only in that way would it become safe for individuals
to adhere to the rules that each of them has a reason to want everyone to
adhere to. According to Hobbes, the realization of morality, though not its
content, depends on political institutions.

However, the important point for our purposes is that Hobbes thought
moral discovery did not depend on any modiﬁcation of human motives.
Rather, the convergence on common standards of conduct characteristic
of morality was the result of social and psychological theory, on the basis of
a single principle of motivation. The problem was, how to create the
conditions of convergence and harmony on the basis of the most reliable
motive, self-interest. The reasoning to that end was essentially instrumen—
tal: An analysis of human interactions and conditions of trust and distrust
suggests a method of overcoming the destructive effects of self-interest and
fear not by altering human motives, but only by changing the means of
their expression. We are not, on this theory, led to accept moral con-
straints on our conduct by a concern for the good of others.

While Hobbes’s recognition of the gap between individual and collec-
tive self-interest, and his proposal for closing it, are among the most impor-
tant insights of moral and political theory, his conception of the motiva-
tional basis of ethics seems too narrow. Intuitively, there seems to be some
reason to refrain from harming others which derives from their interests,
and notjust from your own.

When Locke tries to express this recognition, he appeals both to the
Golden Rule and to the equality of mankind in the sight of God; but the
idea can be understood in completely secular terms—indeed in terms of
the imaginative step already mentioned, of putting yourself in other
people’s shoes. The most basic moral argument, “How would you like it if
someone did that to you?" can be given either a Hobbesian or a Lockean
interpretation. In the former sense, it is an appeal to self-interest, through
an implied reference to general practices and conventions whose imposi—
tion would serve everyone’s interest, yours included. In the latter sense, it
is a direct invitation to imagine the situation from the point of view of the

MORAL EPISTEMOLOGY 205

other, in order to induce a recognition that what happens to him matters
in itself, and should matter not only to him but to you. Thus it is designed
to evoke motives which are in a broad sense altruistic or other-regarding.

This is an example of the sort of appeal to intuition that is as indispens-
able in moral thinking as appeals to observation are in empirical thinking,
and appeals to self-evidence in logical thinking. Moral intuitions are not
infallible, but they provide the only data we have to support or discredit
general hypotheses. Some moral intuitions can be explained away as illu-
sions or prejudices, but even then the alternative is generally supported by
other intuitions, at some level. In the case of Locke, the anti-Hobbesian
intuitions are not limited to a general consideration for the interests of
others, but take the form of a system of equal natural rights, essentially
rights against interference, which are said to constrain us in our dealings
with others even in the absence of a legal enforcement system.

This type of conception has been very prominent in subsequent moral
and political theory. The idea is that morality requires us to accord every-
one an equal status in some sense—the same status we claim for ourselves
in their treatment of us—and that this status should be deﬁned as a kind of
inviolability. Each of us is protected by a moral boundary which accords us
a degree of freedom to act in pursuit of our personal aims without interfer-
ence by others, provided what we do does not violate the identical bound-
ary protecting anyone else. While there has been much disagreement over
what should be included in this category of equal rights, as a form of moral
thought it continues to be very much alive.

However, it has also provoked an equally important reaction, the tradi—
tion of utilitarianism, stemming from the work of Hume. Rights are sup-
posed by Locke to be natural and morally basic. That is, they are not
merely legal or conventional creations which serve an instrumental pur-
pose. This contrasts with Hobbes, who had held that property rights, for
example, serve the common interest but are brought into existence only
with the creation of the state; Locke believed that property rights were
prepolitical. Hume, by contrast with both of them, held that the motiva-
tional foundation of morality was a single sentiment of impartial benevo-
lence, or concern for people’s well—being, but that it did not express itself
directly in the recognition of equal rights. Rather, rights of property,
obligations of contract and promise, and other strict moral boundaries are
in his view conventions—sometimes legally enforced—which are justiﬁed
by the contribution of their strict application to the overall or general
welfare of persons living under them: justiﬁed, in other words, by their
utility.

So Hume differs from Hobbes in believing that morality can rely on a
motive other than self—interest—a motive of benevolence that arises when
we view the lives of all persons, ourselves included, from a detached and

206 SOCIE'I‘Y’S CHOICES

sympathetic perspective. But he differs from Locke in believing that this is
the only fundamental moral principle, and that all others, speciﬁcally the
various individual rights, are derived from it. The sole criterion of the
correct moral rules, on this View, is whether they promote utility or the
general welfare of all persons added together. (Note, this is different from
the Hobbesian standard of the common interest, or the simultaneous inter-
est of each person taken separately.) This position is known as rule-utili-
tarianism, and it holds that while some moral assessments of policies and
actions depend on their direct contribution to overall utility, many of the
most important assessments are indirect—placing an act like respect for
property or contract under a rule or convention that serves utility not act
by act, but only as a whole.

The controversy between natural rights theory and rule—utilitarianism
illustrates an important type of theoretical controversy in ethics. The dis—
putants may agree roughly in their substantive moral judgments of central
cases, but they disagree over what is fundamental and what derivative:
They disagree, in other words, about the correct moral explanation of those
substantive intuitions in which they agree. And this may in turn be con-
nected with disagreements about less obvious substantive questions, which
will be decided differently by the extension of differentjustificatory prin-
ciples. For example, the answer to the question of how much discretion
people should have over the use and disposition of their property will
depend signiﬁcantly on whether property rights are, as Locke thought, an
aspect of a natural right to equal liberty, or, as Hume thought, a set of
conventions designed to promote security, stable long-term expectations,
and the general welfare—in which case their appropriate scope will vary
with contingent circumstances.

In its development by Bentham and Mill2 and later writers utilitarian-
ism became the clearest example of a moral theory based on only a single
purely moral intuition, with everything else following from it with the help
of nonmoral, factual premises. The moral principle at the top is that the
only measure of good is the sum of the welfare ofindividuals, and the only
measure of right is how effectively an act or policy contributes to that
good. Determining how we should live, how societies should be orga-
nized, and what laws and policies they should adopt is then entirely a
matter of instrumental reasoning about what will maximize expected util-
ity (the utility of the possible results combined in proportion to their
relative probabilities).

Many moral theorists are drawn to this structural feature of utilitarian—
ism. It seems cleaner and more reliable to depend on a single, simple
principle that seems intuitively certain, rather than having to rely on moral
intuition over and over again in judging different principles and different
choices. With a single principle like the principle of utility, one can derive

MORAL EPISTEMOLOGY 207

results using only the data of empirical natural and social science, plus
quantitative calculation. The application of morality to life is thus pro-
vided with a well-defined method, often called cost—beneﬁt analysis, and the
only remaining uncertainties or vaguenesses are factual. Most of moral
epistemology becomes factual epistemology.

However, this outlook attracts strong resistance from those who believe
that moral thought is far more complex and autonomous, and that the
structure of values and moral requirements is normative throughout, rather
than just consisting of the deductive and empirical consequences of a
single normative premise. According to this alternative View, morality is
general in the sense that its reasons treat like cases alike, and morally
relevant differences must be found tojustify treating different cases differ-
ently—but this generality cannot be captured in a single, simple principle.

Probably the most important representative of this position is Kant, in
spite of his claim to be able to derive all of morality from a single principle,
the Categorical Imperative. What makes the Categorical Imperative logi-
cally different from the principle of utility is that it cannot be applied
without substantive evaluative judgment all along the way to the conclu-
sion, whereas the principle of utility requires only factual and mathemati-
caljudgment for its application. Kant formulates the Categorical Impera-
tive in more than one way, but the most famous version is the principle of
universalizability—that one should govern one’s own conduct only on prin-
ciples that one could will to be universal laws applying to everyone. The
derivation of particular moral conclusions from this formula is anything
but straightforward, and the words “could will” conceal a demand for fur-
ther normativejudgment.

In contemporary theory, this approach is usually identiﬁed with a
contractarian method of resolving the conﬂicting interests and values of
different individuals. The method has something in common with tradi-
tional social contract theory, but it attempts to place the different points of
view to be combined on a footing of greater equality, by making the con-
tract a hypothetical rather than an actual one, to avoid the inﬂuence on its
outcome of differences in power or threat advantage. What equally situ-
ated individuals would agree to or converge on as a common standard is
offered as ajustiﬂcation for accepting it as morally correct.3 But here
again, the process of justiﬁcation seems normative “all the way down.”

This raises a particularly vexed issue in moral theory: whether the
reliance on evaluative or normative judgment in deriving particular moral
conclusions from general moral principles makes the whole process circu-
lar and the system empty. Rawls, who is a contemporary representative of
the Kantian tradition, has defended the method of moral complexity un-
der the heading of “reﬂective equilibrium.”4 We suppose that our moral
sense is the imperfect apprehension of a complex structure of principles

208 SOCIETY‘S CHOICES

and justiﬁcatory reasons, and we try to reﬁne our understanding of this
structure by exercising moral intuition both at the level of plausible gen-
eral principles and at the level of particular substantive judgments of action
or policy. We proceed by trying through mutual adjustment to produce
the best ﬁt between persuasive principles, plausible speciﬁc consequences
that follow from them, and general theoretical accounts of the overall
structure and motivational foundation of moral constraints. The reason-
ing is moral at every point, but the partial independence of the points
creates a kind of check, and the possibility of conﬁrmation, dis-
conﬁrmation, and rew'sion.

Apart from method, the opposition between the Kantian and utilitar-
ian traditions is also one over the right way to count everyone equally in
moral thought. Utilitarians count everyone equally by counting everyone’s
welfare impartially as a contribution to the total, whose maximization then
serves as the criterion for all other moral requirements. According to
utilitarianism, therefore, all other forms of equality (of rights, opportuni-
ties, status, or resources) are morally favored only if they serve as instru-
mental means to the maximization of that total.

According to the Kantian tradition (which in this respect has some—
thing in common with Locke), there are independent values of equality,
not derivative from the maximization of utility, which in fact limit the way
it is permissible to treat people even in order to advance the general wel-
fare. Certain rights to equal treatment, equal liberty, equal inviolability,
and equal opportunity are not, in other words, merely instrumental to the
promotion of the good, but are morally basic. This is a very deep disagree-
ment about the form of equal regard for everyone that underlies morality.
The issue is whether certain minimal protections for each individual have a
privileged position which cannot be overridden by a greater aggregate
balance of beneﬁts to numbers of other individuals. There is no reason a
priori to think that counting people’s interests equally as input to the total
is the only adequate form of moral respect. Obviously the issue is not going
to be easy to resolve. It can be understood in broader perspective as the
opposition between two conceptions or models of impartiality: the model
of collective sympathy and the model of individual identiﬁcation.

If one wishes to give substance to the idea of impartial respect for
everyone, which is the essence of an ethical system, two psychological mod—
els offer themselves. The ﬁrst is that of an impartial sympathetic spectator,
who cares equally about the happiness and unhappiness, fulﬁllment and
frustration, of all persons. The solution to a typical moral problem in
which individual interests conﬂict would then be the one this spectator
would be motivated to choose by his sympathy for all the affected parties.
Such a method of decision tends toward maximizing the total balance of
happiness over unhappiness; so the sympathetic spectator model has a

MORAL ITISTEMOLOGY 209

natural association with utilitarianism, which accords to everyone equal
status as a potential contributor to that total—but not equality in the out-
come, as such.

The second psychological model of impartiality does not employ a
spectator at all, but imagines someone who instead of remaining outside,
identiﬁes himself with each of the persons whose conﬂicts give rise to the
moral problem—as if each person’s interests and attitudes were his own,
but separately. This model of simultaneous multiple identiﬁcation is much
harder to imagine,5 but the point of the method is to discourage the kind
of blending together of everyone’s happiness and unhappiness that is en-
couraged by the sympathetic spectator model. If one identiﬁes separately
with each individual, those interests cannot be so easily combined.

This is an attempt to build the distinction between different persons
more deeply into the interpretation of impartiality from the start. It calls
for an alternative method of dealing with conﬂicts of interest and of com-
bining advantages and disadvantages to yield a solution. The method
suggested by this model, as an alternative to maximizing the aggregate total
welfare, is that of a system of priorities. To express one’s identiﬁcation with
each individual, one tries to identify an order of priority among needs,
interests, beneﬁts, and harms, and meets higher priority needs before less
urgent ones in case of conﬂict—even if more people would receive the
lower priority beneﬁt. This different method of according people equal
respect requires us to focus on urgent matters of survival and basic capaci-
ties for a minimally decent life before going on to the provision of beneﬁts
higher on the scale of well-being. That will mean resisting the method of
aggregation which allows the accumulated weight of sheer numbers of
better-off people to override the more urgent needs of a minority. (An
example would be the costly provision of education, assistance, and access
to the handicapped, which is hard tojustify in utilitarian terms.) Similar
reasoning may assign priority to the protection of certain basic individual
rights, whose violation can’t then be justiﬁed by appeals to the general
welfare.

The present state of moral controversy reveals a high level of uncer—
tainty about both methods and conclusions, but at the same time there is
clearly a lot of value in the three primary standards I have described:
common interest, overall utility, and equal rights. On some questions
these standards will give the same answer: All of them justify the most
obvious rules against killing, assault, coercion, theft, and breach of prom—
ise, and all of them are plausiblejustiﬁcations for the evaluation of policies,
even if none of them can be the whole truth. It is also important that all of
them try to count everyone the same, in the evaluation of policies and
measures, even though the way interests are counted and combined is
different from one method to the other.

21 0 SOCIETY ’S CHOICES

For an individual or a group wishing to justify policy in the public
forum, it would be a mistake to think there was some standpoint of pure
moral epistemology, above the level of moral disagreement, from which
that can be done. One cannot, in other words, move to a domain outside
of moral controversy to ﬁnd objective grounds for settling it. However
general the principles one appeals to, the arguments must be substantive,
for that is where the problems arise and where their solutions have to be
found. In this respect morality is no different from anything else. There is
no abstract rule for discovering the right answer to every historical, medi-
cal, or economic question either: If there are objective justiﬁcations in
those ﬁelds, they show themselves at the level of substantive argument,
where alternatives are proposed and evidence is evaluated.

I have described some methods of moral thought which to one degree
or another carry conviction, but those engaged in a task like technology
assessment have to actually employ such arguments, and make ﬁrst-order
judgments as to their relative cogency when they yield conﬂicting results.
In the exercise of public responsibility, thosejudgments cannot be merely
personal, but must attempt to express a moral outlook that the public in
whose name the decision is being taken can reasonably be expected to
adopt, in light of the reasons offered. This doesn’t mean that the accept—
able justiﬁcations have to be discovered by surveys of antecedent moral
opinion, since carefully reasoned decisions about public questions should
attempt to supply the grounds for their own acceptance. But it does mean
that new decisions should aim to cohere with a publicly available moral
understanding, and to form part of its natural evolution. In this respect
the task has something in common with that ofa court deciding a difﬁcult
and morally loaded case.

It is not easy to identify a public moral philosophy for the United
States, since we are such a pluralistic society. However, I think it is safe to
say that the quasi-consensus is not Hobbesian, and not utilitarian either.
Rather it is a qualiﬁed priority view, in which (1) the guarantee to everyone
of certain individual rights against interference (justiﬁed partly but not
entirely on rule—utilitarian grounds) limits the methods that can be used to
pursue the general welfare; (2) there is also a prioritized understanding of
welfare itself, with (3) greatest importance being assigned, from the point
of view of public policy, to things that are in everyone’s interest, like de-
fense, security, and the environment (a Hobbesian element), and (4) also
increasingly to the most basic or urgent human needs; (5) above that level
a utilitarian standard is supposed to be roughly approximated by the bal-
ancing of interests in democratic politics, though of course the system
doesn’t often work as it should. But the identiﬁcation of standards and
arguments has to be carried out, in good faith, by those who make deci-
sions and offer reasons for them. It is only by actual argument that we can

MORAL EPISTEMOLOGY 21 1

ﬁnd objective standards, whether we are talking about ethics, biology, or
anything else.

In dealing with controversial cases, there is no substitute for the famil—
iar process of formulating general hypotheses and testing them by the
credibility of their implications in other cases where intuitions may be
clearer. If two people disagree about the right thing to do in a particular
situation, they should be able to find reasons for their different opinions,
and those reasons will reveal principles which in turn imply other decisions
in other cases, permitting thejustiﬁcations to be compared. Of course the
whole system of justification is quite involved, and various principles may
interact, but progress can often be made on this basis—at least to produce
greater understanding of the grounds of disagreement, if not to resolve it
ﬁnally.

Even if morality is ultimately to be based on a single axiom like the
principle of utility, the defense of that claim must involve more than an
appeal to the self-evidence of the principle: It must be shown by detailed
argument and consideration of actual and hypothetical cases to provide
the best way ofjustifying the moral conclusions that, on reﬂection, prove
most convincing. This doesn‘t mean a moral theory has to preserve the
intuitions we start out with, only that if it does not, it must genuinely
persuade us of something else. That is not a matter merely of drawing
logical consequences from a formula, but of changing our values and
motives.

As regards the motivational and attitudinal developments involved in
moral thought, there are two ways of interpreting the process, as we have
already seen. According to the conception common to Hobbes and the
utilitarians, the basic motive stays the same—self-interest or benevolence—
and the details of morality are developed by attaching that motive to differ-
ent policies, institutions, and courses of action, on the basis ofinformation
about what will actually promote either the common interest or the aggre-
gate general welfare. According to the other conception, characteristic of
the modern Kantian tradition, moral thought involves the development of
more complex, morally inﬂuenced motives, as our sense of what is and is
not a sufﬁcient reason for action is altered by changing conceptions of
equity, fairness, responsibility, cruelty, desert, and so forth.

On either conception, the aim of moral thought is to discoverjustiﬂca—
tions which can produce convergence in what people ﬁnd acceptable in
one another’s conduct. Often it will involve breaking a fairly wide existing
consensus on the way to finding a new, ﬁrmer foundation for agreement.
The aim of convergence has nothing essentially conservative about it. AC-
cepted orthodoxies cannot so easily be overthrown in ethics, as in science,
by the discovery of new empirical evidence, but they can be overthrown by
new arguments and new appeals to the moral imagination—as has hap-

212 socm’ry’s CHOICES

pened conspicuously in the recognition of traditional social inequalities as
morally arbitrary.

Let me close by commenting on two related issues, the question of
expertise and the place of moral considerations in political decision.

The ﬁrst issue naturally arises in connection with anything like tech-
nology assessment, because scientiﬁc expertise is indispensable with regard
to the facts, the risks, and probabilities, and often there is no way ofmaking
the full grounds of such expertjudgments generally accessible. Only some-
one with years of training and experience can evaluate them, and others,
including politicians and most of the affected public,just have to try to ﬁnd
grounds for deciding whom to believe. Even where specialists disagree
about the likely effects of an advance, those charged with public decisions
can't really expect to arrive at an independent view of their own.

By contrast, there is much less room for expertise with regard to the
moral and evaluative aspects of policy. Moral judgments are everyone’s
job, and while some people are better at them than others, the reasons
behind them ought to be made available, for the purposes of public choice,
in a way that those responsible, and eventually the public at large, can ﬁnd
directly persuasive. Moral grounds for public decisions, unlike scientiﬁc
grounds, should be at least potentially part of public rather than expert
knowledge. As I said earlier, this doesn’t mean that they have to be familiar
in advance; but if they break new ground, they should nevertheless aspire
to offer reasons which can command assent not only from specialists—even
if those who spend more of their time thinking about these things may be
better able to come up with plausible proposals. Morality’s ambition is, or
at least ought to be, to provide a system of conduct under which everyone
can live, with a sense of mutual justiﬁability. This follows from the condi-
tions of political legitimacy: We do not live in a theocracy, where some
people are thought to have a privileged and direct line to the moral truth.

That brings me to the second issue, which was also mentioned at the
start of our discussion: the modiﬁcation of moral argument for political
purposes. In a democracy, the aim of procedures of decision should be to
secure results that can be acknowledged as legitimate by as wide a portion
of the citizenry as possible. Even those who personally disagree with a
result, or whose interests are harmed by it, should ideally be able to recog-
nize as legitimate the methods by which their preferences and opinions
were overruled by others. This means that in a democratic polity, there
may have to be some restriction on the types of moral grounds on which it
is legitimate to base policy decisions. Those that are too particular to be
generally authorized may have to give way to more public grounds.

Our society is not only democratic but richly pluralistic. Many differ-
ent religions and systems of ultimate value coexist here, and it is important
to their coexistence that they be able to ﬁnd terms for living side by side,

MORAL EPISTEM01.()GY 213

and dealing with potential conﬂicts, that do not require them to convert
one another. The cost of conﬂict resolution and cooperation cannot be
the total elimination of disagreement. It may therefore often turn out that
principles of conduct that serve as moraljustifications within a community
of belief or practice are not suited to serve that role for political or policy
decisions made in the name of the society as a whole. This is conspicuously
true of moral requirements rooted in a speciﬁc religious faith, but it may
also apply more widely.

It can affect not only the rules of conduct one accepts, but also the
correct measure of individual well-being for the purpose of calculating
benefit, harm, and overall utility. For example, the fact that someone cares
more about spending money on a religious pilgrimage than on basic medi-
cal care may provide a good reason for that person to decide how to use his
own resources, but it is a poor reason for a program of public assistance to
support his religious rather than his medical expenditures—because the
value of medical treatment can command public recognition and the reli-
gious claim cannot. While someone’s preferences are ordinarily a good
basis for deciding what is better or worse for him, a less individual standard
of value may be needed for purposes of public justification.6 The pluralism
of our culture requires that public choices be made on a leaner and more
universalistic basis than private ones.

The extent to which universality is itselfa necessary aim of moral theory
is a matter of controversy, There are those who believe that the ambition
of traditional theories to search for the correct principles for persons as
such is misplaced—even if that is not an inappropriate aim for mathemat-
ics and science. I am not sympathetic with this View, but even if one thinks
that morality is by its nature more local than logical or factual thought, the
ambition of universality at least within the community concerned with the
decisions—the community in whose name they are taken, if not all those
affected—follows from the function of moral argument in supporting con-
vergence and mutually acceptable standards of justiﬁcation.

To go beyond this would involve deeper epistemological questions
which cannot be adequately treated in a discussion of this sort. I would say
only that although the aim of moral thought is to provide a basis for
agreement, the bare empirical appeal to community consensus where it
exists is never in itself a moral argument. It can serve only as the starting
point for the examination, and criticism or endorsement, of the reasons
underlying that consensus.

NOTES

1. Thomas Hobbes, Leviathan (1651);]ohn Locke, Second Treatise of Government (1690);
David Hume, Enquiry Concerning the Principles nerrrals (1751); Immanuel Kant, Foundations of
the Metaphysics of Morals (1785).

214 SOCIETY’S CHOICES

2. jeremy Bentham, An Introduction to the Principles ofMorals and Legislation (1788);j0hn
Stuart Mill, Utilitaﬁanism (1863).

3. See john Rawls, A Themy ofjustice (Harvard University Press, 1971); T. M. Scanlon,
“Contractualism and Utilitarianism," in Amartya Sen and Bernard Williams, eds., Utilitarian—
ixm and Beyond (Cambridge University Press, 1982).

4. Rawls, op. cit.
5. Something corresponding to it has been proposed by Rawls in his hypothetical social

contract model called the Original Position.
6. See T. M. Scanlon, “Preference and Urgency,"joumal ofPhilosophy, Vol. 72, 1975.

Public Moral Discourse

DAN W. BROCK
Professor of Philosophy and Biomedical Ethics, Brown University

What is the nature of public moral discourse as it is done by ethics
commissions charged with addressing ethical or moral issues in medicine
and biomedical science and technology.>1 In what ways does it differ from
the methods of moral philosophy and moral philosophers when they ad-
dress such issues? Can public ethics commissions provide reasoned solu-
tions to these ethical issues, and if so how? I shall ﬁrst discuss some features
of the nature of ethics commissions—the different goals they pursue, their
typical charge and composition, and the role in public policy which they
typically play. These features distinguish the processes they employ in
some respects from moral reasoning as it is done by either moral philoso-
phers or ordinary citizens. But I shall argue that these differences are
relatively superﬁcial and that how ethics commissions address and reason
about moral issues is not fundamentally different from the method, when
it is properly understood, of moral philosophy in addressing substantive
moral issues of practice and policy. I shall show as well the respects in
which this method can provide solutions to moral issues in public policy, or
more speciﬁcally the respects in which an ethics commission’s process of
public moral reasoning warrants the claim that the substantive conclusions
reached by that process are justiﬁed.

215

21 6 SOCIETY’S CHOICES

SOME FEATURES OF PUBLIC MORAL DISCOURSE
AS DONE BY ETHICS COMMISSIONS

Goals of Ethics Commissions

What are some of the different goals or aims that public ethics commis-
sions typically have? First, they often are charged with developing relatively
discrete legislation to deal with a particular ethical issue. For example, the
President’s Commission for the Study of Ethical Problems in Medicine and
Biomedical and Behavioral Research (hereafter President’s Commission)
addressed in its ﬁrst study the deﬁnition of death and developed a proposal
for a uniform statutory deﬁnition, which has subsequently been adopted by
nearly all states. Even with this relatively narrowly focused outcome, the
President’s Commission evaluated alternative deﬁnitions of death, for ex-
ample, the “whole brain" account, which it supported, and the “higher
brain" account, which it rejected, and offered philosophical and policy
arguments in support of its choice of the whole brain formulation.

Second, ethics commissions are sometimes charged with addressing
speciﬁc unethical practices and recommending governmental responses to
correct those practices. For example, the National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research
(hereafter National Commission) was established in large part as a re-
sponse to a number of well-publicized examples of abuses of human sub—
jects in research and to an inﬂuential article detailing such abuses.2 A
central component of the National Commission’s recommendations was
the establishment of Institutional Review Boards whose task is to assure
that human subjects are properly protected. The National Commission
also developed detailed guidelines and recommendations governing the
use of speciﬁc populations in research. Here, too, the National Commis-
sion offered arguments in defense of its recommendations, and indeed in
its Belmont Reptm developed the general moral principles on which its rec-
ommendations rested.

Third, an ethics commission may seek to have a broad and diverse
inﬂuence on policy and practice with regard to a particular moral issue.
For example, the President’s Commission in its report, Deciding to Fmego
Life—Sustaining Treatment,3 sought a multifaceted impact on such practices
and policies as institutional, especially hospital, policies that guide practice
within particular health care institutions; court decisions that set the legal
framework of permissible practice; and the beliefs and practices of physi-
cians and other health care professionals. A part of the inﬂuence of the
President’s Commission’s work on this issue derived from its prestigious
nature as a nationally constituted body, as has no doubt been true of other
ethics commissions. But the inﬂuence ofits recommendations also derived

PUBLIC MORAL DISCOURSE 21 7

importantly from the force and persuasiveness of the moral reasoning the
commission offered for its conclusions and recommendations.

Finally, an ethics commission may sometimes have aims rather less
focused on public policy. It may see its role more as inﬂuencing ongoing
public debates on speciﬁc moral issues. In doing so, it may seek to have
quite different kinds of inﬂuence on different occasions, for example, on
the one hand sharpening the issues in dispute or on the other hand seek-
ing to forge a consensus on those issues. These roles too, of course—
whether sharpening the issues or forging consensus—require providing
the ethical analysis and arguments which either sharpen the issues or on
which a new consensus might rest.

Consensus building, broadly understood, is an important part of each
of these four different aims of ethics commissions. In part, this is simply
because in a democratic society public policy is forged in political processes
requiring majority, or at least broad, support of a proposed policy. How-
ever, there are deeper reasons why consensus is seen as especially impor-
tant in the work of an ethics commission. For many public policy issues,
that a majority of policymakers, reﬂecting a majority of citizens support a
particular policy position, is reason enough to warrant its adoption (for
example, decisions to expend public resources on particular projects like
public parks or medical research). It is not that supporters and opponents
will have no reasons for their respective positions on such issues, which of
course they will, but that we consider it appropriate to settle the disagree-
ment by some form of majority rule decision process; within limits, the
position that should be adopted is what the majority supports. On a moral
question, however, it would be at the least odd or problematic for a com-
mission to declare that it found by a vote of 6 to 5 that, for example,
patients have a moral right to forego life-sustaining treatment. Many politi-
cal questions and legal disputes may be reasonably decided by majority
decision procedures, whether in legislatures or courts, but whether a pub-
lic policy is moral orjust is not settled by counting votes. In some sense, the
moral question can only be settled by the quality of the arguments that can
be offered for different positions on it. There are no authoritative bodies
to settle moral questions and disputes such as exist in politics and the law
for settling political and legal disputes. It is in part for this reason that the
development of moral arguments and positions is common to all the di—
verse goals of ethics commissions noted above. The nature of the argu-
mentation that commissions should employ is therefore at the heart of
understanding their work.

Typical Scope of Ethics Commissions’ Concern

Ethics commissions are typically charged with addressing the social,
ethical, and legal issues concerning a particular topic like genetic screen-

21 8 $001”st CHOICES

ing or informed consent. To the extent that moral philosophy addresses
only the moral or ethical issues, the scope, and perhaps in turn the meth-
ods, of ethics commissions‘ work will have apparently to be different from
moral philosophy. However, I believe it is a mistake to see this typical
charge to ethics commissions as instructing them to go beyond the moral
or ethical issues and to take up independent social and legal issues as well.
Instead, this charge is usually best understood as instructing the commis—
sion to address the moral issues of public policy in their broader social and
legal context, rather than to engage in social and legal analysis indepen-
dent of the moral issues. This typical charge reﬂects as well a widespread
confusion as to just what the domain of the moral or ethical is in the
context of public policy, a confusion which has contributed in turn to two
views—both of them, I believe, mistaken—which assign a more restricted
scope to ethics commissions’ proper concerns. The ﬁrst View understands
ethical analysis to be addressed to individual actions, whereas policy analy-
sis applies to many cases and institutional practices, and so must in some
way extend beyond ethical analysis. The second w'ew understands moral
considerations, as well as the method of moral reasoning employing those
considerations, to be only a part of the overall considerations relevant to
evaluation of public policy. In this latter view, moral philosophers and the
methods of moral philosophy may analyze the morality of some policy, but
overall policy analysis and evaluation must take into account additional
nonmoral considerations such as economic costs, political feasibility, legal
constraints, and so forth. Consequently, the distinctly moral or ethical
analysis of an ethics commission would not yield “all things considered”
judgments or recommendations about public policy. To do that the ethics
commission would have to consider these additional nonmoral economic,
political, and legal considerations as well, which it has no special expertise
to do. On the other hand, if these nonmoral economic, political, and legal
considerations are part of the proper province of ethics commissions and
ethical analysis, then it seems all policy analysis has been collapsed into
ethical analysis, an unwarranted ethical aggrandizement of the policy field.
I shall address each of these related, but, I believe, mistaken, views in turn.

In the ﬁrst view, ethical analyses andjudgments apply only to particu-
lar cases, not the general practices that are the province of public policy.
This view is sometimes expressed by a distinction between when one is
“doing ethics” and when one is “doing policy." This putative ethics-policy
distinction rests on what can be called the one—many assumption about the
relation of ethics to policy. Policy evaluation, in this View, is not ethics
because it must address policies that apply to many cases. In the evalua-
tion of what action is ethicallyjustiﬁed or permissible in a particular case,
it is natural to believe that only the particulars of that case are relevant,
though those particulars will include the social context in which the case

PUBLIC MORAL DISCOURSE 21 9

takes place, the social and professional roles of the different involved
parties, the causal impact of what is done in that case on what will be done
in future cases, and so forth. For example, if the case concerns a dying
patient suffering from pain that has proved impossible to relieve adequately
and who requests euthanasia from her physician, it would appear that it is
only the particulars of this case which are morally relevant to its moral
evaluation. Different people will disagree about which features of the case
are morally signiﬁcant or important, and about what moral principles or
reasons bear on it. For example, some people might hold that euthanasia
would be morally wrong in this case because it would be the deliberate
killing of an innocent person, which they believe is always morally imper-
missible; others might see it as morally permissible because it is an exer-
cise of an individual’s moral right to self-determination. Still others of
more consequentialist or utilitarian leanings may evaluate the act by its
impact on the well—being of all affected by the action. If doing it would
make the physician more likely to perform euthanasia in other similar
cases as well, then that too is a consequence of this particular action. But
these are all differences about how the act in question should be morally
evaluated.

The moral evaluation of a social or legal policy, for example, permit-
ting euthanasia, is, of course, not unrelated to the moral evaluation of
particular instances of euthanasia.4 But a person’s moral position about
such a policy need not follow directly from his or her moral position about
a particular case. Many people who grant that there are individual cases in
which euthanasia would be morally justiﬁed nevertheless oppose a public
or legal policy permitting it because of worries about how that policy might
or would be abused, leading to other wrongful performance of euthanasia.
Because the policy must apply over time, in many circumstances and to
many persons, the policy’s effect in these other cases is relevant to its moral
evaluation as well. Many of the differences in the substantive moral prin—
ciples and reasons different people applied to the individual case will resur-
face in the moral evaluation of policy as well. But both evaluations—of the
particular case and of the general policy—can be equally and fully moral
evaluations to which one’s moral principles and reasons apply. The typical
object of moral evaluation by ethics commissions, namely one or another
public policy, does not entail a fundamental difference in the moral prin-
ciples or reasons used in making the evaluation, or in the methodology of
moral reasoning and argument employed.

There is reason then to remind ethics commissions to attend to the
broader social and legal context of the ethical issues they address. The
general practices which are the proper province of concern of ethics com-
missions exist in a social context, often in diverse social contexts involving
individuals with diverse motivations and knowledge. These actions and

220 SOCIETY 's CHOICES

practices are also often regulated by law. Although the law is only one form
of inﬂuence on and regulation of practice, public policy, as opposed to
forms of private regulation of behavior and practice, is often distinguished
by the presence of legal or quasi-legal oversight. Because ethics commis-
sions typically address policy and general practices, not individual actions,
various empirical questions regarding practice are relevant to their delib-
erations: What is the nature of current practice in the area under consider-
ation? What are the possible means of policy and institutional change?
What are the means of enforcement of speciﬁc policies? What would be the
economic and other costs of different policy alternatives? The answers are
relevant and integral to an ethical analysis of the policy issue.

This ethical analysis must also address questions like the following:
What ethical principles and values bear on the ethical evaluation of cur-
rent practice in the areas of behavior in question? What would be ethically
more desirable practice in the areas of behavior in question? What means
are available to shift practice in those desirable ways? Thus, the consider-
ation of economic costs, political feasibility, legal constraints, potentials
for abuse, and so forth, all bear on and must be considered as part of the
ethical case for a particular policy. But this brings us directly up against
the second mistaken view noted above about the proper scope of ethics
commissions’ concern. That View rejects a conception of ethical analysis
which encompasses these economic, political, and legal considerations,
and restricts the ethical analysis only to the distinctly ethical consider—
ations. It follows from this that the ethical recommendation on policy in
a particular area cannot be an “all things considered” recommendation
regarding the policy, whatjohn Rawls claimed forjustice in characterizing
it as the “ﬁnal court of appeal" in practical reasoning.5 Instead, in this
second View of the restricted scope of ethics commissions’ concern, the
ethical analysis takes account of only some considerations relevant to what
policy should be. This implies that when the ethical analysis is completed,
additional relevant considerations will remain that have not yet been taken
into account, but which must be, before drawing a conclusion about what,
all things considered, practice and policy ought to be. Why is this view
mistaken?

It is certainly correct that moral philosophers are not experts on the
economic, political, and legal considerations about which economists, poli-
ticians, lawyers, and social scientists are typically consulted. Consequently,
an ethics commission will still have to consult with these experts when
economic, political, and legal considerations form a significant part of its
policy analysis and recommendations. But why should an ethics commis—
sion be burdened with these additional concerns which apparently go be-
yond its ethical expertise? In part, because ethics commissions are asked to
make public policy recommendations, “all things considered" recommen-

PUBIJC MORAL DISCOURSE 221

dations about what policy should be, not just restricted recommendations
about what would be ethical in some restricted sense. To fulﬁll this role,
they cannot restrict themselves only to the considerations that most people
would intuitively identify as ethical. But this common intuitive distinction
between ethical and nonethical considerations is itself misleading. Per-
haps a very simple example will most clearly make the point. If you prom-
ise to meet a friend tomorrow at 3:00 p.m., that promise gives you a moral
reason to do so. But then tomorrow, quite unpredictably, it turns out that
you must ﬁnish some project or take some action to avoid a very substantial
ﬁnancial loss. Doing so will prevent you from meeting your friend whom
you cannot now reach. Ought you morally to keep your promise at very
substantial and unexpected ﬁnancial cost to yourself? If we apply the intui-
tive distinction assumed above between ethical and economic consider—
ations, then the promise is ethical and the ﬁnancial cost is economic.
Could the ethical analysis concern only the ethical consideration—the
promise? It should be clear that this would make no sense. The moral
question just is the “all things considered” question of whether you must
keep the promise in the face of the very substantial unexpected ﬁnancial
cost to you of doing so. The moral analysis must weigh these two consider-
ations against each other; it cannot consider only the ethical consideration
of keeping promises. The same is true of policy analysis. It is not that the
common intuitive distinction between moral considerations, such as prom—
ise-keeping, and nonmoral considerations, such as ﬁnancial costs, is mis-
taken. The mistake is in thinking that moraljudgments can avoid weighing
the two when they come into conﬂict; when that occurs, the financial cost
becomes a morally relevant consideration in the moraljudgment about
whether the promise ought to be kept. The same will be true of moral
judgments about the public policies that ethics commissions address; for
example, apparently nonmoral considerations (ﬁnancial costs) are morally
relevant to the moral question of how much equality of opportunity (the
moral consideration) requires society to do to improve opportunities for
the handicapped. Does this account make “all things considered” policy
evaluations and recommendations ethical, and so result in unwarranted
aggrandizement of the policy realm by ethics or morality? And why are only
some policy questions then seen as ethical and given to an ethics commis—
sion? My view here does not lead to ethics swallowing up policy. Many
policy choices remain essentially nonethical because ethical considerations
are not signiﬁcantly affected by them and so are not relevant to them. For
example, on the policy questions of what rate of growth of the money
supply and what economic stimulus packages are compatible with holding
inﬂation to a three percent level, the economic analysis is appropriately
sought from bodies such as the Federal Reserve and the Council of Eco—
nomic Advisors, not an ethics commission. (This is not to deny, of course,

222 SOCIETY’S CHOICES

that there are ethical implications of policies to control inﬂation, but that
is a different policy question.) If there is no neat and clear division of labor
for ethical and nonethical considerations, which policy questions should
go to an ethics commission for analysis and which should go elsewhere?
Very roughly, policy questions are appropriately referred to an ethics com-
mission when the considerations commonly and intuitively considered ethi-
cal have a significant role or impact in the policy question. But the ethics
commission cannot then do itsjob of analysis and recommendation with-
out weighing those considerations quite appropriately considered ethical
against other considerations with which they come into conflict, but which
are intuitively seen as nonethical.

Membership of Ethics Commissions

The principal ethics commissions in the United States in recent de-
cades were deliberately established with widely diverse members. Typically,
only a small minority of members are professional ethicists or moral phi—
losophers with extensive professional training in ethics and moral philoso-
phy. But this does not mean that what an ethics commission does when it
addresses moral issues, nor how it does so, is different in kind or method
from how professional ethicists would or do address the same issues. Pro—
fessional ethicists and other commissioners will be engaged together in
ethical reasoning on the issue at hand. Ethical reasoning and argument is
done in the ordinary circumstances of everyday life by ordinary persons
without academic or scholarly training in moral philosophy. It is not an
esoteric subject like cell biology or quantum mechanics, accessible only to
experts. Ordinary people make ethicaljudgments when they morally evalu—
ate different states of affairs, different individuals’ actions and character,
and different social and political institutions. We employ such judgments
in morallyjustifying our own actions to ourselves and to others, as well as in
moral evaluations of the actions of other people.

Professional ethicists and moral philosophers, who are typically at least
represented among commissioners and staff members on ethics commis-
sions, do bring a certain expertise to the work of ethics commissions—
typically, at least the results of having studied ethical reasoning and alterna-
tive ethical theories in a full-time, formal, and rigorous manner. They
should be trained in the careful, critical evaluation of the soundness of
arguments. They should have systematically studied and evaluated argu-
ments for and against different moral theories, principles, reasons, and
positions. Nevertheless, the methods by which professional ethicists or
moral philosophers address substantive moral issues do not differ in kind
from the methods used to address those issues by ordinary persons un-
schooled in the formal study of moral philosophy. Ethics commissions

PUBLIC MORAL mscowmc 223

typically have diverse membership in order to ensure diverse experience,
training, and viewpoints required by the diversity of considerations noted
above that bear on their overall recommendations, not to represent diverse
approaches or methods of doing ethics. I will have more to say about the
role of this diversity below.

METHODS OF MORAL REASONING—IN MORAL PHILOSOPHY
AND IN ETHICS COMMISSIONS

One reason some believe that moral reasoning as done in moral phi-
losophy is different from public moral reasoning as done by ethics commis-
sions is what I consider a mistaken view about the nature of moral reason-
ing in moral philosophy or in public ethics commissions, or in both.
Understanding the respects in which these accounts are mistaken or con-
fused will help clarify the appropriate common method which both moral
philosophy and public moral reasoning can and do employ.

Deductivism

Some believe the method of reasoning by which public ethics commis—
sions address ethical issues in public policy is different from the method of
moral reasoning in moral philosophy from a mistaken view about the
latter. In this View, which I shall call deductivism, the philosophical ap-
proach to moral reasoning in applied and policy contexts ideally consists
in employing the true or correct moral theory and principles, together
with the empirical facts relevant to their application, to deduce logically
the correct moral conclusion for the case or policy in question. When the
issue is not what it is morally correct to do in a particular case, but instead
what public policy should be on an ethical question like whether voluntary
euthanasia should be permitted, the moral calculus will be more complex.
Assume for the sake of illustration that the correct moral theory is some
form of consequentialism or utilitarianism, according to which an action is
morally rightjust in case it has at least as good consequences for human
well-being as any alternative action open to an agent. When the moral
issue is about the evaluation of a public policy, the calculation is much
more complex since it is then necessary to estimate the effects over time of
alternative policies on the well-being of all who would be affected by the
alternative policies. In the case of voluntary euthanasia, the possible ef-
fects to take account of would include positive effects like the relief of
suffering and giving people control over the circumstances of their dying,
together with negative effects like possible abuse of the policy for purposes
of controlling costs or possible erosion of trust in the medical profession.
The empirical determination of the consequences would be difﬁcult, com-

224 SOCIETY'S CHOICES

plex, and controversial, and there would be much ineliminable uncer-
tainty. But deductivism provides a method of moral reasoning that at least
in principle yields right answers to the moral problems of policy that ethics
commissions face.

Once the likely effects on the well-being of the various affected parties
are determined, the consequentialist moral principle can be used straight-
forwardly and deductively to determine which alternative policy is morally
right orjustified. The truth or correctness of the consequentialist theory
would solve the problem ofjustifying the commission’s policy recommen-
dations by transferring its truth to the conclusion that whichever alterna-
tive policy will best promote well-being is morally right or correct. Nothing
about the general method of deductivism depends, of course, on the cor-
rect theory being consequentialism. Ifinstead the correct moral principle,
is that the intentional killing of an innocent person is always wrong, that
principle, together with the premise that euthanasia is the intentional kill—
ing of an innocent person, deductively yields the conclusion that euthana-
sia is morally wrong.

Is deductivism a feasible and defensible account of how moral reason—
ing is and should be done either in policy contexts or in moral philosophy?
One obvious problem is that it does not seem an accurate account of how
ethics commissions in fact function. Most people, including most mem-
bers of such commissions, have no relatively comprehensive, or even more
limited, moral theory that they know, or even believe, to be true or correct,
and so it is hardly a surprise that we do not ﬁnd them using and applying
one in practical contexts. Most people are largely ignorant of philosophi-
cal work in developing general moral theories and principles, and yet they
nevertheless do reason and have moral views about concrete moral issues
like euthanasia. So deductivism is certainly not an accurate description of
the moral reasoning that real people typically do in applied or policy con-
texts. Defenders of deductivism might, nevertheless, respond that it is the
method used in moral philosophy and is how people ought to do moral
reasoning. Is deductivism a defensible account of moral reasoning?

The central difﬁculty with deductivism is that there is no single com—
prehensive moral theory, nor even theories or principles of more limited
scope, which is agreed to be true or correct and so could be deductively
applied to policy issues. For example, even if there were agreement that
the overall effects on human well—being of permitting voluntary euthanasia
would be positive, some people nevertheless would still believe that be-
cause euthanasia is the deliberate killing of an innocent person, it is mor-
ally wrong and should not be permitted. What began as a specific disagree-
ment about what public policy should be about euthanasia has shifted to a
more fundamental disagreement about whether consequentialism is the
correct or true moral theory, or whether instead duties to protect innocent

PUBLIC MORAL DISCOURSE 225

human life are paramount. Those who disagree on the policy will fre-
quently do so because they do not agree about which moral principles or
theories are correct. Consequently, so long as the different moral prin-
ciples and theories are being correctly applied, moral disagreement about
a particular policy will be reproduced in disagreement about the correct
general broader principles or theory. So if moral reasoning should begin
with the correct general moral theory and its principles, which are then
deductively applied to the particular policy in question, we face the embar—
rassment of having no agreement about what are the correct theory and
principles to employ. To make matters worse, if a moral theory or moral
principles can be true or false, correct or mistaken, as deductivism re-
quires, then even were there agreement about which principles and theory
are true or correct, this would be compatible with all parties to that agree-
ment being mistaken.

The existence of disagreement about which general moral principles
and theory are true or correct would not be an insuperable barrier to
deductivism if there were agreement about the criteria for determining
which principles and theory are true or correct. Disagreement about which
principles and theory are correct then might only reﬂect a mistaken appli-
cation of those criteria by one party to the disagreement. I will not canvass
here the different views on this issue, but will only note that there is no
agreement in philosophical ethics, or in ordinary morality, about the crite—
ria which would establish general moral principles or a general moral
theory to be true or correct. A ﬁnal important barrier to deductivism is
that, even if there are basic moral truths, there is no agreement or assur—
ance that they are to be found or established at the level of general moral
principles or theories, which through application could then transfer their
truth to conclusions about particular policies which ethics commissions
address.

Deductivism as a method of moral reasoning takes a position on how
the justification of moral judgments is secured that is commonly called
foundationalist. A foundationalist account of justiﬁcation in moral reason-
ing requires that some moral beliefs, which might be at any level of gener—
ality—the most general moral principles (like the consequentialist prin-
ciple) , very speciﬁcjudgments about concrete cases, or moral beliefs at any
level of generality in between—can be established to be true or correct.6
These foundational moral truths, as we might call them, have foundational
status in moral reasoning in the sense that all other moraljudgments gain
their justiﬁcation by being derived through sound reasoning from them.
Foundationalism assigns privileged epistemic status regarding truth or cor-
rectness to some moral beliefs—foundational status—with the justification
of all other moral beliefs coming from their being deductively derived
from the foundational beliefs.

226 SOCIETY’S CHOICES

Deductivism is the particular version of foundationalism which assigns
this foundational status to general moral principles or to a general moral
theory. Deductivism fails as an account of moral reasoning andjustiﬁca—
tion not only because we lack any agreement either on the true moral
principles or theory, or on any method for determining the true general
moral principles or theory, but also because foundationalism more gener-
ally is a mistaken account of the nature ofjustiflcation in ethics. N0 version
of foundationalism is a correct account ofjustiﬂcation in ethics, as I shall
argue shortly, and that includes deductivism, which accords foundational
status to general principles or theories.

One further problem with deductivism should be mentioned. Con—
sequentialism, in the very simple form specified above, appears to be a
comprehensive and fully determinate theory for the moral evaluation of
both actions and social policies—all are justiﬁed to the extent they pro-
mote human well-being. But in fact there are many possible versions of
consequentialism depending on how some key terms are interpreted. As-
suming a single determinate interpretation, however, there should always
be, at least in principle, a correct answer to the moral evaluation of any
action or policy. This simplicity and comprehensiveness is bought, how-
ever, at the unacceptably high cost of sharp conﬂict with many important
components and complexities of most people’s considered moral judg-
ments. Moral principles and theories that incorporate these other compo-
nents and complexities, however, have their own costs. They typically have
significant indeterminacies in their content which tend to occur atjust the
points of significant moral conﬂict and intrapersonal and interpersonal
controversy—for example, where different moral rights, duties, or impor-
tant values within the theory come into conﬂict.

In the absence of strict priority rules or other determinate methods for
resolving these conﬂicts and the moral issues in which these different moral
considerations come into conﬂict (essentially all the interesting or hard
moral cases), deductivism will be impossible to apply in just the cases in
which we most need it.

Particularism

The polar extreme position about moral reasoning and moral knowl-
edge orjustiflcation I shall call particularism. It holds that moral reasoning
in practical and policy contexts begins and remains with the speciﬁc con-
crete case under consideration. If some moral judgments are true or
correct, and so others false or mistaken, moral knowledge is achieved only
at the level of particular cases. Some particularists hold that there is no
standard for evaluating our moral judgments external to the particular
judgments themselves. Others hold that moral knowledge resides at the

PUBLIC MORAL DISCOURSE 227

level of particular paradigm cases, with moral reasoning in new cases then
consisting of ﬁtting the new cases to the paradigms closest to them.7 Thus,
in the example of the commissioners' policy dispute about euthanasia,
reasoning remains at the level of a particular case, or a particular paradigm
case, of euthanasia, with no external appeal to moral principles or theory
from which, in foundationalist fashion, a conclusion could be derived and
justified about euthanasia.

One problem for the particularist is moral disagreement, illustrated in
the example about euthanasia. If moral reasoning remains only with the
particular case, with no external appeal to moral theory or principles, then
we will have no external appeal by which the disagreement might be re—
solved. Moreover, if two conﬂictingjudgments about a paradigm case of
euthanasia cannot both be true, then particularism seems to provide no
standard by which we might determine which position is true or correct.
Because particularism locates moral knowledge only at the level of particu-
larjudgments and confines moral reasoning only to the particular case, it
seems to provide no standard for determining which particularjudgments
are true when they cannot all be true. But the most serious difﬁculty for
particularism is that it is incompatible with the very process of giving rea-
sons for moraljudgments at all. It is important to see why this is so.

Moraljudgments are unlike some judgments of taste, and moral dis-
agreements are unlike some disagreements over matters of taste, because
moraljudgments must be backed by reasons. If you like vanilla ice cream
and I like chocolate, we canjust accept this as a difference in taste—there
is no correct preference about ﬂavors of ice cream and if asked why I prefer
chocolate, I may only be able to repeat that it tastes better to me. Unlike
matters of taste, moral judgments, for example about whether voluntary
euthanasia is wrong, must have reasons backing them. A moral discussion
between a proponent and opponent of euthanasia might only begin, not
end, with claims that it is right or wrong. An opponent of euthanasia might
challenge its proponent by arguing that the deliberate killing of an inno-
cent person is wrong. A proponent might respond that voluntary euthana-
sia is different from most killing because the victim wants to die and con-
sents to being killed.

And so their discussion might continue. Their initial disagreement
quickly turns into a process of giving and clarifying reasons for their respec-
tive moral views about why euthanasia is or is not morallyjustified. Their
discussion rapidly moves to more general issues about when killing is wrong,
and for what reasons. This is inevitable. Their discussion could not remain
at the level of a particular instance of euthanasia. Whenever we offer rea-
sons in support of a particular moraljudgment, we do so by picking out
properties of the object of thejudgment that support or are the basis for
the moral judgment. Any feature of an object of moral evaluation which is

228 SOCIETY’S CHOICES

offered as a reason supporting a positive or negative moral evaluation of it
will be a property which on another occasion could be a property of other
objects of evaluation. Being an innocent human being, or having con—
sented to be killed, are each properties that can apply in other possible
cases—to other innocent human beings and to other persons who consent
to be killed.

Now clearly neither the proponent nor the opponent of euthanasia
need appeal to a comprehensive moral theory in supporting his or her
position about euthanasia, but both appeal to moral principles or reasons
with some degree of generality—they can be applied to other particular
actions, that is, other possible killings, as well. Indeed, if one of the two was
a consequentialist and was then pressed about why killing human beings
was wrong, she would respond that it is wrong when, and only when, it has
worse overall effects for human well-being than not killing the person in
question. And then she would have been driven to appeal to her most
basic moral beliefs, her comprehensive moral theory, in providing her
reasons for supporting or opposing the particular case of euthanasia. Of
course, most people are not consequentialists and would stop the process
of offering reasons for their moral position about euthanasia well short of
any comprehensive theory, if for no other reason than that most people do
not have any explicit, comprehensive theory that they accept; they might
stop instead with appeal to a basic moral duty not to kill, or a basic moral
right not to be killed. But while not a comprehensive theory, a principle
specifying a general moral duty or right of this sort can be thought of as a
potential part of a broader theory, or a theory fragment.

The central and fatal problem for particularism then is that it is incom-
patible with the very process of having and offering reasons for our moral
judgments, which is the principal feature distinguishing morality from mere
expressions of simple taste or preference. Some, at least partial or frag-
mentary, moral theorizing is an unavoidable part of moral reasoning, of
making and offering reasons for moraljudgments in practical and policy
contexts. What level of generality the reason-giving process in fact reaches
on a particular occasion of moral reasoning or disagreement will depend
both on theoretical factors, such as how deep and general the parties‘
reasons for their positions are, and on practical factors, such as how deep
one’s own uncertainty or another’s challenge goes on the issue in question.
Even ifa person‘s reasons for a particular moraljudgment are so many and
complex that as a matter of fact they fully fit few if any other real cases, the
reasons must be such that they at least in principle can apply to other cases.
Particularism, which locates moral reasoning and knowledge only at the
level of the particular judgment regarding an individual case, is not a
feasible alternative.

PUBLIC MORA L DISCOURSE 229
JUSTIFICATION WITH CONSIDERED MORAL JUDGMENTS

A Critical Screening Process

Neither deductivism, which gives a foundational role to general moral
principles or theories in moral reasoning, nor particularism, which pur-
ports to give no role to general moral principles or theories in moral
reasoning, is a plausible account of the nature of moral reasoning and
justiﬁcation. We need an account of moral reasoning that is neither too
ambitious in the role it gives to moral principles and theories, as deduct-
ivism is, nor too dismissive of their role, as particularism is. One grain of
truth in particularism is that people’s moral thinking does typically begin
with particular practical moral choices and cases. A discussion of euthana-
sia, for example, usually would begin with a particular instance of it, but
proceed with the participants providing reasons in support of their posi-
tions. But how might their different moral judgments and positions be
evaluated in order to determine which are true or false, correct or mis—
taken, orjustiﬁed or unjustiﬁed? I want now to address the problem of
justiﬁcation more directly. If not deductivist or particularist, what method
or process of moral reasoning could ethics commissions use that would
warrant a claim that their conclusions are morallyjustiﬁed?

john Rawls introduced the notion of “considered moraljudgments,”
which can be of use here, though I shall add features to it beyond those
Rawls speciﬁed.8 The idea is to characterize an idealized process at which
both individuals and an ethics commission could aim in their moral delib-
erations. How do considered moraljudgments differ from simply moral
judgments? What does considered add? In answering this question, I will
develop what I will characterize as a critical screening process through
which individuals can put their moral views and judgments. Considered
judgments generally, notjust considered moral judgments, are, ﬁrst,judg—
ments that are not made in conditions that we know from experience often
lead to mistakes. Here are some examples of such conditions: when we
have insufﬁcient time to consider the matter carefully; when we lack signiﬁ-
cant, relevant information bearing on the question at hand; when we have
a relatively ﬁxed commitment to a particular position on the question at
hand that makes us inadequately open to a fair consideration of other
positions; when the question at hand requires technical knowledge or train-
ing that we lack; when we must make a decision while distracted or emo-
tionally overwrought; when we lack sufﬁcient relevant experience to appre-
ciate fully some considerations and to integrate them adequately into our
decision making; and so forth. Notice that none of these are features in
any way special to moral judgments—they are features that, if present,
should equally weaken our conﬁdence in judgments about empirical mat-

230 SOCIETY’S CHOICES

ters of fact. There is in addition at least one important feature which
should likewise weaken our conﬁdence speciﬁcally in our moraljudgments,
a condition that experience tells us often leads to moraljudgments we later
come to believe were mistaken. It is that what we decide morally to believe
or do will importantly affect our own interests—this often leads us to ratio-
nalize in the pejorative sense, that is, to ﬁnd some purported rationale for
why we are not morally required to do a burdensome or unwanted action
that we would have no trouble concluding others morally must do. Of
course, when our interests are importantly at stake this often leads us to
give more careful attention to the issue at hand. This condition does not
rule out considered moraljudgments, but warns us to look carefully for this
form of rationalization. With this qualiﬁcation, considered moral judg-
ments then are, ﬁrst,judgments made in the absence of conditions like
thosejust noted that we know from experience often lead to mistakes.

There is a second aspect of considered moraljudgments that needs to
be brought out. With empirical judgments about matters of fact, our
conﬁdence in ajudgment is increased, other things equal, the more fully
we have been able to consider all relevant evidence that bears on the issue.
While disputes about empirical matters of fact often bear on moral ques-
tions as well, moraljudgments have speciﬁcally moral reasons which sup-
port them. Considered moraljudgments then are alsojudgments made as
a result of having fully considered the reasons that support them. In the
ideal or limiting case, this would involve fully considering to the deepest
level possible the nature of the reasons to which one would appeal in
attempting tojustify one’sjudgment. In the example above of voluntary
euthanasia, this would involve fully probing one’s moral views about killing
and any factors that bear on one’s views about killing in the context of
euthanasia. Any example like this in which different people disagree brings
out another important feature of evaluating the reasons in support of our
moral judgments—this evaluation involves not just exploring as fully as
possible the reasons in support of one’s ownjudgment or position, but also
considering all possible reasons and arguments against one’s own position
and in support of alternative positions. Until one has examined what can
be said both for and against all plausible alternative positions on a particu-
lar issue, one will not have fully considered all alternatives, and all that can
be said for and against all alternatives, to one’s own position.

A third aspect of considered moraljudgments and the critical screen-
ing process which produces them is that the process of considering alterna-
tive positions and evaluating the reasons that support them on any issue
typically has both an intrapersonal and an interpersonal component. It
will often begin as an intrapersonal process as one initially thinks about the
issue oneself; but then it should expand to an interpersonal process as well,
because we know from experience that our moral vision is often enlarged

PUBLIC MORAL [)ISCOURSE 231

by discussion and reasoning with others and by confronting the positions
and arguments of others, either in discussion or in print. Thus at the
limits, arriving at one’s considered moraljudgment about a particular ac—
tion or policy will involve considering all the reasons that can be offered by
anyone for and against any alternative position, choice, or decision on the
matter at hand. A practical implication for ethics commissions is that
having diverse membership helps ensure a process in which diverse moral
perspectives, experience, and views are brought to bear in the commission’s
deliberations.

Reﬂective Equilibrium

In criticizing particularism, I argued that it is impossible to give rea-
sons for moraljudgments while at the same time restricting the implica-
tions of judgments solely to the particular case at hand. By their very
nature, moral reasons can apply to other cases beyond the speciﬁc case in
which they are being employed. Sometimes these reasons have substantial
scope or generality and so potentially apply to many other moral choices
and evaluations that people face. We might therefore say that people’s
moral beliefs, and in turn their considered moral judgments which have
survived the critical screening process I have just sketched, come at all
levels of generality. Now a substantive or normative moral theory can be
brieﬂy characterized for my purposes here as a small body of relatively
general principles applying to the objects of moral evaluation in a given
domain. While the domain of a maximally comprehensive moral theory
would be all possible objects of moral evaluation, most people at best hold
less comprehensive theories, or what are partial theories or theory frag-
ments from the more comprehensive perspective. This means that, al-
though deductivism may be mistaken in holding that moral reasoning and
justification begin from a moral theory already and independently estab-
lished as true and which then could be somewhat mechanically applied to
particular cases, it is correct that at least parts or fragments of moral theo-
ries are either implicitly or explicitly appealed to in reasoning about par-
ticular cases. It is this scope of moral reasons—that they always can apply to
cases beyond the one at hand—that gives considerable force to the require-
ment of consistency in moral reasoning: consistency requires accepting the
implications of the reasons or principles to which one appeals in a particu-
lar case for the other cases to which they also apply. A few important
additional aspects of the appeal to general moral principles need to be
emphasized.

Since our considered moral judgments and beliefs include general
moral principles, these principles can often be appealed to in reasoning
about particular cases or policies. For example, some principle of equality

232 SOCIETY’S CHOICES

of opportunity is an important component of American moral and political
culture, and can be used to help decide what kind of inequalities are
morally acceptable in access to health care. This much is true about
deductivism—sometimes we may have greater moral conviction about a
general moral reason or principle than we do about a particular judgment
concerning a concrete case or policy, and so we largely form or revise our
moraljudgment about the case or policy to ﬁt the more general reason or
principle that applies to it. Our moral conviction about the case or policy
is then principally derived from our conviction about the more general
reason or principle. Different moral judgments about particular cases or
policies as well as different general moral principles are held with different
degrees of conviction by any individual, even at the end of the critical
screening process. This is important for understanding how internal con-
ﬂicts within an individual's moral views should be resolved.

When there is conﬂict between our moral judgments about particular
cases or policies and our moral principles, as often occurs, no systematic
priority can be assigned either to the judgments about the particular cases
and policies or to the general principles regarding which should be re-
tained and which revised or abandoned in the attempt to eliminate the
inconsistency in our moral views. In removing the inconsistency in order
to reach what Rawls has called “reﬂective equilibrium” between an
individual’s particular judgments and general principles, the revision
should be made so as to leave the individual with a consistent view that
retains as much overall conviction as possible. Sometimes the initial judg-
ment about the particular case or policy will be revised or abandoned,
sometimes the more general principle. When an ethics commission is
seeking interpersonal consensus among its members, or in the broader
society, the resolution of conﬂicts will be more complex than, but in some
respects similar to, this intrapersonal process. Compromises between indi-
viduals should be sought which require different individuals to make con-
cessions at points of least conviction, scope, and importance in their views,
and with a presumption for some rough equality in the concessions that
individual members make to the others.

Foundationalist accounts of justiﬁcation, of which deductivism is one
instance, hold that some moral beliefs have privileged status regarding
truth and/ or justiﬁcation, and so are not subject to revision in the case of
conﬂict with other judgments lacking this privileged status. In the differ-
ent account of justiﬁcation sketched here, usually called coherentist, no
judgments are assigned such privileged status that they never should or
could be abandoned or revised. In any instance of conﬂict between par-
ticular judgments and general principles, it is an empirical matter, to be
determined on a case—by—case basis, which carries least conviction and could
be revised with least cost to a particular individual’s other moral convic-

PUBLIC MORAL DISCOURSE 233

tions. To seek reﬂective equilibrium is to seek the consistent, comprehen-
sive set of considered moraljudgments at all levels of generality, including
bothjudgments about particular cases and general moral principles, which
carries for the individual the greatest overall conviction.

Besides this role in reﬂective equilibrium, general moral principles
and theories also play a more direct role in justifying moral judgments
about particular cases or policies which is analogous to how scientiﬁc theo-
ries provide explanatory force to a domain of phenomena. A central func-
tion of theories in natural and social science is to provide order and struc—
ture to a body of observations or data about the world that would otherwise
be merely a large set of unconnected data. Scientiﬁc theories thereby
produce gains in understanding: by displaying a structure and order in the
data, they show us the variables and causal relations that explain what
would otherwise be a disordered and unrelated mass of observations or
phenomena. In this respect, it is the same with moral theories. In moral-
ity, the analog to the observation statements and data that a scientiﬁc
theory explains is the particular moral judgments about some range of
cases which the more general principles of a moral theory, or of a partial
moral theory, explain.

Because the principal role of moral judgments is to guide action, un-
like both data and theories in science whose principal roles are to guide
belief, moraljudgments are subject to a special worry. The worry is that
they may be no more than a hodgepodge of thinly veiled rationalizations
and biases reﬂecting our own self-interest, prejudices, and arbitrary prefer-
ences. General moral principles or theories can help allay this worry by
explaining thesejudgments: they are shown to ﬁt, and to be derivable and
made from, a coherent, uniﬁed moral conception. We come to see that
our particular moraljudgments have a coherent, identiﬁably moral source,
heretofore likely only implicit, and are notjust a cover for our prejudices
and self-interest. The principles and theory display those judgments as
recognizably moral and make the moral basis lying behind them subject to
explicit critical evaluation. This can in turn increase our conviction in
particularjudgments because we come to see that they ﬁt within or have
the same basis as, other judgments about which we may have additional
and/or more conﬁdence. In this coherentist account ofjustiﬁcation no
particular part of a person’s overall moral beliefs or conception has any
privileged status with regard to truth, correctness, or justiﬁcation. Instead,
each component of the comprehensive moral conception gains part of its
justiﬁcation from all the rest of the moral conception of which it forms a
part.

Fully coherent and comprehensive general principles or theories cov-
ering all of one’s moraljudgments are more than most people can in fact
achieve. For most of us, there is no single, uniﬁed moral framework from

234 SOCIETY’S CHOICES

which all our particular moral judgments are made or can be shown to
follow. In fact, I believe that for most people there are multiple different
and independent sources of moral value, or parts of their overall moral
view, with no single deeper uniﬁed account of those parts. One of the
central problems for applied ethics and practical moral thinking and delib-
eration is giving an intelligible account of how the unity of moral delibera-
tion and action is possible, even for a single individual, in the face of this
lack of unity or full coherence in the individual‘s moral beliefs or overall
moral conception created by these different, independent components of
the person’s morality.9 Of course, ifwe look across a culture or society, this
diversity of sources of moral value is greater still—and is one of the greatest
challenges public ethics commissions face.

This process of reaching one’s considered moraljudgments in reﬂec-
tive equilibrium is an ideal which in practice can only be more or less
approached. Besides the obvious limitations of time and effort, there are
always limitations at any point in time on the alternative positions on any
issue that we and others can imagine, as well as on the arguments that we
and others can think of for and against any alternative. So even if this ideal
were fully realized at any point in time, we could never be sure that in the
future we or others would not think of new alternatives and/or arguments,
perhaps on the basis of new experience, that would change our minds.
This critical screening process, even in its ideal form, never warrants abso-
lute certainty about any particular moral judgment that could put it be-
yond further question. While this ideal of considered moraljudgments in
reﬂective equilibrium is never fully achievable in practice, it is useful never-
theless because it specifies an ideal process by which all possibly relevant
reasons and arguments available to anyone and bearing on a moral issue
can be given due consideration; the shortcomings and more restricted
focus of moral reasoning in the real world can be measured against this
ideal.

There is one important respect in which the ideal process of moral
reasoning at which a public ethics commission should aim differs from
what I havejust sketched for individuals. It will rarely, if ever, be appropri-
ate for an ethics commission to seek, much less present in its reports, a
single fully comprehensive and determinate moral conception in support
of its analyses and recommendations, even ifit thought that possible. It will
usually be enough to present the principal reasons and arguments that
bear on and support the speciﬁc policy recommendations it makes. Often
this will require criticizing alternative positions and/or responding to natu-
ral objections to its own positions and recommendations. In the example
of euthanasia discussed above, the commission might at most offer a gen-
eral analysis and argument on the wrongness of killing, and the kinds of
cases, if any, in which killing can be morallyjustified which bear on eutha-

PUBLIC MORAL DISCOURSE 235

nasia. Exploring the implications of the commission’s argument and posi-
tion for other cases of killing, for example, killing in war or capital punish-
ment, would be unnecessary, indeed undesirable, because a source of un-
necessary controversy and a diversion of attention from the commission’s
policy focus on euthanasia. For the same reasons, presenting an entire
moral theory or a complete set of moral principles would be all the more
unnecessary and uncalled—for given the policy focus. Nevertheless, the
process of moral deliberation in which the commission engages, together
with the results of that process which it presents to the public in its reports,
is properly understood within this broader account of moral deliberation,
reasoning, and justiﬁcation.

We noted above that one respect in which general principles and theo-
n'es helpjustify particular moraljudgments is by showing them to be made
from a coherent and uniﬁed moral conception. There are two further
respects in which moraljudgments that have survived the critical screening
process and reﬂective equilibrium are justiﬁed. First, they are justiﬁed
because they are made in relatively ideal conditions forjudging, that is, in
the absence, to the extent possible, of conditions that we know from ex-
perience often lead to mistakes; as noted above, these will include condi-
tions leading to mistakes in judgments generally, as well as conditions
leading to mistakes in moral judgments in particular. Second, they will
have survived a process of critical examination in which all arguments both
for and against them, as well as in support of and against alternative con-
ﬂictingr positions, have received due consideration. In both of these re—
spects, considered moraljudgments in reﬂective equilibrium arejustified
because they have survived a maximally broad critical screening process.
To repeat, this is not to say that we may not later come to change our view,
and/or come to believe that our earlier conclusions were mistaken. Even
when our moraljudgments have been maximally subjected to arguments
for and against both them and other alternative positions, there are limita-
tions in our and others’ moral thinking at any point in time. Thus,just as
withjustified empirical beliefs,justiﬁcation does not provide any guarantee
of the truth or correctness of our moral beliefs.

Some readers may object that this account of moral reasoning and
justiﬁcation, which begins from the moral beliefs we happen to have at any
point in time, is unduly conservative. Our moral beliefs are a result of our
experience and the socialization process to which we have been subject.
Consequently, those beliefs will likely reflect the values and moral beliefs
predominant in our culture and society, and be biased in favor of the status
quo. But this objection is misplaced. The critical screening process for
reaching considered moraljudgments, which describes an ideal of consid-
ering all arguments for and against both the particular moraljudgment or
position with which one began, as well as alljudgments or positions which

236 SOCIETY’S CHOICES

are alternatives to it, asks us to consider all criticisms of and alternative
perspectives on the status quo, no matter how radical. Failures to consider
sufﬁciently radical criticisms or alternatives will be failures of our critical
and moral vision or will, to some degree unavoidable, but not failures
fostered by the method of moral reasoning that I have described.

Relativism and the Subjectivity of Moral Judgments

Is the method of moral reasoning that I have sketched for use both by
individuals and by public ethics commissions objectionably relativist? Moral
relativism is usually understood as the view that different incompatible
moral beliefs can be true for different individuals, groups, or societies. In
this view, whether a moraljudgment is true or correct will depend on who
is making it. One of the central problems of moral methodology is how the
justiﬁcation, rather than the truth or correctness, of the moraljudgments
of either an individual or a group, such as an ethics commission, can be
established. From the standpoint ofjustiﬁcation, the problem of relativism
is whether incompatible moral judgments can each be justiﬁed for differ—
ent individuals or groups. It is a familiar point that even in the case of
judgments that most people believe are noncontroversially capable of be-
ing either true or false, or correct or mistaken, such as empiricaljudgments
about matters of fact, one individual may be justiﬁed in accepting a judg-
ment as true that another individual can be justiﬁed in rejecting as false.
This is because different people may have different evidence available to
them bearing on the judgment in question, and an individual’s justiﬁca-
tion for accepting a belief depends on the relevant evidence he or she has,
or should have. If evidence tending to conﬁrm or disconﬁrm a particular
belief is available to one individual but unavailable to another, they can
each be justiﬁed in holding beliefs both of which cannot be true.

So the question about the relativism of moral judgments is whether
different individuals with all the same empirical or factual information and
beliefs relevant to a moral issue can be justiﬁed in holding incompatible
moral judgments on that issue. Another way of putting this question is
whether some moral disagreement can be in principle, notjust in practice,
rationally irresolvable. Much moral disagreement is in practice irresolvable
when people cling irrationally to beliefs in the face of evidence of their
falsity, make mistakes in their reasoning that cannot be corrected, and so
forth. Moral disagreement that is irresolvable in principle is clearly a more
serious problem for any account of public moral discourse because it means
that even when different people fully conform to the standards for that
moral discourse, there may in the end he no way of resolving their moral
disagreement.

It should be clear that the account of moral reasoning andjustiﬁcation

PUBLIC MORAL DLSCOURSE 23 7

sketched above, which employs a critical screening process together with
reﬂective equilibrium, does allow for the possibility of moral disagreement
that is in principle rationally irresolvable, and for the possibility that differ-
ent individuals may each be justiﬁed in holding incompatible moraljudg—
ments; we can call thisjustiﬁcatory relativism. Of course, we will not know
that any particular moral disagreement, such as among members of an
ethics commission, is in fact irresolvable, either in principle or in practice,
until their different views have gone through the critical screening process
and achieved reﬂective equilibrium. Any conclusion that a particular moral
disagreement is in principle irresolvable should only come at the end of a
full, but failed, attempt to resolve the disagreement. The possibility that
moral disagreement can be even in principle irresolvable is compatible
with moral disagreements rarely, or even never, in fact turning out to be
such. Some moral disagreement does, I believe, turn out to be irresolvable
even in principle, but not as often as many people today suppose. Very
often disagreement that initially appears to be moral turns out on closer
analysis to be empirical disagreement about matters of fact.

justiﬁcatory relativism implies that moral judgments are correctly un—
derstood to be in one sense subjective. Claims about the subjectivity and
objectivity of morality and moraljudgments are commonly so poorly de-
ﬁned and used in so many different senses that they often bring more
confusion than clarity. What I have in mind here by the claim of subjectiv—
ity is this. At the end of the day, so to speak, after the process of moral
reasoning andjustification that I have sketched here has been completed,
a particular individual's moraljudgments, principles, or theory will depend
on what that person is prepared on reﬂection to accept, to try to live by,
and to judge him- or herself and others by. The same is true for groups of
people living together in a society, and for bodies they establish like ethics
commissions to help them address moral issues of public policy. Choice of
and commitment to a way of life in this broad sense cannot in the end be
avoided, and different individuals can choose and pursue different ways of
life. But this hardly implies, as R.M. Hare pointed out long ago, that such
choice is ungrounded or arbitrary; the choice I am describing here is
choice after everything of relevance to the choice has been given due
consideration, which is exactly the opposite of arbitrary choice understood
as choice for which we have no basis.10

The Appeal to an Overlapping Consensus

One important qualification must be put on the account of moral
reasoning I have sketched above for its use in public moral discourse in
contexts in which identifying or forging a consensus about public policy, or
making recommendations about public policy, is the goal. In more recent

238 socm'ry‘s CHOICES

development of his theory ofjustice, john Rawls used an “overlapping
consensus" to capture the idea that people who hold quite different com-
prehensive moral, religious, philosophical, and cultural views might share
an overlapping consensus about principles ofjustice and about the politi-
cal reasons that support those principles.” If people appeal to their com-
prehensive moral conceptions, including the full moral, religious, philo-
sophical, and cultural underpinnings of those views, they will often give
different and conflicting reasons or support for particular substantive posi-
tions on which they agree. The “fact of pluralism“——that different citizens
hold different comprehensive moral, religious, and philosophical concep—
tions—is a permanent feature of free liberal democracies. It implies that
the ethical and political bases that all citizens can reasonably accept for
public policies in a liberal democracy cannot rest on these full comprehen—
sive conceptions. The task of ethics commissions is often to try to ﬁnd a
common public moral discourse that can yield a consensus on which pub—
lic policy can be formed among individuals and groups otherwise in dis-
agreement on many important matters.

The role of an overlapping consensus for policy raises complex and
controversial issues that cannot be explored here, but one point needs at
least to be mentioned. In a liberal democracy, public policy which requires
everyone to act in speciﬁc ways should not be based on sectarian views
reasonably rejected by substantial segments of the population. This is a
goal that cannot always be realized for all policy, certainly in practice, but I
believe in theory as well; still, it is an important goal nonetheless. It im-
plies, for example, that public policy should not be based on speciﬁc reli-
gious beliefs that many do not share. Notjust public policies themselves,
but the reasons that are offered in their support in policy debate, whether
in ethics commissions or other settings, should not be reasons that others
can reasonably reject as a basis for public policy in a pluralistic society. The
common agreement to search for an overlapping consensus in public
policy, a search in which an ethics commission can sometimes play a signiﬁ-
cant role, should be understood to mean not only that we seek to ﬁnd or
forge a consensus on particular policy issues, but that we also seek consen-
sus on the kinds of reasons that we will offer in support of policy positions.
One crucial aspect of this latter is the consensus on what reasons are appro-
priate for policy debate.

This is a qualiﬁcation on the account of public moral reasoning on
policy questions sketched above for ethics commissions, since the full ex—
ploration of one's reasons for one’s moral positions and judgments will
take one deeply into the details of one‘s comprehensive religious, philo-
sophical, and moral views. To appeal to those comprehensive views is to go
beyond what should be the basis of public policy. This restriction on rea-
sons that are appropriate in the policy debates of an ethics commission is an

PUBLIC MORAL DISCOURSE 239

implication ofwanting public policy in a liberal democracy to bejustiﬁed as
far as possible by shared reasons that all could accept as reasonable.

CONCLUSION

I shall emphasize only two general points in conclusion. The ﬁrst is
that the process of public moral discourse in which an ethicscommission
engages is not fundamentally different in its nature from the moral reason—
ing iri’which individual members of the society engage in public and pri-
vate contexts. The second point is that while the process of public moral
discourse, even properly carried out, does not guarantee the truth or cor-
rectness of the conclusions it yields, it can provide us with a warrant for
accepting them as a‘justiﬁed basis for public policy.

NOTES

1. While some people make a distinction, although usually not a clear one. between
“ethics" and “morality," 1 shall use them interchangeably in this paper.

2. D. Rothman, Strangers at the Bedside: A History of How Law and Bioethics Transformed
Medical Decision Making. New York: Basic Books (1991); Henry Beecher, “Ethics and Clinical
Research,” New England journal of Medicine 74 (1966) 1354—1360.

3. President’s Commission for the Study of Ethical Problems in Medicine and Biomedi—
cal and Behavioral Research, Deciding to Forego Life—Sustaining Treatment. Washington, DC:
US. Government Printing Office (1983).

4. Brock, D.W. “Voluntary Active Euthanasia,” Hastings Center Report 22 (March—April
1992) 10—22, and reprinted in Dan W. Brock, Life and Death: Philosophical Essays in Biomedical
Ethics. Cambridge University Press (1993).

5. Rawls,]. 1971. A Theory ofjustiee. Cambridge, MA: Harvard University Press.

6. Foundationalists differ on how this privileged truth status can be secured for some
moral judgments, as well as on what the privileged status is. e.g., contingent or necessary
truth. Intuitionists like H. A. Prichard and W. D. Ross both held that some moral statements
are necessary truths, although they disagreed about whether the moral statements that had
this privileged truth status were concrete, all-things—considered moraljudgments about par—
ticular actions, or general principles specifying moral duties such as to keep promises and
not to deceive, which could be overridden in some particular circumstances.

7. jonsen, AR. and S. Toulmin, The Abuse of Casuistry: A History of Moral Reasoning.
Berkeley: University of California Press, 1988. To what extent jonsen and Toulmin are
examples of what I call Particularists is unclear. They do endorse a “stronger claim—namely
that moral knowledge is essentially particular so that sound resolutions of moral problems must
always be rooted in a concrete understanding of speciﬁc cases and circumstances. . . . The
stronger account sees the primary locus of moral understanding as lying in the recognition of
paradigmatic examples of good and evil, right and wrong." p. 330 (Italics in original) This
suggests that they do accept the epistemic aspect of what 1 call Particularism that moral truth
or knowledge is to be found at the level of particular cases, their “paradigmatic examples. " It
may be that their account of the actual process of moral reasoning, which is centrally a matter
of ﬁtting speciﬁc actual cases to the paradigmatic examples, does make room for general
principles in the manner of reflective equilibrium discussed below, although I am unsure of
this. But it is unlike Rawlsian reflective equilibrium in giving judgments about particular

240 SOCIETY’S CHOICES

cases privileged epistemic status, and that is the only respect in which I am interpreting them
to be Particularists here.
8. Rawls, op. cit.
9. Thomas Nagel has stressed this point in “The Fragmentation of Value,” in Moral Ques-
tions. Cambridge: Cambridge University Press (1979).
10. Hare, R.M. Freedom and Reason, Oxford: Oxford University Press (1963)
ll. Rawls,_]. Political Liberalism. New York: Columbia University Press (1993).

The Value of Consensus

MARTIN BENJAMIN, Ph.D.
Professor of Philosophy, Michigan State University

In 1988, a group of 33 physicians, bioethicists, and medical economists
from ten different countries met at Lawrence University in Appleton, Wis-
consin, to formulate guidelines for stopping medical treatment. Apart
from minority dissents on two matters of detail, the guidelines were en-
dorsed by the group as a whole and subsequently published as “The
Appleton Consensus: Suggested International Guidelines for Decisions to
Forego Medical Treatment” (Stanley et al., 1989). What, if anything, is
added to the value of such guidelines by the inclusion of“consensus" in the
title? Does consensus give special credence or authority to this and similar
outcomes of group deliberation? Should members of such groups be en-
couraged to strive for consensus? Or is preoccupation with consensus
likely to obscure important differences, leading in many cases to recom-
mendations so general or abstract as to be practically useless?

These and related questions have assumed greater importance as gov—
ernments and health care institutions turn to ad hoc or standing commit-
tees or commissions for guidance on perplexing bioethical issues. In what
follows I examine the nature, value, and limits of consensus in bioethics. I
begin by identifying different types of consensus and their relations to
notions like compromise and majority rule. I turn then to a variety of
normative and methodological issues that must be addressed by ethics
committees and commissions as they consider whether, and if so to what
extent, their deliberations should be directed by a search for consensus.

241

242 socmrr’s CHOICES

FORMS OF AGREEMENT

Agreement among members of bioethics committees and commissions
may take a number of forms. At one end of the spectrum is full agreement
on both the substance ofa recommendation and its supporting arguments.
At the other is vote-taking and the group's endorsing the will of the major-
ity. In between are “overlapping consensus” and compromise.

Complete Consensus

A consensus is, most generally, an agreement—a collective unanimous
opinion—among a number of persons. If, for example, members of an
ethics committee immediately agree on a recommendation and its sup-
porting values or principles, consensus is predeliberatively complete. The
entire position—argument and conclusion—of each member is, at the
outset, congruent with that of the others.

Predeliberative complete consensus will, for two reasons, be uncom-
mon. First, questions directed to such committees are usually contested.
Ethics commissions or committees are created when the larger group they
represent must speak with one voice on complex ethical questions to which
members or clients of these groups give uncertain or conﬂicting answers.
Issues likely to elicit complete consensus at the beginning of a group’s
deliberations are, as a result, not often addressed to ethics committees.
Second, committee members usually represent differing social or ethical
viewpoints or differing areas of biomedical, social scientiﬁc, or other types
of expertise, or both. It is, in part, the diverse and representative composi—
tion of such committees that lends special authority to whatever agreement
emerges from their deliberations. At the same time, this diversity is un-
likely to produce predeliberative complete consensus.

Yet if complete consensus rarely emerges at the beginning ofa group’s
deliberations, it will, more often, develop toward the end. Consider, for
example, questions so novel or puzzling that committee members have, at
the outset, no ﬁrm positions on them. “This is not to say,” as jonathan
Moreno puts it, “that they come with no views or principles in relation to
the matter at hand, but rather that they do not hold them in such esteem
that they are prepared to insist that their essence be represented in the
solution” (Moreno, 1990a, p. 43). Here, open-minded, informed, mutu—
ally respectful, give-and-take discussion aimed at well-grounded agreement
may produce convergence on both reasons and conclusion—complete
consensus.

Still, such consensus will not be frequent. Committee members often
bring differing moral outlooks or principles to the deliberations that affect
their reasoning or conclusions. Moreover, individuals representing differ-

VALUE OF CONSENSUS 243

ing areas of expertise are likely to emphasize different aspects of complex,
multidimensional questions in their thinking, leading to differing argu—
ments, if not differing conclusions. If, however, committee members agree
in their conclusions, but come to these conclusions in different ways, the
result may still be consensus, though not complete consensus.

Overlapping Consensus

The term “overlapping consensus” has been coined by political phi-
losopher John Rawls to characterize agreement on basic principles ofjus—
tice among individuals embracing a plurality of different, occasionally con-
ﬂicting, comprehensive moral, religious, and philosophical outlooks
(Rawls, 1993, pp. 15, 133—72). As different premises may lead to the same
conclusion, different comprehensive outlooks, Rawls argues, may support
the same conception of social justice. There is, in this event, overlap
among those parts of different individuals’ comprehensive moral, religious,
and philosophical views that include a particular conception of socialjus-
tice, but not among their moral, religious, and philosophical views as a
whole. Thus, for example, one person may situate his or her support of a
particular conception ofjustice within certain religious convictions, while
another may find a place for the very same conception within either Kant’s
or Mill’s comprehensive (secular) moral theory (Rawls, 1993, p. 145).

Agreement among members of an ethics committee or commission
may also be a type of overlapping consensus. Individuals arguing from
different moral, religious, philosophical, and empirical premises may none—
theless reach the same conclusion with respect to positions or policies in
bioethics.1 Stephen Toulmin observed this sort of consensus in his role as
a staff member with the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research. Although commissioners
were usually in agreement about their recommendations—”even about
quite detailed recommendations”——the consensus did not, Toulmin writes,
extend to the arguments or principles supporting these recommendations:

When the eleven individual commissioners asked themselves what “prin-
ciples" underlay and supposedlyjustified their adhesion to the consensus,
each of them answered in his or her own way: the Catholics appealed to
Catholic principles, the humanists to humanist principles, and so on.
They could agree; they could agree what they were agreeing about; but,
apparently, they could not agree why they agreed about it [Toulmin,
1981, p. 32].2

Consensus in societies acknowledging a plurality of conﬂicting com-
prehensive moral outlooks will often be overlapping. The wish for com-
plete consensus on all moral issues is, as I will show below, utopian. I want

244 SOCIETY’S CHOICES

now to compare consensus—complete and overlapping—with compromise
and (what may be construed as a special kind of compromise) majority
rule.

Compromise

Compromise bears more than a superﬁcial resemblance to consensus,
but it is also importantly different. Central to compromise is the idea of
mutual concession for mutual gain. Consider, in this connection, the
deliberations and conclusions of the Warnock Committee of Inquiry into
Human Fertilization and Embryology (Warnock, 1985b). Among the is-
sues addressed by this group of British physicians, lawyers, theologians,
social scientists, and ordinary citizens, chaired by philosopher Mary
Warnock, was the question of the permissibility of research using human
embryos. Moral opinion on this matter was at the time (and still is) deeply
divided. At the root of the controversy are opposing views of the moral
status of the embryo. Those who believe that human life protected by laws
against murder begins at conception consider the embryo to have the same
status as an adult human being, and are thus strongly opposed to any
research of this kind. Those who regard the moral status of the human
embryo as signiﬁcantly lower than that of an adult are heavily inﬂuenced by
the undeniable utilitarian advantages of such research with respect to in-
quiries into infertility, miscarriage, congenital defects, and related matters.
The Warnock Committee was charged with making a recommendation at
the national level on this highly controversial question. Although moral
views on this matter were divided, a policy embodied in law would necessar-
ily be singular and binding on all.

The most basic recommendation of the majority of the committee’s
members on the question of embryo research seems to have been a com-
promise between the two polar positions. Such research would be permit-
ted, but only for up to 14 days from fertilization. It would, after this, be
categorically forbidden. As Warnock puts it,

in the end the Inquiry felt bound to argue, partly on Utilitarian grounds,
that the beneﬁts that had come in the past from research using human
embryos were so great (and were likely to be even greater in the future),
that such research had to be permitted; but that it should be permitted
only at the very earliest stage of the development of the embryo [War-
nock, 1985a, p. 517].

Thus, each polar position to the disagreement (that representing an
extreme conservative or “pro-life” view of the moral standing of the em—
bryo, and that representing a considerably more liberal, or utilitarian, view)
received part, but not all, of what it was after. Members of the committee
holding either of these positions who nonetheless agreed to the compro-

VALUE OF CONSENSUS 245

mise must be presumed, for one reason or another, to have valued the
committee‘s speaking with one voice on this matter more than they valued
the committee’s endorsing their own view at the price of continued im-
passe.

Compromise in this and similar situations resembles consensus insofar
as the group speaks with one voice in making and supporting a particular
recommendation.3 There is consensus, in these circumstances, on what
position ought to be adopted by the group. Compromise differs from
consensus, however, insofar as those supporting the compromise retain
personal moral views that are more or less at odds with the position they
endorse in their roles as committee members.4 Each party to the compro-
mise makes concessions for the sake of agreement on a single recommen—
dation that seems to have some independent validity and to capture as
much of one polar position as it does of the other. The matter is not,
however, fully settled; there is no closure, no ﬁnal harmony, no complete
or overlapping consensus. Moral compromise is not, strictly speaking,
resolution. It makes the best of what contending parties regard as a bad
situation. Individual committee members may subsequently try to per-
suade those with whom they disagree of the superiority of their initial
position with an aim to its eventually being reconsidered and endorsed by
the group as a whole.

Majority Rule

Occasionally a committee will be unable to reach complete or overlap
ping consensus on a particular issue or to devise a satisfactory compromise.
Still, each member may believe that the group’s making either of two
recommendations on the issue would be better than its making no recom-
mendation at all. In this event a consensus may emerge from taking a vote
between the two alternatives, then endorsing, as a committee, the recom-
mendation receiving a majority of votes.

A resort to majority rule under such circumstances includes elements
of both consensus and compromise. There is, ﬁrst, consensus on the
procedure to be followed in determining the group’s substantive posi-
tion—what we might call procedural—as opposed to substantive, consen-
sus. Second, agreeing to abide by the outcome of this procedure is a type
of compromise. A committee member favoring position A over position B
would rather have the entire committee recommend A on its merits. But
since this will not occur and efforts to ﬁnd a compromise position between
A and B have been unsuccessful, the committee member agrees to the vote
because he or she believes the possibility of B’s winning a majority of votes
and becoming the committee’s recommendation is from an ethical point
of view better than the committee’s remaining deadlocked. If those favor-

246 SOCIETY’S CHOICES

ing position B follow mulatis mutandis the same chain of reasoning, the
result may be characterized as a procedural, as opposed to a substantive,
compromise.

Though less desirable than substantive consensus or substantive com-
promise, employment of majority rule under such circumstances is fair to
all committee members. What would be unfair, however, is resorting to
vote-taking without the consent of all committee members and then attrib-
uting the results to the committee as a whole. A majority position, under
such conditions, is attributable only to those who voted for that position,
and not to those who were opposed to settling the matter by vote-taking.
Where a resort to vote-taking is a product of procedural consensus and
represents procedural compromise, however, the outcome is endorsed by
and attributable to the group as a whole.

Following customary usage, I have to this point restricted the term
“consensus" to pre— and postdeliberative complete consensus and overlap-
ping consensus. But because both compromise and majority rule contain
elements of consensus and are sometimes employed by ethics committees
and commissions, I consider them as forms of consensus in what follows.

STRATEGIC CONSIDERATIONS

Arguments for consensus may be either strategic or normative. Strate-
gic considerations emphasize the instrumental value of consensus. The
principal value of consensus is, on this view, its contribution to obtaining
external acceptance and implementation of a group’s recommendations.
Normative arguments center on a more direct connection between con-
sensus and moral rightness; consensus is regarded as adding substantive
value or weight to the recommendations of an ethics committee or com-
mission. I discuss strategic considerations in this section and normative
considerations in the next.

In an article describing and defending the structure and operation of
the President’s Commission for the Study of Ethical Problems in Medicine
and Biomedical and Behavioral Research, Commission Chairman Morris
B. Abram and attorney Susan M. Wolf emphasize the practical importance
of virtual unanimity or consensus among the commission’s members:

A Commission such as this one has only the power of persuasion. A
group performing ethical analysis with no coercive powers cannot be per-
suasive without internal agreement. Unlike a court or legislature, which
is structured to have effect as long as a majority agrees, a commission
requires agreement that is as close to unanimity as possible, to have any
effect at all. Without such virtual unanimity, the commission members
simply voice possible argumenm; with it the commission can persuade.
The commission method thus forces the commissioners to find areas of
common accord [Abram and Wolf, 1984, p. 629].

VALUE OF CONSENSUS 24 7

The provisions governing membership on the commission, Abram and
Wolf add, mandated that commissioners have diverse backgrounds and
represent a variety of ethical viewpoints. Though making agreement more
difﬁcult to achieve, this same diversity contributes to the persuasive power
of any consensus emerging from such a group. The more dissimilar their
backgrounds and viewpoints, the more likely it is that positions on which
they achieve consensus (or even well-grounded compromise) will be en-
dorsed by legislators and public.

Yet stressing consensus for strategic reasons may weaken the substan-
tive power or coherence of a group's recommendations. Consider, for
example, criticisms of the President’s Commission’s volume on access to
health care. Ronald Bayer, in a well-documented review of the com-
mission’s deliberations on this matter, identifies and sharply criticizes the
“kinds of compromises that were necessary to bring the Commission’s work
[on this topic] to a successful conclusion” (Bayer, 1984, p. 314). Agree-
ment between the commission's staff, who favored the language of rights,
and most commissioners and the staff‘s executive director, who did not,
required replacing the notion of a right to health care with the weaker
notion of a societal obligation to provide access to care. This was, to
Bayer’s mind, an unfortunate concession. “The concept of positive or
social welfare rights,” he argues, has emerged in recent American history as
the most potent political language for those seeking to make claims against
a nonegalitarian social structure. By explicitly rejecting the concept of a
right to health care, thus breaking with recent public discourse on this
matter, the commission deprived those poorly served by the current health
care system of a language with which to express their discontent. In so
doing, the commission implicitly adopted a perspective that views social
change as the consequence of the recognition of moral obligations by the
socially powerful, rather than as a result of demands pressed from below as
a matter of right (Bayer, 1984, p. 320).

This charge has been echoed by john Arras, who argues that the
commission’s “retreat from the right to health care” represents “a signifi-
cant retrenchment of our public commitment to provide health care for
the needy” (Arras, 1984, p. 322).

In a different but related vein, Baruch Brody criticizes the commission‘s
work on access to health care for failing to come to grips with underlying
philosophical questions about distributive justice. “The Commission,” he
maintains, “needed to delve more deeply into the philosophical issues in
order to show the extent to which we lack an appropriate social policy
about access because we lack a social consensus about distributive justice”
(Brody, 1989, p. 3760. A number of deep and divisive philosophical ques-
tions were papered over in the interests of maintaining a strategic consen-
sus. Yet this served no purpose and may even have hampered subsequent

248 SOCIE’I‘Y’S CHOICES

efforts to address the important underlying questions. “By failing to delve
into the philosophical problems about justice in the allocation of re-
sources,” Brody concludes,

the Commission failed to provide a coherent approach to the difﬁcult
problems of securing access to health care. It would have done better, I
submit, to be more philosophical, to present a series of alternative theo-
ries ofjustice and their implications, and to call upon society to make
some choice among them [Brody, 1989, p. 383].

Where deep philosophical differences underlie conﬂicts about policy,
a committee or commission does better to identify these differences and
urge further reflection than to obscure them with a shallow strategic con-
sensus on what proves to be an empty or incoherent substantive recom-
mendation.

In a revealing account of the complex workings of a hospital ethics
committee, Ruth Macklin charts one group’s struggle to reach consensus
on a diﬂicult philosophical question. Charged with developing policy for
blood transfusions involving Jehovah’s Witnesses, the committee was un-
able to agree on guidelines for transfusing pregnant Witnesses. The issue
was whether these patients should have the same right to refuse lifesaving
transfusions as other adult Jehovah’s Witnesses. On the one hand, some
members of the committee believed that pregnant Witnesses should have
the same rights to control their bodies as otherjehovah’s Witnesses. On
the other hand, some physicians maintained that the presence ofwhat they
considered a “second patient”—the fetus—would not permit them to ac-
cede in good conscience to any refusal of a lifesaving transfusion by a
pregnant Witness. After two years of deliberation and numerous reversals
of position, the committee eventually determined that it could not reach a
consensus on speciﬁc guidelines for pregnant Witnesses. “Reluctantly,”
Macklin reports, “the committee adopted the suggestion that it not even
attempt to dictate a policy but limit its task to describing the competing
principles, leaving the decision-making process to the patient and clini-
cian" (Macklin, 1988, p. 20).

NORMATIVE CONSIDERATIONS

Abram and Wolf do not ask whether consensus can have normative as
well as strategic or persuasive value. Does consensus add moral weight to a
position in bioethics? Philosophers have long argued that the mere fact of
agreement does not make a position morally right (Moreno, 1990b). Still
consensus may, in some circumstances and under some conditions, con-
tribute to the normative signiﬁcance of a group’s recommendations. To
show how this is so I must say something about (1) the nature and extent of

VALUE OF CONSENSUS 24 9

moral pluralism; (2) the distinction between rationality and reasonable—
ness; (3) the extent to which questions of biomedical ethics generate genu-
ine uncertainty or reasonable disagreement; (4) the importance of agree—
ment, both in health care institutions and in national policy, on some of
these questions; and (5) the likelihood that informed, unforced agreement
on a particular issue or policy among members of a conscientious, well—
constituted ethics committee or commission will respect, if not incorpo-
rate, all reasonable positions on the matter.

Moral Pluralism

Moral pluralism, as I use the term here, is the w'ew that moral disagree-
ment cannot be eliminated by appeals to abstract impersonal principles.
Our positions on particular issues are usually grounded in our comprehen-
sive moral, religious, and philosophical outlooks and there is no single
comprehensive outlook that should be embraced by all insofar as they are
informed and rational. The comprehensive, identity-conferring outlooks
that we bring to ethical reﬂection include a variety of conﬂicting, often
equally reasonable, world views and ways of life.

A world view is a complex, often unarticulated (and perhaps not fully
articulable) set of deeply held and highly cherished beliefs about the na-
ture and organization of the universe and one’s place in it. Normative as
well as descriptive—comprised of interlocking general beliefs about knowl-
edge, reality, and value—a world view so pervades and conditions our ev-
eryday thinking that it is largely unnoticed (Luker, 1984, p. 158). Among
the elements ofa world view are one's deepest convictions about: (a) God—
that is, whether there is a God and, if so, God’s nature; (b) the nature and
purpose (if any) of the universe and human life; (c) the nature,justif1ca—
tion, and extent of human knowledge; ((1) the nature of human beings
(including, for example, their capacities for free will, goodness, compas-
sion, selﬁshness, and, in certain world views, sin and redemption); (e) the
best way(s) to structure human relationships (including sexual and familial
relationships, friendship, political institutions, and obligations to strang-
ers); (f) the nature and status of morality, especially injunctions and prin-
ciples having to do with the taking of life, the nature of equality, respect for
liberty, and so on; and (g) the moral standing of nonhuman animals and
the intrinsic value (if any) of the natural environment. Aworld view, as this
list suggests, may be theistic or entirely nontheistic.

Closely related to a particular world view is a corresponding way of life.
“Ways of life,” writes Stuart Hampshire, “are coherent totalities of customs,
attitudes, beliefs, institutions, which are interconnected and mutually de-
pendent in patterns that are sometimes evident and sometimes subtle and
concealed.” Ways of life include “repeated patterns of behavior,

250 SOCIE'I‘Y‘S CHOICES

admired ideal types of men and women, standards of taste, family relation-
ships, styles of education and upbringing, religious practices and other
dominant concerns” (Hampshire, 1983, p. 5). A person’s world view and
way of life are dynamically interrelated. A world View helps to structure a
way of life; a way of life presupposes and embodies a particular world view.
Deep changes in one are likely to occasion related changes in the other.

A distinctive and easily recognized world view and way oflife is that of
the Amish. Most world views and ways oflife are, however, more difﬁcult to
delineate in rapidly changing complex societies like ours which permit, if
not encourage, the exercise ofindividual choice. A complex amalgam ofa
wide variety of beliefs, attitudes, values, ideals, and practices, a contempo—
rary world view and way of life is often highly customized. This is not,
however, to say that these more individualized world Views and ways oflife
are less signiﬁcant to those who identify with them than a distinctively
Amish world view and way of life is to those who identify with it. A world
view and way of life gives shape and meaning to a person’s life, providing
the basis for his or her identity and integrity as a moral being.

World views and ways of life come into conﬂict because they are, for
the most part, based on local and particular, rather than more general and
universal, aspects of human life. Their perspectives are historically condi-
tioned, contingent, and sometimes ﬁercely personal and parochial. Loyal-
ties to particular institutions, practices, projects, and persons are often
regarded as essential to one’s way of life; they constitute much of one’s
identity and set one off from others as a particular person.

Not all world views and ways of life are, however, worthy of respect. A
world view and way of life may be criticized for inconsistency or instability,
or for clearly and systematically violating the principle of utility or the
second formulation of Kant's Categorical Imperative (“So act as to treat
humanity, whether in thine own person or in that of any other, in every
case as an end withal, never as a means only”). Though unable fully to
determine our world views and ways of life, these well-grounded principles
serve as important constraints on them.5 Each centers on a morally signiﬁ-
cant feature of human beings that cuts across social, cultural, national,
religious, racial, and sexual differences: sentience (for the principle of
utility) and the capacity for rational self-direction (for the Categorical Im-
perative). World views and ways of life systematically indifferent to or
contemptuous of the principle of utility or the Categorical Imperative must
be rejected (or at least constrained) regardless of their historical roots or
their importance to the identities of those holding them. It is thus that
world views and ways of life endorsing what clearly amounts to wanton
cruelty and neglect, human sacriﬁce, and slavery are widely and rightly
condemned. Campaigns to reform world views and ways of life incorporat-
ing more subtle violations of these principles are now being undertaken.

VALUE OF CONSENSUS 251

Some—for example, those that have added “racism” and “sexism” to our
vocabularies—have already achieved a measure of success. Others—for
example, those attempting to raise our consciousness about homophobia
and speciesism—still have a long way to go. But the general point remains:
World views and ways of life that clearly and systematically violate these
more abstract and general principles are unreasonable and may be restricted.

A world view and way of life is reasonable to the extent that it satisﬁes
well-grounded, widely shared standards and principles of reason. The
problem is that there are a number of reasonable world views and ways of
life that occasionally engender differing answers to moral questions, espe-
cially questions of biomedical ethics. This diversity of reasonable compre-
hensive moral outlooks, as Rawls points out, “is not a mere historical condi-
tion that may soon pass away; it is a permanent feature of the public culture
of democracy” (Rawls, 1993, p. 36). So long as people enjoy a certain
amount of liberty of thought and action they will embrace a variety of
reasonable world views and ways of life that will occasionally yield conﬂict-
ing answers to moral questions. Agreement by all on a single world view
and way of life can be maintained, as Rawls adds, only by “the oppressive
use of state power" (Rawls, 1993, p. 37).

Rationality and Reasonableness

Rationality is, for the most part, an intellectual virtue having to do with
the selection and pursuit of the most effective means to a set of carefully
selected ends. “I behave irrationally,” W. M. Sibley writes,

when I do not bother to ascertain the true nature of the ends I set myself;
or when I heedlessly sacrifice one end to a second, which when attained I
find to be of less worth to me than the first would have been; or when I
select unrealistic means; or when, having reached a rational enough deci-
sion, I fail to implement that decision in practice [Sibley, 1953, p. 556].

One’s ends as a rational agent need not, however, be egoistic. Con-
sider, for example, a paternalistic physician whose world view and way of
life places a premium on improving other people’s health and saving their
lives. Insofar as this physician is rational he will do what he can to pursue
this end. But he is not, simply as a rational agent, required to give equal
respect and concern to the conﬂicting reasonable ends of his patients.
Rationality requires that the physician take his patients’ ends into account
only insofar as doing so is instrumentally necessary for effectively further—
ing those of his ends (which incorporate, in this instance, his conception of
their welfare) that may be distinct from or opposed to theirs. If, therefore,
the physician’s obtaining consent to what he regards as beneﬁcial treat-
ment from a competent adult patient requires that he deceive the patient

252 SOCIETY’S CHOICES

and he knows he can get away with it, the physician will, insofar as he is
rational, be deceptive.

Reasonableness, on the other hand, requires giving equal or fair con—
sideration to the reasonable ends or viewpoints of others for their own
sakes. A person can therefore be rational without being reasonable, as
shown by the example of the paternalistic physician. Reasonableness is a
moral virtue, not simply an intellectual one. To be reasonable is to seek
reasons for one’s conduct that respect the reasonable ends and points of
view of those affected by it.

It is therefore, in the light of moral pluralism, unreasonable to suppose
that there is one and only one right answer to all moral questions. Insofar
as I acknowledge that a disagreement between another person and myself
is rooted in a conﬂict between reasonable world views and ways of life and
I am committed to respecting the (reasonable) ends and points of view of
others, I must admit that abstract, impersonal reason cannot, at least at this
point, provide a resolution (Benjamin, 1990a, Ch. 4).

Bioethical Questions

Questions of biomedical ethics place unusual strain on our moral
frameworks and traditions. In some cases, advances in medical knowledge
and technology create choices and possibilities so complex or radically new
or unprecedented that neither particular world views and ways of life nor
abstract general principles provide much in the way of ﬁrm or direct guid-
ance. The questions, we know, are important, but we are not quite sure
what to think or do about them. We feel a need to learn more about the
complex clinical, scientiﬁc, social, and ethical aspects of them before com-
ing to a decision.

In other cases, these new choices and possibilities—especially those
involving procreation, childbirth, childrearing, the nature of the family,
and the termination of life—elicit clear and firm responses rooted in dif-
ferent world views and ways of life. Not only do we have ethical positions
on these choices and possibilities, but they are deeply held and identity-
conferring. Yet they conﬂict with ethical positions rooted in other (reason—
able) world views and ways of life that we cannot, insofar as we are reason—
able, simply dismiss. Although we are clear about what we, as individuals,
believe to be right, we are not quite sure what should be done by a health
care team, a hospital, or a society when those directly affected hold con—
ﬂicting, yet not unreasonable, positions.

Need for Agreement

It is the need for some sort of agreement or consensus in the light of
the genuine uncertainty and reasonable disagreement characteristic of

VALUE OF CONSENSUS 253

many questions in biomedical ethics that has prompted the development
of ethics committees and commissions. The complexity of modern medi-
cine often requires the close cooperation among members ofa health care
team, patients, and patients’ families. Though some of these individuals
may, at least initially, be uncertain about or hold conﬂicting positions on
bioethical issues, they often need to agree on a single treatment plan.
Respect for reasonable moral differences requires that this agreement be
informed and uncoerced rather than imposed by deception or force by
those with a monopoly on power. If parties to a particular conﬂict are
unable to come to such an agreement by themselves, they may seek assis—
tance from an institutional ethics committee.

The same is true of questions of hospital or national policy. Though
different individuals and organizations may, for example, have conﬂicting,
reasonable views on how transplantable organs ought to be allocated in the
United States, a national system requires agreement on a single set of
principles and criteria binding on all. Here, too, respect for reasonable
moral differences requires that this agreement be informed and uncoerced
rather than imposed by force or deception.

Value of Consensus

Suppose we ﬁnd ourselves in a situation requiring a single policy on a
complex bioethical question characterized by genuine uncertainty or rea-
sonable disagreement. A committee or commission is constituted to exam-
ine the situation and recommend a policy. The committee members rep-
resent or have access to all relevant aspects of biomedical, social scientiﬁc,
cultural-religious, legal, and bioethical expertise on the matter, with em-
phasis on patient-citizen viewpoints. The group makes a concerted effort
to identify all reasonable positions on the issue and to give them fair con-
sideration. Moreover, no committee member or coalition of committee
members is able to dominate the group’s information-gathering, delibera-
tion, or decision-making. Finally, after considering all actual or imagined
reasonable arguments and positions on the matter, the group comes to an
informed, uncoerced agreement on what, for institutional or social pur-
poses, is regarded by each member as the best answer to the question. This
agreement may take the form of complete consensus, overlapping consen-
sus, compromise, or even consensus to endorse the outcome of a vote
between two or more reasonable positions, each of which is regarded by
everyone as superior to the group’s coming to no agreement on the matter.

A consensus meeting these conditions carries moral weight or adds norma-
tive significance to the group’s recommendation because it respects both
the depth of genuine uncertainty or the extent of reasonable disagreement
on the matter and the need for informed, uncoerced agreement. This is

254 SOCIETY’S CHOICES

not to say that the recommendation must be accepted without question.
Yet the burden is on those who disagree to show why, for purposes of
reasonable agreement in a pluralistic society, it is defective.

An Illustration

Consider, as an illustration, a statement of general principles for allo-
cating transplantable organs and tissues developed by the 1991 Ethics Com—
mittee of the United Network on Organ Sharing (UNOS) (Ethics Commit-
tee, 1992).6 The Ethics Committee identified three principles governing
most allocation decisions: (1) Utility (interpreted as net medical beneﬁt);
(2) justice (requiring fair or equitable treatment to all those awaiting
organs); and (3) autonomy (respecting informed, self—directing patient
choice, even if this does not in certain instances maximize utility or pro-
mote equitable distribution). The group then acknowledged possible con—
ﬂicts between the three principles and addressed means of resolving them.

One strategy is to establish a fixed ranking of the principles—to priori-
tize or lexically order them in some way—and to always follow this ranking.
One might, for example, propose that autonomy is prior to and, in cases of
conﬂict, overridesjustice; and thatjustice is similarly prior to and, in cases
of conﬂict, overrides utility. This was, however, rejected as overly rigid.
Whatever ranking one established ahead of time, it is always possible to
imagine situations in which the consequences of adhering to it would be
unacceptable. A second strategy is to address conﬂicts case by case, appeal-
ing to moral intuition. The problem with this is that people’s intuitions
differ widely on these matters, resulting in deadlock or a lack of uniformity
from one transplant center to another and within centers from one person
to another.

A third strategy, which the committee endorsed, is to acknowledge the
complexity of the situation and seek some sort of compromise or accom—
modation among the three principles. With regard to conﬂicts between
utility andjustice, for example, the committee states:

While [individual] members of the Committee hold diverging positions
regarding the ethically correct relations between utility andjustice, a con-
sensus has been reached for purposes of policy relative to organ and tissue alloca-
tion: utility . . . and justice (or fairness in distribution) should be given
equal status. This means that it is unacceptable for an allocation policy to
single-mindedly strive to maximize aggregate medical good without any
consideration ofjustice in distribution or for a policy to be single-minded
about promoting justice at the expense of the overall (medical) good
[Ethics Committee, 1992, p. 2229, emphasis added].

In cases of conﬂict, the committee proposed, justice and utility require
equal consideration:

VALUE or CONSENSUS 255

We make this proposal fully realizing that it may not square with the
personal morality of many people. Some would insist on higher priority
for utility; others for equity. In fact, whole classes of people might be so
inclined invariably to favor one of these principles or the other. The fact
that one group would give very heavy weight to one or the other of the
principles cannot, for public policy purposes, settle the matter. Inas-
much as: (1) neither side can provide conclusive arguments for its posi—
tion; (2) each side can provide plausible arguments for its position; and
(3) ours is a pluralistic society in which individual views cover the entire
spectrum from pure utilitarianism to extreme egalitarianism, we believe
that giving equal consideration to each is afair and workable compromise
[Ethics Committee, 1992, p. 2230, emphasis added].

Apart from minor differences in wording, this line of reasoning closely
resembles the one developed in this section.

Though the committee’s compromise might be rejected as the best
moral position by a number of individuals as individuals, it cannot, the
Committee suggests, be reasonably rejected as a basis for public policy by
individuals as citizens for whom informed, unforced reasonable agreement
on such principles is of great importance.7 While a person may reasonably
reject a policy that ignores or violates his or her personal moral position,
he or she cannot reasonably reject a coherent policy that (1) acknowledges
reasonable disagreement on the matter; (2) incorporates important ele—
ments of his or her personal moral position; and (3) respects as many
different reasonable positions as any workable alternative.

Finally, we should note that this Committee, like the hospital ethics
committee described above by Macklin, was unwilling to reach consensus
at any cost. The subcommittee drafting the initial document could not, for
example, agree on whether (carefully screened, abstinent) alcoholic end-
stage liver disease patients should be able to compete equally with non—
alcoholic patients for access to the limited supply of transplantable livers.
After considerable discussion and a 3—2 straw vote, subcommittee members
concluded they could not, in good conscience, answer this question as a
group. The final document states that “the Ethics Committee has not at this
time reached a single position regarding the nonpunitive use of this factor
[organ-damaging patterns of behavior] in allocation of organs” and then
identiﬁes arguments for and against the alternatives (Ethics Committee,
1992, p. 2234).

PROBLEMS AND LIMITS

A consensus among members of an ethics committee or commission
may be questioned in a number of ways. Doubts may be raised about a
particular group’s composition, its deliberations, and its substantive rec-
ommendations.

256 SOCIETY’S CHOICES

Composition

Recall the “Appleton Consensus” (Stanley et al., 1989). One might
reasonably ask whether a group consisting only of physicians, bioethicists,
and economists has given adequate consideration to all relevant, reason—
able views on questions of foregoing medical treatment. Were, for ex-
ample, the possibly differing, reasonable viewpoints of patient-citizens,
nurses, and allied health professionals given the same weight as those of
the committee members? Were the committee members aware of, and
capable of adequately representing, these other viewpoints? Consensus
among members of a bioethics committee or commission has normative
signiﬁcance only if the group is broadly constituted. The group forming
the Appleton Consensus, though it may in fact have identiﬁed and consid-
ered all reasonable positions, appears to fall short on this ground.

Yet it is one thing to urge that such groups be broadly constituted——
having access to all relevant aspects of biomedical, social scientiﬁc, cul—
tural/religious, legal, and bioethical expertise as well as knowledge of all
reasonable ethical positions on matters that come before it—and quite
another to actually constitute such a committee while retaining workable
size. There is no mechanism or formula for putting together an effective,
broadly constituted bioethics committee or commission. If, however, we
are to attribute normative signiﬁcance to any consensus it may reach, we
must pay careful attention to the breadth ofits membership (Fleetwood et
al., 1989; Lo, 1987).

Deliberations

The deliberations of well-informed, broadly constituted committees or
commissions may go wrong in a number ofways. First, such groups may be
co-opted to serve the partisan interests of those who appoint them
(Callahan, 1992). Second, the View of powerful or charismatic chairper-
sons, individual members, or subgroups may be given more weight than
they deserve. Third, pressure to reach agreement may lead to avoiding
controversial issues, underestimating risks and objections, ignoring un-
popular or powerless viewpoints, failing to consider alternatives, failing to
seek additional information, uncritically accepting secondhand informa—
tion, or failing to exercise sufﬁcient imagination or ingenuity in building
consensus or devising compromise (Lo, 1987, p. 48). A problem endemic
to committee deliberations is “groupthink,” deﬁned by Irving Ljanis as “a
mode of thinking that people engage in when they are deeply involved in a
cohesive in-group, when the members' strivings for unanimity override
their motivation to realistically appraise alternative courses of action” (Ianis,
1972, p. 9).

VALUE OF CONSENSUS 25 7

To be forewarned of these and other pitfalls of group dynamics is,
however, to be forearmed. “Ethics committees that recognize the dangers
of groupthink can,” as Lo points out, “take steps to avoid them”:

First, committees can guard against premature agreement. The chairper-
son may explicitly ask that doubts and objections be expressed or may
appoint members to make the case against the majority. Second, com-
mittees can scrutinize any secondhand information they receive. . .
Third, the committee can look for innovative ways to settle disputes [L0,
1987, p. 48].

Recommendations

That a broadly constituted, well-informed ethics committee or commis-
sion has reached consensus on a particular recommendation is reason for
giving serious, but not uncritical, attention to it. The presumption is that
such multidisciplinary groups have examined all aspects of a bioethical
question characterized by genuine uncertainty or reasonable disagreement
and, after considering all reasonable alternatives, conscientiously come to
informed, unforced agreement on the best position for institutional or
social purposes. This is, however, only a presumption. Given the many
ways in which a group’s deliberations can go wrong, a morally autonomous
individual must critically examine the group’s reasoning before endorsing
its conclusions.

CONCLUSION

Advances in medical knowledge and technology together with moral
pluralism create a variety of bioethical questions about which we are genu-
inely uncertain or deeply divided. The problem is aggravated by the fact
that the complexity of modern medicine requires close cooperation among
members ofa health care team, patients, and patients’ families who may, as
individuals, have differing, but not unreasonable, positions on bioethical
issues. The question, then, is whether it is possible to obtain unforced,
informed agreement on ethical issues requiringjoint conduct among indi-
viduals who are either genuinely uncertain or committed to conﬂicting
positions. The same is true, at the policy level, for hospitals and other
health care institutions and for society as a whole.

In response, governments and health care institutions have turned for
guidance to various more or less broadly constituted, multidisciplinary com-
mittees or commissions. At their best, such groups represent or have access
to all relevant expert knowledge and moral perspectives. They strive to
identify all reasonable moral positions and give them fair consideration.
Avoiding “groupthink” and related pitfalls, the committee or commission

25 8 SOCIETY ’S CHOICES

may then come to informed, uncoerced agreement on what, for institu-
tional or social purposes, is regarded by each member as the best (or most
reasonable) answer to a certain question. Agreement may take the form of
complete consensus, overlapping consensus, compromise, or endorsing
the results of a vote.

The ultimate test of such a recommendation is whether it is speciﬁc
enough to be of practical value and, at the same time, unable to be reason-
ably rejected by the larger population as the basis for informed, uncoerced
agreement (Benjamin, 1989, Scanlon, 1982). These conditions, as indi-
cated above, cannot always be satisﬁed. In such cases committees or com-
missions do better to identify difﬁculties and problems than to paper them
over (Brody, 1989; Fleetwood et al., 1989; Macklin, 1988). In other cases,
however, the deliberations and recommendations of a well-constituted
ethics committee or commission may be able to meet these conditions.
Both the Warnock Committee's recommendation on embryo research
(Warnock, 1985b) and the UNOS Ethics Committee’s recommendation on
principles for organ allocation (Ethics Committee, 1992) seem to me to be
sufﬁciently speciﬁc and, given the need for broad societal agreement, difﬁ—
cult for anyone to reasonably reject. These groups succeed, in part, because
they explicitly acknowledge various conﬂicting positions, together with the
need for reasonable agreement (Warnock, 1985a; Ethics Committee, 1992).
More important than a committee’s achieving consensus among its mem-
bers is its ability to stimulate and guide the development of an informed,
uncoerced agreement in the larger society. Broadly constituted groups
that aim at this end may not always reach consensus. But when they do, it
is more likely to be of genuine value.

NOTES

1. This should not be unfamiliar to bioethicists who can often construct both utilitarian
and Kantian argumean for the same conclusion.

2. Toulmin himself might be reluctant to characterize such situations in terms of “over-
lapping consensus" or different principles leading to the same conclusion. He is prompted
to question the value of principles in ethical reasoning: “So. by the end of my tenure with the
Commission I had begun to suspect that the point of ‘appealing to principles’ was something
quite else: not to give particular ethicaljudgments a more solid foundation, but rather to
square the collective ethical conclusions of the Commission as a whole with each individual
commissioner's other "unethical commitments."

3. There were, however, dissenters and a minority report on this issue in the case of the
Warnock Committee.

4. The discrepancy between an individual’s personal moral position and the compro—
mise position he or she endorses as a member of the committee raises questions of personal
integrity. I cannot pursue these questions here. Elsewhere I have argued that compromise
may, in such circumstances, be integrity-preserving (Benjamin, 1990a, l990b).

5. One must distinguish between the principle of utility and the Categorical Imperative,
on the one hand, and utilimrianism and Kantianism, on the other. The principle of utility

VALUE OF CONSENSUS 25 9

and some form of the Categorical Imperative are likely to be part of any reasonable, compre-
hensive moral outlook. Utilitarianism and Kantianism, however, are particular comprehen-
sive outlooks that derive or subordinate all other ethical considerations to the principle of
utility and the Categorical Imperative, respectively.

6. “Members of the committee were purposely selected to represent diverse fields of
expertise and varying perspectives. Physicians, ethicisrs, clergy, lawyers, transplant coordina-
tors, nurses, patients, and individuals from other ﬁelds are included on the committee”
(1991 Ethics Committee, 1992, p. 2226). I was a member of this committee.

7. This formulation draws on the contractualist criterion of moraljustiﬁcation developed
by T. M. Scanlon (Scanlon, 1982).

REFERENCES

Abram, M. B., and Wolf, S. M.: 1984, “Public Involvement in Medical Ethics," New England
journal ofMedicine 310, 627—32.

Arras,]. D.: 1984, “Retreat from the Right to Health Care: The President’s Commission and
Access to Health Care," Cardozo Law Review 6, 321—45.

Bayer, R.: 1984, “Ethics, Politics, and Access to Health Care," Cardozo Law Review 6, 303—20.

Benjamin, M.: 1989, “Value Conﬂicts in Organ Allocation,” Transplantation Proceedings, 21,
3378—79.

Benjamin, M.: 1990a, Splitting the Difference: Compromise and Integrity in Ethics and Politics, Uni—
versity Press of Kansas, Lawrence, Kansas.

Benjamin, M.: 1990b, “Philosophical Integrity and Policy Development in Bioethics,"journal
of Medicine and Philosophy 15: 375—89.

Brody, B. A.: 1989, “The President‘s Commission: The Need to be More Philosophical,”
journal of Medicine and Philosophy 14: 369—83.

Callahan, D.: 1992, “Ethics Committees and Social Issues: Potentials and Pitfalls,” Cambridge
Quarterly of Health Care Ethics 1, 5—10.
Ethics Committee of the United Network on Organ Sharing: 1992, “General Principles for
Allocating Human Organs and Tissues,” Transplantation Proceedings 24: 2226—2235.
Fleetwood,j.E., Arnold, R.M., Baron, R]; 1989, “Giving Answers or Raising Questions? The
Problematic Role of Institutional Ethics Committees,” journal of Medical Ethics 15:
137—42.

Hampshire, 8.: 1983, Morality and Conﬂict, Harvard University Press, Cambridge, MA.

janis, Irving L.: 1972, Victims ofGroupthink, Houghton Mimin, Boston.

Lo, B.: 1987, “Behind Closed Doors: Promises and Pitfalls of Ethics Committees," New En-
gland journal of Medicine 317: 46—50.

Luker, K: 1984, Abortion and the Politics ofMotherhood, University of California Press, Berkeley
and Los Angeles.

Macklin, R.: 1988, “The Inner Workings of an Ethics Committee: Latest Battle overjehovah's
Witnesses," Hastings Center Report 18: 15—20.

Morena]. D.: 1990a, “What Means This Consensus? Ethics Committees and the Philosophic
Tradition," journal of Clinical Ethics 1: 38—43.

Morena]. D.: 1990b, “Getting to ‘Mayhe‘," Bioethics Books 2: 41—43.

Rawls,].: 1993, Political Liberalism, Columbia University Press, New York.

Scanlon, T. M.: 1982, “Contractualism and Utilitarianism," in Sen, A. and Williams, 13.: 1982,
Utilitarianism and Beyond, Cambridge University Press, Cambridge.

Sibley, W. M.: 1953, “The Rational Versus the Reasonable," Philosophical Review 62: 554—60.

Stanley,]. M. and 32 others: 1989, “The Appleton Consensus: Suggested International
Guidelines for Decisions to Forego Medical Treatment," journal ofMedical Ethics 15:
129—36.

260 SOCIETY’S CHOICES

Toulmin, S. E.: 1981, “The Tyranny of Principles," Hastings Center Report 11:31-39.
Wamock, M.: 19853, A Question of Life: The War/Lock Repon on Fertilisation and Embryology, Basil

Blackwell, Oxford.
Warnock, M.: 1985b, “Moral Thinking and Government Policy: The Warnock Committee on

Human Embryology," Milbank Memorial Fund Qumterly 63: 504—22.

Bioethics Commissions: What Can We
Learn from Past Successes and Failures?

BRADFORD H. GRAY, Ph.D.
Professor, Institution for Social and Policy Studies, Yale University

Who will live and who will die? Who decides, and on what grounds? Are
there certain characteristics—when “deﬁning" life or setting the bound-
aries of permissible genetic experimentation—that are essential for “hu-
manness"? In distributing risks and beneﬁts, when should choices be
left to the consciences of individuals and when should they be con-
strained collectively—by expert or lay groups, legislators, administrators,
orjudges? [From Summing Up (1983), the ﬁnal report of the President’s
Commission for the Study of Ethical Problems in Medicine and Biomed-
ical and Behavioral Research]

Developments in biomedical and behavioral research, and changes in
medical practice and the health care system, have raised many challenging
ethical and policy problems in recent decades. Policymakers, the courts,
scientists, medical practitioners, patients and their families, and the public
at large have been presented with new dilemmas (and new versions of old
problems) that involve conﬂicts between deeply held values. When faced
with problems that involve such conﬂicts, factual disputes, or complicated
technical issues, policymakers often create commissions (or turn to com-
mission-like bodies at the Ofﬁce of Technology Assessment and the Insti-
tute of Medicine) for advice.

The question of whether a new bioethics commission is needed is
again on the policy agenda. The Ofﬁce of Technology Assessment is near-
ing completion of a new report to Congress called “Biomedical Ethics in
US. Public Policy." The Institute of Medicine‘s Committee on Social and
Ethical Impacts of Developments in Biomedicine is also considering the
question.

261

262

SOCIETY’S CHOICES

TABLE 1 Reports of the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research and the
President’s Commission for the Study of Ethical Problems in Medicine
and Biomedical and Behavioral Research

 

National Commission Reports

President's Commission Reports

 

Research on the Fetus, 1975
Research Involving Prisoners, 1976

Research Involving Children, 1977

I’sychosurgery, 1977

Disclosure of Research Information
Under the Freedom of Information
Act, 1977

Research Involving Those Institutionalized
as Mentally Infirm, 1978

Institutional Review Boards, 1978

The Belmont Report, 1978

Ethical Guidelines for the Delivery of
Health Services by DHEW, 1978

The Special Study (Implications of
Advances in Biomedical and Behavioral
Research), 1978

Defining Death, 1981
Protecting Human Subjects, 1981

Compensating/or Research Injuries, 1982
Making Health Care Decisions, 1982
Whistleblowing in Biomedical Research, 1982

Deciding to Forego Life-Sustaining Treatment,
1983

Implementing Human Research Regulations,
1983

Screening and Counseling For Genetic
Conditions, 1983

Securing Access to Health Care, 1983

Splicing Life, 1983

Summing Up, 1983

 

This paper is written at the request of the IOM committee, which asked

for an analysis of the lessons to be learned from the experience of two
earlier commissions that are both generally cited as successesl—The Na-
tional Commission for the Protection of Human Subjects of Biomedical
and Behavioral Research (the National Commission) and the President’s
Commission for the Study of Ethical Problems in Medicine and Biomedical
and Behavioral Research (the President’s Commission). The National
Commission issued ten reports between 1975 and 1978; the President’s
Commission also issued ten reports (plus a summary report) between 1981
and 1983. (These reports are listed in Table 1.) This paper will explore
the senses in which these two commissions were successful and the reasons
behind their successes and failures.

WHAT MAKES A COMMISSION SUCCESSFUL?

The question of what makes a commission successful is far from
straightforward.2 A report that helps to break a policy impasse may be
viewed as successful by advocates of one policy option and as a disaster by

BIOETHICS COMMISSIONS 263

their opponents. Contemplating the same report, a philosopher or legal
scholar mightjudge its success largely by the intellectual quality and rigor
of its analysis, a matter that is distinct from its success as a political docu-
ment. (Defining Death by the President’s Commission is a case in point,
having had a widespread impact on state laws while leaving some philoso-
phers unsatisﬁed.) Although it is certainly fair to judge a report by the
quality and weight of the evidence it assembles and logic of its analysis, a
commission’s inﬂuence may depend as much or more on its prestige3 and
the skill with which it attends to political considerations.

Even a report whose conclusions or recommendations are rejected in
the political process might be considered a success if it becomes the start-
ing point for future discussions of the topic. In terms of its legislative
impact, the Commission on the Cost of Medical Care in 1930 failed. Nev-
ertheless, its work is discussed in health policy circles to this day. (Indeed,
its ﬁnal report, Medical Carefor the American People [1932], is still in print.)
This suggests that the evaluation ofa commission’s success may depend not
only on the criteria that one applies, but also upon one‘s time horizon.
One report’s “success" in resolving an issue may prove to be quite tempo-
rary, while another report’s signiﬁcance may grow over time.

None of this should be surprising. After all, commissions are estab—
lished under many auspices for a great diversity of purposes—to marshal
facts to explain an event, to assess the evidence on a controversial topic, to
call attention to (or increase understanding of) a problem, to clarify policy
options and make recommendations for action, or to substitute for action
when politicians need to do something but cannot agree upon what. A
commission may be created either to play up or play down an issue. All of
these considerations create perplexing problems for the evaluator of “suc-
cess.” At the very least they suggest that different criteria might be applied
to different commissions and to different reports.

THE TWO ETHICS COMMISSIONS

Table 2 summarizes the similarities and differences between the Na-
tional Commission (1975-1978) and the President’s Commission (1980-
1983). Both were established legislatively to deal with ethical issues in
research. Both sets of commissioners were selected through a process that
reﬂected both substantive and political considerations. Appointees did not
necessarily have expertise in the matters assigned to the commission, al-
though some certainly did, and many had connections with key politi—
cians.4 Whether or not this is desirable—arguments can be made either
way—it is probably inevitable, since ofﬁcials responsible for appointments
may pick particular individuals either as an expression of appreciation or
respect or because their views on the issues are seen as congenial.

264

SOCIETY ’S CHOICES

TABLE 2 Key differences between the National Commission and the

President’s Commission

 

National Commission

President’s Commission

 

Was the first bioethics commission

Research involving human subjects was
core mandate, but several other topics
were involved

Eleven members appointed by Secretary,
DHEW; law required them to be “to be
distinguished in the ﬁelds of medicine,
law, ethics, theology, the biological,
physical, behavioral and social science,
philosophy, humanities, health
administration, government, and public
affairs," with ﬁve (and no more than five)
engaged in biomedical or behavioral
research involving human subjects

Members served for life of commission;
except for loss of two commissioners
through death, no membership changes
occurred

Located at NIH; achieved independence
by discharging initial Executive Director,
an NIH ofﬁcial

Budget negotiations internal to NIH, but
budget limitations were not problematic
and did notjeopardize commission‘s
independence (though the potential was
present)

Staff director/initial staff selected by NIH
ofﬁcial

Staff director served primarily
management and quality-control
functions

Had National Commission as a model

Research involving human subjects was
one of several major responsibilities;
commission had a more diverse mandate
than the National Commission and had
power to add topics to it

Eleven members appointed by President;
all to be distinguished—three in
biomedical or behavioral research; three
in medicine or provision of health care;
and five in ethics, theology, law, the
natural sciences, the social sciences, the
humanities, health administration,
government, and public affairs

Commissioners appointed to two-, three-,
or four-year terms, resulting in
complications of changing commission
membership; a total of 21 commissioners
served

Independent agency

Had annual budget authorization of

$5 million; was subject to budget
negotiations with OMB and through the
congressional appropriations process;
potential threat to commission‘s
independence did not become a
problem; total expenditures were less
than $4 million

Staff director selected by commission
chair and hired other staff

Staff director was key intellectual leader
of the enterprise and primary author of
several reports

BI 0E THI CS COMMISSIONS

TABLE 2 Continued

265

 

National Commission

President‘s Commission

 

Issued homely self-published reports
available from the commission

Most staff did not begin as specialists in
ethics

Most staff served for the life of the
commission and participated, to a greater
or lesser extent, in the entire mandate
(though most were identiﬁed primarily
with particular topics)

Commission created for 24 months, later
extended by one year

Issued professionally designed, glossy
reports through the U.S. Government
Printing Ofﬁce

Many staff deﬁned bioethics as their
primary professional activity before
working for the commission

Many staff worked only on particular
reports and had little or no involvement
with others

Commission created for four years, later
extended by three months

 

There were other similarities in the two commissions. The profes-
sional mix of commissioners was speciﬁed legislatively and included scien—
tists, ethicists, lawyers, and others. Commissioners maintained their regu-
lar positions outside of government, while attending regular (usually
monthly) commission meetings. Both commissions had full-time staffs,
which prepared background materials and drafted reports, under the guid-
ance of the commissions. Both staffs were headed by lawyers. In both
instances the staff was a combination of full-time employees (some were
long—term federal employees; others were hired from the outside), part-
time employees, and consultants. Some staffers worked on numerous re—
ports; others were specialized. In the aggregate, the commissioners and
staff represented a complex mix of bureaucratic savvy, interest in law and
ethics, concern to reform or defend the status quo, and political and aca-
demic values.

Both commissions held hearings, commissioned many papers, and
sponsored major empirical studies.5 Both were covered regularly by major
newspapers and the trade press, and both issued ten reports, though the
President’s Commission also issued a very useful summary report.

The fact that each commission issued many reports provides an oppor-
tunity to understand better the complicated nature of commission success.
As we will see, neither commission was uniformly successful across all of its
reports.

There were also many differences between the two commissions. These
differences pertained to the crucially important matters of mandate and
the role of commissioners and staff.

266 SOCIETY’S CHOICES

The Commissions’ Mandates

The National Commission’s core focus was clearly on ethical issues in
research involving human subjects. It was directed to issue reports on four
types of subject populations (the fetus, children, the institutionalized men—
tally inﬁrm, and prisoners), on institutional review boards that review the
ethical acceptability of proposed research, and on the basic ethical prin-
ciples that should underlie research involving human subjects. However,
the National Commission was also asked to report on several other topics:
psychosurgery, ethical issues in DHEW—supported health services programs,
and the applicability of the Freedom of Information Act to research pro-
posals submitted to NIH. Finally, the commission’s mandate included
Senator Walter Mondale’s idea for a “Special Study” of the implications of
new developments in biomedical and behavioral research.

The President’s Commission had a more diverse mandate, which even-
tually included almost every burning bioethical issue (except abortion it-
self) on the policy horizon. Certain topics were assigned to the commis-
sion by the legislation that created it: informed consent in research and
medicine, the definition of death (particularly for patients whose brain
function had ceased but whose other major organ systems were still operat—
ing, often with mechanical assistance), genetic testing and counseling, dif-
ferences in access to health services, and issues of privacy in research and
medicine. It was also directed to report biennially on the adequacy of
federal policies (and their implementation) for protection of human sub—
jects. In addition, the authorizing statute gave the commission the man-
date to ”undertake an investigation or study of any other appropriate mat—
ter which relates to medicine or biomedical or behavioral research . . . and
which is consistent with the purposes of [the legislation] .” As a result, the
commission studied and issued reports on genetic engineering in humans
(at the request of the White House), compensation for injuries to research
subjects, and decision making for terminally-ill patients and seriously de-
fective newborns. Signiﬁcantly, as we shall see, this last topic, undertaken
on the commission’s own initiative, became the commission’s most success-
ful report.

The Roles of Commissioners and Staff

The commissions also differed with regard to bureaucratic location,
who appointed the commissioners, and the ways the chairs and staff were
selected. These differences, in turn, help account for some more subtle
differences in the functioning of the two bodies. Both of these commis-
sions issued reports that were innovative, well—documented, carefully ar-
gued, persuasive, and influential. But the relative strengths of the mem—

BIOETHICS COMMISSIONS 26 7

bership and staff of the two commissions were quite different from each
other. The strength of the National Commission lay in its membership and
chair. The President’s Commission’s strength lay in its staff.

The difference between the commissions was not a simple matter of
credentials and intellectual strengths of their members. Like the National
Commission, the President’s Commission had distinguished members, par-
ticularly the original set of appointees. The differences lay in other areas.

The National Commission’s membership strength came from several
factors. The ﬁrst was its commitment and continuity. The commission had
the same membership, except for the death of two members who were not
replaced, throughout its existence. With its first report—on fetal re-
search—due four months after the members were installed, the National
Commission established a pattern of meeting monthly on a Friday and
Saturday. Under time pressure and with considerable attention from na-
tional media and trade publications (meetings were public), the commis-
sioners struggled intensively to ﬁnd ways to reconcile their differences,
particularly their deep moral division over the abortion issue. They held
hearings, commissioned and discussed background papers, and had ex-
tended, passionate deliberations.

The divisiveness of the issues and the differences between the commis-
sioners—not only regarding abortion but also in their professional back—
grounds (ranging from the chairman of obstetrics/ gynecology at Harvard,
Kenneth Ryan, to deeply anti-abortion law professor, David L0uisell)—
could have destroyed the possibility of respectful working relations among
the commissioners. The chemistry worked in another way, however, and
the pattern was established of members taking each other’s views very
seriously and seeking common ground on which to base recommenda-
tions. (Also contributing to the working relationships among commission-
ers and staff was a practice, established at the very beginning, of a social
occasion or dinner on the Friday night of the commission’s two-day meet-
ing. Bonds and a group history developed that would be hard to match.)

One other early development in the National Commission’s life set the
tone for the relative roles of the commission itself and its staff. Under the
legislation that created the commission—the National Research Act of
1974—members were appointed by the Secretary of Health, Education,
and Welfare and the commission was located administratively in the Na-
tional Institutes of Health, even though several of the topics assigned to the
commission fell outside of NIH’s jurisdiction. NIH appointed Charles U.
Lowe, M.D., a career employee, as executive director, and he hired the staff
director and staff, which included two members of his own staff. Lowe took
an active role in managing the work of the staff and the perception grew
that there was a conﬂict between his role as an NIH ofﬁcial and the
commission‘s need to independently examine ethical issues in NIH-spon-

268 SOCIETY’S CHOICES

sored research. The tensions grew quickly in the ﬁrst few months of the
commission‘s life and culminated in the commission’s decision to request
Dr. Lowe’s resignation.

These events dispelled any doubt regarding whether the enterprise
belonged to the commission or the staff, and left the staff in the hands of
staff director Michael Yesley, a career government lawyer who had been
hired from the Department of Commerce. Yesley devoted himself to mak-
ing sure that the staff was doing what the commission wanted. An impor-
tant, regular staff responsibility was to convert the commission’s discus-
sions into draft material—the meeting transcripts that arrived in the staff
ofﬁce a few days after the meeting were reviewed very closely for guid-
ance—that would be mailed ten days before the next monthly meeting.
(The staff also engaged in many other activities, such as commissioning
background papers requested by the commission, organizing hearings and
site visits, and planning and overseeing empirical research in support of
the commission’s deliberations.)

All of this contrasted with the President’s Commission. The President’s
Commission experienced enormous turnover of membership. Two of its
initial 11 members had to be replaced during the ﬁrst year because the
enabling legislation did not allow federal employees to be members, and
another was replaced the next year. Then, in 1992, eight of 11 commis—
sioners were replaced in the last year of the commission’s life as a result of
the law’s provision for a rotating membership and the election of Ronald
Reagan. Thus, while a total of 11 individuals served on the 11-member
National Commission, 21 individuals served on the 11-member President's
Commission. Only three members of the President’s Commission, includ—
ing its chairman, served throughout the commission’s life.

The President’s Commission had no experiences parallel to the
National Commission’s intensive ﬁrst few months on the topic of fetal
research (the President’s Commission’s ﬁrst report, Defining Death, was
issued two years after the commission was appointed) or the National Com-
mission’s frequent social occasions. As one staffer noted, there was never a
“family" feeling within the President’s Commission.

There were also leadership contrasts. The National Commission’s
chair, Kenneth Ryan, M.D., was elected chair by the commission itself at its
ﬁrst meeting. He was the commission’s own designated leader. As a physi-
cian and researcher from a prestigious institution (chairman of obstetrics/
gynecology at Harvard Medical School and chief of staff at Boston Hospital
for Women), he was able to speak with authority on the core topics in the
commission’s mandate. Ryan had extensive experience with many of the
issues considered by the commission and was the clear leader of the entire
enterprise through the commission’s life.

By contrast, the chair of the President’s Commission was appointed.

BIOETHICS COMMISSIONS 26 9

Although Morris Abram’s appointment by the President unquestionably
carried enormous prestige, it was understood that the appointment was a
reﬂection of President Carter’s gratitude for Abram’s role in Carter’s elec-
tion. Abram’s most pertinent experiences were as a patient who had re-
ceived experimental treatments for a potentially fatal disease. Although
this was valuable on certain topics (particularly those addressed in the
report Making Health Care Decisions), Abram was essentially an informed
layperson on most of the issues addressed by the commission. Perhaps in
recognition of this, he selected a staff director, Alexander Capron, who was
a nationally recognized expert on legal and ethical issues in medicine and
science and who had published books and articles on many of the topics
that were taken up by the commission. Abram worked closely with Capron
for guidance about how the commission should address the issues on its
agenda and was relatively distant from both the staff and other members of
the commission. Capron, in turn, hired a strong staff made up primarily of
professionals who had made career commitments (in law, philosophy, soci-
ology, and medicine) to the issues on the commission's agenda. Individu-
ally and as a group, the President’s Commission’s staff probably had stron-
ger professional credentials than did the commission itself.

So, the National Commission‘s staff was dominated by career govern-
mental employees for whom the staff role was already familiar. The Pres-
ident’s Commission staff was dominated by people from outside of govern-
ment who identiﬁed primarily with their ﬁelds of professional activity and
disciplinary work. As was evident in my survey in 1993, they continue to
evaluate the President’s Commission’s reports primarily in terms of its
scholarly quality. The National Commission was clearly more interested in
ﬁnding a set of recommendations that they could agree upon than in
laying out a rigorous line of reasoning regarding how they got there.

METHODS OF THIS INQUIRY

What does it mean when the National Commission and the President’s
Commission are said to have been successful? And how and why did this
success vary across their various reports? I approached these questions by
using objective measures ofinﬂuence as well as seeking the views of former
members and staff of the two commissions. For each commission, the
major variable across reports was the topics themselves.6 I sought lessons
about the success of these two commissions by seeking to understand the
differences in impact from report to report.

Two methods were used. The first involved searches of on—line data-
bases (Nexis, Lexis, and Medline) for citations to the reports of each com-
mission. The second involved a survey of former members and staffers of
the two commissions to obtain their assessments of their work and of differ-

 

2 70 SOCIETY 13' CHOICES

ences in the success of the reports issued by their commission. (I should
note that I served on the staff of the National Commission and was a long-
term consultant to the President's Commission. My views about the two
commissions and their reports are not among those reported later in this
paper, but my experiences no doubt inﬂuence my interpretations.)

Citations to Commission Reports

In April and May of 1993, searches were done of pertinent databases
for citations to the two commissions and their reports. Table 3 shows
citations to both commissions in the news media covered in the Nexis on-
line service. Table 3A shows cites to the two commissions in the National
Library of Medicine’s Bioethicsline database. It shows a similar number of
cites for the two commissions. Tables 4, 5, and 6 respectively, show cita-
tions to each National Commission report in court cases and the Federal
Register,7 medical journals (including the ethics journals included in the
National Library of Medicine’s Medline database), and law reviews. Tables
7, 8, and 9 have similar tables for the President‘s Commission’s reports.
Unlike the Nexis and legal databases, the Medline data base does not
contain the full text of articles; the searches reported in Tables 5 and 8
report only mentions of the two commissions in the titles or abstracts of
articles, not in the text or footnotes of the articles. Thus, the data provide

TABLE 3 Number of Citations in News Database (Nexis Omni)
to the Two Commissions, Through 1992

 

National Commission: 57
President’s Commission: 238

 

NOTE: The impact of the National Commission is substantially undercounted here
because this database did not exist until ﬁve years after the National Commission
began. These data are presented for information only.

TABLE 3A Citations to Both Commissions in National Library
of Medicine’s BIOETHICSLINE Database, Through 1992

 

News and Scholarly

 

Articles and Books All Citations*
National Commission 177 235
President’s Commission 171 214

 

*Includes such items as commission reports and publications, meeting transcripts,
and Federal Register notices of proposed and ﬁnal regulations.

BIOETHICS COMMISSIONS 271

TABLE 4 Citations to the National Commission in Court Cases (Lexis—
GenFed Mega search) and in the Federal Register (Lexis—GenFed Allreg
search), 1981—1992

 

(lites in
Cites in I‘ederal Register
Name of Report Court Cases (regulations) Total

 

Research on Fetus 3
Research Involving Prisoners 6
Research Involving Children 1
Psychosurgery 1
Disclosure of Research Information

Under Freedom of Information Art 1 1
Research Involving Institutionalized

Mentally Infirm
Institutional Review Boards 4 4
The Belmont Report 2 2
Ethical Guidelines for Delivery of

Health Services by DHEW
The Special Study on Implications

ofAdvances in Biomedical and

Behavioral Research
Swine Flu Consent Review”‘ 6
Cites to the commission itself 1 1

hit—1mm

Total I 1 14 25

 

NOTE: The Lexis data base does not begin until 1981, three years after the last National
Commission Report was issued.

*Under the legislation that indemniﬁed manufzu‘turers of swine ﬂu vaccine in 1976, the
commission reviewed the consent forms prepared by the Centers for Disease (Iontrol for the
Swine Flu Program. This activity did not result in a published report.

an indication of the relative frequency of articles about reports of the two
commissions, but this approach is far from a full measure of the impact of
these reports on the scholarly and scientific literature.

A further caveat about these tables is needed. Except for the Bioethics
line (Table 3A), these tables should not be interpreted as comparing the
two commissions’ impact. The other databases did not come into existence until
several years after the National Commission '3 reports were issued and so do not
capture the initial responses to the National Commission ’s work. This is important
because commission reports generally receive the most intense attention
while reports are being prepared and immediately after publication. The
value of these tables is in the comparison across each commission’s reports.
The data in the tables are a much more complete indicator of the Pres-
ident’s Commission’s impact than the National Commission‘s. Even so,

2 72 SOCIETY‘S CHOICES

TABLE 5 Citations to Nau'onal Commission in Medical journal
Databases (Lexis—GenMed—and National Library of Medicine’s
Medline)*

 

 

Name of Report 1975—1989 1990—Present Total
Research on Fetus 7 7
Research Involving Prisoners 2 2
Research Involving Children 6 1 7
Psychosurgery 3 3
Disclosure of Research Information

Under Freedom of Information Act
Research Involving Institutionalized

Mentally Infirm 4 4
Institutional Review Boards 6 6
The Belmont Report 11 3 14

Ethical Guidelines for Delivery of
Health Services by DHEW

The Special Study on Implications
of Advances in Biomedical and
Behavioral Research

Cites to the commission itself 12 1 13
Commission cited as identiﬁer

of an individual 2 2
Total 53 5 58

 

*Possible duplicate cites to particular articles have not been eliminated. Federal Register
cites have been removed. These databases include the Hastings Center Report, where many of
the cites appear.

the tables do not convey the full impact of even the President’s Com-
mission’s reports; for example, state legislation is not covered, an omission
that particularly understates the inﬂuence of the President’s Commission’s
report Deﬁning Death, which had a widespread impact on state law.

Cites to National Commission Reports

Table 4 shows cites in the courts and in regulatory activity. Much of the
regulatory activity involving National Commission reports was over by the
time the Lexis service began coverage of the Federal Register. There had
already been considerable activity regarding Research on the Fetus, Research
Involving Children, Research Involving Those Institutionalized as Mentally Inﬁrm
(proposed regulations that were never adopted), and Institutional Review
Boards. Table 4 really shows the end of a substantial period of activity.
Research on the Fetus was cited in a handful of court cases in the 19805, but,

BI 0E THI CS COMMISSIONS 2 73

ironically, the most frequent court reference to the National Commission
was on a topic that it did not do a report on at all—the swine ﬂu program.8

In medical journals (Table 5), the most frequently cited National Com-
mission reports are The Belmont Report (on the ethical principles that should
underlie research involving human subjects), Research on the Fetus, Children,
Institutional Review Boards, Those Institutionalized as Mentally Inﬁrm, Psycho
surgery, and Research Involving Prisoners, in that order. The other three
reports were not cited.

Law review citations (Table 6) were concentrated on Research on the
Fetus and the Belmont Report, with Children, Prisoners, and Psychosurgery each
being cited once or twice. The other ﬁve reports were not cited in the law
review literature.

In sum, the citation data suggest that the most inﬂuential reports of
the National Commission were Research on the Fetus and The Belmont Report,
with Children, Institutional Review Boards, the Mentally Inﬁr'm, Prisoners, and
Psychosurgery following in roughly that order. Three reports appeared to
have been completely ignored—they “sank like a rock,” in the words of a
former staff member. They were Disclosure of Information under the Freedom of
Information Act, Ethical Guidelines for the Delivery of Services by the Department of

TABLE 6 Law Review Citations to National Commission Reports, 1981
to Present (Lexis—Lawrev search)

 

 

Name of Report 1981-1989 1990—Present Total
Research on Fetus 10 4 14
Research Involving Prisoners 2 2
Research Involving Children 1 1 2
Psychosurgery 1 1

Disclosure of Research Information
Under Freedom of Information Act
Research Involving Institutionalized

Mentally Infirm 1
Institutional Review Boards
The Belmont Report 5 4 9

Ethical Guidelines for Delivery of
Health Services by DHEW

The Special Study on Implications
ofAdvances in Biomedical and
Behavioral Research

Cites to the commission itself 2 2
Commission cited as identiﬁer
of an individual 2 2

Total 24 9 33

 

2 74 SOCIETY’S CHOICES

Health, Education and Welfare, and The Special Study: Implications of Advances
in Biomedical and Behavioral Research.

Cites to President’s Commission Reports

The number of citations to President’s Commission reports was much
larger in both the mass media (Table 3) and in the courts and scholarly
literature (in part because of the dates covered by the database, as dis-
cussed above). However, variation across reports appears again, in even
more pronounced fashion. Deciding to Forego Life—Sustaining Treatment was
the most frequently cited report in the courts (Table 7), including three
Supreme Court citations9 and many other prominent cases. Defining Death
and Making Health Care Decisions were also used in several cases. (The main
impact of Defining Death was on state laws.) The other seven President's
Commission reports were cited only once or not at all in a court case.

Cites in the Federal Register (Table 7) were concentrated on one re-
port—Protecting Human Subjects (1981)—and stemmed from a single com-
mission recommendation: that there be uniform regulations for human
subjects’ protection across all federal agencies. (Despite this objective
measure ofimpact, it apparently was not a matter about which the commis-
sion took much satisfaction, as indicated by their responses—presented

TABLE 7 Citations to the President’s Commission in Court Cases
(Lexis—GenF ed Mega search) and in the Federal Register (Lexis—Genfed
Allreg search), 1981—1993

 

 

Cites in
Cites in Federal Register

Name of Report Court Cases (regulations) Total
Deﬁning Death 7 7
Protecting Human Subjects 37 37
Compensating for Research Injuries 1 1
Making Health Care Decisions 7 3 10
Whistleblowing in Biomedical Research
Deciding to Forego Life—Sustaining

Treatment 36 5 41
Implementing Human Research

Regulations
Screening and Counseling for

Genetic Conditions 1 l
Securing Access to Health Care
Splicing Life 1 l l 1

Total 52 56 108

 

BIOETHICS COMMISSIONS 2 75

TABLE 8 Citations to President’s Commission in Medicaljournal
Databases (Lexis—GenMed—and National Library of Medicine’s
MedLine)*

 

 

Name of Report 1980—1989 1990—Present Total
Deﬁning Death 42 8 50
Protecting Human Subjects 2 2
Compensating/or Research Injuries 1 1
Making Health Care Decisions 20 14 34

Whistleblowing in Biomedical Research
Deciding to Forego Life—Sustaining

Treatment 7‘2 30 105
Implementing Human Research

Regulations 2 2
Screening and Counseling for

Genetic Conditions 5
Securing Access to Health Care 10 11 21
Splicing Life
Summing Up 2 2
Cites to commission itself 7 7
Commission cited as identiﬁer

of individual 5 5
Report not identifiable 9 1 10
Total 177 67 247

 

*Possible duplicate cites to particular articles have not been eliminated. Federal Register
cites have been removed. These databases include the Hastings Center Report, where many of
the cites appear.

later—regarding the impact of their work. Protecting Human Subjects was
hardly mentioned, perhaps because the recommendation in question was
reached easily and involved no issues with ethical bite.) Splicing Life also
appeared several times in the Federal Registeras NIH established the Human
Gene Therapy Subcommittee of the Recombinant DNA Advisory Commit-
tee, but most commission reports were in little or no evidence in the fed-
eral government’s outlet for announcing regulatory activity.

The databases on medical journals (Table 8) showed almost 250 refer—
ences t0 President’s Commission reports. More than 40 percent were
accounted for by one report, Deciding to Forego Life-Sustaining Treatment.
There were also numerous cites to Defining Death, Making Health Care Deci-
sions, and Securing Access to Health Care, with other reports cited fewer than
ten times.

Deciding to Forego also accounted for 40 percent of the cites in the law
review literature (Table 9). Citations thereafter were more broadly dis—

2 76 SOCIETY’S CHOICES

TABLE 9 Citations to President’s Commission in Law Reviews, 1983 to
Present (Lexis—Allrev search)

 

 

Name of Report 1983—1989 1990—Present Total
Deﬁning Death 4 9 13
Protecting Human Subjects

Compensating for Research Injuries 1 1
Making Health Care Decisions ‘21 10 31

Whistleblowing in Biomedical Research
Deciding to Forego Life-Sustaining

Treatment 40 31 71
Implementing Human Research

Regulations
Screening and Counseling for

Genetic Conditions 6 6 l2
Securing Access to Health Care 13 9 22
Splicing Life 5 10 15
Summing Up 1 1
Cites to commission itself 2 2
Commission as identiﬁer

to individual 6 l 7
Report not identiﬁed 1 1
Testimony at hearings 1 1
Total 99 78 177

 

persed, with Making Health Care Decisions, Securing Access, Splicing Life, Defin-
ing Death, and Genetic Screening all having at least a dozen cites.

In sum, as with the National Commission’s reports, there is striking
variability in Citations across President's Commission reports. Deciding to
Forego Life-Sustaining Treatment is in a class by itself as an inﬂuential docu-
ment, but there are also frequent citations to several other reports. Making
Health Care Decisions, Deﬁning Death, and Securing Access to Health Care were
in a middle group, with Genetic Screening and Splicing Life also receiving
important attention. The other four reports—Compensating for Research
Injuries, Protecting Human Subjects, Implementing Human Research Regulations,
and Whistleblowing in Biomedical Research—received almost no scholarly at—
tention. Protecting Human Subjects, however, was a “citation classic" in the
Federal Register.

Views of Members and Staff

To explore the reasons behind these differences in the impact of the
reports of the two commissions, let us turn to the views of former members
and staffers of the two bodies. In the Spring of 1993 I sent a questionnaire

BIOETHICS COMMISSIONS 277

to former members of both commissions and to professional staff members
who had played a major role in drafting commission reports. I received
responses from six of nine living members of the National Commission
(another wrote to offer to respond orally) and from six of the seven former
staff members to which questionnaires had been sent. From the President’s
Commission, only ﬁve of 18 former members to whom the questionnaire
was sent returned it, as did nine of 12 former staffers who were surveyed.
The minimal response from former members of the President’s Commis-
sion is consistent with an important difference between the two commis-
sions—the extent to which the commission, rather than the staff, took
primary ownership of the process.

Some questions concerned the respondents’ own involvement with the
various topics addressed by their commission and their assessment of the
impact of their commission’s reports and the process that produced it. In
this regard, they were asked ﬁrst about which reports had a “critical impact
on public policy in the U.S.,” which ones had a “signiﬁcant impact on
thought in the ﬁeld of bioethics,” and which ones had gone “on the shelf
[to] collect dust." Then they were asked two pages of questions about each
report. These questions asked them to evaluate their commission’s delib—
erations (how serious and contentious they were and how difﬁcult the
intellectual challenge); to evaluate their own investment in each report; to
evaluate each report’s success, including the ways and reasons that each
report succeeded and did not succeed. They were also asked a set of ﬁxed-
response questions on factors that affected each report, on different par-
ties’ interest in the topics, and on different types of impact.

In this paper, staff and members’ responses are presented together;
only notable differences will be mentioned. Numbers are small and not all
respondents responded to all questions, so responses should be treated
accordingly. Some staff did not respond to questions about reports on
which they played little or no role; this increased the rate of item non-
responses. Nevertheless a reasonably clear picture emerges of how former
members and staff deﬁned success and failure of reports and their explana-
tions for both.

Responses are shown in Table 10 (National Commission) and 11 (Pres-
ident’s Commission). Broadly speaking, four general types of reports’
success were mentioned:

0 Characteristics of the report itself—its clarity, the quality of the analy—
sis, the information and data it contained, and so forth;

0 Impact on the broader debate and future thinking on the topic,
including in the ﬁeld of bioethics;

0 Impact on the behavior of researchers, physicians, or medical insti-
tutions;

O Impact on law (judicial decisions or statutes) and regulations.

278

SOCIETY’S CHOICES

TABLE 10 Terms in which Respondents Described Various Reports of
the National Commission as Having Been Successful or Unsuccessful.
Open-ended Responses from Survey of Former Members and Staff of the

National Commission, Spring 1993

 

Measures of Success

Measures of Failure

 

Gathered new and sometimes unexpected
data

Exposed facts; provided information;
focused debate

Provided a model of clear and logical
ethical analysis (e.g. (Ihildrm); clear
enunciation of issues

Clariﬁed issues and key matters (e.g.,
“therapeutic research"; differences
between physicians' and researchers‘
roles; differentiated scientific and ethical
issues)

Demythilication of some issues (e.g., the
nature of fetal research)

Provided new concepts/distinclions (e.g.,
consent/assent in Childrm)

Broke new ethical ground
Shaped subsequent thinking

Impact on field of bioethics and teaching
therein

Provided guidance for researchers or
IRBS; inﬂuenced the affected parties

Buttressed or codified an existing system
(e.g., lRBS)

Report was understood and accepted in
the research community

Changed practices that some
commissioners disapproved of
(psychosurgery; research on prisoners;
nontherapeutic research on children
were all cited)

Provided at least partial or temporary
resolution for policy disputes, allowing
research to proceed

Recommendations were implemented in
regulations

Lack of intellectual bite; boring; too
bland

Broke no new ground

A few point left open to multiple
interpretations

Recommendations not supported by
evidence (e.g., Prisoners)

Recommendation may have been to
restrictive

Did not influence professional decisions

“Sank like a rock"
Not implemented in regulations
Did not change public policy

Failed to permanently resolve a disputed
area of policy (e.g., Fetal Research)

 

BI 011‘ TH] CS COMMISSIONS

TABLE 11

279

Terms by which Reports of the President’s Commission

Were Described as a Success and as Having Not Succeeded. Open-ended
Responses from Survey of Members and Staff of President's Commission,

1993

 

Terms Describing Success

Terms Describing Lack of Success

 

Raised awareness of significance of a
problem (examples mentioned ranged
from cites in the literature to
Congressional hearings)

Good data collection and new empirical
information

Important compilation of data on issue
(e.g., Securing Access)

Opened new avenues of discussion;
framed future discussions; clarified
issues; conceptual impact; provided good
overview of problem

Achieved consensus, and helped build
wider consensus on complex ethical issue
and provided basis on which future
debate can take place

Resolved some contentious issues; shaped
public policy
Provided authoritative crystallization of

work in ﬁeld; provided groundwork for
subsequent policymaking

Highly influential on professional
thinking and public discourse;
background effect on medical education

Demonstrated need for and usefulness of
[RB site visits by knowledgeable people

Became standard citation on issue;
frequent and/or continued citation

Became the model (the “Bible“) for
decision making in care of terminally ill
nationally (Deciding to Forego)

Major impact on institutional policy;
influence on consent forms

Impact on ethics committees

Major impact on law; provided rationale
accepted by legislators, courts. and policy
makers; highly influential on court
decisions and statutory law (Deciding to
Forage); accelerated statutory uniformity
(Defining Death); became standard
citation in law and hospital policy

Report lacked guts (Securing Access); was
too timid re medical profession (Decisions
In I‘brega); recommendations had little
“bite" (Genetic Screening)

Recommendations were indecisive
( Compensating Research Injuries)

Report did not deal well with certain
issues

Arguments in support of certain
conclusions were weak or flawed (e.g., in
Defining Death)

Report has been largely ignored and has
had little impact on practice (Making
Health (fare Decisions)

Recon)memlations not implemented

 

280 SOCIETY’S CHOICES

The terms in which failures were described were by-and-large mirror im-
ages of these.

Although the success/ failure categories were similar for the two com-
missions, more examples of characteristics of reports and types of impacts
were mentioned by respondents from the President’s Commission. This
may be due to the President’s Commission’s broader mandate, but it may
also reflect greater diversity within the staff.

The multiple dimensions of success create the possibility, already al-
luded to, that a report could be a success in some terms and a failure in
others. We will return to this point.

WHICH REPORTS SUCCEEDED AND WHICH FAILED?

The National Commission’s Reports

Based on the views of former members and staff of the National Com-
mission, its reports can be divided into three categories—successful ones
(4), partially successful ones (3), and unsuccessful ones (3). Responses to
open-ended questions about which reports had an impact on public policy,
which inﬂuenced the ﬁeld of bioethics, and which had gone on to collect
dust are shown in Table 12. Responses to questions that asked for success
ratings for each individual report are shown in Table 13.

The Successes

Four reports were identiﬁed by most respondents as having had a
critical impact on public policy and/ or a signiﬁcant impact on the ﬁeld of
bioethics: The Belmont Report, which identiﬁed the basic ethical principles
that should underlie the conduct of research involving human subjects;
Research on the Fetus and Research Involving Children, which deﬁned the
boundaries on ethically permissible research involving these two catego-
ries; and Institutional Review Boards, which examined the primary mecha-
nism for protecting the rights and welfare of human subjects. (Although
half of the respondents saw Research Involving Prisoners as having had a
signiﬁcant impact on public policy, they did not all agree that this impact
was beneﬁcial.) These same reports were also evaluated most favorably on
the ﬁxed—response question regarding the success of individual reports.

Interestingly, though these reports all dealt with issues at the core of
the Commission’s congressional mandate, they are of quite different na—
tures. Fetus and Children deﬁned what types of research could be ethically
supported by the federal government; to reach its recommendations, com-
missioners had to ﬁnd their way through some fundamental ethical con-
ﬂicts among themselves. Belmont did not have direct regulatory applicabil—

TABLE 12 National Commission Reports Identiﬁed as: (a) Having Had a Critical Impact on Public Policy,
(b) Having Had a Signiﬁcant Impact on Thought in the Field of Bioethics, and (c) Having Gone on the
Shelf to Collect Dust. Open-ended Responses from Survey of Former Members and Staff of the National

Commission, Spring 1993

 

Number of Respondents Offering each Assessment

 

 

Report Had Critical Report Had Signiﬁcant Reports that Are ‘

Name of Report Impact on Public Policy Impact on Bioethics Collecting Dust
Research on Fetus 11 2 l l
Research Involving Prisoners 6 0 0
Research Involving Children 7 3 O
Psychosurgery 4 l 7
Disclosure of Research Information

under Freedom of Information Act 2 0 6
Research Involving Institutionalized

Mentally Inﬁrm 2 0 4
Institutional Review Boards 10 4 O
The Belmont Report 9 l2 0
Ethical Guidelines for Delivery of

Health Services by DHEW 0 0 10
The Special Study on Implications

ofAdvances in Biomedical and

Behavioral Research 0 0 8

 

I83

Z83

TABLE 13 Respondents‘ Evaluations of Whether Individual Reports of the National Commission
Were (a) Very Successful, (b) Partially or Somewhat Successful, or (c) Largely or Wholly
Unsuccessful. Fixed-response Items from Survey of Former Members and Staff of the National
Commission, 1993

 

Number of Respondents Offering each Assessment

 

 

Partially Largely/Wholly

Name of Report Very Successful Successful Unsuccessful No Response
Research on the Fetus 7 5 0 0
Research Involving Prisoners 5 2 O 0
Research Involving Children 9 2 0 1
Psychosurgery 1 4 4 2
Disclosure of Research Information 1 4 2 5
Research Involving Institutionalized

Mentally Inﬁrm 2 6 3 1
Institutional Review Boards 9 1 0 2
The Belmont Report 10 l 0 1
Ethical Guidelines for Health Services 1 1 4 4
Special Study 1 3 5 3

 

Note: One commissioner found all reports successful; one responded only to the ﬁrst question. Non-responses often meant
no recollection.

BIOETHICS COMMISSIONS 283

ity (as did the reports on subject populations); the identiﬁcation of the
ethical principles that should underlie research was primarily an intellec-
tual challenge that commissioners (and their staff and consultants) grappled
with together. Institutional Review Boards evaluated an existing regulatory
mechanism for protecting human subjects and made recommendations
for improvements; matters of fundamental disagreements over ethics were
not involved.

Descriptions of these reports’ impact reﬂect these differences. Re—
spondents pointed to the impact of Fetus in lifting a congressional ban on
research, on regulations, and on future debate on the topic. On Children,
they pointed to the regulatory impact, acceptance by the research commu-
nity, and the impact on research, as well as the clarity and logic of the
report’s analysis. On IRBs, they cited the regulatory impact and the rein-
forcement of the existing system. On Belmont, they cited the report’s im-
portance in providing principles for use by IRBs and in inﬂuencing the
ﬁeld of bioethics. (The impact of Belmont was so substantial that some
respondents were actually troubled that the three basic principles identi-
ﬁed in the report—beneﬁcence, respect for persons, andjustice—had be—
come an uncritically used “mantra,” in the words of one respondent.)

The Mixed Cases

The reports Research Involving Those Institutionalized as Mentally Inﬁrm,
Research Involving Prisoners, and Psychosurgery were viewed in more compli-
cated terms. Most respondents believed that these reports (with the partial
exception of Prisoners) had been well done—with good evidence and ethi-
cal analyses. In addition, several respondents in each case perceived an
impact on public policy; in the latter two reports, the perceived impact was
primarily negative—the ending of research involving prisoners and a dis-
couraging impact on psychosurgery. (Not all respondents agreed that
these had been good policy impacts.) Several respondents saw Mentally
Inﬁrm and Psychosurgery as only gathering dust. At least half of the respon-
dents saw both Mentally Inﬁrm and Prisoners as at least partially successful,
though only three judged Psychosurgery so favorably.

Why were these reports viewed as failures by some? The Mentally Inﬁrm
report was seen as a failure because the recommendations (which respon-
dents still viewed as sound) were never implemented in regulations. Sim-
ply put, a report that made recommendations for regulatory change could
not be deemed a success if those recommendations had largely been ig-
nored. Some also believed the report had suffered because of the legisla-
tive mandate’s focus on the institutionalized mentally inﬁrm, which gave the
report a peculiar emphasis in an era of deinstitutionalization. Moreover,
the commission’s administrative location in NIH seemed anomalous for

284 SOCIETY’S CHOICES

this topic since most funding for research on this population came from
other federal agencies (particularly the National Institute of Mental
Health).

Criticism of Prisoners focused largely on its lack of impact and the
quality of the report (illogical, excessively paternalistic, unoriginal; a well-
intentioned but unrealistic attempt at prison reform). Moreover, this was
also a topic of little relevance to NIH and the Public Health Service regu-
lations for protection of human subjects, since most research involving
prisoners was being ﬁnanced and performed by pharmaceutical compa-
nies or by other federal agencies and were thus not subject to those regu-
lations.

Psychosurgery was seen as a partial failure because of a lack of impact on
either public policy or professional decisions. Although this topic had
been included in the commission’s mandate, it was nevertheless seen as
having been outside the commission’s primary expertise (as practice rather
than research). Accordingly, some respondents believed that the com-
mission's views were not regarded as authoritative.

The Failures

Former members and staff of the National Commission saw three of its
reports as failures. (Indeed, several respondents had difﬁculty discussing
these reports because they were gone from the memory bank.) Disclosure of
Research Information dealt with whether research proposals submitted to
NIH should be available to the public (including competing researchers)
under the Freedom of Information Act. In Ethical Guidelines for the Delivery
of Health Services by DHEW the commission attempted to apply the prin—
ciples developed in The Belmont Report to health services delivery programs.
In preparing The Special Study of the “Implications of Advances in Biomedical
and Behavioral Research," the commission relied heavily on a Delphi study—
a method viewed skeptically by the staff director and several commission-
ers—by a contractor that had little contact with the commission. Although
a thick volume was published, the commission’s report made up only the
ﬁrst ten pages; the remainder was appendices.

A common characteristic of the failures was their periphery to the
commission’s core concern about the ethics of research involving human
subjects. (In the View of some, this was also true of Psychosurgeiy because
the topic was one of medical practice and therefore a matter for clinical
research and medical consensus rather than for a commission concerned
with research ethics.) Many respondents noted these topics’ lack of cen-
trality to the commission's mandate in explaining why these reports had
not been successes. Responses to my questions about their personal invest-
ment in the various reports showed that these topics did not engage com-

BIOETHICS COMMISSIONS 285

missioners nearly as much as did the subject populations, Belmont, and
IRBS. They observed that these topics were not seen as major agenda
items, that the commission lacked expertise and/ or moral authority re-
garding them, and that these topics had no direct connection with regula-
tions and NIH’s responsibilities, as did the core mandates. Even the loca-
tion of the commission in NIH was seen as inappropriate by some on such
topics.10

The National Commission’s failures point to an important aspect of
commissions. An existing study commission—or a legislative vehicle that is
going to create one—tends to attract topics, much as certain types of legis-
lation become Christmas trees for different legislators’ pet projects. In
some cases, topics added to a commission’s legislative mandate through
such processes have little to do with the rest of the commission’s mandate.
What happens then may depend on whether inﬂuential commissioners or
key staff members take a keen interest. Topics need champions, even if
assigned to a study commission by Congress or the White House.

As we shall see, some topics addressed in partly successful reports of
the President’s CommiSSion were added after it was created; in each case,
the topic was of great interest to the executive director and key staffers.
However, in the case of the National Commission, neither commissioners
nor the staff director had much interest in the topics outside of the com-
mission’s core concerns with research involving human subjects. Even the
appointments to the commission reﬂected its core duties. Those who were
responsible for appointing members of the National Commission seemed
to have in mind only its responsibilities in the areas of fetal research,
research involving children, and research involving the mentally infirm;
none of the appointees had particular expertise or interest in the topics of
the reports that became failures.

For a member-driven (as opposed to a staff-driven) commission, the
lack of commissioner interest in a topic almost guarantees that any report
will be cursory, superficial, and likely to gather dust. Of course, this is not
necessarily incompatible with the intentions of those who assigned the
topic to the commission, since this is a convenient, painless way for a
legislature or agency to deal with a prickly or unwelcome topic.

The President’s Commission’s Reports

Like the National Commission, the President’s Commission issued ten
reports which its members and staff View in retrospect as of variable suc—
cess.11 Based on responses shown in Tables 14 and 15, only one report can
be classiﬁed as a clear success; ﬁve were partial successes; and four were
dust collectors, even if not outright failures.

286 sonar/Y’s CHOICES

The Successes

From the perspective of 1993, the commissioners and staff members
who completed my survey viewed only one report—Decisions to Forego Life—
Sustaining Treatment—as an unambiguous success in terms of having both
“critical impact on public policy" and “signiﬁcant impact on bioethics”
(Table 14), as well as having been “veiy successful" (Table 15). All types of
success were mentioned. Regarding the report's qualities, respondents
pointed to its clarity and depth, its having ﬁlled a “tremendous need” in a
sensible and thoughtful way, and its having “crystallized the most progres-
sive mainstream thinking.” As one respondent put it, “it is still an authori-
tative text to this day." Respondents also noted the impact on public and
professional discussion and on court cases, institutional policies, profes-
sional practices, and public policy. Though several respondents criticized
the report—for not being sufﬁciently critical of medical professionals who
ignore patients” desires, or for not dealing with all issues adequately—this
report seemed to have had the desired impact at all levels.

The Partial Successes

On the basis of the responses of former members and staff, ﬁve Pres-
ident's Commission reports could be classiﬁed as partial successes with
regard to impacts on public policy and bioethics.

Deﬁning Death was unanimously regarded as a success from one stand-
point—its inﬂuence on state laws. The commission's recommended revi-
sion in the deﬁnition of death has been adopted in a majority of states.
Nevertheless, there are mixed feelings about the quality of the analysis in
the report. The criticisms were rooted in a basic disagreement, largely
within the staff, over the analysis of alternative brain death deﬁnitions;
several areas of “incoherence” or “intellectual unsoundness” were per-
ceived. There was a sense that the executive director (and the commis-
sion) had been unwilling to deal with some valid issues and that power
rather than persuasive argument had carried the day; a decade later those
feelings remain strong. One former staff member said: “The executive
director had clear and ﬁxed ideas on the topic, which he sought to imple-
ment with a minimum of dispute or controversy. Staff dissent was largely
suppressed.” Another observed that “the commission was determined to
uphold the emerging consensus, whether or not it had any theoretical
basis." These criticisms of the former staffers are supported by a number of
published critiques over the years.

The commission’s report on informed consent, Making Health Care
Decisions, was viewed by almost all respondents as having had an effect on
public policy and/or on bioethics, but a majority saw it as, at most, partially

TABLE 14 President’s Commission Reports Identiﬁed as: (a) Having Had a Critical Impact on Public Policy,
(b) Having Had a Signiﬁcant Impact on Thought in the Field of Bioethics, and (c) Having Gone on the Shelf
to Collect Dust. Open-ended Responses to Survey of Former Members and Staff of the President’s

Commission, Spring 1993

 

Name of Report

Number of Respondents Offering each Assessment

 

Report Had Critical
Impact on Public Policy

Report had Signiﬁcant
Impact on Bioethics

Reports that Are
Collecting Dust

 

Deﬁning Death

Protecting Human Subjects

Compensating for Research Injuries

Making Health Care Decisions
Whistleblowing in Biomedical Research
Deciding to Forego Life—Sustaining Treatment
Implementing Human Research Regulations
Genetic Screening and Counseling

Securing Access to Health Care

Splicing Life

1

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mmwmmmommw

p—d
mmmowv—oowocn

MrhuhU‘OCV—IQU‘O

 

£83

88E

TABLE 15 Respondents’ Evaluations of Whether Individual President’s Commission Reports Were (a) Very
Successful, (b) Partially or Somewhat Successful, or (c) Largely or Wholly Unsuccessful. F ixed—response Items
from Survey of Former Members and Staff of the President’s Commission, 1993

 

Number of Respondents Offering each Assessment*

 

 

Partially Largely/Wholly
Name of Report Very Successful Successful Unsuccessful No Response
Defining Death 9 2 0 3
Protecting Human Subjects 1 6 1 6
Compensating for Research Injuries 1 4 7 2
Making Health Care Decisions 4 7 2 l
VVhistleblowing in Biomedical Research 1 2 4 7
Deciding to Forego Life—Sustaining Treatment 12 1 0 1
Implementing Human Research Regulations 2 5 1 6
Screening and Counselingfor Genetic Conditions 1 7 1 5
Securing Access to Health Care 1 7 3 3
Splicing Life 2 4 2 6

 

*The number of nonresponses in President’s Commission is due in part to commission member and staff turnover and staff specialization.
Many non-respondent’s had no involvement with some particular reports.

BIOETHICS COMMISSIONS 289

successful. The positive assessments focused on the report’s quality—its
“lucid, constructive analysis” and the survey research results it included—
and its value as an educational document. But the perception of most
respondents was that the report had had little or no impact on professional
practice (“Doctors don’t take informed consent seriously and no amount
of writing, however good, makes any difference”), and no one cited any
speciﬁc public policy impact.

The other three partial successes—Securing Access to Health Care, Splic-
ing Life, and Screening and Counseling for Genetic Disorders—followed a similar
pattern. In each case, several respondents saw the report as having had a
signiﬁcant impact on bioethics and, in the case of SecuringAccess, on public
discourse. But most respondents perceived little or no public policy im-
pact.

Securing Access was praised for the data it brought together on the
uninsured and for articulating what became an inﬂuential ethical argu-
ment about the access issue (stated in terms of societal obligations rather
than individual rights). But some were critical of the report, feeling that it
had been watered down at the insistence of the conservative Reagan-ap-
pointed commissioners, and several noted the report’s lack of impact on
public policy.

Splicing Life was also seen as a clear, careful, and thoughtful report that
had included good material, been the subject of a Senate hearing, inﬂu-
enced public debate, and helped lead to the establishment of the Human
Gene Therapy Subcommittee of the NIH Recombinant DNA Advisory Com-
mittee. But some respondents thought that the overall tone was perhaps
too “soothing” with regard to the implications of the issues that it ad-
dressed. The main impact that most respondents cited was intellectual.

Screening and Counseling was praised for its characterization of the is-
sues, for providing a good overview, for its foresightedness and compre-
hensiveness, and for having avoided the “abortion quagmire." But there
was little sense that the report had had any substantial public policy impact,
though the report has been rediscovered to some extent in recent years
owing to developments in genetic screening for cystic ﬁbrosis.

The Dust Collectors

Four reports of the President’s Commission were seen by most respon—
dents as having had little effect on public policy or on the ﬁeld of bioethics
and as having gone on the shelf to collect dust. These were the three
reports on research with human subjects—the two biennial reports that
were part of the commission‘s mandated oversight function, and the report
on Compensating for Research Injuries—and the report on Whistle-Blowing.

290 SOCIETY‘S CHOICES

The perceived lack of effects of the two biennial reports—Implementing
Human Subjects Regulations and Protecting Human Subjects—may have been
partly due to some respondents’ inability to distinguish between them in
attempting to respond to the questionnaire. Moreover, staffwho had been
close to these reports were aware of regulatory impacts that were largely
invisible to nonspecialists.

These two reports also reveal a further complexity in trying to assess
the impact of a commission, because the mandated task that led to these
reports was distinctive. The National Commission had already made rec-
ommendations for protecting human subjects, and these had been partly
incorporated into DHHS regulations. The President’s Commission was
directed to monitor the situation and to report biennially. The heart of the
ﬁrst report was the recommendation for uniform regulations across all
government agencies. As was noted earlier, this recommendation was in
fact adopted by the federal government over the course of the next decade.
So this report clearly had a regulatory impact, though not of the sort to
excite persons who were intellectually engaged with the dilemmas of bio-
ethics. The heart of the second report, issued with little publicity at the
end of the commission’s existence, was whether (and how) federal agen-
cies could know whether institutions were actually implementing the regu—
lations in ways that would protect human subjects. Whatever impact this
report might have had was not visible to the members and staff who re-
sponded to my questionnaire.

Compensating for Research Injuries was seen as a failure because its only
purpose was a public policy change, and none occurred. The report itself
was praised for the thoroughness and ethical sophistication of the analysis
(although the ﬁnal recommendations were seen as “indecisive” by some).
But the recommendations were not adopted by the Department of Health
and Human Services, in part because the problem was not as serious as had
been thought (i.e., few research injuries were identiﬁed) and in part be-
cause of opposition from the “research establishment.”

The ﬁnal report, Whistleblowing in Biomedical Research, was the summary
ofa conference that wasjointly sponsored by the commission, rather than
a full-ﬂedged commission report. The case could be made that this report
cannot be fairlyjudged on the same scale as the reports on which commis—
sioners argued, and staffers wrote and revised, over the course of several
meetings. The fact that only a few respondents perceived an impact is
probably not surprising, although some noted that the report had opened
a topic that has become more important in subsequent years.

In sum, respondents agreed that only two reports, Deﬁning Death and
Decisions to Forego, had a critical impact on public policy, and several men-
tioned Making Health Care Decisions in this regard. More reports were given
credit for a signiﬁcant impact on the ﬁeld of bioethics. At least ﬁve respon-

BIOETHICS COMMISSIONS 291

dents saw six reports as having had this effect—Deﬁning Death, Deciding to
Forego, Making Health Care Decisions, Securing Access to Health Care, Genetic
Screening and Counseling, and Splicing Life. Most respondents thought the
description of sitting on shelves and collecting dust applied to the other
four reports—Compensating for Research Injuries, Protecting Human Subjects,
Implementing Human Research Regulations, and Whistleblowing in Scientiﬁc Re-
search. (Four respondents also put Genetic Screening and Counseling and
Securing Access into this category.)

Responses to the series of questions asking for evaluations of the suc—
cess of each report were consistent with these results. Only three reports
were classiﬁed as “very successful” by more than two respondents—Deciding
to Forego (12), Deﬁning Death (9), and Making Health Care Decisions (4).
However, in contrast to the National Commission, all of the other reports
were seen by at least two respondents as at least “partially successful.”

So, compared to the members and staff of the National Commission,
respondents from the President’s Commission saw it has having hit fewer
home runs, but also as having struck out less often.

Accounting for Success and Failure

National Commission

National Commission respondents attributed reports’ success to sev-
eral types of factors (Table 16): the quality of the process, the efforts of
members and staff in playing their roles, and the commitment to reason
and to obtaining needed information. Interestingly, no one mentioned
the fact that the law creating the commission required the Secretary of
Health, Education, and Welfare to respond in writing to commission rec-
ommendations, including an explanation for any decisions not to imple-
ment them. (Interestingly, the absence of this factor was mentioned by
President's Commission staff in explaining the lack of impact of its report,
Compensating for Research Injuries. The National Commission staff may have
come to take this important statutory provision for granted.)

Explanations of the National Commission’s failures were more diverse
and interesting: the commission’s lack of expertise or authority on certain
topics; the failure of politicians and bureaucrats to implement good recom-
mendations; ﬂaws in the commission’s mandate and bureaucratic location;
time constraints; conﬂicts between multiple goals; and some commission-
ers’ and staff members” unwillingness to free themselves from their precon-
ceptions. The conﬂict with the original executive director that was re-
solved by his resignation was recalled as a crucial period in establishing the
commission’s independence from NIH.

More information on the factors that positively or negatively inﬂu-

292

SOCIETY’S CHOICES

TABLE 16 Explanations Offered by Respondents to Account for the
Success or Failure of Reports of the National Commission. Open-ended
Responses from Survey of Former Members and Staff of the National

Commission, Spring 1993

 

Explanations of Success

Explanations of Failure

 

An open honest process of debate; depth
of inquiry; extensive analysis by
commissioners

Interest and commitment of
commissioners and staff

Commission’s commitment to getting the
facts and the full range of ethical
opinion on topics

Reports were well-argued, based on facts,
and reasonable

Commission’s operating out of academic
rather than political values

Reports were developed in a public
process with press coverage; the public
nature of the commission’s debates

Leadership by the chairman

Was willing to allow publication of
dissents rather than reach bland
consensus (e.g., Fetus, Children)

Excellent staff work
Assembly or development of pertinent
information through commissioned

papers, new research, and site visits

Public policy and scientiﬁc need; public
interest in the topic

Some topics were outside the
commission's expertise

Impact of some reports on vulnerable
populations was reduced once the
Belmont Report and the principles it
identiﬁed were released

Commission had no authority on some
topics

Subsequent interventions by politicians
(e.g., Fetal research)

Subsequent poor regulation writing by
DHHS (e.g., Institutionalized Mentally
Infirm)

Technology or medical practice changed
and left report largely irrelevant (e.g.,
Psychosurgery)

Commission‘s mandate was faulty (e.g.,
the focus on the institutionalized mentally
inﬁrm)

The commission‘s location within NIH
was seen as inappropriate for certain
topics

Time constraints and the end of the
commission

Multiple goals (encourage research and

protect human subjects)

Commissioners or staff with ax to grind
could derail debate

 

BIOETHICS COMMISSIONS 293

enced the National Commission’s reports is shown in Tables 17 and 18.
Looking across all reports, four inﬂuences stand out as having a positive
impact: the composition of the commission, the role of staff, the framing of
the commission‘s charge, and reports and papers written for the commis—
sion. The main negatives cited were time constraints, external interest (a
complicated factor—there was a lack of interest in certain topics, but the
main problem was the excessive external interest in the topic of psycho-
surgery, in which a group of activists disrupted and ended a public hearing
of the commission), congressional politics, and the commission’s bureau—
cratic location. There were also a scattering of complaints about the com-
position of the commission; these mostly pertained to idiosyncracies of
particular commissioners on particular topics.

President ’3 Commission

President's Commission respondents (Table 19) explained its successes
(or lack of success) in somewhat similar terms to those of respondents from
the National Commission. However, the President’s Commission respon-
dents placed much more emphasis on the subject matter as an explanation
of success—certain topics being of high public interest, the time being ripe
for resolution of the issue, the pressing need for clariﬁcation.12 Character-
istics of topics—their not being terribly important or sexy or their having
already been dealt with by the National Commission—were also cited as an
explanation of the lack of success of some reports.

There were also references to detrimental conﬂicts. Some involved the
Reagan-appointed commissioners who entered the fray as the ﬁnal group
of reports was nearing completion. (The enabling legislation provided for
a rotating membership of the commission. Ronald Reagan’s election oc-
curred during the Commission‘s life, and he appointed members with
stronger political than substantive qualiﬁcations. Moreover, the Reagan
appointees mostly had different ideological views on certain issues than did
the commissioners and staff that had already done substantial work on a
topic, particularly the report on access to health care.) There were also
allusions to conﬂicts between the executive director and staff members
assigned to particular topics, perhaps an inevitability when both roles are
ﬁlled with people with strong credentials and, in some cases, with disciplin-
ary differences.

More information on the factors that positively or negatively inﬂu-
enced the President’s Commission’s reports is shown in Tables 20 and 21.
Looking across all reports, three factors stand out as having a major posi—
tive impact: external interest in the topic, the role of staff, and reports and
papers written for the commission. What is remarkable, particularly in
contrast to the National Commission, is how rarely the commission's mem-

294 SOCIETY‘S CHOICES

TABLE 17 Factors that Respondents Saw as Having a “Major Positive”
Impact on National Commission Reports. Fixed-response Items from
Survey of Members and Staff, 1993

 

Factors Cited as Positively Aﬂeeting each Report by
any Respondent (number citing each factor)

 

 

White
Time Budget External Congress. House

Name of Report Constraint Constraint* Interest Politics Politics
Research on the Fetus 2 1 5 5 1
Researrh Involving Prisoners 1 1
Research Involving Children 3
Psychosurgery 1 1
Disclosure of Research Information
Researeh Involving Institutionalized

Mentally Infirm 1
Institutional Review Boards 1 2 1
The Belmont Report 1 1 1
Ethical Guidelines for Health

Services
Sperial Study
Total Mentions 4 6 12 6 1

 

* Those citing budget constraints were referring to the absence of budget constraints.

bership was mentioned as a positive factor. Looking across all ten reports
it was mentioned only 14 times. (Four respondent commissioners ac—
counted for all of these mentions.)

In terms of the negatives, two factors stand out—time constraints and
the composition of the commission. The latter again reﬂects the political
change that came with the eight Reagan appointees in 1982. (This also
underlies the characterization of White House politics as a problem.) The
other factor that was mentioned more than ten times was the lack of exter-
nal interest in the topic, a particular problem with regard to the reports on
compensating injured research subjects and the implementation of the
human research regulations.

LESSONS AND CONCLUSIONS

The National Commission, because of its mandate and the composi—
tion of its membership and staff, seems to have produced narrower reports
that were tightly focused on regulatory questions. The success or failure of

BIOETHICS COMMISSIONS 295

 

 

 

Papers/
Studies
Composition Role of Framing Bureaucratic Done for Public
of Commission Staff of Charge Location Commission Hearings
6 5 6 l 9 5
l 4 2 4 5
6 7 3 2 7 6
3 3 2 2 5
I l l
4 4 2 1 3 3
4 9 3 4 9 3
7 9 t’) 2 8 3
1 l
2 l 1
31 44 25 13 47 26

 

such reports is closely tied to success of the recommendation in the policy
process. The President’s Commission had a more wide-ranging agenda,
with several important topics having no speciﬁc tie to a particular policy
decision. Thus, while a typical National Commission recommendation
included speciﬁcation of regulatory actions a particular agency should take,
the President’s Commission’s conclusions and recommendations (Deﬁning
Death, Protecting Human Subjects, and Compensating Injured Research Subjects
excepted) were aimed at a broad audience of policymakers, professionals,
and the public at large. Perhaps because so many staff members were
oriented toward the ﬁelds ofbioethics and real—world problems, President’s
Commission reports had a kind of broad orientation that was found prima-
rily only in The Belmont Report of the National Commission.

The performance of the National Commission seems to have been
more uneven than the President’s Commission’s. Four of the National
Commission’s reports were viewed as successes, but three were seen as
failures. None of the President’s Commission reports were complete fail-
ures, but only one was seen as an unqualiﬁed success. It is difﬁcult to know

296 SOCIETY’S CHOICES

TABLE 18 Factors that at Least One Respondent Saw as Having a
Negative Effect on National Commission Reports. Fixed-response Items
from Survey of Members and Staff, 1993

 

Factors Cited as Negatively Affecting each Report by
any Respondent (number citing each factor)

 

 

White
Time Budget External Congress. House

Name of Report Constraint Constraint Interest Politics Politics
Research on the Fetus 5 4
Research Involving Prisoners 4 2 1
Research Involving Children I l
Psychosurgery 3 6 4 1
Disclosure of Research Information 3 1 2 2
Research Involving Institutionalized

Mentally Infirm 3 2 2 2
Institutional Review Boards 1
The Belmont Report
Ethical Guidelines for Health

Services 5 3 3 2 1
Special Study 4 2 2 1 1
Total Mentions 25 6 20 17 6

 

whether these are objective differences, since different evaluators are in-
volved. Critics of the President‘s Commission may be tougher, because the
experience is fresher, because there was more conﬂict and disagreement
between staff members and the executive director and commission, and
because more of the former staff members are academics who may apply
scholarly, rather than policy, criteria to reports.

Even so, the commissioner-driven versus staff-driven character of the
two commissions, described earlier in this paper, may explain the differ—
ence. The National Commission staff tended to take its lead from the
commission itself, so a topic might be handled in a cursory way if no
commissioners cared much about it. By contrast, the executive director of
the President’s Commission made stafﬁng provisions for all topics, and the
staff’s performance reﬂected both on their professional credibility and on
the executive director himself.

The work of a commission is a combination of three broad factors—
topics, commissioners, and staff.13 The experience of these two commis—
sions, each of which issued reports that were of highly variable success,
demonstrates the importance of all three factors.14 Complex relation-

BIOETHICS COMMISSIONS 297

 

 

 

Papers/
Studies
Composition Role of Framing Bureaucratic Done for Public
of Commission Staff of Charge Location Commission Hearings
1 1 1
1 1 3
3 l 1
2 2 3
l l 1 1
2 l
1
1
2 2 1 3 1 1
4 l 3 l
13 6 9 17 3 5

 

ships between these three factors have enormous implications for commis-
sion success. Many of these implications can be summarized into seven
“lessons.“

Lesson One

Ethics commissions can play a useful role in helping policymakers,
practitioners, and the public at large deal with the value conﬂicts and
ethical dilemmas that accompany new developments in biomedical and
behavioral research and technology.

A substantial list can be made of the beneﬁcial consequences of the
work of these two commissions. (It must be acknowledged that the meth-
ods used in this project were not likely to elicit the most critical of views.)
The National Commission made recommendations that enabled impor-
tant research to proceed within a regulatory framework that both policy-
makers and the research community found acceptable. There were times
when that did not seem possible. President’s Commission’s reports had an

298

SOCIETY’S CHOICES

TABLE 19 Explanations Offered to Account for Success or Failure of
Reports of the President’s Commission. Open-ended Responses from
Survey of Former Members and Staff of President’s Commission, 1993

 

Explanations for Successes

Explanations for Lack of Success

 

The characteristic of the topic—with
clear need for clariﬁcation and high
public interest; time ripe for an
authoritative analysis; an eager audience
awaited it; issue susceptible to
philosophical analysis

Existence of substantial scholarly
literature on topic

Good background papers by consultants

Involvement of legal and medical
community (Defining Death); involvement
of agency liaisons (Implementing Human
Research Regulations)

Solid work on law, philosophy, sociology,
and history of topic

Investment of time and effort; depth and
quality of report; scholarly analysis; new
data; strength of underlying
philosophical analysis

Hard and excellent staff work

Critical interaction between commission
and intellectual staff; good staff
diplomacy re the commission

Individual commissioners' contributions
on certain new topics

Report crystallized “progressive
mainstream thinking” and took apart
myths and dogmas

Clarity of the analysis and writing in the
report

The grounding of difficult issues (e.g.,
Deciding to Forego Life— Sustaining
Treatment) not only in philosophical,
theological, sociological, and legal terms
but also in the experiences of health
professionals, families, and patients

The particular problem turned out not to
be serious or extensive; not a burning
issue; little interest in issue

No natural audience for a particular
report

Report difﬁcult to translate into action
(Making Health Care Decisions)

Key aspects of issue had been dealt with
already (ie., by National Commission)

Topic did not hold attention of
commissioners (Compensating Research
Injuries) because of technical difﬁculty
and seeming lack of importance

Topic not sexy (Making Health Care
Decisions)

Some arguments in staff drafts were
watered down by commissioners

Staff views (and intellectual rigor)
suppressed because of commission’s or
staff director’s views and desire for
professional support of report and to
keep report in line with emerging
consensus in ﬁeld (Defining Death)

Commissioners generally less qualiﬁed
and involved than staff

Some topics were not priorities; some
reports less substantial

Strong language in one report (Securing
Access) gutted because of changing
commission membership;
recommendations not speciﬁc enough

Report's reasoning too arcane
(Compensating Research Injuries)

There are limits to what can be
accomplished at once; competing
priorities on reports

Acceptance or implementation was
defeated by vested interests, bureaucratic
resistance, or Reagan era ideology/
political climate

 

BIOETHICS COMMISSIONS 299

enormous effect on very difﬁcult issues regarding the terminally ill and the
deﬁnition of death. While they existed, both commissions played a valu-
able role in providing a focal point for work in the ﬁeld of bioethics, and
reports from both groups both lowered the temperature on some heated
issues (research involving children, genetic screening) and became impor—
tant points of reference for much subsequent scholarly work and policy
debate.

Lesson Two

Design details can make an enormous difference in the performance
of commissions.

Although it is difﬁcult to draw sweeping conclusions based on two case
studies, a number of aspects of the ways these commissions were designed
seemed to have important consequences. These include:

(a) The creation of these bodies as governmental, rather than private
entities. Governmental bodies are required to operate under sunshine
laws. This was still new when the National Commission was in operation;
despite initial concerns, broad agreement eventually developed that the
attendance of the press and interested members of the public had a beneﬁ-
cial effect on the process.

(b) Appointment versus election of the chair. The National Research
Act’s unusual requirement that the chair of the National Commission be
elected from within its membership had important, positive consequences
for the leadership of the commission.

(c) Establishing rotating, overlapping terms for commissioners. These
create difﬁcult problems for a study commission that is striving to reach
agreement on difﬁcult value questions. Time-consuming conﬂicts on re—
ports-in-progress can result from membership changes. The rotation of
membership will also tend to increase the power of staff. It seems wiser to
give a commission a life span and a mandate and to appoint a new commis-
sion (with a new mandate) at the end of that life span.

((1) Administrative location of the commission. Independence has
both perceptual and substantive importance for ethics commissions. The
President’s Commission's existence as an independent agency had signiﬁ-
cant advantages over the National Commission’s NIH location.

(6) Where ideological divisions exist, the appointment process is
fraught with potential problems. This is particularly true when political
control of the appointing authority changes, as with the Reagan election of
1980. That experience proved that legislative language about “distin-
guished" appointees or categories of expertise are subject to widely differ-
ing interpretations.

300 SOCIETY‘S CHOICES

TABLE 20 Factors that Respondents Saw as Having a “Major Positive”
Impact on President’s Commission reports. Fixed-response Items from
Survey of Members and Staff, Spring 1993

 

Factors Cited as Positively Affecting each Report by
any Respondent (number citing each factor)

 

 

White
Time Budget External Congress. House
Name of Report Constraint Constraint Interest Politics Politics
Deﬁning Death 1 l 4
Protecting Human Subjects 1
Compensating for Research Injuries 2
Making Health Care Decisions 3
Whistleblowing in Biomedical
Research 1 1
Deciding to Forego Life—Sustaining
Treatment 1 1 1?
Implementing Human Research
Regulations 1
Screening and Counseling for
Genetic Conditions 1 l 1
Securing Access to Health Care 2 2 3 1 1
Splicing Life 1 1 1
Total Mentions 4 4 29 4 3

 

Lesson Three

The appointment of commissions is a very complicated matter, full of
trade-offs and dangers.

Clearly, trade-offs and competing considerations exist in many aspects
of creating a commission and carrying out its work. Will members be
appointed for their expertise or because membership is a plum to be given
to acknowledge past political favors? How much does the official who is
making the appointments care about the commission and its mandate?
Might the official care too much about one or another possible outcome?
The experience of the President's Commission shows how the process can
be politicized. The combination of a rotating membership and a presiden-
tial election can be volatile. And it was not only the Reagan appointees that
are the issue here; some observers looking at the commission and staif
assembled under the Carter administration found the staff to be better

BIOETHICS COMMISSIONS 301

 

 

 

Papers/
Studies
Composition Role of Framing Bureaucratic Done for Public
of Commission Staff of Charge Location Commission Hearings
6 2 2 4 2
1 3 3 2 l
2 l
4 11 3 l 9 2
3 4 2
3 10 4 2 7 6
1 4 3 2 3 1
3 5 1 1 3 1
1 9 2 2 7 7
1 3 1 2 l
14 56 19 12 41 22

 

 

qualiﬁed than the commission. Such a perception on the part of a staff
makes for complicated dealings vw'th the commission, but no one would
suggest that the answer is to appoint a weaker staff. But how does one
guarantee that a highly qualiﬁed commission will be appointed?

Many other trade-offs could be noted: between commissioners who
bring visibility to the activity (e.g., Magic Johnson on the AIDS Commis-
sion) and those who bring substantive expertise; between recommenda-
tions designed to be adopted by policymakers and recommendations that
are intellectually satisfying to rigorous thinkers; between recommendations
that will solve an immediate problem and recommendations that will not
be accepted but may be admired and even adopted some years later; be-
tween consensus achieved by making language general or fuzzy and a
strong, clear recommendation accompanied by a strong, clear dissent.
There is no one right answer for any of these matters, but the itemization
shows how many balances must be stuck in the course of designing and
executing the work of a commission.

3 02 SOCIETY ’S CHOICES

TABLE 21 Factors that at Least One Respondent Saw as Having a
Negative Effect on President’s Commission Reports. Fixed-response Items
from Survey of Members and Staff, 1993

 

Factors Cited as Negatively Affecting each Report by
any Respondent (number citing each factor)

 

 

White
Time Budget External Congress. House

Name of Report Constraint Constraint Interest Politics Politics
Deﬁning Death 1 1
Protecting Human Subjects 2 l l
Compensatingfor Research Injuries 2 1 5 ‘2 2
Making Health Care Decisions 5
Whistleblowing in Biomedical

Rexearch 1 1
Deciding to Forego Life»Su.ttaining

Treatment 5 1 l 1
Implementing Human Research

Regulations 3 1 3 1 ]
Screening and Counselingfor

Genetic Conditions 4 l l
Securing Access to Health Care 3 2 4 8
Splicing Life 3 1 2 1 1
Total Mentions 27 7 15 10 14

 

Lesson Four

A strong staff can overcome serious shortcomings of a commission
itself. Conversely, a strong commission can overcome serious staff
problems.

Both of these commissions are widely viewed as successful. But, as was
described earlier, the relative strengths of the membership and staff of the
two commissions were quite different. The strength of the National Com-
mission lay in its membership and chair, and to a lesser extent its staff. The
President’s Commission’s strength lay in its staff.

Accordingly, the two commissions were characterized by different staff/
commissioner relations. Members of the National Commission debated
among themselves down to the smallest details of reports, in many cases
going line by line over staff drafts to make sure that the staff had captured
exactly what commission members had agreed to among themselves. By
contrast, staff members of the President’s Commission were much more

 

BIOETHICS COMMISSIONS 303

 

 

 

Papers/
Studies
Composition Role of Framing Bureaucratic Done for Public
of Commission Staff ol‘(1harge Location Commission Hearings
1 l
2
5 ‘5 2 l 95
l
1 l
6
1 I
l
9 l l l
2 2 2 2 2 l
27 5 9 5 3 4

 

engaged in trying to work through their own ideas and solutions to the
problems assigned to the commission, and meetings had more ofa ﬂavor
of commissioners providing oversight over what staff had done and of staff
trying to sell the ideas that had been developed.

Lesson Five

Topics need champions—an inﬂuential member or staffer who cares
about it and insists that the commission care.

Ifa commission is asked to study and make recommendations on sev-
eral topics, a particular topic can become an orphan. If this happens, a
perfunctory report may result (as with the National Commission’s Special
Study or its report on ethical issues in the delivery of services by the Depart-
ment of Health, Education, and Welfare). Or the commission may decide
not to even issue a separate report (as with the President’s Commission’s

304 SOCIE'I‘Y’S CHOICES

statutory mandate regarding privacy and conﬁdentiality issues in research
and medical care).

Because the personal interest of inﬂuential commissioners or staff
members is so important, the experience of the President’s Commission
demonstrates that topics that are self-assigned by the commission itself can
be handled with enormous distinction. The report Deciding to Forego Life-
Sustaining Treatmentwas not part of the commission‘s legislative mandate; it
was a topic that was undertaken in response to issues that came to the fore
during the work that led to the report Deﬁning Death.

Lesson Six

Although several definitions of success can be applied to commissions,
nothing substitutes for having a perceptible impact on either policy or
practice.

Although the success ofa commission is multidimensional and may be
difﬁcult to assess objectively, people who are engaged in the enterprise as
commissioners or staffers clearly believe a report must make a difference if
it is to be considered a success. No matter how well reasoned and carefully
documented a report may be, if it does not change something in the world
it will be viewed as a failure.

Even very high quality reports can fail to have a signiﬁcant impact on
policy or practice. A commission report can contribute to the ripening of
a topic by bringing attention to it, but it is also true that carefully docu-
mented reports with clear recommendations can be ignored. This is par-
ticularly likely under two circumstances.

The ﬁrst is when the policy changes that implementation would re—
quire are tightly controlled by vested interests and there is no signiﬁcant
constituency behind the recommendation. (The President's Commission’s
report Compensating for Research Injuries is a case in point, requiring action
by the Department of Health and Human Services with virtually no outside
prodding, except from the commission; bureaucratic inertia easily killed
the recommended ideas. The same was true of the National Commission’s
report on Those Institutionalized as Mentally Inﬁrm.)

Second, reports can fail to have an impact when there is no particular
target for the recommendations, as was the case with the President's Com-
mission's report Making Health Care Decisions. The most that staffers could
realistically expect of the report’s call for more shared decision making
between doctors and patients was to have an inﬂuence on medical educa-
tion; this is a very diffuse kind ofimpact and no one had much conﬁdence
that the issuance of a commission report—even one that based a satisfying
ethical argument on solid empirical grounds (including survey data on

BIOETHICS COMMISSIONS 305

people’s desire for information and data linking good communication to
positive health outcomes)—was likely to have a substantial impact on en-
trenched patterns.

Lesson Seven

Recommendations are not self-implementing.

Commissions that want to see their recommendations enacted in law
or policy need to keep an eye on how agencies or legislative bodies deal
with their recommendations. Recommendations issued near the time that
a commission disbands and with little publicity and no follow-up are easily
ignored by policymakers who have other agendas. The early reports by
both commissions tended to have the best chance of being adopted in
policy.

Requirements that agencies respond publicly to commission recom-
mendations can play a valuable role in this regard—it was particularly
important for the National Commission’s regulatory recommendations—
but other mechanisms (e.g., congressional hearings) can play a role. The
importance of the public information function and the dissemination of
ﬁndings in forms in addition to formal reports should be recognized.

ACKNOWLEDGMENTS

The author acknowledges with gratitude the assistance of Andrea
Adams, Mary Anastasio,jennifer Morgan, and Annie Elizabeth VanDusen.

NOTES

1. Other bodies have had less success. The congressionally created Biomedical Ethics
Advisory Committee foundered over issues of mandate and appropriations and disbanded
without ever issuing a report. Earlier, the Ethics Advisory Board, which was created by the
Department of Health, Education and Welfare in 1978, demonstrated its ability to respond in
a timely fashion to issues of biomedical ethics, but was eliminated with the stroke of a
bureaucrat’s pen when funds were needed elsewhere.

2. A substantial literature exists on presidential commissions. Examples include David
F lictner, 1986, The Politics of Presidential Commissions: A Public Policy Perspective (Dobbs Ferry, NY:
Transnational); Terrence R. Tuchings, 1979, Rhetoric and Reality: Presidential Commissions and
the Making ofPublir Polity (Boulder: Westview), and Thomas R. Wolanin, 1975, Presidential Advi-
sory Commissions: Truman to Nixon (Madison: University of Wisronsin Press).

3. Prestige is to some extent a function of the prominence of the individual members,
but the designation, “President‘s Commission,” itself carries weight and commands attention
from the press and the public. This is one reason why the politically powerful sometimes like
to create commissions and the politically vulnerable worry about the attention and legitimacy
that may be given to a cause or point of view to which they are opposed. and why people from
many camps will seek to inﬂuence the membership of the commission.

306 SOCIETY’S CHOICES

4. For example, both Senator Kennedy and Senator Buckley, who had reached a key
legislative compromise involving fetal research—creating a moratorium pending recommen-
dations from the Commission—had visible hands in the selection of commission members,
and the chair of the President‘s Commission was owed a large political debt by President
Carter. Political connections undoubtedly had a role in other members' appointments; the
least subtle instances occurred when President Reagan made several appointments to the
President’s Commission after the terms of several Carter-appointed commissioners expired.

5. The major examples were the National Commission's study of the Institutional Review
Board system and the President’s Commission‘s extensive survey research project of the
public and physicians to provide documentation for its report Making Health Care Decisions.

6. This statement requires some qualification, since there was some turnover of commis-
sioners and staff, especially in the instance of the President‘s Commission. Moreover, since
staff members tended to concentrate on certain reports and since the interest and commit—
ment of individual commissioners varied across topics, it could be argued that in a sense the
commission and staff both varied from topic to topic or report to report. Yet, for both
commissions, there was one staff director and one chairman and substantially the same set of
commissioners and staffers throughout the commission’s life.

7. Federal Register citations should be interpreted with caution because the same action
may appear numerous times. Moreover, a report may be cited more than once without ﬁnal
regulatory action ever taking place.

8. In legislation to indemnify vaccine manufacturers so that they would produce the
swine flu vaccine, Congress required the Centers for Disease Control to consult with the
National Commission regarding the issue of informed consent; the commission met with
CDC officials and sent them a letter with recommendations. The consultation (though not
the commission’s letter) was cited in several lawsuits alleging injuries from the swine flu
vaccine.

9. Rust v. Sullivan; Cruzan 1). Missouri Department of Health; Bowen v. American Hospital
Association.

10. In the view of some, this was also a problem with the report on the institutionalized
mentally infirm.

11. A methodological point arose with regard to responses of staffch of the President’s
Commission, many of whom devoted much or all of their effort to particular topics and who
had little or no involvement with other topics. Unlike staffers of the National Commission,
who generally attended all parts of all meetings, many President's Commission staffers went
to commission meetings (or parts of meetings) only when their particular topic was on the
agenda. As a result, President's Commission staffers had more difficulty assessing the process
and outcome of the whole group of reports than did National Commission staffers.

12. Perhaps the best example of timing was the coincidental release of the report on
Definition of Death on the same day that an anti-abortion Constitutional amendment that
would deﬁne the beginning of human life was introduced on Capitol Hill. Thejuxtaposition
was too delicious to be ignored by the media and led to a Nightline appearance that night by
the executive director and a member of the Commission, as well as other news coverage.

13. I ﬁrst heard a similar formulation from David Goslin regarding projects at the Na—
tional Research Council.

14. Adequate resources are also a requisite, but this was not an issue in either of these
cases.

Limiting Life-Prolonging Medical
Treatment: A Comparative Analysis of
the President’s Commission and the
New York State Task Force

BARUCH A. BRODY, Ph.D.
Professor of Medicine, Baylor College of Medicine

In 1983, the President‘s Commission for the study of Ethical Problems
in Medicine and Biomedical and Behavioral Research produced a report
on the topic of limiting life-prolonging therapy entitled Deciding to Farego
Life-Sustaining '1"reatment.l Three years later, in 1986, the New York State
Task Force on Life and the Law produced a report on some aspects of this
topic entitled Do Not Resuscitate Orders. It produced in 1987 a second report
on other aspects entitled Life-Sustaining Treatment: Making Decisions and
Appointing a Health Care Agent. In 1992, it produced still a third report
entitled When Others Must Choose?

The report of the President’s Commission has been widely acclaimed.
It is often felt that its report shaped a social consensus on this difﬁcult
topic. On the other hand, the work of the Task Force has attracted consid-
erable criticism and controversy. It seems to have been much less of a
success.

If one accepts these perceptions, then it seems natural to raise a series
of questions in the hope of learning what makes some commissions work
better than others. Was it a function of the membership? Did the
President’s Commission beneﬁt, for example, from not attempting to in-
clude representatives of many diverse religious groups, all of whose con-
cerns needed to be addressed? Was it a function of how the work was
done? Did the President’s Commission beneﬁt from holding many public
hearings before it began shaping its report? Was it a function of the
duration of the commission? Did the President’s Commission beneﬁt from
knowing that it was working under a strict time limit and that it would have

307

308 SOCIETY’S CHOICES

to accomplish its goals in that conﬁned period? Such procedural questions
are inevitable if the above-mentioned perceptions are accepted.

The main thesis of this paper, to which the bulk ofit is devoted, is that
these perceptions are incorrect, both about the President’s Commission
and about the New York State Task Force. The report of the President’s
Commission was a success in summarizing a consensus that had emerged,
and in beginning the process of moving beyond it, not in shaping that
consensus. The reports of the New York State Task Force were a success in
producing legislation that incorporated this consensus, and the contro-
versy was nothing more than the expected accompaniment of any impor-
tant legislative initiative. The nature of their successes differed because
they were operating in different contexts and had different roles. A second
thesis, to which we shall return brieﬂy in the conclusion, is that the struc-
tural and procedural differences mentioned above are reﬂections of these
different contexts and roles, and that the proper conclusion to be drawn is
that structure and process should be a function of context and roles.

The strategy for my analysis is as follows: In the rest of this introduc-
tion, I will present a statement of the current consensus about limiting life-
prolonging treatment. For the sake of this analysis, I will take its validity for
granted. In the next two sections, I will discuss the relation of the work of
the two groups to the current consensus, to the context in which they
operated, and to their roles. It is in those two sections that I will defend my
claims about the nature of their successes. Finally, in the conclusion, I will
briefly return to some of the structural and procedural issues.

I offer the following, which is a modiﬁcation of an analysis recently
presented by Meisel,3 as my statement of the current consensus:

(a) The mere fact that some treatment exists that would prolong the
life of some patient does not by itself sufﬁce to justify providing that therapy
to that patient, because extending life by providing the treatment in ques-
tion may not be beneﬁcial to the patient in light of the patient’s values and
patients have a right to refuse therapy whose provision they judge to be
against their interests.

(b) Both competent and incompetent patients have that right to refuse
life-prolonging therapy; of necessity, the way in which that right is exer-
cised is different in the two cases.

(c) Despite the differences, decision making for both types of patients
should usually occur in the clinical setting without recourse to the courts.

((1) The main role of legislatures is to see that these rights are ad-
equately recognized in law, and the main role of health care institutions is
to insure that there are proper policies and mechanisms in their institu—
tions for facilitating proper processes for such decision making and for
insuring that they are appropriately documented.

LIMITING HIE—PROLONGING MEDICAL TREA ’I‘MENI‘ 309

(e) These refusals may be of all forms of therapy, including artiﬁcial
nutrition and hydration, and they may involve both the withholding of life—
preserving therapy and the withdrawing of such therapy.

(1) Such refusals oflife-prolonging therapy must be distinguished both
from active euthanasia and from assisted suicide.

(g) When the patient is not competent, the attending physician, who
normally makes that decision of incompetency, may rely upon a patient’s
advance directive to refuse treatment incorporated in such documents as
living wills.

(h) If there is no living will or its equivalent, the patient’s right to
refuse treatment may be exercised on behalf of the patient by a surrogate
decision maker appointed by the patient in advance (by use of such mecha-
nisms as the durable power of attorney) or speciﬁed by some statutory
scheme (usually, family members in some ordering of priority). The surro-
gates should apply a substituted judgment standard, or, if they cannot, a
best interests standard.

(i) The same principles should apply to parental decision making
about life-prolonging therapy for their children, especially severely ill new—
borns, but the emphasis must be on the child’s best interests since the
substituted judgment standard cannot apply.

With this statement of the current consensus in mind, I turn to an
analysis of the work of the President's Commission and of the New York
State Task Force on limiting life-prolonging treatment.

ACCOMPLISHMENTS OF THE PRESIDENT’S COMMISSION

As indicated above, the received view is that the report of the
President’s Commission, Deciding to Forego Life-Sustaining Treatment, was very
successful in shaping the current consensus about decisions to limit life-
prolonging treatment. My argument will be that this claim is much too
simplistic, and that once the factors of context and role are taken into
account, a much more complex picture emerges. In particular, we shall
see (a) that most of the elements of the consensus were prominently
present in the public debate before the appearance of that report; (b) that
the report organized and added one crucial element to, offered a sound
foundation for, and placed an ofﬁcial imprimatur on, a very new consensus
that had just emerged; (c) that the report raised many crucial issues that
were to become central to the later debate, and adopted positions, often
quite ambiguous, on these issues. This ambiguity was possible because the
report was not designed to lead to any speciﬁc legislation or hospital policy.
None of this is to say that the report was unsuccessful. It is rather to say that
its success needs to be understood in terms of its context and its role.

31 0 SOCIE'I‘Y’S CHOICES

The report contains a detailed account (pp. 9—11 and pp. 259—74) of
its own genesis and it is worthwhile noting a number ofmajor points made
by the Commission to which we shall return. The ﬁrst is that the whole
topic of limiting life-prolonging treatment was not part of the statutory
mandate for the President's Commission. The deﬁnition of death was
however part of that mandate and the Commission began work on that
topic inJanuary of 1980. But, in the course of hearings on that topic, it was
led to realize that a report was also needed on limiting care to certain
patients, especially vegetative patients. Secondly, the report was seen by
the Commission as an outgrowth of what it had to say in two other reports
which dealt with mandated topics, its report on decision making, Making
Health Care Decisions,“ and its report on the allocation of health care re-
sources, Secming Access to Health (Jamil Finally, as in the case of all of its
other activities, the Commission began with public hearings on the topic
and then moved on to extensive internal deliberations aided by external
reports and additional public comments. Throughout the work on its
report, the Commission’s process was a very open process.

With this understanding of the Commission’s process, let us turn to the
substance of its report. A comparison of the principles of the current
consensus with the summary of the 24 conclusions contained in the intro-
duction to Deciding to I'bi'ega Life—Suslaining Treatment reveals both consider—
able overlap and some differences. We will first examine the extent to
which our consensus principles are incorporated in its summary conclu-
sions and we will then examine those of its summary conclusions which are
not included in our consensus principles.

Our principle (a) is incorporated in its summary conclusions (1), (2),
and (21b). Our principle (b) is incorporated in its summary conclusions
(9), (11), (17c), and (20), although the reference to limitations on surro-
gate authority in (9a) and (21c) is not fully in accord with principle (b),
and will be analyzed below when we discuss ambiguities in the report. Our
principle (c) is incorporated in its summary conclusions (6), (9e), and
(18), with some useful comments about when recourse to the courts would
be appropriate. ()ur principle (d) is incorporated in its summary conclu-
sions (7), (9b), (9d), (17a), (22), and (23). Our principle (e) is incorpo-
rated in its summary conclusions (5) and (11). Our principle (g) is in-
corporated in its summary conclusion (8) about the assessment of
incompetency and (9c) about living wills, although (9c) offers only luke-
warm support for living wills, preferring the use olidurable powers of attor-
ney. Our principle (h) is incorporated in its summary conclusions (9a)
and (9c). Finally, our principle (i) is incorporated in its summary conclu-
sions (13), (15), and (17). There is no doubt then that the President’s
Commission advocated nearly all of the elements of the current consensus.
The only exception is principle (I), which is not clearly articulated in the

LIMITING LIFE-PROLONCING MED/(1A1. TIUiA'I'M/CN'I‘ 31 I

summary of the conclusions but is discussed in the text of the report. We
shall return to it below when we discuss ambiguities in the report.

What other conclusions are presented in the report which are not part
of our list of consensus principles? A few are unproblematic. These in—
clude summary conclusion (4) calling for better options for those who
refuse life-prolonging therapy, summary conclusion (16) calling for deci-
sion makers to have access to the best up—to-date information, and sum-
mary conclusion (24) calling for better education of health care profes—
sionals about these issues. Much more important are summary conclusions
(3b), (3c), and (12) on the impact of resource allocation on this type of
decision making, summary conclusion (10) on the special status of PVS
patients, and summary conclusion (14) on the lack of any need to provide
futile care to severely ill newborns. We shall return to these issues below
when we discuss ambiguities in the report.

Although there are differences then between the principles of the
current consensus and the summary conclusions of the President's Com-
mission, differences which we shall discuss below, they should not blind us
to the obvious tremendous overlap between the current consensus and the
views of the President’s Commission. All of this leads us to ask about the
role of the Commission in forging that consensus. To what extent was the
consensus present before the appearance of Deciding to Forego Life-Sustain-
ing Treatment? What were its contributions to the emergence of that con—
sensus? In order to answer these questions, we need to examine the report
in the context of the discussions about limiting life-prolonging therapy in
the period 1975—1983. Our goal will not be to identify who said what ﬁrst;
it will be, instead, to identify major trends in prominent discussions during
that crucial period.

I want to begin with several prominent discussions in the professional
literature. The ﬁrst is a welLkuown and very influential article in the New
Englandjoumal ofMedirine in 1976 authored by the Clinical Care Commit-
tee of the Massachusetm General Hospital.6 The article describes a newly
introduced system for classifying patients according to the level of thera-
peutic effort they would receive. Patiean in Class C had selective limita-
tions placed on the therapeutic measures provided while patients in Class
D had all therapeutic measures, excepl those indicated for comfort, dis-
continued. Many of the elements of the current consensus are clearly
present in that policy. It is recognized that life-prolonging treatments may
be inappropriate in some cases. That decision is to be made in the hospital
without recourse to the courts. The role of the institution is to insure that
there are policies and procedures in place (including a consultation com-
mittee) to facilitate such decision making and its documentation. All forms
of therapy may be withheld or withdrawn. Other elements of the current
consensus are missing from that document. It places the locus of decision

312 SOCIETY’S CHOICES

making in the attending physician rather than in the patient or those who
speak for the patient. The only exception is for Class D patients, where
consultation with, and concurrence of, the family is required. As a result of
this emphasis on physician decision making, there is no mention of certain
crucial patient-centered elements of the consensus such as the rights of
patients to refuse treatment, the use of advance directives, and the family as
surrogate decision makers attempting to apply the substitutedjudgment rule.

Another important discussion was published in Critical Care Medicine in
1978 by members of the Critical Care faculty at Presbyterian University
Hospital in Pittsburgh.7 It also described a system introduced in 1975 for
classifying patients according to the level of therapeutic effort they would
receive. This system is closer to the system currently used in many institu-
tions, as it divides patients into four categories: total support, all but CPR,
no extraordinary measures (ranging all the way from ICU admission to
parenteral nutrition), and dead. The system described contains all of the
elements of the current consensus contained in the Massachusetts General
Hospital system. Most crucially for our purposes, the policy required that
orders about the level of care to be provided be accompanied by a progress
note indicating that a discussion had taken place with the patient or the
family and that they agreed with the order. As a result of that change from
physician-centered decision making, the document also referred in its dis-
cussion of the policy to the patient’s right to refuse treatment and to
advance directives such as living wills. So the Pittsburgh publication con-
tains many of the patient-centered elements of the current consensus. The
only ones to which I see no allusion are the emphasis on substitutedjudg—
ment by surrogate decision makers and the question of parental decision
making for newborns. I am not Claiming that the Pittsburgh policy is a fully
articulated statement of nearly all of the elements of the current consen—
sus; the patient—centered elements are not given the emphasis they are
given either in the report of the President’s Commission or in the current
consensus. What I am saying is that the Pittsburgh policy moves us much
closer to most of the elements of that consensus.

Many elements of that consensus were also present in two statements
by the judicial Council of the American Medical Association, published in
1982.8 One discussed issues related to quality oflife in both newborns and
adult patients and the other discussed issues related to terminal illness.
Both statements afﬁrmed that life-prolonging therapy can sometimes be
withheld or withdrawn. Both statements assigned a signiﬁcant role to those
who speak for the patient, although parents of newborns are identiﬁed as
the decision makers for them while the wishes of the family speaking on
behalf of the adult patient are only factors to be considered by the physi-
cian who makes the decision. Both statements dealt with all forms of life-
prolonging therapy.

LIMITING [JI'E—PROLONGING MEDICAL TREA TMENT 313

There are many more statements in the professional medical literature
in the period 1975—1982 related to limiting life—prolonging medical treat—
ment; we have only presented a small selection from that much more
extensive literature, a literature whose history deserves a much fuller analy-
sis. But we have seen that Deciding to Forego Life-Sustaining Treatment goes
beyond what was already in the professional literature primarily by empha-
sizing the point that the organizing theme for all policies and decisions to
limit care should be the decisions of the patient or those who speak on
behalf of the patient, because the patient has the right to refuse life-
prolonging therapy. Even that theme was present in some of the profes—
sional literature, but none of that literature made it the organizing theme.
In this way, Deciding to Forego Life—Sustaining Treatment is an application of
the general principles about decision making enunciated in Making Health
Care Decisions.

We turn from the medical literature to legal developments. I want to
emphasize at least two developments, the development of natural death
statutes and the development of right-to-die decisions in the courts. We
shall see in that material ample evidence of the acceptance of most of the
elements of the current consensus.

California passed the ﬁrst natural death statute in 1976. It was followed
in 1977 by Arkansas, Idaho, Nevada, North Carolina, Oregon, and Texas.9
By the time the Commission report came out, 14 states and the District of
Columbia had passed such statutes. This is not the place to offer a full
analysis of all of them. We shall only focus on the extent to which the ﬁrst
seven, which antedated by several years the work of the President’s Com-
mission, incorporated the elements of the current consensus.

The full force of principle (a) of the current consensus, that life-pro-
longing care can be withheld because the patient has a right to refuse it, is
the whole point of all of these natural death statutes. But it is worth noting
that several of them (Arkansas, California, Idaho, and North Carolina)
begin with an explicit statement of that right. I note, parenthetically, that
Arkansas deﬁnes it as both the right to refuse such therapy and the right to
request it and that North Carolina defines it as the right to a peaceful and
natural death. It is also worth noting that while most of them (California,
Idaho, Nevada, Oregon, and Texas) conﬁne their provisions to patient
refusals in certain cases, thereby seeming to limit the recognition of patient
rights, all who do so make it clear that the statute does not limit any more
general right to refuse treatment. Principle (b), that the right extends to
incompetent as well as competent patients, is once more the whole point of
these statutes, but it is worth noting that two of the statutes (Arkansas and
North Carolina) add more provisions which provide for surrogate decision
making on behalf of incompetent patients. As all of the statutes allow
attending physicians to rely upon directives without the authorization ofa

314 SOCIETY’S CHOICES

court, they all incorporate principle (c) of the current consensus. None of
them talk about the role of health care institutions mentioned in principle
(d), but they all exemplify the role for legislatures mentioned in principle
(d), viz., seeing that the right to refuse treatment is recognized in the law.
Five of the seven (California, Idaho, Nevada, Oregon, and Texas) both
offer very broad deﬁnitions of the forms of therapy that are covered and
explicitly cover both withdrawings and withholdings of these therapies; the
other two offer somewhat more limited deﬁnitions of the forms of therapy
covered, but North Carolina does explicitly cover both withdrawings and
withholdings of the covered therapies. So while none explicitly mention
artiﬁcial nutrition and hydration (perhaps because that issue was not very
prominent in 1976—1977), principle (e)’s spirit is found in all seven stat-
utes. Principle (f), the distinction between authorizing the limiting oflife-
prolonging therapy and authorizing suicide or euthanasia, is articulated in
six of the seven statutes (all but the Arkansas statute). Principle (g), the
recognition of living wills, is, of course, the whole point of these statutes.
Elements of principles (h) and (i), about other aspects of surrogate deci-
sion making, are found in several of the statutes, although that is obviously
not their main point. Of particular importance is the fact that Arkansas
addressed the issue of pediatric patients.

The conclusion that emerges from this analysis is that by 1977, seven
states had passed statutes that incorporated most of the elements of the
current consensus. And, of course, eight more jurisdictions passed such
statutes by the time that the report of the Commission came out. Of
particular importance is that these statutes, unlike the professional medical
policies analyzed above, were ﬁrmly grounded in an emphasis on the right
of individuals to refuse therapy. However, some elements of the current
consensus (the role of institutional policies, the standards for surrogate
decision making, and the use of durable powers of attorney) were not
present, usually because they were not relevant to the purposes of the
statutes.

The period in question also saw the appearance of many fundamental
court decisions about limiting life-prolonging therapy. We will focus on
decisions that predated the work of the President’s Commission. The most
important are the New jersey case of In re Quinlan (1976),'0 the Florida
case of Satz v. Perlmutter (1978)”, the New York cases of In re Eichner
(1981),12 and In re Storar (1981),13 and the Massachusetts cases of Superin-
tendent of Belchertown State Hospital '0. Saikewicz (1977),'4 In re Dinnerstein
(1978),15 and In re Spring (1980).'6

Nearly all of the principles of the current consensus that were relevant
were adopted in 1976 by the Supreme Court of Newjersey in the case of
Karen Quinlan, where the father of a PVS (persistent vegetative state)
patient was appointed as her guardian with the authority to authorize the

LIMITING IJI‘E—I’ROLONGINC MEDICAL TREA TMENT 315

discontinuation of all extraordinary life-prolonging therapy. This decision
overruled the opinion of a lower court that thought that the decision
should be left in the hands of the medical profession. Treatment could be
withdrawn because the patient’s right to refuse treatment was to be exer-
cised on her behalf by her father. So the opinion incorporated principles
(a) and (b) of the current consensus as they apply to that case. The
opinion also ruled that recourse to a court would be inappropriate, so it
adopted principle (c) of the current consensus. In calling for hospital
processes including consultation with an ethics committee (not necessarily
what is currently meant by that term), it incorporated much of principle
(d). In authorizing the withdrawal ofa respirator, it incorporated much of
principle (e). It adopted principle (0 by explicitly distinguishing the re-
fusal of life-prolonging therapy from suicide. Finally, since the court au-
thorized a parent to make the decision for his child, it incorporated some
components of principle (i). Moreover, it explicitly indicated that he was
to do so on the basis of his best judgment as to whether she would refuse
the therapy; this emphasis on substitutedjudgment incorporates some of
principle (h). None of the other principles were relevant in that case. So
the opinion in the Quinlan case was a major statement of the current
consensus. Perhaps the one exception was its somewhat confusing discus-
sion of ordinary and extraordinary measures. In fact, when the respirator
was removed from Karen Quinlan, she lived for nine years sustained by
antibiotics and nasogastric feedings. It is hard to be sure, however, whether
this represented the wishes of her father or the court‘s unwillingness to
accept the full force of principle (e).

In 1978, a Florida District Court of Appeal authorized a 73—year-old
competent ALS patient, Abe Perlmutter, to remove his respirator. It based
its decision on a broad appeal to the patient’s rights of self-determination
and privacy, thereby incorporating principle (a). Because the case in-
volved a withdrawal of life-prolonging therapy, the decision incorporated
components of principle (6). It explicitly incorporated principle (f) by
distinguishing the removal of the respirator from suicide. When the
Supreme Court of Florida affirmed the decision in 1980, it called upon
the legislature to legislate in this area, thereby incorporating an element
of (d).

The Saikewicz case, the ﬁrst of our Massachusetts cases, represents the
ﬁrst of our cases that challenged a component of the current consensus,
principle (c). In its decision, the Supreme Judicial Council of Massachu—
setts ruled in 1987 that decisions involving incompetent patients must be
brought to a court. Nevertheless, even that decision incorporated many
components of the current consensus. It incorporated principle (a) by
grounding withholdings of therapy in the right of patients to privacy and
self-determination. It incorporated principle (b) by insisting that incom-

31 6 SOCIE’I‘Y’S CHOICES

petent patients have the same right to refuse treatment as competent pa-
tients, although the process would have to be different. It explicitly adopted
the substitutedjudgment principle, thereby incorporating elements of (h).
This emphasis onjudicial intervention was limited in the subsequent cases
of In re Dinnerstez'n (1978) and In re Spring (1980). So while it is true that
one element of the current consensus was rejected by the Massachusetts
courts in the period before the appearance of the Commission’s report, it
is also true that many more elements of that consensus were afﬁrmed by
those courts and by the subsequent professional literature reﬂecting on its
decisions.

The court that was the furthest from adopting what was to become the
consensus was the New York Court of Appeals in two companion cases, In re
Eichner and In re Storar (1981). In the former case, the New York Court of
Appeals upheld a decision that a respirator could be removed from a PVS
patient who had clearly expressed his wishes that he not receive such life—
prolonging therapy in such a case. In the latter case, the court rejected a
decision authorizing a denial of life-prolonging blood transfusions to a
never competent, retarded patient. Several observations need to be made
here: (1) the elements of the current consensus most clearly rejected were
the insistence in Eiehner on clear and convincing evidence of the patient’s
previously expressed wishes rather than substituted judgments by others
about what the patient would have wished, thereby rejecting a portion of
(h), and the unwillingness in Storar to rely upon any surrogate’s judgment
about the patient’s best interests, thereby rejecting another portion of (h);
(2) nevertheless, the Court of Appeals still accepted limitations on life-
prolonging therapy based upon the right to refuse treatment, thereby ac-
cepting principle (a), and extended that to incompetent patients, thereby
accepting principle (b). As Eichner involved the withdrawing of a respira-
tor, the Court of Appeals accepted an important element of (e). Since
living wills are excellent examples of clear and convincing evidence of the
patient’s previously expressed wishes, the Eichner decision laid the founda-
tion for their recognition, thereby laying the foundation for the accep-
tance of (g).

In short, an analysis of court decisions which preceded the work of the
Commission reveals that major elements of the consensus were accepted in
the most importantjudicial rulings on these issues. While it is true that
there were some elements rejected by some courts, this cannot take away
from the extent to which thejudicial rulings were in consonance with both
the legislation and the professional medical literature analyzed above.

Our ﬁrst conclusion must therefore be that most of the elements of the
current consensus were prominently present and widely accepted before
the appearance of Deciding to Forego Life-Sustaining Treatment. If it were
needed, one could provide further evidence from both the secular and

LIMITING LIHL‘J’ROLONGING MEDICAL TREATMENT 31 7

religious bioethics literature, but I believe that the evidence already pre-
sented is sufficient. What then was the role of that report in the develop-
ment of the current consensus?

I believe that the report of the Commission played four roles in the
development of the current consensus: (1) It summarized in one well-
organized and authoritative statement the consensus whose elements had
emerged in the yearsjust before its work. It needs to be remembered that
all of the material we analyzed was from the last ten years before the
publication of its report. There is some even earlier material, but it is
neither very extensive nor very authoritative. Moreover, no one other
document contained all of the elements of the consensus. The report of
the Commission was needed to give very authoritative approval to, and
advocacy of, the full consensus that hadjust emerged. (2) It offered valu—
able criticisms (pp. 159—60) explicitly directed at the Massachusetts view
about the need for judicial approval, suggesting ethics committees as an
alternative, and it offered a valuable defense (pp. 132—6) of the substituted
judgment/ best interests approach, thereby implicitly criticizing the New
York decision in In re Storar. In these ways, it defended the new consensus
against some alternatives. (3) It also placed great emphasis on durable
powers of attorney for health care decision making, a tool that had not
received enough attention before the report of the Commission. (4) Fi-
nally, the report made it very clear that the organizing theme for the new
consensus was the patient’s right to refuse treatment based upon the
patient’s perception of what was in the patient’s best interest. Although
much of the legal material we examined contained that theme, this was not
as true of the professional material. There was a real need then for this
emphasis. In all four of these ways, then, the report of the President’s
Commission made a valuable contribution to the emergence of the current
consensus, even ifits outline and most ofits elements were widely accepted
before the appearance of the report.

I believe that there was another contribution made by the report, a
contribution that has not been adequately noticed. On a considerable
number of issues, the President’s Commission took positions that went
beyond the consensus then and even the consensus now. Some of the
positions were not clearly articulated, but this ambiguity was possible be-
cause the report was not advocating some speciﬁc legislation or some spe—
ciﬁc hospital policy. Despite these ambiguities, the report was often the
starting point for further discussions about limiting life-prolonging therapy,
discussions that still continue today. The issues were: (1) What is the best
form of advance directives, living wills or durable powers of attorney? (2)
What are the limits of surrogate decision making, both in the case of
newborns and in the Case of incapacitated adults? (3) Can society legiti-
mately prohibit active euthanasia and/ or assisted suicide when requested

31 8 SOCIETY'S CHOICES

by competent adults? (4) Do the special features of PVS patients mean that
decision making to limit life—prolonging therapy for them is different from
decision making to limit such therapy for other patients? (5) Can physi—
cians unilaterally limit futile care? (6) To what extent, and by what process,
can life-prolonging therapy be limited because ofeconomic considerations?
Let us briefly analyze the contribution of the Commission’s report on each
of these issues.

In the last ten years, there has been a considerable debate about the
respective merits of two major forms of advance directives, living wills and
durable powers of attorney.'7 No consensus has emerged on this question.
The concern today about living wills is their lack of specificity. The con-
cern today about the durable power of attorney is whether the surrogate
decision maker really knows what the patient would have wanted. At the
time of the Commission's report, the. concerns about the living will statutes
then in existence were that they were too narrowly drawn and lacking in
assurances that they would be honored, while the concern about the du-
rable power of attorney statutes then in existence was that they had not
been drafted for use in a medical setting and did not have appropriate
safeguards for that setting. As far as I can see, the report was the first to
raise the issue of the merits and demerits of these two approaches. More-
over, while summary conclusion (9c) states that durable powers of attorney
are preferable, the text of the report (pp. 136—53) offers a much more
balanced account, emphasizing the problems as well as the strengths of
both, and the need for legislation to deal with potential problems with
both. But since no specific legislation is proposed as a model statute, akin
to the model statute for brain death proposed in another report by the
Commission, the issue of preferability and of emphasis in legislation is
never really resolved in the text of the report.

Are there any limitations on the right of surrogate decision makers to
refuse life-prolonging therapy for those for whom they make decisions
which extend beyond the limitations on the right of competent adults to
refuse life-prolonging therapy for themselves? While the report discusses
that issue at two points, once (p. 133) in connection with surrogate deci-
sion making for incompetent adults and once (pp. 217—23) in connection
with surrogate decision making for severely ill newborns, the more substan—
tial discussion is in the second context. The continuing controversy on this
issue, both before and after the passage of the current Baby Doe law,18
testifies to the fact that there is no consensus on this issue. The report of
the Commission clearly limits the right of parents, acting as surrogates for
their severely ill newborn child, to refuse life-prolonging therapy which is
in the best interests of the infant; such therapy can be refused only when
the child’s handicaps “are so severe that, continued existence would not be
a net benefit to the infant” (p. 218). An important footnote (footnote 79

LIMITING LIHf-PROIONGING MEDICAL TREATMENT 31 9

on page 219) even cautions that such assessments must be made from the
perspective of the infant, who will grow up with these handicaps and who
will often be able to make adjustments for them, and not from the perspec-
tive of the normal adult surrogate decision maker who may ﬁnd life with
those handicaps excessively burdensome. But the only example of treat—
ment refusals explicitly criticized (p. 219) is the refusal of needed surgery
on Down‘s Syndrome children with intestinal abnormalities. Nothing clear
is said about the harder cases ranging all the way from spina biﬁda to
bilateral severe intraventricular hemorrhages. After reviewing the discus—
sion (on pp. 221—3) of the Lorber criteria for withholding life—prolonging
therapy from children with spina biﬁda, I cannot tell whether the Commis—
sion thought that prolonging life for some of these infants, the better cases
according to Lorber’s criteria, was clearly beneﬁcial and mandatory or
whether they thought that such care is always of ambiguous beneﬁt and
therefore optional in such cases. When do treatments stop being clearly
beneﬁcial, and mandatory regardless of parental wishes, and become of
ambiguous beneﬁt, and therefore open to parental refusal? The report is
unclear on this crucial issue, offering a process of review without a clear
standard for that review. This is in clear contrast with the current Baby Doe
law, which says, for better or worse, that this point is reached only when the
child is irreversibly comatose or clearly dying. Once more, the Commis—
sion raised an important question that takes us beyond the consensus, but
offered an ambiguous answer, the type of answer that could not ground an
operating policy or law. The substantive standard that a hospital commit-
tee might enforce by policy or by law need not be the Baby Doe standard,
but it does need to be something more concrete than a reference to the
best interest of the child, even if we agree with the Commission that any
standards will leave some ambiguities.

Do the arguments justifying honoring refusals of life—prolonging
therapy also justify honoring requests for active euthanasia and/ or assis—
tance in suicide? That issue is today a matter of great controversy; there is
certainly no consensus about it.‘9 The treatment of that issue in the report
is very interesting. The report (pp. 60—89) challenges the conceptual and
moral signiﬁcance of those distinctions (e.g., causing death vs. allowing to
die) which are usually used to differentiate active euthanasia from refusing
life-prolonging therapy, and its rationales for honoring the refusals, espe-
cially the appeal to patient rights, seem to apply to honoring requests for
active euthanasia as well. Nevertheless, the report supports (on pp. 71—3)
the prohibition against mercy killing as a way of continuing a public affir—
mation of the high value of human life. However, that support is condi—
tioned on the prohibition’s not causing too much suffering to patients
because ofa broad understanding of the legitimacy of limiting care and of
supplying adequate pain relief. Those who support the current ban on

320 SOCIETY’S CHOICES

honoring such requests can appeal to the report‘s explicit conclusion,
while those who oppose the current ban can argue that the report’s analy—
sis, supplemented by a fuller understanding of the extent to which patient
suffering cannot otherwise be alleviated, really supports lifting the ban. It
seems to me best to describe the report’s position on this issue as ambigu—
ous. It raised the right questions, and it indicated the factors to be consid—
ered on both sides, but its conclusions were far from unambiguous.

The question of whether or not decision making about life-prolonging
therapy is different in the case of PVS patients is currently a matter of great
controversy. Those20 who support the concept of qualitative futility as a
source for legitimate physician limiting of care independent of patient or
family wishes usually treat PVS patients as their clearest example of when
care can be limited on grounds of qualitative futility; PVS patients are so
different that decision making in their case must also be different. Those
who support the usual processes of decision making in these cases insist
that there is a valuejudgment being made that should be made in light of
the patient’s values as assessed by their surrogates?l The controversy sur-
rounding the Wanglie case22 typiﬁed this continuing controversy. The
report clearly treats PVS patients as different, emphasizing (p. 186) the
very limited interests such patients have in their continued existence given
that they have permanently lost consciousness. I have elsewherez3 criti-
cized this claim, arguing that it presupposes the wrong conception ofinter—
ests. I have also suggested that the report should instead have relied on the
nonpersonhood of PVS patients. But that is not the point that I want to
make here. What I want to note for now is the ambiguity of what is sup-
posed to follow from either the limited interests PVS patients have in con—
tinued existence or the nonpersonhood 0f PVS patients. Does this mean
that life-prolonging therapy can be limited independently of family con-
currence? Support is clearly expressed in the report for the family which
agrees to limit such therapy, but, according to the report, even advance
patient requests for continuing life-prolonging therapy in such circum-
stances need not but may be honored (p. 193). No clear-cut answer is
provided to our question; even the recommendation to appoint a guardian
in such cases (p. 194) is unclear on the crucial issue of how the guardian
should respond to patient requests made in advance, or family requests
made at the time ofdecision making, for continued life-prolonging therapy.
The report raises the right questions, but remains ambiguous in ways that
policies or legislation could not be ambiguous.

The report’s discussion of the issue of limiting life—prolonging care to
patients who will soon die no matter what is done is in some ways less
ambiguous. Those24 who advocate limiting this type of futile care insist
that the normal processes of decision making need not be applied in such
cases; physicians need not offer, they insist, to provide life-prolonging

LIMITING LII'F-PROLONGING MEDICAL TREA TMIL‘NT 321

therapy in such cases, and the concurrence of the patient or the surrogates
to not provide it is not needed in such cases. Those25 who oppose the
concept of futility insist that there is ajudgment to be made about the value
of the remaining period oflife. The patient or the surrogates must decide
whether or not it is worth the burden of the life-prolonging therapy. Natu—
rally, there is also much controversy about how quick must the inevitable
death be before the case is described as futile. The report discusses these
issues most fully in the case of severely ill newborns. It seems to come down
clearly on the second side (p. 220), insisting that parental wishes for con-
tinued life—prolonging therapy should be honored. But this is quickly
limited to those cases where the life-prolonging therapy does not cause
substantial suffering. How much suffering is substantial enough? Who
makes this decision and by what standard will this decision be made? Also,
the report says that health care providers who disagree may withdraw from
the case. What happens when all the neonatologists want to withdraw?
While the report raises crucial questions and offers some answers, it leaves
many ambiguities that would undercut any actual policy or legislation
based on it.

No question is more controversial today than the question of whether
life-prolonging therapy may be limited on economic grounds. Those who
oppose such limitations?6 see them as a failure to be faithful to the needs
of, and the commitments to, patients. Those who support such limita-
tions27 see them as crucial to controlling rapidly escalating health care
costs. While supporting such limitations in principle, the report empha-
sizes (pp. 95—100) that this is not a wise place to focus discussions of cost
containment and that it would be better to first develop acceptable policies
on equitable limits on health care in general and then apply them to
limiting life-prolonging therapy. The report is appealing here to the more
general policies developed in Securing Access to Health Care. In light of the
fact that we as a society are far from having such general policies, and that
what we have by way of intuitions and particular limitations is very ambigu-
ous, the report’s conclusions leave the whole question of economic limita-
tions on life-prolonging therapy totally unresolved for now.

What are we to conclude about the role of the President’s Commission
in taking us beyond the consensus about limiting life-prolonging therapy?
Its report certainly raised many of the issues that have been heatedly de-
bated since its appearance ten years ago. It often identified the main
arguments on both sides. But its conclusions were often very ambiguous.
As a starting point for discussion on these matters, the report was a great
success. As the foundation for concrete policies and/or legislation on
these matters, it was far less successful. An assessment ofits success in these
areas depends therefore upon one’s conception of the role of the report.
When one adds this conclusion to our earlier contextual conclusions about

322 SOCIE'I‘Y’S CHOICES

how the report did and did not contribute to the development of the
consensus, it becomes clear then that a proper assessment of the success of
the President's Commission must be very dependent both upon one's un-
derstanding of the context in which it operated and upon one’s under-
standing of its role.

ACCOMPLISHMENTS OF THE NEW YORK STATE TASK FORCE

Having seen the importance of context and of role in assessing the
accomplishments of the report of the President’s Commission, we will be—
gin our assessment of the reports of the New York State Task Force on
limiting life-prolonging therapy by looking at the context in which the
Task Force was created and in which it issued its reports.

The New York State Task Force was created by Governor Cuomo in
1985 and issued its three major reports in 1986, 1987, and 1992. Two of the
six issues it was asked to look at, decision making for those without deci-
sional capacity and discontinuing life-sustaining therapies, relate to our
topic.

What was the status of New York law and of thinking in New York on
these issues before the Task Force began its work and in the early years of
its work? I think that there are a number of points that need to be kept in
mind:

(1) New York State had no statutes on the deﬁnition of death, on
limiting life-prolonging therapy, and on advance directives.

(2) As noted above, the New York courts in 1981 had rejected part of
the current consensus. In particular, a decision to limit life-prolonging
therapy for an incompetent patient required in New York clear and con-
vincing evidence that the patient would have requested those limitations in
the circumstances at hand, rather than surrogate substitutedjudgments or
surrogatejudgments of the patient’s best interests. In 1988, the New York
Court oprpeals, in an opinion28 written byJudge Wachtler (influenced, it
has been suggested,29 by a case involving his own mother), reafﬁrmed that
position and allowed for limiting such therapy only when the evidence of
the patient’s expressed advance wishes applied very speciﬁcally to the
patient’s actual condition.

(3) At least two very well organized groups in New York, the New York
State Catholic Conference and the Agudath Israel (an Orthodox jewish
organization), expressed strong and politically inﬂuential concerns about
components of the consensus on limiting life-prolonging therapy, con-
cerns growing out of their reverence for human life. Some of those con-
cerns will be discussed below. For now, it is sufﬁcient to say that the New
York State Task Force operated in a context in which important ethical/

LIMITING LIFE-PROLONGING MEDICAL TREA TMEN’I‘ 323

religious voices were not supportive of elements of the consensus that had
emerged elsewhere.

(4) From 1981 to 1984, a grandjury in Queens investigated a hospital
DNR (do not rescuscitate) policy that eschewed the use of explicit DNR
orders, relying instead on a covert system in which purple dots were placed
on the charts of patients, indicating that the patients were not to be resus-
citated. The grandjury’s report in 198430 supported the use of DNR orders
with proper procedural safeguards and called for regulations governing
the use of explicit DNR orders.

(5) In response to this confusing situation, the Medical Society of the
State of New York issued in 1982 a set of guidelines on DNR orders.31 The
guidelines called for the decision on a DNR order to be made by the
physician and the patient (or appropriate family members, if the patient
was not capable of making a decision). Unfortunately, the guidelines
did not address limitations on the use of other forms of life-prolonging
therapy, did not discuss the use of advance directives, and did not discuss
the crucial question of the nature and evidentiary backing for surrogate
decision making.

In short, when the New York State Task Force began its work in 1985, it
confronted anything but a consensus on limiting life-prolonging treatment.
How did it define its role in that situation? That leads us to our second
question, the question of role.

An examination of the governor’s executive order” establishing the
Task Force makes it clear that it was given many roles:

The Task Force studies shall include: a review of current law and practice
pertaining to these issues; an analysis of the proper roles of patients,
family members, health care professionals and the courts in making
health care decisions; the advisability of adopting legislative or adminis-
trative policies affecting these issues, where appropriate; and recommen-
dations to enhance public consideration for those issues not susceptible
to immediate legal or administrative resolution.

From the very beginning, however, the Task Force focussed on the
development of reports which proposed legislation. In light of the context
in which it operated, particularly the limits on surrogate decision making
articulated by the New York Court of Appeals, this was a very reasonable
choice of role. It was, moreover, a role that was supported by the New York
legislature, which adopted in 1987 a DNR law based upon the Task Force’s
1986 report,33 adopted in 1990 a health care proxy law based upon the
Task Force’s 1987 reportf“4 and is currently considering legislation on sur-
rogate decision making based on the Task Force’s 1992 report. It is also a
role that we need to keep in mind as we assess the accomplishments of the
three reports.

324 SOCIETY’S CHOICES

What was the content of the reports? Do they incorporate the current
consensus outlined above? Do they go beyond that consensus in valuable
ways? The answer to these three crucial questions requires a careful analy-
sis of the three reports.

The initial report on DNR orders provided for a presumption for the
use of cardiopulmonary resuscitation (CPR) unless the patient or the sur-
rogate consents to the issuance of a DNR order. The report made it clear
(pp. 9—12) that this approach is grounded in the value of self-determina-
tion and that refusals of CPR should therefore be honored even when the
patient does not have a terminal illness (this was one of the items that was
dissented from by Rabbi Bleich, a member of the Task Force associated
with the Orthodoxjewish community). In these ways, the report accepted
principle (a) of the current consensus. By providing for DNR orders for
both competent and incompetent patients, the report accepted principle
(b) of the current consensus. Although it did provide forjudicial review
under certain circumstances (pp. 87—8), the report's main emphasis was
on decision making outside thejudicial system, so it accepted principle (c)
of the current consensus. By calling for legislation and for institutional
policies and dispute mediation systems (pp. 49—51), the report accepted
principle (d) of the current consensus. Principles (e) and (0 were irrel-
evant to the report’s discussion, which was conﬁned to DNR orders be-
cause of the immediate needs in New York in light of the factors noted
above. The report allowed both for patients indicating in advance that
they do not want CPR and for their appointing surrogates to make that
decision for them. It also rejected the opinion of the Court of Appeals, at
least for the case of CPR (the only therapy it covered), in that it allowed
(pp. 43—4) surrogates to use the substituted judgment and/or the best
interests standard. Therefore, the report accepted principles (g) and (h)
of the current consensus. Finally, the report accepted (pp. 46-9) parental
decision making for minor children, thereby incorporating principle (i) of
the current consensus.

There were some additional components of the report that went be-
yond the current consensus and should be noted. To begin with, it dealt
with the problem of patients who have no surrogate decision maker, allow-
ing for the writing of a DNR order when resuscitation would be futile
(deﬁned by the legislature35 as “CPR will be unsuccessful in restoring car-
diac and respiratory function or that the patient will experience repeated
arrest in a short time period before death occurs”) or when a court di-
rected that such an order be written (the legislature made it clear that the
court could do so using either a substituted judgment or a best interest
standard). Secondly, it addressed the issue, raised by the President‘s Com—
mission, of limitations on surrogate decision making to refuse CPR. The
Task Force (pp. 41—3) limited this authority to cases where the patient has

LIMITING LIFE-PROLONGING MEDICAL TREA TMENI‘ 325

a terminal illness, is permanently unconscious, or is so sick that resuscita-
tive measures would probably be unsuccessful and only prolong the dying
process. The legislature36 modiﬁed those standards by changing the third
to refer to cases in which resuscitation would be futile and by adding the
fourth possibility that resuscitation would be extraordinarily burdensome
in light of the patient’s condition and expected outcome. Both of these
standards are quite close to the Baby Doe standards for parental surrogate
decision making; more crucially, both provide far more guidance than the
standard provided by the President’s Commission. Thirdly, it allowed for
the unilateral withholding of futile CPR at least in some cases; the precise
extent of this became, as we shall see below, a matter of considerable
controversy. Fourthly, it began the very difficult process of deﬁning the
role of hospital ethics committees (although it used the name of dispute
mediation system), addressing such issues as who may call for their use,
what happens while their work is going on, and what happens if they fail to
bring about agreement (pp. 49-51). Finally, it dealt with a great many
questions of concrete details, including the written documentation re-
quired for a DNR order, the conditions under which a physician can in-
voke the therapeutic exception to consult surrogates rather than the pa-
tient, the process for determining patient incompetency, the role of friends
as surrogates, the special procedural protections needed by institutional—
ized patients, the need for review of DNR orders, and the validity of DNR
orders after interinstitutional transfers.

To summarize, when the legislature adopted with some Changes the
Task Force’s proposed legislation, it incorporated into New York law, at
least in connection with CPR, all of the relevant elements of the current
consensus. Moreover, it also incorporated, and even added to, some of the
crucial ideas of the Task Force that went beyond the current consensus. In
light of the context in which the Task Force operated, and given its chosen
role, that was a signiﬁcant accomplishment. No doubt, there was consider-
able controversy generated both by the report and by the legislation; we
shall discuss that controversy below. But none of that takes away from its
accomplishments in its initial report.

We turn now to the second of its reports, the 1987 report on appoint-
ing a health care agent to make decisions. Once more, context is crucial
for understanding the significance of that report. In light of the New York
court decisions about surrogate decision making which required surro-
gates to meet the very high standard of clear and convincing evidence of
previous patient wishes, surrogate refusals of life-prolonging therapy were
severely limited in New York. The essential point of the report was to
propose legislation that would partially remedy this problem. At least in
those cases in which the patient, before he or she became incompetent,
appointed a health care agent (the name they proposed for the person

326 SOCIETY’S CHOICES

awarded a durable power of attorney for health care), the report recom-
mended that the agent be authorized to make decisions on all health care
matters, including but not limited to decisions about life-prolonging
therapy, using either the substitutedjudgment or the best interest standard
(pp. 91—2). The legislature37 limited this provision in decisions to forego
the provision of nutrition and hydration to surrogates who have reasonable
knowledge, but not necessarily clear and convincing evidence, of the
patient’s wishes. Leaving this aside for the moment, we can certainly con—
clude that one of the accomplishments of the report was to lead to the
passage of legislation that moved New York closer to the current consensus,
at least for patients who had appointed a health care agent.

The second report, like the first report, did more than that. It moved
beyond the current consensus in the following ways: (1) Following the lead
of the President’s Commission, it emphasized durable powers of attorney
over living wills. In addition to noting the traditional problem of the
uncertainty of the meaning of living wills, it pointed out (pp. 75—83) that
durable powers of attorney cover all health care decisions, notjust deci-
sions to forego life-prolonging therapy, and also serve as a vehicle for those
who want to direct that life—prolonging therapy be continued even when
their condition was grave, and notjust as a vehicle for those who want to
direct that it be limited. (2) It provided a mechanism for the informal
determination that the patient was incompetent and that the agent there-
fore had authority, it dealt with the patient‘s right to be notiﬁed of that
determination, and it structured an appeals process for that determination
(pp. 152—3). All of these are crucial details for policies and laws that are to
be implemented in the real world; (3) it raised and addressed (pp. 93—4)
the question of liability for costs of the health care chosen by the agent.

There was some controversy about this second report, although it was
on the whole much less controversial than the ﬁrst report. We shall discuss
this controversy, and the modiﬁcations made by the legislature to deal with
the freedom of conscience issues that were central to it, below. None of
this takes away, however, from its accomplishments in bringing New York
closer to the current consensus and in moving beyond it in important ways.

The last of the reports, the 1992 report on deciding for incapacitated
patients (together with its April 1993 supplement), attempted to complete
the process of incorporating the current consensus into New York law. It
called attention (p. ix) to the fact that the major gap in that incorporation
is a failure to deal with surrogate decision making that limits life-prolong-
ing treatments other than CPR when the patient has not appointed a health
care agent and there is no living will to supply clear and convincing evi-
dence of the patient’s wishes, and it attempted to ﬁll that gap. It also
attempted to provide for surrogate decision making about health care in
general when the patient has not appointed a health care agent. As one

LIMITING LIFE-PROLONGING MEDICAL TREATMENT 32 7

would expect, its major recommendations (pp. x—xi) were that such deci—
sion making should be allowed using the substitutedjudgment and/or the
best interests standards.

As with the other reports, this last most comprehensive report moved
beyond the current consensus to deal with a large number of issues which
need to be resolved if such laws are to be implemented in actual cases.
Many of these issues were already treated by the Task Force in its work on
DNR orders. The following seem to be the most important issues ad-
dressed: (l) Incompetent patients without surrogates: the Task Force had
already addressed this issue in its DNR report, but it returned to it in this
latest report. Its recommendations (pp. 157—71) were to allow the physi-
cian to provide routine care using his/her ownjudgment, to provide major
medical treatment after approval by another physician designated by the
hospital, and to forego life sustaining treatment only after additional ap-
proval by a hospital bioethics review committee; (2) Limitations on surro-
gate decision making to limit life-prolonging therapy: the Task Force, fol-
lowing in the path of the President’s Commission, had already addressed
this issue as well in its DNR report, but it returned to it both in the third
report and in its 1993 supplement to that report. In the report itself (pp.
109—15), it limited that authority to cases (i) where the surrogatejudged,
using the substituted judgment and/or best interests standards, that the
therapy was too burdensome and (ii) where the patient would die within
six months, or where the patient was permanently unconscious, or where
an attending physician and a bioethics review committee or a court con-
curred with the decision. In the supplement (p. 2), the last two conditions
were replaced with the conditions either that two physicians concurred
that the provision of treatment would be inhumane or extraordinary under
the circumstances or that the decision was in accord with the reasonably
known wishes of the patient (3) Issues of futility: as in the CPR report, the
new report allowed for the unilateral withholding of futile therapies (now
called therapies without medical beneﬁt) in some cases. The clearest case
(pp. 259—60) is where life-prolonging treatment can be limited for incom-
petent patients with no surrogates if the attending physician, with the con-
currence ofa second physician designated by the hospital,judges that the
patient will die imminently even if the treatment is provided. Restrictions
on that provision, together with a fuller discussion of the Task Force’s views
on futility, will be discussed below when we discuss the controversies sur-
rounding its work (4) The role of bioethics review committees: The Task
Force had already begun working on the role of bioethics committees in
hospitals in its DNR report, but it saw them in that report serving only in an
advisory capacity. This may explain the name given to them in that report,
where they were seen as one of several alternative “dispute mediation sys-
tems.” The new report goes way beyond that. Such committees are now

328 SOCIE’I‘Y’S CHOICES

mandatory, and there are certain cases of limiting life-prolonging therapy
(e.g., from incompetent patients without surrogates) in which their pro-
spective approval is now required. As a result, the report (pp. 137-55) now
contains extensive provisions about composition, procedure, documenta-
tion, etc. (5) Finally, as a continuation of modifications made by the legis-
lature in response to criticisms of the Task Force’s second report, the third
report contains (pp. 187—93) extensive provisions protecting the right of
conscientious objection by institutions and providers. We will return to
these provisions below when we talk about the controversies surrounding
the Task Force’s work.

Having reviewed the content of all three reports, and some aspects of
the legislation adopting, in a modiﬁed fashion, the ﬁrst two reports, what
can we say in response to our initial questions about the content of the
Task Force’s reports? I think that we can say that the reports were based
primarily on the current consensus. I think we can say that the legislation
based upon them incorporated into New York law much of the current
consensus, and that what is missing will be incorporated if and when the
proposed legislation in the third report is enacted into law. I think that we
can say that the reports and the legislation based upon them also attempted
to deal with many crucial issues left unresolved by the current consensus.
In light of the context in which the Task Force operated, and given its
legislative role, these are very considerable accomplishments.

But what about the controversies surrounding the work of the Task
Force? Don‘t they reveal some very fundamental problems and shortcom-
ings either in the content of the reports or in the operating methods of the
Task Force? In order to answer these questions, we need to look more
carefully at those controversies.

There is one that I want to note and to then put aside. This is the
internal controversy within the Task Force represented by the dissenting
opinions of one of its members, Rabbi J. David Bleich. In each of the
reports on life—prolonging therapy, Rabbi Bleich dissented because of his
strong moral/religious convictions, based on his reading38 of the Ortho-
doxJewish sources, that the goal of decision making should be “. . . cure or,
de minimis, maximum prolongation of life."39 This led him to want to con—
ﬁne the writing of DNR orders to cases in which little or nothing can be
gained by resuscitation and to want to limit the authority of surrogates,
appointed by the patient or by the law, to refuse life-prolonging therapy.
These dissents have not, as far as I can tell, attracted that much ofa follow-
ing outside of his own particular community, so I will not focus on them
here.

Most of the controversy centered around the initial DNR report and
the legislation based on it. Fortunately, a great deal of the material associ-
ated with that controversy was presented and analyzed in a 1990 confer—

LIMITING UFE—PROLONGING MEDICAL TREA TMENI‘ 329

ence at Union College, the proceedings of which were to shortly appear.40
I think that there are really several different issues at stake in that contro-
versy, and I want to analyze each of them separately.

Two of the controversies dealt with items of detail that were readily
correctable and were corrected in the 1991 amendments to the DNR stat-
ute.41 The ﬁrst had to do with whether or not patient and/or surrogate
agreements to DNR orders had to be in writing. The original statute
required written agreements from surrogates, although oral agreements
from patients were acceptable. Despite this clear difference, it was widely
reported that many hospitals required written agreements both from pa-
tients and from surrogates. It was also widely believed that this require—
ment was burdensome on staff and difﬁcult for patients and/or surrogates.
All of this led to the claim that increased paperwork and inhumane de-
mands on patients and/or families, rather than improved discussion and
communication, were the main outcomes of the statute.42 The 1991 amend-
ments resolved this problem by allowing both surrogates and patients to
agree orally to a DNR order, requiring only that physicians record that
agreement in the medical record. The second had to do with DNR orders
on nonhospitalized patients who were anticipated to suffer an arrest at
home. Would the emergency medical technicians have to resuscitate them?
Several clinicians and family members had highlighted the difﬁculties
posed by inadequate attention to that issue.43 The 1991 amendments
clariﬁed the procedures for such orders being written and honored, ad-
dressing even the very difﬁcult question of what to do when family mem-
bers insist to the emergency medical personnel that resuscitative efforts be
attempted despite such orders. These controversies are reﬂective of what
you would expect when broad philosophies are operationalized in speciﬁc
legislation; important problems about details that were not anticipated
emerge. The occurrence of these controversies is a sign ofa problem only
if they persist because of legislative inaction. In fact, however, the legisla-
ture did correct these problems. If there were controversies that reﬂected
problems with the work of the Task Force, they had to be more fundamen-
tal controversies. Two possibilities exist.

The ﬁrst was the controversy over whether or not it was appropriate to
discuss DNR orders with patients who were competent rather than with
their family members. There was a feeling on the part of some that this was
inhumane and inappropriate. This claim is, of course, a challenge to the
fundamental presuppositions of the current consensus (a) that the founda-
tion of limiting life—prolonging therapy is the decision of the competent
patient that the beneﬁts of such therapy are not sufﬁcient and (b) that all
surrogate decision making is an attempt to deal with cases in which the
patient is no longer competent. Both the Task Force’s initial report and
the DNR legislation based on it allowed for a carefully deﬁned exception to

330 SOCIETY’S CHOICES

consulting patients when that would pose a serious threat of an immediate
and severe injury to the patient, but both continued to insist upon the
fundamental validity of the current consensus. I ﬁnd it hard to fault the
Task Force for doing so.

The second was the controversy over futile DNR orders. The claim was
made that the Task Force’s report, and the legislation based upon it, re-
quired the provision of CPR even when it was futile as long as the compe-
tent patient or the incompetent patient’s surrogate insisted on it. The only
case where the report and the legislation explicitly and unambiguously
allowed physicians to write DNR orders on the grounds of futility was when
there was no surrogate available. Many felt that this led to inappropriate
resuscitative efforts. This controversy is not about details, but about a
fundamental issue of principle. It is not about a challenge to the current
consensus, but about what the Task Force did when it went beyond the
current consensus. Does this controversy, which was probably the most
contentious controversy surrounding the Task Force’s work in this area,
reveal a fundamental shortcoming in its approach?

Before answering this question, I want to note the Task Force’s own
response to this issue. Although Commissioner Axelrod44 attempted to
defend the above understanding of the law at the Union College confer-
ence, arguing to an unsympathetic audience that futile resuscitation was
not that common, the Task Force has adopted a different approach: (a)
Since 1988, the Department of Health, with the support of the Task Force,
has maintained the view that despite the lack of an explicit provision saying
so, the law creates no requirement to provide futile CPR so long as physi-
cians don‘t use the invocation of futility so commonly as to create a new
system of unwritten DNR orders.45 In the current proposed legislation,
that view is incorporated in the provision that physicians are not required
to provide at the request of a surrogate any form of care they “would have
no duty to provide at the request of a patient with decision-making capac-
ity.”46 Unfortunately, that concept is left undeﬁned both in the report and
in the legislation (b) At the same time, the ﬁnal version of the current
proposed legislation“ actually makes it harder to invoke futility even in
decision making for incompetent patients without surrogates since it im—
poses the additional requirement that the provision of the life-prolonging
treatment “would violate acceptable medical standards.”

It seems clear to me that the Task Force has not yet found an accept-
able solution to this most vexing problem, one that has produced tremen-
dous controversy. In a crucial footnote in the third report (p. 203), it
admits that its own members are split on this issue. But this failure is hardly
a criticism of the Task Force. The uncertainties it feels about this issue are
reﬂective of a lack of a social consensus rather than of a Task Force failing.
When the President's Commission raised this issue but failed to resolve it,

LIMITING LIFE—PROLONGING MEDICAL mm TMENT 331

this gave rise to continued discussion but not to criticism of the President‘s
Commission. When the New York Task Force failed to resolve it, there was
controversy and criticism. Why the difference? I think that it was due to
the fact that the ambiguity was left in legislation that people had to live with
on a day-to-day basis, rather than in a general policy statement. Once
more, we see the importance of understanding context and role when we
assess accomplishments and failures.

Let me conclude with a brief analysis of the controversies surrounding
the health care agent report and the resulting legislation. The two major
issues, raised primarily by the Catholic Conference, related to surrogate
decision making to limit the provision of nutrition and hydration and to
protecting the rights of conscience of individuals and institutions. Resolv-
ing the ﬁrst issue in the legislative process did require a modest withdrawal
from the current consensus, since surrogate decisions to limit such thera-
pies must by statute be based upon more substantial evidence of patient
wishes than decisions to limit other therapies. Resolving the second issue
in the legislative process actually moved New York beyond the current
consensus in very sensitive and informative ways. New York now has sepa—
rate and very thoughtful rules on these matters. If we see the Task Force’s
efforts as part of a larger legislative process, then a quick analysis suggests
that this larger process worked very well to insure that the resulting legisla-
tion was sensitive to the context of a state in which there is tremendous
religious/ ethical pluralism on the difﬁcult questions raised by the limiting
of life-prolonging therapy.

What are we to conclude then about the accomplishments of the New
York State Task Force in its work on limiting life-prolonging therapy? I
would conclude that if its third report is incorporated into legislation, it
will have succeeded, in a context in which these issues were very controver-
sial, in incorporating the current consensus into law, in making that con-
sensus operational by filling in many of the details, and in moving beyond
that consensus in important ways. Some controversy surrounding its work
was inevitable as broad policy was incorporated into legislation and fol-
lowed on a daily basis, but the New York legislative process has successfully
handled much of that controversy. The remaining controversy about futil-
ity is a very different matter, but its continuation is more ofa reﬂection on
a current social uncertainty about that issue than a reﬂection on the work
of the Task Force.

CONCLUSION

The analysis we have offered of the President‘s Commission and of the
New York State Task Force has shown the centrality of the understanding
of context and of role in the assessment of these two commissions. This is,

332 socm’rys CHOICES

of course, the main thesis of the paper. But I want in this conclusion to add
a speculative suggestion relating to the structure of, and the processes used
by, these two commissions. In particular, I want to suggest that their differ-
ent contexts and roles made different structures and processes appropriate
for these two groups.

If your role is to develop, and to serve as advocates for, legislation in a
context in which there is much disagreement on the topic of the proposed
legislation, it is probably very important that the many groups (including
the religious groups) with the diverse views on the topic be represented in
the process of developing the legislation so that as few as possible feel that
the legislation is being imposed on them. It may well be a good idea to ﬁrst
try to work out a common legislative proposal in informal private discus-
sions, allowing for less posturing and for more attempting to ﬁnd a com-
mon consensus, and to present it for public discussion only after a com—
mon plan has emerged. Given the vagaries of legislative timetables and
given the need to fashion further compromises in a legislative process, it is
probably a mistake to set a ﬁrm date for the conclusion of activities.

The situation is very different if your role is to articulate and system-
atize a recently emerged consensus and to begin discussions of moving
beyond the consensus. Here, what may be needed is a very public process,
where the diverse groups appear and present their positions before a group
of well-respected individuals (with a strong staff) who are good at listening
and synthesizing. It is, moreover, easier to talk ofa limited time frame for
these activities.

These are, of course, very speculative claims, but I ﬁnd them quite
plausible. Moreover, they help complete the explanation of the successes
of the two commissions. I do think therefore that they are deserving of
serious consideration.

NOTES

1. President's Commission for the Study of Ethical Problems in Medicine and Biomedi-
cal and Behavioral Research, Deciding to Forego Life—Sustaining Treatment (Washington, D.C.:
US. Government Printing Office, 1983).

2. The New York State Task Force on Life and the Law, [)0 Not Resuscitate Orders (New
York: Task Force, 1986), Life—Sustaining Treatment: Making Decisions and Appointing a Health
Care Agent (New York: Task Force, 1987), and When Others Must Choose (New York: Task Force,
1992). That last publication is supplemented by Supplement to Report and Proposed Legislation
(New York: Task Force, 1993),

3. Meisel, A. “The Legal Consensus about Forgoing Life-Sustaining Treatment: Its Status
and its Prospects" Kennedy Institute of Ethics journal vol. 2 (1993) pp. 309—45.

4. President's Commission for the Study of Ethical Problems in Medicine and Biomedi-
cal and Behavioral Research, Making Health Care Decisions (Washington, D.(I.: U.S. Govern-
ment Printing Ofﬁce, 1982).

5. President’s Commission for the Study of Ethical Problems in Medicine and Biomedi-

LIMITING LIFE-PROLONGING MEDICAL TREATMENT 333

cal and Behavioral Research, Securing Access to Health Care (Washington, DC: US. Govern-
ment Priming Ofﬁce, 1983).

6. Clinical Care Committee of the Massachusetts General Hospital, “Optimum Care for
the Hopelessly 111" New Englandjournal ofMedicine vol. 295 (1976) pp. 362—4.

7. Grenvik, A. et al. “Cessation of Therapy in Terminal Illness and Brain Death” Critical
Care Medicine vol. 6 (1978) pp. 284—91.

8. judicial Council, Current Opinions of the judicial Council of the American Medical Associa—
tion (Chicago: American Medical Association, 1982). The opinions in question are num-
bered 2.10 (“Quality of Life") and 2.11 (“Terminal Illness”).
9.The statutes in question are Ark. Stat. Ann. 82—3801—3804 (March 30, 1977), 1976 Cal Stat
Chapter 1439, Health and Safety Code, 7185—7195 (Sept. 30, 1976), Idaho Code 39-4501—4508
(March, 1977), Nev. Rev. Stat. 449.550—590 (May 6, 1977), NC. Gen. Stat. 90—320—322 (July 1,
1977), Or. Rev. Stat. 97.050—090 (lune 9, 1977), and Tex. Rev. Civ. Stat. Ann. 4590b (August
29, 1977).

10. In re Quinlan 70 NJ. 10,355 A. 2d 647

11. Satz v. Perlmutter 362 So. 2d 160.

12. In re Eichner 52 NY. 2d 363, 420 NE 2d 64

13. In re Starar 52 NY. 2d 363, 420 NE. 2d 64

14. Superintendent ofBelchertown State Hospital v. Saikewicz 373 Mass. 728, 370 NE. 2d 417.

15. In re Dinnerstein 6 Mass. App. 466, 380 NE. 2d 134

16. In re Spring 380 Mass. 629, 405 NE. 2d 115

17. For an introduction to some of these issues, see Emanuel, E]. and Emanuel, LL.
“Proxy Decision Making for Incompetent Patients"jAMA vol. 267 (1992) pp. 2067—71.

18. PL. 98-457 (Oct. 9, 1984). A good introduction to the continuing controversy is
Kopelman, LM. et al. “Neonatologistsjudge the ‘Baby Doe’ Regulations” New Englandjoumal
ofMedicine vol. 318 (1988) pp. 677—83.

19. As a good example of that controversy, consider the discussion prompted by publica—
tion of Quill, T.E. “Death and Dignity: A Case of Individualized Decision Making" New
Englandjoumal ofMedicine vol. 324 (1991) pp. 691—4.

20. Schneiderman, L]. et. al. “Medical Futility: Its Meaning and Ethical Implications"
Annals ofIntemal Medicine vol. 112 (1990) 949—54.

21. Truog, RB. et al. “The Problem with Futility” New Englandjournal ofMedicine vol. 326
(1992) 1560—4.

22. Angell, M. “The Case of Helen Wanglie” New England journal of Medicine vol. 325
(1991) pp. 511—2.

23. Brody, B.A. “Special Ethical Issues in the Management of PVS Patients” Law Medicine
and Health Care vol. 20 (1992) pp. 104—15.

24. Blackhall, LJ. “Must we Always Use CPR" New England journal of Medicine vol. 317
(1987) pp. 1281—4.

25. Youngner, 3.]. “Who Deﬁnes Futility”]AMA vol. 260 (1988) 620-1.

26. A classical statement, which still recognizes some physician roles in cost-containment,
is Angell, M. “Cost Containment and the Physician” jAMA vol. 254 (1985) 1203—7.

27. Menzel, P. Strong Medicine (New York: Oxford University Press, 1990) and Morreim,
E.H. Balancing Act: The New Medical Ethics of Medicine ’5 New Economics (Dordrecht: Kluwer,
1991).

28. In re Westchester County Medical Center (O'Connor) 72 NY. 2d 517, 531 NE. 2d
607. judge Wachtler has defended his position in Wachtler, S. “A judge’s Perspective: The
New York Rulings" Law Medicine and Health Care vol. 19 (1991) pp. 60—2.

29. Belkin, L. “New York Rule Compounds Dilemma over Life Support" New York Times
May 11, 1992, p. 1

30. McClung,].A., and Kamer, R.S. “Legislating Ethics: Implications of New York‘s Do—
Not—Resuscitate Law" New England journal of Medicine vol. 323 (1990) pp. 270—2.

334 SOCIETY’S CHOICES

31. ibid.

32. Reprinted in Annual Report ofNew York State Task Force on Life and the Lao/for 1988 pp.
10—1 1.

33. N.Y. Public Health Law Article 29—3.

34. N.Y. Public Health Law Article 29-C.

35. Article 29-B, Section 2961.

36. Article 29-B, Section 2965.

37. This special provision is discussed in New York State Department of Health, The Health
Care Proxy Law: A Guidebook for Health Care Professionals (Albany: Department of Health, 1991)
pp. 16—7.

38. For an alternative reading, see Brody, B. “A Historical Introduction tojewish Casuistry
on Suicide and Euthanasia" in Brody, B. Suicide and Euthanasia (Dordrecht: Kluwer, 1989)
pp. 39—75.

39. Life Sustaining Treatment, supra note 2. pp. 147—8.

40. Baker, R. and Strosberg, M.A. Legislating Medical Ethics (Dordrecht: Kluwer. 1994).

41. Amendments to New York Public Health Law 29-13 (July 15, 1991).

42. Letter of Baker and Strosberg (April 23, 1991), reprinted in Baker and Strosberg,
supra note 40.

43. O’Brien, D.D. "()ne Family’s Experience with the New York DNR Law" and Quill, T.E.
“When the Ambulance Goes Home”, both to appear in Baker and Strosberg, supra note 40.

44. Rosenthal, E. "Rules on Reviving the Dying Bring Undue Suffering, Doctors Contend”
New York "imes (October 4, 1990) p. l.

45. Swidler, R.N. “The Presumption of Consent in New York State’s Do-Not-Resuscitate
Law" New York State journal of Medicine (Feb. 1989) pp. 69—72,

46. Found in the 1993 supplement, p. 16.

47. Ibid p. 23.

48. See Gutis, P.S. “Accord Near on Proxy Plan for Life-Support Decisions" New York Times
(May 30, 1989) p. B3 and Miler, T. “New York State’s Health Proxy Law" New York Lawjoumal
(August 16, 1990) p. 1.

The Formulation of Health Policy by
the Three Branches of Government

LAWRENCE GOSTIN,].D., L.L.D. (Hon)

Professor and Co—Director, Georgetown University Law Center/
johns Hopkins School of Hygiene and Public Health
Program on Law and Public Health

Modern health policy poses complex legal, ethical, and social ques-
tions. The goal of health policy is to protect and promote the health of
individuals and the community. Government officials can accomplish this
objective in ways that respect human rights, including the right to self-
determination, privacy, and nondiscrimination. Numerous papers have
addressed the question, What is sound health policy?1 However, assess—
ments rarely address the following important questions: Which bodies are
best equipped to solve which health policy problems and why? What data
do policymaking bodies need? How can that data best be made available to
decision makers?

The United States is a highly diverse and complicated society. Many
groups “weigh in“ on significant health policy issues. America's expansive
range of policymaking bodies and groups seeking to influence policy ren-
der it impossible to offer a systematic and comprehensive analysis of health
policy formulation. To make an examination of policy development man-
ageable, I will work from the following assumption, which is partly, but not
wholly, valid. I will assume that formal development of health policy is the
primary preserve of the three branches of government—the executive,
legislature, and‘judiciary—at the state and federal levels. In practice, many
other bodies make policy (such as professional associations or ethics groups
through guidelines.)2 This essay focuses on official government policy-
making that is legally binding or at least has persuasive force in law. It
evaluates the relative strengths and weaknesses of each branch of govern—
ment with respect to health policy formulation. It also examines sources of

335

336 SOCIETY’S CHOICES

information and inﬂuence that help drive policymaking. These include
presidential and congressional commissions, task forces and advisory bod—
ies, professional and trade associations, and public interest, consumer, and
community—based groups.

Although I argue below that health policy is best formulated through
rigorous and objective assessment of data, I do not support any restriction
on the right of interest groups to publish their views and to appropriately
lobby policy makers. A robust constitutional society that values freedom of
expression and unrestricted participation in the political process should
support a role for interest groups in health policy formulation. It should
not censor or fetter the views of those who seek to participate in the pro-
cess. Yet, the various branches of government should be able to rely on
full, objective information and advice based upon sound scientific evidence.
This essay will explore some mechanisms for achieving these aims.

Health policy encompasses a vast range of issues in health care, public
health, and biotechnology. This essay selects illustrations from several areas
that, over a period of time, have generated a great deal of policy formu—
lated by each branch of government. These include reproductive rights,
the right to die, and mental health. I will also use examples in the ﬁelds of
health care reform, AIDS, and civil rights of persons with disabilities.

CHARACTERISTICS OF SOUND POLICY DEVELOPMENT

What factors are important in developing sound health policies? The
policies themselves are rarely subjected to scientific scrutiny. Whether
society seeks to reform the health care system, to restrict or to expand
women’s choices to receive an abortion, or to authorize or to criminalize
physician-assisted dying, it has no precise means by which to test for the
“correct” approach. Health policy decisions often reﬂect choices between
competing values, as well as assessments of available data. Interest groups,
including organizations representing various health care professionals, se-
lect their values and evaluate data through their own lenses. Clearly, groups
comprised of highly expert and well-intentioned professionals often make
markedly different decisions about health policy.

The New York case of New York State Society of Surgeons 1). Axelr0d3 exem-
pliﬁes the difficulty of deciding on one “correct” policy solution to com-
plex health problems. The highest state court considered whether the
state health commissioner had correctly categorized HIV infection as a
communicable disease. This policy, on its face, appears noncontroversial
and subject to neutral assessment. Yet, health professionals strongly split
on this issue. Many public health organizations (e.g., the American Public
Health Association) supported the commissioner, because the communi-
cable disease classiﬁcation under New York law adopted a voluntary ap-

FORMUIA TION OF HEALTH POLICY 337

proach to controlling the HIV epidemic. However, many medical and
surgical organizations (e.g., the American Medical Association) favored
the classiﬁcation of HIV infection as a sexually transmitted disease. This
would authorize greater use of compulsory testing, reporting, and con—
tact tracing. What factors should have guided the court‘s decision be-
tween these two sets of respected professionals, who each used reasoned
argument and data to argue that their preferred health policy was more
effective?

Governmental ofﬁcials need a framework for the development of sound
health policy. Adopting the model I set out below does not guarantee that
policies will be “effective”; but it does provide a way to ﬁlter out obvious
biases and to focus attention on scientiﬁc data and reasonably objective
assessments of arguments. Applying this framework allows interest groups
to continue making their voices heard, while it encourages decision makers
to obtain information from more neutral sources as well.

Several factors are important for developing sound health policies.
First, to the extent possible, the policymaker should be objective and dis-
passionate. This means that decision makers should have no conﬂict of
interest or improper ﬁnancial or professional incentive. Policymakers
should be able to understand the data and arguments presented, to assess
them reasonably objectively, and to balance competing values fairly. In
many areas of health policy, it is not necessary or even desirable for policy-
makers to be “experts” themselves, as long as they have access to expert
advice.

Second, policymaking bodies should be publicly accountable for their
decisions. If science or existing societal values do not support a decision, a
democratic means for altering the decision is often desirable. Democratic
societies thrive on the principle that government action that affects indi-
viduals and communities is subject to public review. Periodic elections
provide an opportunity for the public to demand explanations and for
public ofﬁcials to articulate and justify their decisions.

At least one kind of health policy is not always best made through fully
accountable decision makers: the kind that fundamentally affects the hu-
man rights of individuals and minority communities. Health policies that
seriously burden individual rights to liberty, privacy, and nondiscrimina-
tion may require judicial, rather than majoritarian, determinations. For
example, a fetal protection policy that excludes all women from unsafe
work places to promote the health of infants may violate fundamental
rights of nondiscrimination. In johnson Controls, the US. Supreme Court
unanimously ruled that a fetal protection policy was discriminatory even
though the company presented some scientiﬁc evidence that the fetus of a
pregnant worker could be at risk.4

Third, the decision making body should be positioned to receive and

338 SOCIETY'S CHOICES

to evaluate full and objective information on all aspects of a health policy.
Government entities often have access to a great deal of information, but
assessing the reliability of that information may be difﬁcult. judges receive
information from legal advocates as well as “experts” selected by each side
of a case; likewise, legislators and executive ofﬁcials receive information
from a wide array of lobbyists and professional groups. Policymakers may
recognize that information is coming from a potentially biased source, but
may have difﬁculty weighing the relative value of the information they
receive.

In addition to receiving information from the wide variety of tradi-
tional sources, policymakers need access to objective and complete infor-
mation from reasonably neutral sources. This includes data and argument
on the scientiﬁc, ethical, social, and legal aspects of the issue. Decision
makers may seek information from one or several different objective
sources in order to develop sound health policy.

Fourth, policymakers must have well—considered criteria for making
the decision. Objective criteria help to guide decision makers in formulat-
ing goals, selecting means, and establishing the scientiﬁc, social, and ethi-
cal parameters for decision making. They also reduce the arbitrariness or
biases that often are inherent in decision making processes. I suggest the
following steps to guide policymakers:5

(a) Examine the public health interest. Does the proposed policy seek to
achieve a compelling health objective? The policymaker should clearly and
narrowly deﬁne the health purpose(s) of the policy. This protects against
biases in decision making, helps communities to understand the policy
rationale, and facilitates public debate.

(b) Examine the overall effectiveness of the policy. Is the proposed policy
likely to be effective in achieving the stated goal(s)? This step requires an
assessment of whether the policy is an appropriate intervention to achieve
the stated objectives and whether it is reasonably likely to lead to effective
action. The policymaker should gather scientiﬁc data and apply logic to
analyze whether a policy will be effective.

(c) Evaluate whether the policy is well-targeted. Is the proposed policy
narrowly focused on the health problem? A decision maker should deter-
mine whether a policy is narrowly tailored to address the speciﬁc health
problem, or whether it is over— or underinclusive. Overbroad policies tar-
get a population that is much larger than necessary to achieve the health
objective. For example, the Bush and Clinton policy that interned or
repatriated all Haitian refugees with HIV infection was overbroad, because
it affected all of the group, regardless of whether individuals engaged in
safe sex or other practices. It adversely affected individuals who did not
pose a signiﬁcant risk of transmission of HIV.6

FORMULATION or HEALTH POLICY 339

(d) Identify the human rights burdens. This step requires an inquiry into
the nature, invasiveness, scope, and duration of human rights violations.
Does the policy interfere with the right to liberty, autonomy, privacy, or
nondiscrimination? For example, a policy that requires women to use
contraceptives as a condition of receiving welfare beneﬁts might interfere
with the right to reproductive privacy and discriminate against women
(because the policy does not apply to men) and the poor (because the
policy does not affect higher-income women). It may also burden the
social and economic rights of dependent children if beneﬁts were with-
drawn.

(e) Examine whether the policy is the least restrictive alternative. A policy-
maker should assess whether the health objective could be achieved as well,
or better, with fewer restrictions on human rights. This step helps to
ensure that a policymaker considers alternatives that may better accommo-
date societal and individual interests.

Fifth, the policymaker should pursue a fair process to arrive at the
decision. This requires a careful examination of all relevant facts and
arguments. Procedures may include inquisitorial or adversarial hearings,
investigations, or other rigorous methods for ﬁnding facts and examining
arguments. A fair process requires that all persons or organizations that
have a legitimate interest in the outcome should have a reasonable means
of presenting evidence or arguments. Careful attention to decision mak-
ing processes achieves both more accurate fact ﬁnding and greater equality
and fairness to interested individuals and groups.

These ﬁve elements of policymaking (impartial decision making, ac-
countability, collecting full and objective information, applying well—con-
sidered criteria, and following a rigorous and fair process) are often help-
ful in developing sound health policies. In the following section, I apply
these criteria to decision making by each of the three branches of govern—
ment and assess which bodies are most capable of resolving which health
policy problems and why.

GOVERNMENT BODIES AND THE CAPACITY TO
ADDRESS HEALTH ISSUES EFFECTIVELY

The Judiciary

In theory, thejudiciary provides the least ideal forum for the develop-
ment of many health policies. Certainly,judges are thought to be impartial
and able to assess evidence and arguments from a variety of sources objec-
tively. However, many judges are insulated from public accountability.
They are appointed by political ﬁgures, often for their political ideologies;

340 SOCIETY’S CHOICES

they may have long-term or life appointments; and many are not subject to
election or reappointment. judges usually bring legal skills to the bench;
they may lack experience with scientiﬁc or ethical thinking. They rarely
receive education or training in health issues.7

More importantly, the adversarial nature of judicial proceedings mili-
tates against a prominent role forjudges in health care policy formulation.
The information that judges receive is often partial and incomplete; also,
attorneys usually present narrow legal arguments that may not endorse the
most desirable policy position. The legal system frequently assumes judges
can produce a balanced, accurate decision after hearing two extremist
versions of an issue. Yet, each version may be biased or unreliable. Courts
lack the tools for assessing the validity of complex scientiﬁc or technologi-
cal evidence and arguments. Courts rely on “expert” witnesses. However,
expert witnesses are usually paid for their testimony; this presents a conﬂict
of interest. Also, they may not be the most qualiﬁed in their ﬁelds, and
they may offer opinions that the majority of their peers do not accept and/
or that may not have been subjected to adequate scientiﬁc inquiry.

In Daubert v. Mmell Dow Pharmaceuticals, the US. Supreme Court ruled
for the ﬁrst time on the place of scientiﬁc evidence in federal proceedings.8
The decision involved an appeal about whether the drug Bendectin caused
birth defects. The federal district court and the court of appeals had
dismissed the lawsuit, ruling that data concerning birth defects were
inadmissible because they were not “generally accepted” in the scientiﬁc
community.

The Supreme Court rejected the “general acceptance” standard that
looked to the conclusions of the expert witness, and it took a broader view
of the scientiﬁc process, with an emphasis on “methods and procedures."
The Court established judges as active gatekeepers charged with insuring
that “any and all scientiﬁc testimony or evidence admitted is not only
relevant, but reliable.” It asked judges to screen out ill—founded or specula-
tive scientiﬁc theories. The Court held thatjudges should focus on the
reasoning or methodology behind scientiﬁc testimony, rather than on
whether the conclusions of an expert witness have won general acceptance
in the scientiﬁc community. Speaking for the Court, Justice Blackmun
said, “In order to qualify as scientiﬁc knowledge, an inference or assertion
must be derived by the scientiﬁc method” and must have been tested or at
least subject to testing. While publication in a peer reviewedjournal was
not essential, it was relevant.”9 In dissent, Chiefjustice Rehnquist,joined
by justice Stevens, warned that the decision would require judges to be-
come “amateur scientists.“

The Daubm case may well enable judges to assess expert testimony with
somewhat greater reliability by reference to the scientiﬁc method. But, as
justice Blackmun stated, “There are important differences between the

FORMULATION OF HEALTH POLICY 341

quest for truth in the courtroom and the quest for truth in the laboratory.”
These differences still place courts in a uniquely difﬁcult position to assess
health policy. Courts must frame their questions under the terms ofa case
or controversy and the applicable law. Courts do not adopt criteria to help
them assess the benefits and harms of a health policy; they only resolve
whether a policy is lawful. Also, courts rarely appoint neutral experts.
Accordingly, even if they are able to ﬁlter out confounded scientiﬁc theo-
ries, they lack access to the objective expertise necessary for developing
health policy. Courts could considerably enhance their ability to assess
scientiﬁc questions if they systematically appointed neutral experts paid
only by the state. Appointed experts could help the court perform a thor-
ough, objective examination of the state of the science, which is essential
for sound decision making.

Despite these numerous disadvantages courts have been instrumental
in developing several important health policies. I will discuss three areas
where courts have made major contributions to health policy—reproduc-
tive rights, the right to die, and mental health. The important role of the
judiciary in the field of reproductive rights has been well discussed.10 Be-
ginning with the seminal cases of Gn'swold 1). Connecticut” and, later, Roe v.
Wade,12 the courts for nearly two decades defended the reproductive rights
of women. The Supreme Court found a constitutional right to “privacy”
even though no mention of the concept appears in the Bill of Rights. The
courts used the newly construed right to privacy to prevent the state from
interfering with the sale and distribution of contraception.‘3 The Supreme
Court explained that contraception concerns “the most intimate of human
activities and relationships.”14

The Supreme Court stated that the constitutional promise of privacy
protects not only the right to use contraception, but also the right to
decide whether to carry a fetus to term.15 It defended a woman’s right to
choose, and the privacy of her relationship with her physician, through the
mid-19805.16

In recent years, the changing composition of the Supreme Court has
led to a significant erosion of reproductive rights and medical privacy. The
Court upheld the authority of the state to restrict the use of public employ-
ees and facilities for the performance of nontherapeutic abortions.l7 The
Court also upheld a Department of Health and Human Services regulation
prohibiting federally funded family planning clinics from counseling or
referring women for abortions.18 The DHHS regulation became known as
the “gag rule" because it prohibited funded programs from providing
women with objective clinical information about reproductive choices. In
Planned Parenthood of Southeastern Pennsylvania v. Casey,19 the Supreme Court
changed the legal standard by which to evaluate restrictions on abortion.
This decision will have a profound effect on access to reproductive health

342 SOCIE'I‘YXS‘ (11101055

care.20 It will allow states to place restrictions on access, such as require-
ments that abortions be performed in hospitals that are not publicly
funded; restrictions on the timing, such as waiting periods for abortions;
and mandatoryjustification and information requirements, such as limit-
ing the reasons women can use for an abortion and requiring the doctor to
present state-approved information.” This shift in the composition and
decision of the Supreme Court vividly shows how changeable the courts
can be in assessing health policy and defending human rigth.22

Many argue that the development of the right to privacy from 1965
through the early to mid‘1980s had profound, positive effects on reproduc-
tive policy. Neither the legislative nor the executive branch produced
similarly clear and consistent policies on contraception and abortion. Cur—
rent efforts in Congress (e.g., the Freedom of Choice Act) and in state
legislatures to protect reproductive privacy use the same “fundamental
rights” analysis that the Supreme Court employed in 1306.23 Courts also
developed thoughtful rulings on surrogate motherhood24 and artiﬁcial
reproduction that some state legislatures are emulating.25

The judiciary has also displayed leadership in formulating policy
around the right to withdraw life-sustaining treatment, beginning with the
Karen Ann Quinlan decision of the New jersey Supreme Court in 1976.26
While the US. Supreme Court has rarely extended the right to privacy
beyond reproductive decisions,27 many state courts have interpreted the
federal and state constitutions as conferring a right to refuse life-sustaining
medical treatment.28 The court in Buuvia held that a patient’s decision to
forego medical treatment “is a moral and philosophical decision that, be-
ing a competent adult, is hers alone.”‘-"~’ The right to refuse medical inter-
vention has been extended to persons who have become incapable of mak-
ing a decision30 and those who have always been incapable.“ The courts
have almost uniformly respected the decisions of surrogates, particularly
family members, in making choices for persons who could not decide for
themselves.32

The courts have defined the circumstances under which treatment
could be terminated with greater specificity over the years. Most courts
have rejected the distinction between withholding and withdrawing treat—
ment, between ordinary and extraordinary treatments, and between termi-
nally ill and nonterminal cases. The courts have protected the right to
refuse treatment in cases involving ventilators and blood transfusions, as
well as those involving nutrition and hydration.33 Many courts have set out
procedures and criteria for decision making ranging from second opin-
ions, prognosis, and ethics committees:H to ombudsmenf”

Despite the courts' own insistence that legislatures would make these
decisions better, thejudiciaiy has formulated much of the policy surround-
ing termination oflife-stistaiiiing treatment. Only recently has the locus of

FORMULA ’1‘]()N or HEALTH POL/er 343

policy begun to shift to federal and state legislatures. The Supreme Court’s
decision in szan provided an impetus for the move to legislative policy-
making on the right to die}‘6 In (Iruzan, the US Supreme Court upheld
the decision of the Missouri Supreme Court to adopt a clear and convinc-
ing evidence standard for the termination oflife-sustaining treatment. The
Supreme Court never mentioned the word “privacy" in its decision. In-
stead, it found that competent patients had a “liberty interest” to refuse
treatments. The Court did not view the individual's liberty interest as
“fundamental”; this suggested that the state interest in preserving life could
prevail.

Legislatures began to conceive of ways in which the decisions of per-
sons to refuse life-sustaining treatments could be more routinely respected.
In her concurrence in szan, justice O'Connor gave some guidance by
suggesting that the Court might in the future constitutionally protect the
advance directives of patients. In 1990, Congress enacted the federal Pa-
tient Self-Determination Act, with an implementation date of December 1,
1991. The Act conditions health care providers’ receipt of Medicare or
Medicaid dollars on their provision of written information at the time of
admission about patients’ rights under state law to accept or refuse medical
treatment and to formulate advance directives. Since szan, state law on
advance directives has increasingly been crafted by legislatures.

The field of mental health policy shows a similar pattern ofjudicial
leadership followed by legislative enactment. During the 1970s, the courts
began a process that would transform mental health policy in America.
The courts struck down mental health statutes as unconstitutionally vague
and insufficiently related to the states’ valid interests in protecting the
public from harm.37 The courts refused to allow broad discretionary lan-
guage in civil commitment statutes ifit described psychiatric decision mak-
ing purely in medical terms, such as “mentally ill,” “in need of treatment,”
personal “welfare,” or “best interests.” Nor would the courts allow civil
commitment in the absence of rigorous due process including the right to
notice, counsel, and a hearing?“ The courts constitutionally required the
standard of proof at civil commitment hearings to be more than a prepon—
derance of evidence; typically, commitment demands “clear and convinc-
ing evidence.”9 More recently, the courts also developed standards for
refusal of treatment by persons with mental illness:m Mental health legisla-
tion in America has been fundamentally reformed to comply with the
constitutional requirements set by thejudiciary.

I do not argue here about whetherjudicial policies in these three areas
have been effective. Some have claimed that abortion cases too rigidly
adhered to the scientiﬁcally and socially questionable trimester framework;
that the right to die cases gave insufﬁcient weight to the need to preserve
life; and that the mental health cases led to a decade of deinstitutional-

344 SOCIETY’S CHOICES

ization that increased human suffering, homelessness, and violence in
America. I do observe that thejudiciary has had a profound, lasting effect
in these and other areas of health policy, which other branches of govern-
ment have emulated.

What factors made these issues particularly suited forjudicial decision
making? At least one of three factors was common to each of these areas of
health policy. First, each issue involved emotionally charged social ques-
tions that divided the public. The right to life is perhaps the single most
controversial and enduring problem in health policy formulation. The
issue of preservation of life is central to both abortion and termination of
life-sustaining treatment. While the mental health cases do not engender
the same emotion, they still involve sharp differences between profession-
als and civil libertarians about the right of society to confine and to treat
persons with mental illness. Indeed, the culture of the time inﬂuenced
much of the discourse, and ultimately, litigation. Rosenhan’s “ On Being
Sane in Insane Places,”1 Szasz’s “Myth of Mental Illness/’42 and Goffman’s
“Asylums”43 each symbolized the antipsychiatry movement of the day.
Courts in some ways are uniquely suited for dealing with such areas of
social divisiveness. They can often remain aloof from the controversy and
rely on “neutral” legal doctrine. The legislative and executive branches of
government are more vulnerable to interest groups, lobbyists, and ﬁnan-
cial pressures.

The second factor common to at least one of these health issues is the
absence of formal policy existing at the time of the litigation. When the
New Jersey Supreme Court was deciding Karen Quinlan’s case, there was
little legislative or executive guidance on the termination oflife-sustaining
treatment. The court was simply deciding the case with which it was pre—
sented. It had to craft a reasoned decision based upon traditional legal and
ethical principles: respect for persons, autonomy, and privacy. The courts
that followed Quinlan had to look to priorjudicial decisions in otherjuris—
dictions because the legislatures, for the most part, still had not acted.44
The courts in the right—to—die cases appeared to be ﬁlling a vacuum in
policy. This second factor suggests that the courts are more likely to inter—
vene in areas where there was lack of consensus or established policy.

Prior to 1973, some liberalization in the scope of lawful abortions was
evident in several legislatures, but few statutes approached the breadth of
the privacy right decreed by the court in Roe. Most of the existing legisla-
tion was haphazard and inconsistent. It often did not balance individual
interests with those of the state.“ It is an open question as to whether the
Supreme Court would have intervened in quite so decisive a manner if
more settled policy on abortion rights had existed. The Court moved, at
least in part, because of the absence of a national consensus on the issue.

judicial decisions in mental health cases, unlike abortion or right-to-

FORMULA TION OF HEALTH POLICY 345

die cases, did not simply ﬁll a policy vacuum. At the time of this litigation,
all 50 states had civil commitment statutes that were fairly uniform in con—
tent. The courts appeared to usurp the ﬁeld by requiring the legislatures
to enact new statutes to comply with constitutional guarantees.

The judiciary, then, has sometimes acted as a pathﬁnder when there
was a paucity of established policy. In an atmosphere of uncertainty in
health policy, the courts can answer questions on a case-by-case basis. It is
only after years of case law that a consistent policy emerges and gains
public acceptance. At that time, the legislature can begin its work in
clarifying and codifying policy choices.

A third characteristic shared by all three health issues is the presence
of a fundamental claim to human rights by individuals and groups. These
human rights claims weighed heavily in the balance of scientiﬁc, social, and
ethical issues. In the ﬁelds of reproductive rights and the right to die, the
courts repeatedly echoed the theme of individual choice, self—determina-
tion, and privacy. In the mental health cases, the courts emphasized funda-
mental claims to due process and liberty. This third factor (i.e., the central
importance of human rights) is likely to be the most important in deciding
whether the courts will, or should, intervene in signiﬁcant cases of health
policy. Unlike the executive and legislative branches of government, the
courts are suited to protect the rights of individuals or groups. They are
less concerned with pleasing the majority and less likely to give in to
majoritarian pressures that may oppress vulnerable individuals or groups
or restrict their rights. The judiciary also has appropriate criteria and
procedures for ensuring the protection of individual rights. Courts can
invalidate oppressive state action through constitutional review, and can
protect minorities through civil rights decisions.46 While the legislature or
executive may focus more strongly on using science to promote the health
of the community, these two branches sometimes overlook or insufﬁciently
weigh human rights concerns. Where human rights become a deﬁning
value in health policy, courts may be the most appropriate body to make
decisions.

The Legislature

If the judiciary is the least suited branch of government to develop
health policy in many areas, the legislature may be the most suited. The
legislature is thought to be impartial and publicly accountable; it has the
capacity to collect full information from a wide range of objective sources;
part ofits mandate is to protect and promote the health of the public; and
it has the power to engage in a lengthy and deliberative process in enacting
legislation.

Classic American federalism suggests that the legislature possesses spe-

346 SOCIETY is (11101055

cial authority to develop policy.47 In essence, the power to make law re-
poses exclusively in the legislature, though it may delegate rule-making
and regulatory powers to departments in the executive branch. Thejudi-
ciary and the executive (apart from the veto power) are not permitted to
intrude into its legislative powers. Article I, Clause 8, of the US. Constitu-
tion empowers Congress to “make all Laws which shall be necessary and
proper for carrying into Execution. . . . the powers vested by this Constitu-
tion in the Government of the United States, or in any Department or
Ofﬁces thereof.” The state legislatures have police powers to protect and
promote the health, safety, and morals of the community.“ This power
may establish the legislature as the appropriate policymaking body in most
circumstances.

In theory, neither the executive nor the judiciary has a mandate to
create health policy. The court system, apart from its historic role of
constitutional or judicial review,49 principally interprets, construes, and
applies the law. Moreover, the federal courts exercise their powers only to
resolve “cases” or “controversies" (Article III). The principal power of the
executive in domestic affairs is to carry the laws into effect and secure their
observance.50 The scope of executive rule making cannot constitutionally
reach beyond the bounds of the applicable legislation.51 Thus, while the
various agencies of the federal and state governments that deal with health
can powerfully affect policy through rule making, the direction and limits
are placed by the legislature.

Democracies usually pride themselves on having elected legislatures
that are independent and fully accountable to the public. It is for this
reason that so much concern is focused on tightening legal and ethical
rules for ﬁnancing campaigns, controlling lobbyists and pressure groups,
and prohibiting conﬂicts of interest. To be sure, questions remain about
whether legislators have ﬁnancial conflicts of interest or have been unduly
inﬂuenced. Nevertheless, legislators must meet increasingly strong legal
and ethical standards and are subject to periodic elections.

Legislatures are also appropriate policymakers because they draw on
the experience of a diverse membership and staff. Importantly, they can
collect information from a wide variety of sources. Legislative committees
receive written and verbal suggestions from interested groups, and often
request information from more objective sources.

Legislatures, if provided with adequate resources, can establish stand-
ing bodies designed to help gather and analyze the scientiﬁc data necessary
for sound policy development. They can also create commissions to advise
on particular health policy issues such as AIDS52 or bioethics. Congress’s
Ofﬁce of Technology Assessment (OTA)53 provides an apt model of a
standing advisory body. The OTA is an analytical support agency of the
US. Congress. It helps congressional committees understand policy that

FORMULA ’I‘ION OF HEALTH POLICY 34 7

often involves highly complex technological issues. Congress can frame
health policy questions that are most useful to its legislative agenda and
receive timely assistance. The OTA can issue contracts and assemble inter-
disciplinary working groups to obtain specialized information. The OTA
has provided extensive data and analysis to Congress in numerous areas of
health policy ranging from the human genome to HIV disease54 and tuber-
culosis.“

Congress can also request studies from the US. General Accounting
Office on health policy issues. Recent reports of the General Accounting
Office include studies of organ transplantation,56 needle exchange pro-
grams,57 and Medicaid.58

While legislatures rarely operate according to clear, written criteria,
their constitutional mission to preserve the health, safety, and morals of
the community sets the parameters for their activities. Moreover, legisla—
tures can require committees to observe the criteria for sound decision
making that have already been suggested—Le, to establish policies that are
effective, well-targeted, and minimally burdensome of human rights.

Legislatures have the capacity to follow a rigorous, fair decision mak—
ing process. Legislative hearings can be thorough and expansive in ways
that are simply not feasible in other branches of government. While judi-
cial hearings are adversarial in nature, legislative committees may use many
methods to gather information and hear from interested parties. Legisla-
tures may provide forums to review societal perspectives, as Congress did in
the hearings involvingjustice Clarence Thomas; they also can invite inter-
est groups, consumers, professionals, and academics to present testimony.
In sum, legislatures can garner a massive amount of information in open,
impartial ways that make them strong candidates for sound policymakers.

There are, of course, major detriments to legislative policymaking.
First, most legislators belong to political parties whose partisan character
may lead them to View policy issues through a narrow lens. Rather than
independently seeking the most effective health policy, leaders of a politi—
cal party may powerfully inﬂuence legislators. For example, the 1992 presi-
dential candidates spent a great deal of time discussing the “gridlock” in
Congress. On almost every policy issue of consequence, political parties
found little common ground. Indeed, when particularly divisive issues
such as abortion policy or fetal tissue research are at stake, entire pieces of
legislation can be thwarted through noncooperation, filibusters, and threats
of a presidential veto from the opposing political party.

Second, legislators may be indebted to particular individuals and
groups that helped them to get elected. Financing modern political cam-
paigns is extraordinarily expensive. Legislators may have to think long and
hard before making decisions against the interests of large contributors.
For example, substantial contributions from the pharmaceutical, tobacco,

348 SOCIETY’S CHOICES

agricultural, or automobile industries can strongly inﬂuence legislators’
judgments on policies affecting the public health and safety.

Third, legislators are highly sensitive to well—organized interest groups.
These include professional associations such as the American Medical As-
sociation (AMA) or American Bar Association (ABA). These organizations
are perceived to be able to inﬂuence a large number of voters. A legislator
may be concerned as much with the way he or she will be viewed by power-
ful interest groups as with the impact of the health policy under consider—
ation. Many health policy analysts, for example, believe that Medicare
beneﬁts should be modiﬁed to provide more cost effective coverage for
persons who can least afford health insurance. Yet, this is a politically
difﬁcult area to tackle because of the inﬂuence of organizations represent-
ing older populations. Similarly, legislators often give deference to the
plaintiff’s bar on medical malpractice or the AMA or health insurers on
health care reform.

Fourth, legislators frequently operate on a limited horizon. Legislators
are elected for a short term, and may not be interested in the longer term
beneﬁts of a policy. They may, for example, be concerned more with the
immediate electoral problems caused by increased taxes necessary to pro-
vide universal health care coverage, than with the long—term health and
ﬁnancial beneﬁts of reforming the health care system.

The Americans with Disabilities Act (ADA) provides an illustration of a
statute that fulﬁlls all of the promise of the legislature as an effective
policymaker. While the ADA provides a strong weapon against discrimina—
tion against persons with disabilities, its impact on the health care system is
less well understood. Several areas of impact on the health care system
have been observed by courts and commentators: the duty of health care
professionals to treat patients with disfavored health conditions such as
AIDS, the duty not to discriminate in health care beneﬁts coverage, and
the duty to exercise compulsory public health powers fairlyf”9

The ADA was born of a remarkable coalescence of the interests of a
large and diverse group of people. The act was supported by groups repre-
senting persons with disabilities, civil liberties groups, AIDS advocacy orga—
nizations, and mental health associations. It was supported on a broad
bipartisan basis with leadership from Republicans (e.g., Senators Dole and
Weicker) as well as Democrats (e.g., Senator Kennedy and Congressman
Waxman). Notably, it had the support of President Bush, who signed
legislation passed by a Democratic Congress.”61

The ADA is the latest in a series of statutes enacted by Congress that
proscribe discrimination on the basis of race, sex, age, and disability. These
accomplishments in the ﬁeld of civil rights are widely perceived as critically
important policies that have been the preserve of the legislative branch of
government. More recently, many state legislatures have enacted antidis—

FORMULA TION OF HEAL TH POLIC Y 3 4 9

crimination statutes to protect persons with HIV infection or disease62 or
persons with genetic traits or conditions.63

What are the qualities of the legislative process that made it possible to
achieve the social good that has emerged from civil rights legislation? And
why has the legislature had such difﬁculty replicating this success in other
areas where social change is equally imperative, such as health care re-
form?

The success of legislatures in the ﬁeld of civil rights is largely attribut-
able to the growing consensus in society about the evils of discrimination
based upon personal characteristics such as race, sex, disability, or health
status. Historians may well observe one striking feature in the passage of
the ADA. There was widespread consensus around the antidiscrimination
principles inherent in the legislation. The legislative debates literally rang
with the Virtues of equal opportunity and human rights for persons with
disabilities in society;64 diverse interest groups came together and worked
in a coordinated fashion in their lobbying efforts; and there was an absence
of a vocal and organized opposition.

Even the individuals and groups that would have been expected to
stand in the way of these changes refrained from doing so. Conservative
persons in Congress never actively opposed the legislation, but narrowed
their objections to certain “undeserving” groups such as drug users, homo-
sexuals, and persons with psychiatric disorders involving antisocial behav—
ior or gender identity.65 They also objected to parts of the ADA that fed
directly into the fears of the public, even though those fears were not
supported by the epidemiologic evidence. Considerable congressional
debate was engendered concerning food handlers with HIV infection. A
compromise was ultimately reached to direct the Secretary of Health and
Human Services to prepare a list of food-borne diseases where persons
could be restricted from working in the food service industry.66 Predict-
ably, when the list was published a year after the passage of the ADA, HIV
disease was not mentioned by the Secretary.*

The absence of significant opposition to the ADA was due, in part, to
the fact that in wider society it was becoming culturally and socially inap-
propriate to vocally oppose civil rights for persons with disabilities.

*The desire to override antidiscrimination principles for persons infected with HIV contin-
ued in Congress after the enactment of the ADA. The Kimberly Bergalis Act required states
to determine whether HIV—infected health care professionals could safely practice invasive,
exposure-prone procedures. The statute was passed despite the opposition of virtually all of
the national medical and public health associations. Similarly, Congress added HIV infec-
tion to the list of dangerous contagious diseases that would allow compulsory screening and
exclusion of travelers and immigrants. The smtute was passed against the advice of the
Department of Health and Human Services.

350 SOCIETY‘S CHOICES

The experience of the passage of the ADA suggests that the legislature
can most effectively act in situations where it is implementing the will of
society, where pressure groups act in unity, and the opposition is muted.
This is true majoritarian politics. When it works, it can provide powerful
and lasting benefits to society. The problem, however, is that legislative
processes rarely work in an atmosphere of consensus, especially in the
highly controversial health policy arena.

In health policy, the issues are often bitterly contested and divisive.
One disease may be pitted against another. For example, legislators may
be lobbied to divide scarce resources between competing diseases such as
AIDS, tuberculosis, cancer, heart disease, and mental illness67 or between
competing segments of the health care industry such as prevention, acute
care, long-term care, and research. The interests of patients may be pitted
against those of health care professionals. A pertinent case is the ongoing
struggle between doctors and patients for the “right to know” the HIV
status of the other. Struggles between generations are even apparent as
debates ensue about who should bear the financial burden of paying for
health care and who should receive the benefits—the young versus the old,
the poor versus the rich, the healthy versus the sick.

A classic example of legislative failure to produce a badly needed pub—
lic benefit is in health care reform.“ Health care reform, on its face, ought
not to be inordinately difficult for legislatures. A substantial majority of
Americans express dissatisfaction with the health care system.69 Indeed,
both candidates in the 1992 presidential campaign supported health care
reform.”71

The current system has failed to provide universal access to health care
with an equitable sharing of'benefits and burdens. An estimated 37 million
people do not have health care coverage, with many more people inad-
equately covered.” Disparities in access to health care and poor health
outcomes have been shown on grounds of socioeconomic status,“74 race
and ethnicity,” and gender.76

The current system has also failed to control escalating health care
costs relative to health care expenditures in other countries. The United
States spent more than $666 billion on health care in 1990, approximately
12 percent of the nation's gross national product.77 Health care expendi-
tures are projected to reach $1.6 trillion, between 16 and 18 perent of the
gross domestic product by the end of the decade if effective controls are
not instituted.”

Given the fact that the current system appears not to serve the interests
of large numbers of individuals, as well as the ﬁscal interests of American
society, one would have expected (longress to act. Prominent members of
Congress have worked on commissions and other initiatives to accomplish
that objective,79 and congressional committees have conducted many hear-

FORMULA TION 01" Hm 1. TH POLICY 35]

ings. The gridlock can probably be attributed to the powerful interest
groups whose vision of reform differs substantially. Organized medicine is
concerned with limits on the doctor’s income and freedom to practice; the
organized bar is concerned about malpractice reform; the health insur-
ance industry is concerned about its survival and the ability to continue
traditional underwriting practices; consumers worry about loss of the abso-
lute right to choose their doctor; and the business community and taxpay-
ers are concerned about the cost. The ability of Congress to rise above the
strong competing interests and inﬂuences to provide a fair and effective
health care system remains in doubt.

The Executive

The executive branch of government brings to health policy formation
many of the same benefits as the legislature. The executive branch can be
both objective and accountable. Certainly, the chief executive is a political
party ﬁgure subject to many of the ingrained ideologies that many politi-
cians bring to their decision making. Yet, as the head of his or her party,
the chief executive may be free to divert from party political positions or to
change those positions. The executive branch, moreover, usually has many
agencies concerned with health and social policy. Individuals who work in
those agencies often are not connected to political parties and bring a wide
body of knowledge and expertise to their ﬁelds. This creates enormous
possibilities for impartial, accountable, and comprehensive assessments of
health policy.

In many ways, the executive branch of government is in the best posi-
tion to marshall all of the evidence, data, and reasoning necessary for the
formulation of sound health policies. The U.S. Department of Health and
Human Services, for example, has an unequaled capacity to obtain data in
areas of clinical and policy research (e.g., the National Institutes of Health
and the Agency for Health Care Policy and Research), prevention and
public health strategies (e.g. the Centers for Disease Control and Preven-
tion), and financial impacts (e.g., the Health Care Financing Administra-
tion). While the executive branch does not hold hearings like thejudiciary
or the legislature, it can solicit written and oral comment from organiza-
tions and experts. It frequently holds open meetings to discuss public
health strategies.“ It can, moreover, receive rigorous assessments of difﬁ-
cult health science and policy questions through contracts and grants with
research institutions.

Presidents and governors can use their agencies wisely to achieve sub-
stantial health benefits for the public. The Human Genome Initiative, for
example, was designed not only to answer many of the essential scientiﬁc

35 2 SOCIETY 13‘ CHOICES

questions about the detection, prevention, and treatment of genetic condi—
tions, but also the ethical, social, and legal questions.81

The executive branch of government has considerable power to de-
velop, shape, and expand health policy through executive orders, rule
making, and interpretive guidance. The Equal Employment Opportunity
Commission (EEOC), for example, has been active in pursuing claims
under federal disability law. The EEOC has recently issued interpretive
guidance suggesting that the ADA prohibits discrimination in health
insurance coverage against particular individuals or groups with speciﬁc
diseases.82

Despite the signiﬁcant potential for the executive branch to develop
health policy with all the beneﬁts of the best research and rigorous assess-
ments, it has frequently failed to follow sound scientiﬁc recommendations.
This has resulted in administrations ignoring or rejecting the advice of
scientiﬁc and policy commissions. It has also resulted in substantial swings
in health policy from one administration to the next. The probable reason
for discounting the objective advice of its agencies and commissions is that
the executive, perhaps more than any other branch of government, is
ideologically driven.

Many illustrations can be found to demonstrate the fragility of the
commitment of administrations to neutral scientiﬁc assessments of health
policy. The Reagan and Bush administrations both refused to allow federal
funding for fetal tissue research in spite of the recommendation of an NIH
advisory panel. President Reagan barely acknowledged the work of the
President’s Commission on AIDS. The Commission reported after exten-
sive investigation, and made hundreds of recommendations. The only
recognition the Administration gave to the 200-plus—page Commission re-
port was a short press release. The Commission’s central recommenda-
tions were never implemented.83 Later, the National Commission on AIDS
complained vehemently about being ignored by President Bush.84 Very
few of the recommendations made in several reports were ever seriously
considered in the White House.85

Administrations sometimes act in ideological ways that anger virtually
all of the health policy community. In McGann, a federal court of appeals
held that an employer who reduced an employee’s health coverage from
$1 million to $5,000 after he made claims for HIV disease had not unlaw-
fully discriminated under ERISA.86 Many public health and medical orga-
nizations ﬁled amicus curiae briefs asking the Supreme Court to overturn
the decision. Yet, the court decided not to hear the case largely because
the Bush Administration opposed the appeal.87

The disrespect administrations sometimes show for scientiﬁc advice is
also illustrated by substantial swings in health policy on controversial is-
sues. The behavior of successive administrations on reproductive health

FORMULATION OF HEALTH POLICY 353

policy provides a vivid illustration. For a dozen years Republican adminis-
trations developed and maintained highly restrictive policies on abortion
rights: (i) in a 1984 order known as the “Mexico City Policy,” President
Reagan prohibited the United States from providing foreign aid to family
planning programs that were involved in abortion-related activities; (ii) in
memoranda in 1987 and 1988, the National Institutes of Health placed a
moratorium on federal funding of research involving the implantation of
fetal tissue from induced abortions; (iii) by memoranda of 1987—1988, the
Department of Defense banned all abortions at US. military facilities, even
where the procedure was privately funded; (iv) in a 1988 regulation known
as the “gag rule,” the Department of Health and Human Services prohib—
ited family planning clinics funded under Title X of the Public Health
Service Act from counseling or referring women for abortion; and (v) in
two Import Alerts issued in 1988—1989, the Food and Drug Administration
excluded Mifepristone (RU-486) from the list of drugs that individuals can
import into the United States.

On the twentieth anniversary of Roe v. Wade, January 23, 1993, Presi-
dent Clinton signed ﬁve memoranda that repealed all ﬁve of these poli-
cies—reversing a dozen years of policy on reproductive rights and medical
privacy. The result of these sharp changes in policy by the executive is that
America never seems to attain a settled policy on the issue of reproductive
rights. The strongly ideological positions of the executive branch often
allows it to lose sight of the questions that are central to the development
of sound health policy—will the policy be effective in protecting and pro-
moting the health of the public and will it adequately safeguard human
rights?

CONCLUSION

As this paper is being written, the President’s Task Force on National
Health Care Reform, chaired by the First Lady, has completed its work, and
the President has sent a bill to Congress for systematic reform of the health
care system.88 The President and the First Lady have compared this initia-
tive of the executive to the Manhattan Project and the New Deal. The
President was able to marshal] the resources of several hundred experts
within and outside of government to fundamentally reform the ﬁnancing,
organization, and delivery of health care in the United States.

This will provide a unique opportunity to observe the workings of two
powerful branches of government on a health policy issue that can pro-
duce enormous social good for millions of Americans by enhancing their
access to care, reducing inequalities, and allocating beneﬁts and burdens
more equitably. Will the President and Congress jointly develop a new
health care system that is beneﬁcial andjust? Or will they become stalled in

3 5 4 SOCIETY’S CHOICES

conﬂict and paralyzed by competing interest groups and ideologies? As
years of careful thinking and writing on health care reform turns into a
season of political debate and decision, the strengths or inadequacies of
the two branches of government may become painfully obvious.

NOTES

1. E.g., National Research Council. AIDS: The Second Decade. Washington, DC: Na-
tional Academy Press, 1990.

2. E.g., Hastings Center. Guidelines on the Termination of Life—Sustaining Treatment and the
Care of the Dying. Briar Cliff Manor, NY, 1987.

3. New York State Society of Surgeons v. Axelrod, 77 N.Y.2d 677 (1991).

4. International Union, UAWv. johnson Controls, Inc., 499 U.S. 187 (1991).

5. A considerably more detailed “human rights impact assessment" is contained in Gostin
L., Lazzarini, Z., Public Health and Human Rights in the AIDS Pandemic. Geneva, Switzerland:
World Health Organization, in press.

6. Haitian Centers Council, Inc, v. Sale, 823 F. Supp. 1028 (E.D.N.Y. 1993).

7. In 1993, the U.S. Public Health Service conducted the ﬁrst PHS workshop for state
judges on tuberculosis and AIDS. See Costin, L., Lazzarini, 2., Tuberculosis, the Law, and Public
Health. Agency for Health Care Policy and Research, in press.

8. Daubert v. Merrell Dow Pharmaceuticals, 113 S.Ct. 2786 (1993).

9. Greenhouse L. justices putjudges in charge of deciding reliability of scientiﬁc testi-
mony. New York Times, June 29, 1993: A13.

10. Butler, ].I)., Walbert D.F., eds. 1992. Abortion, Medicine, and the Law, 4th ed. New
York: Facts on File.

11. Griswold 11. Connecticut, 85 S.Ct. 1678 (1965). See also Loving v. Virginia, 388 U.S.
1(1967); Eisenstadt v. Baird, 405 U.S. 438 (1972).

12. Roe v. Wade, 410 U.S. 113 (1973).

13. Griswold v. Connecticut, 85 S.Ct. 1678 (1965).

14. Carey v. Population Services International, 97 S.Ct. 2010 at 2016 (1977). See Eisenstadt v.
Baird, 405 U.S. 438 (1972).

15. Roe v. Wade, 410 U.S. 113 (1973).

16. See, e.g., City of Akron v. Akron Center for Reproductive Health, 462 U.S. 416 (1983);
Thornburgh v. American College of Obstetrics and Gynecologists, 476 U.S. 747 (1986).

17. Webster v. Reproductive Health Services, 492 U.S. 490 (1989).

18. Rust v. Sullivan, 111 S.Ct. 1759 (1991).

19. 112 S.Ct. 2791 (1992).

20. Benshoof,] Planned Parenthood v. Casey: The impact of the new undue burden stan—
dard on reproductive health care. jAMA 1993: 269:2249—2257.

2]. Dellinger, W. Abortion: The case against compromise. In: Butler,].D.,Wa1bert, D.F.,
eds. Abortion, Medicine, and the Law, 4th ed. New York: Facts on File, 1992: 90—98.

22. Van Alstyne, W.W. The cycle of constitutional uncertainty in American abortion law.
In: Butler,].D., Walbert, D.F., eds. Abortion, Medicine, and the Law, 4th ed. New York: Facts
on File, 1992:79—89.

23. Benshoof, op. cit.

24. In re Baby M., 217 NJ. Super. 313 (1987), mud in part, 525 A.2d 1128 (1988).

25. Yoon, M. The Uniform Status of Children of Assisted Contraception Act: Does it
protect the best interests of the child in a surrogate arrangement? Americanjoumal of Law
and Medicine 1990, 16:525-553.

26. In re Quinlan, 70 NJ. 10, 355 A.2d 647, cert. denied sub. nom., Garger v. Newjersey,
429 U.S. 922 (1976).

FORMULA TION OF HEALTH POLICY 355

27. See Bowers v. Hardwick, 106 S.Ct. 2841 (1986).

28. See, e.g.,john F Kennedy Memorial Hospital, Inc. v. Bludworth, 452 So.2d 921 (Fla. Sup.
Ct. 1984); In re Guardianship of Grant, 109 Wash. 2d 545, 747 P.2d 445 (1987), modiﬁed 757
P.2d 534 (Wash. july 15, 1988); Rasmussen 11. Fleming, 154 Ariz. 207, 741 P.2d 674 (1987);
Brophy v. New England Sinai Hospital, Inc., 398 Mass. 417, 497 N.E.2d 626 (1986). See Gostin,
L. and Weir, R., Life and death decisions after Cruzan: Caselaw and standards of professional
care. Milbank Quarterly 1991, 69:143—173.

29. Bouvia 11. Supreme Court (Glenchur), 225 Cal. Rptr. 297 (Ct. App. 1986).

30. E.g., In re Guardianship ofBrowning, 568 So.2d 4 (Fla. Sup. Ct. 1990); In re Severns, 425
A.2d 156 (Del. Ch 1980); In re Torres, 357 N.W.2d 332 (Minn. 1984).

31. E.g., In re Guardianship of Grant, 747 P.2d 445 (1985), modiﬁed, 757 P.2d 534 (Wash.
july 15, 1988); Superintendent of Belchertown State School 1;. Saikewicz, 370 N.E.2d 417 (Mass.
1977); In re Eichner (In re Storar) 438 N.Y.S.2d 266 (1981).

32. E.g., In re Guardianship ofIngram, 689 P.2d 1363 (Wash. 1984); In re Guardianship of
Hamlin, 689 P.2d 1372 (Wash. 1984).

33. See Rhoden, N.K. Litigating life and death. Harvard Law Review 1988, 1022375—446.

34. See, e.g., In re jobes, 529 A.2d 434 (NJ. 1987); In re Guardianship of Hamlin, 102
Wash.2d 810 (1984).

35. In re Conroy, 486 A.2d 1209 (NJ. 1985); In re Peter, 529 A.2d 419 (NJ. 1987).

36. Cruzan v. Director, Missouri Department ofHealth, 110 S.Ct. 2841 (I990).

37. E.g., Lessard v. Schmidt, 349 F. Supp.1078 (E.D. Wis. 1972);]ohnson 1). Solomon, 484 F.
Supp. 278 (D. Md. 1979).

38. E.g., Vitek v. jones, 445 U.S. 480 (1980); Colyar 11. Third judicial Dist. Court, 469 F. Supp.
424 (D. Utah 1979); Suzuki 11. Yum, 617 F.2d 173 (9th Cir. 1980).

39. Addington v. Texas, 441 U.S. 418 (1979).

40. E.g., Washington 1). Harper, 110 S.Ct. 1028 (1990); Mills v. Rodgers, 457 U.S. 291 (1982).

41. Rosenhan, D.L. On being sane in insane places. Santa Clara L. Rev. 1973; 13:379.

42. Szasz, T.S. The Myth of Mental Illness: Foundations of a Theory of Personal Conduct. 1961,
rev. ed. 1974.

43. Goffman, E. Asylums: Essays on the Social Situation of Mental Patients and Other Inmates.
Garden City, N.Y.: Anchor Books Doubleday, 1961.

44. The courts did have a growing body of ethics literature in this area to guide its deci-
sions, notably the President's Commission report.

45. George, 311- State legislatures versus the Supreme Court: Abortion legislation into
the 19903. In: Butler,_].D., Walbert, D.F., eds. Abortion, Medicine, and the Law, 4th ed. New
York: Facts on File; 199223—77.

46. See Gostin, L. The AIDS Litigation Project: A national review of court and human
rights commission decisions, Part II: Discrimination. jAMA 1990; 263:2086—2093.

47. For a comprehensive examination of the constitutional role of federaljudicial, legisla—
tive and executive power, see Tribe, L. American Constitutional Law, 2d ed., Mineola, N.Y.:
Foundation Press, 1988.

48. facobson v. Massachusetts, 197 U.S. II (1905).

49. Marbury v. Madison, 5 U.S. (1 Cranch) 137 (1803).

50. Tucker 11. State, 35 NE. 2d 270,291 (Ind. 1941).

51. American Medical Assn. v. Heckler, 606 F. Supp. 1422, 1439 (SD. Ind. 1985).

52. National Commission on AIDS. AIDS: An Expanding Tragedy, Final Report. Washing-
ton, D.C.: 1993.

53. U.S. Congress, Ofﬁce of Technology Assessment. Genetic Monitoring and Screening in the
Workplace. Washington, D.C.: OTA, 1990. The Role of Genetic Testing in the Prevention of
Occupational Disease. Washington, D.C.: 1983.

54. U.S. Congress, Ofﬁce of Technology Assessment. The CDC’s Case Deﬁnition of AIDS:

35 6 SOCIETY’S CHOICES

Implications of the Proposed Revisions—Background Paper. OTA-BP—H-89 Washington, DC: U.S.
Government Printing Ofﬁce, August 1992 (listing a dozen other OTA reports on HIV dis-
ease).

55. U.S. Congress, Ofﬁce of Technology Assessment, The Continuing Challenge of Tubercqu
sis, OTA-H—574 (Washington, D.C.: U.S. Government Printing Ofﬁce, Sept. 1993).

56. U.S. General Accounting Ofﬁce. Organ Transplants: Increased Effort Needed to Boost
Supply and Ensure Equitable Distribution. GAO/HRD—93—56, Washington, DC, April 1993.

57. U.S. General Accounting Ofﬁce. Needle Exchange Programs: Research Suggests Promise as
an AIDS Prevention Strategy. GAO/HRD—93—60, Washington, DC: March 1993.

58. U.S. General Accounting Ofﬁce. Medicaid: States Turn to Managed Care to Improve Access
and Control Costs. GAO/HRD—93—46, Washington, D.C.: March 1993.

59. Goston, L. The Americans with Disability Act and the U.S. Health care system, Health
Affairs 1992; 11:248—257.

60. West,]. The social and policy context of the Act. Milbank Quarterly 1991; 69 (Supp. 1/
2):3—24.

61. Gostin, L., Beyer, H., eds. Implementing the Americans with Disabilities Act: Rights and
Responsibilities of All Americans. Baltimore: Brookes Publishing Co., 1993.

62. Gostin, L. Public health strategies for confronting AIDS: legislative and regulatory
policy in the United States. jAMA 1989; 261:1621—1630.

63. Gostin, L. Genetic discrimination: the use of genetically based diagnostic tests by
employers and insurers. Americanjournal ofI.aw and Medicine 1991; 17:109—144.

64. See volume 136 of the Congressional Record,]uly 1990 for legislative history.

65. The ADA does not protect persons currently using illegal drugs ($510) or a range of
socially disapproved behaviors such as gender identity disorders, pedophilia, exhibitionism,
compulsive gambling, kleptomania and pyromania (5.511).

66. Report of the judiciary Committee, no. 101—485, part 3 (to accompany HR. 2273 at
146—147. See Gostin, L., Public health powers: the imminence of radical change. Milbank
Quarterly 1991; 69 (supp. 1/2):268—290.

67. Bayer, R. Public health policy and the AIDS epidemic. An end to HIV exceptionalism?
New Englandjoumal ofMedicine 1991; 324:1500—1504.

68. But see the successful reform efforts in several smtes such as Hawaii and Maryland.
General Accounting Ofﬁce. Access to Health Care: States Respond to the Growing Crisis. Washing-
ton, D.C.: Government Printing Ofﬁce; 1992.

69. Blendon, R. Bridging the gap between expert and public views on health care reform.
jAMA 1993; 263:2573—2578.

70. Clinton, B. The Clinton health care plan. New Englandjoumal ofMedicine 1992; 327—
804.

71. Sullivan, L. The Bush Administration's health care plan. New England journal of
Medicine 1992;327:801.

72. Bureau of National Affairs. Number of uninsured persons increases to 36.6 million in
1991. Daily Labor Report Jan. 12, 1993.

73. Wise, P.H., et a1. Racial and socioeconomic disparities in childhood mortality in
Boston. New England journal of Medicine 1985; 3132360.

74. Pear, R. Big health gap tied to income is found in U.S. New York Times. july 8,
1993:A1, B10.

75. Council of Ethical and judicial Affairs. Black-white disparities in health care. jAMA
1990; 26322344.

76. Ayanian,].Z., Epstein, A.M. Difference in the use of procedures between women and
men hospitalized for coronary heart disease. New Englandjournal ofMedicine 1991; 3252221.

77. Sullivan, L. The Bush Administration's health care plan. Op cit.

78. Congressional Budget Ofﬁce. Projections of National Health Expenditures. Washing-
ton, D.C.: U.S. Government Printing Ofﬁce; 1992.

FORMULA TION OF HEALTH POLICY 35 7

79. Rockefeller, IV,_].D. A call for action: the Pepper Commission's blueprint for health
care reform. jAIVIA 1991; 265:2507.

80. See, e.g., National Institutes of Health Workshop on Breastfeeding Research, july
1993.

81. US. Department of Health and Human Services and US. Dept. of Energy. Under-
standing Our Genetic Inheritance: The US. Human Genome Project: The First Five Years (FYI 991 —
1995). Washington, DC, 1990.

82. Equal Employment Opportunity Commission. Interim Enforcement Guidance on the Air
plication of the ADA to Disability-Based Provisions of Employer—Provided Health Insurance. june 8,
1993. See Freudenheim, M. Insurers accused of discrimination in AIDS coverage: Disability
law is cited. New York Times. June 1, 1993: A1. D2.

83. The White House. Implementing Recommendations of the Presidential Commission on Hu-
man Immunodeficiency Virus: The IO—Part Plan. August 2, 1988.

84. National Commission on Acquired Immunodeﬁciency Syndrome. Report Number
One, at p. 2, 6, December 5, 1989. See Rudavsky, 8., AIDS Panel Faults Bush Administration
Leadership. Washington Post,]une 25, 1992:A3.

85. Gostin, L. Preface to the Harvard Model AIDS Legislation Project: A decade of a
maturing epidemic: an assessment and directions for future public policy. American/currial
ofLaw and Medicine 1990; 16:1—32.

86. McGann v. HC‘J’H Music Company, 946 F.2d 401 (5th Cir. 1991), cert. denied sub. nom.,
Greenberg v. Héh’H Music Company, 113 S.Ct. 482 (1992).

87. Freudenheim, M. Patients cite bias in AIDS coverage by health plans. New York Times,
june 1, 19932Al.

88. Gostin, L. Foreword: Health care reform in the United States—The Presidential Task
Force. Americanjournal ofLaw and Medicine 1993; XIX:1—20.

The Role of Religious Participation
and Religious Belief in Biomedical
Decision Making

CHARLES M. SWEZEY, Ph.D.
Dean of the Faculty, Union Theological Seminary in Virginia

Biomedical decisions usually focus on speciﬁc problems or cases, and
particular decisions gain standing and legitimacy when they become part
of a practice. By practice, I mean standard ways to deal with typical cases
that emerge over time and are accepted by medical practitioners and soci-
ety. Practices arejustifled by explicitly stated moral values and characteris—
tic ways of understanding and so interpreting illness. Also important are a
long history of care, professional training and socialization, and accepted
ways of assimilating new knowledge. These and other factors, however,
require an ethos of support.

The explosion of knowledge in biology and other fields of inquiry,
combined with recent innovations in medical technology, dramatically in-
crease the human capacity to intervene in the natural life process. They
also call into question some of the standard ways of dealing with typical
cases. Well—known examples are subject to public debate. May physicians
assist in actively terminating human lives? Is it permissible to use human
fetal tissue in medical research? Under what conditions, if any, should
patients receive organ transplants from nonhuman animals? The central
issue in these and other questions is whether what can be done technically
ought to be done morally. The issue has attitudinal dimensions. We re-
spond to innovations in medical technology with wonder and awe. We are
grateful for beneﬁts, yet we fear deleterious consequences, so we search for
guidance by exploring possibilities and seeking limits, understanding that
limits have their own consequences. To set limits and attain possibilities, of
course, are ways of specifying what may be done in particular cases, that is,
of redeﬁning medical practice.

358

ROLE OF RELIGIOUS PARTICIPATION ANI) BELIEF 359

The search for guidance does not take place in a vacuum, but in the
context ofa perceived erosion of conﬁdence. The costs of health care rise
amid serious debates about access to care and the adequacy of health
insurance. Litigation increases amid important questions about the rela-
tion of causal accountability to moral and legal responsibility. Questions
about the rationing of care appearjust when physicians are charged with
overtreating patients. Though all of medical practice is not disputed, the
number of signiﬁcant problems and the lack of consensus in dealing with
them set a context for scrutiny by an increasingly broad public. The inter-
acting roles of patient and physician are reexamined; the numbers of eth-
ics committees and review boards grow; pressure groups and lobbies
emerge. Medical practice seems to have become everybody’s business.
Along with other aspects of life, it becomes increasingly specialized and at
the same time seeks legitimation in a democratic forum.

At the heart of these discussions are disagreements about proper modes
of treatment. These disagreements are the source of fears that are larger
than disputes about individual cases. One fear concerns the possible ef-
fects of a lack of uniformity in practices. The desire for uniformity is
rooted in part in an understanding of fairness, the principle that similar
cases should be treated similarly. When similar cases are not treated simi-
larly, something seems askew morally. Judgments are difﬁcult here, for there
is room for diversity. Adultjehovah’s Witnesses, for example, undoubtedly
will continue to refuse blood transfusions, a refusal generally accepted as
an exception to standard practice. At issue is the amount of diversity a
practice will tolerate. The specter which haunts is that the ethos that
sustains standard practices will falter. Thus the second fear is that the very
practice of medicine will erode, a practice inherited from the past which
has served society well. These fears are strong enough to set a context for
addressing the issue of the role of religious belief and participation in bio-
medical decision making. Clearly religion has the potential to erode, sus-
tain, or enrich at least the ethos that nourishes standard medical practice.

FACTORS IN RELIGIOUS BELIEF

The topic this paper addresses is part of the more general problem of
the relation of religion to modern society. The pioneering studies of Max
Weber and Ernst Troeltsch have been followed by an enormous literature
from several ﬁelds.1 Though not unmindful of these studies, the primary
intention of this paper is to provide a framework for understanding the
relation between religion and biomedical decision making, and it undoubt-
edly reﬂects the viewpoint ofa mainline Protestant ethicist. I ﬁrst provide
a scheme which points to important dimensions of religious belief. Al-
though this scheme oversimpliﬁes in ways that. offend even my own schol—

360 SOCIETY’S CHOICES

arly sensibilities, it draws attention to several important factors. I next
sketch the elements of decision making. Interactions are then traced, and
a concluding section follows.

The Vision of God

In the traditions of the West, religious beliefs are intellectual con—
structs grounded in an experience of the reality of God. Piety, faith, and
ecstasy, as well as other terms, refer to this experience. A religious object,
God, is disclosed, and this object is characterized in different ways, e.g.,
king, lord, father, steadfast love, shepherd,judge, deliverer. This experi-
ence and its corresponding object is a vision of God, and its effects vary.
Different sensibilities are evoked, e.g., reverence, wonder, and gratitude.
Liturgical performance is elicited, e.g., praise, confession, and supplica-
tion. Certain deeds or acts are enjoined or prohibited, e.g., honoring
parents or not bearing false witness.

Believers also articulate the character of the religious object in the
form of beliefs. This response has multiple roots, e.g., attempts to clarify
liturgical practice, efforts to persuade others of the authenticity ofa vision,
or simply the struggle to better comprehend and explain the deity. Many
who formulate these beliefs are aware of the inadequacy and shortcomings
of propositional statements. Indeed, a certain poignancy accompanies the
work of theologians who are aware of the agonies of excess or defect, or of
claiming either too much or too little for knowledge of God. Still the
attempt is as important as it is inevitable, for what is believed about God is
decisive in specifying God’s relation to the world.

One difficulty is that religion is located in an institution, whereas,
presumably, God is not so confined. This difﬁculty is compounded by the
complexity of the world. james M. Gustafson, for example, writes about
different “arenas” in which God’s presence may be discerned—nature,
history, culture, and society.2 To claim that God is present to society and
culture, for example, requires that something be said about God’s relation
to family life, economic institutions, government, technology, the arts, and
the sciences. In the face of these difficulties, some theologians affirm that
God is absent from the world, or perhaps present as a condemningjudge
who calls the faithful away to a better life. Others argue that God’s gover-
nance includes sustaining and ordering powers that may be discerned in
each of these arenas. Still others suggest that God as creator provides the
occasions for new possibilities and so enables human innovation. Each of
these beliefs, and many others, are thematizations. It is a mistake to reduce
them to the status of intellectual propositions to which believers give cogni—
tive assent. This move abstracts from important dimensions of religious
belief and fails to see them as construals which, by specifying God’s relation

ROLE OF RELIGIOUS PARTICIPATION AND BELIEF 361

to the world, interpret all of life in theological dimension. Theological
beliefs seek a coherence and consistency which, faithful to the divine real—
ity, make sense in relation to the world.

If the task of theology in a strict sense is to articulate the vision of God
in the form of stated beliefs so that the relation of God to the world gains
specificity,3 its larger task is to elaborate this vision by addressing four issues
that recur perennially.4 The four issues are the relation of good and evil,
the nature of religious participation, estimates of reliable sources of knowl-
edge, and the character of moral guidance. Each is part of religious belief,
and the Vision of God becomes clearer as they are answered. If these
questions are not always answered explicitly, they are nonetheless present
in the lives of believers as implicit, unstated assumptions. Those who do
not share a religious vision offer nonreligious counterparts to explicitly
religious answers to these questions.

Good and Evil

The first issue is the relation of good and evil. More precisely, the
question concerns their location and extent as well as their relation. This
problem emerges in everyday life whenjudgments are made about relative
goods. One television program rather than another is watched, an adoles-
cent selects a college to attend, a second career is chosen, and so forth.

A key for understanding the interaction of good and evil is found in
human responses to certain events. When college students receive mid-
term grades, for example, responses range from indifference to overly
enthusiastic optimism. These and other moods may occur ﬂeetingly in
response to particular events. Over time, however, moods may persist and
become attitudes adopted toward the world. With apathy, what one does
makes little difference; with cynicism, what others say or do makes no
difference; with despair, the exercise of intentions is useless. These and
other attitudes develop into patterns of being human, so that life is “staged,”
for example, with deep resignation or with quiet conscientiousness. Atti—
tudes have roots in human nature, but it is human nature patterned in
response to a discernment of good and evil forces in the world.

The interaction of good and evil requires an interpretation which sets
particular events in a larger frame. Theology provides an interpretation by
construing the world in a particular way, and this construal is part of the
vision of God. One result may be a thoroughgoing dualism which assigns
deﬁnite locations to good and evil forces. For example, the dominant
culture or mere physical existence becomes the locus of evil, and the pure
religious community or spiritual existence is the locus of good. God is
envisioned asjudge of the dominant culture or as not blessing physical life,
and also as the savior who delivers the faithful into true community or

362 SOCIETY’S (1101055

spiritual bliss. Certain patterns of life follow. The perception of evil in
thoroughgoing dualisms is neither universal nor radical. Since evil is as-
signed a rather deﬁnite location, it is not all—pervasive or universal. Since
forces for good seem relatively exempt from evil, the extent of evil is limited;
it is not truly virulent or radical.

Other theological interpretations locate evil more universally and View
its extent more radically; they also provide an account of forces for good.
The quest genre of literature provides an example. Grasped by a vision of
God, a band of pilgrims ventures ajourney and sets forth in the world only
to encounter pitfalls, dangers, and temptations. Their challenge is to re—
spond to these encounters in ways which faithfully honor the original Vi—
sion. Those on the journey eventually learn that evil is found not only in
the world, but lurks in the heart of each venturer. Moreover, those on the
journey inevitably experience moments of grace when, surprisingly, they
encounter forces of good outside their own company. The world is thus
experienced as an arena of interacting good and evil forces, but without a
thoroughgoing dualism. These encounters are means of clarifying the
original vision of God who now is perceived as an ordering power who
sustains and nurtures human existence as well as the rest of life, and who,
as the creator of new possibilities, enables thejourney to continue.

To remain with the image of the quest, patterns of life develop which
train and equip venturers to deal with the experience of evil. Established
ways of living, like the “inner-worldly asceticism” Max Weber attributed to
the Puritans, are perduring attitudes adopted toward the world. Because
the common experience of believers is that present reality does not ex-
haust the goodness of God, a way of life can be sustained in the face of truly
tragic encounters with evil. What Weber called “the ethical irrationality of
the world” is faced, namely, the realization that good results do not always
flow from good intentions and that evil persons, despite themselves, may
bring beneﬁts.5 Eschatologies, or beliefs about the way interacting good
and evil forces ﬁnally play out, are born in these experiences and so ex-
pand the vision. Some eschatologies are radically dualistic; others are not.
The result, in any case, is a vision of God which interprets human existence
in the world.

Perceptions of good and evil, including eschatologies, are not con—
fined to theology. For example, discussions of the consequences of genetic
interventions in humans often include estimates of the future which strik-
ingly resemble strands of religious beliefs about the interactions of good
and evil, and well—known scientists who are not self—consciously religious
spin out their own versions of the human prospect.6 One cannot but
wonder about the possibilities of mutual discourse. At issue is what is
known scientiﬁcally about the natural world and humanity’s place in it, and
the role this knowledge plays in interpreting the present and conjuring the

ROI}: 0F RELIGIOUS PARTICIPATION ANI) BELIEF 363

future. Also at issue are patterns of existence in the world and the sources
of knowledge deemed reliable. In any event, religious belief is clearly a
source for understanding the relation of good and evil, though it does this
in different ways.

Religious Participation

A second factor in religious belief is the relation of those who share a
religious vision to those who do not explicitly acknowledge it. This ques-
tion is part of everyday life for believers and, in larger form, is present to
all. How relate to those who differ in some signiﬁcant respect? Resolutions
of the explicitly religious issue are deeply conditioned by the distinctive
form of religious association that ﬁrst emerged in the West. This form of
association is called “congregational religion."

According to Max Weber, congregational religion is an association of
persons who embody, though imperfectly, belief in a transcendent God.7
Transcendent here means the conception of a deity who brings the world
into existence, stands over against it, and wills a way of life which differs
from that customarily practiced. The embodiment of this belief takes place
through three interacting provisions, each of which, again, stabilizes and
secures beliefin communal form. First, standard ways ofvenerating and so
recalling the nature of the deity in a properly religious way are enacted
regularly. Thus a cult is created, including sacraments and other forms of
worship. Second, beliefin God is ﬁxed in a message that serves as court of
appeal and authoritative source of knowledge. This takes place by demar-
cating canonical writings and by enunciating doctrines which state the
meaning of these texts. Third, a means is found to recognize and order
religious leaders in the association.

The clergy so ordered take up the task of being true to the transcen-
dent God by leading worship and by interpreting scripture and doctrine.
They also bear special responsibility for attracting and maintaining follow-
ers in the religious association, and they are successful in this calling to the
extent that laity participate in the community, share the religious vision,
and comprehend the rest of life in its light. Congregational religion em-
phasizes two primary methods for interacting with the laity who, notori—
ously, are unwilling to give up customary ways of living and know better
than the clergy the meaning of belief. One is preaching and the other is
pastoral care. The two are related, and each is suited to clerical tasks.
Pastoral care, or attention to the needs of the laity with a distinctively
religious focus, requires clergy to attend to matters which concern the
everyday life of parishioners. Preaching affords the regular and formal
opportunity to respond to these concerns by interpreting the religious
message in the context of worship.

364 SOCIETY’S CHOICES

The beginnings of a voluntary principle for human associations are
properly found in the emergence of congregational religion.8 In ways just
enumerated, religion differentiates from other forms of human associa-
tion, including the family, the market, and the state. Being located in one
realm raises the question of God’s relation to these other realms. This
issue is compounded in the modern world which, with its growing segmen-
tation, is increasingly aware of autonomous rationales for differing institu-
tions. Different forms of associations serve independent purposes. The
dominant purpose of the economic realm, for example, is to produce and
distribute goods and services. The political arena provides a system of
governance charged with ensuring order in society. The family fosters
mutuality and provides nurture for infants. One purpose of medicine is to
provide health care. Religion serves none of these purposes, at least not
directly. The irony is that one of the largest challenges faced by religion is
posed by its own principle of organization. An enduring task of religion is
to comprehend and interpret theologically all of life; but by gaining inde-
pendence as an organization, its relation to other areas oflife is called into
question, and so the challenge is set.

Weber’s colleague, Ernst Troeltsch, argued that congregational reli-
gion exhibits three tendencies in relating to the world.9 The religious
association may dissociate from the dominant society by withdrawing in
more active or passive ways; it tends more exclusively to its own nurture.
The religious community may oppose the dominant society by protest, or by
seeking to change or overthrow it. Or the dominant society may be af-
ﬁrmed, as an inevitable necessity, by critical acceptance, or more whole—
hearted embrace. These tendencies, then, represent three typical patterns
of participation.

A new expression of congregational religion, the denomination, ap-
peared with the disestablishment of state-sanctioned religion. For the de-
nomination, the voluntary principle is the organizing feature of congrega—
tional life. Personsjoin, presumably, only when they consent to its norms,
that is, to the implicit or explicit consensus that exists in the group. The
need to gain the consent of laity introduces a democratic impulse into
congregational life and presents a political task to religious leaders who
want to attract and retain members. Once the element of democracy is
acknowledged and the active consent of laity is present, congregations can
become seedbeds of activism.10 Congregational activities proliferate; new
institutions like the Sunday school are formed; alliances with other associa-
tions develop. Recent American religious history illustrates that these con—
ditions are an environment for change as in, for example, the emergence
of politically conscious evangelicals, the decline of the Protestant mainline,
and the growing inﬂuence of the Roman Catholic Church.11

Denominational life is subject to numerous factors, many outside its

ROLE OF RELIGIOUS PARTICIPA ’1‘[()N AND BELIEF 365

control. One thinks of the increase in global interdependence; one thinks
of the emergence of pluralism and the recognition of different viewpoints
and communities; one even thinks of demographic factors. All of these,
and more, are conditions to which congregations must respond. H. Richard
Niebuhr once commented, “We are more acted upon than acting,” and
that may be true of denominations.l2 Still, within whatever limits, denomi—
nations retain the capacity to exercise intentions in their many actiw’ties.
There are different units and levels of participation, including indi—
viduals, small groups, congregations, regional bodies, national bureaucra—
cies, etc., and all of these in relation to other organizations and other
arenas of existence. Religious participation, then, has many meanings and
dimensions. ‘3

The basic tendencies noted by Troeltsch illustrate ways in which reli-
gious participation takes place in relation to society. Recall that the reli-
gious vision grows clearer and God’s relation to the world gains specificity
with each factor in religious belief. With the factor of religious participa-
tion, the relation of God to the community which shares the religious
Vision is spelled out, and God‘s relation to the world thereby becomes
clearer, that is, God’s relation to those who do not explicitly or organiza-
tionally acknowledge the religious vision. At least two basic patterns
emerge. One pattern identiﬁes God's presence or emphasizes God's rela-
tion to the religious association in ways which are not true of God’s relation
with the larger world. For this pattern, the tendency of the religious asso-
ciation is to oppose the dominant society. On the other hand, the religious
community may be viewed as the realm of the conscious acknowledgment
of God’s more universal presence or relation to the world. The tendency
of the religious association in this pattern is to afﬁrm the dominant society.

These patterns have consequences for the vision of God and for the
interaction of good and evil. When God is uniquely related to the religious
community, it is less likely that the presence of God as an ordering, sustain-
ing, nurturing, and redeeming power will be discerned in the world, which
is viewed as the locus of evil. Thus believers tend to oppose the world. If
opposition to the dominant society takes the path of changing the world, it
is likely that God’s positive presence will be selectively identified with cer-
tain elements in society, thus modifying the interaction of good and evil.
When God’s presence is more afﬁrmatively related to the dominant soci-
ety, discerning the presence of God in the world as an ordering, sustaining,
nurturing, and redeeming power is more likely. The location of evil is apt
to be viewed as more universal and radical, but enough good is discerned
in the world to encourage afﬁrmation, as an inevitable necessity, by critical
acceptance, or more wholehearted embrace.

These generalizations are regrettably abstract, and, no doubt, particu—
lar historical instances will not conform. They nonetheless draw attention

366 SOCIETY’S (rim/(15$

to major patterns of religious participation. In sum, religious participation
is multifaceted in depth and breadth.

Sources of Knowledge

The issue for the third factor in religious belief may be posed as a
question. What sources of knowledge are reliable, and how are they re-
lated? Since answers to any question depend on one or more sources of
knowledge, this issue emerges in everyday life. Even the fabled Cynics who
rigorously rejected the reliability of all knowledge adopted a stance on this
issue, albeit a ﬂatly negative one. Answers in everyday life range from
reliance on common sense to disciplined appeals to specialized ﬁelds of
learning. I concentrate here on sources deemed reliable for morality.

Appeals to sources of knowledge in religion are sometimes more nar-
row and exclusive, sometimes broader and more inclusive. Sole reliance
on an authoritative text illustrates a narrower, more exclusive, answer,
which often joins with an appeal to the religious community as the only
authentic interpreter of the canonical witness. By contrast, various theo-
ries of “natural law" illustrate broader, more inclusive, appeals. They as-
sume that believers and nonbelievers share a common source of reliable
knowledge, like perceptions ofhuman nature or a common moral sense. A
dominant strand in the Roman Catholic tradition afﬁrms that what is known
morally by reason is given by God and universally shared; this knowledge,
moreover, is not contradicted by scripture though the latter provides cer-
tain commands that go beyond the duties of ordinary living. The so-called
quadrilateral of the Methodist Church appeals to four interacting sources
of knowledge, namely, scripture, tradition, reason, and experience. It
thereby combines more distinctively religious sources with those which
presumably are more widely shared. Of course, the exact meaning of each
term in the quadrilateral and their relation to each other continue to be
debated.

Religious answers to the question about sources of knowledge appeal
in some normative fashion to canonical writings. Since the uses of authori-
tative texts vary, the ways scripture actually functions as a normative source
also vary. For example, scripture may be viewed as disclosing knowledge of
the reality of God, revealing the relation of good and evil, providing guid-
ance in the form of moral values, engendering attitudes, exhibiting vir-
tues, providing direct answers to moral questions, and so forth. It is impor-
tant to draw fairly precise distinctions in order to understand particular
claims.

Some theologians claim on descriptive grounds that multiple sources
of knowledge are inevitably present in decision making. Lisa Sowle Cahill
argues that four interacting sources of knowledge are invariably present in

ROLE OF RELIGIOUS PARTICIPATION AND BICIJFT 367

religious ethics: canonical writings, the religious tradition, normative ac-
counts of the human, and descriptive accounts of the human.” Her argu-
ment suggests that the normativity of scripture cannot be upheld in actual
use unless brought into conscious relation with other sources of knowl-
edge. Judgments, of course, must be rendered about the number of sources
and also about their relation. The point here is that some theologians self-
consciously use multiple sources, and arguments for their use are not only
descriptive but have theological ﬂavor. It is obvious that recourse to “de—
scriptive accounts of the human" places believers on at least some common
ground with biomedical decision makers who may not share the religious
vision.

These few examples illustrate the plurality of answers to the question
about sources. This factor interacts with others. Recall again that the
religious vision becomes clearer when each factor of religious belief is
taken into account. When the factor is sources of knowledge, God’s rela-
tion to the world is specified in reference to the availability of reliable
moral knowledge to the religious community and to those who do not
share the religious vision. In other words, sources of knowledge clearly
interact with the factor of religious participation. I delineate two general
patterns.

First, to the degree that God’s positive presence is identified more
exclusively with the religious community in contrast to the rest of human-
ity, emphasis is placed on the need of the community to rely on more
distinctively religious sources of knowledge like canonical writings. For
example, if God is more exclusively present to the religious community as
lawgiver or commander, a belief grounded in scripture, believers will be
enjoined to obey these laws or commands, e.g., do not resist evil or enter
the land of Canaan to conquer and occupy. Again, ifa religious commu-
nity gathers around the personality of a leader and does not yet have an
authoritative text, the belief that God is present to the world exclusively
through those who follow the leader is grounded in a personality; believers
are enjoined to follow the leader’s directives. A more comprehensive
account requires an estimate of the type of knowledge available to nonbe-
lievers; when such accounts are given, they correlate with perceptions of
the location and extent of good and evil in the world. For example, the
world may be seen as a locus of evil to the extent that it does not follow the
teaching of nonviolence or to the extent that it does not follow the teach-
ings which ﬂow from the leader’s personality.

Second, to the degree that God's positive presence is related to the
world, some emphasis is placed on sources of knowledge which are shared
by believers and nonbelievers, at least in moral matters. If God’s ordering
power is present to the world in sustaining life through the structure of the
family, for example, reliable knowledge about being a spouse or a parent

368 SOCIETY 13‘ CHOICES

may be given through an “order of creation" ordained by the deity and
perceived by reason and experience, that is, sources of knowledge univer-
sally shared. A more comprehensive account requires an estimate of the
role of scripture as a distinctively religious source of knowledge. This
estimate may be that reason and scripture do not conflict in moral matters,
but that scripture moves beyond reason in certain ways. A more paradoxi-
cal claim is that reason and scripture are both required but serve different
functions; reason informs us how to restrain evil in the world and scripture
gives us reborn hearts. These and other claims also depend upon percep—
tions of the interaction of good and evil.

These patterns are again regrettably abstract and, of course, particular
historical instances may not exactly conform. Although more detailed
analysis would require greater nuance, the generalizations indicate two
major patterns. They also show that factors in religious belief interact
dynamically. If one is persuaded that multiple sources of knowledge are
required and also of the reality of God, for example, then one is forced to
give a theological account of how God makes reliable knowledge available
to the world, say, in the sciences. In sum, the factors of religious belief
interact dynamically and are complex.

Moral Guidance

A fourth and ﬁnal factor in religious belief also takes the form of a
question raised in everyday life. What types of guidance, if any, aid in
facing the demands of life? By demands of life I refer to a broad array of
matters, like choosing a vocation, raising children, electing surgery, or
donating money. Possible forms of guidance are also far-ranging, for ex-
ample, principles and rules, symbols by which to comprehend circum—
stances, training in character, and distinctions between relative goods. The
religious form of this issue is the type of guidance which ﬂows from or is
consistent with a vision of God. Religion offers rich resources with respect
to these possibilities, but I concentrate here on guidance in the form of
moral principles.

Whether the ﬁrst requirement ofa religious vision is a reborn heart or
obedient conduct is a perennial debate, often couched in terms of the
priority given to inner or outer dimensions of life. The inner dimension
emphasizes a new disposition, the outer stresses good deeds. Though
exceptions exist, these options are usually viewed as complementary, not as
alternatives. Recurring discussions draw boundaries by identifying “legal-
ism" and “antinomianism” as extremes to avoid. An emphasis on inner
freedom to the neglect of good conduct is antinomian or “against the law."
Legalism emphasizes proper conduct to the neglect of matters of the heart.
These distinctions are more successful in indicating extremes to avoid than

...\-

ROLE OF RELIGIOUS PAR'I‘ICIPA TION AND BELIEF 369

in stating a middle ground. An agricultural metaphor poses the issue of
relating inner and outer dimensions of life in a pattern responsive to the
religious vision. How are the “roots” ofa plant related to its “fruits," that is,
how are the inner dispositions of a way of life related to conduct? The
image assumes that both roots and fruits are required and related.

Moral principles are a means to guide conduct. Theirfmm and content,
as well as their use and purpose, stem from a relation between roots and
fruits. They are also conditioned by the religious factors of belief which
specify God’s relation to the world. The relation of good and evil, we have
seen, may lead to a thoroughgoing dualism. When the location and extent
of evil are more universal and radical, however, this dualism moderates.
With the factor of religious participation, tendencies to dissociate or op-
pose the world stand in contrast with more afﬁrmative stances. With the
issue of sources, reliable moral knowledge may be more exclusively avail-
able to the religious community or more universally distributed. The reli-
gious vision clearly directs these possibilities, but the vision is also shaped
by these other factors in belief.

Many combinations of these factors are possible, and I shall indicate
two major patterns. In the ﬁrst, a vision of God with a thoroughgoing
dualism which lacks a radical and universal sense of evil links with a ten-
dency to oppose the world. These factors, in turn,join with the tendency
for the knowledge provided by God to be more exclusively related to be-
lievers. With this pattern, moral guidance often takes the rigorous form of
a “higher law." Conscientious obedience is expected, and there is little
likelihood of dialogue with persons outside the religious community about
the form and content of guidance. The guidance offered may be directed
primarily towards the inner religious life, though necessarily cast in out-
ward form, e.g., a vow of obedience to a religious superior; or the guidance
may be more overtly moral, though obedience springs from the heart, e.g.,
not swearing in court.

A variation in this pattern occurs if the tendency to oppose the world
takes the form of seeking to overthrow it. The rigorous content of the
moral guidance may then become more militant and conscientious obedi-
ence is still expected, e.g., launching a violent crusade against an enemy. If
the tendency to oppose the world is not explicitly violent, but nonetheless
expresses an intention to change the world, moral guidance is likely formed
in relation to selected sources of knowledge available in the world.

In the second pattern, the vision of God views the extent and location
of evil as more universal and radical. Lacking a thoroughgoing dualism, it
includes an afﬁrmative posture toward the world and assumes that moral
knowledge is more universally distributed. With this pattern, the form of
moral guidance is less rigorous in the sense that it more likely compromises
with various aspects oflife in the world. Guidance is more responsive to the

3 70 SOCIE'I‘Y’S CHOICES

demands of culture and society, and is directed to both the religious com-
munity and the world. Dialogue about the form and content of this guid-
ance is possible in principle and practice. The more explicit purposes of
moral guidance depend in part on the virulence of evil in the world and
range from the restraint of evil to more positive directives. If evil is so
virulent that little positive good can be accomplished, restraint is empha-
sized; if possibilities for human flourishing exist, more positive forms of
guidance emerge.

The well-known debate about “uses” of the law in the sixteenth century
illustrates the purposes of guidance in this second pattern. The command—
ment “Do not kill” is a form of moral guidance with particular content. For
John Calw'n,” its ﬁrst use is theological, that is, to convict of sin and per-
haps prepare the way for repentance. So the command is radicalized to
include anger in the heart, an inner disposition. The second use is politi-
cal, that is, to restrain evil. A murderer is a killer and a menace to society
who must be punished by the state, an outward deed. The third use pro-
vides moral guidance which is grounded in the heart and expressed in
outward form. The positive intention of the prohibition not to kill is to
respect human life. More exact formulations come with dialogue. Unlike
Calvin, some theologians endorsed only the first two uses; for these latter,
the primary purpose of guidance in the world is the restraint of extremely
virulent evil. It may be noted that in the pattern of thought where the
tendency is to oppose the world, the commandment not to kill may take
the form of a “higher law” and stand as a prohibition in the religious
community against all lethal violence. If the tendency toward the world is
seeking to overthrow it, this command may be superseded by a different
form of “higher law," namely, the call to violent revolution.

Once again, these generalizations are regrettably abstract, and once
again, historical instances do not exactly conform. However, the central
points about guidance in the form of moral principles should not be lost.
Moral principles in a religious context presume a relation between inner
and outer dimensions of existence. Their form and content are likely to be
more rigorously conscientious or more responsive to the demands of cul-
ture and society. They also serve certain purposes. These three features of
guidance, in turn, are informed by the religious vision and conditioned by
perceptions of good and evil, estimates of reliable sources of knowledge,
and different tendencies in religious participation. The factors in religious
belief are complex and mutually conditioning.

Summary

Religion is a way oflife grounded in a vision of God, and one response
to this vision is articulating beliefs. Believing is part, but only part, of

ROLE OF RELIGIOUS PARTICIPATION ANI) BELIEF 3 7]

walking a way. To analyze religious beliefs is to discern that a religious
vision speciﬁes the relation of God to the world by dealing with four dis-
tinct yet related factors. Each is important, and each displays its own
qualities. To take religious participation as an example, its roots are found
in faith and piety which nurture, express, and condition its shape. It is also
inﬂuenced by the form of a religious association, e.g., a denominational
congregation, and it embodies one of the tendencies which belong to this
factor, namely, to dissociate from, oppose, or afﬁrm the world. These
Characteristics blend to compose the distinctive quality of religious partici-
pation. This factor, in turn, conditions and interacts with the other factors,
each with its own qualities. When informed by a vision of God, the qualities
of these four factors form a more or less integrated pattern. This complex
and interacting whole provides resources which are brought to everyday
life, including the medical arena. Every pastor and physician is aware that
those informed by a religious vision respond out of the resources provided
by a way of life, sometimes courageously in the face of tragedy and some—
times in despair.

THE ELEMENTS OF DECISION MAKING

An analysis of religion‘s role in the medical arena could begin induc—
tively by examining the actual responses of believers to illness and health.
This paper, however, inquires about the interaction of religion and moral-
ity in the medical arena by ﬁrst setting forth the elements of decision
making. just as the integrity of religion is not well served if reduced to
decision making, so the elements of morality deserve their own consider-
ation. Indeed, to ask about the interaction of religion and moral decisions
assumes that the latter stands somewhat independently of the former. Yet
differing views of morality are conditioned by perspectives which are either
more or less comprehensive, and religion presses for a broader, more
comprehensive, view. Morality retains its relative independence, but is
conceived broadly enough to interact fully with the factors of religion
which, again, have nonreligious counterparts; the wider conception is not
a product of a religious view only.

This section of the paper states four distinct but related components of
decision making, and together, these elements deﬁne the subject matter of
morality.16 I do not mean to imply that all religious persons share this
understanding, but stating these elements is a basis for inquiring about
their relation to religion. Two of the components, moral values and situ-
ational analysis, are the common coin of contemporary moral discourse. A
third element, loyalties, is more often neglected. The ﬁnal element is
human agency. These components are formal in the sense that different
clusters of content are attracted to each.

3 72 SOCIE’I‘Y‘S CHOICES

Moral Values and Situational Analysis

A strong consequentialism is present in biomedical decision making
because interventions in the natural life process are undertaken with the
expectation that certain results will follow. But will they? And are the
predicted results truly beneﬁcial or good? These questions point to two
important issues. One concerns facts and values, and the other concerns
the adequacy of the method of calculating consequences for ethics. Con-
sideration of these two issues raises a third, namely, the place of purpose in
this component of decision making.

The vast literature about the relation of facts and values illustrates that
different types of evidence count in making decisions. A division between
facts and values presupposes a model in which one type of evidence consist-
ing of pure moral values is applied to another type of evidence consisting
of factually delineated situations. This model is endorsed in the important
writings of Paul Ramsey.l7 For Ramsey, when a medical team considers
resuscitation, it first “reads the situation” by determining whether the pa-
tient is dying or nondying. This assessment is a matter of medical fact, and
a patient’s condition is such that resuscitation will either restore health or
prolong the dying process. Once this situation is comprehended, the
moral value of “care, but only care” is applied. Care requires informed
consent. Care also requires an intervention to restore health, as may be
possible, if the consenting patient is nondying. If the patient is dying,
however, the obligation “only to care” does not require resuscitation, which
would only prolong the dying process, but a ministry to suffering, pain, and
loneliness, and the patient is allowed to die. Whether or not patients are
always described adequately as either dying or nondying, the two kinds of
evidence posit a division of labor. Medical science provides the facts and
morality supplies the values to be applied.

This matter, I think, should be treated more subtly. Are “dying” and
“nondying” purely factual terms? Any conception of death includes some
notion ofwhat is valued about life which, when lost irreversibly, enables the
judgment that a person is in fact dead.” Similarly, it may be asked whether
“care” is a purely moral value which stands independently of factual mate—
rial. Kubler-Ross’s famous studies of the stages of death, for example,
emerged out of value—laden observations about what takes place in the
processes of dying, and this material shaped notions of care.19

Concepts likejustice and stealing include and combine different types
of evidence. Notions of distributivejustice, for example, are formulated by
paying attention to situations in which competition exists for scarce re-
sources. Certain situations which otherwise would not be understood are
properly described as stealing. These observations do not erase the con-
ceptual distinction between moral values and situational analysis, though

ROLE OF RELIGIOUS PARTICIPA 'I'ION AND BELIEF 3 73

the two may coalesce. Rather each of these components combines differ—
ent types of evidence. So one comprehends the signiﬁcance of situations
in value—laden ways, and moral values are informed by data from the world.

The second issue is whether to modify or erase consequentialism, a
question also introduced by Ramsey who argued that the business of moral-
ity is to provide rules of right conduct, not to calculate consequences. For
Ramsey, it would be morally wrong to assume that death is always a bad
consequence; this would tempt us to seek the better result of preserving life
at any cost. As a rule of right conduct which does not calculate conse-
quences, the canon of care does not prolong the dying process but allows
the patient to die.

Still, Ramsey‘s stance presupposes that mere survival is not the purpose
of human existence. If the “good” of health is assumed to be mere physical
existence, care as a rule of right conduct might well support preserving life
at very high costs, even in dying patients. The deep problem here is to
understand health in relation to the purposes of human existence.20 If
health is the central purpose of existence, it likely will be identiﬁed with
survival or mere existence. On the other hand, if health is only one aspect
of human purpose and a condition for its other aspects, mere existence is
not so highly prized. Understanding the good of health in relation to
other human purposes is not determined by moral principles; rather, moral
principles are placed in their service, in either more or less consequential
ways.

With respect to the question of method, my ownjudgment is that rules
of right conduct and calculating consequences are both necessary. A bet—
ter way to say this is that human conduct is evaluated by referring to the
kind of activity it constitutes and in terms of its consequences. Sole reli-
ance on either flounders, if only because of the former‘s unwillingness to
take into account adequately what can be known about the future, and the
latter‘s ultimate inability to foresee the future.

Human purposes condition each of these crucial elements and their
interaction. The evidence for reading situations perceptively varies, and
the forms of situational analysis range from intuitive perceptions to highly
disciplined inquiries informed by different ﬁelds of learning. These forms
and their content arejudged more or less adequate in terms of their pur—
pose. Again, the evidence which counts in formulating moral values varies,
and the forms of moral values also vary, including everything from rules of
thumb to ethical principles. The adequacy of these forms, as well as the
adequacy of their content, is conditioned by their purposes. In sum, the
uses of situational analysis and moral values in decision making inevitably
serve human purposes. These purposes are set in relation to human ca—
pacities and needs in interaction with the structures of society and cultural
norms.

3 74 SOCIE’I‘YXS‘ CHOICES

Loyalties

“Loyalties” is shorthand to refer to objects of human desire, expecta-
tion, and trust. When afﬁrmed, these objects receive our allegiance, hence
the term loyalties.21 The nation is a potential object of devotion, for ex—
ample. One may desire to be a citizen of a particular country and actively
participate in its civic life. One may expect a country to provide protection
and guarantee certain rights, and one may expect to participate actively in
the processes of ruling and being ruled. If these desires and expectations
are fulﬁlled in some fashion, enough trust develops that an allegiance is
formed. Though the process is more complicated than indicated here, the
result is that the loyalty of patriotism etnerges, and this, in turn, shapes
those who hold it.

Loyalties perform three functions, those of orienting, motivating, and
providing a general direction). As orientation, patriotism provides a per-
spective from which to view and interpret life. As motivation, it provides
reasons of heart and mind to participate in civic society. The political form
ofa countty, e.g., a constitutional democracy, provides a general direction
for at least one aspect of life.

The exact meaning of particular loyalties is discussed and debated, and
different loyalties demand different allegiances which interact in various
combinations. For example, the family is a potential object of desire,
expectation, and trust, and so may become a loyalty. Parenthood provides
orientation, motivation, and direction. Conflict in motivation is experi-
enced if the demands of patriotism fail to agree with the perspective and
direction of parenthood. Persons form many allegiances and in turn are
shaped by them, e.g., economic prosperity and health, so the adjudication
of interacting loyalties is perennial.

Loyalties take institutional form and embody cultural values.22 For the
parent, institutional forms of the family embody the values of parenthood.
For the patriot, institutional forms of government embody the values of
democracy. For the physician, different institutionalizations of care em—
body the values of health. For the entrepreneur, institutionalizations of
business embody values like hard work and success. These and other
loyalties form identity because they are purposive. They exist for a reason,
and these reasons are brought to bear on decision making. Why go to war?
In part because one is a patriot. Why not go to war? In part because
patriotism itself may give reasons to do otherwise. Why nurture children?
In part because one is a parent. Why provide care? In part because one is
a physician.

The interaction of different institutions with cultural norms helps
shape a general ethos which is more or less diverse and demanding. This
ethos exists in the present, but is deeply conditioned by recollections of the

ROLE OF RELIGIOUS PARTICIPATION ANI) BELIEF 3 75

past and expectations of the future. As background and frame of refer-
ence, this ethos itself conditions decision making in society, and when
ethos changes, existing practices will erode, gain support, or be enriched.

Human Agency

Stated brieﬂy, assumptions which guide conduct are made about the
capabilities of human agents, their motives, and their possibilities and limi-
tations within the courses and workings of nature, history, culture, and
society. Human beings are a highly diverse lot equipped with a remarkable
range of capabilities. People differ according to their genetic endowment
and their psychological development, as well as their settings in time and
space, and different people have differing motives and intentions. They have
different capacities for action and different inclinations toward moral deeds.

Nevertheless, they share a common nature.23 Human agents are more
or less integrated creatures with certain limits and possibilities. Within the
context of culture and society, people are formed as their natural endow-
ments develop and interact with the historical formation of dispositions,
intentions, and basic convictions. In their varied forms, the motives and
intentions of agents are shaped by historic convictions and expressed in
conduct. The different motives and intentions of different persons, then,
must be taken into account.

Human agency is expressed and embodied in a way oflife, one impor-
tant dimension ofwhich is character.24 Character refers to the Greek word
hexis, as in Aristotle, which was translated into Latin as habitus, as in Tho-
mas Aquinas, and became the term “habit" in English. A habit or disposi-
tion is a readiness to act in a consistent manner, like reading or writing, or
a persisting tendency to do things in fairly predictable ways, like driving a
car or playing the piano. These skills are not endowed directly by nature,
but are acquired over time when training and practice are offered by com-
munities like the family, school, or synagogue. When habits are deemed
moral, they are called virtues. Honesty, for example, is a disposition which
characterizes some people; we observe, “They are as honest as the day is
long," which means at least that they are not tempted to steal every time
they go through a checkout counter. The acquisition of habits and dispo-
sitions forms identity. A child who learns to read is identified as a “reader”
just as an adolescent who learns to drive is known as a “driver.” Similarly,
practitioners of medicine and those who repair automobiles are identified
correctly as physicians and mechanics. These and other identities display
the character ofa social roles, though these admit a wide variety of expres-
sion since they are ﬁltered through individuals. Still, physicians are ex—
pected to care and auto mechanics are expected to tell the truth. Charac-
ter is necessary, both individually and in social roles, if agents are to sustain

3 76 SOCIETY’S CHOICES

identity over time. Agency may also take corporate forms, but enough has
been written to suggest that it is shaped by a variety of factors which are not
readily reducible to a concept like freedom.

Assumptions about character as well as other aspects of agency “ﬁt” the
other elements of decision making, both in the sense that they inﬂuence
them and in the sense that these other elements also shape these assump-
tions. The moral principle “Do not kill” ﬁts humanity; the commands
typically given to other animals, like dogs, do not. Situational analysis is
conditioned by these assumptions, and differing assumptions about hu-
man nature make differences in how situations are described. The appre-
hension and statement of the purposes of life in the form of loyalties also
ﬁt perceptions of humanity. These interactions are reciprocal.

Summary

One neutral way to pose the moral question is to ask, What ought I to
do? Answers are given in the form ofjudgments, acts, and policies. When
judgments are made, acts performed, or policies enacted, they may be
challenged. These answers to the moral question are then defended or
discussed by giving “reasons” which support them, and these reasons take
their form and content from the four components of morality.

Should the patient be resuscitated? If the answer is ajudgment, “No,”
and thisjudgment is questioned, reasons are given tojustify it. One reason
appeals to situational analysis: The patient is irreversibly in the process of
dying and attempts at resuscitation would only prolong the dying process.
A second reason appeals to a moral value. The obligation of the medical
team is to care for the patient, but only to care. This means that the patient
will be allowed to die, but requires that pain, loneliness, and suffering be
attended. A third reason appeals to loyalties: Health is a human good, but
not an end in itself. Since health is a condition for other aspects of human
ﬂourishing, and these aspects are now beyond attainment, there is reason
to allow the patient to die. A fourth reason appeals to human agency:
Allowing a person to die accords with the finite nature of humanity and,
one presumes, coheres with the dying patient’s motives and intentions.

The four reasons are distinct, but together form a larger pattern which
coalesces with the complex interaction betweenjudgments, acts, and poli-
cies. If thejudgment is followed by an act, for example, the patient is not
resuscitated. We respond to similarly situated cases in the same way, if only
because of the demand of fairness. The result is a policy which, when
adopted, becomes a practice which defines, embodies, and expresses the
meaning of medical care and gains the support of an ethos.

The interacting reasons of the four components of decision making
are in turn conditioned and inﬂuenced by the factors of religious belief, or

ROLE OF RELIGIOUS PARTICIPATION AND BELIEF 3 77

if not them, by their nonreligious counterparts. What is the extent, loca-
tion, and relation of forces of good and evil? How relate to those who
differ in some signiﬁcant respect? What sources of knowledge are reliable?
What types of guidance aid in facing the demands of life? To the degree
that a vision of God informs answers to these questions, religious belief
interacts with biomedical decision making. The possibilities are multiple.

INTERACTIONS

The multiple possibilities are too rich to be explicated fully here. The
whole is a complex and dynamic ﬁeld of interaction in which a vision of
God and the factors of religious belief mutually condition each other and
each of the elements of decision making and vice versa. I shall illustrate
some of these interactions, but ﬁrst comment on the relation between
loyalties and a religious vision.

Vision and Loyalties

The interaction between a vision of God and human loyalties is impor-
tant, though frequently neglected. Recall that loyalties are objects of hu—
man desire, expectation, and conﬁdence which form allegiances like pa-
triotism and parenthood. These are embodied in institutional forms which
express cultural values, and so are causes which serve human purposes and
shape identify. Loyalties change in content over the course of time, interact
with other allegiances, and require adjudication. That is, they are con-
stantly reformulated, related to other loyalties, and so ordered. This order-
ing is done by a center of value, a perspective which relates the demands of
differing allegiances and aids in formulating their content.25 These inter—
actions have inner dimensions insofar as desire, expectation, and trust are
coordinated into a whole; they have outer dimensions insofar as the con—
tending demands of external allegiances are ordered coherently. A result
is the formation ofidentity as a pattern oflife which orients, motivates, and
directs agents in the world.

When a religious vision interacts with human loyalties, its basic import
is to distinguish the ultimate from the proximate by subordinating other
allegiances to devotion to God. This matter stands at the heart of religious
life as the problem of idolatry. To have no other God does not eliminate
other human loyalties; it requires they be apprehended as nonultimate.
Proximate values in a religious vision range from those which are not
worthy of esteem to causes worth serving even to the point of death, e.g.,
martyrdom on behalf of one’s family. Devotion to God as the center of
value orders the relative worth of these proximate allegiances in inner and
outer dimension. The inner dimension is that the religious vision elicits

3 78 SOCIETY’S (HO/(15s

human trust, expectation, and desire, and transfers them to God. To use
traditional Christian language, they are transformed so that trust as faith in
God, expectation as hope in God, and desire as love of God, characterize
inner devotion to an ultimate cause. What is believed about God as the
object of faith, hope, and love has important external dimensions. As the
center of value, these beliefs deal with the contending demands of the
world by helping to order, relate, and formulate the proximate meaning of
other human allegiances. When these inner and outer dimensions coa-
lesce, an integrated pattern of life emerges which provides identity as ori—
entation, motivation, and direction for walking a way.

The possibilities considered by Paul Ramsey when he wrote about the
meaning of care illustrate the interaction between a vision of God, other
human loyalties, and the prospect ofintervening in the natural life process.
For a patient with appendicitis who is not irreversibly dying, for example, a
medical intervention is likely to restore health; otherwise, premature death
may result. Suppose, however, that intervention is opposed because it
“plays God” by usurping the deity’s sovereign rule. God is conceived as the
direct giver and “taker” of life since the divine presence in the world is
identiﬁed with the natural life processes of cause and effect. A loyalty to
health as physical existence is of little worth when ordered in relation to
this center of value.

On the other hand, if an intervention is sanctioned which restores
health, God’s presence as sustainer of life may be discerned indirectly
through a surgical procedure which at the same time mediates God’s or-
dering power. As the center ofvalue, beliefin God correlates with a loyalty
to health which esteems the gift of physical existence more highly than
when intervention is foregone. This latter stance, of course, avoids a “God
of the gaps” position in which scientiﬁc notions of cause and effect are
antithetically‘juxtaposed with beliefs about the deity. If God is conceived as
an active power whose presence in the world is mediated in time and space,
then what actually takes place in the world must be related in some way to
this belief. Vision, loyalties, and the possibility of intervening are interact-
ing variables; knowledge of God is admittedly conditioned by perceptions
of the world, not only ideas about health but also notions of cause and
effect.

The case of the patient who is irreversibly dying also illustrates the
interaction of these variables and the inﬂuence of belief in God as the
center of value. A medical intervention prolongs the dying process. This
intervention correlates with a conception of health as mere physical exist-
ence, for the point can only be to “respect” life by preserving it as long as
possible. When the limits of technology are not acknowledged, concep-
tions of God’s power to sustain life transcend or remain independent of
cause and effect processes.

R0115 01" RELIGIOUS m RTICIPA TION A NI) BELIEF 3 79

If no intervention is undertaken, on the other hand, the patient is
allowed to die. Lack of intervention correlates with a conception of health
as a condition for other aspects of human ﬂourishing, and when these
aspects are beyond attainment, mere existence is not so highly prized. God
as the center of value is imaged as the indirect giver of life, and also as an
ordering power whose purposive presence is mediated in and through the
various arenas of life. When these divine purposes, which correlate with
other aspects of human ﬂourishing, are no longer attainable, the impor-
tance of health as mere survival diminishes. Moreover, a distinction be-
tween God and creaturely existence is upheld. So again, the religious
vision is the center of value which orders other human loyalties, and this
center gains specificity by the way it interacts with the ways things are in the
world, in this case, perceptions of health and notions of cause and effect.

The Other Factors of Belief

Loyalties and the vision of God do not stand alone. Their interaction
with possibilities for intervening are conditioned by the factors of religious
belief, and these, in turn, inﬂuence the other components of decision
making and vice versa. A religious stance with a thoroughgoing dualism
which opposes the world, uses exclusive sources of knowledge, and offers
rigorous guidance to the religious community, for example, differs consid-
erably from one which moderates a thoroughgoing dualism, affirms the
world, uses inclusive sources of knowledge, and offers guidance to the
world. Keyed to distinctive beliefs about God, these and other stances
qualify the components of morality differently.

Some of these differences may be illustrated brieﬂy by reverting to the
case of the irreversibly dying patient where attempts at resuscitation pro-
long the dying process. In respect to good and evil forces, a thoroughgo—
ing dualism could View the end of life as the central locus of evil and set
human existence over against death as good. The extent and location of
evil are not universal or radical but confined to life and death issues, a
position which could be elaborated by an eschatology which protests or
rebels against human finitude. With respect to religious participation,
opposition to the world could be expressed in a refusal to accept the limits
of technological innovations, and with it, a failure to recognize the limita-
tions of the medical segment of society. With respect to sources of knowl-
edge, a more exclusive stance could ignore scientific accounts of cause and
effect and object to the statement that a patient is irreversibly dying. With
respect to moral guidance, conscientious obedience to a rigorous higher
law could instruct the religious community to disregard the limits of tech-
nology and foster attempts to always preserve life.

Each of these factors is keyed to a vision of God’s power to sustain life

380 SOCIE'I‘Y’S CHOICES

which transcends or remains independent of cause and effect processes.
Together, they reinforce the interaction between a vision of God, a concep-
tion of health as mere existence, and attempts to preserve life as long as
possible. This combination of factors, moreover, counters the moral rea-
sons which would allow a patient to die, though in ways too intricate to
enumerate here in detail. Still, health is not conceived as a condition and
one aspect of human ﬂourishing, but as physical existence. Human ﬁni-
tude is not accepted but protested. Instead of the canon of care, emphasis
is placed on the moral value of preserving life, and instead of saying that
the patient is irreversibly dying, it could be said that the patient is tempo—
rarily ill.

Allowing an irreversibly dying patient to die, on the other hand, may
also be supported by the factors of religious belief. With respect to good
and evil forces, a moderated dualism could discern God’s ordering pres-
ence in the world amid these interacting powers, though the divine pur—
poses of existence in the varied arenas oflife are beyond attainment for the
patient. The gift of life could be acknowledged as a ﬁnite good to be
received with a gratitude expressed properly to both its proximate and
ultimate sources, a position which could be elaborated by an eschatology
which afﬁrms the goodness of God and the value oflife even in the face of
ﬁnitude and death. With respect to religious participation, afﬁrmation of
the world could be expressed by accepting the limits of technological inno-
vation, and with it, a recognition of the limitations of the medical segment
of society. With respect to sources of knowledge, a more inclusive stance
could accept scientiﬁc accounts of cause and effect and endorse the state-
ment that a patient is irreversibly dying. With respect to moral guidance
more responsive to the demands of culture and society, the canon of care,
but only care, could be afﬁrmed.

Each of these factors is keyed to a vision of God as the indirect giver of
life and an ordering power whose mediated presence is discerned in the
various arenas of life. Together, they reinforce the interaction between a
vision of God, a conception of health as a condition and aspect of human
ﬂourishing, and a willingness to forego attempts at resuscitation. This
combination of factors, moreover, supports the moral reasons which would
allow a patient to die in ways which, I hope, are clear in basic outline.

The factors of religious belief do not entail or precisely determine the
exact qualiﬁcations of the components of moral decision making, which
retain their relative independence, yet profoundly condition and inﬂuence
them. The result is that a vision of God and the factors of belief interact
with the elements of morality to form a way of life, The qualities of each of
the factors of religious belief, we have seen, join Math 21 Vision of God to
form a pattern, and these, in turn, link with qualiﬁcations of the compo-
nents of decision making to fashion a way of walking in the world.

ROI!) 0F RELIGIOUS PARTICIPATION AND BELIEF 381

The image of ajourney draws to attention that a way of life does not
always move from a vision and the factors of belief to moral problems, but
often the reverse.26 Nojourney is complete at its beginning, but continues
through encounters with problems which may be viewed as pitfalls, dan—
gers, and temptations. These provide the occasion for seeking guidance,
acquiring skills, and forming identity in community. Venturers are thereby
oriented, motivated, and directed to walk a way in the world. Depending
on the vision, and, no doubt, the character of the travelers, encounters in
the world may also be viewed as challenges and opportunities. Perhaps a
paradox in the vitality of religious beliefis found at this point. The deepest
convictions of life are often religious, so there are reasons to hold them
ﬁrmly. If held defensively, for whatever reason, encounters in the world
are viewed only as temptations, dangers, and pitfalls. Yet ﬁrmness of belief
may also bring something like the “cosmic optimism" Perry Miller attrib-
uted to the Puritans, a certain conﬁdence in the vision which provides
encouragement for the‘journey oflife.27 Venturers are then challenged to
respond to encounters as opportunities to clarify the meaning of existence
in the world in relation to the vision.

Prophetic Protest, the Status Quo, and Apocalypticism

More could be said about the rich interaction between a religious
vision, the factors of religious belief, and the elements of decision making,
but enough has been written to provide a partial basis for explaining how
religion sometimes functions as a cover for other interests.28 The essence
of the process is an inversion at the point of loyalties so that beliefs about
God become a function of other allegiances which are the actual center of
value. The phenomenon is as old as Western religion and stands at the
heart of prophetic protests against “priestly” religion, that is, the type of
religion sometimes endorsed by the leaders of congregational religion.
Prophets typically use moral language to criticize false forms of worship,
e.g., “I take no delight in your solemn assemblies . . . letjustice roll down
like waters" (Amos 5:21, 24). What is centrally at stake, however, is specify—
ing God’s relation to the world with respect to a way of life. In congrega—
tional religion priests are responsible for leading worship and interpreting
the religious message. Trained by an establishment, these leaders may be
conservative in two senses: ﬁrst, they set forth a religious message from the
past in the context of worship, and second, along with influential laity, they
have a stake in maintaining the status quo. By contrast, the urgency of a
prophetic message objects to liturgical practice when it sanctions a way of
life unresponsive to God’s active presence and provides moral guidance in
the form of moral principles which point to a true way of life in the world.

The religious participation of “priestly religion” opposes any change in

382 SOCIETY'S CHOICES

the status quo, and its use of moral principles reﬂects this interest. Repeat-
ing an unrevised religious message in a liturgical setting, priests insist that
the exclusive source of reliable knowledge is the authoritative tradition in
which they have been trained and overlook what. is actually taking place in
the world. They know with scholastic assurance that true belief is cognitive
assent to intellectual propositions.29 The forces of good are located in the
status quo, and evil is defined as threats or challenges to this same order.
These priests do not provide a religious construal ofexistence which leads
to a way oflife responsive to God’s active presence. The heart of the matter
is an inversion at the point ofloyalties, so that beliefs about God function as
a cover for other interests which are the actual center of value.

Prophetic criticism of priestly religion can depart from discerning
God’s ordering presence in the world and focus more completely on the
way the world ought to be in the future. The moral urgency of apocalyptic
messages is directed toward a new order. Guidance no longer takes the
form of moral principles but endorses those inner attitudes deemed neces-
sary for the emergence of a new world. Religious participation does not
endorse the existing order but opposes it by ﬂeeing, protesting, seeking
change, or attempting to overthrow it. Reliable knowledge is drawn selec-
tively from authoritative texts and other sources which point to a new
order. God’s relation to the world is specified in terms of what should be
rather than what is, though foretastes of the new order may be seen in the
present. judgments must then be made about whether allegiance to a new
order is the actual center of value, so that religion functions as a cover for
this interest, or whether belief in God actually demands this proximate
loyalty. The criteria used to test these judgments are drawn from the
religious vision, the factors of belief, and the components of decision
making.30

Summary

These commean provide the occasion for a summary which focuses on
the link between forms of religious participation and beliefs about God’s
ordering presence in the world which, in turn, interact with the ethos
which supports medical practice. Again, the patterns delineated are re-
grettably abstract. One pattern of religious participation dissociates from
the world. With this pattern, God’s active presence is not discerned in the
world, and interaction with ethos is minimal; medical practice, in all prob-
ability, is ignored and sustained by benign neglect.

A second pattern of religious participation opposes the world. When
opposition takes the form of protest, God’s ordering power as a positive
presence in the world is largely absent. Protest may erode the ethos which
supports medical practice or perhaps lead to change. When opposition

ROLE OF RELIGIOUS PARTICIPA’I‘ION AND BELIEF 383

takes the form of Change, God’s ordering presence in the world is allied
with selective tendencies in the culture. The result creates tension in the
supporting ethos which perhaps leads to modiﬁcations in medical practice,
or, if change is not successful, to erosion. When opposition attempts to
overthrow the world, ethos is not supported; medical practice may change,
remain unchanged, or erode.

The third pattern affirms the world. When afﬁrmation takes the form
of virtual embrace, God’s ordering presence is identiﬁed with the existing
order. Ethos, as well as medical practice, is sustained. When afﬁrmation
takes the form of an inevitable necessity, God’s restraining order is per-
ceived in a world continually threatened by chaos. The ethos which sup-
ports medical practice is endorsed to the extent that it continues to limit
threats to chaos. When affirmation takes the form of critical acceptance,
God’s ordering of the world includes sustaining andjudging dimensions,
and also prospects for new possibilities. The ethos which supports medical
practice may be enriched or modiﬁed.

CONCLUDING OBSERVATIONS

I conclude with four observations. First, the conception of religion in
this paper presses for a broader, more comprehensive, view of morality. It
is uneasy with more restrictive views that split fact from value, focus on
applying purely moral principles to purely factual situations, conceive
agency as moral only to the degree it is free from historical and other forms
of conditioning and neglect the importance of human purposes. The
primary reason offered in this paper for a broader view is theological. A
vision of God is articulated only when the factors of religious belief aid in
specifying the deity’s relation to the world, and this vision requires a con-
ception of morality responsive to its concerns. Since the factors of religious
belief are not always qualified from an explicitly religious point of view,
nonreligious reasons could also be adduced for a broader view.

Second, contributions by religion to biomedical decision making are
more likely when religious participation is more afﬁrmative, sources of
knowledge are more inclusive, moral guidance is directed toward the world,
evil is conceived as universal and radical, and God’s active presence in the
world is discerned in an interacting field of good and evil forces without a
thoroughgoing dualism. There is room for caution even here, however.
For example, medical practice has learned from those whose religious
stance is quite different about respecting persons who refuse medical treat—
ment.

Third, not the least ofGod’s mercies is that the whole scheme outlined
in this paper does not have to be used every time a decision is made. Most
decisions in ordinary life are a product of informed intuitions, habits, and

384 SOCIETY'S CHOICES

practices; an analytical framework certainly does not guarantee better deci-
sions. Moreover, if one's religious stance is more afﬁrmative on participa-
tion, more inclusive on sources, more worldly in moral guidance, and so
forth, theological reasons exist for not having to articulate an understand—
ing of God for every decision. Indeed, theologians may participate in good
conscience in public decision making without referring explicitly to their
deepest convictions about God, and my suspicion is that something like
this stance is often adopted by theologians who serve on public commis-
sions. Readers of this paper will have observed that the description of the
moral components ofdecision making is not theological, though they could
be qualified more directly by religious content than I have indicated.

On the other hand, I am persuaded that the factors of religious belief
deeply condition decision making, whether qualiﬁed by religious or nonre-
ligious perspectives. When explicit or implicit assumptions about these
factors are divisive, which is more often than we usually care to acknowl-
edge, they require explicit attention, and it may well be helpful to call
attention to them even when implicit agreement appears to be present.
They are, after all, at the heart of some of the deepest of human convic-
tions. One would think, moreover, that theologians who serve on public
commissions would be expected to contribute to discussions from a reli-
gious perspective.

Fourth, all knowledge is historically conditioned and so perspectival in
at least two senses.“ What one sees and knows depends on where one
stands, for example, twentieth—century America in contrast to first-century
China. What one sees and knows depends also on the glasses or lenses
used to view the world, for example, common sense, one or more of the
sciences, theology, or whatever. Since no neutral standing point or privi—
leged perspective exists, a theologian may be forgiven for observing that a
“confessional" dimension inevitably enters discourse. The four factors of
religious belief profoundly condition decision making, and no point of
view exists from which to qualify them which is not historically conditioned
and perspectival.

Those persuaded of the reality of historical conditioning are uneasy
with notions of what is “public” if they imply the absence ofa point of view,
as if, for example, religion represents a private domain set over against
more publicly accessible knowledge. Even science is not public in the
sense that it is unconditioned by perspectives and history. Those trained in
physics often use mathematics in ways which are not easily accessible to
biologists, and chemists sometimes have difficulty conversing with biolo—
gists, not to mention paleontologists. I agree withjames M. Gustafson that
“there is no scientiﬁc public, except perhaps on very, very generalized or
abstract grounds?“2 As one historically conditioned point of View among
others, religion has its own perspective. Its potential contribution to biomedi-

ROLE ()F RELIGIOUS PARTICIPA 77()N AND BELIEF 385

cal decision making is not privileged, of course;judgments must be made
on the basis ofits arguments, the evidence it cites, its willingness to learn in
dialogue from other points of View, and its cogency in open forums.

NOTES

1. See especially, Max Weber, Economy and Society, 3 vols., ed. Guenther Roth and Claus
Wittich (New York: Bedminster Press, 1968), vol. 2, pp. 399—640, and Ernst Troetsch, The
Social Teaching of the Christian Churches, 2 vols., trans. Olive Wyon (Louisville: Westminster/
john Knox Press, 1992).

2. James M. Gustafson, Ethics from a Theocentric Perspective, 2 vols. (Chicago: The Univer-
sity of Chicago Press, 1981, 1984), vol. 1, Theology and Ethics, pp. 209—225. Gustafson also
mentions “the self." An enormous literature seeks to describe the modern world, e.g., Niklas
Luhmann, The Differentiation of Society, trans. Stephen Holmes and Charles Larmore (New
York: Columbia University Press, 1982). For suggestive summaries in a theological context,
see Max L. Stackhouse, Public Theology and Political Economy: Christian Stewardship in Modern
Society (Lanham: University Press ofAmen'ca, 1991), pp. 163-174, and Douglas F. Ottati, “The
Contemporary Situation for Mainstream Theology and Ministry,” Affirmation, vol. 4, no. 1
(Spring 1991), pp. 1—24.

3. The two basic questions of theology are, Who is God and how is God related to the
world? The central traditions of Christianity answer the ﬁrst question by saying trinity, and
the second by saying creator, governor, and redeemer (the term “governor” includes images
of ordering, sustaining and nurturing, preserving and restraining, and judging). The ﬁrst
answer distinguishes Christianity from Judaism, but the two traditions share at least some
common ground in answers to the second, which in theology is known as the “nature-grace"
issue. This paper concentrates on answers to the second question.

H. Richard Niebuhr in Christ and Culture (New York: Harper and Brothers, Harper
Torchlight Books, 1951) shows how answers to both questions are related in Christianity, and
his reflections are informed by the study of Charles Norris Cochrane, Christianity and Classical
Culture: A Study of Thought and Action from Augustus to Augustine (New York: Oxford University
Press, A Galaxy Book, 1957). I regret that I am not competent to take into account the
literature ofjudaism and Islam in this paper.

4. These four issues, along with answers to the two questions in the previous endnote,
are elements central to a systematic theology. My treatment of these matters is informed by
H. Richard Niebuhr's Christ and Culture, itselfa response to Troelmch‘s The Social Teaching.

5. Weber, Max, “Politics as a Vocation," in From Max Weber: Essays in Sociology, trans. and
ed. H. H. Certh and C. Wright Mills (NewYork: Oxford University Press, 1958), pp. 122—124.

6. For examples, see Mary Midgley, Evolution as Religion: Strange Hopes and Stranger Fears
(New York: Methuen, 1985) and Science as Salvation: A Modern Myth and Its Meaning (New
York: Routledge, 1992); see alsojames M. Gustafson, “Sociobiology: A Secular Theology” [a
review of On Human Nature by Edward O. Wilson], Hastings Center Report, vol. 9, no. 1 (Febru-
ary 1979), pp. 44—45.

7. Weber, Max, Economy and Society, vol. 2, pp. 452—468.

8. Adams,]ames Luther, “Mediating Structures and the Separation of Powers," Voluntary
Associations: Socio—cultural Analyses and Theological Interpretation, by james Luther Adams, ed. ]
Ronald Engel (Chicago: Exploration Press, 1986), pp. 217—244.

9. Troeltsch‘s well—known typology of church, sect, and mysticism, appears in The Social
Teaching.

10. See Adams, “Mediating Structures,” and his “The Voluntary Principle in the Forming
of American Religion," Voluntary Associations: Sociocultural Analyses and Theological Interpreta-

386 SOCIETY’S CHOICES

tion, pp. 171—200. See alsoklames M. Gustafson, “The Voluntary Church: A Moral Appraisal,"
Voluntary Associations: A Study of Groups in Free Societies, ed. D. B. Robertson (Richmond: john
Knox Press, 1966), pp. 299—322.

11. Roof, Wade Clark and William McKinney, American Mainline Religion: Its Changing
Shape and Future (New Brunswick: Rutgers University Press, 1987).

12. I cannot locate an exact quotation, but see H. Richard Niebuhr, The Responsible Self:
An Essay in Christian Moral Philosophy (New York: Harper 8c Row, 1963), pp. 47—68.

13. Normative and descriptive studies exist. For Protestantism, Paul Ramsey, Who Speaks
for the Church? A Critique of the I 966 Geneva Conference on Church and Society (Nashville:
Abingdon Press, 1967) initiated a continuing debate. See also,]ames M. Gustafson, Protestant
and Roman Catholic Ethics: Prospects for Rapprochement (Chicago: University of Chicago Press,
1978), pp. 126437. For Roman Catholicism, a place to begin is Readings in Moral Theology No.
3, The Magisterium and Morality, ed. Charles E. Curran and Richard A. McCormick (New York:
Paulist Press, 1982). See also The Crisis in Moral Teachings in the Episcopal Church, ed. Timothy
Sedgwick and Philip Turner (Harrisburg: Morehouse Publishing, 1992), and Todd
Whitmore, “Reason and Authority in Church Social Documents: The Case for Plausibility
and Coherence," Ethics in the Nuclear Age: Strategy, Religious Studies, and the Churches, ed. Todd
Whiunore (Dallas: Southern Methodist University Press, 1989), pp. ISL—231. Descriptive
accounts are found in a number of social studies.

14. Cahill, Lisa Sowle, Between the Sexes: Foundations for a Christian Ethics of Sexuality (Phila-
delphia: Fortress Press, 1985), p. 5. Cahill's statement should be compared with Gustafson’s
four sources in Protestant and Roman Catholic Ethics, p. 142.

15. Calvinklohn, Institutes ofthe Christian Religion, 2 vols. (Philadelphia: Westminster Press
[Library of Christian Classics, vol. 20, ed._]ohn T. McNeill], 1960), trans. Ford Lewis Battles,
vol. 1, pp. 348-366. The impact of these formulations had far-ranging consequences on the
Puritans and in America. For a fascinating but neglected study, see David Little, Religion,
Order, and Law: A Study in Pre—Revolutionary England (New York: Harper Torchbooks, 1969
[reprint, University of Chicago, Midway Press, 1984]).

16. Four components of decision making are cited by a number of different authors,
though in differing forms, e.g., Ralph B. Potter, War and Moral Discourse (Richmond: john
Knox Press, 1970), pp. 23—24, James M Gustafson, Protestant and Roman Catholic Ethics, pp.
139—141, and Gustafson, Ethicsfrom a Theocentric Perspective, vol. 2, Ethics and Theology, p. 143.
My views are informed by Gustafson though I think he collapses proximate loyalties into his
“theological base." The usefulness of the four components for analytical purposes is illus-
trated in Harlan Beckley, Passion for justice: Retrieving the Legacies of Walter Rauschenbusch, john
A. Ryan, and Reinhold Niebuhr (Louisville: Westminster/john Knox Press, 1992). This latter
book, incidentally, shows that theological convicu'ons can be important in formulating con-
ceptions ofjustice and demonstrates that theologians from different Christian denomina-
tions contributed to the “public" moral discourse in twentieth century America.

17. Ramsey. Paul, The Patient as Person (New Haven: Yale University Press, 1970), pp. 113—
164.

18. Veatch, Robert M., Death, Dying, and the Biological Revolution: Our Last Quest for Responsi-
bility, rev. ed. (New Haven: Yale University Press, 1989), pp. 15—44. The literature is extensive.

19. Kubler—Ross, Elisabeth, 0n Death and Dying (New York: Macmillan Company, 1969).
See also, Milton Mayeroff, 0n Caring (New York: Harper 8: Row, Perennial Library, 1971).

20. See Leon R. Kass, “The End of Medicine and the Pursuit of Health," Toward a More
Natural Science: Biology and Human Affairs (New York: Free Press, 1985), pp. 157-186.

21. Augustine’s treatment of loyalties remains influential, perhaps especially the nine—
teenth book of Concerning the City of God Against the Pagans, trans. Henry Bettenson, intro.
David Knowles (Baltimore: Penguin Books, 1972), pp. 843—894.

22. john Rawls writes about practices in “Two Concepts of Rules," Philosophical Review, vol.
64, no. 1 (January 1955), pp. 3—32, an article cited byjames M. Gustafson in The Contributions

1:011: or RELIGIOUS PARTICIPA TION AND BELIEF 38 7

of Theology to Medical Ethics (Milwaukee: Marquette University Theology Department, 1975).
On practices, see also Alasdair Maclntyre, After Virtue: A Study in Moral Theory (Notre Dame:
University of Notre Dame Press, 1981).

23. My abbreviated account is informed by Gustafson, Can Ethics Be Christian? (Chicago:
University of Chicago Press, 1975), pp. 25—47. Theological construals of human nature
inevitably presuppose a philosophical account. Both Mary Midgley, Beast and Man: The Roots
of Human Nature (Ithaca: Cornell University Press, 1978) and Melvin Konner, The Tangled
Wing: Biological Constraian on the Human Spirit (New York: Holt, Rinehart and Winston,
1982) show that a dualism between nature and spirit, or between phenomenal and noumenal
aspects of agency, cannot be sustained in light of contemporary knowledge of biology.

24. My brief account of character is informed loosely by Aristotle, Thomas AquinasJames
M. Gustafson, and Stanley Hauerwas.

25. Niebuhr, H. Richard, Radical Monotheism and Western Culture: With Supplementary Essays
(New York: Harper 8: Brothers, 1943, 1952, 1955, 1960), uses the term “center of value."
Both Niebuhr and Gustafson are informed by Augustine as well as josiah Royce. Gustafson
explicitly mentions faith, hope, and love, as well as desire, expectation, and confidence, in
Ethics from a Theocentric Perspective, vol. 1, Theology and Ethics, pp. 224-225, and like Niebuhr,
distinguishes faith as confidence from faith as ﬁdelity.

26. Augustine, “The Way of Life of the Catholic Church," The Catholic and Manichean Ways
ofLife, trans. Donald A. Gallagher and Idella]. Gallagher (Washington, DC: Catholic Uni-
versity Press, 1966), pp. 3—61, has had an enormous inﬂuence in Christianity. The classic
delineation of religion as a way of life in sociology is Max Weber, Economy and Society, vol. 2,
pp. 399—640. See also, Paul M. van Buren, A Theology of the jewish—Christian Reality, Part I,
Discerning the Way (San Francisco: Harper 8c Row, 1980).

27. Miller, Perry, The New England Mind, vol. 1, The Seventeenth Century (Boston: Beacon
Press, 1961), p. 18.

28. Roof, Wade Clark, Community 67’ Commitment: Religious Plausibility in a Liberal Protestant
Church (New York: Elsevier, 1978), delineates “local” and “cosmopolitan" outlooks as vari—
ables of religious meaning and belonging. Religion as a “function" of other interests is a well-
worn topic in sociology.

29. Observations about a scholastic religious response to modernity are found in ClifTord
Geertz, Islam Observed: Religious Development in Morocco and Indonesia (New Haven: Yale Uni-
versity Press, 1968).

30. For two discussions of criteria, see Douglas F. Ottati, “Christian Theology and Other
Disciplines,” journal of Religion, vol. 64, no. 2 (April 1984), pp. 173—187, and James M.
Gustafson, Can Ethics Be Christian .7, pp. 130—143. Stackhouse's more intuitive appeal to evi-
dence from “the world” and from “the Word" is of interest; see Public Theology and Political
Economy.

31. A literature that began more than thirty years ago stresses the importance ofa point of
view in science. See Norwood Russell Hanson, Patterns of Discovery: An Inquiry into the Concep-
tual Foundations of Science (Cambridge: Cambridge University Press, 1965; originally 1958);
Michael Polanyi, Personal Knowledge (New York: Harper and Row, 1964; originally 1958);
Stephen Toulmin, Foresight and Understanding (New York: Harper and Row, 1961); and Tho—
mas S. Kuhn, The Structure of Scientiﬁc Revolutions, 2d ed. (Chicago: University of Chicago
Press, 1970; originally 1962). A philosophically aware and clear discussion of these matters is
Harold I. Brown, Perception, Theory and Commitment: The New Philosophy of Science (Chicago:
University of Chicago Press, 1979). See also, Stephen Toulmin, Human Understanding: The
Collective Use and Evolution of Concepts (Princeton: Princeton University Press, 1972).

32. Gustafson,]ames M., “Response to Francis Schussler Fiorenza," The Legacy ofH. Rich-
ard Niebuhr, ed. Ronald F. Thiemann (Minneapolis: Fortress Press, 1991), p. 79. My previous
sentence is drawn from this article.

Trust, Honesty, and the
Authority of Science

STEVEN SHAPIN, Ph.D.

Professor of Sociology and Science Studies,
University of California, San Diego

There is as much modern uneasiness about putting scientists in a posi-
tion to make ethical decisions as there is about releasing them totally from
such responsibilities. On the one hand, many contemporary areas ofethi—
cal choice implicate such technical knowledgeability that few but the pos-
sessors of relevant expertise can hope competently to address the issues
involved, while, on the other, it is not now supposed that those who have
expert knowledge are ethically privileged or more likely to make virtuous
decisions than anybody else in our society. In dominant sensibilities, to
know more than other people about human respiration is quite a different
capacity than knowing when it is right to turn off the respirator.

That, indeed, is a way of stating the problem. If these sensibilities did
not obtain, then there would be widespread contentment that doctors
should disconnect life-support systems and molecular biologists should
determine the nucleotide sequence of the entire human genome without
any intervention by “ethical experts” or those trusted to represent the
concerns and preferences of interested parties. But there is no such con—
tentment. Authority to speak on what is true is disengaged from authority
to speak on what is good.

As a lay member of late—twentieth-century American society, I recog-
nize that sentiment and have found myself endorsing it frequently enough.
I have not routinely imputed special virtue to scientists and physiciansxjust
as I am sure that few modern scientists regard themselves, or wish to be
regarded, as moral paragons, with all the attendant responsibility. I have
no very clever ideas about how the relationship between morality and ex-

388

TRUST, HONES’I‘Y, AND THE AUTHORITY OF SCIENCE 389

pertise ought to be managed, and, while in general I like the idea of
opening up decision—making processes to a range of interested parties, I
am not comfortable with the notion of ethical expertise. For all that, I do
not expect that my personal views on such matters ought to be of the
slightest interest to anyone.

It is, rather, as an historian of early modern science and as a sociologist
of scientiﬁc knowledge that I feel I might have something to contribute to
contemporary debates over science and ethics. I want to draw attention to
how the modern state of affairsjust outlined came to be. Historical per-
spectives occasionally have the capacity to encourage a more disengaged
look at present predicaments, while the fact that the divorce between ex-
pertise and virtue is, as I shall indicate, a strikingly recent one can prompt
the thought that there may be some point in seeking to “unwind" a bit of
history. There is nothing inherently “natural” about the late—twentieth—
century distinctions between virtue and scientific knowledgeability. The
historical record offers a vision of alternative arrangements. Moreover, the
same historical perspective can suggest that the modern disengagement
between virtue and expertise may be more in the appearance than the
reality. To the extent that we accept such a disengagement as real, right,
and proper, I suggest that we are storing up problems not‘just for scientists’
moral authority but for their credibility.

Indeed, I want to approach the problem ofscientists‘ moral authority
by way of an historical inquiry into their credibility, the grounds on which
scientists’ pronouncements about the natural world are taken as true, ob-
jective, or reliable. just because personal morality and knowledgeability
are so widely considered as distinct in the modern condition, I start by
outlining a scheme of things in which they were not reckoned to be so in
the past. I shall describe a culture in which the credibility of scientiﬁc
claims and the moral standing of those who make the claims are inter-
twined. Speciﬁcally, I mean to describe a relationship between credibility
and virtue by drawing attention to the importance of trust relations in the
making of scientiﬁc knowledge. I suggest that while those trust relations
continue to be vitally important in modern science it has become harder
and harder to appreciate them. One consequence of the invisibility of
trust is the very attitude towards the disengagement between virtue and
expertise which gives our modern dilemma its basic shape.

WHAT IS THE BASIS OF SCIENTISTS’ CREDIBILITY?

Why do we believe what scientists tell us about the natural world? Why
do we trust them to tell the truth? The fact of that trust, as well as its
enormous extent and consequences, should be in no doubt. Most of our
formal knowledge of the natural world is derived from no other source

3 90 SOCIETY 15' CHOICES

than what scientists tell us, or, more precisely, from what is told us by their
apparent spokespersons: those who teach science, those who are repre—
sented as applying it in our personal domains, those who write or speak
about it in the public culture. That we have to trust them for almost all
aspects of our formal natural knowledge should also be in no doubt. For
practical reasons alone we are unlikely to subject scientists’ claims to effec-
tive personal skepticism. If indeed we know these things at all, we take on
faith the principles of aerodynamics and hydrostatics, the role of DNA in
heredity and development, the chemical structure of benzene. And the
public “we” includes scientists as well as the laity, for scientists are largely in
the position of laypersons when it comes to the specialist knowledge of
other types of scientists.

just noting the extent of the trust-dependency of our natural knowl-
edge is enough to set some current worries about “antiseience” into per—
spective. The homage paid to science is best evident in the very existence
of a public stock of formal natural knowledge. All those who believe that
the earth goes around the sun, that DNA is the genetic substance, that
there are such things as electrons, and that light travels at 186,000 miles
per second are, by so believing, doing scientists honor. Nor is that honor
restricted to blind acceptance. Many of those who doubt that CFCs are the
cause of a shrinking ozone layer, that the burning of fossil fuels is raising
global temperatures, or that organic change is accounted for by natural
selection of small continuous variations, may likewise be regarded as doing
science honor. Here, skeptics may be questioning where the real scientists are
in disputed territory, or whether, indeed, any of the claims in question
have the legitimate status of “science.” Yet in so doing they reinforce the
notion that there is such a thing as real science—objective, true, and pow-
erful. Similarly, legitimate concerns over the “use” and “consequences” of
scientific knowledge do not affect the honor paid to science: the very
problems that science is said to generate flow from the recognition of its
potency.

The point to which I wish to draw attention here is not whether the
public trusts science, or trusts it enough. Opinions can legitimately differ
about whether there is a problem of insufficient public conﬁdence and
respect for some group of scientists or some corpus of scientiﬁc knowledge.
Rather, starting from the observation that public trust in science is enor-
mous, I want to pose some questions about the basis of that trust. On what
grounds, on the basis of what understandings, do we trust scientists to tell
the truth about the natural world, as opposed to some other group of
practitioners like psychics or captains of industry? I will argue that an
important element of our response to the question “Why trust scientists?"
proceeds from an understanding of what kind of people scientists are and
how they relate to the sources of their knowledge and to other members of

TRUST, H ONES TY, AND THE A UT H ()RI TY OF SCIENCE 391

the scientiﬁc community. Are scientists thought to be exceptional in re—
spect of their personal morality, their rugged individualism, the extent of
their disinterestedness, their skepticism? And are any or all of those per-
sonal traits regarded as sufficient to ground our conﬁdence in scientiﬁc
reliability and truthfulness? Or are scientists understood to be ordinary
people whose extraordinary knowledge is guaranteed by characteristics of
the institutions in which they are placed? We trust science, in large part,
through having some sort of understanding of what scientists are like,
individually and collectively.

This paper is in four parts: (1) I argue the importance of trust rela-
tions among scientists as a general matter, and I describe the historical
development ofa sensibility which makes it hard for those trust relations—
and hence the role of virtue in the scientiﬁc community—to be appreci-
ated; (2) I describe the pre- and early modern culture which forged a
publicly recognized link between the integrity of individuals, on the one
hand, and their ability and willingness to speak the truth, on the other; (3)
I note some evidence that this traditional relationship between under—
standings of individual virtue and of intellectual honesty may be breaking
down, and that the public is increasingly being offered a different view of
the bases of scientiﬁc truthfulness; (4) I argue that this emerging new view
of the bases of scientiﬁc credibility—one which takes as a matter of course
the divorce between expertise and virtue—is just the framework which
makes the idea of scientists’ moral authority so problematic. I suggest that
it is ultimately a misguided view and that an understanding of the nature of
scientiﬁc work which does not recognize and enforce a degree of indi-
vidual virtue threatens the moral economy in which scientiﬁc knowledge
itself is created and maintained. Virtue and credibility, I will conclude,
cannot stably be so disengaged as present-day sensibilities seem to accept. I
suggest that a reinspection of the cultural patterns outlined in (2) can
inform the present debates over the ethical authority of science and ethical
conduct in science.

I mean to focus upon scientists’ honesty or sincerity as an element in
the public credibility of their knowledge.‘ However, I need to make a
caveat against seeming to claim too much for such considerations. Sup—
pose we say that there are three main features endemically implicated in
assessments of what we are told, whether by scientists or others: the plausi-
bility of the claim; the intellectual entitlement of the source; and the hon-
esty of the source? First, all things being equal, we are likely to believe
claims that accord with what we already know about the world, even if they
are told us by people whose knowledgeability or expertise in the matter is
slight. just for that reason plausibility may be a trouble, rather than a
positive resource, in fostering public trust in science, at least to the extent
that novel or noncommonsensical claims are at issue. How can scientists

3 92 SOCIETY ’S CHOICES

hope radically to revise or add to the public stock of knowledge unless
there is some other basis for belief than plausibility?

Second, we are more likely to accept claims from sources of recognized
expertise and knowledgeability than from those considered to lack these
entitlements. This too is a fully general maxim of assent. Specialized
scientiﬁc expertise is no invention of the modern era: even in antiquity
practitioners of the mathematical sciences—astronomy, optics, and statics,
as well as pure mathematics itself—were understood to possess arduously
acquired special knowledge and skills which set them apart from the com-
mon culture, with the consequence that only other specialists were in a
position adequately to assess knowledge-claims in these domains.3 The
view that there exists a special, universal, and efﬁcacious “scientiﬁc
method,” though intermittently denied by eminent scientists as well as
historians and sociologists of science, represents a particular form of the
attribution of expertise, and we ought to have a better understanding of
what the public believes about “method” in science and its potency. Scien-
tiﬁc specialization has, of course, vastly increased in modern times, but the
problems that specialization poses for public belief are far from new.

Third,just because we are unlikely to be in a position directly to verify
expert knowledge-claims, we must have some other warrants for believing
them. Even our recognition that these people are experts has to be grounded
on something other than our independent knowledge of their expertise,
for example, upon our belief in the honesty of those who, directly or
indirectly, vouch for their expertise. Accordingly, the acknowledgment of
expertise is embedded within the recognition of honesty: experts have
honestly reported how matters stand in the world; their legitimate posses-
sion of expertise has been honestly represented and vouched for. In this
sense, the recognition of practitioners as truthful—indiw'dually or collec-
tively—is a fundamental basis of public credibility. Other inducements to
credibility must pass through ajudgment that those who speak do so hon-
estly.“ That is to say, against much modern sensibility, that scientists’ au-
thority to say what is true implicates some conception of virtuous behavior.

TRUST AND THE QUALITY OF SCIENTIFIC KNOWLEDGE

I want briefly to describe the historical development of a picture of
scientists’ relations with the natural world and with each other which has
made the role of trust difficult to see and to value. I will suggest that this
picture is systematically misleading, and later I will argue that it has come
to constitute a major problem for an informed public view of what an
honest scientist is and does, and, by extension, for the moral authority of
science. Failure to appreciate the trust-dependency of science therefore
endangers not only the public credibility of science but also, indirectly, the

TR UST, H ONES TY, A ND THE A U' I ‘H 0R1 TY ()1" SCIENCE 3 93

economy in which scientists can continue to produce credible knowledge
and to take a role in debates over the proper uses of science.

The sentiment that regards trust and authority in the guise of potential
problems for genuine scientiﬁc knowledge has the most spotless of philo-
sophical pedigrees. It is as old as modernity itself. The seventeenth-cen-
tury “modems” enjoined those who would reform traditional natural knowl-
edge and set it upon proper foundations to reject reliance upon
authoritative ancient texts and the hearsay testimony of other people. In
one formulation, experience was to be preferred to authority, the Book of
Nature to the texts of Aristotle and “old wives’ tales.” In another, rationally
disciplined self-inquiry was deemed superior to the whole stock of Scholas-
tic knowledge. Bacon and the English empiricists embodied the ﬁrst ten-
dency, Descartes and the Continental rationalists the other. Descartes
locked himself up alone in his stove-heated room in order to set aside the
authoritative knowledge he had acquired from the Schools, “resolving to
seek no other science than that which could be found in myself.” An
individual, equipped with right method, need not rely for his knowledge
upon any intellectual tradition, or upon the relations of any other person.5
In john Locke’s view: “We may as rationally hope to see with other men’s
eyes, as to know by other men’s understandings. So much as we ourselves
consider and comprehend of truth and reason, so much we possess of real
and true knowledge. . . . In the sciences, every one has so much as he really
knows and comprehends. What he believes only, and takes on trust, are
but shreds.”6 In their different modes, both sets of “modems" viewed
reliance upon traditionally trusted sources as an inadequate basis for proper
knowledge. The role of trust and authority was shown to stand against the
very idea of science. Knowledge was supposed to be the product of a
sovereign individual confronting the world. Our knowledge was said to be
secure insofar as its producers were conceived as solitary. That sentiment is
at the root of the modern disengagement between truth and the social
virtues. So far as truth-making is concerned, the social virtues may even be
treated as an impediment.

Seventeenth—century moderns placed the solitary knower at the center
of a scientiﬁc stage where he has remained—minority academic voices
notwithstanding—until the present day. From those moderns we inherit
the legacy of epistemic individualism, a legacy which makes the constitutive
role of trust and authority in the making of knowledge hard to see and
harder still to appreciate as a virtue. Yet all forms of collectively held
natural knowledge, including the most valued bodies of modern scientiﬁc
knowledge, are utterly trust-dependent. The seventeenth-century modern
rhetoric which rejected trust and authority signaled skepticism about an-
cient authority and credulous acceptance of hearsay testimony. It did not,
in practice, mean the wholesale rejection of trust in other people’s narra-

3 94 S OCIE TY’S CHOICES

tions as an adequate basis for empirical scientiﬁc knowledge. The Royal
Society’s motto—Nullius in verba—meant, in operational terms, Do not give
ancient authority or indirect testimony your whole and unconditional trust.

The new empirical and experimental practitioners of the seventeenth
century relied massively upon trust in human testimony about the natural
world, and, indeed, it is impossible that they could have produced any
recognizable body of natural knowledge had they not done so. The “pub-
lic” experiments so vigorously advocated by Royal Society publicists were
rarely witnessed by more than a handful of practitioners, and more rarely
still replicated by distant others. Experimentally produced phenomena
became part of the stock of collective knowledge largely through the testi-
mony of trusted authors. The experiment—called “crucial" by Robert
Boyle—in which a barometer was carried up the Puy-de-Déme in France in
order to show that we lived at the bottom of an ocean of air yielded knowl-
edge for Boyle insofar as he trusted Blaise Pascal, who narrated the experi-
ment, who in turn trusted his brother—in-law, who carried the apparatus up
the mountain and reported that the mercury level fell.7 Natural historical
knowledge of distant phenomena similarly relied upon the narrations of
trusted travelers: scientists who remained the whole of their lives in the
south of England knew that the world contained polar bears, icebergs,
regularly spouting geysers, and men “whose heads do grow beneath their
shoulders” on no other basis. Many naturally occurring phenomena were
accessible only to individuals privileged by space and time to see them, but
knowledge of them became widespread through these persons’ credible
testimony. Those who never themselves witnessed the comet of 1664 knew
its apparent motion through the heavens by trusting those who had, while
the very notion ofa comet’s path only existed through trust relations since
no one individual observed all of its positions.8

Late-twentieth—century science is no less trust-dependent, and arguably
it is more so. The great specialization of modern science means in a very
obvious way that individual scientists do not hold the whole of their own
discipline’s knowledge, and still less that of science in general, in their
heads. The chemical knowledge needed by biologists to conduct an assay,
like the physical knowledge embodied in their instruments, is largely taken
on trust and, often literally, “off the shelf." This much has been intermit-
tently noted by modern scientists and commentators upon science. As
Michael Polanyi observed in 1958, “The overwhelming proportion of our
factual beliefs [are] held at second hand through trusting others."9

Modern scientists, no less than the laity, hold the bulk of their knowl-
edge, even the knowledge of their own disciplines, so to speak, by courtesy.
As students they acquire their knowledge from authoritative sources, and
as mature practitioners they rely upon the trustworthiness of other expert
sources. The sociologist Barry Barnes points out that to say that a society

TRUST, HONESTY, AND THE A UTHORITY OF SCIENCE 395

“knows” something which no one individual in that society knows is proper
speech only by virtue of recognizing the role of trust relations in constitut-
ing knowledge:

If an individual knows Euclid’s geometry up to the twentieth theorem we
can straightforwardly say that he is in a position to prove the twenty-ﬁrst
theorem: he knows all it is necessary to know. But imagine that this
knowledge is spread over the members of a society, some known by some
individuals, some by others. We cannot say of this society that it knows
enough to prove the twenty-ﬁrst theorem. To think of the society as an
individual writ large in this way would be quite misconceived. Suppose
that the different individuals, with the different necessary bits of knowl-
edge, did not know each other, or how to ﬁnd each other. Or suppose
they did not trust each other, or know how to check on each other’s
trustworthiness. In both cases, the twenty-first theorem would remain
unproven. The technical knowledge would have been present in the
society, but not the necessary internal ordering—the necessary social re-
lationships—for the proof to be executed. Individuals would have known
enough mathematics, but not known enough about themselves.10

Trust appears as a “problem” in formal commentary on science just
because its constitutive role is so rarely recognized and is so often vigor-
ously denied. Tojudge that one holds one's knowledge at “second hand,"
as Polanyi himself says, is reckoned to identify its potential inadequacy.11 It
is right to draw attention to the quantity of knowledge which scientists hold
on no other basis than what they are told by trusted sources. Yet it is not
right, save in a restricted sense, to juxtapose trust-dependency to more
direct warrants for knowledge. Scientists are sometimes skeptical of rel-
evant claims, and they do sometimes aim to replicate claims or subject them
to independent scrutiny, though the extent of such skeptical replication
has undeniably been grossly exaggerated in popular portrayals of scientiﬁc
practice. However, the ineradicable role of trust is as apparent in acts of
skepticism as it is in routine trust.

Suppose that a molecular biologist, declining to accept what authorita-
tive sources claimed, was skeptical that the HIV virus contained RNA. Such
a scientist might indeed secure an independent supply of the virus and
subject it to analysis, and in so doing might rightly be said to be rejecting
trust and seeking personal veriﬁcation. But that act of focused doubt
would only be possible if the skeptical scientist took on trust almost every—
thing else relevant to the act: the identity of the virus sample with which he
or she had been supplied, the identity and claimed purity of the reagents
used in the assay, the labeled speed of the centrifuge and the proper
working of other instruments, and the honesty of technicians and of the
authors of papers and manuals functioning as necessary resources in per-
forming this act of skeptical checking. It should, therefore, be evident that

396 SOCIETY’S (1101055

each act of distrust would be predicated upon an overall framework of
trust, and, indeed, all distrust presupposes a system of takings-for-granted
which make this instance of distrust possible. Distrust is something which
takes place on the margins of trusting systems.l2

HONOR, HONESTY, AND FREE ACTION
IN EARLY MODERN SCIENCE

I have sketched a general argument that trust is constitutive of the very
idea of knowledge and that, despite much seventeen th-century and present-
day rhetoric to the contrary, the empirical knowledge of natural scientiﬁc
communities is no less trust-dependent than other cultural practices whose
knowledge is less highly valued. There must always be some practical
solution to the question “Whom to trust?”, while the content of the answer
to that question varies from setting to setting and time to time.

Seventeenth-century answers to the question “Whom to trust?” in sci-
ence do overlap considerably with those familiar to late-twentieth-century
moderns. Early modern practitioners were, for example, more likely to
believe the observation-reports and interpretations of skilled astronomers
than of those with no such entitlements. Indeed, contemporary culture
possessed rich resources for identifying the limitations and inadequacies of
common sense, the unreliability of uninstructed observation, and the li-
ability of “the vulgar” towards delusion and credulity. The same “modern”
tendency which insisted upon direct observation as a bulwark against trust
in ancient authority also cautioned that not everyone was capable of reli-
able observation and that experience always needed to be instructed by
educated reason. Consequently, as I have already indicated, the recogni-
tion of expertise has always been a powerful inducement to assent.

I have also noted that experts will not be believed unless their honesty
in reporting what they know to be the case is also granted. How, then, were
sincerity and truthfulness recognized at the origins of modern science?
Here there was a variety of answers to the questions “Who told the truth
about the world?” and “On what bases did they tell the truth?” In ancient
Greece the role of the philosopher was deﬁned around his love of truth.
The philosopher was that exceptional person, set apart from civil society,
who spurned worldly rewards and pleasures and dedicated himself solely to
truth.13 He not only needed less of the world’s goods and applause to
produce his cultural goods, he positively needed disengagement from the
mundane system of material rewards to seek truth and to be seen to do so.
Only he who was free from worldly motives was free to conduct disinter-
ested inquiry and to ﬁnd truth. As the ancient story has it, when the
philosopher Diogenes was asked by Alexander whether there was anything
he wanted, the philosopher replied, “Yes, I would have you stand from

TRUST, HONESTY, AND THE AUTHORITY OF SCIENCE 3 97

between me and the sun.”‘4 Socrates prided himself on “how many things
there are which I do not want.” The integrity of the traditional philos—
opher’s knowledge was recognized to flow from the special integrity of his
person. By his love of truth alone the philosopher was understood to
imitate God, the source of all truth.15

That ancient cultural appreciation of the philosopher’s identity and its
guarantee of his honesty persisted for many centuries, modiﬁed and rein—
forced by patterns of Christian intellectuality. In 1690john Locke merely
echoed Greek philosophical sentiments in announcing: “He that would
seriously set upon the search for truth, ought in the ﬁrst place to prepare
his mind with a love ofit. For he that loves it not, will not take much pains
to get it; nor be much concerned when he misses it.”16 However, by the
seventeenth century another type of social ﬁgure was increasingly partici—
pating in formal intellectual inquiry, bringing with him a different warrant
for truthfulness. This ﬁgure was the gentleman. In the sixteenth century,
humanist writers were urging that learning not be left to professional schol-
ars and that gentlemen would increase their virtue as well as their social
utility if they too participated in the life of the mind. By the end of the
sixteenth century and the early seventeenth century such writers as Francis
Bacon were offering inﬂuential arguments for the special civic utility of
scientiﬁc studies and their special suitability for gentle participation.” The
founding of the Royal Society of London in 1660 is witness to the impact of
those arguments, and the person of its most eminent member—the
Honourable Robert Boyle, son of the Earl of Cork—embodied the con-
junction of scientiﬁc inquiry and gentlemanly virtue. The Society’s first
historian aptly described the early Royal Society as an organization pre-
dominantly made up of “Gentlemen, free, and unconﬁn’d."18 The culture
surrounding the seventeenth-century gentleman offered a quite special
appreciation of the bases of gentle truthfulness. Gentlemen were said to
tell the truth because they were free of any inducements to do otherwise.
He who lied revealed his servility, baseness, and cowardice: he was, as both
Montaigne and Bacon said, brave towards God and a coward to his fellow
man.19 Within a traditional honor culture, the imputation of fear and
baseness was a grave act. Truthfulness was a measure of honor, and to
represent another as mendacious was precisely to dispute his identity as a
man of honor, a gentleman. Accordingly, it was only the accusation that a
man lied which, in early modern society, could reliably provoke a challenge
to a duel.

Reputation for truthfulness was, therefore, basic to the identity of a
gentleman, while early modern English gentle culture offered a rich reper-
toire of appreciations of why the gentleman was a reliable truth—teller. On
the surface, these accounts look different from those explaining philo-
sophical veracity. They were, for the most part, secular in idiom. Among

398 SOCIE’I'Y’S CHOICES

the most important understandings of the gentleman’s truthfulness was an
attributed causal link between the integrity of his social and economic
circumstances and the integrity of his word. It was not that the gentleman
was he who possessed the most money or the most power: the king and the
great courtiers had more of those commodities. But those who had need
to flatter, or those who were duty bound to represent their country’s inter-
ests, might be under an obligation to deceive. On the other hand, those
who possessed very little money or power were routinely in a position where
they needed to seek advantage, or, if servants, were required to submerge
their integrity in their masters’ interests. Hence, both want or need, and
very great power, induced departures from truthfulness. However, the
English gentleman liked to see himself at the “golden mean” of the social
order, and this was considered to be the position where integrity was un-
constrained.

The gentleman told the truth because no inﬂuences worked upon him to
shift his narratives out of correspondence with what he believed to be the case. His
integrity was recognized to flow from his capacity for free action, and that
same free action underwrote the truthfulness of his word. Conceptions of
innate honor were, in that culture, bound up with notions of free action,
gentle identity, and truth-telling. Understandings of the philosopher’s and
the gentleman’s truthfulness therefore differed. But they concurred in two
respects: (1) the truthfulness of both the philosopher and the gentleman
emerged out of the acknowledgment that these were quite special sorts of
persons, and (2) for both, the virtue of the person underwrote the veracity
of his narratives.

FROM VIRTUE TO VIGILANCE

The culture which thus tied intellectual veracity to personal virtue
persisted in European and, later, in American culture. In particular, the
special reliability and objectivity of the scientist’s testimony continued
strongly to be associated with the special virtues of the scientist’s personal-
ity. What was said of Boyle and Newton in the late seventeenth century
continued to be applied to heroic scientiﬁc truth-seekers. When Boyle
died in 1691 the funeral sermon advertised the spotless character of a
“Christian Virtuoso”: “He could neither lie, nor equivocate.“20 In 1725 the
editor of his works wrote of Boyle’s “candour” and “ﬁdelity” as adequate
grounds for belief, even in the most philosophically implausible claims:
“We may certainly depend upon this, that what Mr. Boyle delivers as an
experiment or observation of his own, is related in the precise manner
wherein it appeared to him: no one ever yet deny’d, that he was a man of
punctual veracity.” Into the nineteenth century, commentators on Isaac
Newton insisted upon the relationship between his genius and his moral

TRUST, HONES’I‘Y, AND THE AUTHORITY ()FSC‘IENCE 399

makeup. In 1857 the philosopher and historian ofscience William Whewell
wrote that “those who love to think that great [scientiﬁc] talents are natu-
rally associated with virtue, have always dwelt with pleasure upon the views
given of Newton by his contemporaries; for they have uniformly repre-
sented him as candid and humble, mild and good."21

In eighteenth-century England the chemistjoseph Priestley wrote that
“A Philosopher ought to be something greater, and better than another
man.” If the scientist was not already virtuous, then the “contemplation of
the works of God should give a sublimity to his virtue, should expand his
benevolence, extinguish everything mean, base, and selﬁsh in [his] na-
ture," and such sentiments were standard in the British natural theological
tradition well into the nineteenth-century.22 Dorinda Outram’s splendid
biography of the early-nineteenth-century anatomist Georges Cuvier shows
how the French public was given to understand the causal relationship
between special scientiﬁc gifts and special personal virtues, and how objec-
tivity was seen to flow from personal authenticity.23 And Charles Paul
describes how the eloges delivered to the eighteenth—century Paris Academy
of Sciences repeatedly pointed to the special personal virtues of great
scientists: simplicity, righteousness, modesty, candor, frankness, and
sincerity.24

Great nineteenth-century scientists were widely advertised as moral
heroes. The experimental biologist Claude Bernard inﬁuentially portrayed
the special personal kindliness and modesty of those pursuing experimen-
tal truth. Such self-denial was necessary to preserve that “absolute freedom
of mind” which allowed the experimentalist to be skeptical even of his own
favored theories and to submit himself to truth alone.25 Celebration of
scientiﬁc heroism and virtue arguably reached its apogee in accounm of the
life of Louis Pasteur: “Like his scientiﬁc prowess, Pasteur’s moral ﬁber was
incomparable. . . . [His] spiritual life was imbued with lofty ideals: sincer-
ity, honesty, decency, and affection for truth.”6 In early—twentieth-century
Germany, Max Weber’s essay on “Science as a Vocation“ advertised the
intensely self-denying “passionate” and “inner devotion” necessary to pur-
sue the life of modern specialized research?7 For many educated Ameri-
cans Sinclair Lewis’s Characters of Max Gottlieb and Martin Arrowsmith
(1925) came to represent the very special nature of the scientist’s vocation:

To be a scientist [says Dr. Gottlieb]—it is notjust a differentjob, so that a
man should choose between being a scientist and being a bond-salesman

It makes its victim all different from the good normal man. The
normal man, he does not care much what he does except that he should
eat and sleep and make love. But the scientist is intensely religious—he is
so religious that he will not accept quarter-truths, because they are an
insult to his faith.28

400 SOCIETY’S CHOICES

A picture of scientists as moral heroes, and an appreciation that their
virtuous heroism underwrote the truthfulness of their claims, thus per-
sisted well into this century. Yet some time around the 193OS—one ought
to be no more precise than that—a quite different understanding of the
scientist’s character, and a different view of what guaranteed the truth of
scientiﬁc knowledge, began to be made available to the public. One of the
most interesting sites in which this View surfaced was closely associated with
the origins of the academic discipline known as the sociology of science.

By the late 19305 and 1940s Robert K. Merton, one of the most inﬂuen—
tial American sociologists, was presenting it as a matter of course that scien-
tists “were as other men,” and that the production of objective knowledge
could not possibly be underwritten by the dispositions and temperaments
of individual practitioners. Disinterested and objective knowledge was pro-
duced by interested and, occasionally, irrationally acting individuals: “A
passion for knowledge, idle curiosity, altruistic concern with the beneﬁt to
humanity, and a host of other special motives have been attributed to the
scientist. The quest for distinctive motives appears to have been misdi-
rected.” There is no satisfactory evidence that scientists are “recruited
from the ranks of those who exhibit an unusual degree of moral integrity”
or that the objectivity of scientiﬁc knowledge proceeds from “the personal
qualities of scientists." Rather, what underpins scientiﬁc truthfulness was
said to be an elaborated system of institutional norms, whose “internaliza—
tion” guarantees that transgressions will generate psychic pain and whose
implementation by the community guarantees that transgressors will be
found out and punished.29

Of course, such arguments against the so-called “motivational level of
analysis” served important disciplinary purposes: they demarcated sociol—
ogy from psychology and showed the legitimacy of social-structural answers
to questions about scientiﬁc objectivity. Nevertheless, these and similar
appreciations of the scientist's personality and communal relations fed
into a public culture which was, in any event, increasingly being made
aware from a variety of sources that the scientiﬁc “vocation” was rapidly
changing from a “calling" to a “job.” The scientist was not understood as
“called” to a passionate search for truth but to be doing ajob like any other,
except that its products counted as truth. Meanwhile, a small number of
psychological studies of scientists broadly supported that understanding
while pointing out that scientists were not notably competent in their indi-
vidual command of the formal principles of logical reasoning.30 When
james Watson’s The Double Helix (1968) caused such apparent public de—
light (and mock consternation) about the all-too—human face of modern
science, Robert Merton was joined by a number of leading statesmen of
science in saying, in effect, “I told you so.” john Lear described Watson’s
book “as therapy for those who think of science as a realm permeated with

TRUST, HONESTY, AND THE AUTHORITY 0!" SCIENCE 401

unalloyed idealism and of scientists as plumed knights searching always
and exclusively for truth.”31

Thus, by the middle of the twentieth century it appears that the causal
link posited by early modern gentlemanly culture between truth-telling
and virtuous free action had been turned upside down. In fact, we still
know relatively little about current lay attitudes towards science and scien-
tists, and we ought to know much more, yet it is not unreasonable to
assume substantial overlap between what the public is persistently told
about science and scientists and what they may come to believe.” And
what the public is pervasively told is that objective scientiﬁc knowledge is
not now guaranteed by the participation ofvirtuous “Gentlemen, free, and
unconﬁn’d,” but by institutions which most vigilantly constrain the free
action of their members. Robert Merton was, accordingly, well aware of
apparent lese majesty in declaring that “the activities of scientists are subject
to rigorous policing, to a degree perhaps unparalleled in any other ﬁeld of
activity.”33 The modern place of knowledge here appears not as a gentle-
man’s drawing room but as a great Panopticon of Truth.

“AFI‘ ER VIRTUE” AND ITS EFFECTS

Iwant to sketch some possible consequences of this changing apprecia-
tion of the grounds of scientiﬁc credibility, drawing out the link between
credibility and moral authority outlined at the beginning of this paper.
These notes are frankly speculative, intended not as deﬁnitive conclusions
but as promptings to reﬂect on the nature of the modern predicament
and, from this somewhat unfamiliar historical and sociological perspective,
to consider anew what might be done about it.

As an historian and sociologist, I am unaccustomed to making recom-
mendations about what scientists and policymakers “ought to do.” (That is
to say, my academic community tends to have its own institutional separa-
tion between our expert knowledge and our moral authority.) Neverthe-
less, I feel that the historical understandings outlined above license a sug-
gestion that some present-day initiatives for dealing with alleged problems
of ethical behavior in science are in danger of getting it quite wrong.

If what I have had to say about the fundamental and ineradicable role
of trust in science is broadly correct, then systematic attempts to subject the
conduct of the scientiﬁc community to vigilant policing are more likely to
kill the patient than to cure the disease. Vigilance can do serious damage
to science for the reason that trust relations among scientists are constitutive
of the making, maintenance, and extension of scientiﬁc knowledge, that is,
to the capacity of the scientiﬁc community to produce consensual knowl—
edge upon which others may rely. Only when that trust dependency is
ignored or seen solely as a problem for science do vigilance models possess

402 SOCIETY’S CHOICES

their apparent appeal. Vigilance as a solution to problems of dishonesty
amounts in practice to the enforcement of skepticism and distrust among
scientists. Scientiﬁc reports may be fraudulent, so scientists are enjoined
more and more systematically to replicate others’ experiments and obser-
vations, and to ensure that their own reports will stand up to others’ more
vigorous skeptical scrutiny. Inference from evidential ﬁndings is to be
more tightly controlled, so scientists are recommended more thoroughly
to report exactly what was done and exactly how it was done. And if they
will not do so, then, it is said, external means must be put in place to ensure
skepticism and distrust.

To suggest that skepticism and distrust should be very much more
common in science is, in effect, to take the position that much of our
modern structure of scientiﬁc knowledge should be unwound, put into
reverse, and ultimately dismantled. Instead of laboratories for the produc-
tion of new knowledge, we should build great facilities for the close re-
inspection of what is currently taken to be knowledge. Grants will be given
for checking routine ﬁndings; published reports will look more and more
like laboratory notebooks; libraries will have to be expanded to house an
unimaginably vast literature reporting upon acts of distrust; relations be—
tween scientists will become uncoordinated, unproductive, and unpleas-
ant. No one actually defends such consequences, largely because those
effects of enforced skepticism have not been clearly foreseen. Nor would
anyone seriously advocate measures that might lead to anything like these
consequences if the constitutive role of trust in making scientiﬁc knowl-
edge were more widely recognized. It needs to be understood that trust is
a condition for having the body of knowledge currently called science. As
Hardwig puts it, “the alternative to trust is . . . ignorance.”34

No doubt, those who argue for such measures do so in good faith,
convinced that skepticism and distrust are the very essence of what it is to
be scientiﬁc. In this respect, they endorse the seventeenth-century “mod-
ern” rhetoric of epistemic individualism. Yet, as I have sought to show,
individualistic rhetoric, however important as a cultural evaluation of how
proper knowledge ought to be secured, fails to represent the realities of
scientiﬁc practice. Science is a trusting institution. Trust is not an epistemic
problem for science; it is—if one wants to engage in such evaluations—an
evident epistemic virtue. It is only by trusting others that scientists hold the
vast bulk of their knowledge, that their knowledge has scope, that they can
know things they themselves have not experienced, and, indeed, that they
can be effectively skeptical when they wish to be. The very existence of
highly interdependent, specialized, and differentiated knowledge-commu-
nities testiﬁes to the real extent of that trust—dependency.

The point is not that vigilant policing is incapable of controlling some
forms of undesirable behavior in science. Of course, the policing of sci-

TRUST, HONESTY, AND THE AUTHORITY 0E SCIENCE 403

ence does in principle have that capacity,just as it does in ﬁnancial circles
or in everyday life. The question to be asked before embarking upon such
policing is whether the nature of the practice is likely to be distorted or
destroyed by enforced skepticism, whether that for which the practice is
valued, and supported, by society is itself critically dependent upon trust
rather than its opposite. Put another way, are there any special reasons for
exempting science from the sort of policing to which many other areas of
everyday life are routinely subject?

I have suggested that there are such reasons. Take any institution in
modern society with whose workings and products we are broadly satisﬁed.
Then come to a reﬂective appreciation of the extent to which those work-
ings and those products are trust-dependent and liable to be eroded by the
imposition of vigilant skepticism. If we are on the whole satisﬁed with the
quality of scientiﬁc knowledge, and if we understand that science is funda-
mentally a trusting institution, then we have adequate grounds for the
exemption in question. I know more about science than about other
modern specialized institutions, but I do not doubt that there are others
that meet the conditions for exemption: one thinks of sectors of the
ﬁnancial system and the civil service. Policy in such matters ought to be
informed by our best current understandings of the conditions in which
geese lay golden eggs. My fear is that the historical and sociological under-
standings that currently seem to inform the relevant policy debates are not
as good as they ought to be.

If what I have had to say about the fundamental role of trust in science
is broadly correct, then some aspects of the modern sensibility that sepa—
rates virtue and credibility can be usefully reassessed. In that sensibility,
what is agreed upon among scientists as “the facts of the matter” is widely
considered an unproblematic element in any potential discussions over
“what then ought to be done” as a morally relevant decision. That isjust a
way of phrasing the disengagement between expertise and virtue which lies
at the heart of the modern sensibility.

Yet, insofar as trust is critical to the making and maintenance of scien-
tiﬁc knowledge, then the attribution of expertise—specialized knowledge
of what is true—cannot be divorced from the practical recognition of vir-
tue—in this case, ofintegrity and honesty. Agreement about the “scientiﬁc
facts” is itselfa moral matter. Being “trust-dependent,” such agreement is
no less interesting and no less problematic than “the ethical application” of
agreed-upon facts. Our technical knowledge is only as secure as the moral
economy in which it is produced. The “scientiﬁc portion” of any ethical
decision contains institutionalized moraljudgments, and the fact that we
do not recognize them as such is itself an aspect of the modern condition.35
Wejust do not yet have a very satisfactory understanding of the processes
by which scientists come to agree, or agree not to disagree, and hence how

404 SOCIETY’S CHOICES

the “facts of the matter” come to appear an unproblematic element in
ethical decision-making.

It is the “vigilance model” of scientiﬁc objectivity that seems to gener-
ate some of our fundamental current dilemmas about the moral authority
of science. Scientiﬁc knowledge will be seen as reliable insofar as scientists
are subject to internal and external vigilance and, in that sense, the rel-
evant invigilated experts will inevitably take part in ethical decisions involv-
ing specialized knowledge. Yet, if scientists are seen as no more honest and
selﬂess than anyone else, then it follows that they will not be accorded any
more moral authority than anyone else. The result may be a strange and
an unsatisfactory situation in which those most intimately familiar with the
“facts of the matter at hand” will neither be given, nor encouraged to take,
any special role in the moral disposition of “the matter at hand." That we
can contemplate this situation with equanimity is an expression of modern
sentiment that holds the divorce between knowledgeability and virtue to be
“natural,” to be accepted as a matter of course. If, however, history holds
any lessons, it is that the relationship between the two is a contingent
matter. And what is historically contingent is historically revisable.

What is to be done? Again, I pretend to no special authority to partici—
pate in such discussions. Yet, as I suggested, the disengagement afforded
by an historical perspective can loosen up our sense of possibilities. One
idea would take seriously as a problem the link between questions of scien-
tific honesty and moral authority introduced at the outset. If our current
appreciation of the former leads to problems with the latter, then the
remedy can only be to try to reconstitute an appreciation of the scientist as
“more virtuous” than other people, and to disseminate that appreciation,
without embarrassment, in the wider culture.

The moral philosopher Alasdair MacIntyre distinguishes between a
“practice” and an “institution.”36 A practice is an organized form of human
activity which provides its members “internal goods,” rewards which can
only be secured by accepting the standards of excellence that belong to
that practice and to it alone. By contrast, there are coherent social institu-
tions which offer their members “external goods,” those available through
participation in the institution, but which do not differentiate that institu-
tion from others and which may even be had without accepting its internal
standards. So, a person may, indeed, get money by cheating at chess or at
science: chess or science may be widely seenjust as a way of getting money.
But then they do not have the status of practices. Chess and science are
practices insofar as participants actually desire those internal rewards which
can only be had by wanting to solve problems or extend understanding,
and then doing so.

The extent to which that idea seems embarrassing and old-fashioned is
the extent to which we have a problem of scientific honesty and, therefore,

TRUST, HONESTY, AND THE AUTHORITY OF SCIENCE 405

of moral authority. The Greeks had the notion of a philosopher as some-
one who loved truth and would not tell a lie, and the early modern English
had their understanding of a gentleman as someone who valued the integ-
rity of his word as he valued his sense of honor. If we are in fact serious
about addressing problems of intellectual dishonesty and the erosion of
moral authority, I doubt very much whether we can do better than try, over
a long period, to revive and reinstill some such culture ofvirtue. This is not
a “quick fix,” but, at the end of the day, it may well be our only stable “fix.”
The Greeks and the early moderns understood that Virtue had to be prac-
ticed and that it could be taught. Efforts at ethical education, if seriously
intended and well-designed, are likely to have an effect. However, nothing
can be as effective as the daily visibility of respected individuals who are
seen to be doing science “for the love of truth,” “for the pleasure of solving
puzzles and getting it right,” and not “for the love of lucre.” Such individu-
als would be understood not to lie because nothing they wanted could be
gained from a lie. The proposed solution must be recognized as having
two sides. Just as one is saying that we ought specially to trust scientists, so
one is saying that scientists ought to deserve to be regarded as specially
trustworthy people.

And such individuals might, for that reason, possess a useful form of
moral authority. There should be no illusions about the nature of the
moral authority which the scientist—restored-to-virtue might have. It would
be of a very general sort. If there really are such people as “ethical experts”
in our society, then this scientist would not be one. Rather, he or she might
have whatever general moral authority still attaches to someone reputed to
be honest and selﬂess, to possess integrity, to love truth more than lucre.
More than that cannot, I think, be reasonably hoped for in our society.
Less than that should be considered unacceptable.

NOTES

1. I appreciate that the present committee is not primarily interested in questions of
scientific honesty or dishonesty, but I shall be trying to show why—properly conceived—such
questions are indeed germane to some of this committee’s concerns about the moral author-
ity of science.

2. This is a simpliﬁed version of an account of maxims of credibility developed in Steven
Shapin, A Social History of Truth: Civility and Science in Seventeenth-Century England (Chicago:
University of Chicago Press, 1994), ch. 5.

3. Thomas S. Kuhn. “Mathematical versus Experimental Traditions in the Development
of Physical Science,” in idem, The Essential Tension: Selected Studies in Scientific Tradition and
Change (Chicago: University of Chicago Press, 1977), 31—65, esp. pp. 35-37.

4. This point has recently been nicely summarized in a philosophical idiom by john
Hardwig, “The Role of Trust in Knowledge,"joumal ofPhilosophy 88 (1991), 693—708, esp, pp.
700—701.

5. Rene Descartes, “Discourse on the Method,“ in The Philosophical Works ofDeseartes, eds.

406 SOCIETY’S CHOICES

and trans. Elizabeth S. Haldane and C.R.T. Ross, 2 vols. (New York: Dover, 1955; orig. pub].
1637), I, 79—130, quoting p. 86.

6. John Locke, An Essay Concerning Human Understanding; ed. Alexander Campbell Fraser,
2 vols. (New York: Dover, 1959; orig. publ. 1690), I, 115.

7. Robert Boyle. “A Defence of the Doctrine Touching the Spring and Weight of the
Air," in idem, Works, ed. Thomas Birch, 6 vols. (London, 1772; text orig. publ. 1662), 1, 118-
185, on p. 151. For studies of experimental performances and replication in seventeenth—
century England, see S. Shapin, “Pump and Circumstance: Robert Boyle’s Literary Technol-
ogy,” Social Studies o/‘Science 14 (1984), 481—520; Shapin and Simon Schaffer, Leviathan and the
Air-Pump: Hobbes, Boyle, and the Experimental Life (Princeton, N]. Princeton University Press,
1985), esp. chs. 2 and 6.

8. The management of empirical testimony in seventeenth-century England is treated in
detail in Shapin, A Social History of Truth, esp. ch. 6.

9. E.g., Michael Polanyi, Personal Knowledge: Towards a Post-Critical Philosophy (Chicago:
University of Chicago Press, 1958), esp. 207—208, 216, 240—241, 375, quoting p. 208. For a
more recent. albeit limited, philosophical appreciation of trust in science, see, e.g., Philip
Kitcher, The Advancement of Science: Science without Legend, Objectivity without Illusions (New
York: Oxford University Press, 1993), ch. 8; also Michael Welbourne, The Community ofKnowl—
edge (Aberdeen: Aberdeen University Press, 1986); and the more full-bloodedly sociological
Hardwig, “The Role of Trust in Knowledge."

10. Barry Barnes. About Science (Oxford: Basil Blackwell, 1985), 82 (and see ch. 3, passim,
for an excellent sociological appreciation of the role of trust and authority in science). As
Hardwig (“The Role of Trust in Knowledge," 697) nicely puts it: “Knowing [is] not a privi-
leged psychological state. If it is a privileged state at all, it is a privileged social state.”

11. Accordingly, while pointing to the central role of trust in modern science Polanyi
(Personal Knowledge, 217) described an ideal chain of skepticism whereby members of special-
ized scientiﬁc communities might validate each other’s knowledge: even though scientist A
was obliged to take the knowledge. of scientist C on trust, he or she was able directly to check
over the knowledge of B, who was, in turn, competent to assess C.

12. See Barry Barnes' concise account of the knowledge-dependency of skepticism with
respect to anomalous scientiﬁc ﬁndings: About Science, 59—63, and, for practical trust in the
“black-boxed" knowledge and routines of modern science, see Kathleenjordan and Michael
Lynch, “The Sociology of a Genetic Engineering Technique: Ritual and Rau'onality in the
Performance of the ‘Plasmid Prep' in The Right Tools for the job: At Work in Twentieth-Century
Life Science, eds. Adele Clarke and joan H. Fujirnura (Princeton, N]: Princeton University
Press, 1992), 77—114, esp. pp. 93, 102.

13. The "apartness" of the philosopher as a pervasive cultural trope is discussed in S.
Shapin, ‘The Mind is Its Own Place': Science and Solitude in Seventeenth-Century En-
gland," Science in (Jontext4 (1991), 191—218, esp. pp. 192—198, and, for classic treatment of the
vita contemplation, see Hannah Arendl, The Human Condition (Chicago: University of Chicago
Press, 1958). See also Owsei Temkin, “Historical Reﬂections on a Scientist's Virtue," Isis 60
(1969), 427—438, esp. pp. 427—428.

14. Plutarch, The Lives ofthe Noble Grecians and Romans, trans.]ohn Dryden and rev. Arthur
Hugh Clough (New York: Modern Library, l 1932]), 810.

15. Classic sources for these sentiments include Diogenes Lartius, The Lives and Opinions of
Eminent Philosophers, trans. C.D. Yonge (London: Henry G. Bohn, 1853), quoting p. 66, and
Thomas Stanley, The History ofl’hilosophy, 3 vols. (London, 1655—1660).

16. Locke, Essay Concerning Human Understanding II, 428.

17. S. Shapin. "‘A Scholar and a Gentleman': The Problematic Identity of the Scientiﬁc
Practitioner in Early Modern England," History of Science 29 (1991), 279—327, esp. pp. 282-
299; julian Martin, Francis Bacon, the State, and the Reform of Natural Philosophy (Cambridge:
Cambridge University Press, 1992), ch. 6.

TRUST, HONESTY, AND THE AUTHORITY OF S(.'IENCE 407

18. Thomas Sprat. The History ofthe Royal Society (London, 1667), 67; also 405-407. For the
scientiﬁc signiﬁcance of the gentlemanly wake-up of the early Royal Society, see Steven
Shapin, “The House of Experiment in Seventeenth-Century England,” Isis 73 (1988), 373-
404, and, for Boyle as gentleman-scientist, see Shapin, A Social History of Truth, ch. 4. I draw
attention here to the special signiﬁcance of gentlemanly codes for early modern English
science. I argue that those codes were influential for the subsequent development of the
natural sciences while recognizing that Continental patterns showed significant difference.

19. Michael de Montaigne. The Complete Essays of Montaigne, trans. Donald M. Frame
(Stanford, CA: Stanford University Press, 1965; orig. publ. 1580—1588), 505; Francis Bacon,
“Of Truth," in idem, The Moral and Historical Works o/‘1.ord Bacon, Including Hi: Essays . . ., ed.
joseph Devey (London: Henry G. Bohn, 1852; orig. publ. 1597), 1—4.

20. Gilbert Burnet. “Character ofa Christian Philosopher, in a Sermon Preachedjanuary
7, 1691—1692, at the Funeral of the Hon. Robert Boyle,“ in idem, Lives. Characters, and an
Address to Posterity, ed.‘]ohn‘]el)b (London, 1833), 368.

21. Peter Shaw. “General Preface,” in idem, ed., Boyle’s Philosophical Works (London, 1725),
ix-xv.

22. William Whewell. Selected Writings on the History ofScience, ed. Yehuda Elkana (Chicago:
University of Chicago Press, 1984), 63. In this connection. see especially Richard Yeo, “Ge—
nius, Method and Morality: Images of Newton in Britain, 1760—1860," Science in Context 2
(1988), 257—284. Recent historical work on Newton‘s character has been notably more
harsh.

23. joseph Priestley. The History and Present State of Electricity, 2 vols., 3rd ed. (London,
1775), 1, xxiii.

24. Dorinda Outram, Georges Cuvier: Vocation, Science, and Authority in Post-Raiolutionary
France (Manchester: Manchester University Press, 1984), esp. 63—64, 79, 94, 117.

25. Charles B. Paul. Science and Immortality: The Eloges of the Paris Academy of Sciences (1691—
1799) (Berkeley: University of California Press, 1980), esp. 92—109.

26. Claude Bernard. An Introduction to the Study of Experimental Medicine, trans. Henry Copley
Greene (New York: Dover, 1957; orig. publ. 1865), esp. 28, 35—39, quoting p. 35.

27. P. Vallery-Radot. Louis Pasteur: A Great Life in Brief, trans. Alfred joseph (New York:
Alfred A. Knopf, 1966; orig. publ. 1885), vi. As with Newton, recent historical work has taken
Pasteur’s reputation for personal virtue down several pegs.

28. Max Weber. “Science as a Vocation," in idem, From Max Weber: Essays in Sociology, eds.
and trans. H.1-1. Gerth and C. Wright Mills (London: Routledge, 1991; essay orig. publ.
1919), 129—156, quoting pp. 135, 137. For useful treatment of the nineteenth- and early
twentieth-century German scientist as moral exemplar and producer of wertfrei knowledge,
see Robert N. Proctor, Value—Free Science? Purity and Power in Modern Knowledge (Cambridge,
MA: Harvard University Press, 1991), chs. 5—10.

29. Sinclair Lewis. Arrowsmith (New York: Signet, 1980; orig. publ. 1925), 267. For the
cultural signiﬁcance and scientiﬁc model of the character of Martin Arrowsmith, see Charles
E. Rosenberg, “Martin Arrowsmith: The Scientist as Hero," in idem, No Other Gods: On Science
and American Social Thought (Baltimore, M1):>]0hns Hopkins University Press, 1976), 123—131.

30. Robert K Merton. The Sociology of Science: Theoretical and Empirical Investigations, ed.
Norman W. Storer (Chicago: University of Chicago Press, 1973; quoting art. orig. publ. 1942),
275-276; see also 259, 290—291; idem, SociologicalAmbivalence and Other Essays (New York: Free
Press, 1976; art. orig. publ. 1963), 34—35. The conclusion that scientists, even the great ones,
“were as other men" was evidently being argued, against residual tendencies to the contrary,
within the scientiﬁc community at the time: see, for example, (1.1-1. Hardy, A Mathematician’s
Apology (Cambridge: Cambridge University Press, 1992; orig. pub] 1940). 78: “Ambition has
been the driving force behind nearly all the best work. . . . We must guard against a fallacy
common among apologists for science, the fallacy of supposing . . . that physiologists, for
example, have particularly noble souls."

408 SOCIETY‘S CHOICES

31. This work is usefully assessed in Michael j. Mahoney, “Psychology of Scientists: An
Evaluative Review,” Social Studies of Science9 (1979), 349-375, esp. pp. 354—356.

32. Robert K. Merton. “Making It Scientifically,” in james D. Watson, The Double Helix: A
Personal Account of the Discovery of the Structure of DNA: Text, Commentaries, Reviews, Original
Papers, ed. Gunther S. Stent (New York: W.W. Norton, 1980; orig. publ. 1968), 213—218;]ohn
Lear, “Heredity Transactions," ibid., 194—198 (quoting 194—195); see also reviews by Richard
C, Lewontin (pp. 185—187, for comparisons with Martin Arrowsmith), Mary Ellman (pp. 187—
191), PB. Medawar (pp. 218—224): [Watson’s book ought to prevent anyone from going]
“on believing that The Scientist is some deﬁnite kind of person." Some scientist—reviewers, to
be sure, found Watson’s portrayal of normal scientiﬁc practice both wrong and damaging to
the reputation of science. At about the same time, Daniel S. Greenberg’s The Politics of Pure
Science (New York: New American Library, 1967) and his journalism for Science magazine did
much to form a public awareness of scientists as entrepreneurs “on the make.” Indeed,
Greenberg’s semi-fictional “Dr. Grant Swinger" was somewhat more merely human than the
average stockbroker.

33. For reﬂective study of the public credibility of science and its bases, see, e.g., Brian
Wynne, “Public Understanding of Science Research: New Horizons or Hall of Mirrors?"
Public Understanding of Science 1 (1992), 37—43; idem, “Misunderstood Misunderstanding: So-
cial Identities and Public Uptake of Science," ibid., 281—304, esp. p. 298; also Marcel C.
LaFollette, Making Science Our Own: Public Images of Science, 1910—1955 (Chicago: University
of Chicago Press, 1990).

34. Merton, The Sociology of Science, 275—276.

35. Hardwig, “The Role of Trust in Knowledge," 707; also Shapin, A Social History of Truth,
ch. 1.

36. The sociologist H.M. Collins has studied episodes of “extraordinary science," in which
scientists cannot effectively appeal to “the facts of the matter” to settle disputes, since it is
those facts which are being contested. In such episodes, scientists may invoke characteriza-
tions of participants’ basic competence and morality in attempts to achieve resolution:
Collins, Changing Order. Replication and Induction in Scientific Practice, 2nd ed. (Chicago: Uni-
versity of Chicago Press, 1992).

37. Alasdair MacIntyre. After Virtue: A Study in Moral Theory, 2nd ed. (Notre Dame: 1:
Notre Dame University Press, 1984), esp. chs. 13—14. MacIntyre’s views are brought to bear
upon the problem of fraud in science by C]. List, “Scientific Fraud: Social Deviance or the
Failure of Virtue?” Science, Technology and Human Values 10, 4 (1985), 27—36, esp. 30—32.

Institutional Ethics Committees:
Local Perspectives on Ethical Issues
in Medicine

ELIZABETH HEITMAN, Ph.D.
Assistant Professor, University of Texas School of Public Health

THE HISTORICAL DEVELOPMENT OF
INSTITUTIONAL ETHICS COMMITTEES

Institutional ethics committees (IECs) have evolved over the past two
decades in the United States and Canada as health care professionals,
hospital administrators, regulatory agencies and legal authorities, and pa-
tients and their families have struggled to make good decisions about ap-
plying resuscitative and life—sustaining technologies. Much of the history of
the IEC parallels the development of medical ethics as an academic and,
more particularly, clinical discipline. However, the practical nature of
clinical ethics and constraints of law and institutional policy have also led
IECs to a theory and practice distinct from academic ethics.

The first public call1 for an advisory body on clinical ethics2 came in
1971 from the Catholic Hospital Association of Canada (CHAC) and the
Canadian Catholic bishops.3 Their Medico—Moral Guide (1), a handbook on
the application of the Roman Catholic teachings known as the Ethical and
Religious Directives for Catholic Hospitals, recommended that Catholic institu-
tions establish special committees to: (a) educate the hospital community
on the moral dimensions of life-sustaining technologies; (b) provide a
forum for interdisciplinary dialogue on their appropriate use; (c) make
institutional policy on the application of the CHAC’s guidelines in treat-
ment; and (d) serve as a legislative watchdog for Catholic interests.

The ﬁrst mention of such committees in the United States appeared in
a 1975 article on the highly publicized nontreatment of a newborn with
Down’s Syndrome at johns Hopkins Hospital (2). Physician Karen Teel

409

4 I 0 SOCIETY ’S CHOICES

observed that doctors often hesitated to make difﬁcult medical decisions
because of the perceived threat oflegal action against them. She suggested
that an institutional sharing of responsibility for morally charged treat-
ment decisions might make it easier for physicians to take appropriate
action. Teel recommended that multidisciplinary committees analyze treat-
ment options for deformed infants in light of their legal, ethical, and social
aspects, and support physicians in their implementation.

In 1976 the Newjersey Supreme Court cited Teel’s work in its ruling In
re Quinlan (3). Although the Court assumedjurisdiction over the issue of
surrogate decision making and awarded Karen Ann Quinlan’s father guard—
ianship for the express purpose of consenting to the withdrawal of her
ventilator, it contended that the court was not the proper site for such
decisions. Instead, it declared that the authority of an incompetent
patient’s guardian included decisions to limit or refuse life support, and
that such decisions should be made in consultation with an “ethics commit-
tee,” as described by Tee], or a “reasonable counterpart.” The Court un-
derstood the committee’s role more in terms of assessing the patient’s
prognosis than resolving the ethical dilemmas of treatment, and mistak-
enly assumed from Teel’s comments that hospitals commonly had such
committees. The state then issued guidelines for such prognostic bodies,
consisting of physicians from varied specialties, and for their role in deci-
sions to withdraw life support (4). In 1977, the Hastings Center held a
conference on the actual and potential roles and responsibilities of IECs.
Participants’ experience of the roles and constitution of such bodies dif-
fered, but they generally agreed that multidisciplinary committees, well
versed in the ethical issues of medicine, could serve in a valuable advisory
capacity to physicians and families confronted with difﬁcult treatment deci-
sions (5).

In 1983, the President‘s Commission for the Study of Ethical Issues in
Medicine and Biomedical and Behavioral Research issued its report on the
ethical, medical, and legal issues in decisions to forego life-sustaining treat-
ment (6). The report focused on the creation of procedures for such
decisions, and examined the role of public and private organizations in
establishing and governing the process. The Commission recommended
that hospitals formulate specific policies on withholding and withdrawing
life support for competent and incompetent adults, and children and in-
fants. In evaluating procedures for surrogate decision making, they re-
jected the practice of seeking formaljudicial review as too cumbersome,
too adversarial, too expensive, too public, and too harmful to the process
of patient care (6, 159). They concluded that institutions should establish
institutional procedures to “promote effective decisionmaking for inca-
pacitated individuals” (6, 160), including neonates (6, 227); one such pro-
cedure was review by a hospital ethics committee (6, 439—442).

INSTITUTIONAL ETHICS COMMITTEES 41 I

As envisioned in a model bill included in the report (6, 439—442),
institutional ethics committees could serve to: (a) conﬁrm the patient’s
diagnosis and prognosis; (b) provide a forum for discussing the social and
ethical issues that a particular case might raise; (c) educate staff on the
identification and resolution of ethical problems; ((1) formulate institu-
tional policy and procedural guidelines on decision making; (e) review
treatment decisions made for speciﬁc patients by doctors and surrogates;
and (f) mediate conﬂict over patient care between health care profession-
als, patients, family members, and the institution. They recommended a
multidisciplinary committee that would be available to staff and patients
and their families, and that would operate formally, keeping minutes and
placing consultation records in patients’ charts.

The Commission’s survey of hospitals found that few had established
formal institutional structures, and those that had reported them to have
widely divergent functions and composition (6, 443—457). While the Com-
mission concluded that IECs offered an appropriately sensitive, rapid, and
private approach to safeguarding the interests of incompetent patients, it
cautioned that there needed to be more study of their use and outcomes
before their adoption could be recommended, much less required. It
further suggested that both the American Hospital Association (AHA) and
the joint Commission on the Accreditation of Hospitals (ICAH) examine
the formation and varied functions of IECs.

In 1983, when the federal government established guidelines equating
nontreatment of severely impaired newborns with discrimination against
the handicapped, known as the Baby Doe rules (7), both the AHA and the
American Academy of Pediatrics (AAP) challenged the regulations on the
grounds that local ethics review would be more valuable than federal over-
sight. The AHA, AAP, and American Medical Association (AMA) ﬁled suit
to have the rules invalidated, and later that year, the AAP issued guidelines
for the establishment of multidisciplinary “infant bioethics committees” to
review the proposed nontreatment of severely impaired infants using a
best-interests standard that recognized the limits of technological interven-
tion (8).

When the regulations were overturned in early 1984, ajudgment sub-
sequently affirmed by the US. Supreme Court (9), Congress attempted
“compromise legislation” that made the withholding of “medically indi—
cated” treatment a form of child abuse or neglect (10). An essential part of
this legislation was the requirement that hospitals with neonatal intensive
care units (NICUs) have a multidisciplinary Infant Care Review Committee
(ICRC) to assist in the determination of appropriate intervention for af—
fected infants, in keeping with the AAP guidelines. Also in 1984, the AMA
(11) and AHA (12) each called for the formation of voluntary ethics com—
mittees in hospitals and other inpatient institutions to “consider and assist

41 2 SOCIETY’S CHOICES

in resolving unusual, complicated ethical problems” in such areas as qual—
ity of life, terminal illness, and the use of limited resources (11). The AHA
suggested that the IEC could serve to establish policies on withdrawing and
withholding treatment at the end oflife; to educate staff, patients, and the
public on the medico-moral aspects of caring for terminally ill and/or
severely deformed infants; and to provide consultation to doctors, other
health professionals, patients, and families in situations where the use of
medical technology created ethical conflict (12).

In 1987, the state of Maryland enacted legislation requiring hospitals
to establish IECs to advise caregivers, patients, and family members on
ethical aspects of the treatment of terminal illness (13). The law also
suggested that committees review and formulate institutional policy on the
use of life support as well as conduct educational programs for hospital
staff and patients and their families on ethical issues in medical decision
making. The Act speciﬁed standards for the IEC's composition, as well as
a variety of procedural aspects, including that it: (a) notify all patients ofits
existence and their right to seek an advisory opinion; (b) consult all care-
givers, the patient, and the patient’s family in its deliberations; (c) and
keep written, but conﬁdential, records and place its formal recommenda—
tion in the patient’s chart. The Act also freed the IEC from legal liability
for recommendations given in good faith.

In 1990, the US. Supreme Court afﬁrmed Missouri’s right to impose a
strict standard of evidence of patients’ wishes regarding withholding and
withdrawing treatment (14), ruling in the case of Nancy Cruzan, a perma-
nently unconscious woman whose family sought to discontinue her tubal
feeding. As Cruzan was unfolding, Missouri Senatorjohn Danforth, intent
on preventing the need for court intervention in treatment decisions, pro-
posed legislation to require hospitals and other inpatient institutions to
inform patients about their state’s law on the use of life-sustaining treat-
ment, and to ask patients upon admission whether they had an advance
directive. The initial version of the federal Patient Self—Determination Act
(PSDA) called for the creation of IECs to educate caregivers, patients, and
the public about advance directives, and to consult on difﬁcult treatment
decisions. This provision was dropped in the ﬁnal version of the bill (15),
however, because of widespread concern that IECs were relatively new and
their effectiveness unknown (16).

While the federal government ultimately did not mandate the creation
of ethics committees, the joint Commission on the Accreditation of
Healthcare Organizations (ICAHO, formerlyJCAH) did so in late 1990 in
its 1992 Accreditation Manualfor Hospitals (AMH) (l7). jCAl-IO’S new ac-
creditation standards on patient rights included a requirement for a “mech-
anism (s) for the consideration of ethical issues in the care of patients and
to provide education to caregivers and patients on ethical issues in health

INSTITUTIONAL ETHICS COMMITTEES 413

care” (17, 156). As ofjanuary 1, 1992, these standards require U.S. hospi—
tals to have an IEC or a similar body or process as a condition for accredi-
tation and eligibility for Medicare payments.

There has been tremendous growth in the numbers of IECs in the last
decade, although their actual prevalence has been difﬁcult to assess. In
1982, the President's Commission survey of 602 hospitals found that only
3% had an IEC or other organizational body that might be involved in
medical decision making; all were in hospitals with over 200 beds (6, 439—
457). A 1983 national survey by the AHA’s National Society for Patient
Representatives found that 26% of hospitals responding had an IEC; by
1985 that number had grown to 60% (18). The most likely hospitals in the
survey to have an IEC were large, teaching hospitals; surprisingly, the num-
ber of nonteaching hospitals with an IEC dropped almost 10% in the two
years between the surveys. In a study of the effects of Maryland’s 1987 law
requiring IECS two years after the Act’s passage, 55 of the 63 hospitals
surveyed responded that they had an IEC, compared with 14 of 18 in the
District of Columbia and 29 of 114 in Virginia (19). Hospitals with fewer
than 250 beds were not likely to have an IEC, and many of the administra—
tors of hospitals in the District of Columbia and Virginia commented that
they did not perceive a need for such a committee.

Although considerable time has passed since JCAHO’s patient rights
standards were proposed, there are still hospitals with no formal mecha-
nism in place, particularly small private hospitals and those in rural areas.
Despite an extensive literature in clinical and hospital ethics and the avail-
ability of several handbooks on IECs (20-25) , many hospital administrators
are unsure of what is required of them or where to turn for information.
Even in hospitals with established IECs, committee members may be uncer—
tain about the committee’s purpose, as well as their own roles and the
adequacy of their knowledge in ethics, law, or medicine (19; 26; 27). This
uncertainty, coupled with the fact thatJCAI-IO instituted the requirement
for IECs at the same time as a host of other changes, suggests that hospitals
that create IECs primarily to conform to the AMH’s standards are unlikely
to have active committees for some time to come (19).

ROLES OF THE IEC

As described above, the IEC has three typical roles, which are comple—
mentary and mutually sustaining: (a) the recommendation or creation of
policy on ethical issues in patient care; (b) the education of hospital staff,
patients, family members, and the community on ethical issues and the
philosophy and policies of the institution; and (c) the consideration of and
consultation on ethical issues in patient care generally and questions about
the treatment of speciﬁc patients. Not every IEC is involved in all of these

4 I 4 SOCIETY’S CHOICES

activities, and some have additional responsibilities. jCAHO standards
require only that committees provide education on ethical issues and a
forum for their discussion (17).

Policy

Much of the uncertainty that surrounds difficult treatment decisions
can be prevented with well-written, comprehensive institutional policies
governing the areas where conflict is most likely. Since IECs were ﬁrst
conceived, their primary responsibility in the area of policy has been to
deﬁne institutional guidelines and procedures for the withholding and
withdrawing of resuscitative and life-sustaining treatment, as recommended
by the President’s Commission.

Although they do not stipulate that the IEC be responsible for making
polichCAHO‘s standards on patient rights (17) also outline requirements
for institutional policy in several areas where the IEC may have consider-
able interest, and where its advice or leadership may be valuable (28):

0 The objectives, procedures, andjurisdiction of the IEC;

0 Resuscitative services and the use of do-not-rescuscitate (DNR)
orders;

0 Informed decision making and informed consent;

0 Advance directives and their implementation, and withholding and
withdrawing life-sustaining treatment generally;

0 Surrogate decision making for incompetent patients, including in-
fants, children, and the unconscious;

0 Assessment and management of pain;

0 Transfer of patients to other facilities; and

' Respect for patients’ religious and cultural preferences.

The [EC should be sufﬁciently familiar with existing policies and proce-
dural guidelines and state and federal law, to clarify, rather than compli-
cate, the standards of clinical practice.

Education

It takes an educated committee to write good policy and provide mean-
ingful consultation, educated caregivers to carry out policies and recom-
mended courses of action, and educated patients and families to appreci-
ate the institution’s policies and make meaningful personal choices. While
the necessary scope oflEC members’ background in medicine and ethics is
controversial, they certainly need a foundation in clinical ethical theory
and practice, medical law relevant to issues of treatment at the end of life,
and the process and techniques of mediation (22—27; 29—31). Education

INSTITUTIONAL ETHICS COMMITTEES 415

in clinical ethics, as in medicine, is an ongoing process, as new issues may
arise that require committees to reevaluate “settled” questions (30). Turn-
over of committee membership implies a need for introductory materials
for new members and ongoing committee education to ensure that the
members have a common framework, without which the committee risks
inconsistency in policymaking and consultation.

Physicians and hospital staff need ongoing education on the insti-
tution’s policies and relevant law on such issues as DNR orders, advance
directives, withholding and withdrawing treatment, and surrogate decision
making. These elements are frequently omitted from the orientation of
new personnel, and where physicians practice in more than one facility
differing policies among institutions can lead to confusion and conﬂict.
Routine medical staff education is also essential in teaching hospitals where
house staff and faculty trained in other states may incorrectly assume that
laws and policies are national. Many younger health professionals have
some education in ethics; however, caregivers need continuing ethics edu—
cation to avoid the well—intentioned application of theories and laws that
have been modiﬁed or superseded (23). Finally, staff members must learn
how to contact the IEC to clarify questions of policy or law or to request
consultation.

Under the PSDA and the jCAHO standards, hospitals and other inpa-
tient institutions are required to provide education to patients, their family
members, and the community on their rights to make certain treatment
decisions, including the right to formulate advance directives, and on the
institution’s mechanism for resolving conﬂict over treatment. Such educa-
tion should involve meaningful discussion of the goals and real limits of
medical intervention (32), so that lay people truly understand the nature
of the decisions that they are called to make. Lastly, patients and their
families need information about the IEC, its purpose, and how to use it;
unfortunately, even in hospitals with well-established committees, most
patients and family members still know nothing about the IEC (19; 33; 34),

Consultation

Consultation is the IEC's most controversial role, as some physicians
question the need for ethics consultation. Where consultation does take
place it assumes numerous forms (29; 34—41). There remains no real
consensus on some important aspects of consultation, even after almost a
decade of discussion and experience. The primary issues include:

Who may seek consultation?The President’s Commission andJCAHO call
for the IEC to be available to all members of the institutional community,
including physicians, nurses, allied health professionals, patients, family
members, and potentially even outsiders. However, some IECs that oper-

4 I 6 SOCIETY ’S CHOICES

ate ()n a conservative interpretation of the AMA guidelines (11) limit con-
sultation to physicians; thejCAHO standard on universal access to consul-
tation will likely meet with resistance in such hospitals. In some facilities,
this limitation has led to the creation of parallel “nursing ethics commit—
tees,” where nurses seeking advice or interpretation of policy may get an
answer directly; often their issues involve conflict with physicians (42).
Clinical ethicists typically advocate broad access to a central IEC, concerned
that nursing committees marginalize nurses and compartmentalize institu—
tional issues along disciplinary lines.

Who may attend meetings, participate in discussion of cases, and attend a
consultation? Closely related to the issue of who may seek consultation is
whether meetings and case discussion are open only to members or to the
hospital at large (40; 43). The openness of regular business meetings is
typically less a problem than is the open discussion of cases where both the
patient’s confidential information and the caregivers’ insecurities may be
exposed. Many committees hold open business meetings, particularly in
teaching hospitals. Some IECs permit anyone to attend a consultation who
is involved in the relevant patient’s care, but hold formal deliberation
privately. Others hold closed business meetings and case review, admitting
nonmembers only by invitation. Some critics have argued that too many
committees exclude even the patient and their surrogates, denying them
due process (34; 35) and violating conﬁdentiality (29; 35; 40; 44). IECs need
to distinguish between concern for protecting conﬁdentiality and the risk—
averse desire for secrecy before the question of openness can be resolved.

How formal a consultation is necessary for different levels of advice? A num-
ber of levels of consultation are possible, from the quick telephone call to
conﬁrm the meaning of a policy, to the bedside consultation by an ethics
consultant or IEC subcommittee, to the convening of the entire IEC for
formal presentations and extensive discussion. The level of formality varies
with the information needed, the patient’s condition, and the complexity
of the issue, including the duration of the controversy and the roles of the
caregivers and family members involved (41). Most clinical ethicists now
agree that, except in straightforward cases of'deﬁning policies, the consult—
ing ethicist or a representative of the IEC should see the patient (33—36; 38;
39). For some this Visit is intended to confirm the patient’s diagnosis and
“gather . . . a clinical database” (39); for others it is to talk with the patient
and the family ﬁrsthand about the issues (34; 35).

Much, and by some accounts most, of the apparent conﬂict that
prompts a call for ethics consultation is the result of poor communication
(‘22, 241—243; 31). Consequently, the best type of consultation may de-
pend on the severity of the miscommunication or the format most likely to
resolve the particular communication problem. A formal meeting of the
entire committee can seem adversarial to some patients or family mem-

INSTITUTIONAL ETHICS COMMITTEES 41 7

bers, who may feel threatened or inadequate before a large group of “hos-
pital authorities”; physicians may also become anxious in a setting that
looks too much like a peer review hearing (40). However, a full committee
consultation may be quite effective when communication is the real prob-
lem, as the committee’s need for a complete picture also affords the prin-
cipals an opportunity to hear others’ perspectives. Although the IEC can
promote comprehensive communication among caregivers, the patient,
and family members, an IEC consultation is neither the only nor the best
format for achieving such results; multidisciplinary family conferences can
be equally effective in many instances.

Who is told of the IEC’s recommendation? How? When? The IEC‘s recom-
mendation will vary in its speciﬁcity and formality in part according to the
format of the consultation. Clearly the person requesting the consultation
should be informed of the IEC’s recommendation, as should the other
principals, including the patient and attending physician (33—35). At some
point, too, others involved in the patient’s care will need to be informed of
any changes in the treatment, and their rationale. The question of how
and by whom the information should be relayed is tied into:

What documentation should be kept, and where? The President’s Commis-
sion and most other bodies with guidelines on the conduct of IECs call for
a consultation record to be put in the patient’s chart in much the same way
that other consultations generate chart notes; additional copies of the
recommendation could be provided to the attending physician, patient, or
person seeking the consultation, as needed. This format works very well in
many institutions.

However, many hospital attorneys and many more physicians are leery
of formal records, worried that a patient who is the subject of an IEC
consultation is likely to become the focus of litigation (23; 27; 44). Some
fear that a formal IEC note—or even a mention of the IEC’s involvement—
in the patient’s chart might heighten a malpractice attorney’s curiosity
about any physician wrongdoing; in some hospitals, the consultation notes
are kept only in the IEC‘s ﬁles, ostensibly to protect them from discovery.
The committee’s chair or another member confers with the attending
physician and the patient or family to relate, and if necessary interpret, the
IEC’s opinion; the physician is then responsible for writing orders that
reﬂect treatment plans in light of the recommendation. Unfortunately,
this practice offers physicians none of the beneﬁts of the “institutional
sharing of responsibility,” and may confuse other staff who must rely on
word-of-mouth information to learn about the IEC’s perspective. More-
over, in the few cases where litigation is pursued, the absence of an IEC
record in the chart may generate interest in “undiscoverable” material that
otherwise might be left alone.

What if the attending physician disagrees with the IEC’s recommendation?

41 8 SOCIETY’S CHOICES

Most IECs consider even their formal opinions to be advisory only, and as
with other clinical consultations, the physician is free to follow all, part, or
none of the IEC's advice. Although IEC recommendations are typically the
product ofa consensus in which the physician has participated, doctors are
suspicious of formal consultation because they fear that the IEC will “rule”
against them, and that disagreeing with the IEC will create a risk of litiga-
tion (23; 27; 44; 45). Some have argued that, in practice, even informal
recommendations may function as binding decisions (46). Where the IEC
is not able to resolve a conﬂict between doctor and patient or family, the
IEC typically informs the patient or family that they may seek another
physician, and reminds the physician of the professional (and in some
states legal) duty to facilitate a transfer should the patient or surrogate
decision maker request it.4

What ifthe patient orfamz'ly disagrees? Including the patient or family in
discussion and planning of treatment typically prevents conﬂict, and the
communication that the IEC facilitates often results in compromise and
consensus that includes patients’ or family members’ views. Often the
question involves conflict among family members that may have nothing to
do with the patient’s care; here it is more important to determine who has
decision-making authority than to achieve consensus. Ifa patient or family
member with decision-making authority disagrees with the IEC’s recom-
mendation and the attending physician’s advice, the patient may request to
be transferred to another physician or hospital, and the physician should
facilitate the transfer, if possible.

Increasingly, such situations have involved family members’ requests
for treatment that physicians and IECs contend are unduly burdensome
for the patient, inappropriate to the goals of treatment, or “futile” (34; 47—
49). Many hospitals claim to follow the guidelines of the Society of Critical
Care Medicine (34; 48), which state that the attending physician is under
no obligation to provide treatment that “has no chance of achieving ben-
efit” (50). However, determinations of medical futility have become quite
controversial in light of two court rulings that appear to have given patients
a right to “futile” treatment that the physician and hospital sought to dis-
continue (51; 52). This question is likely to remain unresolved for some
time, as the clinical issues converge with the social debate on the right to
health care and the value of life in any form (32; 33; 48; 49).

ADMINISTRATIVE ASPECTS

Despite its broad mandate, the IEC is a hospital committee with the
same administrative considerations as other committees, many of which
are shaped more by the general practices and culture of the institution
than by the IE 1’s formal charge. Several of the proposed guidelines for

INSTITUTIONAL ETHICS COMMITTEES 41 9

IECs attempt to deﬁne administrative structures and processes (11; 20—25).
JCAHO’s standards are exceptionally open, in keeping with its Principles
of Quality Improvement, which are intended to support institutions’ ef-
forts to tailor guidelines to their own needs (17). Some basic administra-
tive questions to be resolved at the institutional level include:

Should the IEC be under thejmisdiction of the medical staﬂ administration, or
governing board? A number of aspects of the committee’s structure and
function may be inﬂuenced by its place in the hospital’s administrative
structure. The IEC’s authority, accountability, leadership, membership,
and length of terms may all be defined by its location in the institutional
hierarchy. The AMA recommends that the IEC work under the Medical
Executive Committee, primarily to ensure that physicians have a promi-
nent voice in policy (11), but some would argue that such lECs might not
have the independence necessary to question physicians’ practice (29).
Others place the committee under the administration, as administrators
are typically responsible for what may be perceived as the risk-management
and policy aspects of the committee’s work. However, such placement may
marginalize the committee in clinical practice if physicians do not have a
sense of ownership (29). Placement under the governing board can give
the IEC the authority and political freedom to work effectively throughout
the institution, but requires strong committee leadership, and a self-critical
sense of purpose among the members. The IEC’s budget and the availabil-
ity of support staff, meeting rooms, and other essentials may also be de-
ﬁned by its relationship to particular ofﬁces. These considerations are
especially important in smaller hospitals, and where staff and facilities are
overburdened owing to ﬁnancial constraints.

The maintenance, availability, and discoverability of the IEC’s records
may also be affected by its placement in the hospital's administrative struc-
ture (22; 23; 27; 29; 45). The IEC’S minutes and case reports might be
safeguarded like quality assurance materials if the IEC is an administrative
committee; records might come under peer review protection if the IEC is
a medical staff committee. However, neither of these assumptions has
been tested, and there is no consensus of legal opinion about the protec-
tion of IEC documents or the potential testimony of IEC members in
litigation. Moreover, preoccupation with secrecy is not consistent with the
publicly projected image of the IEC as a means of ensuring the account-
ability of health care professionals and institutions in decision making.

Who should chair the IEC? Leadership is crucial to the proper function—
ing of any group, especially one that has a potentially controversial role.
The head of the IEC must have the respect of the hospital community for
the committee to be effective (22; 23; 29). Some guidelines suggest that
the chair have a highly visible position of authority within the hospital;
elsewhere, experience suggests that a chair’s high profile may limit the

or consultation coordinator. The rotation of leadership varies greatly
among institutions, again dependent on structural and personal variables

as much as administrative order.
Who should be members? Members need to be respected members of the

INSTITUTIONAL ETHICS COMMITTEES 421

From the beginning, physicians have been skeptical about the value of
an IEC, and have been worried that the committee would be looking con-
stantly over doctors’ shoulders, telling them how to practice medicine (22;
29). While some of this initial hesitance has abated, especially among
younger doctors, some physicians are unwilling to serve on what they per-
ceive will be a meddlesome committee, or are fearful of the political conse-
quences of appearing to sit injudgment of their peers (29). Others do not
want to participate in a multidisciplinary IEC because they are unaccus-
tomed to working with nonphysicians, or they may object to the im-
plication that others can adequately assess the ethical dilemmas that
doctors face. However, some IECs have found that critics of the committee
can become its champions if they are invited to share their opinions as
members.

Nurses of various specialties, including floor nursing, critical care, and
administration. Nurses are especially important because of their experi-
ence in carrying out treatment orders in controversial situations and their
appreciation of the more personal responses of patients and families to
serious illness. Moreover, they often recognize the political issues at stake
in both policy and practice, and know how to negotiate them. In most
institutions, nurses are eager to take part in the IEC, and it may be difficult
to determine who among a number of qualiﬁed candidates should serve.
Some nurses hope that the IEC will provide an opportunity to redress
injustices that nurses have suffered in the past; butjust as physicians must
work with others, nurses must be willing to work with doctors.

Social workers, patient representatives, and discharge planners, valu-
able because they are often called upon to handle the problems of “difﬁ-
cult” patients, whose “trouble making” may be the result of conﬂicting
ethical or sociocultural values. They typically know both how to recognize
the sources of conﬂict among caregivers, patients, and family members and
often how to present options to resolve the conflict. Social workers and
discharge planners can be central to the strategic aspects of an IEC’s con-
sultation, as they know what options are possible and how to use commu—
nity resources to support patients’ and families wishes for care that cannot
be provided in the hospital.

Physical and respiratory therapists, seldom included in lists of prospec-
tive members, but whose familiarity with the care of the chronically ill and
comatose, as well as knowledge of the stresses and rewards of rehabilita-
tion, make them invaluable to some committees. They, like nurses, typi-
cally implement treatment orders for patients likely to fall under IEC poli—
cies, and they see the long-term consequences of critical care. They can be
helpful in case consultation because they often give social and emotional
support to patients and families, and their teaching skills often enable
them to communicate complex medical concepts to lay people.

422 SOCIETY’S CHOICES

Clergy, whether hospital chaplains or clergy from the community, who
can assist the IEC in appreciating the religious meaning that both health
professionals and lay people may ﬁnd in illness and medical care, and in
identifying symbolic issues that can complicate decision making. Clergy
can offer reassurance and reinterpretation of religious teachings to pa-
tients, family members, and staff who mistakenly fear that their intended
actions are prohibited within certain religious traditions. Many clergy are
trained in moral analysis, and although the perspective of their particular
denomination may not be immediately applicable, their ability to identify
central ethical themes and questions can be quite useful to the consultative
process. Community-based clergy can be particularly helpful when they
are familiar with the values, experiences, and daily life of the hospital’s
patient population.

Hospital administrators, who are often responsible for drafting and
implementing hospital policy that may affect the IEC. As committee mem-
bers they may both facilitate the IEC’S work in policy and learn lessons
from the IEC’s experience that will make hospital policy more appropriate
to clinical needs. The presence of the hospital’s CEO or other upper
management on the IEC can also lend authority to its work. Administra-
tors, like physicians, however, must appreciate the necessary collegial na-
ture of the IEC and its deliberation, and refrain from imposing top-down
decisions based on business criteria.

Community representatives, including former patients or their family
members who can provide important insight into the lay person’s perspec-
tive on medical issues, and represent the committee and the hospital out-
side the institution. In case consultation they may be able to translate the
language of health professionals into words and ideas more familiar to
patients, and offer reassurance that the conﬂict over care is not a medical
conspiracy. Community representatives are typically the most difficult for
IECs to recruit and retain, often not because community members are
unwilling to serve, but because the professional staff does not know whom
to recruit. To identify potential community members, the IEC must know
its patient population and what characteristics might be representative.
Where community members are not effective representatives of the hos-
pital’s patient population, patients and their families may perceive the IEC
to be simply another way in which the hospital protects its self-interest (29;
33).

Attorneys and ethicists, who may be found on the lECs oflarger, urban
hospitals, especially university-afﬁliated institutions with a program in medi-
cal ethics or medical humanities. Many of the country’s first IECs were
started in collaboration with faculty from such programs. Some university—
afﬁliated hospitals now have clinical ethics programs that offer ethics con-
sultation sen/ices, as part of or independent of the IEC. Attorneys and

INSTITUTIONAL ETHICS COMMITTEES 423

ethicists have analytic skills and knowledge of tradition and contemporary
standards that can strengthen the IEC’s conﬁdence and effectiveness. The
place of lawyers and ethicists on the IEC has been debated, however, and
many hospitals have no opportunity to include experienced professionals
in health law or clinical ethics in their committees.

Lawyers and theoretical ethicists, with no clinical experience may mis-
understand the issues and mislead the IEC with information and perspec-
tives that, while technically correct, are inappropriately applied (22; 27;
54). Hospitals with an attorney on retainer are often hesitant to pay to
have legal counsel attend committee meetings, and few nonuniversity hos—
pitals contract for an ethicist’s ongoing professional services. Small hospi-
tals in large for-proﬁt chains may work primarily with lawyers at a corporate
headquarters who know little about the speciﬁc institution. Attorneys who
see their single role as protecting the hospital from liability may encourage
the IEC to become a risk-management committee; ethicists who see them—
selves as the patient’s only advocate may put off the very caregivers who
most need consultation; both may hamper the effectiveness of the IEC in
consultation and the creation of policy.

Some handbooks written by clinical ethicists concede that there is no
need for a staff ethicist on many IECs, but note that committees should
attempt to include professional ethicists among their educational speakers
(22; 23). However, the continued growth of this discipline and the educa-
tional opportunities in clinical ethics will almost certainly increase the
prominence of clinical ethicists in the hospital setting.

Since the publication of its patient rights standards,]CAI-IO has taken
interest in the makeup of IECs, and has begun to consider standards for
IEC membership and ethics consultation (55). jCAHO’s interest comes at
a time when there is already a spirited discussion among clinical ethicists
about the value of professional certiﬁcation (56). Ethicists themselves are
far from agreed on whether clinical ethics consultation is a profession, and
if so what level of education, training, and expertise should be expected of
its members. jCAHO is interested in the practice and credentials of clini-
cal ethicists, but is particularly concerned about the quality of IECs in small
and rural hospitals where ethicists are virtually nonexistent and few care-
givers are likely to be proficient in clinical ethics. jCAHO is currently
observing the creation of ethics committee networks in Virginia, with the
hope that similar afﬁliations elsewhere could serve as cooperative regional
ethics committees for institutions unable to create IECs individually (E.M.
Spencer, personal communication).

Over the past several years, a number of local and statewide IEC net-
works have evolved across the country (57). Typically networks develop as
members of newly formed IECs seek advice from other institutions, par-

424 SOCIETY‘S CHOICES

ticularly in the areas of policy and consultation. Some networks have
worked on standardized forms for DNR and supportive care orders, and
others have deﬁned community standards for withdrawing treatment; even
informally, networks provide a means of establishing community standards
for IECs by informing members about the operations and activities of other
committees against which they may measure their own work. Some net-
works coordinate public educational efforts; others provide committee edu-
cation or review difﬁcult cases. With the implementation of health reform,
such administrative umbrellas are likely to be increasingly important in
facilitating the integration of IECs within health alliances, and safeguard-
ing the ethical quality of care from the potential negative consequences of
managed competition.

ISSUES ON THE HORIZON

As many new IECs become established, others are entering their sec-
ond decade. The future of ethics committees will be difﬁcult to predict, as
much remains unknown about them currently. Some issues on the hori-
zon include the development of IECs in long-term care facilities; the liabil-
ity of IECs and their members for their consultation; the role of IECs in
cost containment; and the need for formal evaluation of IECs and their
varied roles.

IECs in Long-Term-Care Facilities

Although nursing homes and other long-term care facilities are subject
to the PSDA and required to meet JCAHO standards in order to receive
Medicare payments, there has been little study of IECs in such institutions.
Some research and anecdotal evidence suggests that many do not inform
patients or their families about their right to an advance directive or their
options for treatment, and few have established IECs (58—61).

For many hospital IECs, nursing homes and other long-term care facili-
ties are a source of ethical problems, as their residents are repeatedly
hospitalized for the treatment of strokes, infections, and fractures from
which they will neither recover nor die. Most patients come from such
facilities to the hospital unable to make their own decisions, and many have
no available family member or other surrogate decision maker (59; 61).
However, hospitals often discharge patients to long-term care rather than
face difﬁcult questions of appropriate intervention in the treatment of
comatose or otherwise incompetent patients whose quality of life is limited.
Typically there is little communication between hospitals and long-term
care institutions over advance directives, DNR orders, and the goals of
treatment, which itself may contribute to ethical conflict in such patients’

INSTITUTIONAL ETHICS COMMITTEES 425

care. IECs in nursing homes will be increasingly important in the coming
years, as the population ages and hospitals and health policymakers re-
evaluate the use of acute care facilities and life—sustaining interventions.
Long-term care facilities present many of the same institutional challenges
as hospitals in terms of education in clinical ethics and policymaking; their
higher turnover and typically less well-trained personnel make ongoing
education and clear policies even more important. The prevalence of
incapacitated patients means that surrogate decision making may be the
norm, and the low rate of reimbursement for physician visits may make
doctors less willing to spend time with patients and their families for ad-
vance planning. The role for IECs in long-term care facilities must be one
aspect of a comprehensive assessment of the care of the elderly and se—
verely disabled under health care reform.

IECs’ Liability for Malpractice and Other Legal Action

Ethics committees were ﬁrst suggested as a forum for resolving the
conﬂicts that might lead to a court’s intervention; both the New Jersey
Supreme Court and Congress anticipated that IECs would help to keep
medical decisions out of the courtroom (3; 16). Good policies should
prevent hospitals and physicians from needing a court’s opinion in all but
extreme cases, and IEC consultation should reduce the risk of malpractice
litigation against physicians as evidence that “due care” was used in deci-
sion making (29). Moreover, most malpractice suits stem from poor com-
munication between patient and from physician, and patients’ or families'
perceptions that their opinions did not count (62). By actively including
patients and their families in controversial decisions, taking their views
seriously, and mediating conﬂict, IECs should prevent the resentment that
typically leads to suit.

There remains the possibility, however, that IECs themselves could
become the target of litigation, either from a patient or family member
who is dissatisﬁed with the consultative process or advisory opinion, or
from a physician sued after relying on an IEC’s recommendation. While
Maryland law makes ethics committees immune from legal action, IECs in
other states have no such protection (63). In 1986, an IEC in California
was sued by Elizabeth Bouvia for its role in supporting a physician’s deci-
sion to force-feed her through a nasogastric tube (64). That conﬂict was
ultimately resolved without going to trial, and there have been no such
suits since. However, there are a number of gray areas in which an IEC
might recommend action that could be considered to violate the patient’s
legal rights: the discontinuation of “futile” life—sustaining treatment against
a surrogate’s wishes is a likely possibility. Where the IEC makes binding
rulings or “optional” recommendations that are not really optional (46), a

426 SOCIETY'S (31101053

physician sued for following the IEC’s advice might seek damages from the
committee or its individual members.

In either situation, the IEC would need to demonstrate the duty of care
that ethics committees have to patients, and establish that it had not
breached that duty. In a case of a recommendation on a controversial
issue, it would have to show how it arrived at the conclusion, and that it
followed the standard of practice that similar bodies would accept in reach-
ing a conclusion. Individual members would need to show that they had
the knowledge and exercised the skill andjudgment of a reasonable mem-
ber of an IEC in deliberating and reaching a recommendation. Records
supporting the ICE’s position would be crucial, as would evidence that
documented the process.

Because there are no well—established standards for IECs, including
criteria for membership and appropriate process, a committee under pub-
lic scrutiny might ﬁnd it difﬁcult to prove that it met a standard of care.
Moreover, as some committees keep only minimal records, documenting
the decision-making process could be even more troublesome. In the
unlikely, but equally possible, case that an IEC came under criminal inves-
tigation for such crimes as conspiracy to commit murder or child or elder
abuse, the existence of formal measures and the availability of records
would be even more important. While IECs will likely always face some risk
oflegal action, clear professional and institutional standards for their con-
stitution and operation would reduce that risk.

IECs and Cost Containment

For many caregivers, questions of appropriate intervention become
ethical questions when the patient cannot pay for care. In a recent nonﬁc—
tion book portraying the work of an IEC in a large urban hospital, eco—
nomic issues lie behind every treatment decision (65). Although the IEC
never discusses the cost of care, the book is laced with descriptions of
caregivers and other institutional bodies considering the ﬁnancial impact
of the intensive care and technological intervention provided to indigent
patients. Ethics committees have typically focused as a matter of principle
on serving the patient’s best interests. They have sought to remain above
the debate about cost containment and allocation of resources.

Increasingly, the inequalities of access to care, the inequalities of care
once accessed, and the high cost of many life saving interventions—some
in short supply—are likely to force IECs into the discussion of costs, espe-
cially in light of health care reform. The question of how IECs should
participate in the discussion and how they should use ﬁnancial information
in their consideration of patient care and policy remains unanswered (65—
68). IECs should know what role their individual institutions expect them

INSTITUTIONAL ETHICS COMMITTEES 42 7

to play in the hospital’s larger agenda, and ensure that the ethical criteria
for its policies and practices are not subverted by other interests. The IEC
can promote the hospital's healing mission where others serve the bottom
line, and it can examine head-on the issue of cost containment in selective
policy and case review, providing the institution with a clear understanding
of the difference between ethics and economics.

On a societal level, IECs and ethics committee networks can consider
the Canadian Catholic bishops’ suggestion that they observe and respond
to governmental efforts to address health care (1), safeguarding the inter-
ests of patients and caregivers in the process of health care reform by
sharing with policymakers their ethical expertise and practical experience.

Measuring the Effects of IECs

In the more than ten years that professional organizations and licens-
ing and accrediting bodies have recommended or required the establish-
ment of IECs, a number of manuals have offered guidelines on their self-
assessment, and there have been many calls for substantive evaluation of
their effects (5; 6; 16; 21—23; 31; 43; 53; 70—73). To date, assessment has
been conﬁned to a few academic articles, workshops at professional meet-
ings, and the informal shoptalk of clinical ethicists. Given the limited
degree to which any technology is evaluated before its widespread diffusion
into clinical practice (72), and the limited funds available for health ser-
vices research, this uncritical adoption of IECs is not surprising. Assess—
ment of the effects of IECs is also complicated by the fact that these com-
mittees are intended to serve a variety of purposes, not all of which have
been clearly deﬁned even among practicing clinical ethicists.

Establishing what is meant by “success,” the standards by which IECs
should be measured, and the rationale for these definitions is essential
before meaningful assessment can take place (53; 69; 70; 72). AstAHO
surveyers gain experience with IECs in their varied formats, it is likely that
the AMH will set more speciﬁc standards and assessment criteria for their
composition and function. The establishment of formal standards should
not be left to JCAHO alone, however, but should involve the ethicists,
clinicians, and policymakers whose work has led to the growth of clinical
ethical theory and the rise of active IECs, and the individual committees
themselves.

Anecdotal evidence suggests that IECs have been successful at the
widely claimed goal of limiting court intervention in treatment decisions.
It is less clear whether this effect is truly due to the IECs’ mediating capaci-
ties, their occasional tendency to function as risk—management commit-
tees, the effectiveness of staff and patient education on ethical issues, or a
growing social consensus about appropriate treatment at the end of life.

428 SOCIETY’S CHOICES

Each of these questions is worthy of study, and should provide valuable
insight into the future direction of IECs.

NOTES

1. Some discussions of the development of IECs find important parallels to institutional
review boards (IRBs) governing biomedical research with human subjects and/or Seattle's
dialysis allocation committee of the 19605. Like the IRB, hospital ethics committees are
intended to safeguard patients’ interests and right to informed consent; like Seattle’s “God
Committee," IECs may deliberate on the appropriate use of advanced life-sustaining treat-
ment. However, neither of these bodies is truly similar to the IEC. Its mandate has been
much broader than that of the other structures, and was derived primarily from the need to
define whether and how to end treatment that physicians might construe as being in the
patient’s interests.

2. For simplicity, all such institutional structures and processes will be referred to here as
IECs.

3. Clinical ethics has developed as a ﬁeld in Canada in parallel with the United States;
although under somewhat different guidelines, IECs serve much the same purposes there as
here.

4. In a some instances, however, patients and families will not seek transfer and doctors
do not seek to remove themselves from the patient's case. Although this phenomenon has
not been explored, it appears to be more common in community hospitals and where the
physician and patient have had a long—term relationship. For patients, families, and doctors
faced with a life-threatening situation, conflict in a familiar relationship may be preferable to
the anxiety and unknown outcome of change.

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The Ethical, Legal, and Social
Implications Program of the National
Center for Human Genome Research:

A Missed Opportunity?

KATHI E. HANNA
Science and Health Policy Consultant, Washington, I). C.

ELSI is not a guarantee that all is well in the Genome Project, that all
moral problems will be neatly anticipated, dissected, and managed. It is
ludicrous to think that a handful of scholars and clinicians who comprise
[sic] the ELSI Working Group are capable of such heroic wisdom and
foresight, or even to believe that the many scholars whose independent
work is being funded through the ELSI program can do the same. The
ELSI Working Group is not a commission or regulatory agency empow-
ered to speak for the public or to exercise control in the public interest.
Experts in medicine or ethics or law, although they may clarify issues and
offer useful critiques of public policy, lack the moral and political author—
ity to decide what ought to be done.

There are dangers here. The public, including public ofﬁcials, must not
be misled about what ELSI can do, lest it let down its guard.

Thomas H. Murray,
member of the ELSI Working Group (1992)

The Human Genome Project of the National Institutes ofHealth (NIH)
and the Department of Energy (DOE) was initiated in ﬁscal year 1988 as a
line item in the federal budget to map and sequence the entire comple-
ment of genetic information in the human genome. The project, the ﬁrst
major federally funded biology initiative, is expected to take 15 years at a
cost of approximately $3 billion. Simultaneously hailed as the search for
the biological “holy grail” (Hall, 1990) and big science at its worst (Lewin,
1986a, 1986b; Walsh and Marks, 1990), the human genome project is un-
precedented in many ways. Besides being “big biology," the research alli—

432

ETHICAL, LEGAL, AND SOCIAL IMPLICATIONS PROGRAM 433

ance between NIH and DOE was also a ﬁrst (see Cook-Deegan, 1991; NRC,
1988; OTA, 1988), as was the allocation of 3 percent of the research budget
for the study of ethical, legal, and social implications of the application of
knowledge gained from the mapping and sequencing research enterprise.
Never before had the federal government rushed headlong into such an
ambitious research program while at the same time supporting efforts that
would raise questions about the wisdom, pace, and potential social conse-
quences of its actions.

The knowledge gained from the Human Genome Project is expected
to have major impacts on the understanding of disease, both genetic and
acquired, for society in general, and for us, as individuals. It is the ability to
characterize and proﬁle the genetic information of individuals that has led
to speculation and concern about the use and potential abuse of such
information in terms of discrimination, stigmatization, and potential medi-
cal harm.

Although these concerns are not new—they were previously raised in
concert with early genetic diagnostic capabilities such as sickle cell carrier
screening and the use of prenatal diagnosis for selective abortion—the
debate about the human genome initiative brought many of these issues to
the surface once again because of the scale and magnitude of the mapping
effort. Whereas ethical, legal, and social concerns were previously ad-
dressed on a case-by—case basis, the accelerated pace of new discoveries
from the Human Genome Project could render such an approach danger-
ously obsolete. The genome project will inevitably lead to genetic tests that
are faster, cheaper, more accurate, and more applicable to a multitude of
diseases. The effects on the conduct of biomedical research and ap-
proaches to disease treatment could be revolutionary.

james D. Watson, codiscoverer of the molecular structure of DNA and a
early proponent of a federal effort to map the human genome, recognized
the need to confront these policy issues early in the project. He reiterated
his commitment at a press conference in October 1988 announcing his ap—
pointment as the first head of the NIH Ofﬁce of Human Genome Research:

Some very real dilemmas exist already about the privacy of DNA. The
problems are with us now, independent of the genome program, but they
will be associated with it. We should devote real money to discussing
these issues. People are afraid of genetic knowledge instead of seeing it
as an opportunity [quoted in Roberts, 1989].

Watson felt that the NIH program should spend some of its genome
money on pursuing the social, legal, and ethical issues raised by rapid
advances in genetic knowledge. This belief led to the creation of the
Ethical, Legal, and Social Implications (ELSI) Program, a grant-making
and policymaking body within the National Institutes of Health.

434 SOCIETY’S (11101053

Watson continued to defend his surprising and somewhat controver-
sial proposal as the months of debate about federal support for the project
went on (Watson, 1988). Because concerns about the social and ethical
implications of genetic research were not new in Washington—and, in fact,
were the subject of several congressional hearings as well as the work of the
National Academy of Sciences, Congress's Ofﬁce of Technology Assess-
ment, and the President’s Commission for the Study of Ethical Problems in
Medicine and Biomedical and Behavioral Research (President‘s Commis-
sion)—some argue that Watson was wise to take the bull by the horns and
preempt any attempt by policymakers to prematurely inhibit progress
through overzealous regulation or legislation.

The fact that the historical leader of modern American molecular
genetics would argue so strongly for public funding for social studies of
science was welcome news to some observers and suspect to others, who
viewed the diversion of funds from science to social research as, at best, an
“unavoidable political tax” that the shrewd Watson was willing to pay to
accomplish scientific goals (Iuengst, personal communication, April 1993).
That ethics tax, like any tax, is not without controversy. While it is, at best,
encouraging that the Human Genome Project has an ethics component,
the value of such an organization in affecting decisions and policy remains
to be seen. And some observers are downright skeptical. In the words of
Judith Swazey:

ELSI—an imagistically unfortunate acronym—certainly is being taken se-

riously by the social scientists, ethicists, lawyers, and assorted other schol-

ars, who have seldom had such financial largesse available to them, and

their studies should yield a body of interesting and in some cases practi-

cally useful ﬁndings and recommendations. But in both the short term

and the long run, the signiﬁcance of the ELSI component will be greatly

diminished if the concerns that generated it, and its work and results, are

seen by scientists and clinicians as politically necessary but basically irrele-

vant appendages to the “real work" of the Genome Project [Swazey, 1992].

Those who have worked closely with Watson on the creation of the
National Center for Human Genome Research and its ELSI program claim
that he truly believes in the need for such analyses and that the policy issues
which will arise out of genome research are too important to be left to
scientists alone (Cook-Deegan, personal communication, May 1993).

A HISTORY OF BIOETHICAL DISCOURSE
IN GENETICS IN PUBLIC POLICY

Major public discussion of the social impacts of genetics date back to
1975, when the National Academy of Sciences (NAS) issued a report on
genetic screening (NAS, 1975). In the same year the NAS report was

ETHICAL, u;(;A1., AND SOCIAL IMPLICA ’I‘IONS PROGRAM 435

released, scientists met in Asilomar, California, to discuss the safety of
proceeding with recombinant DNA experiments. This meeting set off a
lengthy debate not only about the safety of such research, but the roles of
science in regulating itself and the public in participating in the decision-
making process (see Fredrickson, 1991).

The debate would result in the formation of the NIH Recombinant
DNA Advisory Committee (RAC), created to oversee and approve the safety
of such experiments. The RAC still stands today as testimony to the ability
of the scientiﬁc community to proceed cautiously in certain areas of re-
search. But the RAC was not designed to monitor the use of the informa-
tion that would arise from advances in molecular biology (i.e., genetic
screening and testing), only the research that would precede such ad-
vances.

In the early 1980s, the President’s Commission issued reports on gene
therapy and genetic screening (President’s Commission, 1982; 1983), build-
ing on the earlier work of the Hastings Center (Institute of Society, Ethics,
and the Life Sciences, 1972; Powledge and Fletcher, 1979) and the Na—
tional Academy of Sciences (1975).

The Commission’s genetic screening report correctly identiﬁed issues,
but languished until eight years later, when the discovery of the gene for
cystic ﬁbrosis (CF) rekindled a national debate about the social, ethical,
and legal implications of widespread population carrier screening for CF.
In 1990, House congressional committees asked Congress‘s research
agency, the Ofﬁce of Technology Assessment (OTA), to study the issues
raised by the ability to identify carriers in terms of discrimination, stigma-
tization, access to health care, reproductive planning, and professional and
regulatory practice (OTA, 1992). OTA reviewed policy issues and con—
cluded that congressional action was most relevant in the areas of increas-
ing public education and professional training, protecting against discrimi-
nation, and ensuring clinical laboratory and medical device regulation.

The gene therapy report of the President’s Commission, Splicing Life
(President’s Commission, 1983), served to ground a potentially explosive
discussion and to thwart legislation under consideration (Cook—Deegan,
1994). The report was released at a hearing before Albert Gore,]r., then a
member of the House of Representatives. The hearing focused on the
implications of human genetics, particularly gene therapy. Splicing Life
emphasized the distinction between genetically altering somatic cells, which
would not lead to inherited changes, and altering germ cells (sperm, egg
cells, and their precursors), which would induce inherited changes. This
distinction permitted policymakers and others to clearly understand that
there were cases of gene therapy that would not be morally different from
any other treatment, clearly pointing to some cases where gene therapy
might be technically preferable—and morally equivalent—to other treat-

436 SOCIETY’S CHOICES

ments. The report moved the debate away from vague speculations about
playing God and how to thwart the technological imperative and towards
prudent policies of research protocol review and processes to formulate
policy (Cook-Deegan, 1994; Walters, 1992).

SplicingLife recommended that the National Institutes of Health review
progress in gene therapy through its Recombinant DNA Advisory Commit-
tee, and that NIH consider the broad implications of commencing gene
therapy. The Recombinant DNA Advisory Committee accepted this rec—
ommendation in April 1983 and began to debate the merits of the new
technology and to assess its social implications. A working group on hu-
man gene therapy was established later that year. The working group
proceeded to draft “Points to Consider in the Design and Submission of
Human Somatic Cell Gene Therapy Protocols,” adopted in 1986 as the key
document in public oversight of the new technology (Fletcher, 1990;
Murray, 1990; Walters, 1992). The working group was later reconstituted
as the current Human Gene Therapy Subcommittee. Thus, the work of the
President’s Commission and the Human Gene Therapy Subcommittee has
adequately addressed concerns arising from gene therapy research.

Splicing Life also noted that there was a need for public debate of
genetic issues, which could be mediated by an ad hoc commission on
genetics or by a standing federal bioethics commission. Representative
Gore was impressed with the report and by the process that produced it.
He subsequently introduced legislation to create a President’s Commission
on human genetic engineering, favoring permanent oversight of advances
in human genetics and reproduction. This became the seed for legislation
enacted in 1985 to create the Biomedical Ethics Board and Advisory Com-
mittee within the Congress, with a broader mandate than human genetics,
as Gore became convinced that a broader mandate would be more useful.
But the ethics of genetic research arose early on in the short history of the
Biomedical Ethics Advisory Committee1 (Cook—Deegan, 1994; Hanna et al.,
1993).

In 1989 the Advisory Committee was pursuing its congressional man-
date to report on ethical issues related to “human genetic engineering."
LeRoy Walters of the Kennedy Institute of Ethics testified before the com-
mittee as chairman of the NIH subcommittee that oversaw gene therapy.
He cited 17 reports already produced on gene therapy and observed that
there was little need for another one. Furthermore, he testiﬁed, there was
already a consensus on gene therapy policy at the NIH and the Food and
Drug Administration. Walters then pointed to genetic tests, saying that
there were many unresolved issues raised by genetic testing and screening,
such as the potential for stigmatization and discrimination, that were in
need of attention (Cook-Deegan, I991).

The debate over the need for a national body dedicated to analysis of

ETHICAL, LEGAL, AND SOCIAL IMPLICATIONS PROGRAM 43 7

social, ethical, and legal issues raised by genetic technology persisted. Af-
ter moving to the Senate, as chair of the Science, Space, and Technology
Subcommittee, Senator Gore held hearings in 1989 on the Human Ge-
nome Project. The need for a mechanism for addressing social, legal, and
ethical issues again surfaced when Senator Gore queried a Department of
Energy ofﬁcial about the department’s intent to fund an ethical compo-
nent along with its science agenda. As DOE equivocated on this question
over the ensuing months, james Watson warned that if DOE did not di—
rectly fund ethics, . . Congress will chop your head off” (Cook-Deegan,
1994). At the same hearing, Watson had featured his plans for the ELSI
program of the National Center for Human Genome Research in his open-
ing statement before the subcommittee.

Eventually, the ELSI program would be the recipient of 3 percent of
the genome budget and, today, 5 percent of the NIH share. Watson has
even suggested that spending could rise to the 10 percent level by 1996
(US. Congress, House, 1991).

Gore was not alone in Congress in his concern about the use of genetic
information. Others voiced concerns about potential misuse or abuse of
genetic information gleaned from the Human Genome Project. Senator
Orrin Hatch was concerned about increases in prenatal diagnosis and abor-
tion. Senator Barbara Mikulski was concerned about adverse social
impacts of advancing too rapidly on the Human Genome Project, and
Representative David Obey raised questions about the potential for dis—
crimination by insurers and employers as the ability to diagnosis genetic
conditions is magniﬁed through the technological advances of the Human
Genome Project (Cook-Deegan, 1991).

Had the BEAC survived (see note 1), issues of genetics and public
policy would have been on the top of its agenda. As it was, there was no
national public forum in which to analyze, debate, and recommend policy
regarding issues raised by the Human Genome Project, even though groups
such as the Recombinant DNA Advisory Committee of the NIH, OTA, the
Institute of Medicine (IOM), and the congressional hearing process were
able to contribute piecemeal to policy debates. The time was ripe for some
type of action in this area. The question remains, however, whether the
ELSI program the best route to take in facing the social consequences of
the Human Genome Project?

The Ethical, Legal, and Social Implications Program

Specific funding for genome research at NIH, in general, began in
fiscal year 1988, two years before the establishment of the National Center
for Human Genome Research. During that two-year interval, research
funds were administered by the National Institute for General Medical

438 SOCIETY’S CHOICES

Sciences, and the scientiﬁc community advised NIH staff on a conﬁgura-
tion for what is now NCHGR (NCHGR, Annual Report 1990). Then NIH
director james Wyngaarden assembled a group of scientists, administra-
tors, and science policy analysts to develop an NIH plan for the human
genome project.

In 1988, james Watson was named associate director for human ge-
nome research and an Ofﬁce of Human Genome Research was created in
the Ofﬁce of the NIH director. In the following year an advisory commit-
tee was named which established working relationships with DOE and other
federal agencies. Two members of the advisory committee were to play key
roles in the development of the ELSI program, Nancy Wexler, President of
the Hereditary Disease Foundation and on the faculty of neurology and
psychiatry at Columbia University, and Victor McKusick, a medical geneti-
cist at johns Hopkins University and keeper of Mendelian Inheritance in
Man, the largest database in the world of genetic disorders.

When NCHGR was approved and funded by Congress in 1990, the
advisory committee and NIH and DOE staff had already developed a ﬁve-
year scientiﬁc plan (NCHGR, Annual Report 1990). Part of the plan ad-
dressed ethical, legal, and social considerations, with speciﬁc directives to:

0 Develop programs addressing the understanding of the ethical, le-
gal, and social implications of the Human Genome Project.

0 Identify and deﬁne the major issues and develop initial policy op—
tions to address them.

The advisory committee, in its initial deliberations, decided to spin off
working groups to address speciﬁc areas of the project. Nancy Wexler was
to become the chair of the ELSI working group, which would eventually
serve both NIH and DOE as ajoint working group.

Federal rules concerning working groups are intended to make them
temporary. Thus, while Wexler serves as an advisory committee member
chairing the Working Group, the other six members are actually ad hoc
technical consultants—serving at the pleasure of the director of NCHGR—
representing basic and clinical genetics, law, and ethics. If NIH were to
charter the working group and make it permanent, it might speak with
greater authority. On the other hand, chartering the Working Group
would essentially create a commission under the genome project—a move
that could both undermine its independence and give the impression of
the fox guarding the chicken coop. This last concern might be adequately
addressed by ensuring appropriate leadership and broader representation
on the working group.

It is not clear what criteria were used in selecting the members but,
according to one member of the group, Watson felt strongly thatjonathan
Beckwith, a molecular biologist and skeptic about the Human Genome

ETHICAL, LEGAL, AND SOCIAL IMPLICATIONS PROGRAM 439

Project, be named to the group (Cook-Deegan, personal communication,
May 1993). The other members had previous experience serving on na-
tional bioethics commissions and advisory panels, or as policy analysts.
Since the working group was ﬁrst selected there have been repeated
requests from the disabilities community and genetics disease groups for
representation (Cook-Deegan, personal communication, 1993; juengst,
personal communication, April 1993). The response from the Working
Group has been to invite an equal number of non-Working Group mem-
bers to each meeting, depending on its topic. In addition, members of the
Working Group have submitted to NIH staif the names of individuals they
feel would improve the diversity and representativeness of the group. No
action has been taken as of this writing because of the uncertain technical
status of the Working Group and because ofa wider debate about the need
for a national forum for addressing bioethics which could result in a
reconﬁguration of ELSI in the national bioethics infrastructure.

Development of an Agenda

The Working Group ﬁrst met in 1989 to deﬁne and develop a plan of
activities. Meetings are, ostensibly, open to the public but are not publi-
cized. At the ﬁrst meeting, representatives of the National Science Founda-
tion and the National Endowment for the Humanities were invited to
present their programs for research on ethics, science, and society. After
discussion, the Working Group operationalized its mission by agreeing to
the following activities:

0 stimulate research on issues through grant making;

0 reﬁne the research agenda through workshops, commissioned pa-
pers, and invited lectures;

0 solicit public input through town meetings and public testimony;

0 support the development of educational materials; and

' encourage international collaboration in this area.

Thus, at the operational level, the Working Group developed realistic
and practical goals in the model of data gathering and dissemination. In a
sense, their early mission was to study what should be studied, both by
policymakers and the public. In terms of policymaking, the group devel-
oped the following objectives:

0 clarify the ethical, legal, and social consequences of mapping and
sequencing the human genome through a program of targeted research;

0 develop policy options at professional, institutional, governmental,
and societal levels to ensure that genetic information is used to maximize
the beneﬁt to individuals and society;

440 SOCIETY’S CHOICES

0 improve understanding of the issues and policy options through
educational initiatives at public, professional, and policymaking levels; and
0 stimulate public discussion of the issues and policy options.

Although it is not clear whether the ELSI Working Group was pre-
pared to take on the above listed challenges or assign them elsewhere,
speciﬁc program objectives were addressed in the original ﬁve-year
plan.

In addition, speciﬁc topics were recommended for research support
(see Table 1). In fact, much policy research had already been conducted
or was under way on some of the topics listed, such as the use of genetic
information by employers (OTA, 1983, 1991), its use in the criminaljus-
tice system (NRC, 1992; OTA, 1990), commercialization (Holtzman, 1989;
OTA, 1987, 1988, 1989); and genetic testing when no therapy is available
(Holtzman, 1989). One wonders whether the Working Group found exist-
ing work to be so inconclusive as to warrant repeat attention. Neverthe-
less, the development of a laundry list for topics to be addressed by future
grantees is an expansive, if inefﬁcient, method for setting priorities.

Three sets of issues were identiﬁed as particularly important consider—
ations: privacy of genetic information, safety and efficacy of new genetic
testing options, and fairness in the use of genetic information. While
critical, these issues are narrowly conﬁned to what could be considered a
civil liberties orientation. Were the membership of the Working Group
more diverse, other equally important issues might have been placed on
the agenda, such as the effects of commercial interests on the research
agenda, intellectual property rights, conflicts of interest for genome scien-
tists, and quality assurance and control beyond issues of safety and efﬁcacy.
According to several members of the Working Group, these issues were
“missed” for a variety of reasons, including lack of diversity in the Working
Group. Another prominent reason, according to Working Group member
Robert Cook—Deegan, is that the group operated on the premise that issues
related to commercialization (e.g., conflict of interest, intellectual prop—
erty, public/private interests) were being handled by other staff within
NCHGR. In any case, lack of communication, erroneous assumptions, or
poorjudgment led to lack of attention to an important social issue that
would contribute to the ﬁrst policy consequence of the Human Genome
Project.

The issues addressed by the Working Group in their initial agenda are
forward thinking and apply to the transfer of technology into clinical prac-
tice, but ignored current concerns that arise within the scientiﬁc culture as
most of the work is still in the research stage. There is no evidence that the
ELSI Working Group ever directly addressed issues related to the effect of
the Human Genome Project on the scientiﬁc enterprise. Only one grant

ETHICAL, LEGAL, AND SOCIAL IMPLICATIONS PROGRAM 441

TABLE 1 Working Group Topics Suggested for Research Support

 

Fairness in the use of genetic information
0 insurance
' employment
0 the criminal justice system
the education system
adoptions
' the military
The impact of knowledge of genetic variation on the individual
0 stigmatization
0 ostracism
0 labelling
' individual psychological responses
Privacy and conﬁdentiality
0 ownership and control of genetic information
' consent issues
The impact of the Human Genome Project on genetic counseling
prenatal testing
pre—symptomatic testing
carrier status testing
0 testing when there is no therapeutic remedy
0 counseling and testing for polygenic disorders
0 population screening versus testing
Reproductive decisions inﬂuenced by genetic information
0 effect of genetic information on options available
I use of genetic information in the decision-making process
lssues raised by the introduction of genetics into mainstream medical practice
0 qualiﬁcations and continuing education of all appropriate medical and allied
health personnel
0 standards and quality control
0 education of patients
' education of the general public
Uses and misuses of genetics in the past and the relevance to the present
0 the eugenics movement in the United States and abroad
0 problems arising from screening for sickle-cell trait and other recent examples
' the misuse of behavioral genetics to advance eugenics 0r prejudicial stereotypes
Commercialization of the products of the Human Genome Project
0 intellectual property rights
' property rights
' impact on scientiﬁc collaboration and candor
0 accessibility of data and materials
Conceptual and philosophical implications of the Human Genome Project
0 the concept of human responsibility
' the issue of free will versus determinism
I the concept of genetic disease

 

SOURCE: Adapted from Understanding ()u‘r Genetic Inheritance: The US. Human Genome Project:
The First Five Years, FY 1991—1995, U.S. Department of Health and Human Services, Public
Health Service, National Institutes of Health, and U.S. Department of Energy, Office of
Energy Research, Ofﬁce of Health and Environmental Research (Bethesda, MD: National
Center for Human Genome Research, NIH Publication No. 901580, April 1990).

442 SOCIETY’S CHOICES

was awarded that was directly related. In 1992, $100,000 was awarded for
the study of academic—industry relationships in genetics.

The issues of patenting cDNA and potential conflicts of interest for
genome ofﬁce ofﬁcials and researchers would eventually bring the genome
project’s director, james Watson, in direct confrontation with Bernadine
Healy, then Director of NIH, and would later contribute to his resignation.
Meanwhile, the issue was assigned by Congress for analysis to OTA and by
the executive branch to the Federal Coordinating Committee on Science
and Technology (FCCSET) committee of the White House Ofﬁce of Sci-
ence and Technology Policy.

The representativeness 0f the Working Group is not sufﬁciently broad
to ensure that priority—setting will be reﬂective of society. For example, a
major mission of the Working Group has been evaluating issues pertaining
to genetic information and insurance but there are no representatives on
the Working Group of the insurance industry, consumers, employers who
self-insure, or their employees. The Working Group’s involvement in de-
veloping a statement on the Americans with Disabilities Act was initiated
despite a lack of representation from disabilities or civil rights groups,
although their views were solicited. A report of the House Committee on
Government Operations noted: “These interests do not necessarily need to
participate in developing a genetic information research agenda. They
must be involved in developing a genetic information policy agenda” (US.
Congress, House, 1992, p. 27).

Beyond setting a research agenda, the NCHGR‘s ELSl program was
assigned the broad goal of “developing the safeguards required as new
genetic information is put to practical purposes” (NCHGR, Annual Report,
1990, p. 35). The language of NCHGR literature is ﬁlled with ambitious
verbiage such as “develop sound policy recommendations that will govern
the conﬁdentiality of genetic test results, insure equal access to adequate
education and counseling for patients, establish minimum qualiﬁcations
for clinicians, assure quality control for genetic tests, establish guidelines
for genetic testing programs, and deﬁne ethical and legal responsibilities
of clinicians who perform tests” (NCHGR, Annual Report, 1990). These
are awesome goals for an entire government, let alone a working group of
seven people. The basic ﬂaw in the design of the ELSI program and its
Working Group, to be argued later, is that is has no authority to affect
policy and no clear route for communicating the information it gathers to
the policy arena. This dilemma has been the subject of debate at virtually
every meeting of the Working Group as it has grappled with its role in
policymaking and the best route to affect decision making in this area
(Cook-Deegan, personal communication, May 1993; King, personal com-
munication, May 1993).

ETHICAL, LEGAL, AND SOCIAL IMPLICA ’I‘l()NS PROGRAM 443

Policymakiug Through Extramural Research

What distinguishes ELSI from other national ethics bodies is its man-
date to administer a grants program. The ELSI grants programs solicit
proposals through the routine program announcements and requests for
applications used throughout the federal scientiﬁc establishment. At NIH,
the Division of Research Grants reviews all grants applications and assigns
them to the appropriate study sections. The multidisciplinary review groups
consist of bioethicists, educators, genetic counselors, lawyers, theologians,
philosophers, psychologists, and geneticists. After study section review, the
National Advisory Council for Human Genome Research provides a sec—
ond round of review. Unlike other NIH study sections, there is no standing
ELSI study section. Each grant is reviewed by a different set of reviewers,
based on assignment by NIH staff. NIH justifies this practice based on the
wide variability in applications Guengst, personal communication, 1993).
While this View might be valid, the practice also militates against consis-
tency and creates a situation where no one has the big picture regarding
the quality and substance of grants under review.

The peer-review method of selecting grants might work well for ensur-
ing the quality of the work but cannot guarantee that proper and appropri-
ate attention is being given to important issues. It is not the best way to set
a policy agenda because the only citizens with access to the process are
those schooled in an academic or professional discipline and capable of
responding to the requirements of grant writing. In many ways it is a
reductionist process that runs the risk of ignoring the most pressing policy
issues. Academicians are not representative of society and can be danger-
ously naive when it comes to public policy. On the other hand, setting a
policy agenda through a bottoms-up approach provides the potential for
more long-term analytical approaches to issues that might otherwise be
subject to political winds. The President‘s Commission and the National
Commission, however, were able to function appropriately in a nonparti-
san manner despite pressures from many political extremes (Hanna et al.,
1993). The President’s Commission adhered to an open process of hear-
ings and publication, ensuring an opportunity for representativeness that
does not exist with the ELSI Working Group. The bottoms-up approach of
ELSI can in no way guarantee fair representation of all points of view.

The first set of ELSI grantees, for example, were hardly representative
of the general population. They were all specialists in genetics and ethics,
having written numerous publications on the topics they proposed to study.
The titles of their grants were general and similar: “Legal and Ethical Issues
Raised by the Genome Project,” “Ethical and Legal Implications of Genetic
Testing,” “Ethical and Legal Issues in the Diffusion of Genetic Tests.”
Nearly $900,000 went to eight white, male principal investigators in aca-

444 socm’rrs CHOICES

demic and science policy settings. It is a small universe that directs and
beneﬁts from the ELSI grant program (see Table 2 for a listing of sample
grants). Analysis of projects funded over the course of the ELSI program
reveals that Working Group members have been listed as principal investi-
gators or key personnel on projects, although there is no evidence that
members of the Working Group have any influence in the grants process.

In its ﬁrst year, the ELSI program also undertook the support of four
scholarly conferences to “begin the process of developing sound profes-
sional and social policy” about these issues. In its ﬁrst annual report, the
program claims to have accomplished four important preliminary goals:
(1) inaugurating open discussions of ELSI issues by the public, the schol-
arly community, and policymakers; (2) initiating a program of research;
(3) facilitating the development of professional and social policy; and (4)
fostering public education. Indeed, one of the ELSI program's primary
goals was to provide for the development of important factual information
that is now lacking regarding social policy and genetic information. One
can argue about whether developing this information through the process
of peer review and grant making is either efﬁcient or productive.

The ELSI program is principally designed to support academic re—
search, and this it does well. In fact, one of the major products of the ELSI
program has been articles published by the principal investigators. One
principal investigator, for example, lists eight published books and articles
resulting from ELSI support. Surely such productivity enhances the schol-
arly writings in the ﬁeld, and is consistent with the traditional output of
federally funded research, but is it in the public interest? The writings that
have arisen from the grant funds appear in peer-reviewedjournals and the

TABLE 2 Representative Grants of the ELSI Program

 

Ethical and Legal Issues in the Diffusion of Genetic Tests ($969,513)

Ethical and Policy Issues in Cystic Fibrosis Screening ($695,696)

The Human Genome Project: Human and Scientiﬁc Dimensions ($328,250)

Insurance Implications of a Complete Genome Map ($518,097)

Access to the Genome: justice at the Frontier of Science ($162,622)

The Human Genome Project and Women ($193,688)

Reassessing Health, Normality, and Conﬁdentiality ($175,494)

Ethical and Legal Studies Relating to the Program to Map and Sequence the
Human Genome ($424,941)

Human Heredity in American Popular Culture ($206,104)

Theological Questions Raised by the Human Genome Initiative ($260,991)

A Paradigm Approach to Ethical Problems in Genetics ($215,510)

Genetic Counselors as Educators on Human Genome Issues ($278,132)

 

SOURCE: Funding Status Report, February 1993, National Center for Human Genome Re‘
search, Ethical, Legal, and Social Implications Program.

ETHICAL, LEGAL, AND SOCIAL IMPIJCA TI()NS PROGRAM 445

academic press, hardly accessible to most policymakers and much of the
public. There is no mechanism for ensuring that the results of these
scholarly pursuits will make their way back to the policy arena unless one
relies, in the words of one grantee’s abstract, on absorption of the facts by
“a general audience of intelligent readers.” This lack of feedback from its
extramural program into the policy process is perhaps the most troubling
aspect of viem'ng ELSI as a policymaking body. Many credit the success of
the President’s Commission to its publications, which accurately and read-
ably presented the issues debated by the Commission (OTA, 1993). ELSI
has no such mechanism and its deliberations are not publicized. The ELSI
process would be greatly improved by adherence to a publication schedule
that analyzes and synthesizes its deliberations and the results of its grants
program. This lack of an opportunity to synthesize the many inputs into
the knowledge base is a missed opportunity.

Congressional Oversight

The lack of a clear mechanism for ELSI input into the policy process
has not gone unnoticed by Congress. The following exchange between
Representative Bob Wise and NIH Director Bernadine Healy at a 1991
hearing illustrates the lack of clarity in the authoritative power of the ELSI
program:

MR. WISE: Suppose that one of the papers or groups that has been
commissioned by ELSI contains a valuable legislative recommendation.
How does that work its way through the administrative process of the
executive branch, eventually getting to Congress? Does the Bush admin—
istration, for instance, have to endorse such a proposal before you distrib-
ute it?

DR. HEALY: No, not at all. In fact, the history of NIH’s ventures
into these areas—even in some very delicate areas—shows that those re-
ports are independent, and they are available to everyone; and usually
incite rather informed and vigorous dialogue. There is nothing hidden
or conﬁdential about these recommendations, depending upon what po-
litical leadership we have in the executive branch of government.

The President does not involve himself in these activities; he strongly
endorses both the Human Genome Project and the process of the ELSI
program, but in no way tried to inﬂuence the process in a policy sense.

MR. WISE: But does the administration, at some point, endorse a
proposal? It would seem to me that there does need to be administration
leadership at some point if something is to come to Congress, particularly
if the administration is going to advocate it.

DR. HEALY: There has not been to date, to my knowledge. But if
there were a speciﬁc recommendation where we needed a legislative ac-
tion, the executive branch of government, the Department of Health and

446 SOCIETY’S CHOICES

Human Services, would review it and would have input and would either
disagree or agree. But that same document would, of course, be available
to Congress. This is not exclusive advice for the executive branch of
government.

MR. WISE: But, presumably, then it would go the Secretary of Health
and Human Services—

DR. HEALY: Yes, it would go through Secretary Sullivan, through
Dr. Mason, the Assistant Secretary, and there would be a policy debate at
that level. Then, if appropriate, it would go on up to the White House.

MR. WISE: Via OMB?

DR. HEALY: Yes. But what I am trying to say is that ELSI is not the
genomic OSTP of the Department of Health and Human Services. I
mean, this is an independent group that is examining legal and social
and ethical implications of human genome research, but it is outside of
any particular political ideology. It is quite removed and quite indepen-
dent [U.S. Congress, House, 1992].

In 1992, the Committee on Government Operations in the House of
Representatives released a report calling for the formation of an indepen—
dent policy review mechanism for exploration of the ethical, legal, and
social implications of the Human Genome Project (US. House, Govern-
ment Operations, 1992). The report notes that “neither department [NIH
or DOE] has established a clearly deﬁned timetable, goal, or set of priori-
ties for the ELSI programs.” The report goes on further, saying, “The ELSI
programs do not have the ability to present policy recommendations to the
Nation, the Congress, or the executive branch in an effective manner.
There is no existing policy process that will use the results of the ELSI
research to make recommendations.” The scientiﬁc and academic ap—
proach to addressing social issues has worked against developing time-
tables or expectations. In testimony before Congress in October 1991,
NIH director Bernadine Healy and DOE associate director David Galas
gave few clues as to the jurisdiction, scope, or expectations of the ELSI
programs (US Congress, House, 1992).

Injune 1992, the NIH ELSI program was ofﬁcially elevated to branch
status, a bureaucratic action that formalizes relations between ELSI and
NCHGR and elevates the status of the ELSI program within the NIH bu-
reaucracy (Human Genome News,quy 1992). This action placed ELSI more
permanently in the NIH organizational chart, which has both advantages
and disadvantages. The advantages are the ability of the program to pro-
vide assistance to and participate in similar social issues discussions across
NIH and to have some status and authority within NIH. The disadvantage
is exactly the concern illustrated in the exchange between Dr. Healy and
Representative Wise: the ability of ELSI to make independent policy rec-
ommendations free of the politics and bureaucratic hurdles associated
with executive management is further diminished.

ETHKIAL, LEGAL, AND SOCIAL IMPLICATIONS PROGRAM 447

Because it has never been tested, the ability of the ELSI Working Group
to clear any recommendations through the executive branch hierarchy is
purely speculative. It is hard to imagine that such recommendations would
survive intact the delays and interference inherent in such a process. If,
however, ELSI were to produce analytical policy documents, the informa—
tion would become part of the general debate, not necessarily exclusively
for consumption by the executive branch. That contribution alone is worth
pursuing.

ELSI’s Forays into Policymaking

The controversy over ELSI’s role in the policymaking process has fol—
lowed it throughout its history. Even within the Working Group there is
disagreement about its role in policymaking and there have been numer-
ous discussions about the lack of clarity in its mandate (Cook-Deegan,
personal communication, May 1993; King, personal communication, May
1993). Although NCHGR literature cites the policymaking role as a mis-
sion of ELSI, and appropriations language from Congress has repeatedly
prescribed a policymaking function, only recently has proposed legislation
codiﬁed the role of ELSI in the policy process (S. l and HR. 4). General
language charging ELSI with a policy function has not been sufficient in
providing a mechanism by which to implement that function. The distrac—
tion of the grants program has prevented ELSI staff from having the time
or resources to produce policy documents.

If ELSI is to recommend policy in the same manner as the President's
Commission, OTA, or IOM, it is ill-equipped to do so in a timely fashion. It
lacks diversity, staff, and a clearcut mechanism for transmitting its recom-
mendations. It is impossible to expect that ELSI staff can administer a
grants program, organize ELSI meetings, write policy papers, and prepare
publications. Instead, the Working Group has chosen a variety of mecha-
nisms to assist in the policy process. The largest effort has been to set
policy through the extramural program, as is being done in the cystic
fibrosis pilot projects (described below). Less ambitious efforts have been
through a lengthy information collecting process that has, in one case,
resulted in a policy statement on the Americans with Disabilities Act, and in
another a report issued in 1993 on insurance aspects of genetic informa-
tion. Each effort is described below.

Population Carrier Screening for Cystic Fibrosis

The ﬁrst singular issue taken on by ELSI involved the use of a new
diagnostic test to determine carrier status for cystic fibrosis (CF), a lethal
autosomal recessive disorder prevalent in the Caucasian population. The

448 SOCIE’I‘Y’S CHOICES

gene for CF was discovered in 1988 and, initially, the most common muta-
tion could be found in approximately 70 percent of carriers. As more
mutations have been found the ability of the test to detect carriers has
improved to nearly 90 percent, and in some cases, 95 percent. When
widespread carrier screening was ﬁrst contemplated, policy analysts and
bioethicists saw CF as an important test case for the application of future
genetic tests. The ability of genetic services and the public to assimilate
and interpret this test would provide useful precedential information re-
garding the introduction of genetic tests developed through the Human
Genome Project.

Opponents of routine CF carrier screening argued that past experi-
ences with genetic screening programs do not adequately address potential
adverse consequences raised by widespread screening, and argued vocifer-
ously for federally funded pilot projects specific to CF. Despite these con—
cerns, federally funded pilot projects were not quick to come (Roberts,
1990). At the urging ofjames Watson, who urged ELSI to stretch its self-
definition, the Working Group decided to go beyond its reconnaissance
mission and seek funds for pilot projects to assess the impact of wide-scale
population carrier screening for CF (Iuengst, personal communication,
April 1993).

To analyze the implications for genome research, the ELSl Working
Group convened a workshop in September 1990, inviting 12 experts from
various sectors of genetic services to discuss the technical status of CF
testing and to outline the policy issues facing the nation (NIH-DOE Work-
shop Report, 1990).

The Working Group identiﬁed the following issues to be considered in
preparing for the introduction of new tests such as CF: (1) the need for
trial testing and screening programs; (2) assessment of how genetic tests
are paid for; (3) professional education; (4) public education; (5) labora—
tory quality control; (6) informed consent and confidentiality; and 7) dis-
crimination against families at genetic risk. The Working Group was sufﬁ—
ciently concerned about these issues to forward a resolution to the NCHGR
Advisory Committee recommending that NCHGR take a leadership role in
developing support for funding pilot research projects. Meanwhile, OTA
had initiated a study of these issues at the request of two House committees
(OTA, 1992).

In April 1991, NCHGR issued a request for applications (RFA) for
studies of testing and counseling for cystic fibrosis mutations. A series of
questions was presented in the RFA describing the research goals of the
pilot projects, viz., to gather information that can be used to “identify
clinical practices that best increase patient understanding of disease-gene
carrier testing and test results, and best protect individuals and families
from test-related psychological harm, stigmatization and discrimination.”

ETHICAL, LEGAL, AND SOCIAL IMPLICATIONS PROGRAM 449

The RFA also stressed the importance of coordination between grantees
through workshops to be convened by NIH. Eight clinical research institu—
tions received a total of $1 million in late 1991 to start work in 1992.

This studied approach to understanding the complexities of CF car-
rier screening is certainly needed and will, no doubt, be useful informa-
tion in devising strategies for offering future tests. Its timeliness, however,
in terms of contributing to the policy debate, is remarkably delayed. The
OTA report on CF carrier screening was released in August 1992 citing
several policy options to be considered by Congress, including profes-
sional and public education, discrimination, and clinical laboratory and
medical device regulations. The OTA report concluded that CF carrier
screening was quickly entering the realm of genetics practice and saw little
need for congressional action other than through oversight and regula-
tion. By early 1993, the cost of CF carrier screening had dropped dramati-
cally, the sensitivity of the test had risen to 90 to 95 percent, and much of
the debate about its use had subsided. Any incremental gain that will be
gleaned from the federally funded studies will inform the counseling pro-
cess but is insufﬁcient to a priori prevent routine screening from proceed-
ing (OTA, 1992).

Thus, the pilot studies, unless they reveal unpredictable and surprising
results, will contribute little to the policy debate but will provide useful
information to the clinical research community and future recipients of
new diagnostic tests. Supporting research to address a policy issue is useful
around the margins but ineffective if not constrained in time or place.
When the consortium does report its results, it is not clear who the policy
audience will be. This is not meant to undermine the value of the pilot
study process to the clinical genetics community. The lag in time between
consideration of the issue and the production of useful results leaves a void
for practitioners and attorneys, who must rely on pronouncements regard—
ing the standard of care generated amidst much controversy. And the lack
of an authoritative voice leaves room for commercial interests to move
ahead unfettered.

In a positive way, however, through the CF pilot studies, the ELSI
program established an important professional policy precedent: incorpo-
rating assessment of psychosocial impact into clinical studies usually domi-
nated by concerns of medical safety, reliability, and efficacy. Other insti-
tutes within NIH would later follow suit, with the National Cancer Institute
adding client-centered assessment guidelines in evaluating the clinical use
of the p53 genetic marker for increased cancer risk in families (Li et al.,
1992). Thus, the ELSI Working Group, through its approach to the CF
pilot studies, has had an impact on the practice of clinical investigation, an
impact that should be emphasized when assessing ELSI’s role in affecting
change.

450 socm’zys (11101039

Pedigree Studies Workshop

Another example of the ELSI program’s unique ability to assist the
Public Health service in developing sound research practices came with a
workshop it cofunded with the National Institute of Mental Health (NIMH)
and the Ofﬁce for Protection from Research Risks (OPRR) of NIH. The
workshop was convened to discuss the special considerations needed when
conducting genetic research on extended families. Issues such as discrimi-
nation and stigmatization and the need to ensure conﬁdentiality while
recruiting family members for study fall directly in the domain of NIMH
and CPR.

These issues were initially raised by genetic disease support group rep-
resentatives at an ELSI Working Group workshop on privacy issues in 1991
and conﬁrmed as important at an ELSI-funded conference in 1992. In
response NCHGR and OPRR collaborated to convene yet another working
group to develop guidance for investigators and research review boards
considering genetic studies of families. The guidance was to be available
sometime in 1993 (NCHGR, 1993 draft annual report). Although the
bureaucratic response can be painfully slow, the ﬁnal result will be better
guidance for investigators and, presumably, better protection for families
with genetic disease.

Insurance Task Force

Since its inception, thejoint NIH-DOE Working Group focused on its
concerns regarding the insurability of individuals diagnosed with genetic
disease, or predisposition or susceptibility to disease. The Working Group
has also made the fair use of genetic information by employers a priority
issue. In _]anuary 1991, the Working Group formed the Task Force on
Genetics and Insurance to gather information and prepare a report of
policy options to prevent discriminatory use of genetic information by
insurance companies and policy purchasers. The Task Force includes
representatives from the insurance industry, corporate beneﬁt plans, con-
sumer and health voluntary groups, and scholars researching insurance
issues (NIH-DOE, 1993). This group plans to formulate principles and
policy options for addressing the major issues identiﬁed by the group.
These issues have been identiﬁed through several information-gathering
meetings.

A draft of the Task Force’s ﬁnal report written by NIH staff was circu-
lated for discussion at a November 1992 meeting of the Insurance Task
Force. Another meeting to discuss the draft report and policy options was
held in early 1993 and the ﬁnal report was published in May 1993.

Several additional federal and private sector efforts aimed at studying

ETHICAL, LEGAL, AND SOCIAL IMPLICATIONS PROGRAM 451

the insurance and discrimination consequences of the Human Genome
Project have been initiated, resulting in a variety of products. These efforts
include projects of IOM (funded through ELSI), OTA, American Council
of Life Insurance (ACLI) and the Health Insurance Association of America
(HIAA) Task Force on Genetic Testing. Thus, ELSI was not the first or the
only group to tackle these issues.

In addition to the work of the ELSI Insurance Task Force, several
projects pertaining to insurance and genetic information have been funded
through the ELSI grant-making mechanisms. These range from confer-
ences with sessions devoted to insurance issues to interdisciplinary, multi—
year projects focused solely on insurance issues, resulting in journal articles
and conference proceedings.

Policies regarding genetics and insurance are difﬁcult to tackle be—
cause of the diffuse and complex nature of insurance. One wonders what
impact ELSI can have other than participating in the debate and ensuring
that the appropriate parties are invited to the table. In fact, the insurance
industry has already moved to address these issues internally. The major
trade associations of the health and life insurance industries (HIAA and
ACLI) have embarked on several initiatives related to genetic information
and insurance. A CEO-leveljoint task force on genetic testing was formed
to assess the public policy implications of the emerging technology. In
late 1992, the task force issued a report on genetic testing with recommen-
dations on the industry response (ACLI/HIAA, 1991). The report en—
courages industry to deal with the genetic testing issue now, while the
technology is still emerging and public opinion is not yet set (Chase,
1992).

A report of the ACLI’s Subcommittee on Privacy Legislation accompa-
nied its task force report on genetic testing. This report encouraged insur—
ers to adopt voluntary conﬁdentiality programs at the corporate level as
well as support uniform state privacy legislation. It also contained speciﬁc
recommendations regarding the privacy of genetic information.

A conference for insurance medical directors on genetic issues in
insurance medicine” was held in February 1993, cosponsored by the Ameri-
can Academy of Insurance Medicine, ACLI, HIAA, and the American Soci-
ety of Human Genetics. The conference addressed current genetic tech-
nology as it applies to insurance risk assessment. Similar conferences have
been held for insurance medical directors in the past on new medical
developments.

Again, the fact that other groups have already been assembled, col-
lected information, and issued reports with recommendations is evidence
that the ELSI process, as currently conﬁgured, is inadequate for making
policy because in order to be most effective, ELSI must be in front of, not
behind, an issue. Perhaps ELSI‘s academic approach to policymaking

452 SOCIE’I‘Y’S CHOICES

reﬂects its unease with its perceived lack of authority to assemble the ﬁnd-
ings of the research, identify the values involved, and offer a coherent set of
recommendations. Perhaps it merely reﬂects a lack of adequate staff and
resources. Whatever the outcome of the Insurance Task Force delibera-
tions, it is hard to imagine an entire community of insurers, employers,
labor unions, civil liberties groups, and health care providers accepting the
recommendations of a small group of individuals with no clear authority
when their respective parent organizations have already taken a stand. At
best, the Task Force report can be marketed as a voice of moral authority
that can guide ongoing debates.

Statement on Americans with Disabilities Act

In April 1991 the ELSI Working Group convened experts from law, the
humanities, genetics, and voluntary health organizations to discuss the
Americans with Disabilities Act (ADA) to determine the effect of the law on
individuals with identiﬁed disease or susceptibility genes. This meeting
resulted in an ELSI statement to the Equal Employment Opportunity Com-
mission identifying three areas in which signiﬁcant changes to the EEOC
regulations should be made to improve ADA’s protections against genetic
discrimination in the workplace (Joint Working Group, 1991):

0 discriminatory actions based on genotype, including the possibility
of having affected children, should be covered by the ADA;

0 post-offer, employment entrance medical examinations should be
limited to assessingjob—related physical and mental conditions; and

- limits should be enacted to protect the genetic privacy of employees.

The EEOC responded to the concerns raised by the Working Group
but none of the recommendations were incorporated into the ﬁnal EEOC
regulations implementing the ADA. However, this should not be consid-
ered a diminution of ELSI’s efforts. This type of direct communication
between two federal bureaucracies is beneﬁcial and noteworthy and per-
haps one of the best uses of the information gathered by ELSI through its
workshops and grantees. Were ELSI to routinely to serve as a conduit for
getting information into the decision-making apparatuses of government,
there would better information about the use of genetic technologies
throughout the government so that those with the authority to govern
could make more informed decisions. The statement on the ADA was one
of the few instances where the Working Group rapidly took a strong stand
on issues important to them. A lack of response from the EEOC reﬂects
the strength of the legislative compromise that led to the enactment of the
ADA. Amendments, no matter where they arise, will be difﬁcult to achieve.

ETHICAL, LEGAL, AND SOCIAL IMPIJCA TIONS PROGRAM 453

CONCLUSIONS

The ELSI program is a unique effort aimed at assessing the social
consequences of the Human Genome Project. To date, it is the only extant
national forum that can speak with authority about the ethical, legal, and
social implications of genetic technologies. As such, it has both great
potential and tremendous drawbacks. In many ways, the future policy-
making power of the ELSI program lies within its Working Group and its
willingness to change its direction, expand its mandate, assert itself, and
produce results that are not only accessible but far reaching. Although
ELSI, the grant-making body, has been conferred branch status in the NIH
bureaucracy, ELSI, the policymaking body, seems very much a temporary
organization. If it is to be deliberative, offeringjudgment and policy, then
its base is far too narrow and its staff much too small.

ELSI has the potential to contribute in numerous ways to the policy
debate about genetic technology. Given its place in the federal bureau—
cracy, it is in a unique position to advise the Public Health Service on issues
related to genetic research and clinical genetics. Its ability to do this has
been demonstrated through its work on CF pilot projects and pedigree
studies. It can also serve a useful reconnaissance or watchdog function by
alerting other federal agencies about genetics issues that fall within their
domain, as it did with its statement to the EEOC regarding the Americans
with Disabilities Act. But if it is to pursue these activities with due diligence
then it must demand a research staff skilled in such policy tasks. Further-
more, it must ﬁnd a mechanism for publishing its deliberations. In fact,
one of ELSI’s most tenable contributions is its potential to improve profes-
sional and public understanding of genetic issues.

The ELSI program has the power to do what a broad-based commis-
sion cannot, fund the development of educational materials regarding
clinical genetics and the human genome. Among its education support
activities, for example, is support of a two-year project by the Council of
State Governments to educate state government ofﬁcials and legislators
about genetic issues. This type of direct communication ofinformation to
state policymakers is useful and fills a void. ELSI’s support of educational
activities will contribute to stimulating public interest and sophistication
about the social issues of the Human Genome Project.

Commissions can be representative, build public support, add author-
ity or legitimate activity, or reassure. Or, in the words of political scientist
David Flitner, they can be “used as a tool for surmounting the pathologies
of organizational complexity” (1986). It is not clear that the ELSI pro—
gram, as currently conﬁgured, can do any of these things. Although it
remains untested, im ability to surmount the pathologies of organizational
complexity within the Department of Health and Human Services is dubi-

454 SOCIETY’S CHOICES

ous. It is worth mentioning that if the Ethics Advisory Board (EAB) of the
NIH is reconstituted, some of the issues addressed in theory by ELSI grant-
ees might be considered in practice by a body charged with the review of
speciﬁc controversial research protocols. It is possible that the current
uncertainty regarding the reestablishment of a national forum for bioeth-
ics contributes to the tentative nature of ELSI’s policymaking powers.

If the ELSI Working Group is to confront issues in a timely manner,
reliance on the extramural grants process is too elitist and far too slow.
Were the ELSI Working Group to become a larger, more diverse group of
individuals, it might rely on the courage of its convictions to forge ahead of
the grantees is issuing policy recommendations. The narrow base of the
current group precludes this conﬁdence. As Tom Murray stated in the
quote that introduced this manuscript, the Working Group as currently
constituted “lack[s] the moral and political authority to decide what ought
to be done.” Members of the Working Group are keenly aware of these
limitations, and themselves face the quandary of how to engage in policy.

The growth of the field of bioethics and growth in the number of
individuals who are described as bioethicists has enhanced the analytical
capacity of the nation to discuss bioethical issues. These developments
also run the risk of breeding discussions that are ingrown and out of touch
with the real world of the practitioner or the public. Thus, any new orga—
nization developed to address social and ethical issues must be representa-
tive of society, not just organized bioethics and science policy. The ELSI
program, in its current configuration, runs the risk of being an overly
academic, highly inbred mechanism for addressing issues of broad social
impact. In order for it to be effective, it must diversify. And, ELSI must
find a way to analyze, synthesize, and disseminate the results ofits delibera-
tions. Otherwise, it will be remembered as a missed opportunity to aggres—
sively address the complex social issues raised by the Human Genome
Project.

NOTE

I. The Biomedical Ethics Advisory Committee (BEAC) was a I4-member group whose
multidisciplinary membership was appointed by the Biomedical Ethics Board (BEB), com-
prised of 12 members of Congress—three each from the majority and minority parties of the
House and Senate. The BEAC ceased to exist before ever issuing a single report as a result of
irresoluble moral conﬂicts over abortion rights on the part of the BEB.

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AIDS, Ethics, and Activism:
Institutional Encounters in the
Epidemic’s First Decade

RONALD BAYER, Ph.D.
Professor, Columbia University School of Public Health

It is an extraordinary fact that no medical dimension of the epidemic
of HIV infection has escaped ethical scrutiny. Among the issues that have
drawn attention are: the duty of physicians to care for those who are in
need,| the limits and signiﬁcance of medical conﬁdentiality? the obliga-
tion to seek informed consent before testing and commencing treatmentf”
the functions of counseling infected individuals about their duties to part-
ners4 and of assisting women who are infected as they are compelled to
make reproductive decisions,5 the clash between the canons of research
and the canons of care,6 the limits of acceptable underwriting by insurance
companies,7 and, ﬁnally, the rights ofindividuals with costly medical condi-
tions to emigrate.“

Despite the extraordinary context of the epidemic during the past
decade, what is striking about the issues that have been pressed to the fore
is that they are not new. They are subjects that have drawn the attention of
ethicists and humanists over the past two decades as they have considered
the role of medicine in society. What is new is the intensity of the discus-
sion, the broad participatory nature of the debate, the political forces called
into play, the demands their representatives have made, and the solutions
they have sought to impose.

It is that political context that has given definition to the role ethicists
have sought to assume in shaping policy on AIDS; it is that political con text
that has fostered an unusual series of institutional efforts to engage activists
in the process of establishing guidelines for AIDS policy. What was unique
about these efforts was not that those who spoke on behalf of the vulner-

458

AIDS, ETHICS, AND AC'I‘IVISM 459

able were engaged at some level, but rather that representatives of vulner-
able populations were sought out as collaborators. In the ﬁrst years of the
epidemic this process was facilitated by the existence of a politically orga-
nized, sophisticated gay community with the professional and intellectual
resources that were crucial for the process of collaboration. It was the
political strength and potential inﬂuence of the gay community and the
widespread recognition that effective AIDS policy would require its involve-
ment that necessitated an effort to engage it in a collaborative process.

In this paper I would like to examine the role of consultation between
ethicists and those at risk for HIV infection in confronting a series of
critical policy questions raised by the AIDS epidemic, each of which en-
tailed a potential clash over the interests of privacy and individual rights on
the one hand and communal well-being on the other. Five such instances
will be examined: the development of guidelines for the protection of the
subjects of epidemiological research, 1984; the development of guidelines
for HIV screening, 1986; the development of policy options on testing of
pregnant women and newborns, 1990; the development of a consensus
policy on clinical research, 1991; policy recommendations for the control
of tuberculosis, 1992*

CREATING GUIDELINES FOR CONFIDENTIALITY
IN RESEARCH ON AIDS

That the debate over bathhouse closure, with its implications for re-
strictions on gay sexual behavior, and the relevance of the public health
power of quarantine to the control of AIDS would have directly engaged
gay political leaders is not surprising. More unusual was their close and
watchful involvement in the conduct of public and private research into
the etiology, course, and epidemiology of AIDS even before HIV was iden-
tiﬁed. Fear of being labeled, of being incarcerated, and of being deprived
of access to employment and insurance marked the tension between the
representatives of the gay community concerned with privacy and research-
ers who asserted that the public health required the conduct of epidemio-
logical studies based upon the most intimate details about AIDS patients’
lives and identities. The conﬂict arose early as the Centers for Disease
Control sought the names of AIDS patients reported to public health au-
thorities throughout the country. Recognizing the critical importance of
longitudinal studies to a broad research program, gay leaders were never-
theless fearful that providing federal health ofﬁcials with such data would

*In all but the effort to draft recommendations on the testing of pregnant women and
newborns, I was a direct project participant. In the projects on epidemiological research,
HIV screening. and tuberculosis, l was a project co—director. Thus this paper relies on and
has all the strengths and weaknesses ofa study based on participant observation.

460 SOCIE’I‘Y’S (21101053

create the circumstances for the deprivation of the civil rights of gay men,
intravenous drug users, and undocumented aliens. For them, the techni-
cal requirements of research had to be viewed within a broad political and
ethical context.

How much did federal researchers need to know? Could codes be
substituted for names? Were codes inviolable? Could the CDC’s profes—
sional scientists be trusted to protect the conﬁdentiality of their data? What
were the links between public health researchers and public health enforc-
ers? These were the questions that proved so troublesome. Doubts about
the capacity or willingness of federal researchers to protect the privacy
interests of AIDS patients came from many sources. The commissioner of
health in the District of Columbia thus stated:

I wouldn’t trust the CDC one moment not to give up to the FBI, the CIA,
or the Social Security Administration. The CDC is a federal agency. You
and I both know that federal agencies do exchange information, and they
will always do that on what they understand to be an appropriate need-to-
know basis. And they will not consider that a breach of confidentiality.9

Virginia Apuzzo, executive director of the National Gay Task Force, under-
scored the social context of the conﬁdentiality debate:

In this country we [gays] are illegal in half of the states. We can’t serve in
the armed forces, we can’t raise our own kids in many states, and we sure
as hell can’t teach other people’s kids. When you tell us you’re interested
in our social security numbers, when we know we are not permitted to
have security clearance, we would . . . be naive, at best, not to ask “What
will you do with the information? Can we trust you enough?"10

The dilemma posed for gay leaders was pinpointed byJeff Levi of the
National Gay Task Force: “We could not be more interested in the gather-
ing of accurate information about AIDS, but we also firmly believe that
reporting mechanisms must guarantee conﬁdentiality.”ll

While some believed that no tension existed between the imposition of
ironclad protections and the conduct of epidemiological research, others
felt it imperative to note that, while it was possible to strike a compromise
position, all such efforts involved trade—offs in the speed and ease with
which data could be gathered and subjected to analysis. The New York
Native, a gay newspaper, soberly observed:

Confidentiality and epidemiology may not be as mutually compatible as
some gay leaders would have us think. Confidentiality and epidemiology
are matters of tense negotiation, not marriage. We are in a gray area in
which abuses on both sides could occur. On the one hand, someone
could illegally obtain a list of people with AIDS and try to create havoc.
On the other hand, some well-intentioned gay leaders who think that
AIDS is primarily a civil liberties issue may be “endangering” research.12

AIDS, ETHICS, AND ACTIVISM 461

In a remarkable and quite unusual process, all the more striking since
it occurred during the conservative Reagan years, representatives of gay
organizations entered into a complex set of negotiations over the nature of
the conﬁdentiality protections that were to be afforded to AIDS research
subjects. Out of this process of negotiation and confrontation, compro-
mises were fashioned for the protection of conﬁdentiality. While some
have asserted that the interests of public health were sacriﬁced, others
acknowledged that the volatile setting of AIDS research required such
adjustments. A refusal to yield would have produced inadequate or inaccu-
rate reporting. james Allen of the CDC thus noted, “It clearly is a compro-
mise position, which will make it more difﬁcult to do our work. But if we
are not getting reports, we can’t do it either.”13

It was within this context that the ﬁrst institutional response to AIDS
on the part of those professionally involved with bioethics occurred. In
1982, Daniel Callahan, the director of the Hastings Center, was called by
Dr. Mathilde Krim (a member of the Center’s board of directors and among
the researchers ﬁrst concerned about the emerging epidemic) to ask him
to send a representative to a meeting at the New York City Department of
Health that was to discuss the issue of conﬁdentiality and epidemiological
research. More speciﬁcally, the meeting was to discuss the question of the
reporting ofAIDS cases by name to the Centers for Disease Control. It was
as a result of attendance at that session that Carol Levine, editor of the
Hastings Center Report and managing editor of IRB: A Review of Human
Subjects Research, became engaged in the complex set of questions being
posed by the new disease.

Issues of conﬁdentiality and the ethics of research were not new to the
Hastings Center, and so it seemed only a natural extension of its institu—
tional mission to confront these questions. Through the efforts of Dr.
Krim, the Center was able to receive a small grant from the Charles A. Dana
Foundation to undertake its work. This was the ﬁrst private foundation
grant to support work on AIDS in the United States.

From its very inception, the project on conﬁdentiality, which lasted for
approximately one year (1983—1984), was marked by the unique sensitivi-
ties that were to characterize work on ethical issues raised by the AIDS
epidemic. In addition to experts on the ethics and law of human subjects
research, public health representatives, and specialists on civil liberties, the
group created to examine the question of conﬁdentiality and research
included representatives of the gay community. A physician who was
among the ﬁrst to seek a cure for those with AIDS, a patient of his who had
early emerged as a spokesperson for people with AIDS, representatives
from the Lambda Legal Defense and Education Fund, and the National
Gay Task Force were all involved. Additionally, since Haitians were at that

462 SOCIE’I'Y’S CHOICES

time thought to be at increased risk, efforts were made to engage represen-
tatives of that community.

Over the period of several months when the group met, discussions
were often spirited, revealing the depths of suspicion on the part of those
who were at risk for both the new disease and breaches of conﬁdentiality,
as well as the impatience that could sometimes characterize those commit-
ted to the efﬁcient conduct of research. By design the discussions sought
to underscore the points of consensus as well as to make manifest the
points of disagreement. As a matter of principle, it appeared critical to the
project’s directors to avoid language that would mask the differences with
well-meaning banalities.

The guidelines, broadly agreed to by the group and endorsed by much
larger constituencies of experts on ethics as well as by representatives of the
gay community, were published at the end of 1984.

Any investigation involving a possibly communicable disease poses a
tension between an individual’s desire to control personal information and
the desire of others to have access to that information. Although this
tension is not unique to AIDS, it is particularly sharply drawn in this case
because those groups that have been identiﬁed as at high risk are also
highly vulnerable socially, economically, and politically. Because in the
early 19805 so much was unknown about AIDS, researchers believed they
had to explore many intimate aspects of an individual's medical, social,
and behavioral history and had to keep these data for an extended period.
Investigators had to seek information that revealed, for example, that a
subject had engaged in homosexual or other sexual practices that are
illegal in many states and are subject to social stigma; had injected drugs
obtained illegally; had engaged in criminal activities, such as prostitution;
or had entered the country illegally. The guidelines thus argued:

Furthermore, disclosure of a diagnosis of AIDS—or perhaps even involve-
ment in AIDS research—carries a stigma that can adversely affect a per-
son’s interests socially, politically, and economically. Potential subjects,
either individually or through organizations representing their interests,
have sought recognition of these risks and assurances that appropriate
measures will be taken to protect their privacy. For these reasons we
believe that special guidelines are necessary for AIDS research.14

Clearly the guidelines embraced the concerns of the vulnerable. De-
spite a remarkable degree of consensus on the need to embrace confiden-
tiality protections, to prevent the misuse of research data, and to employ
personal identifiers only when cn'tical to the task oflinking research records
in longitudinal studies, disagreement persisted on the topic of whether
social security numbers should be used in AIDS research. For the advo—
cates of such identifiers, they presented the greatest potential for matching

AIDS, ETHICS, AND ACTIVISM 463

data sets; for those who opposed their use, they posed the greatest threat to
conﬁdentiality.

Recognizing the prospect of an ever-expanding series of questions
posed by research into AIDS, the guidelines proposed the creation of a
national board that would consider such matters. Although never acted
upon, this recommendation reflected the emerging commitment to a broad
consultative model, which would include representatives of the communi-
ties most at risk for AIDS, for conducting work on the ethical issues posed
by the AIDS epidemic.

It was this model of collaboration that was to inform the next major
undertaking of the Hastings Center as it confronted the question of the
tension between public health and civil liberties in the context of the AIDS
epidemic. With support from the recently organized AIDS Medical Foun-
dation (later to be called the American Foundation for AIDS Research)
and a number of small liberal foundations, a much larger and more ambi—
tious project commenced in 1985. It took as its agenda the exploration of
the fundamentals of public health in light of contemporary ethical and
constitutional standards for the limitation of the powers of the state. Re-
ﬂecting ofits broader scope, the project brought together leaders from the
national gay community, health officials from the epidemic’s epicenters
(New York, San Francisco), and experts on ethics, law, and history.

For the project’s organizers the involvement of representatives of the
gay community was critical not only because they believed it necessary to
hear their opinions. As important, it was necessaty to learn from those who
could uniquely convey the insights, fears, and needs of those most at risk
for AIDS. Not long after it began its discussions the Hastings group elected
to focus its work on the ethical challenges posed by the prospect of sero-
logical screening for HIV infection. Here, too, the Center was able to bring
its long—time concern with the ethics of population screening to bear on
the special problems posed by AIDS.

THE ETHICS OF SCREENING FOR HIV

From the outset the test developed to detect antibody to the AIDS
virus—and ﬁrst used on a broad scale in blood banking—was mired in
controversy. Uncertainty about the signiﬁcance of the test’s ﬁndings and
about its quality and accuracy provided the technical substrate of disputes
that inevitably took on a political character, since issues of privacy, commu—
nal health, social and economic discrimination, coercion, and liberty were
always involved. For those who feared that public anxiety about AIDS
would turn individuals identiﬁed as infected with the AIDS virus into tar-
gets of irrational social policy and practice, the antibody test became em-
blematic of the most threatening prospect in the community’s response to

464 SOCIETY’S CHOICES

AIDS. Vigorous encouragement of testing would ineluctably lead to man-
datory approaches as the impatient appealed to the authoritarian history of
public health. Since conﬁdentiality would not be preserved, the conse—
quences would be stigmatization and deprivation of the right to work, go to
school, and obtain insurance. Most ominously, the identiﬁcation of the
infected could threaten freedom itself. No marginal advance of the public
health, those who argued against wide-scale testing asserted, could warrant
such a catastrophic array of personal burdens.

“Don‘t take the test" became the rallying cry of the leaders of the gay
community. In an editorial, the New York Native wrote: “No gay or bi-
sexual man should allow his blood to be tested. . . . The meaning of the test
remains completely unknown. Scientists and physicians agree that a posi-
tive test result cannot be used to diagnose anything." What was far from
uncertain, however, was the

personal anxiety and socioeconomic oppression that [would] result from
the existence ofa record ofa blood test result. . . . Will test results be used
to identify the sexual orientation of millions of Americans? Will a list of
names be made? How can such information be kept conﬁdential? Who
will be able to keep this list out of the hands of insurance companies,
employers, landlords, and the government itself?

What was critical was for gay and bisexual men to modify their behaviors in
order to protect their own health and that of their sexual partners. For
those purposes, what role could such an ambiguous and potentially dan-
gerous test play? “If you test positive, will you act with any more wisdom or
concern than if you test negative? Will you be less or more conscious of
following safe and health sexual guidelines?”15

Those who believed that the identiﬁcation of the infected or poten-
tially infected provided an opportunity for strategically targeted measures
designed to modify risky behavior saw in the test a great opportunity. Some
advocates of testing, opposed to the use of coercion and attentive to mat-
ters of privacy so forcefully articulated by gay groups, stressed the impor-
tance of preserving the right of each individual to determine whether to be
tested, protecting the conﬁdentiality of tests results, and guaranteeing the
social and economic rights of those whose test results revealed infection
with HIV. Theirs was a posture that sought to demonstrate the compatibil-
ity of an aggressive defense of the public health with a commitment to the
privacy and social interests of the infected and those at risk of infection.
The stress on voluntariness was reﬂected in the early policy statements of
the national organization of state public health ofﬁcials, the Association of
State and Territorial Health Ofﬁcials (ASTHO).

In August 1985, ASTHO convened a national consensus conference
devoted to the antibody test. On this occasion, earlier doubts about the

AIDS, ETHICS, AND A (ITIVISM 465

test, its use, and what recommendations should be made to those who
tested positive had all but gone. ASTHO’s published report declared:
“With less than six months’ experience, it is clear that [the tests] are more
than simply measures to screen donated blood. Their high sensitivity,
speciﬁcity, and in higher prevalence groups, their predictive powers for
exposure to HTLV-III will substantially assist the disease prevention effort.
When properly used, test information may also enhance the education
efforts which remain for now the principal intervention to prevent HTLV-
III transmission.”16 But an increased reliance on voluntary testing was
predicated on the capacity to protect the confidentiality of test results.
Acknowledging the skepticism of the gay community—indeed, at least one
representative of the gay community was involved in the process of drafting
the ASTHO report—the document stressed the importance of convincing
those at risk that all measures would be taken to preclude the unwarranted
disclosure of test findings.”17 The defense of conﬁdentiality was not anti—
thetical to the protection of public health; it provided the condition for the
required interventions.

There were, of course, those who rejected the emphasis on volun—
tariness. Some argued for “routine screening.” Others asserted that the
defense of the public health required coercion and limitations on the
liberty of the infected. For them screening on a compulsory basis was both
necessary and inevitable. Assertions that the public health would not re-
quire such efforts merely masked, they argued, the willingness to sacriﬁce
the communal welfare to private interests. The specter of such coercion
haunted the discussion of all public health efforts, even the apparently
voluntary attempts to facilitate identiﬁcation of the infected.

Ultimately, the debate over testing and other public health measures
designed to identify the infected would force a confrontation over which
proposed interventions could most effectively contribute to the transfor-
mation of the private behaviors linked to the spread of HIV infection and
the development of a public culture that would encourage and reinforce
such changes. Bold moves might advance the cause of public health in the
face of the AIDS epidemic, or they might subvert that very cause. Caution
might represent wisdom or a failure to grasp the opportunity to affect the
pattern of HIV transmission. Appeals to the history of public health would
inform the perspectives of those who encountered each other as antago-
nists; so too would profound differences over the weight to be given to
communal well-being and personal liberty. Empirical considerations,
historical perspectives, and philosophical commitments each thus
helped to shape the fractious struggles that characterized the politics of
identification.

Given the profound gulf that separated those who believed that HIV
testing was crucial to the strategy of preventing the spread of a lethal

466 socns'ry’s CHOICES

infection and those who saw in such testing not only a misdirection of
public efforts but a potentially dangerous approach to the epidemic, it
would have been futile in 1986 to seek a common ground on the question
of the place of testing in the campaign against AIDS. What was possible,
however, was to provide the ethical foundations for an approach that re-
jected mandatory screening. Relying on the principles first enunciated in
The Belmont Report, as well as on constitutional principles, limiting the exer-
cise of state power in the name of the public health and welfare, it was
possible for the directors of the Hastings project to provide a clear enuncia-
tion of the case for voluntary HIV testing. More speciﬁcally the guidelines,
published in the journal of the American Medical Association, provided a re-
sponse to the concerns voiced by gay leaders. Arguments for the protec-
tion of conﬁdentiality and against discrimination were clearly asserted. So
too was the necessity of informed consent with pretest counseling—re—
quirements that were to become the platform of those committed to liberal
AIDS policies.

The Hastings Center authors were unencumbered by a commitment to
produce a consensus report. Nevertheless, they worked to elicit broad
support for the guidelines from their working group. Drafts were repeat-
edly circulated. Comments and criticisms were considered carefully. It
was, however, the relative independence of the guidelines’ authors that
made it possible for them to take a rather striking position in favor ofwide-
scale voluntary testing and against the moral right of those who had been
tested not to know their status. “We conclude,” stated the guidelines, “that
given the disastrous consequences of HIV infection and the imperative of
the harm principle, those who are infected have an obligation to know
their antibody status, to inform their sexual partners, and to modify their
behavior.”18 As a consequence those who had elected to undergo testing
had no moral claim to shield themselves from those results. But that
posture, in defense of what was perceived to be a public health imperative,
was for the Hastings group intimately linked to the defense of the liberal
values that inspired the voluntarist strategy for dealing with AIDS. Thus
the guidelines concluded:

We believe that the greatest hope for stopping the spread of HIV infec-
tion lies in the voluntary cooperation of those at higher risk—their will-
ingness to undergo testing and to alter their personal behavior and goals
in the interests of the community. But we can expect this voluntary coop-
eration—in some cases, sacrifice—only if the legitimate interests of these
groups and individuals in being protected from discrimination are heed-
ed by legislators, professionals, and the public. Yet voluntary testing is
not enough. We must proceed with vigorous research and educational
efforts to eliminate both the scourge of AIDS and the social havoc that
has accompanied it.

AIDS, ETHICS, AND AC’I‘IVISM 46 7

TESTING PREGNANT WOMEN AND NEWBORNS

The approach to consultation with those at risk adopted by the Work-
ing Group on HIV Testing of Pregnant Women and Newborns, organized
under the aegis of the johns Hopkins University School of Public Health,
was more conventional than that which had been adopted by the Hastings
Center. Described by its chair, Dr. Ruth Faden, as a “self-appointed group,”
it included a range of experts in public health, law, ethics, and policy
drawn from the Hopkins community, the Georgetown Law Center, and the
Kennedy Institute of Ethics.19 Funded by the American Foundation for
AIDS Research, the group undertook, through a series of meetings in the
late 1980s, an examination of a range of complex screening issues involv-
ing women and newborns.

Given the epidemiology of HIV infection in women, this was a project
that had to confront a set of questions with enormous implications for
women of color. Like the Hastings Center group, the Working Group on
HIV Testing of Pregnant Women and Newborns demonstrated a singular
commitment to the privacy rights of those who might be the target of
screening and efforts at prevention. Most critically, the group sought to
underscore its commitment to the reproductive rights of those with HIV:
“ . . we reject the implementation of counseling and screening, policies
that interfere with women’s reproductive freedom or that result in the
unfair stigmatization of vulnerable social groups.”20

Incorporating the well-established ethical principles that inform ge-
netic counseling, the Working Group explicitly rejected efforts to discour—
age pregnancy on the part of HIV-infected women. In so doing the Work-
ing Group had adopted a position long advocated by feminists but one that
stood in sharp contrast to the formal policy of the Centers for Disease
Control and many state health departments which urged HIV-infected
women to consider the postponement of pregnancy. Even more striking
was the position adopted by the Working Group on the question ofwhether
information and screening resources should be targeted to those commu-
nities at greatest risk for HIV infection—poor inner-city communities of
color. Here the Working Group was initially divided, with some favoring
such targeting as the rational application of public health principles and
others believing that programs that targeted poor black and Latina women
would be stigmatizing. On this topic the group was ultimately strongly
inﬂuenced by its one-time consultation with representatives ofa number of
organizations representing the interests of African American and Latina
women. It was this encounter, which occurred as part of a daylong session
with representatives of communities at risk as well as public health ofﬁcials,
that led the Working Group to deﬁne as “unjust” any program that either
implicitly or explicitly targeted women of color and to state that, “to add

468 SOCIE’I‘Y’S CHOICES

the stigma of AIDS contagion to poor women of color is to further harm a
group of persons who are already unfairly disadvantaged."21

In considering the unique impact that the one-time consultation had
played, the Working Group chair, Dr. Faden, has lamented the fact that
limited resources had not permitted a more systematic and ongoing in-
volvement of those at risk—the poor women themselves as well as the
advocacy groups that spoke on their behalf. Nevertheless, even the modest
consultation that did occur represented more than had been undertaken
in the past. Was it AIDS itself that had pressed Faden and her group in a
new direction? “Probably,” she has said. But as important was the commit-
ment to developing a consensus, one that was “in tune” with the communi-
ties of color affected by the threat of AIDS.

Going beyond the consultative efforts of both the Hastings and the
Hopkins groups were there those which were undertaken in response to
the challenge posed by AIDS to the process of new drug development in
the United States. Here the search for a new consensus necessitated a level
of collaboration that was unprecedented.

THE ETHICS OF DRUG TRIALS

In the mid-19705, the National Commission for the Protection of Hu-
man Subjects of Biomedical and Behavioral Research issued The Belmont
Reﬂmt, which codiﬁed a set of ethical principles that sought to inform the
work of researchers. Those norms provided the foundations for regula-
tions subsequently enacted by the Department of Health and Human Ser-
vices and the Food and Drug Administration. At the core of those guide-
lines was the radical distinction between research designed to produce
socially necessary, generalizable knowledge and therapy designed to ben-
eﬁt individuals. Against the former, The Belmont Repmt held, individuals—
especially those who are socially vulnerable—need protection against con-
scription.

AIDS has forced a reconsideration of this formulation. There had
been challenges to federal protections in the past, for example, when pris-
oners atjackson State Prison in Michigan demanded that they be permit-
ted to serve as research subjects because participation provided them with
social advantages. But the HIV epidemic has provided the circumstances
for the emergence of a broad and potent political movement that has
sought to reshape radically the conditions under which research is under-
taken. The role of the randomized clinical trial, the importance of placebo
controls, the centrality of academic research institutions, the dominance of
scientists over subjects, the sharp distinction between research and therapy,
and the protectionist ethos of The Belmont Report have all been brought into
question.

AIDS, ETHICS, AND AC'I‘IVISM 469

Although scholars concerned with the methodological demands of
sound research and ethicists committed to the protection of research sub-
jects have played a crucial role in the ensuing discussions, both as defend-
ers of the received wisdom and as critics, the debate has been driven by the
articulate demands of those most threatened by AIDS. Most prominent
have been groups such as the People with AIDS Coalition and ACT-UP,
organizations made up primarily of white, gay men. But advocates of
women’s, children’s, and prisoners” rights have also made their voices
heard. What has been so stunning, disconcerting to some, and exciting to
others has been the rhythm of challenge and response. Rather than the
careful exchange of academic arguments, there has been the mobilization
of disruptive and effective political protest.

The threat of death has hovered over the process. As Carol Levine has
noted, “the shortage of proven therapeutic alternatives for AIDS and the
belief that trials are, in and of themselves, beneﬁcial have led to the claim
that people have a right to be research subjects. This is the exact opposite
of the tradition started with Nuremberg—~that people have a right not to be
research subjects.”22 That striking reversal has resulted in a rejection of the
model of research conducted at remote academic centers, with restrictive
(protective) standards of access, and strict adherence to the “gold stan-
dard” of the randomized clinical trial. Blurring the distinction between
research and treatment—”A Drug Trial Is Health Care Too”—those insis-
tent on radical reform have sought to open wide the points of entry to new
“therapeutic” agents both within and outside of clinical trials; they have
demanded that the paternalistic ethical warrant for the protection of the
vulnerable from research be replaced by an ethical regime informed by
respect for the autonomous choice of potential subjects who could weigh,
for themselves, the potential risks and beneﬁts of new treatments for HIV
infection. Moreover, the revisionists have demanded a basic recon—
ceptualization of the relationship between researchers and subjects. In
place of protocols imposed from above, they have proposed a more egali-
tarian and democratic model in which negotiation would replace a scien-
tiﬁc authority.

The reformulation of the ethics of research that has begun under the
brutal impact of AIDS has implications that go far beyond the epidemic of
HIV disease because the emerging new conceptions and standards could
govern the conduct of the entire research enterprise. Furthermore, the
role of the carefully controlled clinical trial as providing protection against
the wide—scale use of drugs whose safety and efﬁcacy have not yet been
proven no longer commands unquestioned respect.

Protagonists who have been locked in often acrimonious debate fore-
tell very different consequences of the changing social standards of re-
search. Proponents of a revised ethos hold out the prospect of a new

4 70 SOCIETY’S CHOICES

regime that is both respectful of individual rights and the requirements of
good science. Martin Delaney of Project Inform in San Francisco, for
example, has stated:

Regulatory practices contribute to the failure of science, demean the pub—
lic good, and tread heavily on our civil liberties. . . . Scientist and patient
alike would be better served by a system that permits life-threatened pa—
tients some form of access to the most promising experimental therapies,
peacef‘téljy coexisting alongside a program of unencumbered clinical re-
search.“

Those who are less sanguine have spoken in a different voice. George
Annas has warned that the blurring of the distinction between research
and treatment can only harm the desperate: “It is not compassionate to
hold out false hope to terminally ill patients so that they spend their last
dollars on unproven remedies that they might live longer.”24 jerome
Groopman of New England Deaconess Hospital in Boston has gone fur-
ther, viewing liberalization as a threat to the research enterprise itself: “If
the philosophy is that anyone can decide at any point what drugs he or she
wants to take, then you will not be able to do a clinical.”25

Here was an issue that raised questions somewhat different from those
involved in the confrontation between public health and privacy. Never-
theless, it was an issue that entailed a clash between differing conceptions
of the demands of the common good and of the priority that ought to be
accorded to those demands. For the American Foundation for AIDS Re—
search (AmFAR), which had been instrumental in funding virtually every
effort on AIDS and ethics, the debate over drug trials was of central impor-
tance. That Mathilde Krim, AmFAR’s founding co—chair, was an early and
persistent critic of the research orthodoxies was, of course, a critical con-
tributing factor. But most important, the challenge to the research estab-
lishment by AIDS activists made the question of the conduct of research
trials a topic that no one concerned about AIDS could ignore. It was the
existence of such activism that would fundamentally shape the design of
the project funded by AmFAR to examine the issues at hand.

The project directors, Carol Levine, Robert Levine, and Nancy Dubler,
had long and distinguished records for examining issues involving human
experimentation. But for a project that was charged with the responsibility
of forging a new consensus on research ethics, one that would “entail a
reappraisal of the ethical balance between protecting the rights and wel-
fare of subjects and expanding their options for possibly beneficial but still
unproven drugs,"26 it would have been unthinkable to approach the ques-
tions without fully involving those who had forced the issue onto the na—
tional agenda. And indeed the task force constituted represented the most
serious effort to date to develop a fully collaborative relationship between

AIDS, ETHICS, AND ACTIVISM 471

activists and ethicists. Community-based researchers, members ofACT-UP,
representatives of minority communities, as well as lawyers, ethicists, and
policymakers, were recruited. That collaboration was especially crucial
since the project goal was to develop a consensus document that would
serve as a platform for reforming drug trials in the United States.

The degree to which the task force was successful in achieving its goal
of consensus was in no small part a function of the care and skill of its
directors in selecting the participants. “We could have had a total standoff
on any issue if there had been noncompromisers in the group,” said Carol
Levine. “We [sought out] people who could hear other points of View and
who could accept something less than the full incorporation of their own
views and values in a ﬁnal document.”27 In the process of seeking a “nego-
tiated settlement,” it was crucial to lay the foundations for the broad points
of agreement, thus moving those questions upon which consensus could
not be reached to the margins, no matter how important they were.

When ﬁnally published in IRB: A Review of Human Subjects Research in
1991, the report, “Building a New Consensus: Ethical Principles and Poli-
cies for Clinical Research on HIV/AIDS," reﬂected agreement on the need
to replace the overly protective and paternalistic ethos that had informed
the regulation of research and to open wide access to therapeutic trials to
those who had previously been excluded or who had faced severe restric-
tions—women, prisoners, drug users, members of minority groups. Re-
ﬂecting the political demands of AIDS activists, the consensus not only
stressed the critical importance of community consultation but argued
that such consultation should not be viewed as a way to obtain acceptance
of an already agreed-upon protocol; the task of shaping the protocol itself
“must be a partnership." Thus did the process of arriving at a consensus
on research through the joint efforts of ethicists and activists produce a
recommendation for partnership in the enterprise of investigating new
drugs.

Despite the spirit of cooperation that animated the process of consen-
sus building, there was one issue that remained intractable: the question of
whether research participants were morally obligated to be truthful with
investigators on matters of compliance and criteria for inclusion in trials.
At stake, in a fundamental way, was the extent to which participants in
research trials had obligations to others that could constrain their behav-
ior. Failure to reach consensus thus represented in an acute way the
profound tension between a perspective driven by a commitment to the
survival interests ofindividuals with HIV and that which while sympathetic
to those interests did not view them as trumping all other concerns. Rather
than disguise the clash of perspectives, the consensus statements openly
acknowledge them. Those who held that participants had a duty to candor
believed that a failure to adhere to such a norm represented a violation of

4 72 SOCIETY’S CHOICES

the trust of the researchers that could “harm the interests of current and
future patients because the trial may result in scientiﬁcally invalid data and
have a negative effect on their care.” To others the legacy of injustice in
research and the health care system made it difficult to demand compli-
ance from those who viewed access to a drug trial as providing the only
access to a potentially lifesaving drug. In the face of this irresolvable con-
flict the consensus document retreated from the task of making normative
statements and instead underscored the prospect for improving candor
and compliance if a number of meliorative measures were taken.

The experience of preparing the report on drug trials thus revealed
both the strengths and limitations of efforts at consensus building between
ethicists and activists. Those who believed that consensus was always pos-
sible simply did not understand the extent to which unbridgeable ideologi-
cal differences might surface in the course ofjoint effort. It was these
limitations that would be revealed in 1992 when a task force was consti—
tuted to examine the ethical challenges posed by the resurgence of tuber-
culosis in the face of the AIDS epidemic.

PUBLIC HEALTH AND TUBERCULOSIS CONTROL

From the mid—19805 on, the century-long decline in the incidence of
tuberculosis came to an end. Fueled by a rise in poverty, homelessness,
untreated drug addiction, and the crowding of prisons, this stark shift was
fundamentally linked to the HIV epidemic. Those who are dually infected
with HIV and microbacterium tuberculosis are at sharply increased risk for
developing tuberculosis disease. Complicating the epidemiological pic-
ture was the dramatic increase in multiple-drug-resistant tuberculosis, the
treatment of which involves toxic drugs and is costly, long and often inef-
fective. The rise in drug-resistant tuberculosis has been attributed to the
failure of those who commence treatment to complete the course of
therapy. In New York City, only slightly more than half of those who are
diagnosed with tuberculosis complete treatment. In that city 20 percent of
diagnosed cases are resistant to two or more drugs.

Tuberculosis is, of course, not AIDS. It is airborne and can be trans-
mitted through casual contact. It is these factors that provide the biologi—
cal foundations for the strategy of TB control which is compulsory at its
core, standing in marked contrast to the voluntaristic strategy for dealing
with HIV. To those whose ﬁrst extended engagement with the public
health challenges posed by a communicable disease was the AIDS epi-
demic, the resurgence of tuberculosis provoked profound concerns.

Given the epidemiology of the tuberculosis epidemic, its relationship
to HIV infection, and the fact that it is the most socially marginalized
individuals who are typically sick or at risk, there was a danger that the

AIDS, ETHICS, AND ACTIVISM 4 73

demands by the public for increased health protections would create a
climate within which the rights and interests of those with tuberculosis and
HIV would be disregarded. Additionally, there was the potential that the
policies created during the ﬁrst decade of the AIDS epidemic that pro-
moted and protected individual choice and conﬁdentiality and that sought
to prevent unwarranted acts of discrimination could be subverted in the
name of tuberculosis control.28 Finally, the resurgence of tuberculosis
necessitated an examination of the compatibility of the voluntaristic strat-
egy for dealing with HIV and the compulsory tradition of dealing with
tuberculosis.

These concerns inspired two ethicists (Ronald Bayer and Nancy
Dubler) and a physician (Sheldon Landesman) long associated with work
on the AIDS epidemic to constitute a working group under the auspices of
the United Hospital Fund in New York City, with additional funding by
AmFAR. Emboldened by the experience of past working groups that had
successfully achieved broad consensus on critical policy issues posed by the
HIV epidemic, the three project directors constituted a panel that was built
on the model of the first Hastings Center working group on AIDS. It
included clinicians, lawyers, philosophers, public health ofﬁcials and rep-
resentatives of the gay community. Although an explicit decision was made
not to develop a consensus report, every effort was to be made to achieve
consensus on all critical issues.

When the report Tuberculosis in the 19905: Ethical, Legal and Policy Issues
in Screening, Treatment and the Protection of Those in Congregate Facilities was
issued at the end of 1992, it did, in fact, reﬂect the successful attainment of
agreement on a number of issues that the working group had struggled
with over time: there was no need to initiate mandatory HIV testing in
order to effectively conduct compulsory or routine TB screening; resources
should be made available to provide the social and support services neces—
sary to enhance the capacity of the poor, the homeless, the mentally ill, and
the drug addicted to comply with their TB treatment; those with HIV
infection should not be excluded from work settings where they might be
exposed to tuberculosis.

Where consensus eluded the group was when it confronted the ques-
tion of a mandatory system of directly observed therapy for all tuberculosis
patients in the postacute phase of treatment. Here the chasm between
those whose perspective was informed by a primary commitment to the
preventive values became clear. Despite repeated efforts the gap was un-
bridgeable. In the end two working group members—representatives 0f
the Gay Men’s Health Crisis and the Lesbian and Gay Rights Project of the
American Civil Liberties Union—refused to sign the report. In summariz-
ing this controversy the authors of the report wrote:

4 74 SOCIETY‘S CHOICES

Some have argued that requiring all patients to submit to directly ob-
served therapy is an unacceptable intrusion on privacy and liberty.29 Why
should those who have no prior record of failure to adhere to treatment
be subjected to a regime that is appropriate only for those who cannot be
trusted to take their medication? Wouldn't such a requirement be over-
broad? Wouldn't it represent a violation of the constitutional principle
that for each individual the least restrictive alternative should be relied
on in pursuing the goals of public health? Opponents of such a require-
ment also argue that the cost of directly observed therapy in all instances
represents a misallocation of scarce public health resources. We recog-
nize that a requirement that all patients undergo directly observed thera-
py will entail impossible supervision on some patients who might other—
wise complete the course of treatment without such oversight.
Nevertheless, we believe that the marginal intrusions on privacy and re-
strictions on autonomy represented by supervised therapy are justiﬁed,
on balance, by the public health benefits that could be achieved. Given
the social costs of noncompliance, the expenditure of resources on man-
dated directly observed therapy, at least during the initial phase of treat-
ment, clearly would represent a cost-effective approach to tuberculosis
control.30

CONCLUSIONS

As ethicists have sought to make an impact on the shaping of public
health policy in the context of the AIDS epidemic—an undertaking that
has perforce required an extension of the principles ﬁrst developed in the
context of the challenges posed by the clinical encounter—they have
tended to develop positions most compatible with the political perspectives
of those most at risk. In part the ideological content of the work ofethicists
during the ﬁrst decade of the AIDS epidemic reﬂected their own political
identiﬁcation as American liberals; in part it reﬂected the extension of the
concern for the subordinate party in the clinical encounter that so shaped
the development of medical ethics since the late 19605. Finally, the pre-
eminent place of the values of liberal individualism in contemporary bio-
ethics was critical in forging an identiﬁcation between those whose profes—
sional work centered on bioethics and those most at risk for HIV infection
who for historical reasons harbored deep suspicions about the role of the
state and its agencies. But the challenges of public health were not com-
pletely analogous to those of the clinical setting. After all, the public
health authority could be deployed to protect vulnerable communities in a
way that was fundamentally different from the paternalistic exercise of
physician authority over a nonconsenting competent adult.

It was the concern over the protection of the community—whether
involving the advocacy of voluntary HIV testing at a time when gay organi-

AIDS, ETHICS, AND ACTIVISM 4 75

zations saw in the test a terrible threat, the protection of the research
enterprise from subversion by those who failed to comply with protocols,
or the recommendation for universal directly observed therapy for tuber—
culosis—that the gap between the ideological perspective of bioethicists
drawn to the issue ofAIDS and the most articulate proponents of the rights
of those groups most at risk was manifest.

Nevertheless, the lessons of the past decade have made clear that to the
extent that bioethics seeks to enter the policy arena there are considerable
advantages to open collaborative relationships with activists. In some in—
stances it is only through such collaboration that bioethicists can learn
about the complexity of the issues to which they will bring their analytical
tools, and can fully appreciate the contextual forces that shape the lives of
the individuals who will be affected by particular policy choices. Most
important, such collaboration will be enhanced if those selected for vari-
ous working parties are committed to the possibility and value of com-
promise. But on some matters it may not be possible to identify such
individuals. There are occasions when compromise will be viewed as an
unacceptable capitulation to expedience rather than as a virtue. (Needless
to say, the unyielding adherence to principle or position may characterize
ethicists or activists.) Under such circumstances fruitful collaboration may
not be possible. At best it may be possible only to agree to disagree.

Fortunately, that was not, for the most part, the case during the ﬁrst
decade of the AIDS epidemic. At a time when national administrations
were indifferent, even hostile, to the concerns of those with HIV it was vital
for ethicists and activists to ﬁnd common ground in shaping perspectives
that were both humane and effective. That they did so was a singular
achievement.

NOTES

1. Zuger, A., and S.H. Miles. 1987. Physicians, AIDS and occupational risk: Historic
traditions and ethical obligations. jAMA 258:1924—1928.

2. Dickens, B. 1989. Confidentiality and the duty to warn. In L. Gostin, ed., AIDS and the
Health Care System. New Haven: Yale University Press.

3. Bayer. R., C. Levine, and S. Wolf. 1986. HIV antibody screening: An ethical frame-
work for evaluating proposed programs. jAMA 256:1768—1774.

4. Shoeman, F. 1991. AIDS and privacy. In F. Reamer, ed., AIDS and Ethics. New York:
Columbia University Press.

5. Bayer, R. 1991. AIDS and the future of reproductive freedom. In D. Wilkin, D.
Nelkin, and S. Paris, eds., A Disease ofSoriety: Cultural and Inxlitutional Responses to AIDS. New
York: Cambridge University Press.

6. Levine, (1., N.N. Dubler, and R.]. Levine. 1991. Building a new consensus: Ethical
principles and policies for clinical research on HIV/AIDS. IRB: A Review ofHuman Subjects
Research 1321—17.

7. Oppenheimer, G.M., and R.A. Padgug. 1991. AIDS and the crisis of health insurance.
In F. Reamer, ed., AIDS and Elhirs. New York: Columbia University Press.

4 76 SOCIETY‘S CHOICES

8. Gostin, L., P. Cleary, K. Mayer, et a1. 1990. Screening immigrants and international
travelers for the human immunodeficiency virus. New Englandjoumal ofMedicine 322:1743—
1746.

9. The Washington Post,july 18, 1983, p. 4.

10. The Washington Posthluly 18, 1983.

11. “‘Conﬁdentiality‘ Issue May Cloud Epidemiologic Studies of AIDS," jAMA, Oct. 21,
1983, p. 1945.

12. New York Native, Nov. 7—20, 1983.

13. The Washington Post,]u1y 18, 1983.

I4. IRB: A Review ofHuman Subjects Research, 1984, 6(6).

15. New York Native, October 8—21, 1984, 5.

16. Association of State and Territorial Health Ofﬁcials, ASTHO Guide to Public Health
Practice: HTLVIII Antibody Testing and Community Approaches. Washington, D.C.: Public Health
Foundation, 1985, 16.

17. (bid.

18. Bayer, R., C. Levine, and S.M. Wolf. 1986. HIV antibody screening: an ethical
framework for evaluating proposed programs. jAMA 256:1768—1774.

19. Interview with Ruth Faden.

20. Working Group in HIV Testing of Pregnant Women and Newborns. 1990. “HIV
Infection, Pregnant Women, and Newborns: A Policy Proposal for Information and Testing."
jAMA 264(18).

21. Working Group on HIV Testing of Pregnant Women and Newborns. 1990. HIV
infection, pregnant women, and newborns: a policy proposal for information and testing.
jAMA 264:2416—2420.

22. Levine, C. 1988. Has AIDS changed the ethics of human subjects research. Law,
Medicine and Health Care 16:167—173.

23. Parallel track system defended. 1989. CDC AIDS Weekly. December 11, 3.

24. Annas, GJ. 1989. Faith, healing, hope and charity at the FDA: The politics of AIDS
drug trials. Villanova Law Review 34:771—797.

25. Parallel track system defended. 1989. CDC AIDS Weekly December 11, 3.

26. IRB: A Review ofHuman Subjects Research, 1991, 13(1—2).

27. Interview with Carol Levine.

28. Bayer, R. 1991. Private Acts, Social Consequences: AIDS and the Politics of Public Health.
New Brunswick, NJ: Rutgers University Press.

29. Gostin, L. 1993. Controlling the re—emergent tuberculosis epidemic: A fifty-state
survey of TB statutes and proposals for reform. jAMA 269:255—261.

30. Bayer, R., N.N. Dubler and S. Landesman. 1993. The dual epidemics of tuberculosis
and AIDS: Ethical and policy issues in screening and treatment. American journal ofPublic
Health 83:649—654.

“La Pénible Valse Hésitation’”:
Fetal Tissue Research Review and the
Use of Bioethics Commissions in France
and the United States

R. ALTA CHARO, ].D.

Assistant Professor, Program in Medical Ethics, School of Law,
University of Wisconsin, Madison

[Unlike the naive rationality of the French Revolution, in which igno-
rance was always bad for mankind,] it is understood today that ignorance
is not the only enemy of man, and that science must submit to a superior
morality ifit is to continue to be his ally. Oppenheimer had already faced
this conﬂict when he stood before the atom bomb. The advances in
genetics that bring beneﬁts but also exceptional risks to humanity lead us
to the same dilemma. . . ‘ Our society has as much need of philosophers
as it does of scientists.2

The unyielding antiabortion stance of the Bush and Reagan adminis-
trations, combined with the continuing mutual distrust between abortion
rights advocates and antiabortion forces in Congress, has created a growing
paralysis on vital bioethical matters. For example:

O The congressional Biomedical Ethics Advisory Committee and the
board that appointed it collapsed in a political squabble centered on abor-
tion. The committee was supposed to report to Congress on such issues as
human genetic research, fetal research, and the withholding of food and
water from dying patients.

0 Experiments deemed scientifically worthwhile by National Institutes
of Health reviewers have gone unfunded because a federal ethics board
that must review them doesn’t exist.

0 Candidates for scientiﬁc posts in the Department of Health and
Human Services under the Reagan and Bush administrations were asked
their positions on abortion and fetal tissue transplants, leading some to
withdraw from consideration.

477

4 78 SOCIE’I‘Y’S CHOICES

0 Potentially valuable drugs, such as RU- 486, are left relatively un-
investigated 111 the United States because the private sector perceives the
likelihood of a biased federal 1eview and hostile public reaction

Both the United States and France have attempted to use bioethics
commissions to overcome these tensions, and to smooth the way toward
coordinated public policy, whether in the form of executive action or legis-
lation. The French experience, however, may prove somewhat more suc-
cessful. In part this is due to the differing political traditions of the two
nations. In part, it reflects a simpler conflict to be addressed by the French
commissions.

The long history of central government, whether by monarchy or Paris-
based national legislatures, has made the French public more apt to accept
the pronouncements of national commissions. And a comparative review
of national bioethics commissions by Sonia Le Bris of the University of
Montreal found that centralized nations tended, not surprisingly, to have
centralized (though still purely advisory) bioethics commissions.3

The correlate to this phenomenon is that French commissions appear
to take far longer to develop their positions, as there is no federalist system
by which local commissions can experiment with different legal approaches
to the same problem. Further, in the absence of the laboratory of state
governments, the French commissions appear to make a genuine effort to
ground their pronouncements in an appeal to universal values, often char—
acterized as philosophical precepts.4 “If it’s not scientiﬁc, it’s not ethics,”5
declared jean Bernard, former chairman of the French national bioethics
commission (the “Comité Consultatif National d'Flthique pour la Santé et
les Sciences de la Vie” or CCNE)“. And from a political viewpoint, the French
parliament viewed much of the CCNE’s work as consistent with the very
deﬁnition ofa “liberal" (in the European sense of the word) democracy:

We wanted to set the least restrictive rules of a tolerant society, each
person being free to impose upon himself or herself the strictest possible
code consonant with his or her convictions and free to forgo possibilities
offered under the law. To want to impose upon all a religious morality
that, by definition applies only to the individual, would not only be a
grave error vis—a—vis our fellow citizens, but also would seriously overstep
the authority of Parliament. We must, at any price avoid a moral order
which, imposed by some, would tell others what is good and bad.7

This attitude helped to maintain the impression that the conclusions
of this commission were somehow inevitable, rather than merely reactions
to the political and legal temperament of the times. For example, the
French view the experience of German commissions, which have been
extraordinarily strict with regard to biotechnology, as a continuing response
to the Nazi era. Spain’s unusually liberal rules on assisted reproduction are

IA PENIBLE VA LSE HESITA TION 4 79

viewed as a reaction to Franco's years of conservative rule. And, of course,
American deliberations are seen as reﬂecting, more than anything else, the
political divide created by legal abortion. In France, politicians and phi-
losophers like to think that their reﬂections are less driven by political
history and more by ethical analysis.8

This paper will brieﬂy compare the CCNE with the US. commission
appointed to examine the use of fetal tissue in federally funded research.9
As the French have had little to say on the issue of fetal tissue,10 the exami—
nation of the French commission will review its history and its reception by
French politicians, researchers, the medical community, and leading com-
mentators.ll

Overall, the most remarkable difference between the French and US.
experiences lies in the nature of the central conﬂict to be resolved by the
ethics commission. In France, the fundamental debate still appears to be
one over the control of science. Speciﬁcally, does government have the
right and the duty to limit scientific inquiry or practice in the name of
inchoate political or cultural values? In the United States this same ques-
tion is asked. But in general the research community in the United States
has long grown accustomed to political control, at least by virtue of funding
priorities. Thus, U.S. debates tend more to be about whether a particular
application of political control—for example, the ban on the use of fetal
tissue—is wise or effective. This in turn relates closely to the political
popularity of the goal of the research or moratorium, and thus makes the
American commission discussions more responsive to grass—roots political
movements.

The signiﬁcance of this observation lies in its implications for the struc-
ture and membership of future commissions. In France, where the ongo-
ing struggle is between the technical and political communities, the cred-
ibility ofa commission’s conclusions lies in their persuasiveness within the
research community. French physicians, who (unlike their American coun—
terparts) have little ﬁnancial stake in proffering novel technologies, tend
to have interests aligned with the research community, i.e., the “producers”
of new biotechnologies. It is no accident, therefore, that the new director
of the French commission is a leading French scientist, or that the com-
mission’s “public hearings” consisted of prepared statements by 17 lumi-
naries and prepared questions by a number of leading theologians and
intellectuals.12

In the United States, where the debate is somewhat less about limiting
the freedom of researchers and somewhat more about limiting the free-
dom of potential patients (service consumers) or physicians (service retail-
ers), the credibility of commissions lies in their persuasiveness within the
lay and medical communities. This in turn would seem to argue for com-
mission leadership that is political rather than technical, and for hearings

480 SOCIETY’S CHOICES

that are open to the general public. It also means that a commission’s work
will be far more subject to the vagaries of the general public’s political
sensibilities on issues such as abortion or the role of religious teachings in
public policy.

FETAL TISSUE RESEARCH: THE U.S. EXPERIENCE

Fetal research has led to a vaccine for polio, to improved treatments
for diseases of both fetus and expectant mother, and now, through trans-
plantation, to prospects for curing Parkinson’s disease andjuvenile diabe-
tes. Perhaps most important, it has helped develop basic understanding of
cell biology, particularly of cancer cells. In the words of R]. Levine, “Even
this incomplete list should serve to demonstrate the enormous value of
fetal research."‘3 And sensitivity to the potential ethical problems raised by
the use of fetal tissue prompted the creation ofa national panel of medical,
ethical, and legal experts as early as December 1986, meeting at Case
Western Reserve University in Cleveland to quietly endorse such research
as “ethically acceptable.”M

But the American experience with rew'em'ng the use of fetal tissue in
research and transplantation, while seemingly raising lofty questions of
morality, has in fact been mired in far more sticky political problems.
Indeed, the effort to ground the process in serious epidemiology discuss-
ing cause-and—effect (would permitting research increase the number of
abortions?) or philosophical concepts of responsibility (does a good use of
data derived from arguably evil procedures make the researcher and ben-
eficiary complicit in the evil act?) was drowned out by the admittedly sym-
bolic issue at hand: whether allowing anything of any value15 to emerge
from the abortion decision would destigmatize the procedure to the point
of weakening political opposition to it.16

The Uniform Anatomical Gift Act, passed by all 50 states and the Dis—
trict of Columbia between 1969 and 1973, authorizes donation of “all or
part of the body” of an aborted fetus for research or therapeutic purposes.
But individual states also can regulate or restrict fetal tissue donation, and
the 25 state laws on the subject contain vague and sometimes conﬂicting
provisions. Some of the state laws do not even define what a fetus is or what
constitutes fetal research. For example, Arizona bans the use of “any hu-
man fetus or embryo” in nontherapeutic research. California bans non-
therapeutic research upon the “product of conception,” Illinois upon a
“fetus,” Oklahoma and Pennsylvania upon the “unborn child.”17 The all-
inclusive Missouri law, by contrast, covers “the offspring of human beings
from the moment of conception until birth at every state of its biological
development, including the human conceptus, zygote, morula, blastocyst,
embryo and fetus.” Many of the laws regulating research on aborted fe—

LA PENIBLE VALSE HES] TA TION 48 I

tuses “seem designed to preclude any medical or social beneﬁts of elective
abortion,” according to reproductive rights specialist Lori Andrews.18

The ﬁrst major ﬂap at the federal level over fetal research occurred in
the 19705, when reports surfaced of experiments on live aborted fetuses.
The image was so distasteful that it helped Congress to pass the National
Research Act in 1974,19 creating the National Commission for the Protec-
tion of Human Subjects of Biomedical and Behavioral Research (National
Commission). Meanwhile, a moratorium was imposed halting all research
“on a living human fetus, before or after the induced abortion of such
fetus, unless such research is done for the purposes of assuring the survival
of such fetus." The act also set up a national commission charged with
recommending the circumstances, if any, under which the moratorium
should be lifted.

In 1975, the National Commission issued its report Research on the Fe—
tus,2° in which it outlined proposed limitations on research with dead fe-
tuses and fetal tissue. These proposals, eventually adopted and codiﬁed21
by the Department of Health, Education, and Welfare, followed the Na-
tional Commission’s unanimous proposal that “use of the dead fetus, fetal
tissue, and fetal material for research purposes be permitted, consistent
with local law, the Uniform Anatomical Gift Act and commonly held con-
victions about respect for the dead.”22

By the mid-19805, promising research in Sweden and Mexico on the
use of fetal tissue transplantation for the treatment of Parkinson’s disease
made this form of research far more visible than it had been. By the same
time, anti-abortion forces had expanded the scope of their efforts to in-
clude a number of collateral issues, including the development of new
abortifacients; use of alcohol and other drugs among pregnant women;
regulation of in vitro fertilization; and mandatory contraception for female
child abusers.23 In late 1987, consistent with its promise to reward the anti-
abortion movement for its help in two successive elections, President
Reagan, through the auspices of his White House staffer Gary Bauer, made
it clear that fetal tissue research would no longer be ﬁnanced without some
further review.

On March 22, 1988, the Reagan administration rejected a request from
the National Institutes of Health for permission to transplant fetal tissue
into the brain of a patient with severe Parkinson’s disease, and imposed a
moratorium on all research using tissue from aborted fetuses.24 The proto-
col, which had already been passed for scientiﬁc value by NIH, was held up
while NIH directorjim Wyngaarden sought guidance from assistant secre-
tary of health Robert Windom. The guidance he received consisted of a
letter from Windom, directing Wyngaarden to convene an outside advisory
panel to look at the ethics of fetal tissue transplantation, and listing speciﬁc
questions to be answered.25

482 SOCIETY’S CHOICES

That panel was appointed in 1988, and was known as the Human Fetal
Tissue Transplantation Research Panel (HFTTR). An ad hoc selection
committee deliberately chose a politically acceptable chair, Arlin Adams.
Known as a conservative opponent of abortion, Adams nonetheless took
seriously the appearance ofimpartiality ﬂowing from his position as a fed—
eral judge. A prominent physician (Kenneth Ryan), ethicist (Leroy
Walters), and abortion opponent (James Bopp) were added to the roster to
round out appearances and leadership, and an additional 17 panel mem-
bers were selected by NIH’s internal ad hoc committee.26

On September 9, 1988, during the week before the NIH panel opened
its hearing, a draft executive order from President Reagan banning all fetal
tissue research was disclosed. The order appeared to have been drafted
and circulated by White House domestic policy adviser Gary Bauer. Ac—
cording to a published news account, “Some committee members ex-
pressed dismay that the White House would draft such an order before the
NIH advisory panel had a chance to hear a word of testimony, but spokes-
man Marlin Fitzwater said the draft did not represent the official White
House position.”7 From the beginning, then, the efforts of this national
panel to provide dispassionate advice leading to a consensus on research
regulations had a bit of a farcical quality; political considerations seemed
clearly to dominate ethical concerns.

Nonethless, on September 14—16, 1988, the NIH special advisory panel
held three days of hearings on fetal tissue research. While most speakers
urged the panel to consider the scientiﬁc value and ethical acceptability of
fetal tissue research apart from controversy over abortion, the abortion
issue quickly dominated the debate. At the conclusion of the hearings, the
panel voted 19 to 0, with two abstentions, that use of tissue from legally
aborted fetuses for medical research and treatment is “acceptable.” Chair-
man Adams called that vote “tentative,” but said it meant that “we are
willing to go ahead with the use of fetal tissue in medical research if we
could take a series of steps to insure that the abortion procedure is sufﬁ-
ciently insulated from the medical research that comes afterward."28 The
vote was preliminary and unbinding, however, and the panel carefully took
no stand on the morality of abortion. Indeed, Kenneth Ryan, the NIH
panel’s scientific chairman, said the committee would try to “steer a concil-
iatory, practical approach to policy" on fetal tissue research, despite the
volatility of the abortion issue.29

A month later the NIH advisory committee met again to continue its
work on its advisory report to NIH ofﬁcials. The panel attempted, within
severe time constraints and the subject matter limitations of Windom’s
charge to the committee, to arrive at a consensus concerning the principles
and values that ought to guide fetal research. Those included (1) the
moral status of the fetus and of abortion; (2) the possibility that deriving

LA PENIBIJL‘ VALSE HESI'I‘A TION 483

good from abortion is an example of complicity in evil; (3) the possibility
that deriving good from abortion would increase the number of abortions
(i.e., the level of evil in the world); and (4) the possibility that the decision
to abort deprived a woman of the usual moral authority a parent has over
the disposition of a child’s remains.

The attack on fetal research was grounded partly on the idea of com—
plicity: “Investigators, who do not themselves perform the abortions, were
portrayed as accomplices whose work creates the impression that the ‘abor—
tion industry’ is legitimate."30 It also relied on the incorrect belief that,
contrary to evidence from countries where such research is permitted, a
woman who for moral reasons is ambivalent about having an abortion
might decide to proceed if she is reassured that some good might come of
it—for example, that a Parkinson’s-disease patient might receive therapy.
Worse, a woman might choose to get pregnant merely to produce research
material; perhaps she could sell her fetus or give it to a relative who has
diabetes. Fetal research was also denounced as being unethical because
the subject cannot give informed consent and no one appears to have the
standing to give proxy consent—surely a mother who has chosen to end
the life of her “unborn child” cannot be relied on to guard its interests.”31

Underlying all these discussions, but particularly those concerning the
moral status of the fetus, was a tension between the value of fetal life and
the value of adult life that might be helped by the use of the tissue. In
other words, the conﬂict was not one between science for the sake of
science versus the potentially immoral effects of yielding to the technologi-
cal imperative. Rather, it was a more pragmatic balancing of the benefits of
applied science for one group of people (Parkinson’s patients) against the
disadvantages to another group (fetuses and their defenders). And as
neither group of persons could claim moral primacy based on biology
alone,32 the fetuses won moral primacy based upon their symbolic value
and the political efforts of the well-organized anti-abortion movement.

In the end, therefore, despite efforts to reach a consensus by accepting
for the sake of argument the evil nature of abortion and then working
forward to whether this prohibits some good from emerging from its prac—
tice, the panel failed. Dissenting opinions were written, and the 18—?) vote
of the panel to lift the moratorium was ignored. During the subsequent
Bush administration, secretary of health and human services Louis Sullivan
rejected the panel’s report on the dubious excuse that he was not con-
vinced by the epidemiological evidence that abortion frequency would
remain unchanged should fetal tissue donation be permitted.

But the fundamental dynamic at play concerned appearances, not flne
analytical reasoning. As suggested by panel member Rabbi David Bleich,
“federal funding conveys an unintended message of moral approval for
every aspect of the research program.”3 In the end the issue here was not

484 SOCIETY’S CHOICES

primarily one of whether fetal tissue transplantation was a potentially valu-
able therapy for living adults, or whether restrictions on this research via
federal funding moratoria constituted an untoward invasion into the pur—
suit of scientiﬁc reason. Rather, the issue was one of pure politics and
appearances. To the extent that fetal tissue research offended the sensibili-
ties of abortion opponents, it could legitimately be discouraged. Efforts by
panel members such asjohn Robertson or Leroy Walters to analyze why
social legitimation of abortion does not follow from use of fetal tissue (just
as social legitimation of homicide or drunk driving does not follow from
use of cadaveric tissue) were futile because they were directed at the merits
rather than the emotional content of the social legitimation argument.

By November 1989, newspapers were reporting that the scientiﬁc com-
munity had reached an impasse with the administration and its willingness
to let political concerns over the abortion issue block promising research
and promising therapies. A sample:

Frustration has been building among medical researchers for the last
year, according to several interviewed this week. They said the seemingly
irreconcilable split over abortion has created a climate in which one bio-
ethical issue after another has become politically too hot to handle—or
even discuss.

Concern rose to a new pitch last week when the secretary of health and
human services, Louis W. Sullivan, extended a ban on research using
transplants of tissue from aborted fetuses. Sullivan ignored the advice ofa
special federal panel that had concluded that the research could help
millions of afﬂicted people and would not increase the number of abor-
tions.

“In effect, this is a suppression oflegitimate science at the federal level,"
saidjohn Fletcher, a bioethicist at the University ofVirginia. “When polit-
ical considerations dominate science, it concerns me very, very deeply."34

The failure of the federal commission to reach an reﬂective consensus
led to a series of private efforts by medical societies, whose members spe-
cialized in therapies hampered by the absence of good fetal research, to
rally public support through self-regulation of fetal tissue research. For
example, a report titled “Medical Applications of Fetal Tissue Transplants”
was issued by the American Medical Association in june 1989, calling for
the use of fetal tissue grafts. Under guidelines approved by the AMA
panel, the use of fetal tissue for transplantation was considered ethically
permissible when it is not provided for proﬁt and when the recipient is not
designated by the donor. A woman’s decision to have an abortion should
be made before any discussion of the transplantation use of the fetal tissue
is initiated, according to the report, and doctors who participate in the
abortion should not receive any beneﬁt from the transplantation of the
tissue?5

[A PENIBLE VALSE HES]TA TION 485

Another effort was led by ACOG and AFS, who created a privately
funded organization called the National Advisory Board on Ethics in Re—
production (NABER). Kenneth Ryan, a member of the NABER board and
an advocate of developing guidelines said: “Research on fetal tissue and
reproductive technologies is going on in this country and will continue
with or without Government regulation,” said Ryan. “The time is ripe for a
private group to shoulder the task of setting standards to insure that such
research is ethically and scientiﬁcally sound.” But Douglas johnson, legis-
lative director of the National Right to Life Committee, which opposes
legalized abortion, objected to the new, private board, saying: “I see this in
part as an attempt to undermine the policies that the Federal Government
has established. I also oppose it to the extent that it will be a tiny elite clique
deciding fundamental ethical issues, such as when we can treat human
beings like laboratory animals." Arthur Caplan, director of the Center for
Biomedical Ethics at the University of Minnesota, supported the privat-
ization of ethical review of fetal tissue transplantation, noting: “There is a
vacuum on public policy in these areas. We are moving by conscious
inaction. There is abortion gridlock, and in the Government there is also
just plain fear of any issue pertaining to reproduction."36

The federal government, faced with this revolt by patient-consumers
and their provider-advocates, stepped in again in the form of congressional
action, when legislation was introduced in 1992 to overturn the fetal tissue
ban as part of an overall NIH funding bill. The bill passed with substantial
majorities in both houses of Congress, prompting a wave of public adver-
tisements37 and public statements38 on both sides of the issue, directed at
President Bush and his veto power.

In june 1992, however, as expected, President Bush vetoed legislation
that would have overturned a federal ban on fetal tissue research, saying
that such work is “inconsistent with our nation’s deeply held beliefs” and
that many Americans ﬁnd it “morally repugnant.”9 Bush, who made it
clear early in the bill’s history that he would never support research that
involved using tissue obtained from elective abortions, said he found the
legislation “unacceptable to me on almost every ground: ethical, fiscal,
administrative, philosophical and legal.”40 The House immediately sched-
uled an override vote, but supporters of the legislation could not muster
the two-thirds vote needed.41 Thus the ban remained in place until its
removal by exective order upon Bill Clinton’s ascension to the White House
in january 1993.

Interestingly enough, the US. experience is not generally representa-
tive of North American experience. Canadian concerns about fetal tissue
research centered not on its effect on the frequency or morality of abor-
tion, but rather on commercialization of this and other forms of organ
donation.

486 SOCIE’I‘Y’S 0101055

The Royal Commission on New Reproductive Technologies was estab-
lished by the Canadian federal government in October 1989. Its mandate
directs it to examine medical and scientiﬁc developments around new
reproductive technologies, in particular their social, ethical, health, re-
search, legal, and economic implications, and their impact on women,
children, and society as a whole. The Commission has established a multi—
faceted Consultations program to enable it to hear the views and opinions
of people from all sectors of Canadian society. It has also set in motion a
comprehensive and multidisciplinary program of research and evaluation
to provide rigorous, credible, and timely information about, and critical
analysis of, the issues surrounding new reproductive technologies.

In response to requests from academics and policymakers for raw data
and underlying analysis, the Royal Commission began releasing copies of
its working papers to the public. The paper on fetal research, entitled
“The Use of Human Embryos and Fetal Tissues: A Research Architec-
ture,"42 examines the decades—long use of human fetal tissue by pharma—
ceutical and biotechnology companies to develop vaccines and to test the
efﬁcacy of new pharmaceutical products. It notes that it has more recently
been a critical tool in viral research on infections such as human inﬂuenza,
hepatitis B, measles, and human immunodeﬁciency virus (HIV). The pa—
per concludes that, while the scope of application for human embryo and
fetal tissue research is increasing, there is a lack of public policy to address
the social, ethical, legal, and regulatory issues their use raises.

The French Experience: The Comité Consultatif National d’Ethique

The CCNE, the ﬁrst national bioethics commission in Europe, was
created by executive decree in February of 1983. At the request ofjacques
Chirac, prime minister, the CCNE’s reflections were developed into a volu-
minous report by Guy Braibant. This study, entitled “Sciences de la vie: de
l’éthique au droit” (“Life Sciences: From Ethics to Law”), was submitted to
the government and to the public in early 1988, and listed more than 150
speciﬁc measures that could be taken by executive or parliamentary action
to bring French law into conformity with the advisory opinions of the
CCNE.43

The Braibant report is notable for its attempt to propose an enormous
number oflegal changes consistent with a few thematic conclusions of the
CCNE. These included the indivisibility of body and soul, and the result-
ing importance of bodily integrity and the noncommercialization of body
parts,44 principles endorsed by the Ministry ofjustice:

It‘s the inalienability of the body that makes it wrong both to touch my
body without my consent or to make my body the object of patrimony or
commercialization: the body is not an element that can be regarded as
the object of property rights, either of others or of one’s self.45

LA PENIBLE VA LSE HESITA '1‘10N 48 7

A later prime minister, Michel Rocard, extended this work by request-
ing that the Braibant report be transformed into discrete pieces of draft
legislation. Thus, beginning in early 1989, a drafting effort was led by
Claude Evin, health minister, and Pierre Arpaillage, minister ofjustice.
Rocard hoped to present amendments to the civil code and the public
health code by the spring of that year, in time to coincide with the bicen-
tennial celebrations. But that was not to be:

Michel Rocard's preferred schedule was ignored from the beginning, and
thus began the hesitation waltz that would last for three long years. Voic-
es quickly were raised to protest the Braibant proposals, in more or less
radical fashion and to denounce all precipitous action. . . . The need for
a bioethics law fed an intense cacophony in the government at this time.
By the end of 1989, . . . the minster of research was saying that a legislative
initiative was no longer at all desirable. Claude Evin . . . was taking the
position that the draft law project should be reduced in scope, while
Pierre Arpaillage . . . was calling for a rapid parliamentary review of the
entire text. 45

All eyes looked to Mitterrand to unblock the legislative path toward a
bioethics law. After some two years of delay he appointed the “maitre des
requétes” Noelle Lenoir to the Council ofState,47 to oversee a report by the
parliamentary ofﬁce of technology and science assessment (the Serusclat
report) and a parliamentary advisory report (the Bioulac report).

Further movement would await the efforts of deputy minister of justice
Michel Sapin, who called in September 1991 for a declaration of the “rights
of the biological being” and an embodiment in the civil code of a legally
deﬁned status for the human body. By March 1992, Sapin had persuaded the
Council of Ministers to adopt three draft law projects, which then were sent to
the National Assembly, with health minister Kouchner as their proponent.48

Thus, by March 1992, the French cabinet had adopted a biomedical
code of ethics to prevent the alteration of genes, a trade in organs, surro-
gate motherhood, or the use of artiﬁcial insemination except for women
who are sterile or whose husbands have genetic diseases.49 Based upon the
decade-long efforts of the CCNE, the code would ban manipulation of
genes except for speciﬁc therapeutic purposes, and limit the use of genetic
identiﬁcation techniques to establish a child’s parentage. It would also
outlaw payment for donated blood or organs, and keep all donors anony-
mous. It would ban the use of any part of a person’s body without prior
consent.

The French code proposal followed years of heated debate over
whether to limit innovative scientiﬁc techniques. Critics feared such inno-
vations could lead to nightmarish experiments; others argued that scien—
tiﬁc progress must not be impeded. It took eight months for the cabinet’s
adoption of the code to be accepted by the National Assembly.50 Despite

488 SOCIETY’S CHOICES

the series of commissions since the mid-1980s, each created to review the
recommendations of the purely advisory CCNE, and despite the call for
action by French president Mitterrand,51 further legislative action stalled
again in May 1993, and Senate review and action was not expected until
late 1993.52 This occurred despite Mitterrand’s enthusiastic vision of a
bioethics law that transcends political party or even national boundaries
and which would, incidentally, position France as the leader in the Euro-
pean bioethics movement: As Mitterrand stated in April 1993:

The Parliamentary debates . . . have shown that political divisions did not
affect this kind of discussion. . . . Besides, the principle of respect for
persons has universal appeal, so despite some differences in ideas or sen-
sitivities . . . it is desirable that all European countries ﬁnd their way
toward a common set of values. 53

As in the United States, some of the resistance to implementing
Mitterrand's vision lay in the politics of the abortion movement. For ex-
ample, there was the pressure of researchers ﬁghting anti-abortionists over
the issue of sanctity of research versus embryonic life, and general fear that
unforeseeable consequences of the new technologies would outstrip legis—
lative, religious, and philosophical efforts.54 The American anti-abortion
movement exported some of its most violent forms of debate to France in
the form of Operation Rescue. In its local incarnation, the movement
focused mostly on clinic services, but it did register opposition to the bio-
ethics law project as well, using the public hearings as an occasion on which
to attack the underlying law concerning abortion.55

And the National Assembly debates did feature some very forceful anti-
abortion rhetoric. For example, the appointment of member Yvette Roudy
as the chair of the assembly’s ad hoc committee to examine the law propos-
als (Bioulac was its rapporteur) drew a blistering response by conservative
member Christine Boutin, who charged that the appointment was an “open
provocation,” as Roudy was known to be a woman “leading the struggle
against the defense of the embryo, and therefore against life."56

On the other hand, another commentator characterized the proce—
dure by which the CCNE opinions became legislative proposals as one that
“does honor to French democracy." He noted that, in the beginning of the
process ten years ago, the project was universally embattled “by three con-
tradictory forces: the conservatives, for whom any law would be too liberal;
the liberals, for whom any debate risked a return to debate over abortion
law; and some researchers, for whom any law would be a potential obstacle
to pursuing biological and medical research.”57 But the sincere desire of
French politicians to sink their teeth into a signiﬁcant and sexy subject
seems to have countered those forces inherently inclined toward the status
quo:

LA PENIBLE VALSE HE’SITA TION 489

“Since becoming a member of the Parliament,” explained one politician,
“I have rarely had, other than today, the simultaneously exhilarating and
anguishing feeling of exercising a decisive responsibility with regard to
the French people, and, at the same time, to express my values in accom-
plishing the central calling of politics, by knowing how to reconcile my
ethics of personal conviction with my ethics of public responsibility.”58

And indeed the politicians did take advantage of their opportunity to
reﬂect upon the subject. The Roudy—Bioulac parliamentary report did not
slavishly follow CCNE recommendations. Instead, a number of amend—
ments were made to the proposed law project, including: protection of
ﬁnancial interests in cell lines and other products derived from tissues and
cells (although the original donation of unimproved tissue would remain
uncompensated); special procedures for the conservation of embryos for
future implantation; and creation ofa national registry to ensure accurate
transcription of each person’s wishes concerning potential organ donation
upon death. But most interesting, perhaps, are the amendments that
sought to reinforce the CCNE’s original position that reproductive tech-
nologies are to be used for “medical” purposes only.59 These amendments
concerned prenatal diagnosis:

These would be strictly limited to the prevention or treatment of “an
afﬂiction of particular gravity, and in the interest of the child to be born"
. . . [subject to] conﬁrmation by two physicians, at least one of whom is
affiliated with an authorized center; and the creation of registries permit—
ting identification of the causes for therapeutic abortions and veriﬁcation
of the accuracy of the prenatal diagnosis. . . .50

In an article reﬂecting upon the ten years of the CCNE’s work, one
commentator suggested that the fundamental dilemma posed by new repro-
ductive technologies, and indeed, most new medical technologies, was one
of competing claims to power by the medical and political communities:

Ten years after the creation of the national bioethics commission, the
following question still remains: are physicians morally obligated to satis-
fy every request for services made to them for the simple reason that the
technology exists? If they do so, they become mere retailers of services; if
they do not, they become sole judges. Therefore, it is urgent that we
create social regulations that do not depend only upon physicians’ own
conceptions, but also upon the fact that society is made of humanity.
Medicine is a human affair, treated on a case-by—case basis, but within a
framework that spells out which things are legal and which are not (e.g.,
setting a maximum limit of twelve weeks for the performance of abor-
tions).61

With the prenatal diagnosis amendments, the National Assembly rein-
forced the notion that these technologies ought to be developed within the

4 90 SOCIETY’S CHOICES

boundaries of a “superior morality” that governs the potential consumer
class. Physicians are appointed to enforce that morality by virtue of their
role as interpreters of the law. This sort of power sharing among elite
classes—the political elite and the technical elite—is one reason for the
effectiveness of the consensus development on bioethics issues that has
taken place in France since 1983. It creates a uniﬁed front against which
religious leaders, feminists, leftist and rightist radicals, or any other mar-
ginalized group must struggle.

One of France’s leading researchers,_[acques Testart, has written about
the various possible formulations for a commission reviewing genetic plan-
ning. Interestingly, he concludes that no commission will be able to resist
the power of researchers and physicians, because it is they who will give
meaning to the terms “infertility” or “grave genetic malformation.” To the
extent that any commission uses such terms in an effort to deﬁne legal and
illegal uses of genetic planning or in vitro fertilization, the law will ulti-
mately return power wholly to the hands of practitioners.62 He notes that
this is exactly what has stymied the national commission on biology and
reproductive medicine, created in 1988 to implement the CCNE advisory
opinions, and thus he is critical of almost all “regulatory” proposals to date.

But the most recent political dam was created more by the vagaries of
the legislative session than by any substantive concern over the proposed
laws themselves. Despite anti-abortion action during the National Assem-
bly debates, for example, the legislation was passed with a large majority
reﬂecting a broad coalition encompassing all but the extreme right and
left ends of the political spectrum.“ But the Senate debates were delayed
by overlapping committeejurisdictions and the failure to appoint in their
stead an ad hoc committee, the decline of Mitterrand’s socialist party in
the most recent elections, and the loss of Prime Minister Pierre Beregevoy.64

One commentator feared that any further delay in Senate action to
translate policy into law would subject France to another series of “media
coups” that awaken patient demands based on outlandish examples of
reproductive technology, such as “insemination of young virgins, preg-
nancy after menopause, or gender selection, which stir up people’s fancies
for three or four days—the time for which the media hopes to temporarily
increase its sales or audience share—and leave physicians to face the result-
ing requests for services."65 These controversial uses of reproductive tech-
nologies, in turn, could scuttle the effort of years to put into place basic law
governing the donation of tissues and cells in a manner that reduces risk of
viral transmission.66 And further delay could mean that the legislative
proposals would need to be reviewed yet again:

The role of the legislator is so sensitive that the rapidity of scientiﬁc
progress and the evolution of social mores can render obsolete a piece of
legislation that hasjust been passed."67

IA PENIBLE VALSE HESITA'I‘ION 491

The Senate adopted the CCNE proposal in january 1994 to have its
recommendations deﬁnitively made into law, the CCNE itself is hoping to
enlarge its scope of activities beyond consideration of medical research to
all aspects of medical practice. This is largely in reaction to Mitterrand’s
call for its greater involvement in the question of AIDS policy and the
CCNE's own three efforts to shape public screening proposals.68 This ex-
pansion of its role is not favored, however, by the Council of the Order of
Physicians,69 as it would theoretically enlarge the CCNE’s role to encom—
pass nearly every aspect of medical practice. But the CCNE has already
been expanding its activities even within its current advisory, executive
branch, research-oriented structure, and the pace at which it issues its
opinions has quickened since 1988. Senate passage of the legislation dis—
cussed above would authorize the CCNE by statute and its opinions legal
force subject to review each five years for their conformity with technical,
political, and philosophical developments. 0

As of May 1993, the future of the CCNE was a bit uncertain. While its
continued existence was not in doubt, its membership and mission were
subject to change. Some commentators continued to deplore the presence
of researchers on the commission, asserting that they are unable to act in a
disinterested manner, and called instead for a commission made up en—
tirely of philosophers and theologians. “The researchers propose, and
society disposes,” one commentator suggested. “Briefly, there must be
ethics for the sake of ethics.”71

Others confronted the divide between research and law even more
directly, and worried openly that the appointment of scientist Pierre
Changeux to replace philosopher jean Bernard as head of the body was
inconsistent with the very premise of a bioethics commission:

First of all, science is not beyond the reach of the law. . . . The desire to
see research placed literally outside the law has been expressed by some
scientists, first by opposing the very idea of a bioethics law, and then, this
first battle lost, by wanting to write into the preamble of the law the
principle of the development of science under the same heading and
level as the principle of respect for the person. This sentiment was partic—
ularly expressed by Pierre Changeux . . . [who says]

“Man was conceived as a moral being whose free will must distinguish
between good and evil, particularly in the face of the new scientiﬁc hori—
zons that open before him. Science, however well circumscribed by law,
must remain in second place. . . . It is man who creates science, and
chooses only its beneficial fruits; it is not science that creates man.”72

Indeed, Pierre Changeux may prove to be the beginning of a pro-
foundly different path for the CCNE. Although he, like his predecessor
jean Bernard, hopes to enlarge the scope of CCNE’s charge, Changeux is

4 92 SOCIETY’S CHOICES

cal out of hand:

Any scientist who refuses to succumb to the comfortable mental split of
the believer and who wants to remain internally consistent and to endeav-
or to reject all reference to the metaphysical must search for the natural
bases of ethics. [This is nothing more than a rediscovery of the underly-
ing premises of the French Revolution] with the considerable beneﬁts we
can procure from recent advances in neuroscience, cognitive science,
and social anthropology. The most important function of science is to
permanently chase away all irrationality in order to obtain objective knowl~
edge.74

LA PENIBLE VALSE HESITA TION 493

of reason over superstition, secularism over clericalism, and knowledge
over ignorance. Thus, the main task left to the government today is to
work out an accommodation between necessary public health regulation
and the chafed sensibilities of the research and medical communities. The
discussion between the two groups, although heavily covered in the daily
newspapers, are rather abstract and largely distant from the day-to-day
concerns of the general population.

By contrast, bioethics in the United States has devolved largely into a
debate on the autonomy of service consumers and providers. Thus it pits
government against the individual, and opens classic debates about the
degree to which moral teachings ought to be imposed upon the popula-
tion in the name of good order and morale. This in turn generates a
rights—based discussion, in which competing interests of competing groups
of persons are pragmatically weighed against one another, subject to occa—
sional limits based on principles embedded in the Constitution and the Bill
of Rights. Such a discussion, which is inherently political, is an invitation to
grass-roots politicking. Any bioethics commission created for the US.
government will have to be responsive to this political reality.

NOTES

1. “The Wearisome Hesitation Waltz.” The title “La Pénible Valse Hésitation” is taken
from an article byjean-Yves Nau in the French daily, Le Mamie.

2. “Evoquons aussi la fameuse formule attribuée au professeur jean Bernard, ‘Tout ce
qui n’est pas scientiﬁque n’est pas éthique.m Cette formule faussement rationnelle et vrai-
ment idéologique renverse 1a charge de la prévue en exigeant d‘une position éthique qu‘elle
se soumette d’abord aux reﬂes de la logique scientiﬁque. La loi bioéthique retrouve 1e
chemin interrompu de l’humanisme. L’homme y est concu comme un étre moral dont le
libre jugement doit séparer 1e bien du mal, en particulier face aux nouveaux horizons
scientiﬁques qui s‘ouvrent devant lui. La science, désormais encadrée par la loi, retrograde a
la second place, derriére le primat moral. C’est l’homme qui produit la science et en choisit
les seuls fruits positifs; ce n'est pas la science qui produit l’homme. On comprend
aujourd’hui que l’ignorance n’est pas la seule ennemie de l'homme et que la science doit se
soumettre a une morale supérieure pour demeurer son alliée. Oppenheimer devant l’atome
avait déja rencontré ce débat. Les découvertes de la biologie génétique porteuses de bénéﬁces
mais aussi de risques exceptionnels pour l’humanité conduisent aux memes dilemmes. . . .
Notre société a autant besoin de philosophes que de scientiﬁques.” Stasse, F—X, “Santé,
éthique, et argent,” Le Monde, 5 February 1993.

3. Nau,]—Y, “L’éclosion internationale de la bioéthique,” Le Monde, 20 May 1992.

4. The four principles are “1e bénévolat, la gratuité, l‘anonymat et le volontariat” (be-
nevolence, non—commercialization, anonymity, and autonomy), and are equally applicable to
reproductive technologies, AIDS screening, or organ donation. See Nau, _]-Y, “La Pénible
Valse Hésitation,” Le Monde, 19 March 1993.

5. “Tout ce qui n’est pas scientiﬁque n’est pas éthique." Stasse, F—X, “Sante’, éthique, ct
argent" Le Monde, 5 February 1993.

6. The CCNE consists of members appointed from a variety ofdisciplines. They include:
ﬁve members representing a “family of philosophical and theological thought," appointed by

494 SOCIETY’S CHOICES

the President; fifteen others appointed by virtue of their “interest and competency" in bio-
ethics, nominated in varying numbers by several minstries (health, social affairs, education
family, industry, justice, research, labor); and one member each appointed by the Prime
Minister (who may be ofa different party than the President), the President of the National
Assembly, the President of the Senate, the President of the Cours de Cassation, and the Vice-
President of the Council of State. An additional fifteen members are appointed by various
organizations within the medical and research communities. Members are to serve two year
terms, with half the membership changing every second year. Nau,‘]-Y, “Dans l’attente du
renouvellement de ses effectifs et de son president: Le Comité national d’éthique est au bord
de l’asphyxie," Le Monde, 13 May 1992.

7. “Nous avons voulu ﬁxer les regles minimales d’une société tolérante, chacun étant
libre de s‘imposer des regles plus strictes en fonction de ses convictions et de ne pas recoun’r
aux possibilités offertes par la loi. Vouloir imposer a la collectivité une morale religieuse
qui, par deﬁnition, ne s‘applique qu’a l’individu, non seulement serait une erreur vis-a~vis de
nos concitoyens, mais outrepasserait gravement le role du Parlement . . . Il faut éviter a tout
prix l'ordre moral, qui, impose par les uns, dirait aux autres ce qui est bien et ce qui est mal.

. .” Paris, 0,, “A l’Assemblée nationale: Les députés souhaitent que les textes sur la bio-
éthique soient adoptés avant la ﬁn de la legislature,” Le Monde, 23 November 1992.

8. Paris, (1., “A l‘Assemblée nationale: Les députés souhaitent que les textes sur la bio-
éthique soient adoptés avant la ﬁn de la legislature," Le Monde, 23 November 1992.

9. The IOM requested an international comparative study on fetal tissue panels. This
paper will be more an international comparison than a study of fetal tissue panels, because
no other country seems to have devoted as much time to the subject as the United States.

10. The CCNE originally endorsed a moratorium on embryo research and the use of fetal
tissue, but lifted the moratorium within a year.

11. As per request by the committee, this paper will be very brief, and will be based upon
publicly available sources only. Thus, the CCNE review will be based upon its own docu—
ments and upon a review of over 137 articles in the French newspaper Le Monde.

12. Nau, j-Y, “L'audition publique de dix-sept ‘grands témoins’: Une loi-cadre pourrait
étre proposée pour la bioéthiqlle,” Le Mamie, 27 March 1991.

13. Levine. RJ., “Fetal research: the underlying issue; Human fetal research,” Scientiﬁc
American 261 (2):1 12 (August 1989).

14. Timothy _]. McNulty, “Murky Moral Issues Surround Fetal Research,” Chicago Tn'bmie,
July 27, 1987, at Pg. 1.

15. Other than a woman‘s own satisfaction at ending her pregnancy.

16. For a more complete review of the internal squabbles of the Fetal Tissue Panel, see
Childress,].F., “Deliberations of the Human Fetal Tissue Transplantation Research Panel,” in
Institute of Medicine (K. Hanna, ed.), Biomedical Politics (National Academy Press, 1991). For
a review of congressional efforts to overturn the ban, see Vawter, D.E., “Fetal Tissue Trans—
plantation Policy in the United States," 12(1) Politics and the Life Sciences 79:85 (February
1993). President Clinton lifted the moratorium shortly after taking ofﬁce.

17. U.S. Congress, Ofﬁce of Technology Assessment, Infertility: Medical and Social Choices
(OTA—BA—358) (U.S. G.P.O.; Washington, D.C.: 1988). As of 1988, restrictions on fetal re-
search existed in 25 states. Id.

18. Don Colburn, “The Fetus, Medicine, Law, and Morality,” Washingion Post, October 18,
1988, at Health Section, Pg. 16.

19. P.L. 93-348; 88 stat. 348.

20. National Commission for the Protection of Human Subjects of Biomedical and Behav-
ioral Research, “Research on the Fetus: Report and Recommendations” (DHEW—OS—76—128)
(U.S. G.P.O., Washington, DC: 1975).

21. See 45 CFR Part 46, Subpart B.

LA PENIBLE VALSE HES/TA TION 495

22. On the other hand, the proposed regulations also provided stringent safeguards for
research on living fetuses, such as requiring that such research be done only when therapeu-
tic for the fetus or when it posed minimal risk to the fetus and the information to be gained
was compellingly important and impossible to otherwise obtain. These proposals were subse-
quently adopted as regulations. See generally 45 C.F.R. Part 46. The regulations provided for
a federal Ethics Advisory Board (EAB) that could issue waivers from that restrictive policy on
a case-by—case basis, but the EAB granted only one waiver before it was dissolved and has
never been reappointed.

23. Charo, R.A., “Mandatory Contraception in the US," The Lancet 1992; 33921104—1105
(5/2/92); Charo, R.A., “A Political History of RU-486,” in Institute of Medicine (K. Hanna,
ed.) Biomedical Politics (National Academy Press, 1991).

24. “Note that this moratorium deals only with the use of tissues and cells of dead fetuses.
The 1974 commission had considered such use to be relatively unproblematic; its central
concerns were, rather, over the possibility that a living fetus might be harmed or wronged to
serve research interests. Although the morality of abortion has always ﬁgured in the debate
over the ethical permissibility of fetal research, it is notable that those who oppose the trans-
plantation of fetal tissues seem to consider it the only issue.” Levine, RJ., “Fetal research:
the underlying issue; human fetal research,” Scientiﬁc American 261(2):112 (August 1989).

25. Letter from Robert Windom to james Wyngaarden, 22 March 1988.

26. 1988 HFI'I‘R Panel: Arlin Adams (Chair), Schnader, Harrison, Segal & Lewis, Phila-
delphia; Kenneth Ryan (Chair, Scientiﬁc Issues), Brigham and Women’s Hospital, Boston;
LeRoy Walters (Chair, Ethical and legal issues), Kennedy Institute of Ethics, Washington
D.C.; David Bleich, Cardozo Law School, New York City; james Bopp, Brames, McCormick,
Bopp 8c Abel, Terre Haute, 1N;james Burtchaell, University of Notre Dame, Notre Dame, IN;
Robert Cefalo, University of North Carolina School of Medicine, Chapel Hill;]ames Childress,
University of Virginia, Charlottesville; K. Danner Clauser, Pennsylvania State University,
Hershey; Dale Cowan, Marymount Hospital, Garﬁeld Heights, OH;]ane Delgado, National
Coalition of Hispanic and Human Services Organizations, Washington, DC; Bernadine Healy,
Cleveland Clinic Foundation, Cleveland; Dorothy Height, National Council of Negro Women,
Alexandria, VA; Barry Hoffer, University of Colorado Department of Pharmacy, Denver;
Patricia King, Georgetown University Law Center, Washington, DC; Paul Lacy, Washington
University School of Medicine, St. Louis; joseph Martin, Massachusetts General Hospital,
Boston; Aron Moscona, University of Chicago Department of Molecular Biology, Chicago;
john Robertson, University of Texas Law School, Austin; Daniel Robinson, Georgetown Uni-
versity Department of Psychology, Washington, DC; Charles Sweezey, Union Theological
Seminary, Richmond, VA.

27. Don Colburn, “The Fetus, Medicine, Law, and Morality," Washington Post, October 18,
1988, at Health Section, Pg. 16.

28. Don Colburn, “The Fetus, Medicine, Law, and Morality," Washington Post, October 18,
1988, at Health Section, Pg. 16.

29. Don Colburn, “The Fetus, Medicine, Law, and Morality,” Washington Post, October 18,
1988, at Health Section, Pg. 16. The article notes that: “The issue of fetal research has
generated a range of opinions that sometimes cut across traditional political lines. A group
called The Value of Life Committee last week called on President Reagan to ban federally
funded research using tissue from aborted fetus. Signers of the letter to Reagan included not
only anti-abortion activist Bernard Nathanson but also libertarian Village Voice columnist Nat
Hentoff and Pulitzer Prize-winning novelist Walker Percy, a physician. On the other hand,
syndicated columnistjamesj. Kilpatn'ck, whose credentials as a conservative are unimpeach-
able, endorsed fetal tissue research in a recent column because ‘I believe the living may
benefit from the dead‘ and because it ‘might permit at least the rationalization that a fetus
has not died in vain.m

4 96 SOCIETY ’s CHOICES

30. Levine, K}, “Fetal research: the underlying issue; Human fetal research,” Scientific
American 261 (2):] 12 (August 1989).

31. “Note that this moratorium deals only with the use of tissues and cells of dead fetuses.
The 1974 commission had considered such use to be relatively unproblematic; its central
concerns were, rather, over the possibility that a living fetus might be harmed or wronged to
serve research interests. Although the morality of abortion has always ﬁgured in the debate
over the ethical permissibility of fetal research, it is notable that those who oppose the trans-
plantation of fetal tissues seem to consider it the only issue."

32. That argument, i.e., that live-born persons matter more than fetuses, circled directly
back to the underlying conﬂict on abortion. Those wishing to overturn the ban tried very
hard to make arguments that were not based on rehashing the abortion debate directly.

33. Bleich, DJ., “Dissenting Statement, Fetal Tissue Research and Public Policy,” pp. 39—
43, in vol. 1 of the Report of the Fetal Tissue Transplantation Research Panel (Bethesda, MD;
DHHS 1988).

34. Richard Saltus, “Research, ethical issues stalled by abortion debate,” The Boston Globe,
November 10, 1989, Friday, City Edition, Pg. 1.

35. G. Croucher, “AMA issues fetal tissue, life support guidelines," U.P.I.]une 21, 1989,
Wednesday, BC cycle.

36. Phillip Hilts, “Groups Set Up Panel On Use of Fetal Tissue," New errk Timegjanuary 8,
1991, Tuesday, Section C; Pg. 3; Col. 1.

37. For example, the following is the text of an advertisement that ran in the May 12, 1992
edition of the congressional newspaper “Roll Call”:

Does fetal tissue research have anything to do with abortion?

Ask NARAL: The National Abortion Rights Action League (NARAL) intends to score
H.R. 2507, a bill to provide taxpayer funding of abortion—dependent fetal research, in their
annual congressional roll call scorecard.

Ask Ted Kennedy: On April 5, 1992, Ted Kennedy told a cheering pro-abortion rally
on Capitol Hill that Senate passage of H.R. 2507 proved “your message is getting through, in
a very important and signiﬁcant way. Make no doubt about it.”

Ask Laurence Tribe: Harvard Law Professor Laurence Tribe testiﬁed that medical
demand for fetal tissue gives Congress constitutional authority to pass the so-Callled “Free-
dom of Choice Act” to ensure a nationwide policy of abortion on demand.

Abortion advocates agree: H.R. 2507 has everything to do with abortion.

—— A congressional vote to fund abortion-dependent fetal tissue research would give
the abortion industry something it's never been able to achieve on its own: respect-
ability.

— Such a vote will make the abortion industry look good, but make Congress look
awfully bad. Especially when Congress can use these funds for other, equally prom-
ising, research methods that do not require an unprecedented alliance with the
abortion industry.

—— 63 percent of Americans oppose spending tax dollars for transplant research that
uses tissue from induced abortions Uanuary 1992 Wirthlin poll).

— Americans want limits to abortion on demand. So why does Congress think now is
the time to begin collaborating with the very industry that performs and proﬁts
from it?

Why should Congress give the abortion industry a good name and taxpayer dollars?

Vote No on H.R. 2507!

The Committee on Research Ethics; National Right to Life Committee; Southern Bap-
tist Christian Life Commission; Christian Coalition; Doctors for Life; American Association
of Pro-Life OB/Gyns; National Association of Pro-Life Nurses; United States Catholic Confer»
ence; American Association of Pro-Life Pediatricians; American Academy of Medical Ethics;

LA PENIBLE VALSE HESITA TION 497

Black Americans for Life; Pharmacists for Life; Catholic Women’s Institute; Christian Action
Council; Knights of Columbus; American Life League; National Conference of Catholic
Women; Ad Hoc Committee in Defense of Life; University Faculty for Life; Value of Life
Committee; Life Issues Institute; Concerned Women for America; National Association of
Evangelicals; Capitol Hill Women for Life; Women Exploited by Abortion;jewish Anti-Abor-
tion League; Women for Faith and Family; Women for Women; Fortress International; Fam-
ily Research Council; Professional Women’s Network; Traditional Values Coalition; Ameri-
can Victims of Abortion; Presbyterians for Life; Scientists for Life; Feminists for Life; Eagle
Forum; jews for Morality.

38. For example, here is the text of statement by Americanjewish Congress, May 19, 1988,
in support of HR. 2507.

“It is truly unfortunate that fetal tissue transplantation research, which holds great
promise for treating a number of devastating diseases, has become a battleﬁeld in the ongo-
ing national debate over abortion. After extensive study by a distinguished Task Force on Bio-
Ethics, AjCongress has reached the conclusion that women should be permitted to donate
fetal remains so that they may be used for research and treatment that could preserve and
extend human life.

“Opponents of such research argue that elective abortions will increase if transplanta-
tion of fetal tissue becomes successful, either because of financial incentives or because
some women will choose to abort in order to save the lives of others. The National Institutes
of Health Reauthorization, however, contains stringent safeguards that would both eliminate
any ﬁnancial incentive to encourage abortions and which would insulate a woman‘s decision
to abort from her consent to the use of fetal remains. And it is highly unlikely that even
ambivalent women would be inﬂuenced in such a difficult decision by a desire to donate the
fetal remains to an anonymous recipient.

“The current moratorium on fetal tissue transplant research wholly ignores the
suffering of millions of Americans who endure the diseases which such research could ame-
liorate. We therefore urge that the current ban on federal funding of fetal tissue transplan-
tation research be rescinded.”

39. Marlene Cimons, “Bush vetoes repeal of fetal tissue research ban,” Los Angeles Times,
June 24, 1992, Part A; Pg. 6; Col. 2.

40. Marlene Cimons, “Bush vetoes repeal of fetal tissue research ban," Los Angles Times,
june 24, 1992, Part A; Pg. 6; Col. 2.

41. When the chamber approved the bill, the vote was 260 to 148. In the Senate, 85
members voted for the legislation.

42. Copies of this publication, as well as information about the Royal Commission on New
Reproductive Technologies, are available by calling the Commission at 1-800-668—7060.

43. Nau,_]-Y, “L‘Assemblée nationale examine trois projets de loi sur la bioéthique: Les
garde-fous de la science,” Le Monde, 20 November 1992.

44. Nau,_]-Y, “L’Assemblée nationale examine trois projets de loi sur la bioéthique: Les
garde—fous de la science,” Le Monde, 20 November 1992.

45. “C’est a la fois l’indisponibilité du corps Bianco, ministre des affaires sociales et de
l‘intégration, Hubert Curien, ministre de la recherche et de la technologie, et Michel Sapin,
ministre délégué a la justice. Dans un entretien au Monde, ce dernier précise les orienta-
tions choisies par le gouvernement.

. statut du corps humain. Il devra correspondre a un certain nombre de grands
principes.

Lesquels? C‘est a la fois l’indisponibilité du corps on ne peut pas toucher 51 mon corps
sans mon consentement et la on ne peut pas toucher 23 mon corps sans mon consentement et
la non-patrimonialité ou non-commercialité: le corps n’est pas un élément qui peut faire
l’objet d’une propn'été, ni des autres ni de sci-meme.” Statement by Michel Sapin, Deputy

498 SOCIETY’S CHOICES

Minister ofjustice, in Nau,j-Y, Nouchi, F., and Michel Sapin. “Un entretien avec M. Michel
Sapin” Le Mamie, 19 December 1991.

46. “Le calendrier souhaite’ par M. Rocard ne put étre respecté et on assista au début
d‘une valse-hésitation qui devait au total durer trois longues années. Rapidement, des voix
s’élevérent pour contester, de maniere plus ou moins radicale, le travail réalisé sous l'autorité
de M. Braibant et dénoncer toute precipitation. La necessité d’une loi sur la bioéthique
alimenta a cette époque une intense cacophonie gouvernementale. Fin 1989, M. Hubert
Curien, ministre de la recherche, déclarait qu’une initiative legislative n’était nullement
souhaitable. M. Claude Evin, ministre de la santé et de la protection sociale, prenait position
en faveur d’un “tronconnage” de l’avant—projet de loi alors que M. Pierre Arpaillange,
(ministre de la justice), souhaitait une discussion rapide au Parlement du texte dans sa
globalité.” Nau,j-Y, “L’Assemblée nationale examine trois projets de loi sur la bioéthique:
Les garde-fous de la science,” Le Monde, 20 November 1992.

47. Director of appeals?

48. Nau, J-Y, “L’Assemblée nationale examine trois projets de loi sur la bioéthique: Les
garde—fous de la science," Le Mamie, 20 November 1992.

49. Reuters Library Report, “French Cabinet Adopts Bio—Ethics Code,” 25 March 1992.

50. Nau, _]—Y, “Le dixieme anniversaire du Comité national d’éthique; M. Beregovoy
souhaite que la future Assemblée adopte au plus Vite les projets de loi sur la bioéthique,” Le
Monde, 10 February 1993.

51. “Dans un entretien aujournal La Vie Francois Mitterrand souhaite l‘adoption deﬁnitive
des projets de loi sur la bioéthique" (unauthored column), Le Monde, 15 April 1993.

52. “Malgré le colloque “De l’éthique au droit," suivi du rapport Braibant, puis du rapport
Lenoir, du travail de la commission parlementaire, du travail de la commission senatoriale,
de l’adoption en premiére lecture a l‘Assemblée nationale au mois de novembre 1992 (ce, :1
une trés large majorité), le vote déﬁnitif des projets de loi relatifs a l’éthique biomédicale,
faute de la convocation d’une session extraordinaire du Parlement, n’est pas intewenu.”
Frydman, R., “Procréation médicalement assistée: De l’éthique au droit: le piége de la poli-
tjque,” Le Monde, 10 February 1993.

53. “Les débats parlementaires (. . .) ont démontré que les clivages politiques n’affectaient
pas ce type de discussion," afﬁrme—t—il. En outre, puisque “les principes de respect de la
personne humaine” ont “vocation universelle,” et malgre “des differences de conception ou
de sensibilité,” M. Mitterrand estime “souhaitable que tous les pays d’Europe se retrouvent
autour de valeurs communes.” “Dans un entretien au journal La Vie, Francois Mitterrand
souhaite l‘adoption déﬁnitive des projets de loi sur la bioéthique” (unauthored column), Le
Monde, 15 April 1993.

54. “Pourquoi une telle frilosité? Les explications sont nombreuses: poids d'un lobby qui
voit certains milieux de la recherche soutenus en l‘espece par des courants confessionnels
violemment opposés 51 ce que la loi traité du statut de l‘einbryon humain; craintes du pouvoir
devant les consequences imprévisibles que pourrait avoir une démarche legislative dans un
domaine ou les conceptions philosophiques, morales et religieuses l’emportent presque
toujours sur la logique des partis. . . .” Nau,_]—Y, “Regards sur la Legislature Bioéthique: Une
penible valse—hésimtion," Le Monde, 19 March 1993.

55. Chombeau, C., “Le retour des “croises” de l’avortement: La multiplication des actions
anti-IVG, a l’image d‘un mouvement qui se développe aux Etats—Unis, conduit le gouvem-
ement a réagir," Le Monde, 9January 1991.

56. “Mme Roudy présidera la commission spéciale sur les projets de bioéthique" (un-
signed column), Le Monde, 30 April 1992.

57. “La procedure par laquelle la loi bioéthique s’est construite fait honneur a la démo—
cratie francaise. Il faut, en effet, rappeler qu’a l’origine le projet de loi fut combattu par trois
forces contradictoires: les conservateurs, pour qui toute loi serait trop libérale; les libéraux
pour qui tout débat risquerait de voir remise en cause la loi Veil sur l'interruption volonmire

LA PENIBLE VALSE HESITA'I‘ION 499

de grossesse; certains scientifiques, pour qui toute loi constituerait un obstacle potentiel a la
poursuite de la recherche biologique et médicale.” Stasse, F—X, “Santé, éthique et argent,” Le
Monde, 5 February 1993.

58. “Depuis que je suis parlementaire, a expliqué M. Toubon, j’ai rarement eu, autant
qu’aujourd‘hui, le sentiment in la fois exaltant et angoissant d’exercer une responsabilité
déterminante a l’égard des Francais et, en meme temps, d’exprimer mes valeurs en ac-
complissant ce que la vocation du politique a d’essentiel, a savoir concilier mon éthique de
conviction avec mon éthique de responsabilité.” Paris, 0., “Le débat sur la bioéthique: Les
députés afﬁrment l’inviolabilité et l‘indisponibilité du corps humain,” Le Mamie, 23 Novem-
ber 1993.

59. To that end, for example, the law projects speciﬁed that artiﬁcial insemination by
donor was to be used only when husbands carried genes for genetic disorders resulting in
early childhood death or when husbands were sterile. Other uses, for “convenience" or by a
single woman, would be subject to legal punishment.

On the other hand, the government proceeded to declare itself in favor of private
sperm banks, despite CCNE’s opinion to the contrary. CCNE had said that private sperm
banks would not only put the non-commercialization of gamete donation at risk, but would
be harder to control in the effort to restrict use of the sperm to those with “medical” needs.
Nau,]—Y, “En contradiction avec l’avis du Comité national d’éthique: Le ministére de la santé
pourrait autoriser les laboratoires privés a créer des banques de sperme,” Le Mamie, 10 Au—
gust 1992.

60. “Celui-ci serait limité a la prevention ou au traitement d’une affection d’ ‘une
particuliere gravité dans l’intérét de l’enfant a naitre.’ L’encadrement passerait par les
dispositions suivantes: conﬁrmation du diagnostic prénaml par deux praticiens agréés dont
l’un au moins doit exercer son activité dans un centre autorisé; création de régistres per-
mettant d’établir les causes des interruptions thérapeutiques de grossesse et de verifier
l’authenticité de l’anomalie décelée par diagnostic prenatal." Nau,]—Y, “La protection du
corps humain et de l'identité génétique,“ Le Monde, 20 November 1992.

61. “Dix ans apres la création du Comité national d’éthique, la question suivante demeure:
le médecin a—t—il l’obligation morale de satisfaire toutes les demandes qui lui sont faites sous
prétexte qu’il possede la technique? S’il répond oui, i] devient prestataire de services; s’il
répond non, i] devient 1e seuljuge. 11 y a donc besoin urgent de créer des regles sociales qui
ne dependent pas que de la conception des médecins et correspondent a l’idée que la
société se fait de l’homme. La médecine est une affaire humaine traitée au cas par cas mais
dans un certain cadre qui autorise ce qui est licite et ce qui ne l’est pas (par exemple douze
semaines pour le terme maximum de 1’IVG).” Frydman, R., “Procre’ation médicalement
assistée: De l’éthique au droit: 1e piége de la politique,” Le Mamie, 10 February 1993.

62. Testart,]., “Sélectionne humaine,” Le Monde, 26 November 1992.

63. Paris, (3., “A l'Assemblée nationale: Les députés ont adopté les trois projets de loi sur
la bioéthique,” Le Monde, 26 November 1993.

64. Nau, J-Y, “Le dixieme anniversaire du Comité national d‘éthique: M. Beregovoy
souhaite que la future Assemblée adopte au plus Vite les projets de loi sur la bioéthique,” Le
Monde, 10 February 1993.

65. “La période qui s’ouvre sera interrompue comme a l’accoutume’e par decoups médi-
atiques" du genre insemination de jeunes ﬁlles vierges, grossesse apres 1a menopause, choix
du sexe, qui agiteront les esprits trois ou quatre jours, le temps pour les médias d’espérer
augmenter transitoirement leur chiffre dc vente ou leur taux d’écoute et de laisser les
médecins face a des demandes réactivées." Frydman, R., “Procréation médicalement assistée:
De l’éthique au droit: le piege de la politique,” Le Mamie, 10 February 1993.

66. The fear is not misplaced. By 20 May 1993, the next two controversies had broken—a
regional court denial of a widow’s request for the frozen embryos created with the gametes

500 SOCIETY’S CHOICES

from her late husband, and the revelation of the destruction of over thirty frozen embryos by
an IVF center. “Une legislation sur la bioéthique est devenue d’une urgente necessité”
(unauthored column), Le Maude, 20 May 1993.

67. “Le role du législateur est d’autant plus délicat que la rapidité du progres scientiﬁque
et l‘évolution des moeurs peuvent rendre obsolete une norme legislative qui vient d'étre
adoptée.” Paris, 0., “Le débat sur la bioéthique: a l’Assemblée nationale M. Kouchner: la loi
doit tracer une frontiere entre ce qui est possible et ce qui est souhaitable.” Le Maude, 21
November 1993.

68. Nau,_]-Y, “Aprés les declarations du president de la République sur la bioéthique. Le
Comité national d’éthique souhaite élargir son champ d’activité,” Le Maude, 17 April 1993.

69. This organization is roughly equivalent to the A.M.A. in the United States.

70. Nay,j-Y, “Le Pénible Valse Hésitation,” Le Maude, 19 March 1993.

71. “Au tribunal, les experts ne font pas partie du jury. On peut imaginer un comité
d‘éthique formé uniquement de représentants de la société civile et religieuse, faisant appel
aux avis parfois contradictoires d’experts médicaux. Les chercheurs proposent, la société
dispose. . . . En bref, il faut une éthique pour l‘éthique.” Dumaz, Y, “Bioéthique: Entre la
dérive et le progrés,” Le Maude, 26 November 1993.

72. “Deux principes majeurs en emergent: Tout d'abord, la science n‘est pas au—dessus de
la loi.]e me place ici sur le plan philosophique, et non sur le plan juridique. La volonté de
mettre la science littéralement hors la loi a été expn'mée par cermins scientiﬁques, d’abord
en s'opposant a l’idée meme d’une loi bioéthique, puis, Cette premiére bataille perdue, en
voulant faire inscrire dans le préambule de la loi le principe de la protection du develop-
pement de la science au meme titre et au méme rang que le principe du respect de la
personne. Cette prétention a été exprimée en particulier par M. jean-Pierre Changeux, ce
qui laisse perplexe de la part du nouveau president du Comité national d‘éthique.

L‘homme y est concu comme un étre moral dont le libre jugement doit séparer le
bien du mal, en particulier face aux nouveaux horizons scientiﬁques qui s’ouvrent devant lui.
La science, désormais encadrée par la loi, retrograde a la seconde place, derﬁére le primat
moral. C’est l’homme qui produit la science et en choisit les seuls fruits positifs; ce n’est pas
la science qui produit l’homme.” Stasse, F—X, “Santé, éthique, et argent,” Le Maude, 5 Febru-
ary 1993.

73. Nouchi, F., “Succédant au professeur jean Bernard: Le professeur Jean-Pierre
Changeux va présider le Comité national d‘éthique,” Le Maude, 3june 1992.

74. “Tout scientiﬁque qui refuse de succomber [au clivage mental comfortable] du croyant,
qui souhaite rester coherent avec lui-méme [et s’efforce de rejeter toute référence a la méta—
physique], devra tenter, dans sa réﬂexion, de rechercher les bases naturelles de l’éthique. Ce
n’est, somme toute, que réactualiser la démarche des Lumieres et de la Revolution francaise,
avec le bénéﬂce considerable que peuvent nous procurer les résultats récents des neuro-
sciences, des sciences cognitives et de l’anthropologie sociale.” [En résuméz] “La science a
pour vocation premiere de pourchasser, en permanence, l’irrationnel pour atteindre la
connaissance objective.” Nouchi, F., “Succédanl au professeur Jean Bernard: Le professeur
jean-Pierre Changeux va présider le Comité national d'éthique,” Le Maude, 3June 1992

APPENDIX

Past Commissions and
Advisory Boards

This Appendix is an expansion of the background information on
some of the past commissions and advisory boards that have served to
consider social, ethical, or legal issues related to advances in biomedicine.
These are the:

0 Ethics Advisory Board of the Department of Health, Education, and
Welfare (DHEW);

0 National Commission for the Protection of Human Subjects of Bio-
medical and Behavioral Research (National Commission);

0 President's Commission for the Study of Ethical Problems in Medi-
cine and Biomedical and Behavioral Research (President’s Commission);

0 NIH Recombinant DNA Advisory Committee;

0 Working Group on Ethical, Legal, and Social Implications of the
Human Genome Project (ELSI Working Group);

0 Biomedical Ethics Advisory Committee;

0 New York State Task Force on Life and the Law; and

0 NewJersey Bioethics Commission.

5 03

504 APPENDIX

ETHICS ADVISORY BOARD OF THE DEPARTMENT OF
HEALTH, EDUCATION, AND WELFARE (DHEW)

Dates of operation: 1978-1980

Sponsorship/ appointing authority: DHEW Secretary

Function: to consult on all DHEW programs and policies, review of
waiver submissions for proposals of fetal research potentially exceeding
existing standards of risk, and advise the DHEW Secretary regarding such
projects’ approval or disapproval

Scope: DHEW only

Membership characteristics: rotating; included attorneys, theologians,
and physicians

Members:
Chairman Maurice Lazarus
James C. Gaither,j.D. Chairman, Finance Committee
Cooley, Godward, Castro, Huddleson Federated Department Stores, Inc.
and Tatum Boston, Massachusetts

San Francisco, California

Richard A. McCormick, S.T.D.

Professor of Christian Ethics

Kennedy Institute for the Study of
Reproduction and Bioethics

Vice Chairman
David A. Hamburg, MD.
President, Carnegie Corporation of

New York . . _ Georgetown University
Member, Institute of Medicme Washington, DC.
Members
Sissela Bok, Ph.D. Robert F. Murray, MD.

Chief, Division of Medical Genetics
College of Medicine
Howard University

Lecturer in Medical Ethics
Harvard University

jack T. Conway

Senior Vice President Mitchell W. Spellman, M.D.
United Way of America Dean for Medical Services and
Washington, DC. Professor of Surgery

Harvard Medical School
Henry W. Foster, MD.

Professor and Chairman Daniel C. Tosteson MD.
Department of Obstetrics and Dean Harvard Medical School
Gynecology ’
Meharry Medical Couege Agnes N. Williams, LLB.
Donald A. Henderson, M.D. Potomac, Maryland
Dean, School of Hygiene and Public _
Health Eugene M. Zw1eback, M.D.

Surgeon in Private Practice

Iohns Hopkins University
‘ Omaha, Nebraska

Report:
Repmi and Conclusions: Support of Research Involving Human In Vitro Fertiliza—
tion and Embryo Transfer, 1979

APPENDIX 5 05

THE NATIONAL COMMISSION FOR THE PROTECTION OF
HUMAN SUBJECTS OF BIOMEDICAL AND BEHAVIORAL
RESEARCH (NATIONAL COMMISSION)

Dates of operation: 1974—1978

Sponsorship/ appointing authority: US. Congress (under National
Research Act of 1974, PL. 93-348); appointments made by the Secretary of
the Department of Health, Education, and Welfare (DHEW)

Function: to identify basic ethical principles that should underlie the
conduct of biomedical and behavioral research involving human subjects,
develop guidelines that should be followed in such research to assure that
it is conducted in accordance with such principles, and make recommen-
dations to the DHEW Secretary regarding the development of regulations

Scope: limited to research conducted or funded by the DHEW, study
topics were congressionally mandated

Membership characteristics: 5 scientists, 3 lawyers, 2 ethicists, and 1
social worker

Members:
Chairperson Karen Lebacqz, Ph.D.
Kenneth]. Ryan, MD. Associate Professor of Christian Ethics
Chief of Staff Paciﬁc School of Religion

Boston Hospital for Women

David W. Louisell,j.D.

Professor of Law

University of California, Berkeley

Members

joseph V. Brady, Ph.D.
Professor of Behavioral Biology
johns Hopkins University Donald W. Seldin, MD.
Professor and Chairman
Department of Internal Medicine

University of Texas at Dallas

Robert E. Cooke, MD.

President

Medical College of Pennsylvania
Eliot Stellar, Ph.D.

Dorothy I. Height Provost of the University

President Professor of Physiological Psychology
National Council of Negro Women, University of Pennsylvania
Inc.

Robert H. Turtle, LLB.

Albert R.jonsen, Ph.D.
Associate Professor of Bioethics
University of California, San Francisco

Patricia King,j.D.
Associate Professor of Law
Georgetown University Law Center

Attorney
VomBaur, Coburn, Simmons 8: Turtle
Washington, DC.

506 APPENDIX

Reports:

Report and Recommendations: Research on the Fetus, 1975

Appendix to Report and Recommendations: Research on the Fetus, 1975

Proceedings of the March 14—15, I 975 Meeting

The Belmont Report: Ethical Principles and Guidelines for the Protection of
Human Subjects of Research 1978

Appendix (Volumes I and II) to 7he Belmont Report: Ethical Principles and
Guidelines for the Protection of Human Subjects of Research 1978

Report and Recommendations: Research Involving Prisoners, 1976

Appendix to Report and Recommendations: Research Involving Prisoners, 1976

Report and Recommendations: Research Involving Children, 1977

Appendix to Report and Recommendations: Research Involving Children, 1977

Report and Recommendations: Psychosurgery, 1977

Appendix to Report and Recommendations: Psychosurgery, 1977

Disclosure of Research Information Under the Freedom of Information Act, 1977

Report and Recommendations: Special Study: Implications of Advances in
Biomedical and Behavioral Research, 1978

Report and Recommendations: Research Involving Those Institutionalized as
Mentally Inﬁrm, 1978

Appendix to Report and Recommendations: Research Involving Those
Institutionalized as Mentally Inﬁrm, 1978

Report and Recommendations: Institutional Review Boards, 1978

Appendix to Report and Recommendations: Institutional Review Boards, 1978

Report and Recommendations: Ethical Guidelines for Delivery of Health Services
by DHEW, 1978

Appendix to Report and Recommendations: Ethical Guidelines for Delivery of
Health Services by DHEW, 1978

APPENDIX 507

PRESIDENT’S COMMISSION FOR THE STUDY OF ETHICAL
PROBLEMS IN MEDICINE AND BIOMEDICAL AND BEHAVIORAL
RESEARCH (PRESIDENT’S COMMISSION)

Dates of Operation: january 1980—March 1983

Sponsorship/ appointing authority: U.S. Congress (under: Biomedical
Research and Training Amendments of 1978, P.L. 95-622); appointments
made by the President

Function: to advise the President and Congress on bioethical issues

Scope: report topics mandated by Congress, but commission also had
authority to undertake studies upon its own initiative

Membership characteristics: rotating; as speciﬁed by law, there were
11 active commissioners at a time, 3 of whom were active in the practice of
medicine, 3 biomedical or behavioral researchers, and 5 members from

other fields
Members:

Chairman

Morris B. Abram,j.D., L.L.D.
New York, New York

(july 1979—March 1983)

Members

H. Thomas Ballantine,]r., M.D., M.S.,
D.Sc.

Harvard Medical School

(Aug. 1982—March 1983)

George R. Dunlop, MD.
University of Massachusetts
(Feb. l982-March 1983)

Renee C. Fox, Ph.D., D.H.L.
University of Pennsylvania
(Iuly 1979—Feb. 1982)

Mario Garcia-Palmien’, MD.
University of Puerto Rico
(Iuly 1979—Aug. 1982)

Franes K Graham, Ph.D.
University of Wisconsin
(May 1980—Jan. 1982)

Bruce Kelton jacobson, MD.
Southwestern Medical School
Fort Worth, Texas

(Aug. 1982—March 1983)

Albert R. Jonsen, S.T.M., Ph.D.
University of California, San Francisco
(Iuly 1979—Aug. 1982)

Patricia A. King,].D.
Georgetown University
(Iuly 1979—May 1980)

Mathilde Krim, Ph.D.

Sloan-Kettering Institute for Cancer
Research

(Iuly 1979—Oct. 1981)

Donald N. Medearis, M.D.
Harvard University
(July 1979—Feb. 1982)

john]. Moran, B.S.
Houston, Texas
(Aug. 1982—March 1983)

Arno G. Motulsky, MD.
University of Washington
(Iuly 1979—March 1983)

Daher B. Rahi, D.O.
St. Clair Shores, Michigan
(Feb. l982—March 1983)

Fritz C. Redlich, MD.
University of California, Los Angeles
(july 1979—Feb. 1980)

508

Anne A. Scitovsky, M.A.

Palo Alto Medical Research
Foundation

(Iuly 1979—Aug. 1982)

Seymour Siegel, D.H.L.
jewish Theological Seminary
New York, New York

(Feb. 1982—March 1983)

Lynda Hare Smith, B.S.
Colorado Springs, Colorado
(March 1982—March 1983)

Kay Toma, M.D.
Bell, California
(Aug. 1982—March 1983)

Charles]. Walker, MD.
Nashville, Tennessee
(July l979—March 1983)

Carolyn A. Williams, Ph.D.

University of North Carolina, Chapel
Hill

(Sept. 1980—Aug. 1982)

Executive Director
Alexander Morgan Capron, LLB.
(Dec. 1979—March 1983)

Deputy Director
Barbara Mishkin, M.A.,_].D.
(Ian. 1980—jan. 1983)

Assistant Directors
MEDICINE

joanne Lynn, M.D., M.A.
(Ian. 1981—March 1983)

LAW
Alan Meisel,J.D.
(Aug, 1982—Dec. 1982)

APPENDIX

Alan]. Weisbard,_].D.
(Ian. 1980—Aug. 1982)

Professional Staff
ECONOMICS

Mary Ann Baily, Ph.D.
(March 1980—Feb. 1983)

ETHICS
Dan Brock, Ph.D.
(july 1981—July 1982)

Allen Buchanan, PhD.
(Ian. l982—Dec. 1982)

HEALTH POLICY
Kathryn Kelly, M.S., M.S.W.
(Oct. 1981—Dec. 1982)

Susan Morgan
(Feb. 1981—Feb. 1983)

SOCIOLOGY
Marian Osterweiss, Ph.D.
(Ian. 1981-jan. 1983)

PUBLIC HEALTH
Renie Schapiro, M.P.H.
(March 1980—Feb. 1983)

ETHICS
Daniel Wikler, Ph.D.
(Sept. 1980—Aug. 1981)

Continuing Consultants
SOCIOLOGY

Bradford H. Gray, Ph.D.
(Aug. 1981—Dec. 1982)

ETHICS
Dorothy E. Vawter
(March 1980—Feb. 1983)

APPENDIX 509

Reports:

Defining Death: A Report on the Medical, Legal, and Ethical Issues in the
Determination of Death, 1981

Protecting Human Subjects: The Adequacy and Uniformity of federal Rules and
their Implementation, 1981

Whistleblowing in Biomedical Research: Policies and Procedures for Responding to
Reports of Misconduct, 1981

Making Health Care Decisions: A Report on the Ethical and Legal Implications of
Informed Consent in the Patient—Practitioner Relationship. Volume I: Report,
1982

Making Health Care Decisions: A Report on the Ethical and Legal Implications of
Informed Consent in the Patient—Practitioner Relationship. Volume 2:
Appendices, Empirical Studies of Informed Consent, 1982

Making Health Care Decisions: A Report on the Ethical and Legal Implications of
Informed Consent in the Patient—Practitioner Relationship. Volume 3:
Appendices, Studies of the Foundations of Informed Consent, 1982

Splicing Life: A Report on the Social and Ethical Issues of Genetic Engineering
with Human Beings, 1982

Compensating for Research Injuries: The Ethical and Legal Implications for
Programs to Redress Injured Subjects, 1982

Deciding to Forego Life-Sustaining Treatment: A Report on the Ethical, IVIedical,
and Legal Issues in Treatment Decisions, 1983

Implementing Human Research Regulations: Second Biennial Report of the
Adequacy and Uniformity of Federal Rules and Policies, and of their
Implementation, for the Protection of Human Subjects, 1983

Screening and Counseling for Genetic Conditions: The Ethical, Social, and Legal
Implications of Genetic Screening, Counseling, and Education Programs, 1983

Securing Access to Health Care: The Ethical Implications of Differences in the
Availability of Health Services. Volume I: Report, 1983

Securing Access to Health Care: The Ethical Implications of Differences in the
Availability of Health Services. Volume 2: Appendices, Sociocultural and
Philosophical Studies, 1983

Securing Access to Health Care: The Ethical Implications of Differences in the
Availability of Health Services. Volume 3: Appendices, Empirical, Legal, and
Conceptual Studies, 1983

Summing Up: Final Report on Studies of the Ethical and Legal Problems in
Medicine and Biomedical and Behavioral Research, 1983

510 APPENDIX

NIH RECOMBINANT DNA ADVISORY PANEL

Dates of operation: authorized in February 1975, ongoing

Sponsorship/ appointing authority: Department of Health, Education,
and Welfare, National Institutes of Health, Ofﬁce of Recombinant DNA
Activities

Function: to provide guidance to the NIH on issues in the ﬁeld of
recombinant DNA research, review protocols for federally funded recom-
binant DNA research, and develop guidelines for the conduct of this re-
search

Scope: research conducted or supported by the NIH

Membership characteristics: size has ranged from 15 to 40 members;
today RDAC has 24 members, including lawyers, ethicists, political scien-
tists, researchers, and clinicians

Members:

Chairman

LeRoy B. Walters, Ph.D.
Kennedy Institute of Ethics
Georgetown University
Washington, DC.

Members

Constance E. Brinckerhoff, Ph.D.
Dartmouth Medical School
Hanover, New Hampshire

Nancy L. Buc, L.L.B.
Well, Gotshal, and Manges
Washington, DC.

Alexander M. Capron, L.L.B.
The Law Center

University of Southern California
Los Angeles, California

Ira H. Carmen, Ph.D.
University of Illinois
Urbana, Illinois

Gary A. Chase, Ph.D.
Thejohns Hopkins University
Baltimore, Maryland

Patricia A. DeLon, Ph.D.
University of Delaware
Newark, Delaware

Roy H. Doi, Ph.D.
University of California
Davis, California

Krishna R. Dronamraju, Ph.D.
Foundation for Genetic Research
Houston, Texas

E. Peter Geiduschek, Ph.D.
University of California, San Diego
Lajolla, California

Mariann Grossman
Institute of Human Gene Therapy
Philadelphia, Pennsylvania

Robert Haselkorn, Ph.D.
University of Chicago
Chicago, Illinois

Susan S. Hirano, Ph.D.
University of Wisconsin
Madison, Wisconsin

Donald]. Krogstad, M.D.
Tulane University School of Medicine
New Orleans, Louisiana

Abbey S. Meyers

National Organization for Rare
Disorders

New Fairﬁeld, Connecticut

APPENDIX

Dusty A. Miller, Ph.D.

Fred Hutchinson Cancer Research
Center

Seattle, Washington

Arno G. Motulsky, MD.

University of Washington Medical
School

Seattle, Washington

Robertson Parkman, M.D.
Childrens Hospital of Los Angeles
Los Angeles, California

Leonard E. Post, Ph.D.
Parke-Davis Pharmaceutical Division
Ann Arbor, Michigan

Marian G. Secundy, Ph.D.

Howard University College of
Medicine

Washington, DC.

Reports:

511

Brian R. Smith, MD.
Yale University School of Medicine
New Haven, Connecticut

Stephen E. Straus, MD.
National Institutes of Health
Bethesda, Maryland

Doris T. Zallen, Ph.D.

Virginia Polytechnic Institute and State
University

Blacksburg, Virginia

Executive Secretary

Nelson A.Wivel, M.D.

Ofﬁce of Recombinant DNA Activities
National Institutes of Health
Bethesda, Maryland

Points to Consider in the Design and Submission of Human Somatic-Cell Gene
Therapy ProtocoLs, 1985 (Human Gene Therapy Subcommittee)

512 APPENDIX

WORKING GROUP ON ETHICAL, LEGAL, AND SOCIAL
IMPLICATIONS OF THE HUMAN GENOME PROJECT
(ELSI WORKING GROUP)

Dates of operation: 1988, ongoing

Sponsorship/ appointing authority: NIH Center for Human Genome
Research and the Department of Energy

Function: to stimulate research on issues through grantmaking; to
reﬁne the research agenda through workshops, commissioned papers, and
invited lectures; to solicit public input through town meetings and public
testimony; to support the development of educational materials; to encour-
age international collaboration in this area. In terms of policy-making, the
goals of the ELSI Working Group are to clarify the ethical, legal, and social
consequences of mapping and sequencing the human genome through a
program of targeted research; to develop policy options at professional,
institutional, governmental, and societal levels to ensure that genetic infor-
mation is used to maximize the benefit to individuals and society; to im-
prove understanding of the issues and policy options through educational
initiatives at public, professional, and policy—making levels; and, to stimu-
late public discussion of the issues and policy options.

Scope: all social, legal, and ethical issues relating to the Human Ge—
nome Project

Membership characteristics: with the exception of the chairperson,
members are ad hoc technical consultants representing basic and clinical
genetics, law, and ethics

Members:

Chairperson Patricia King, j.D.
Nancy Wexler, Ph-D- Professor of Law
Hereditary Disease Foundation, and Georgetown University Law Center
Department of Neurology and Washington, DC.

Psychiatry
College of Physicians and Surgeons Victor McKusick, M.D.
Columbia University Division of Medical Genetics
New York johns Hopkins Hospital

Baltimore, Maryland

Members
Jonathan Beckwith, Ph.D. Robert F. Murray,_]r., MD.
Department of Microbiology and Department of Pediatrics

Molecular Genetics Howard University College of Medicine
Harvard Medical School Washington, DC.

Boston, Massachusetts
Thomas H. Murray, Ph.D.

Robert Cook-Deegan, M.D. Center for Biomedical Ethics
Institute of Medicine School of Medicine
National Academy of Sciences Case Western Reserve University

Washington, DC. Cleveland, Ohio

APPENDIX 513

Reports:

Workshop on the Introduction of New Genetic Tests, 1990
Genetic Discrimination and the Americans with Disabilities Act, 1991

514 APPENDIX

THE BIOMEDICAL ETHICS ADVISORY COMMITTEE (BEAC)

Dates of operation: September 1988-September 1989

Sponsorship/appointing authority: Congressional Biomedical Ethics
Board (BEB); (under Health Research Extension Act, May 1985)

Function: to study and report to Congress on a continuing basis on
ethical issues arising from health care delivery and biomedical and behav-
ioral research

Scope: mandated by BEB; first three reports mandated were on (1)
implications of human genetic engineering, (2) fetal research, and (3)
nutrition and hydration in dying patients

Membership characteristics: 14 members appointed from the ﬁelds of
law, ethics, biomedical research, and clinical care, including two lay mem-

bers; appointment process took almost two and a half years

Members:

julianne Beckett

Associate Director for Consumer
Affairs

National Maternal and Child Health
Resource Center

University of Iowa

james Bopp,]r. Esq.
Brames, McCormick, Bopp 8c Abel
Terre Haute, Indiana

Watson Allen Bowes,]r., MD.

Professor, Department of Obstetrics
and Gynecology

University of North Carolina
School of Medicine

Alexander Morgan Capron

University Professor of Law, Medicine
and Public Policy

The Law Center

University of Southern California

Christine K. Cassel, M.D., F.A.C.P.
Chief, Section of Internal Medicine
Pritzker School of Medicine
University of Chicago

james Franklin Childress, Ph.D.

Professor, Department of Religious
Studies

University of Virginia

Theodore Friedmann. M.D.

Center for Genetics

Department of Pediatrics

University of California School of
Medicine

San Diego

Ms. Sylvia Drew Ivie

Executive Director

T.H.E. Clinic for Women, Inc.
Los Angeles, California

Reverend Donald G. McCarthy, Ph.D.
Church of Saint Antoninus
Cincinnati, Ohio

Edmund D. Pellegrino, MD.
Director, Kennedy Institute of Ethics
Georgetown University

Washington, DC.

Kenneth N. Rosenbaum, M.D.

Childrens’ Hospital National Medical
Center

Washington, DC.

APPENDIX

Kennethjohn Ryan, M.D.
Brigham and Women‘s Hospital
Boston, Massachusetts

Stanley Burton Troup, MD.

Professor of Medicine, Health Care,
and Human Values

Department of Internal Medicine

University of Cincinnati College of
Medicine

* Replaced in 1988 by Don Nickles (R—OK)

515

Members of Congressional Bioethics Board
SENATE MEMBERS

Albert Gore (D-TN), Vice Chair

Dale Bumpers (D—AK)

David Durenberger (R—MN)

Gordon Humphrey (R—NH)

Edward Kennedy (D—MA)

Lowell Weiker (R—CT)*

HOUSE MEMBERS

Willis Gradison (R—OH), Chair
Thomas Bliley (R—VA)

Thomas Luken (D—OH)

J. Roy Rowland (D—GA)
Thomas Tauke (R—IA)

Henry Waxman (D-CA)

 

516 APPENDIX

NEW YORK STATE TASK FORCE ON LIFE AND THE LAW

Dates of operation: March, 1985 to present

Sponsorship/ appointing authority: New York Governor Mario Cuomo

Function: to develop recommendations for New York State public
policy (in the form of proposed legislation, regulation, public education,
and other measures) on a wide range of issues arising from recent advances
in medical technology; reports seek to inform and focus public debate

Scope: such issues as the determination of death, the withdrawal and
withholding of life—sustaining treatment, new reproductive technologies
(artificial insemination and in vitro fertilization), surrogate parenting, the
treatment of disabled newborns, organ transplantation, and, in a more
limited context, abortion

Membership characteristics: 25 members; includes prominent physi-
cians, nurses, lawyers, academics, and representatives of numerous reli-

gious communities
Members:

Karl Adler, M.D.
Dean, New York Medical College

Rev. Msgr.john A. Alesandro
Chancellor, Roman Catholic Diocese
of Rockville Centre

John Arras, Ph.D.

Clinical Associate Professor of
Bioethics

Albert Einstein College of Medicine

Monteﬁore Medical Center

Mario L. Baeza, Esq.
Debevoise 8c Plimpton

The Right Rev. David Ball
Bishop, Episcopal Diocese of Albany

Rabbi]. David Bleich

Professor of Talmud, Yeshiva
University

Professor ofjewish Law and Ethics

Benjamin Cardozo School of Law

Evan Calkins, MD.
Professor of Medicine, Emeritus
SUNY Buffalo

Richard]. Concannon, Esq.
Kelley, Drye 8c Warren

Myron W. Conovitz, M.D.

Attending Physician, North Shore
University Hospital

Clinical Associate Professor of
Medicine

Cornell University Medical College

Saul]. Farber, M.D.

Dean and Provost

Chairman, Department of Medicine

New York University School of
Medicine

Alan R. Fleishman, MD.

Director, Division of Neonatology
Albert Einstein College of Medicine
Monteﬁore Medical Center

Samuel Gorovitz, Ph.D.

Dean, College of Arts and Sciences
Professor of Philosophy

Syracuse University

APPENDIX

jane Greenlaw,_].D., R.N.

Director, Division of Medical
Humanities

University of Rochester School of
Medicine and Dentistry

Beatrix A. Hamburg, M.D.

Chairman, Division of Child and
Adolescent Psychiatry

Mount Sinai School of Medicine

Denise Hanlon, R.N., M.S.
Clinical Specialist

Rehabilitation and Gerontology
SUNY Buffalo, School of Nursing

Rev. Donald W. McKinney
First Unitarian Church of Brooklyn
Chairman Emeritus, Choice in Dying

Maria I. New, MD.

Chief, Department of Pediatrics
New York Hospital

Cornell Medical Center

Reports:

517

john]. Regan,].S.D.
Professor of Law
Hofstra University School of Law

Rabbi A. James Rudin

National Director of Interreligious
Affairs

The American Jewish Committee

Rev. Betty Bone Schiess
Episcopal Diocese of Central New York

Barbara Shack
The New York Civil Liberties Union

Rev. Robert S. Smith

Director, Institute for Medicine in
Contemporary Society

SUNY Health Science Center at Stony
Brook

Elizabeth W. Stack

Commissioner, New York State
Commission on Quality of Care for
the Mentally Retarded

The Required Request Law, March 1986

Do Not Resuscitate Orders, April 1986

The Determination of Death, july 1986

Life—Sustaining Treatments: Making Decisions and Appointing a Health Care
Agent, July 1987

Transplantation in New York State: The Procurement and Distribution of Organs
and Tissues, january 1988

Fetal Extrauterine Survivability, january 1988

Surrogate Parenting: Analysis and Recommendations for Public Policy, May 1988

When Others Must Choose: Deciding for Patients Without Capacity, March 1992

518 APPENDIX

NEW JERSEY COMMISSION ON LEGAL AND ETHICAL PROBLEMS
IN THE DELIVERY OF HEALTH CARE

Dates of operation: 1985 to 1991

Sponsorship/ appointing authority: Governor of Newjersey, New jer-
sey Senate President, and Speaker of the General Assembly

Function: to provide a comprehensive and scholarly examination of
the impact of advancing technology on health care decisions and to recom-
mend policies to the governor, legislature, and citizens of Newjersey

Scope: focused on three areas: surrogate motherhood, decision mak—
ing about medical treatment (especially advance directives), and determi-
nation of death

Membership characteristics: 26 members, including 4 legislators, 9
representatives of executive agencies and major statewide professional and
health care organizations, as well as representatives from the ﬁelds of law,
medicine, nursing, science, humanities, theology, and health care adminis-

tration
Members:

Chairman
Paul W. Armstrong, M.A.,‘].D., LL.M.
Councellor at Law

Members
Sr. jane Frances Brady
President, St. joseph’s Medical Center

Thomas P. Brown, M.A.
Acting Ombudsman for the
Institutionalized Elderly

The Hon. Gerald Cardinale, D.D.S.
Senator—District 39

Diana Czarepuszko, R.N., L.N.H.A.
Executive Director, Cheshire Home

Robert W. Deaton
Director of Long Term Care
Diocese of Camden

joseph Fennelly, M.D.
Vice Chairman, Bioethics Committee
Medical Society of Newjersey

j. Richard Goldstein, MD.
President, Stopwatch, Inc.

Noreen Haveron, R.N., B.S.N.
Assistant Nursing Supervisor
Nutley Nursing Service

Lois Hull
Director, Division of Aging

The Hon. C. Richard Kamin
Assemblyman—District 23

Rabbi Charles A. Kroloff
Rabbi, Temple Emanu-El

The Hon. David C. Kronick
Assemblyman—District 32

Paul Langevin, M.A.
Assistant Commissioner for Health
Facilities Evaluation

Mary K. Lindner, R.N., M.A.

Senior Vice President, Patient Services
and Executive Director of Nursing

Overlook Hospital

Rita Martin
Legislative Director
NJ. Citizens Concerned for Life

APPENDIX

Russell L. Mcintyre, Ph.D.

Associate Professor (Medical Ethics)

University of Medicine and Dentistry of
Newjersey

Robert Wood Johnson Medical School

Patricia Ann Murphy, RN, PhD.
Clinical Specialist (Bereavement)
Newark Beth Israel Medical Center

Michael Nevina, M.D.

Internist, Chairman, Bioethics
Committee

Pascack Valley Hospital

Sally Nunn, R.N.
Chair, Bioethics Committee
Shore Memorial Hospital

Robert L. Pickens, M.D.
Chairman, Bioethics Committee
Medical Society of Newjersey

David Rogoff, M.S.

Director, Haven Hospice
john F. Kennedy Medical Center

Reports:

519

RitaMarie G. Rondum

Member, State Legislative Committee

American Association of Retired
Persons

Mary S. Strong
Chair, Citizens' Committee on
Biomedical Ethics

joseph F. Suozzo, Esq.
Assistant Director of Litigation

Edward Tetalman, Esq.
Assistant Commissioner for
Intergovernmental Affairs

Robert S. Olick, M.A.,].D., Executive
Director

Michael Vollen, M.A., Associate
Director

Adrienne Asch, M.D., Ph.D., Associate
in Social Science and Policy

Anne Reichman Schiﬂ‘, LL.M.,
Associate in Law

Ellen B. Friedland, Esq. Consultant

Sally Sulphen, B.A., Admnistrative
Assistant

Problems and Approaches in Health Care Decision Making: The New jersey

Experience, 1990

Advance Directives for Health Care: Planning Ahead for Important Health Care

Decisions, 1991

The New jersey Advance Directives for Health Care and Death Acts: Statutes,

Commentaries, and Analyses, 1991

After Baby M: The Legal, Ethical, and Social Dimensions of Surrogacy, 1992

Death and the Brain—Damaged Patient, 1992

The New jersey Advance Directives for Health Care Act (and the Patient Self-
Determination Act): A Guidebook for Health Care Professionals, 1992

Index

A

Abortion, 47, 172
as bioethics topic, 187-188
fetal research and, 97, 98, 138, 173,
481, 482-483, 484, 496497 nn.37—
38
French debate, 488
grassroots movements, 8, 138-139
legal environment, 106, 107, 341-
342, 344
in National Commission
deliberations, 267
political conﬂicts over, 94, 353, 477-
478
women’s movement and, 50, 52
Abram, Morris 3., 246-247, 269
Academic-industry collaboration, 2, 3,
27, 39-41
beneﬁts of, 60-61
ELSI Working Group on, 441-442
Access to care, 3, 359
antipoverty programs and, 48
hospital resources and, 37
insurance trends in, 37-38, 57
new medical technology and, 38-39

President’s Commission on, 92, 93,
101, 102, 162, 266, 289
socialjustice issues in, 247-248, 350
Accountability
in health care, 35-36
in policymaking, 337
of science, 79—80
in science research, 62
Accreditation, 7, 125, 181, 412-413
ACT-UP. See AIDS Coalition to Unleash
Power
Action-forcing power
of national commissions, 91, 101,
174, 191
of supra-agency ethics commission,
21-22, 191
Adams, Arlin, 482
Advance directives, 100, 105, 163, 309,
313, 317, 318, 322, 324, 412
legal conceptualizations, 343
Advisory Committee on Human
Radiation Experiments, 33-34
African Americans, 48-49, 139-140, 141,
156
Agency for Health Care Policy and
Research, 120—121

521

522

AIDS Coalition to Unleash Power
(ACT-UP), 8, 53, 137, 138, 469,
471
AIDS/HIV, 96, 119
antidiscrimination legislation, 349,
350
conﬁdentiality in autopsy reports,
117
conﬁdentiality in research, 459—463
ethical issues in, 168, 458
ethicist—activist collaborations, 475
gay and lesbian concerns, 52-53
grassroots organizations, 137-138
hospital utilization and, 56
in minority populations, 49
new drug research, 470-472
policy conﬂicts in, 459
political context of policymaking in,
352, 458-459, 474-475
public health classiﬁcation, 336-337
research funding, 52-53, 352
research protocols, 468-472
screening for, 463-466, 491
testing pregnant women and
newborns, 467-468
tuberculosis and, 472-474
women’s issues, 51, 467—468
American Academy of Pediatrics, 7,
1 19, 41 1
American Association of Bioethics, 120
American Association of Colleges of
Nursing, 82
American College of Obstetricians and
Gynecologists, 7, 118, 120, 180,
485
American College of Physicians, 7, 119
American Council of Life Insurance,
451
American Dental Association, 82
American Fertility Society, 118, 180, 485
American Foundation for AIDS
Research, 470
American Hospital Association, 36,
411, 412
American Medical Association, 7, 69,
117-118, 120, 348,411, 419,484
American Thoracic Society, 7, 119
Americans with Disabilities Act, 348-
350, 352
ELSI and, 442, 447, 452

INDEX

Antibiotics, 15, 170
tuberculosis resistance, 472
Argentina, 110
Arizona, 480
Arkansas, 313
Armstrong, John A., 61
Arras,]ohn, 247
Artiﬁcial insemination, 499 n.59
Asilomar conference, 78, 95, 435
Assisted suicide, 36, 119, 184, 317-318,
319-320
state regulation of, 18-19
vs. refusal of treatment, 309, 315
Association of American Medical
Colleges (AAMC), 81, 83
Association of State and Territorial
Health Ofﬁcials, 464-465
Augenstein, Leroy, 69
Australia, 109, 110

B

Baby Doe issues, 102, 119, 121, 318-
319, 411
Baby M case, 100
Barnes, Barry, 394—395
Bauer, Gary, 481, 482
Bayer, Ronald, 247
Bayh-Dole Patent and Trademark Laws
Amendment Act, 59
Beckwith, jonathan, 438-439
Beecher, Henry, 32
Beneﬁcence, 91
Benthamhleremy, 206
Bernard, Claude, 30
Bernard,]ean, 491, 492
Beta-thalassemia, 140
Bioethics
academic development, 67-70
centers for study of, 8, 69, 131-133
complexity of moral decision
making in, 252
conceptual evolution, 4, 176
core issues, 358, 359
current deliberations, 73, 168
as government domain, 5-6
multidisciplinary investigations, 74-
75
as philosophic discipline, 70-73

INDEX

professional forums for
consideration of, 7—8
professional practitioners, 68, 423
in public discourse, 68, 72-73
scientists in, 5, 75-80
Biomedical Ethics Advisory Committee,
6, 437
expiration, 94, 187, 305 n.1, 454
n.1, 477
mandate, 94, 436, 454 n.1, 477
membership, 94, 454 n.1, 514—515
origins of, 436
political context, 94, 103, 187
Biomedical Ethics Board, 93-94, 172,
436
Biotechnology Industry Association,
59
Birth control pills, 51
Blackmun, Harry, 340-341
Bleich,_]. David, 324, 328, 483
Blood transfusions, 359
religious objection to, 248
Bouvia v. Supreme Count, 342, 425
Boyle, Robert, 397, 398
Breast cancer, 51
British Medical Association, 113
Brody, Baruch, 247-248
Brooklyn jewish Chronic Disease
Hospital, 32
Bush administration, 348, 352, 445,
477, 483, 485
Bypass surgery, 15, 170

C

Califano,]oseph, 94, 95
California, 313, 314, 480
Natural Death Act, 105, 313
Calvin,]ohn, 370
Canada, 110, 115, 428 n.3, 485-486
Cancer, 480
research, 63, 96
Canterbury v. Spence, 34
Capron, Alexander, 269
Cardiopulmonary resuscitation, 324—
325
Carter administration, 135, 269, 300,
306 n.4

523

Centers for Disease Control, 94
in AIDS/HIV research, 459, 460,
461, 467
Changeux, Pierre, 491—492
Civil rights movement, 4, 48
Clinical practice guidelines, 116
artificial nutrition and hydration,
121-122
problems of, 120-121
for seriously ill newborns, 121, 411
Clinton administration, 8, 27, 33-34,
58, 62, 157, 173, 353, 485
Cloning, 14-15
Closed meetings, 11-12, 156-159, 171,
299
in hospital ethics committee
deliberations, 416
Cobbs 1;. Grant, 34
Comité Consultatif National d’Ethique
pour la Santé et les Sciences de
la Vie (CCNE), 478—479, 486—493
Commercialization, 3, 440
See also Academic-industry
collaboration
Commission on the Cost of Medical
Care (1930), 263
Commissions on bioethics
bureaucratic location, 114, 299
commitment of participants in, 303-
304
complete consensus in, 242-243
composition, 256
compromise in, 161, 244-245
congressional, 6, 90-94
consensus-building in, as evaluation
criterion, 13, 160-162, 257-258
contextual assessment of, 331-332
contributions of, x, 297-299
credibility of, 479—480
decision by majority rule in, 245-246
decision-making methods, vs. moral
philosophy methods, 217-218,
223, 239
deductivism in moral reasoning of,
224-226
democratic values in, 11-12, 77, 155-
159
design as performance factor in, 299
dissemination of ﬁndings, 159—160

524

effectiveness of, 12-13, 103, 159-164,
297—299

elitist model, 112

ethical-political scope of, 217-222,
234-235

evolution of, viii-ix

explicit moral systems in, 234—235

in federal agencies, 19, 94-99

in France, 478—479, 486493

goals of, 216—217, 332

growth of mandate and
effectiveness of, 285

ideological conﬂict in, 293, 299

implementation of
recommendations, 305

institutional settings, 7

as instrument of consensus, 217

intellectual integrity in, 9-11, 77,
153-155

international comparison, 6, 107-
115, 492—493

leadership, 299

methodology, 165-166

moral reasoning in, 215

national, role of, 103, 115, 178

open vs. closed meetings, 156-159,
171, 299, 416

overlapping consensus in, 243-244

policy/ practice impact, 304-305

in policymaking, 1-2, 216—217

populist model, 110-112

potential negative outcomes of, 14,
164—167

prestige factors, 305 n.3

private model, 112-113

problems of process, 256-257

professional dominance of, 114

professional ethicists in, 222-223

in professional scientiﬁc societies, 7-
8

public access, 114

public education role, 111, 217

report-writing style, 12, 159

role of, 261

role of consensus in, 252-253

single-interest advocacy in, 14, 164-
165, 475

sponsorship, 114, 299

staff structure, 115, 302-303, 306 n.6

INDEX

state—sponsored, 6, 19, 99—100, 184-
185
supra—agency national organization,
15-16, 19—23
trade-offs in design/ activities of,
301
See also Evaluation of commissions;
Mechanisms of ethical decision
making; Membership of
commissions; speciﬁc commission
Community-based organizations, 8-9,
137, 139-141, 143—144
Compromise, 161, 232, 244—245, 258
n.4, 475
See also Consensus
Conﬁdentiality, 97
AIDS/HIV and, 458, 459-463, 464,
465, 466
American Medical Association on,
117
in genetic research, 440, 450, 451
in hospital ethics committee
deliberations, 416
in human subjects research, 123
legal basis of medical privacy, 341,
342
National Commission on, 284
President's Commission on, 92, 93,
266
supra—agency commission on, 186
Congress, U.S.
bioethics advisory boards, 6
ELSI Working Group and, 445—447
legislative authority, 345-346
Office of Technology Assessment,
130, 346-347
political functioning, 45-46
in regulation of scientific research,
33, 40, 62, 78, 90—94
supra-agency national commission
and, 189, 190
Conroy case, 99, 122
Consensus, 13, 102, 151
in AIDS/ HIV research design, 470-
471
in bioethics commissions, 252-253,
257-258
closed meetings and, 157-159
complete form, 242—243

INDEX

composition of deliberating body
and, 256
compromise and, 244—245, 258 n.4
in construction of moral belief, 202,
203, 211-212, 217, 237-238
in design of resource allocation
guidelines, 254-255
diversity of views in, 332
as evaluation criterion for bioethics
bodies, 13, 160-162, 257-258
forms of, 242
groupthink in, 256-257
investigative process as obstacle to, 77
legislative process and, 350
majority rule and, 245-246
meaning of, 241, 257
moral pluralism and, 249-251
multitiered decision-making system
for, 177-178
normative value of, 248-249
overlapping form, 237-238, 243—244
problems of, 256-257
process, 29
as role of ethics commissions, 217
in state-level forums, 184—185
strategic role of, 246-248
value of, 253-254
Consumer groups, health care, 3, 4,
36, 53-54, 136
Contraception, 50, 51, 79, 106, 156, 339
legal environment, 341, 342
private research, 138-139
Contractualist philosophy, 207, 259 n.7
Cooperative Research and
Development Agreements, 40, 59
Cost of care, 4, 56, 359
distribution of spending, 58
ethical debate and, 164
hospital ethics committees and, 426-
427
hospital management trends, 37
trends, 350
Cost-shifting, 37
Council for International
Organizations of Medical
Science, 108
Council of Europe, 108-109
Criminaljustice system, 97
genetic research in, 440

525

Cruzan 11. Director, Missouri Department of
Health, 105, 122, 343, 412
Cystic ﬁbrosis, 131, 140, 289, 435
ELSI program, 447-449

D

Dalkon Shield, 51
Dauberl v. Merrell Dow Pharmaceuticals,
76, 80, 340
Death, deﬁnition of, 79, 322
moral values in, 372, 373
President’s Commission on, 92, 93,
101, 151-152, 164, 216, 266, 286,
306 n.12
public education on, 111
state ethics commissions on, 6, 99,
100, 105, 184, 185, 322
Declaration of Helsinki, 31
Deductive reasoning, in moral justi-
ﬁcation, 223-226, 229, 231, 232
Deinstitutionalization, 343-344
Democratic process
American tradition, 4344, 335—336
in bioethics forums, 11-12, 77, 155—
159
citizen participation in health care
decisions, 143144
ethical pluralism in, 238
legislative process, 345-346
moral legitimacy in, 212
moral pluralism in, 251
policy making in, 45-46
religious activism in, 364
scientiﬁc process and, 76
Denmark, 110-112, 163
DES. See Diethylstilbestrol
Diabetes, 480
Dialysis, vii, 37, 39
Dideoxyinosine, 53
Diethylstilbestrol, 51
Dinnerstein, In re, 314, 316
Disease screening
HIV, 459, 463466, 467—468
sickle cell anemia, 49
state responsibility, 19, 184
tuberculosis, 473~474
Do not resuscitate orders, 99, 163—164,
323—325, 328-330

526

Documentation
for do not resuscitate orders, 325, 329
of hospital ethics committee

proceedings, 417, 419

Down’s Syndrome, 319, 409

Drug testing, 112

Duty to care, 426
as HIV issue, 458

E

Economic issues
abortion funding, 106, 341
academic-commercial relationships,
3
AIDS research funding, 52-53
biomedical research funding, 39-40
biomedical research spending, 58
biotechnology industry, 59
funding for bioethical
investigations, 16
government funded research, 58-59,
62
government funding of social
impact research, 97
government health insurance, 54-55
health care ﬁnancing, 2, 37-38
health care industry, 58
health care spending, 350
in hospital ethics committees, 426-
427
in life-prolonging therapy decisions,
321, 326
pharmaceutical research spending,
59—60
political contributions, 346, 347-348
research grant review process, 443
selling of fetuses for research, 483,
484
Eichner, In re, 314, 316
Elderly persons
artiﬁcial nutrition and hydration
for, 121-122
ethical dilemmas in care for, ix
health care reform and, 57-58
ELSI Working Group. See Ethical,
Legal, and Social Implications
Working Group

INDEX

Emergency medical services, 329
Energy, Department of, 97, 437
Epistemology
moral philosophy, 201-203
trust—dependency in scientiﬁc
knowledge, 392-396
in utilitarianism, 207
Equal Employment Opportunity
Commission, 352, 452
Eschatology, 362, 379
Ethical, Legal, and Social Implications
(ELSI) Working Group, ix, x, 6,
74
on Americans with Disabilities Act,
442, 447, 452, 453
budget, 437
bureaucratic status, 438, 446, 453-454
cystic ﬁbrosis screening program,
447-449
development of, 437-438
on family genetic research, 450
genetic research bioethics prior to,
434-436
grants program, 443-445, 447
on insurance issues, 450-452
membership, 97, 438-439, 442, 512
opportunities for improvement,
454
origins, 2829, 96-97, 433-434, 436-437
in policymaking, 442, 445-447, 451-
452, 453—454
in public education, 444, 453
recommendations for, 16, 179
reports, 513
on research procedure, 449, 450
research topics, 440—442
role of, 3, 97, 135, 175-176, 512
scope of deliberations, 439—440,
512
signiﬁcance of, 453
Ethics Advisory Board (EAB), 172, 454
demise of, 93, 95, 173, 305 n.1
mandate, 94, 173, 495 n.22, 504
membership, 94, 504
as model for ethics commissions,
19, 186
origins, 94
reports, 94—95, 504
European Community, 109, 113115

INDEX

Euthanasia, 18-19, 36, 184, 317-318,
319—320
ethical vs. policymaking
perspectives in, 219, 223, 224—
225, 227-228, 234-235
vs. refusal of treatment, 309
Evaluation of commissions
citations to National Commission as
criterion for, 270-274
citations to President‘s Commission
as criterion for, 270-272, 274—276
comparative, on life-prolonging
medical treatment, 307-308
consensus as criterion for, 13, 160-
162, 257-258
criteria, 9—14, 114—115, 152-153, 171-
174, 262-263
as educational mechanisms, 152
hospital ethics committees, 427—428
institutional review boards, 17—18,
125, 181-182
legal inﬂuence as criterion for, 13
methodology for, 269-270, 276-280
obstacles to, 150-152, 166, 171—173
by participants, 276-280
policy inﬂuence as criterion for,
152, 280, 304-305
Expert witnesses, 76, 80, 118, 340—341
Experts in ethics
qualiﬁcations, 10
resources of science and law in, 76-

77

F

Facts, 80
Faden, Ruth, 467, 468
Federal Coordinating Committee on
Science and Technology, 442
Federal government
absence of bioethics review in, 116-
117, 118, 168, 173
bioethics advisory bodies, 6, 94-99,
186
biomedical research funding, 58-59
executive branch in policymaking,
351-353
on fetal tissue research, 481—484,
485

527

genetic testing issues in, 175
in health care policymaking, 335—336
health insurance programs, 54-55
human research regulation, 7, 31,
32-34, 89
legislative authority, 345-346
in new medical technology
development, 38-39
political process, 45—46
recommendations for, 19, 186
in scientiﬁc research, 61-63
See also Congress, U.S.; speciﬁc agency
Federal Technology Transfer Act, 59
Feminist philosophy, 73, 79, 165
Fetal disorders, viii
Fetal protection laws, 337
Fetal tissue research, 168, 306 n.4
abortion and, 97, 98, 138, 162, 173,
481, 482—483, 484, 496497 nn.37-
38
bioethics commissions on, 481-486
Biomedical Ethics Board on, 94
in Canada, 485—486
contributions of, 480, 486
ethics issues in, 482—483
federal guidelines, 481
French bioethics commission, 479,
486—493
funding for, 481, 485
HFTTRP on, 6, 97-99, 172, 173, 191,
482-484, 495 n.26
moral arguments in, 244
National Commission on, 283
political context of policy debate,
353, 479, 480, 495 n.29
professional societies on, 484—485
state regulations, 480-481
supra-agency commission on, 186
transplantation, 97—99
Fialuridine, 124
Firth, R., 71
Fletcher, joseph, 34, 69
Florida, 315
Food and Drug Administration, 17, 40,
51, 53, 182, 468
Foundationalist beliefs, 225-226, 232,
239 n.6
Fox, Renee, 82
France, 112, 114, 478—479, 486-493

528

Freedom of Information Act, 91, 95,
266

Futility of medical care, 320—321, 327,
330

G

Gays and lesbians, 52—53, 137
HIV screening, 459—463, 464
political mobilization of, 459, 469
General Accounting Ofﬁce, 347
Genetic research, 7, 27, 130, 362
academic-industry relationships in,
40
commercialization issues, 440
conﬂict of interest in, 442
ELSI in policymaking for, 453-454
ethical dilemmas in, 3, 29, 39
evolution of ethics concerns in, 434—
437
in families, guidelines for, 450
in France, 487
government oversight, 15, 93—94
insurance issues and, 442, 450-452
marker cells, 96
multilevel impacts, 175-176
President’s Commission on, 152,
266, 289
public education, 453
religious thought on, 135
social impacts, 97
somatic cell vs. germ cell in, 435
supra-agency commission on, 186
See also Human Genome Project;
Recombinant DNA research
Genetic screening, 19, 129
community response, 139-141
for cystic ﬁbrosis, 447-449
ELSI program research topics, 440
in France, 489-490
state responsibility, 19, 184
Golding, Martin, 69
Gore, Albert, Jr., 93, 435, 436, 437
Government. See Congress, U.S.;
Federal government; Policy-
making; State governments
Grant applications
ELSI program, 443—445, 447

INDEX

ethical implications reviewed in, 16
federal ethics board for review of,
477
at National Institutes of Health, 443
reductionism in review process, 443
trends, 40
Grassroots organizations, 5, 8—9, 87, 88,
165
bioethics deliberation in, 136-139
in policymaking, 43—44, 46, 178
in state policymaking, 185
Griswold v. Connecticut, 105-106, 341
Groupthink, 256-257
Gustafson,]ames, 69

H

Harris, Patricia, 95
Hastings Center, 8, 69, 132-133, 410,
461-463, 466
Health, Education, and Welfare,
Department of, 6, 32, 33, 90, 91,
93, 94-95
Health and Human Services,
Department of, 118, 173, 341,
351, 445—446, 453-454, 477
Human Fetal Tissue Transplan-
tation Research Panel, 97-99
recommendations for, 19, 22, 186,
192
Health care agent, 325-326
Health Care Financing Agency, 175
Health care professionals
bioethicists, 68
conscientious objection to life-
prolonging therapy decisions,
328, 331
ethics training for, 18, 81-84, 182-183
with HIV, 349 n., 350
humanistic training for, 82
status of, 35, 55
training in technology vs.
caretaking, 80—81
women as, 51
Health care reform, ix
advocacy in, 14
aging population and, 57-58
American political tradition and, 45

INDEX

citizen participation in, 143—144
ethical decision making in, 8, 177-178
ethical issues in, 15, 27, 170
evaluation of process in, 353-354
insurance trends, 55

legislative effort, 350-351

lobbying in, 351

patient rights issues in, 36

state role in, 18, 185

Health care resource allocation, 7,

359
dialysis technology, vii-viii, 39
ethical dilemmas in, vii-viii, 2, 15, 30
ethical system for transplant
allocation, 254
Institute of Medicine on, 7, 128
in intensive care units, 119
in legislative process, 350
Oregon program, 141-143
participants in design of, 143
practitioner guidelines, 120
supra-agency commission on, 186

Health care system

accountability in, 35-36

Americans with Disabilities Act and,
348

consumers in, 53-55

deliberative capacity in, 177

development of hospitals in, 55-57

employment-based health coverage
in, 54

ethical issues in, 2—3, 34

ethics advisory bodies in, 7

executive branch in policymaking
for, 351-353

finance issues, 37-38

ﬁnancial structure, 58

gays and lesbians in, 52-53

judiciary in policymaking for, 339-
345

legislative processes in policymaking
for, 345-351

life-prolonging treatment decisions,
conceptual evolution of, 311-313

minorities in, 48-50

new technologies in, 35, 38—39

policymaking goals, 335

policymaking process, 335-336

reimbursement systems in, 54—55

529

self-care movement in, 136, 137
women in, 50-52, 78
See also Health care professionals;
Health care reform
Health maintenance organizations, 35,
116, 120
Healy, Bernadine, 442, 445-446
HFI‘TRP. See Human Fetal Tissue
Transplantation Research Panel
Hippocratic tradition, 30
HIV, See AIDS/HIV
Hobbes, Thomas, 203-204, 205, 210, 211
Hospital ethics committees, 3, 5, 77
administrative structure, 419
consensus-making in moral
decisions, 248
consultative process, 415—418
cost containment issues, 426—427
disagreement with decisions of, 417-
418
documentation, 417, 419
educational role, 414-415
effectiveness of, 127
evolution of, 125-126, 325, 327-328,
409-412
future of, 127
genetic testing issues, 175
guidelines for, 119
leadership, 419-420
legal liability, 425—426
in long-term care settings, 4244125
membership, 126, 420423
networks, 126—127, 423—424
performance evaluation of, 427—428
prevalence, 413
professional ethicists in, 422—423
recommendations for, 17, 180—181
role of, 7, 126—127, 181, 411, 413418
standard of care issues, 426
Hospitals, 178
ﬁnancial management in, 37
in life-prolonging treatment
decisions, 308, 311
spending in, 58
trends, 55-57
Human Fetal Tissue Transplantation
Research Panel (HFITRP), 6,
97-99, 172, 173, 191, 482-484,
495 n.26

530

Human Genome Project, ix, 3, 6, 28-
29, 39, 63, 74, 168, 351-352
budget, 432
goals, 433
origins of, 432
signiﬁcance of, 432-433
See also Ethical, Legal, and Social
Implications Working Group
Human research subjects, x, I, 27, 113
AIDS and, 468-470, 471
compensation/incentives for, 123,
266, 290
conﬁdentiality issues, 123
federal oversight, 90, 94, 266
historical concerns/developments,
2, 30-31, 89
informed consent for, 123
institutional review boards for, 122-
124
international bodies on, 108
minorities as, 51
National Commission on, 216, 266,
284
President's Commission on, 289, 290
regulations for protection of, 2, 31-
34,91,172,174
risk assessment, 123
subject truthfulness, 471-472
vulnerable populations, 123
women as, 51, 129
Human rights, 339
AIDS/HIV issues, 459-460, 466
antidiscrimination legislation, 348-
349
in legal health care decisions, 345
tuberculosis control and, 472—473,
474
Hume, David, 203, 205-206

Idaho, 313, 314
Ideal Observer theory, 71
Immunizations, 15, 170
Impartiality
in ethics commissions, 102, 156
as moral philosophical concept,
208—209

INDEX

in policymaking, 337
In vitro fertilization, 15, 116-117, 170,
490
government oversight, 94, 95, 173
research funding, 118
Individual interest
in American social tradition, 3—4, 43—
44
collective self-interest and, 203-205
in construction of moral belief, 202,
203
in ethical debate, 29
impartial resolution of conﬂicts in,
models of, 208-209
in moral system, 233
in natural rights formulation, 205, 206
public interest vs., viii, 213
public interest vs., in research
protocols, 470
in reproductive decisions, 105-106
in universalizability formulation of
morals, 207, 208, 213
in utilitarian philosophy, 205—207,
208, 211
Infectious disease
classiﬁcation of, as policy issue, 336-
337
state responsibility, 19, 184
tuberculosis, 472—474
Informed consent, 2, 119
conceptual development in health
care, 34—36
as HIV issue, 458
in human subject research, 31
in institutional review board
criteria, 123, 124
in Patient Bill of Rights, 36
President’s Commission on, 92, 93,
162, 266, 286—289
right to refuse treatment, 105
Institute for Society, Ethics, and Life
Sciences, 69
Institute of Medicine, 7, 261-262
bioethics deliberations in, 127—130
membership, 127-128
recommendations for, 17, 181
Institutional ethics committees. See
Hospital ethics committees

INDEX

Institutional review boards, 2, 5, 91,
178, 283
development of, 428 n.1
documentation, 124
evaluation of, 17-18, 125, 181—182
Hasting Center on, 133
limitations of, 124
origins of, 33, 122
review procedures, 123
role of, 7, 122
structure, 122-123
Insurance system, 2
antidiscrimination regulations, 352
ELS] and, 442
employers in, 54
expenditures, 58
genetic research and, 97, 450-452
HIV and, 458
Medicare and, 54—55
participation in, 54
recent developments, 37—38
risk selection, 54
trends, 55
Intellectual property rights legislation,
59
Intensive care units, 119
International Association of Bioethics,
109
International comparisons
bioethics forums, 6, 107-115
French bioethics commissions, 478-
479, 486-493
Intuitional ethics, 77-79, 211, 221-222,
239 n.6
Italian Americans, 140
IUDs, 51

J

Japan, 133

Jehovah’s Witnesses, 248, 359

Jewish people, Tay-Sachs disease risk
for, 140—141

Jewish thought, 134, 156

Johnson administration, 48

Joint Commission on Accreditation of
Health Care Organizations
(JCAHO), 36, 125, 126, 181, 411,

531

412, 413, 414, 415—416, 419, 423,
427

Jonas, Hans, 69

Jonsen, A. R., 239-240 n.7

K

Kaback, Michael, 140

Kant, Immanuel, 203, 207-208, 250,
258-259 n.5

Kennedy Institute of Ethics, 8, 69, 90,
132, 133

Koop, C. Everett, 53

Krim, Mathilde, 461

L

Leake, Chauncey, 68-69
Legal system, 5

accountability of science in, 79-80

advance directives in, 343

antidiscrimination legislation, 348-
349

care for severely impaired newborns
in, 411

cites to National Commission, 272-
273

cites to President's Commission, 274

context of ethics commissions in, 220

deﬁnition of death in, 102

in do not resuscitate guidelines, 324

documentation of hospital ethics
committee proceedings, 417

establishment of hospital ethics
committees, 412

as ethical decision-making
mechanism, 6, 104—107, 171

evaluation of ethics advisories in, 13

fetal protection laws, 337

forms of public discourse and, 76-77

in health policy formulation, 339-345

informed consent concept in, 34—35

liability of hospital ethics
committees, 425—426

life-prolonging treatment decisions,
121-122, 308, 313-316, 342

malpractice claims, 38

mental health policy in, 343, 344-345

532

in policymaking process, 337

professional organizations in, 180

regulation of biomedical research,
58-59

as regulatory mechanism, 106-107

reproductive issues in, 105-106, 341-
342

right to refuse medical treatment,
36, 105, 313-316

scientiﬁc method and, 76

scientiﬁc testimony, 76, 80, 118,
340—341

surrogate decision-making
apparatus in, 318

Levine, Carol, 470, 471
Life-sustaining procedures/

technologies, 7

allocation dilemma, vii-viii

components of moral decision
making, 376—377

concept of futility in, 320-321, 327,
330

conceptual evolution in health care,
311-313

conscientious objection to decision
making, 328, 331

current consensus, 308—309

economic justiﬁcation, 321, 326

Institute of Medicine on, 128

institutional responsibilities in
decision making, 308, 311, 315,
317, 324

legal conceptualizations, 105, 180,
313-316, 342-343

moral evaluation in decision
making, 372, 379—380

New York State Task Force on, 307,
308, 322-332

nonpersonhood issues in, 320

patient classiﬁcation systems for
decisions in, 311, 312

patient competency in decision
making, 308, 309, 313, 315-316,
322, 329-330

patient’s perspective in, 308, 312,317

for persistent vegetative state
patients, 320

practitioner guidelines, 118, 119

INDEX

President’s Commission on, 101—102,
307,308, 310-311, 313, 316-322
refusal of, euthanasia vs., 309, 314,
319
refusal of, suicide vs., 309, 314, 315,
319
right to refuse, 36, 308, 342
for seriously ill newborns, 121, 318-
319, 411
state regulation of, 18, 172, 184
supra-agency commission on, 186
surrogate decision making, 309,
313, 314, 315, 316, 318—319, 324,
325-326
withdrawal of, x, 105, 313-322, 342-
343
Living wills, 309, 314, 317, 318, 326
Lobbying, 346, 347-348
Locke,]ohn, 203, 204-205, 206, 208,
393, 397
Long—term care facilities, 424—425
Lowe, Charles U., 267-268

M

Majority rule, 245-246
Malpractice, 38, 118
hospital ethics committees and, 425-
426
Managed competition, 55, 57
Maryland, 412, 413, 425
Massachusetts, 315—316, 317
McGann v. H 67° H Music Company, 352
McKusick, Victor, 438
Mechanisms of ethical decision making
citizen participation in, 143-144
contributions of, 87-88
dimensions of, 113-115
ethics centers as, 8, 69, 131-133
formal vs. informal style, 77
goals of, 88-89
grassroots efforts in, 136-139
historical developments, 2-3
impartiality in, 29, 71
Institute of Medicine as, 129-130
legal system as, 104—107
in multitiered system, 177-178

INDEX

Ofﬁce of Technology Assessment as,
131
professional forums, 115-122
professional guidelines as, 120-122
public forums, 5
range of, 87
religious formulations in, 134-135,
371-377
role of, ix-x
scientiﬁc and legal models for, 76-77
in state government, 19, 184-185
See aLso Commissions on bioethics
Medicaid, 48, 343
Medical schools, bioethics training in,
69, 81-84, 182-183
Medicare, viii, 37, 54—55, 56, 125, 343,
424
Membership of commissions
Biomedical Ethics Advisory
Committee, 94, 454 n.1, 514—515
ELSI Working Group, 97, 438—439,
442, 512
Ethics Advisory Board, 94, 504
evaluation of national commissions
by, 276—280
hospital ethics committees, 126,
420-423
individual commitment of, 303-304
leadership, 299
National Commission, 90-91, 100-
101, 267, 505
Newjersey Commission on Legal
and Ethical Problems in the
Delivery of Health Care, 518—519
New York State Task Force on Life
and the Law, 516-517
President’s Commission, 92, 100-
101, 268, 269, 507-508
qualiﬁcations, 154
Recombinant DNA Advisory Panel,
510—511
staff functioning, 302-303
supra-agency recommendations, 21,
22, 189
terms of, as performance factor, 299
Mental health care
deinstitutionalization, 343—344
hospitals, 90
legal decisions in, 343, 344—345

533

Mental hospitals, 91
Merton, Robert, 400, 401
Mexico, 110
Mifepristone. See RU-486
Mill,]ohn Stuart, viii, 206
Minorities, 48-50, 51, 156
Missouri, 480
Mitterand, Francois, 488
Mondale, Walter, 89, 90
Moral philosophy, 27—29, 70-73
bioethical questions in, 252
in bioethics debate in France, 489-
490, 491-492
Categorical Imperative, 207, 250,
258-259 n.5
coherentist account, 232, 233
collective self-interest in, 203-204
concept of expertise in, 212
consensus in, 217
consideredjudgments in, 229-231
contractarian view, 207, 259 n.7
critical screening process for
judgments in, 229-231, 235-236
decision-making methodology of
ethics commissions vs., 217-218,
223, 239
deductivism in, 223-226, 229, 231, 232
differences of taste vs. moral
differences, 227—228
dimensions of religious belief, 359-
360, 370-371
epistemological methodologies in,
203
as epistemological subject, 201-202
expertise in, 222
foundational beliefs in, 225-226,
232, 239 n.6
generalizability of, 231, 233
goals of, 211-212, 213
good and evil in, 361-363, 379
guidance for conduct, 368-370,
373
human agency formulations in, 375-
376
in human embryo research debate,
244—245
identiﬁcation of, in ethics
commission justiﬁcations, 234-
235

534

impartial resolution of conﬂicts,
models of, 208-209

individual differences and, 375

individual moral systems,
development of, 233-234

interaction of belief factors, 377-382

interaction of loyalties in, 374—375,
376, 377-379

intuition in, 77-79, 211, 221-222,
239 n.6

justiﬁcation of actions, 376-377

methodology, 215

moral knowledge vs. factual
knowledge, 202-203, 388-389

moral way-of—life, 249-251

moral world-view, 249, 250—251

morality as consensus, 202, 211-212

natural rights formulations, 203,
204—205

notions of equality in, 208

overlapping consensus in policy-
making, 237-238, 243-244

particularism in, 226—229, 239—240 n.7

political legitimacy and, 201

priorities in, 209, 210—211

rational and reasonable behavior in,
251-252

reﬂective equilibrium in, 207—208,
232-236, 239-240 n.7

relativism in, 236-237, 384

role of, 373

self-interest as basis of, 233

situational analysis and, 372-373

sources of moral authority, 366-368

universalizability formulation, 203,
207-208, 213

utilitiarianism, 205-206, 207, 208,
210, 211, 223-224, 226, 244, 258-
259 n.5

Moreno,]onathan, 242

N

Narrative ethics, 165

National Abortion Rights Action
League, 8, 137, 138

National Academy of Sciences, 7, 77,
127, 434—435

INDEX

National Advisory Board on Ethics in
Reproduction, 7, 118-119, 180,
485
National Cancer Institute, 449
National Center for Human Genome
Research, 3, 63, 96-97, 135, 437-
438, 446
National Commission for the
Protection of Human Subjects of
Biomedical and Behavioral
Research (National Com-
mission), viii, 33, 157
accomplishments of, 70, 102, 163,
171, 172, 174, 269,297
action-forcing power, 91, 101, 174,
191
assessing effectiveness of, method
for, 269—270
bureaucratic location, 267-268, 299
citations to, 269, 270—274
consensus in, 243
evaluation by participants, 276-285,
291-293
on fetal research, 481
mandate, 90, 101, 266, 285, 505
membership, 90—91, 100-101, 265,
267, 505
origins of, 2, 6, 90, 481
on patient rights, 36
policy influence, 280-283, 294—295,
304
President’s Commission and, 100-
102, 263-265, 266-267, 294—296
products of, 91-92, 101-102, 262, 506
role of, 70, 101, 216
staff role, 302
structural factors in performance of,
103, 267—268, 269, 293, 296-297,
299
National Council of Churches, 135
National Heart Institute, 89-90
National Institutes of Health, 129, 353
bioethics advisory bodies, 6
in biomedical research funding, 38,
39, 48, 62
genome research, 437-438
grants management in, 40, 62, 443
human research guidelines, 31, 51

INDEX

National Center for Human
Genome Research, 3, 63, 96—97
National Commission and, 267-268
National Research Service Award, 189
pedigree studies workshop, 450
Recombinant DNA Advisory
Committee, 95-96
recommendations for, 16, 17, 179,
182
in vitro fertilization research, 94
National Organization for Women, 50
National Research Act of 1974, 33, 90,
122, 267, 481
National Research Service Award, 189
National Right to Life Committee, 8,
138-139
National Science Foundation, 58, 62
Natural rights, 203, 204—205, 206
Nazi Germany, 2
Nevada, 313, 314
Newjersey, 314, 410
Newjersey Commission on Legal and
Ethical Problems in the Delivery
of Health Care, 6, 99-100, 103,
156,157,163, 185, 518-519
New technologies, ix
bioethical deliberation in develop-
ment of, 16, 78-79, 178-179
government funded, 58—59
government oversight, 89-90
medical ethics and, 35, 38-39
socially-constructed value of, 77-78
as source of ethical dilemmas, 2, 3,
30
training of physicians in, vs.
caregiving skills training, 80—81
New York, 316, 317
New York State Society of Surgeons v.
Axelrod, 336
New York State Task Force on Life and
the Law, x, 19, 99, 157, 162, 163,
171, 172
on advance directives, 163
closed meetings of, 157, 171
on do not resuscitate orders, 323-
325, 328—330
on hospital ethics committees, 327-
328

535

on life-sustaining medical
treatment, 172, 307, 308, 322-332
mandate, 6, 99, 323, 516
on medical staff conscientious
objection, 327-328
membership, 516-517
origins, 99, 322
reports, 99, 172, 517
on surrogate decision making, 325-
331
on surrogate parenting, 162
Newton, Isaac, 398-399
Noninvasive assessment, 30-31, 57
Norplant, 156
North Carolina, 313, 314
Nufﬁeld Foundation Council on
Bioethics, 113
Nuremberg Code, 2, 31, 89
Nurses/nursing, 82, 416, 421

0

Ofﬁce of Science and Technology
Policy, 22, 192
Office of Technology Assessment
bioethics deliberations in, 7, 127,
130-131
on cystic ﬁbrosis screening, 449
in evaluation of bioethics
commissions, 171
on genetic research, 176, 435, 442
political process and, 131
recommendations for, 17, 181, 192
role of, 130, 261, 346-347
structure, 130
Oklahoma, 480
Oregon, 141-143, 185
right to refuse life—prolonging
treatment in, 313, 314
Organ transplantation, 99, 184
Outcomes research, 36
Outpatient care, 57

P

Pan American Health Organization, 109
Parkinson‘s disease, 480, 481

536

Patents and trademarks, 59, 442
Patient Bill of Rights, 36
Patient competency, 308, 309, 313,
315-316, 322, 329-330
Patient rights, 91
conceptual development, 34, 91
ethical dilemmas in, 35
hospital accreditation and, 125
hospital ethics committees and, 181
infant patient, decision making for,
318-319
proxy authority. See Surrogate
decision making
to refuse treatment, 105, 308
social movement for, 4, 34, 36
terminally ill, 94, 99
See also Informed consent
Patient Self-Determination Act, 105,
184, 343, 412, 415
Patriotism, 374
Peer review, 76, 89
in grants process, 443
Pennsylvania, 480
People with AIDS Coalition, 469
Persistent vegetative state (PVS), 314,
316, 318, 320
Personhood issues, 320
Pharmaceutical industry
AIDS treatments, 53, 138, 470—472
contraception research, 138—139
new product development, 59-60
physicians and, 119
women’s movement and, 51
Philanthropy, 37
Physicians
disagreement with hospital ethics
committee, 417-418
hospital ethics committee
consultations, 415-417
as hospital ethics committee
members, 420-421
malpractice risk management,
38
pharmaceutical industry relations,
119
training of, recommendations for,
18, 182-183
See also Health care professionals
Planned Parenthood of Southeastern

INDEX

Pennsylvania 11. Casey, 106, 341-
342

Policymaking

abortion deliberations, 187—188,
477—478

AIDS issues, 458-459, 474-475

American tradition, 43—44

bioethical philosophy in, 72-73

bioethicist—activist collaborations,
475

classiﬁcation of disease in, 336-337

diversity of views in, 332, 454

ELSI program in, 442, 445—447, 451-
452, 453-454

ethical decision making in, viii, 218-
222, 239

ethical issues as subjects of, 5-6

as evaluation criteria for bioethics
bodies, 152, 280, 304—305

evaluation of advisory reports in, 9-
14

evaluation of proposals, 338-339

executive branch in, 351-353

expert ethics advisors in, 8, 67—68

fetal tissue research in, political
context of, 479, 480

forums for ethical debate, 5

framework for, 336—339

French bioethics commissions in,
478—479, 486-493

gay and lesbian issues in, 53

genetic research in, 434—437

as goal of bioethics commissions, l-
2, 216-217

grassroots movements in, 89

in health care, 335-336

HIV screening, 463—466

human rights considerations in, 339

impartiality in, 29, 71

information-gathering for, 337—338,
347, 351

interest group lobbying in, 346, 347-
348, 351

judiciary in, 339—345

legislature’s role in, 345—351

long-term perspective in, 348

minorities in, 48-50

moral conceptualizations in, 210,
212-213

INDEX

moral philosophy in context of,
201, 210, 212—213
multilevel approach, 15-16, 174-176,
177-178
national bioethics commissions in,
115
National Commission inﬂuence,
280-283
nongovernmental participants in,
16—18, 178-183
overlapping moral consensus, 237-
238
participants in, 336
political process and, 45—46, 346, 347
President’s Commission inﬂuence,
286, 289
professional organizations in, 116
public participation in, 337
religious groups in, 44, 46—48
research funding, 62, 444-445
research grant review process and,
443, 444—445, 449
restrictions on reasons for
justiﬁcation, 237-238
right to die legislation, 343
role of consensus in, 217
role of New York State Task Force
on Life and the Law in, 323
single-interest advocacy in, 14, 156,
164—165, 475
systems of moral justiﬁcation in,
223-228
value of commission consensus in, 247
women’s movement in, 50
Power of attorney, 317, 318, 326
Preexisting conditions, 38, 54
Prenatal diagnosis, 489
Presbyterian Church, 8, 134
President‘s Commission for the Study
of Ethical Problems in Medicine
and Biomedical and Behavioral
Research (President’s
Commission), viii, ix, x, 73, 107,
157, 171
on access to care, 162
action-forcing power, 101, 191
on assisted suicide/ euthanasia, 319-
320
autonomy of, 103, 299

537

citations to, 269, 270-272, 274-276

consensus in, 246-247

context in evaluation of, 309

criticisms of, 286, 289

on deﬁning death, 101, 151-152,
164, 216, 306 n.12

effectiveness of, 174, 216—217, 269-
270, 272, 297-299

evaluation by members of, 276-280,
285-291, 293-294, 306 n.11

evaluation of, method for, 269-270

factors for success in, 293—294, 295-
296

funding 0f, 92—93

on genetic research, 152, 435—436

on hospital ethics committees, 410-
411, 417

ideological conﬂicts, 293, 300—301,
306 n.4

leadership, 268-269

on life-sustaining procedures, 307,
308, 310311, 313, 316-322

mandate, 101, 266, 310, 507

membership, 92, 100-101, 268, 269,
507—508

National Commission and, 100-102,
263-265, 266—267, 294—296

openness of, 443

origins of, 92

on patient rights, 36, 105, 162

policy inﬂuence, 286, 289, 295, 304

products of, 93, 101-102, 153, 262,
269, 509

public education efforts, 163

role of, 3, 6, 92, 101

social justice issues in, 247-248

staff functioning, 302-303, 306 n.6

structure of, 92-93, 265, 299

Prisons/prisoners, 90, 91, 209, 283, 284
Professional organizations/ societies

bioethics commissions in, 7, 115-122

ethical decision-making guidelines,
7, 82

on fetal tissue research, 484—485

international, 109

patient advocacy by, 180

public interest in, 16—17

recommendations for, 17, 179-180

in sciences, 397

538

Property rights, 205, 206
Psychosurgery, 283, 284
Public debate
fetal tissue research, 97, 98
in France vs. U.S., 492-493
national commissions in, 103
range of ethics forums, 87-89
role of courts in, 344
social context of, 143-144, 359
in state bioethics deliberations, 184
traditions of law and science in, 76-
77
Public education, 13
ELSI Working Group in, 444, 453
as evaluation criteria for bioethics
bodies, 152, 163
as goals of ethics commissions, 111,
217
national ethics commission in, 21,
1 10-1 1 1
open meetings and, 157
successful ventures, 163
Public Health Service, 32, 52, 90, 450,
453
Public interest
American tradition of, 3—4, 43-44
bioethics in, 27
biomedical research as, 58
ethics issues as, 1-2
individual interest and, viii, 203-204,
213
individual interest vs., in research
protocols, 470
professional conduct as, 16—17, 180
in utilitarian View, 206, 208, 210,
21 1
Public opinion
authority of science in, 79
in construction of moral belief, 201-
202
credibility of bioethics commissions
in, 479-480
credibility of scientists in, 389-392
ethical decision-making capability
of scientists in, 388
public participation in
policymaking and, 156
role of government in, 4445
science research in, 62-63

INDEX

in shaping policy, 4344
status of physicians in, 35, 55, 56
status of scientists in, 400—405

Q

Quinlan, Karen Ann, 6, 99, 104, 105,
171, 314-315, 342, 344, 410

R

Radiation studies, 33-34
Rahner, Karl, 69
Ramsey, Paul, 72, 372, 373, 378
Rationing of resources. See Health care
resource allocation
Rawls,john, 208, 220, 229, 232, 238,
243
Reagan administration, 53, 173, 293,
294, 299, 300, 306 n.4, 352, 353,
477, 481, 482
Recombinant DNA Advisory
Committee, 6, 95-96, 175, 289,
435, 436, 510—511
Recombinant DNA research, 59, 78
concerns in, 95, 435
government oversight, 95-96
Recombinant DNA technology, 59
Relativism, 236—237, 384
Religious communities
in bioethical discussion, 4—5, 8
bioethics deliberations in, 134—135
child abuse exemptions, 119
community relationships, 363-366
dimensions of belief, 359—360, 370-
371
hospital ethics committees and,
422
interfaith, 135
on life-prolonging therapy, 322-323,
328
patterns of participation, 382-383
in policymaking, 44, 46—48
priestly religion, 381-382
prohibitions against life-saving
medical procedures in, 248
in public discourse, 74-75
in state bioethics commissions, 99
See also Theological thought

INDEX

Reproductive rights, 50-51
HIV testing and, 467
legal decisions, 105-106
legal proceedings, 341-342
political conﬂicts over, 352-353
Reproductive technologies, ix, 90, 97,
110
bioethics debate in France, 489—490
European commissions on, 112, 113
in medical research, 489
prenatal diagnosis, 489
professional self-regulation, 118—1 19
state regulation, 18, 106, 184
Research protocols
AIDS/ HIV, 468~472
confidentiality in AIDS research,
459-463
ELSI contributions, 449, 450
fetal tissue transplantation, 97-99
germ—line cell manipulation, 96
government oversight, 6, 7, 89, 118
institutional review boards in review
of, 122-124, 182
professional self-regulation, 119
psychosocial impact assessment in,
449
recombinant DNA, 96
Risk management, 38
Risk selection, 54
Robertson,john, 484
Roe v. Wade, 105, 106, 171, 341, 342,
344, 353
Roman Catholic Church, 72, 74, 134,
409
RU-486, 52, 112, 138-139, 168, 353, 478
Ryan, Kenneth, 268, 482, 485

S

Salz v. Perlmutter, 314, 315
Sandoz Pharmaceutical Corporation, 40
Schwitalla, Alfred, 31
Scientiﬁc community
advisers to Congress, 346-347
in bioethical decision making, 5, 75-
76, 78—79, 80
credibility of, 389—392
ethical intuition in, 77-79

539

ethical sense in, 388—389
ethics advisory bodies in, 7
executive branch advisers, 351, 352
French, 479
integrity of members of, 396-398
legal accountability, 79-80
moral authority of, 403—405
policing of, 401-403
social authority of, 79-80
special insight of, 75, 78-79
virtuousness of, 398—400
Scientific method
credibility of, in public opinion,
392
as discursive model, 76—77
embedded values in, 79
ethical nature of, 75
facts in, 80
legal process and, 76
moral knowledge vs. factual
knowledge, 202-203, 388-389
in style of public discourse, 76—77
trust—dependency in, 393-396
Scripps Research Institute, 40
Self-help movements
in health care, 136, 137
women’s, 51
Shapiro, Harold, 61
Sickle cell anemia, 48, 49, 139-140, 141
Silicone breast implants, 51
Sinsheimer, Robert, 78
Situational analysis, 372-373, 376
Small Business Patent Procedure Act,
59
Smoking, 139
Social workers, 421
Society for Health and Human Values,
81
Sociology, 400
Sources of ethical dilemmas
anticipating, 168—169
cumulative effects, ix, 15, 170
in current environment, 2-3, 168
deﬁnitional issues, 27-29
evolution of, 1, 3—4, 27
Specialization in medicine, 3, 34, 35,
37, 56
Sperry, Williard, 69
Spina biﬁda, 319

540

Spring, In re, 314, 316
State governments
abortion regulation, 106, 342
bioethics advisory bodies, 6, 99—100
bioethics commissions, 99—100
constitutional authority, 346
death and dying legislation, 105,
313—316
executive branch in policymaking,
351-353

fetal tissue research regulation, 480—

481
genetic testing regulation, 175

in health care policymaking, 335—336

national commission ﬁndings and,
103, 185
political process, 45
President’s Commission inﬂuence,
272, 286
recommendations for, 18—19, 176—
177, 183-185
See also specific states
Sterilization, 118
Stevenson-Wydler Act, 59
Storar, In re, 314, 316, 317
Superintendent of Belchertown Hospital 11.
Saikewicz, 314, 315-316
Supra—agency ethics commission
action-forcing powers, 21-22, 191
advantages of, 20, 187
advisory role, 21-22, 190-191
appointment process, 21, 189-190
dissemination of ﬁndings, 190-191
duration, 20, 22, 192
educational role, 21
external advisory committee for,
23
funding and staff, 22, 191
government sponsorship, 189
interim operations, 23, 192—193
mandate, 20-21, 186-188
membership structure, 21, 22, 189
models for, 15
in multitiered system, 15-16, 174—
175
public participation, 190
recommendations for, 19-23, 186-
193
resources for, 22

INDEX

Surrogate decision making
in absence of patient guidance, 326—
327
best interest standard, 315, 324,
326, 327
documentation for, 329
health care agent for, 325-326
in home care, 329
for incompetent patients, 313, 318-
319
legal environment, 342
legal instruments in, 326
New York State Task Force, 99,
324
parents in, 315
state statutes, 313, 314, 316
substituted judgment standard, 309,
315, 316, 324, 326, 327
Surrogate parenting, 99, 100, 106, 118,
162, 342
practitioner guidelines, 120
Swine ﬂu vaccine, 306 n.8

T

Tay-Sachs disease, 140-141
Technology transfer
genetic science, 40-41
legislation, 59
university—industry collaborations
and, 61
Teel, Karen, 409-410
Terminally ill patients, 94, 99, 119, 266
artiﬁcial nutrition and hydration
guidelines, 121—122, 309, 314
do not resuscitate orders, 163-164,
323—325, 328—330
legal guidelines for treatment
decisions, 342-343
as research subjects, 124, 469-470
See also Life-sustaining procedures/
technologies
Testart, Jacques, 490
Texas, 313,314
Theological thought
basic questions in, 385 n.3
in bioethics, 73-74, 134, 383-385
concept of human loyalties in, 377-
379

INDEX

conceptualizations of deity in, 360-
361, 365, 367, 377-378, 379-380
conceptualizations of good and evil
in, 361-363, 379
in medical decision making, 371,
379-380
moral guidance in, 368-370
in moral philosophy, 72
sources of knowledge in, 366-368
Therapeutic misperception, 124
Thielicke, Helmut, 69
Toulmin, Stephen, 239-240 n.7, 243,
258 n.2
Transplantation technologies, vii, 99
allocation guidelines for, 254-255
fetal tissue research, 97—99, 162, 480,
484
heart, 89-90
organ procurement from
anencephalic infants, 119
state regulation of, 19, 184
Troeltsch, Ernst, 359, 364, 365
Tuberculosis, 459, 472-474
Tuskegee syphilis study, 2, 32-33, 48,
49, 90

U

UNESCO, 108

Uniform Anatomical Gift Act, 480, 481

Uniform Determination of Death, 151

United Kingdom, 112—113, 114

United Nations, 108

United Network on Organ Sharing,
254—255, 258

Utilitarianism (consequentialism), 205-
207, 208, 210, 211, 223-224, 226,
244, 258—259 n.5

541

Vaccines, 59

W

Walters, Leroy, 482, 484
Wanglie, Helen, 320
Warnock, Mary, 244
Warnock Committee, 114, 244—245,
258, 258 n.3
Watson,]ames, 63, 78, 433-434, 437,
438, 442, 448
Weber, Max, 359, 362
Wexler, Nancy, 438
Whistleblowing, 290
Wilkinson 11. Vesey, 34
Windom, Robert, 97
Wise, Bob, 445-446
Wolf, Susan M., 246-247
Women‘s health issues, 50-52, 79, 129
Working Group on HIV Testing of
Pregnant Women and Newborns,
467-468
Workplace
drug testing in, 112
genetic research implications, 97
genetic testing in, 440
health care insurance in, 54
World Council of Churches, 135
World Health Organization, 108
World Parliament of Religions, 135
Wyngaarden,james, 97, 438

Y
Yesley, Michael, 268

CUSLHSEEHE