Biomedical Ethics in U.S. Public Policy

June 1993

OTA-BP-BBS-105

NTIS order #PB93-203768

GPO stock #052-003-01325-8
Recommended Citation:

U.S. Congress, Office of Technology Assessment, Biomedical Efhics in U.S. Public

Policy —Background Paper, OTA-BP-BBS-1O5 (Washington, DC: U.S. Government

Printing Office, June 1993).
Foreword

ver the past two decades, a desire for mechanisms to articulate common values

and foster consensus about biomedical advances in the face of cultural and

religious heterogeneity resulted in the creation of Federal bioethics commissions. In hindsight, clearly some of these efforts have had lasting, measurable

impacts. For over a decade, though, no such initiative has been functionally operational.

Recently, however, Congress has renewed its interest in a bioethics commission—signaling, in part, the increasing importance of medical and biological technologies

in daily life. In September 1992, Senator Mark O. Hatfield, Ranking Minority, Committee

on Appropriations; Senator Edward M. Kennedy, Chairman, Committee on Labor and

Human Resources; and Senator Dennis DeConcini, Chairman, Subcommittee on Patents,

Copyrights, and Trademarks, Committee on the Judiciary, asked the Office of Technology

Assessment (OTA) to examine past, broad-based bioethics entities in the context of the

question: If Congress decides to create a new Federal bioethics body, what does past

experience reveal about which particular factors promote success and which should be

avoided?

OTA prepared Biomedical Ethics in U.S. Public Policy with the assistance of

workshop participants, contractors, and reviewers selected for their expertise and diverse

points of view. Additionally, scores of individuals cooperated with OTA staff through

interviews or by providing written material. OTA gratefully acknowledges the contribution

of each of these individuals, As with all OTA Reports, however, responsibility for the

content is OTA’s alone,

The Report reviews the history of four Federal bioethics initiatives: the National

Commission for the Protection of Human Subjects of Biomedical and Behavioral Research,

the Ethics Advisory Board, the President’s Commission for the Study of Ethical Problems

in Medicine and Biomedical and Behavioral Research, and the Biomedical Ethics Advisory

Committee. Today, as Congress considers whether to create a new Federal bioethics body,

it can be guided by considering the strengths and weaknesses of these efforts. We believe

that lessons from the past will prove instructive for the future. As the frontiers of biomedical

research and technology continue to advance, it will become increasingly important for

policymakers and the public to understand the ethical implications of such innovation.

(7’+- -

Roger C. Herdman, Director

iii
workshop Participants

David Blumenthal, Workshop Chair

Massachusetts General Hospital

Boston, MA

Adrienne Asch

Boston University School of Social Work

Boston, MA

Alexander M. Capron

University of Southern

California Law Center

Los Angeles, CA

Robert M. Cook-Deegan

Institute of Medicine

Washington, DC

Ruth R. Faden

Johns Hopkins University School of

Hygiene and Public Health

Baltimore, MD

John C. Fletcher

University of Virginia

Charlottesville, VA

Jonathan Glover

Oxford University

Oxford, United Kingdom

Patricia A. King

Georgetown University Law Center

Washington, DC

Bartha Maria Knoppers

University of Montreal Law Faculty

Montreal, Canada

Charles R. McCarthy

Kennedy Institute of Ethics

Washington, DC

Ellen H. Moskowitz

The Hastings Center

Briarcliff Manor, NY

Gail J. Povar

George Washington University

Medical Center

Washington, DC

Donald W. Seldin

University of Texas Southwestern

Medical School

Dallas, TX

David Shapiro

Nuffield Council on Bioethics

London, United Kingdom

Michael S. Yesley

Los Alamos National Laboratory

Los Alamos, NM

NOTE: OTA appreciates and is grateful for the valuable assistance provided by the workshop participants. The workshop

participants do not, however, necessarily approve, disapprove, or endorse this report. OTA assumes full responsibility for the

report and the accuracy of its contents.

iv
Robyn Y. Nishimi

Project Director

Preject Staff

Ellen L. Goode

Research Analyst

Michael Gough Linda Rayford-Journiette CONTRACTORS

Program Manager PC Specialist Kathi E. Hanna

Biological and Behavioral Sciences Churchton, MD

Jene Lewis

Cecile Parker Administrative Secretary Constance M. Pechura

Office Administrator Editor

Bethesda, MD

Daniel J. Wikler

University of Wisconsin

Madison, WI
contents

1 Introduction 1

What is Bioethics? 2

Origins and Organization of the Report 2

Chapter 1 References 5

Box

1-A The Tuskegee Syphilis Study 3

Table

1-1 Broad-Based Federal Policy Bodies in Biomedical

Ethics 4

2 Lessons From the Past 7

Federal Initiatives 7

State Entities 13

International Efforts 15

What Worked? 17

Chapter 2 References 18

Boxes

2-A Ethical, Legal, and Social Issues Programs,

National Institutes of Health and U.S. Department

of Energy 8

2-B The National Institutes of Health Human Fetal

Tissue Transplantation Research Panel 9

Table

2-1 Typology of International Bioethics

Commissions 16

3 Prospects for the Future 25

What Role Could a Commission Plan? 25

What Types of Forums Should be Considered? 28

What Elements Are Important? 31

Summation and Prospectus 38

Chapter 3 References 39

Boxes

3-A Bioethics and the National Institutes of Health

Revitalization Act of 1993 30

3-B What Might a New Effort Cost? 32

*-

~ ‘, ‘: ?’;

.

vii
A

B

c

Tables

3-1 Biomedical Research Topics That May Raise

Unresolved Ethical Issues 29

3-2 Possible Bioethical Issues for a Broad-Based

Effort 29

APPENDIXES

International Bioethics initiatives 43

Legislation, Regulations, or Statutes

for Previous U.S. Bioethics Initiatives 61

Acknowledgments 84

INDEX 89

viii
Introduction

Ethics and science need to shake hands.

Richard Clarke Cabot (1868-1939)

The Meaning of Right and Wrong

T

hough penned decades ago, today these words ring more

true than ever. Increasingly, physicians, researchers,

policymakers, and the public face numerous quandaries

brought on by advances in biology and medicine

advances the law is often ill-equipped to address. Years ago, a

physician facing a frail newborn, such as ‘Baby Doe,’ had only

to counsel the parents, perhaps call in a minister for additional

family support, and offer the limited care then available until the

child died. Now, such simplicity is nonexistent.

Scientific breakthroughs and novel medical technologies have

led society to a point where pig and baboon livers have been

transplanted into terminally ill persons (l-3), women with severe

brain damage have been kept alive mechanically to continue their

pregnancies (8), and research to help patients with Parkinson’s

disease has slowed due to a ban on federally funded protocols

that use fetal tissue from induced abortions for transplantation

(21). Even advances in medically assisted reproduction are

simultaneously considered a blessing and immoral (20).

Often these dilemmas call for tragic choices, where two

positive motivations are in conflict, such as a societal incentive

to cut costs in the final weeks of life and the individual desire to

keep a dying relative alive (19). Even when a legal imperative

1

--%.

seemingly exists, more often than not decisionmaking blurs I

because of ethical and moral considerations. That is, while courts

1
2 Biomedical Ethics in U.S. Public Policy

have issued decisions involving surrogate motherhood (e.g., the ‘‘Baby M“ case), termination of

life support (e.g., the cases of Karen AM Quinlan

and, more recently, Nancy Cruzan), and assisted

suicide (e.g., the situation with Dr. Jack Kevorkian), ethical questions still remain.

Once generally the province of philosophy and

religion, discussions about these and other highly

complex and contentious issues have entered the

political arena. During the past two decades, such

discussions have crystallized into a discipline

referred to, alternatively, as ‘‘biomedical ethics”

or ‘bioethics. ’ Today, how to set boundary rules

for policy purposes amidst a web of ethical

complexity has become extremely critical. As the

21st century approaches, Congress faces policy dilemmas for which informed decisions

require understanding bioethical considerations, as well as legal or economic dimensions.

Furthermore, situations that demand ethical

analysis are likely to arise with greater frequency and urgency.

WHAT IS BIOETHICS?

The late 1960s and early 1970s marked the

turning point in how Americans viewed medical

innovation and biomedical research (16). Human

subjects research in the United States reached its

nadir with revelations of the Tuskegee syphilis

study (box l-A) and other abuses, such as the

injection of liver cancer cells into patients at the

Jewish Chronic Disease Hospital in Brooklyn,

New York, and the intentional infection with

hepatitis of residents of the Willowbrook State

School for the Retarded (4,7,16). At about the

same time, the term bioethics was coined by V’

Rensselaer Potter, a cancer researcher in Madison, Wisconsin (15).

Originally, the word was envisioned as broadly

encompassing an examination of the ethics of all

biological science=. g., ecology and agriculture (14)-not just biomedical research, medicine, and health care. With time, however, bioethics has become synonymous with biomedical

ethics. This report uses bioethics and biomedical ethics interchangeably, excluding areas of

inquiry that others might include (e.g., environmental implications or the use of animals in

experimentation).

Bioethics evolved from the need to bring the

perceived chaos of biology and medicine into the

order of moral principle (12). Today, although

most Americans might lack knowledge of bioethics as a discipline, the issues within its domain

touch thousands each day; millions more are

acquainted with them. Through mass media

popularization, for example, few Americans are

likely to be unfamiliar with the dilemmas raised

by euthanasia or surrogate motherhood.

Bioethics is a field of study and a practice that

involves professionals of many backgrounds—

including philosophers, theologians, attorneys,

clinicians, and researchers-who have a range of

opinions; no one individual or profession can

represent the breadth of perspectives that exist.

Tens of thousands of individuals serve on Institutional Review Boards to review research involving human subjects or on institutional ethics

committees in health care settings to consider

ethical problems that arise in patient care (9).

About 20 universities now offer degrees in

bioethics (17), though the curricula vary widely

(18). The growing importance of bioethics in

society reflects both social change and the increased impact and complexity that advances in

biology and medicine have brought to American

life-advances that raise delicate policy questions.

ORIGINS AND ORGANIZATION OF

THE REPORT

The social and cultural revolutions of the 1960s

gave rise to the belief that government ought to

seek resolution of issues raised by biomedical

research and medical technology in a secular

manner, consistent with pluralism. Ethical analysis has evolved as a useful tool for the evaluation

and governance of new technologies, and

biomedical ethics has been long of interest to
Chapter I—Introduction 3

Box l-A—The Tuskegee Syphilis Study

Just over 60 years ago, the U.S. Public Health Service (PHS) and several foundations began a

study on approximately 600 African American males in Tuskegee, AL (5,6,11,13). At that time, the

Tuskegee area had the highest incidence of syphilis in the Nation, and more than 400 of these men had

this sexually transmitted disease, for which limited treatment was then available.

The men were lured into participating by the promise of free medical treatment, food, and burials.

Initially, they were treated with mercury and arsenic compounds-then standard therapy-when the

drugs were available. However, they also endured spinal taps without anesthesia and were denied

penicillin long after it became apparent in 1945 that this antibiotic was the preferred drug. In fact, to

prevent participants from receiving treatment by the US. Army, PHS also instructed draft boards not to

induct them. Under congressional scrutiny, PHS officials offered the excuse that treating the subjects

with penicillin would have arrested the disease and made following the long-term effects of syphilis

impossible (11).

In 1972-four decades after it began-front page news reports brought this notorious abuse of

human research subjects to an end (10). Elucidation of the Tuskegee syphilis study, along with other

abuses in research involving human subjects (4,7,16), marked the start of bioethics’ role in US. policy

decisionmaking.

SOURCE: Office of Technology Assessment 1993.

Congress (7,16). Federal interest in integrating . the prospect that bioethical issues will arise

bioethics into policy decisionmaking stems from

a desire to understand the ethics surrounding

Federal support for certain types of research,

delivery of services in Federal programs, or

payment for services in programs such as Medicare and Medicaid. The appeal of an institutionalized role, however, has waxed and waned over the

past two decades. At present, no national policy

forum exists for generally analyzing ethical issues

associated with biological research and new

medical technologies, though bioethicists test@

before Congress and serve on Federal advisory

committees.

In spring 1992, Congress signaled renewed

interest in a formal role for bioethics in American

governance during the Senate debate on reauthorization for the National Institutes of Health. Three

factors stimulated this revived awareness and led

to the congressional request for this background

paper:

. concern about the many bioethical issues

that have not been analyzed at the Federal

level;

with increased frequency and urgency in the

future; and

. recognition that a national, institutional body

to explore the role of biomedical ethics in

U.S. public policy was nonexistent.

In September 1992, Senator Mark O. Hatfield,

Ranking Minority, Committee on Appropriations;

Senator Edward M. Kennedy, Chairman, Committee on Labor and Human Resources; and

Senator Dennis DeConcini, Chairman, Subcommittee on Patents, Copyrights, and Trademarks,

Committee on the Judiciary, asked the Office of

Technology Assessment (OTA) to conduct a

study that would assist Congress in determining

possible approaches to examine policy problems

with biomedical and ethical dimensions. That is,

if Congress decides to create a new bioethics

entity, what options should be considered?

Specifically, the congressional request sought

a brief review of the history of broad-based

Federal bioethics initiatives such as the National

Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
4 I Biomedical Ethics in U.S. Public Policy

Table l-l—Broad-Based Federal Policy Bodies in Biomedical Ethicsa

Year Inltlative Locus

1974-78 b National Commission for the Protection of Department of Health, Education, and

Human Subjects of Biomedical and Welfare

Behavioral Research

1978-80’ Ethics Advisory Board Department of Health, Education, and

Welfared

1978-83” President’s Commission for the Study of Independent executive branch

Ethical Problems in Medicine and commission

Biomedical and Behavioral Research

1985-89f Biomedical Ethics Advisory Committee Congress

a Currently, ~ part of the Human Genome project, the National Institutes of Health and the U.S. Department of Energy **~nd 9rants

through an Ethical, Lagal, and Social Issues (ELSI) program. A joint ELSI Working Group advises both programs, but it is not a policy body.

b public LW 93-34s (s 202, S8 Stat. 342, 1974) created the National -mission in July 1974.

C Aithough disban~ in 19@, ~rrent DHHS r~uiations pro~de for the existence of an EAB (~ CFR 48.2’04). in f&2t, effOrtS tO reestablish

and recharter an EAB stalled in 19SS (53 FR 35232).

d With rWrganization of the Departmmt in 19w, ~Bbe part of the Us. mpartm~t of H~ith and Human %NICS.

e public Lm 95+22 (4,2 UCS.C, Cht6A) a~horiz~ creation of the presi~nfs ~mmission in Novem~r 1978 ati set its termination fOr

December 1982. Public Law 97-377 extended this date through March 1963. Due to deiays in appointments and funding, the President’s

Commission was actuaity operational for just over 3 years.

fin reaiity, B~C function~ forappmximateiy 1 year. pubiic ~991 ~ estabi~h~ B~C in Mq 1985. itw~ overseen by the Biomedical

Ethics Board (BEB), which was comprised of Members of Congress. Almost a year elapsed before BEB was appointed and then nearfy

2 1/2 more years before BEAC was constituted.

SOURCE: Office of Technology Assessment, 1993.

(National Commission), the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research

(President’s Commission), and the Biomedical

Ethics Advisory Committee (BEAC), and asked

OTA to analyze three questions based on this

background material. First, what lessons could be

learned from each of these entities? Second, what

worked, or did not work? And finally, why?

To place these questions in context, chapter 2

briefly reviews the history of biomedical ethics in

policy decisionmaking. In keeping with congressional interest and prerogative, the report focuses

on the successes and failures of the three Federal

bodies just mentioned, as well as the Ethics

Advisory Board (EAB) of the Department of

Health and Human Services. It also presents

information on State and international initiatives;

appendix A describes international bioethics bodies in greater detail. Appendix B presents the

statutes or legislation establishing the National

Commission, President’s Commission, and BEAC,

as well as the regulations that pertain to EAB and

the charters under which it has operated. Federal

bioethics initiatives devoted to a single issue are

not analyzed in detail. Also excluded are the large

number of academic bioethics centers, privately

funded centers, and ethics committees of professional societies.

Chapter 3 examines the potential outlook for

biomedical ethics in policy decisionmaking. It

discusses what type of Federal effort might be

created, factors to consider in launching a new

body, and the role of Congress in such deliberations. The chapter is based, in part, on an OTA

workshop convened in December 1992, in which

participants from past Federal, State, and international bioethics forums, as well as individuals

who observed (or used products of) these forums,

discussed lessons from the past in light of future

demands. As Senator Hatfield noted in opening

the l-day OTA workshop:

. . . in public policy, if there is a vacuum, government eventually will fill it, right or wrong, good
Chapter 1 —Introduction 5

or bad. We just can’t let difficult bioethical

matters evolve at will, we ought to help direct

them.

For, as then OTA Director John H. Gibbons

pointed out, biology and medicine raise so many

ethical issues of both a personal and public nature

that:

[in] a Nation that is extraordinarily more pluralistic, traditional authorities-for instance a single

church or cultur-can no longer provide guidance that will be acceptable to all. Thus, these

issues come to rest with our government.

This report is intended to provide Congress

with background material on what form a new

Federal bioethics body could take and what might

make a commission function effectively, not

whether a commission should be established.

Thus, discussions of specific bioethical dilemmas

or an analysis of what issues are pressing are

beyond the scope of this background paper.

CHAPTER 1 REFERENCES

1.

2.

3.

4.

5.

6.

7.

8.

Altman, L., “Terminally Ill Man Gets Baboon’s

Liver in Untried Operation,” New York Times,

June 29, 1992.

Altman, L., ‘‘Man Dying From Hepatitis Is Given

a Baboon’s Liver, ’ New York Times, Jan. 11,

1993.

Associated Press, “Woman Gets Liver From a Pig

But Dies,” Oct. 13, 1992.

Beecher, H. K., “Ethics and Clinical Research,”

New England Journal of Medicine 274:1354-

1360, 1966.

Caplan, A. L., “Twenty Years After: The Legacy

of the ‘Ibkegee Syphilis Study-When Evil

Intrudes, ” Hastings Center Report 12(6):29-32,

1992.

Edgar, H., “Twenty Years After: The Legacy of

the Tuskegee Syphilis Study-Outside the Community,’ Hastings Center Report 22(6):32-35, 1992.

Faden, R.R. and Beauchamp, T. L., A History and

Theory of Informed Consent (New York NY:

Oxford University Press, 1986).

Fisher, M., “Germany’s Fetal Position: If a

Mother Dies, Should Her Pregnancy Continue?,’

Washington Post, Oct. 29, 1992.

9.

10.

11.

12.

13.

14.

15.

16.

17.

18.

19.

20.

21.

Fletcher, J. C., “The Bioethics Movement and

Hospital Ethics Committees,” Maryland Law

Review 50:859-894, 1991.

Heller, J., “Syphilis Victims in U.S. Study Went

Untreated for 40 Years, New York Times, July 26,

1972.

Jones, J. H., Bad Blood: The Tuskegee Syphilis

Experiment (New York, NY: Free Press, 1981).

Jensen, A. R., “American Moralism and the Origin of Bioethics in the United States,” JournaZ of

Medicine and Philosophy 16:113-130, 1991.

King, P, A., “Twenty Years After: The hgacy of

the ‘Ihskegee Syphilis Study—The Dangers of

Difference,” Hastings Center Report 22(6):35-

38, 1992.

Potter, V. R., Bioethics: Bridge to the Future

(Englewood Cliffs, NJ: Prentice-Hall, 1971).

Reich, W.T., Georgetown University, Washington, DC, ‘How Bioethics Got Its Name, ’ remarks

at the conference, “The Birth of Bioethics,”

Seattle, WA, September 1992.

Rothman, D. J., Strangers at the Bedside: A

History of How Law and Bioethics Transformed

Medical Decisionmah”ng (New York, NY: Basic

Books, klC., 1991).

Schrage, M., “ ‘Bioethics’ Burgeons, and Along

With It Career Opportunities,” Washington Post,

Oct. 16, 1992.

Thornton, B. C., Callahan, D., and Nelson, J. L.,

“Bioethics Education: Expanding the Circle of

Participants,” Hastings Center Report 23(1):25-

29, 1993.

U.S. Congress, OffIce of Technology Assessment,

Life-Sustaining Technologies and the Ela2?riy,

OTA-BA-306 (Washington, DC: U.S. Government Printing Office, July 1987).

U.S. Congress, Office of T~hnology Assessment,

Infertility: Medical and Social Choices, OTA-BA358 (Washington, DC: U.S. Government Printing

Office, May 1988).

U.S. Congress, Office of Technology Assessment,

Neural Grafting: Repairing the Brain and Spinal

Cord, OTA-BA462 (Washington, DC: U.S. Government Printing Office, September 1990).
From

the Past 2

I

n the absence of a single authoritarian church or other

mechanisms to handle bioethical issues, American society

often turns to government or the courts for resolution of

thorny ethical issues. The reemerging interest in the role of

bioethics in U.S. public policy signals the increasing importance

of medical and biological technologies in daily life. The creation

of Federal commissions stems from a desire for mechanisms to

articulate common values and foster consensus in the face of

growing cultural and religious heterogeneity. The need is not so

much for finding moral solutions to complex policy matters, but

rather, for identifying problems and either making recommendations or defining tradeoffs among alternatives.

FEDERAL INITIATIVES

Congress has exhibited an enduring interest in bioethics

entities. Even before the term bioethics was coined in the early

1970s (73), the U.S. Senate deliberated in 1968 about a National

Commission on Health Science and Society to examine “the

social and moral” implications of biomedical advances (90).

Since then, Congress has established three bodies to address

ethical issues in medicine and research: 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 the Biomedical Ethics Advisory Committee (BEAC). A

fourth Federal initiative, the Ethics Advisory Board (EAB),l

originated from a recommendation of the National Commission.

IFeder~ ~cwlations (45 cm 46) call fOr ‘‘Ethical ~viso~ Bomd$’ ‘d *e

original charter is for the “Ethical Advisory Board” (40). Soon after the board was

constituted, however, it came to be referred to as the ‘Ethics Advisory Board ”-a change

also reflected in the second charter (9).

7

JAIuk’+ . .
8 I Biomedical Ethics in U.S. Public Policy

Box 2-A—Ethical, Legal, and Social Issues Programs,

National Institutes of Health and U.S. Department of Energy

Since fiscal year 1988, Congress and the executive branch have made a commitment to determine

the location on the DNA of all genes in the human body (e.g., as has been done for sickle cell anemia,

cystic fibrosis, and Tay-Sachs disease) (84). The Human Genome Project is estimated to be a 15-year,

$3-billion project. It has been undertaken with the expectation that enhanced knowledge about genetic

disorders, increased understanding of gene-environment interactions, and improved genetic diagnoses

can advance therapies for the 4,000 or so currently recognized human genetic conditions (15).

To address the ethical, legal, and social issues of the Human Genome Project, and to define

options to address them, the National Institutes of Health (NIH) and the U.S. Department of Energy

(DOE) each funds an Ethical, Legal, and Social Issues (ELSI) program. Funds for each agency’s ELSI

effort derive from a set aside of 3 to 5 percent of appropriations for the year’s genome initiative budget.

In fiscal year 1991, DOE-ELSI spending was $1.44 million (3 percent) and in fiscal year 1992 it was

$1 .77million (3percent);fiscal year 1993 spending is targeted at $1 .87million (22). NIH-ELSl spending

for fiscal years 1990 and 1991 has been $1.56 million (2.6 percent) and $4.04 million (4.9 percent),

respectively. For fiscal year 1992, NIH-ELSI spent $5.11 million (5 percent) and aims to spend $5.30

million in fiscal year 1993(5 percent) (37).

ELSI funds bioethics research related to the Human Genome Project to expand the knowledge

base in this area. The program operates in the model of peer review competition for grant funds. The

ELSI Working Group, which advises both programs, initially framed the agenda and establishes priority

research areas. Nevertheless, the nature of grant programs means the ultimate direction evolves from

the bottom up-i.e., from the individual perspectives of researchers pursuing independent investigationsrather than from the top down i.e., through policymakers or an overarching Federal body.

Furthermore, no formal mechanism exists for ELS1-funded research findings to directly make their way

back into the policy process (18,28,30,45,78). And although the ELSI programs have a large funding

base for grants, they lack resources for in-house policy analysis. The ELSI Working Group, however,

has played a role in policy analyses related to genetics and the Americans With Disabilities Act, cystic

fibrosis carrier screening (88), and genetic research involving several family members (36).

Finally, although issues in human genetics are broad ranging, they comprise only a portion of

bioethical issues. Because ELSI is the largest Federal funding source for bioethics studies, there is

concern that a brain drain is occurring from nongenetic areas of bioethics to the ethics of human genetics

research and applications (2).

SOURCE: Office of Technology Assessment, 1993.

Beyond these four bodies,2 which had a general Human Fetal Tissue Transplantation Research

focus, bioethics has been a part of American Panel (Fetal Tissue Panel) (box 2-B), the Presigovernance via topic-specific initiatives, includ- dential Commission on the Human Immunodefiing: the Ethical, Legal, and Social Issues (ELSI) ciency Virus Epidemic (Executive Order 12601;

programs, National Institutes of Health (NIH) and 52 FR 24129), the National Commission on

U.S. Department of Energy (box 2-A), the NIH Acquired Immune Deficiency Syndrome (Public

2 In January 1993, MI-I formally established a Science Policy Studies Center to advise the NIH Director on the ethical, legalj economic,

and social implications raised by reswck plans for staffing, establishing policies, and setting priorities we undex development (1,43).
Chapter 2—Lessons From the Past 9

Box 2-B—The National Institutes of Health Human Fetal Tissue

Transplantation Research Panel

Fetal tissue has long been used in research, including research involving transplanting fetal

thymus tissue into humans (26,86). In 1975, the National Commission for the Protection of Human

Subjects of Biomedical and Behavioral Research scrutinized ethical issues related to the use of fetuses

in research (93) and developed the guidelines that were incorporated into Federal regulations for use

of fetuses in research (45 CFR 46). Nevertheless, when scientists began using fetal tissue for neural

grafting in the mid-1980s, questions were raised about the adequacy of these regulations for such

research because they did not address specifically the therapeutic use of fetal tissue (86). The prospect

that Federal funds would be used to support an intramural research protocol for implanting fetal neural

tissue from induced abortions into persons with Parkinson’s disease pushed matters to a head in 1987.

Lacking an Ethics Advisory Board within the Department of Health and Human Services to turn to,

the Director of the National Institutes of Health (NIH) sought guidance from the Assistant Secretary for

Health, In turn the Assistant Secretary directed NIH to appoint an ad hoc panel in March 1988, while

simultaneously imposing a moratorium on Federal funding for the use of human fetal tissue from induced

abortions for transplantation. The NIH Human Fetal Tissue Transplantation Research Panel,

established as a subcommittee of the NIH Director’s Advisory Committee, consisted of 21 members

representing public interest, clinical, research, ethics, religious and legal perspectives (105).

The Panel’s agenda was set by the Assistant Secretary through ten sets of ethical, social, legal,

and technical questions. It met three times from September to December 1988 and, after considering

material from invited speakers, public testimony, and commissioned papers (106), issued its report in

December 1988 (105). The report concluded-on a 17 to 4 vote-that funding research involving the

transplantation of human fetal tissue from induced abortions is acceptable public policy as long as

carefully crafted safeguards are in place (105).

The recommendations were accepted unanimously by the NIH Director’s Advisory Committee,

which recommended the moratorium on fetal tissue transplantation research be lifted; the NIH Director

concurred in a memorandum to the Assistant Secretary for Health in January 1989(110). Despite these

actions, none of the Panel’s recommendations was implemented at that time. The Secretary extended

the moratorium indefinitely in November 1989 (75), until it was lifted by President Clinton (58 FR 7468)

when NIH was directed to develop guidelines based on the Panel’s report in January 1993.

The ad hoc approach employed by the Federal Government clearly and publicly articulated the

policy and ethical dimensions of fetal tissue transplantation and led to a specific recommendation, albeit

with dissent; the process worked, although the recommendations were ignored by the initial client.

However, the events leading up to the moratorium, and those that followed, raise questions of their own

and add another layer of ethical considerations to the fetal tissue transplantation controversy: Is the

Government’s process for bioethical analysis adequate? And, what is the relationship between personal

ethical convictions and the appropriate shape of public policy in a pluralistic society?

SOURCE: Office of Technology Assessment, 1993.

Law 100-607; $241-249, 102 Stat. 4223, 1988), range of issues (80-89). Additionally, bioethical

and the U.S. Department of Health and Human considerations have been included as part of the

Services’ (DHHS) Organ Transplantation Task deliberations about gene therapy by the NIH

Force (Public Law 98-507). OTA reports also Recombinant DNA Advisory Committee (RAC),

have considered the bioethical dimensions of a though the focus and function of RAC and the
10 I Biomedical Ethics in U.S. Public Policy

AIDS commissions are less bioethics per se than

either the ELSI programs or the Fetal Tissue

Panel. The Ethics and Values in Science and

Technology Program of the National Science

Foundation once supported analyses of ethical

issues related to specific issues arising from

research, but avoided aspects related to clinical

care because they were beyond the agency’s

mission. Although not involved in policy development, the National Endowment for the Humanities has also supported projects in bioethicstypically courses, book projects, or workshops.

This section briefly reviews the history of the

four principal, broad-based Federal initiatives:

the National Commission, EAB, President’s

Commission , and BEAC; it discusses their creation, procedures, and products. Chapter 3 analyzes these practices and processes in the context

of defining common elements to elucidate alternative Federal forums to integrate biomedical ethics

in U.S. public policy. For additional detail,

appendix B contains the statutes or legislation

establishing the National Commission, President’s Commission, and BEAC, as well as the

regulations and charters that pertain to the EAB.

■ National Commission for the

Protection of Human Subjects of

Biomedical and Behavioral

Research

The National Research Act (Public Law 93-

348 (§ 202, 88 Stat. 342, 1974) created the

National Commission in July 1974, after earlier

attempts at constituting a similar commission

failed (23,74,90). In establishing the National

Commission, Congress directed it to identify the

principles of ethics needed to protect human

subjects involved in research and to use those

principles to recommend actions by the Federal

Government.

Eleven members were appointed by the Secretary of the then Department of Health, Education,

and Welfare (DHEW): five scientists, three lawyers, two ethicists, and one person in public

affairs (11 1); appointments were for the full term

of the commission years. Of the five scientists, three were physicians and two were psychologists (11 1). During its existence, commissioners

met on nearly a monthly basis (111). Within the

first year, 16 staff were hired, and in May 1975,

the National Commission issued its first report,

which addressed research involving fetuses (93).

By July 1975, this report’s recommendations had

been translated into Federal regulations. The

startling speed with which change was effected

was brought about by a clause in the law that

forced the Secretary to accept the National

Commission’s recommendations or make public

the reasons for rejection. The clause, however,

seemed to have an effect only as long as the

National Commission was operative. After it

disbanded, DHEW began to ignore the forcing

clause for recommendations of later reports

(38,39).

Ten reports and many appendixes followed the

initial effort (94-102); some as successful, others

not. For example, the National Commission’s

reports on ethical guidelines to protect certain

classes of human subjects in research-fetuses,

prisoners, and children (93,94,97)-led to Federal regulations (45 CFR 46), and today an NIH

office oversees their enforcement (61). The National Commission identified the basic ethical

principles to be applied in the ethical evaluation

of human subjects research (98), which was also

codified (45 CFR 46). More controversial and

largely ignored (16,11 1) was the National Commission’s work on psychosurgery (96). Its work

on research and the ‘‘institutionalized mentally

infirm” (101) was never implemented; regulations were proposed after the National Commission’s demise, but never finalized-in violation

of the law (38,39).

The National Commission brought its work to

a close in 1978, but spawned the next broad-based

Federal entity, the EAB-again through the

forcing clause. Rather than publish objections

within 180 days as to why a continuing Federal

body should not be established, DHEW incorpo-
Chapter 2—Lessons From the Past 11

rated the National Commission’s recommendations into its regulatory framework (45 CFR

46.204) and established the EAB.

■ Ethics Advisory Board

As early as 1970, NIH discussed the need for a

body to advise the Secretary and DHEW on

controversial ethical, legal, and social issues

posed by biomedical research protocols (23,24).

Nevertheless, the EAB was not established until

1978, following a recommendation of the National Commission.

The Secretary appointed an n-member Board

that included lawyers, a theologian, a philosopher, clinicians, researchers, and a member of the

public. Initially, the Board had eight staff, as well

as consultants and student assistants. During its

approximately 2-year existence, it met approximately 20 times (42). In vitro fertilization (IVF)

was the first topic addressed by EAB, and its 1979

report stipulated several criteria to be met for

approval of federally funded research in this area.

Among the report topics that followed were a

report on fetoscopy and items related to Freedom

of Information Act inquiries (41). In all, EAB

produced four documents (91,92,103,104).

Although Federal regulations define EAB’s

scope to issues involving the fetus, pregnant

women, and human IVF (45 CFR 46.201), the

original charter under which the Board operated

clearly defines EAB’s scope much more broadly

as a standing body to review ethical issues of

biomedical research (40); the scope and level of

activities were further widened with the subsequent charter (9). And in fact, the Secretary used

EAB in a broad manner to report on ethical issues

raised by research unrelated to the three specified

activities (41,103,104).

In contrast to the other three Federal initiatives,

EAB was intended as an ongoing, standing board

with a mission to examine issues related to

specific protocols or types of research as they

arose-a logical notion given the quickening

pace of biomedical research. Additionally, Federal regulation required an EAB review prior to

funding research on human IVF (45 CFR46.204d).

Nevertheless, despite the regulatory requirement

for an EAB (45 CFR 46.204), DHHS disbanded

it in 1980 at the direction of the Office of Science

and Technology Policy (35), and thus violated its

own regulations (77). The appearance of the

President’s Commission in 1978 contributed to

EAB’s demise because policymakers failed to

distinguish their distinct purposes. Through its

broad charter, EAB was positioned to examine

research protocols that raised novel issues and to

devise procedures and criteria for their review and

implementation. In contrast, the Presidents Commission was a forum for national debate on global

issues of bioethical concern.

In 1988, OTA’s report on medical and social

issues of infertility (84) forced the debate over

DHHS ‘S failure to maintain an EAB to the surface

(77,79). Federal funding for peer-reviewed, approved projects was clearly blocked without an

EAB.3 DHHS promised to reestablish the Board

and published a proposed charter for a new EAB

in 1988 (53 FR 35232). The new charter called for

an expanded membership of 21 individuals—

drawn from specific, but diverse fields of expertiseto serve for overlapping 4-year terms. Meetings

were to take place approximately 10 times

annually. The comment period generated nearly

200 signatories to various positions-with a clear

majority in favor, although with caveats about the

frequency of meetings, number of individuals,

and other details. A revised charter was drafted,

but never signed in the waning days of the Reagan

Administation, and no EAB materialized during

the Bush administration.

3 NIH es~t~ this & facto ban on federally funded research related to h~ IVF was such that more than 100 grant applications in this

area were not submitted between 1980 and 1987 because of a widespread awareness that while such grants might be approved, they would go

unfunded because no EAB would exist to review them (27,84).
12 Biomedical Ethics in U.S. Public Policy

■ President’s Commission for the

Study of Ethical Problems in

Medicine and Biomedical and

Behavioral Research

Congress created the President’s Commission

in 1978 (Public Law 95-622; 42 U.S.C. Ch.6A).

As just mentioned, amid confusion that the

President’s Commission’s mandate overlapped

the EAB’s, Congress convinced DHEW to divert

its appropriations to support the new body (18).

And though funding for the President’s Commission eventually came from other sources (13),

EAB remains dormant. Congress also elevated

the new body to independent presidential status,

in contrast to the National Commission, which

had operated autonomously within DHEW. The

scope was extended beyond human subjects

research to include medical practice, and the

commission was granted broad authority to expand beyond the seven mandated topics to report

on emerging issues on its own initiation or at the

request of the President or the head of an agency.

Appointment powers resided with the President. By summer 1979, the 11 commissioners had

been appointed for rotating terms, and the first

meeting was held in January 1980. By law,

commissioners were drawn from specific areas:

three who practiced medicine, three biomedical or

behavioral researchers, and five from other fields.

Over the President’s Commission’s duration, this

latter category included individuals from law,

sociology, economics, and philosophy, as well as

a homemaker and a businessman. In all, 21

different commissioners served on the President’s

Commission. The body was well staffed: During

the 3 years the President’s Commission functioned, about 30 to 40 people worked for it, but

generally only 20 at any given time.

Like the National Commission, the legislation

creating the body also had a forcing clause. But

unlike the National Commission, the reports of

the President’s Commission-as a matter of

explicit policy-made few specific recommendations (108) to which agencies needed to respond.

Instead, the President’s Commission produced

consensus reports that largely articulated mainstream views (108) on the mandated topics, as

well as three additional reports not requested in

the original legislation; a summary document of

the Commission’s work was also published, as

well as several appendixes and proceedings (62-

72). These documents were highly regarded and

many have had sustained policy influence (109).

For example, its report on the definition of

death became the foundation for statutory changes

adopted throughout the Nation (12). Its report on

foregoing life-sustaining treatment-undertaken

on the Commission’s own initiative-was probably the most influential (7,13,35) and remains an

important point of reference for courts and

legislatures. The Commission’s report on recombinant DNA research (66) led the NIH RAC to

establish a working group to consider both

technical and ethical aspects of human gene

therapy. On the other hand the report on health

care access was less influential (4,6,20,21). Still

others suffered inattention at the time of their

release+. g., the report on genetic screening and

genetic counseling and the report on whistleblowing in biomedical research (13)-but were remarkably prescient about issues that surfaced in

the 1990s (8,88,112).

After one 3-month extension for its authority,

the President’s Commission expired in March

1983. Its recommendation that a similar body be

created on its termination became the focus of

almost immediate attention (18), thus setting the

stage for the most recent congressional sortie into

institutionalizing biomedical ethics.

■ Biomedical Ethics Advisory

Committee

In May 1985, Congress looked to itself to

house the fourth, and most recent, Governmentsponsored bioethics body: BEAC (Public Law

98-158). With the President’s Commission’s

sunset in March 1983, Congress repeatedly expressed interest in reconstituting some type of
Chapter 2—Lessons From the Past 13

bioethics coremission (16-18,76). Overseeing BEAC

was the Biomedical Ethics Board (BEB), modeled on the Technology Assessment Board that

oversees OTA: 12 Members of Congress equally

divided by chamber and political affiliation.

Nearly a year passed before the House and

Senate leaderships appointed Board members,

who in turn were charged with appointing a

14-member BEAC. Two lay members and representatives from law, ethics, biomedical research

and clinical care were appointed-2 1/2 years

later. Less than 1 week before it was scheduled

to expire, BEAC held its first meeting in

September 1988.

Two full-time staff worked for BEAC, which

initially was to analyze three mandated topics:

human genetic engineering (i.e., gene therapy),

fetal research, and feeding and nutrition of dying

patients (18). To address the first topic, it held its

second meeting in February 1989. Shortly thereafter, however, Senate BEB members deadlocked

on choosing a chairman along partisan, prochoiceantiabortion lines (18). BEAC’s proposed budget—

sufficient for 12 staff to address the mandated

topics—was cut and spending made contingent

on a fully constituted BEAC. BEAC expired in

September 1989 having issued no reports.

commission currently is unfunded and Colorado’s effort has not yet been funded (13,44).

■ New Jersey Commission on Legal

and Ethical Problems in t he Delivery

of Health Care

New Jersey’s efforts to address bioethical

issues developed from a series of landmark

decisions by the State Supreme Court, beginning

in 1976 with the ‘‘Karen Ann Quinlan case"—

the first case to address refusal of life-sustaining

treatment (32). In 1985, the court dealt with a

proposal to withdraw a feeding tube from a

debilitated and demented elderly nursing home

patient (31). In both cases, the court stated that the

opinions were not intended to set guidelines for

life-sustainin g treatment decisions and that these

issues are more suitably addressed by the legislative process, which can accommodate the different needs and interests represented in New

Jersey’s communities.

In November 1985, the State legislature created

the New Jersey Commission on Legal and Ethical

Problems in the Delivery of Health Care (New

Jersey Bioethics Commission) as a permanent

legislative commission (New Jersey Public Law

1985, Chapter 363). Though currently unfunded,

it operated for 5 years with the mandate to

STATE ENTITIES

“provide a comprehensive and scholarly examination of the impact of advancing technology on

Although bioethics forums were initially confined to federally funded efforts, more recently,

State legislatures and executive branches have

begun formal efforts to incorporate bioethics in

their analytic and decisionmaking processes (34).

Most State panels have been devoted to a single

issue, particularly health care access (e.g., California (14), Minnesota (1 1), Oregon (25), Vermont (107)). The Minnesota House of Representatives created a bioethics subcommittee and

held hearings during its 1991-92 session (10). At

least three States—New Jersey, New York, and

Colorad o-created entities designed to consider

a broad range of issues, though New Jersey’s

health care decisions [in order to] enable government, professionals in the fields of medicine,

allied health care, law, and science, and the

citizens of New Jersey and other States to better

understand the issues presented, their responsibilities, and the options available to them.

The New Jersey Bioethics Commission was

comprised of a diverse, multidisciplinary group

of 27 appointed members. Commissioners were

drawn from a broad spectrum of expertise and

opinions, including medicine, nursing, health

care administration, natural science, social science, law, the humanities, theology, ethics, and

public affairs. By law, the Coremission included
14 Biomedical Ethics in U.S. Public Policy

representatives of the State legislative and executive branches, major professional and health care

associations, and professional and public communities. Fourteen at-large members were appointed

by the Governor, the Senate President, and the

Speaker of the General Assembly. One Commissioner represented the Citizens’ Committee on

Biomedical Ethics-demonstrating the trend toward grassroots organizations in bioethics and

health care decisionmaking (19,29,34).

The Commission’s statutory mandate was broad,

and it enjoyed substantial freedom to set its own

agenda. Areas addressed included: determination

of death, advance directives, and decisionmaking

for incompetent patients without advanced directives (46-48,50,5 1). Following the decision in the

‘‘Baby M case” (33), the Commission undertook

a study of surrogate motherhood (49).

During its approximately 6-year existence,

fiscal support varied widely. Staffing ranged from

five full-time professionals and two part-time

consultants to two full-time professionals and two

consultants (3,60). Staff to the Commision had

broad freedom to consult outside experts, select

papers for presentation to the Commission, hold

public hearings, and do empirical research on

life-sustaining treatment, determination of death,

and reproductive issues. At least one former staff

member, however, believes the Commissioners

and staff did not have adequate access to the

Governor or ongoing cooperation from the Governor or the Legislature (5). Conflicts between

staff and commissioners over substantive and

nonsubstantive issues also hampered some deliberations (5).

The New Jersey Bioethics Commission conducted its deliberations publicly, believing that

openness to public participation and scrutiny was

necessary if the Commission was to be responsive

and credible; it also held numerous public hearings. At times, the meetings were highly politicized. In particular, the four legislators on the

Commission were often divided; three didn’t

approve of the Commission’s existence and spent

much of their time trying to disband the Commission rather than participate in discussions on a

particular issue (5). On the other hand, including

elected representatives and executive branch

officials established an important liaison to those

who ultimately effect change; it worked well

sometimes, but was obstructionist on other occasions (3,60).

The Commission also created five ad hoc task

forces for detailed studies of new reproductive

practices, institutional ethics committees, public

and professional education, AIDS, and protection

of vulnerable patients. Each task force consisted

of 12 to 20 members, including both Commissioners and others selected for their specialized

expertise. Task Forces made recommendations to

the Commission, which retained authority to

accept, reject, or modify the proposals.

For each of the topics it studied, the New Jersey

Bioethics Commission, sometimes jointly with a

task force, published reports designed to explain

“the intent and spirit of the recommendations”

and to ‘‘enhance understanding and promote

discussion of bioethical issues by policymakers,

members of the legal and health care communities

and by all New Jersey citizens” (48). The

Commission published six documents, ranging

from comprehensive policy analyses to a guidebook for health professionals to consumertargeted information documents (46-51), one of

which also was published in Spanish (47). Commission work in several areas resulted in specific

State laws, including: the New Jersey Declaration

of Death Act (New Jersey Public Law 1991,

Chapter 90) and the New Jersey Advance Directives for Health Care Act (New Jersey Public Law

1991, Chapter 201).

 New York State Task Force on

Life and the Law

In the early 1980s, New York State faced a

mounting crisis over “Do Not Resuscitate”

(DNR) orders, directives that advise physicians

whether to resuscitate a patient. A grand jury

investigation revealed widespread abuses associ-
Chapter 2—Lessons From the Past 15

ated with DNR orders in health care facilities, and

the grand jury’s findings and accompanying

public outcry helped lead to the establishment in

1984 of the New York State Task Force on Life

and the Law. The Task Force still functions today,

receiving funds on an annual basis. Designed to

provide counsel on a broad range of topics-e. g.,

surrogate parenting, determination of death, and

physician assisted suicide-it makes policy recommendations to the State executive and legislative branches; its agenda is established in consultation with the Governor and New York State

Department of Health (44).

The Governor appoints all Task Force members, who include doctors, nurses, and representatives of different religious communities and

public interest groups. Members are chosen from

both political parties and to reflect different

perspectives within the State. The role of the Task

Force is purely advisory; it is not involved with

final policy determination. The group was set up

as an independent entity, not as a division of an

existing department. Nevertheless, by factoring in

the views of representatives from various State

communities, it has been able to identify points of

consensus and recommend proposals that were

acceptable to the legislature, State agencies, and

the Governor (44).

In addressing a topic, the Task Force examines

existing literature and takes into account the

range of political and social concerns in the State

to create generalized guidelines that fit the

vagaries of New York State’s legal and cultural

climate (44). The Task Force has been well

staffed and is further aided by consultants, who

participate on a pro bono basis.

Because the Task Force is advisory, it has been

exempt from open meeting laws that apply to

other State bodies. To date, its meetings have not

been open to the public. Nor has the Task Force

held public hearings, although after recommendations have been made, hearings have been held as

part of the legislative process. One former staff

member believes that the ability to conduct closed

meetings has contributed to the Task Force’s

success—i.e., that private deliberations insulate

members from political pressures that can surround issues under consideration (44).

The Task Force has produced eight reports

supporting its recommendations (52-59). Most

included legislative or regulatory proposals, and

all recommendations were drafted and enacted in

some form. Topics addressed include: organ and

tissue transplantation, determination of death,

health care agents, surrogate parenting, and surrogate decisionmaking for incapacitated patients.

Reflecting the difficulty of achieving consensus,

abortion has not been a Task Force issue.

INTERNATIONAL EFFORTS

In the past few years, bioethics has become a

global enterprise (table 2-l). Hospitals the world

over have established ethics committees, and

many academic and professional bioethics forms

have been created in other countries. The governments of at least 27 nations on 6 continents have

established national commissions of some type or

currently have legislation pending. Thus, while

U.S. Government-sponsored bioethics forums

have disappeared, government initiatives are on

the rise elsewhere. Multinational organizations

have also begun to analyze bioethical issues

through committees or coremissions. Appendix A

chronicles these and individual country efforts;

this section summarizes some common themes

and highlights some differences.

Not surprisingly, the purposes of bodies in

other countries vary widely. Some advise parliaments directly, others exist to stimulate and

educate the public. Still others assume the role of

distilling and articulating the country’s sensibility

on bioethics matters.

Each country integrates biomedical ethics into

its policymaking structure in a different manner,

and no single approach predominates. Unique

cultural aspects are key and influence the development of bioethical approaches in a particular

country; what might be viewed as acceptable in

one country could be unethical in another. Until
16 I Biomedical Ethics in U.S. Public Policy

Table 2-1—Typology of International Bioethics Commissionsa,b,c

National Other government

commission commission Hospital Professional Academic Private

Argentina . . . . . . . . . . . I

d

Australia. . . . . . . . . . . . . 1

Austriaf

. . . . . . . . . . . . .

Belgium. . . . . . . . . . . . . d

Botswana . . . . . . . . . . .

Brazil. . . . . . . . . . . . . . . 1

Canada . . . . . . . . . . . . . 2

Chile. . . . . . . . . . . . . . .

China. . . . . . . . . . . . . . . d

Columbia h. . . . . . . . . . .

Croatia. . . . . . . . . . . . . .

Cyprusf. . . . . . . . . . . . . 

d

Czeoh Republic. . . . . . 1

Denmark. . . . . . . . . . . . 2

Egypt. . . . . . . . . . . . . . .

Finland . . . . . . . . . . . . . 2

France . . . . . . . . . . . . . . 1

Germanyj 

. . . . . . . . . . .

Ghanak. . . . . . . . . . . . . .

Greece. . . . . . . . . . . . . 1

Holy Seef. . . . . . . . . . . .

Hungary. .....,,,.. 2

Iceland. . . . . . . . . . . . .

Irelandf

. . . . . . . . . . . . .

Israel. . . . . . . . . . . . . . . 2

Italy . . . . . . . . . . . . . . . . 2

Japan . . . . . . . . . . . . . .

Kuwait” . . . . . . . . . . . . .

Liechtensteini.n. . . . . .

Luxembourg . . . . . . . . . 1

Malta . . . . . . . . . . . . . . . 1

Mexico . . . . . . . . . . . . . . 1

The Netherlands . . . . . . 2

NewZeaiand. ,....,, 1

d

Norway . . . . . . . . . . . . . 3

Peru. . . . . . . . . . . . . . . .

The Philippine@. . . . . . 1

Poland . . . . . . . . . . .. 3

Portugal . . . . . . . . . . . . . 1

Romania . . . . . . . . . . . .

Russia . . . . . . . . . . . . . . 1

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

a,g

9

i

i

e

●

Y

Y

Y

Y

Y Y

Y

Y

Y

Y

Y

Y

Y Y

Y

Y

Y

g,l

Y

Y

Y

Y

Y

I

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

g,o Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

recently, most bioethics commissions in other

countries have been temporary bodies devoted to

one or a small number of topics selected in

advance by the sponsor. In 1983, however, France

created abroad-based bioethics commission, and

since then several other European nations have

followed suit.

In contrast to the United States, many of the

national commissions abroad limit public access,

and meetings are generally closed; in some cases,

members of the public may offer their views

through periodic public symposia. As in the

United States, however, most governments strive

to include membership of non-health care professionals; in some cases, physicians and scientists

are a clear minority-such as on the 17-member

Danish Council of Ethics, where laypersons

represent the majority.
Chapter 2—Lessons From the Past 17

National Other government

commission commission Hospital Professional Academic Private

Scotland% . . . . . . . . . . .

South Africa. . . . . . . . .

Spain. . . . . . . . . . . . . . .

Sweden. . . . . . . . . . . . . 1

Switzerland. . . . . . . . . .

Turkey. . . . . . . . . . . . . . Id

United Kingdom.. . . . .

United States. . . . . . . .

Uruguay. . . . . . . . . . . .

Y

r

g,l Y

9 Y

g Y

Y

9 Y

e,9 Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y Y

Y Y

Y Y

Y

Y Y

Y Y

Y

a unless ~the~i~~ indi~~t~, information i9 b~ed an OTA survey of international government officials and bioethks experts. However, because

survey responses varied widely, this table likely represents an incomplete picture of activities in the area of hospital, professional academic, and

private entities. Hence, conclusions should not be drawn about absences for any particular entry.

b Numbers un~r the l$National ~mmission” column indi~te how many federally sponsored entities Wrrently exist to examine either bioethical

issues, generally, orresearch-related issues, specifically. “Hospital” refers to hospital ethics committees or research ethics boards. “Professional”

refers to subcommittees within or between professional groups, such as medical or nursing assodations. “Academic” refers to departments or

curricula in medical schools or other academic institutions. “Private” refers to private organizations devoted to the study of bioethics, excluding

professional or academic groups. “Y” indicates these activities in a country.

C Though n. all-enmmp=sing international organization exis~, several multinational Organizations (e.g., the council of Europe and the commission

of the European Community) have issued policy statements and sponsored forums for discussing bioethlcal issues (app. A), In addition, regional

bioethics commissions andor regional private groups have begun tocollectivelyorganize (e.g., in Central/Eastern Europe, Scandinavia, and Latin

America).

d ~gislation is pending t. create a new, or additional, national bioethb ~mmission.

e ~mI or regional commissions have existed.

f s ~ Bris, ‘iNational Ethi~ Bodies,” ~ntract document forthe council of Europe, Ad Hoccommittee of Experb on Bioethics, Round Table of Ethics

Committees, Madrid, Spain, Mar. 24, 1992.

9 Ad hoc, topic-specific commissions have existed.

h F. Sanchez-Torres, “Backgrouti and Current Status of Bioethics in Columbia,” B“oethics: issues and Perspectives, S.S. Connor and H.L.

Fuenzalida-Puelma (eds.) (Washington, DC: Pan American Health Organization, 1990).

i Laws addressing specific bioethical issues have been enacted.

j H.-M. Sass, “Blue-Ribbon Commissions and Political Ethics in the Federal Republic of Germany,” Jourrra/ofMedicirre and Philosophy 14:465-472,

1989; and D. Wilder and J. Barondess, “Bioethics and Anti-Bioethics in Light of Nazi Medicine: What Must We Remember,” Kennedy Institute of

Ethics Journa13:39-55, 1993.

k J, Hevi, ‘{in Ghana, Conflict and Complementarily,” Hastings Center Report 19(4) :S5-S7, 1989.

I Religious leaders have formed committees to discuss bioethical kSUeS.

m M. ~-Mutawa, ‘tHealth care Eth&i in Kuwait,” Hashlrgs Center Report 19(4):S11 -S12, 1989.

n No ethi~ b~ies exist in this muntry.

O The government has commissioned reports from individuals.

P L.D. de Castro, “The Philippines: A Public Awakening,” Hastings Center Report 20(2):27-28, 1989.

q D.M. Tappin and F. Cockburn, “Ethics and Ethics Committees: HIV Serosurveillance in Scotland,” Journa/ of Medica/ Ethics 18:43-46, 1992.

r The government has issued guidelines and reports in bioethics, but not through commissions.

SOURCE: Office of Technology Assessment, 1993.

WHAT WORKED?

Each past effort existed in unique circumstances that contributed to its success or failure.

It’s largely acknowledged that three of the four

Federal efforts succeeded. However, the most

recent endeavor, BEAC, failed, New Jersey and

New York approached biomedical ethics with

different approaches, but each State’s effort

worked for its own jurisdiction. Commissions

abroad offer a rich array of options to evaluate,

although until recently most have been topical.

France, Denmark, and the United Kingdom,

however, have well-developed, wide-ranging efforts, and all have their strengths.

What generally made bioethics bodies successful? Many factors—tangible and intangible—

contributed to success. Timing and personalities

were important, but were difficult to predict

beforehand. A few themes, nevertheless, persisted across the success stories and were notably
18 Biomedical Ethics in U.S. Public Policy

absent in the failure. As elaborated in the next

chapter, adequate staffing and funding improved the chances for success. Successful

commissions were relatively free of political

interference, had flexibility in addressing issues, were open in their process and dissemination of findings, and were comprised of a

diverse group of individuals who were generally free of ideology and had wide ranging

expertise.

Individually examining past Federal bioethics commissions reinforces this assessment. The

National Commission was formed in response to

a critical need to resolve several biomedical

research issues that had accumulated over time.

Its appearance was well-timed, and it was well

staffed. Its placement within the agency it would

guide-the U.S. Department of Health, Education, and Welfare-and requiring this agency to

respond to its recommendations were critical to

the National Commission’s subsequent contribution in ensuring ethical conduct in federally

funded research involving humans. The EAB’s

structure allowed for a flexible agenda to respond

to the biomedical research community’s pressing

needs for guidance, and as a standing unit it also

could respond quickly. The President’s Commission was able to distance itself from political

influence, was adequately funded and well

staffed, and received abroad mandate. In contrast,

BEAC and its congressional board suffered from

insufficient staffing, political conflict, and excessive debate over its agenda.

Lessons from State efforts can also be drawn,

though New York provides a less useful model

because it holds closed deliberations-a process

that would be illegal for any new Federal effort

presumably subject to the sunshine provisions of

the Federal Advisory Committee Act that require

open meetings (5 U.S.C. Ap. 2, §1 et seq.). Still,

both bodies in New Jersey and New York were

well staffed, had leeway to consult experts

outside the commission, and had flexible agendas.4 In contrast, international commissions are

poorly staffed compared to U.S. efforts and most,

like New York, hold closed meetings. Public

funding for outreach in Denmark, the wide media

and government attention paid to France’s effort,

and the unusual cooperation of the U.K. Government with its private council are striking and

undoubtedly contribute to their success.

1.

2.

3.

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5.

60

7,

8.

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4 New York still operates under these conditions. The Task force does, however, hold public hearings once recommendations have been

put forth.
Chapter 2—Lessons From the Past I 19

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I Biomedical Ethics in U.S. Public Policy

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Chapter 2—Lessons From the Past I 21

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61. Porter, J. P., “The Office for Protection From

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Chapter 2—Lessons From the Past I 23

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1992.
Prospects

for the

Future 3

0

ver the past two decades, the creation of Federal

bioethics commissions resulted from a desire for

mechanisms to articulate common values and foster

consensus about biomedical advances in the face of

cultural and religious heterogeneity. With the accelerated pace of

technological innovation, it will become increasingly important

for policymakers to understand the bioethical issues of such

advances. How best to incorporate bioethical analyses into

policy decisionmaking is a challenge facing Congress today

(8,26-29,40,42). If Congress decides to create a new Federal

bioethics body, what type of effort should it consider based on

past experience? Which particular factors promote success, and

which should be avoided?

WHAT ROLE COULD A COMMISSION PLAY?

The National Commission for the Protection of Human

Subjects of Biomedical and Behavioral Research (National

Commission), the Ethics Advisory Board (EAB), the President’s

Commission for the Study of Ethical Problems in Medicine and

Biomedical and Behavioral Research (President’s Commission),

and the Biomedical Ethics Advisory Committee (BEAC) were all

Federal responses to address ethical disputes in medical practice

and the conduct of biomedical research. With the conclusion or

demise of each of these efforts came calls for anew Federal entity

(1,12,15,18,20,34,48). Today, however, no public body exists for

the exclusive deliberation of complex bioethical dilemmas. For

nearly 4 years-the longest period of time since bioethics

burgeoned as a discipline—the Federal Government has

been without a formal forum that addresses bioethical issues.

In fact, a fully operational body has not existed in over a

decade.

25
26 Biomedical Ethics in U.S. Public Policy

The current void has not gone unnoticed by

either the professional communities or policymakers. Today, both parties increasingly decry

the lapse (26,28,83), just as Members of Congress

(70) and experts (1) sought a new venue for

bioethics after the President’s Commission concluded its work. A sense of urgency permeates

current appeals for two reasons: the accelerated

pace of biomedical innovation and the length of

time that has elapsed since the last government

initiative.

Even without a formal Federal effort, however,

bioethical analyses have been incorporated into

selected public policy analyses. Several OTA

reports include bioethical analyses (73-82), and at

the request of Congress or the executive branch,

the Institute of Medicine (IOM)l has addressed

ethical issues in relevant reports (25,31,33,35,

50,58,71). As described in chapter 2, the Ethical,

Legal, and Social Issues programs of the National

Institutes of Health (NIH) and U.S. Department of

Energy currently fund bioethics research related

to the Human Genome Project.

Today, policy decisionmakers find themselves

besieged with bioethical issues seeking resolution

(8,26-29,40,42). The intellectual fecundity of

these issues is apparent by the presence of a

growing corps of bioethicists (65) and bioethics

organizations. The American Association of Bioethics was launched in March 1993 (5,14), and the

International Association of Bioethics held its

inaugural congress in 1992. A few State efforts

have succeeded in exploring bioethical issues (ch.

2). In addition, many academic or private efforts

exist. Several medical or research organizations

have formed ethics groups, including the American Medical Association, American College of

Obstetricians and Gynecologists, American Fertility Society, American Society of Human Genetics, American Public Health Association, and

American Academy of Pediatrics. And while

nongovernmental groups (e.g., the National Advisory Board on Ethics in Reproduction) lack the

public sanction and authority that inhere with

government-appointed bodies (88), nongovernmental associations play an important role in

shaping the bioethics debate and have been

particularly effective in framing the dialogue in

countries without national bodies (43,64,67,88,90).

Still, no Federal initiative with sufficient authority or visibility exists to systematically analyze

the ethical implications of important issues such

as genetic privacy, embryo and fetal research, and

research involving people with mental illness.

Despite the lack of a Federal forum for

bioethics, the development of different approaches involving many voices at many levels

is viewed as beneficial by some, but insufficient

by others. A widespread, pluralistic approach

has advantages over a single national commission by fostering diversity; no issue becomes

captive to any central authority. Another advantage is that individuals who will be the actual

implementors or enforcers of the guidelines have

more opportunities to participate in the process.

Regional or local approaches also allow a community’s values to be integrated into local political processes.

Nevertheless, the diversity in bioethics organizations-while bringing the debate to the

State, local, or institutional level-cannot always succeed in addressing areas that require

expansive access to information and expertise.

As much as a practitioner or local organization

would like to keep abreast of developments in

bioethical analyses, expedient decisions often

must be made. The availability of guidance that is

consistent with a broader, national approach can

be invaluable and sometimes even preferred

(91 )-i.e., ad hoc decisions might be appropriate

I IOMis part of the National Academy of Sciences, a private, nonprofit organization established by Federal charter to advise the Government

on scientilc matters. ‘I’he majority of its studies are undertaken at tlw requ~t of the executive branch. In 1992, it began, on its own initiative,

a broad study of methods of bioethical problem solving by society, including government community bodies, professional societies, and

religious groups. The study is not confiied to formal co remissions and agencies, and publication is expected in early 1994.
sometimes, but guidance in the form of generally

agreed upon principles helps maintain a level of

consistency and comparability across the health

and legal professions (60). A Federal body can

identify areas of national consensus or division.

Thus, while OTA uncovered a range of

opinions on the optimal framework to incorporate bioethics into U.S. public policy decisionmaking, OTA found strong sentiment on the

need for a Federal initiative, or initiatives, that

would involve diversely trained individuals to

monitor, analyze, and report on the interface

between ethics and medicine, health care, and

biomedical and behavioral research. Such organizations could be charged with the responsibility of informing legislators, regulators, judges,

health care providers, scientists, and the lay public about the ethical implications raised by new

situations in medicine and biomedical research.

There are pitfalls attendant to centralization,

however, including a tendency to lose flexibility

in interpretation, diffusion arising from forced

consensus (6,41 ,89), and the potential for capture

by political interests. Yet, centralization brings

authority to a process that is rarely achieved with

decentralization. A Federal effort generally can

exceed private or State resources. It also carries

cachet, as well as a nationwide power to gather

data, convene meetings, generate relevant analyses, and invite testimony. The process by which

this background paper was produced demonstrates this value: Though allocated a limited

budget and a short timeframe, the cooperation of

workshop participants, survey respondents, interviewees, and reviewers moved forward because it

was a congressional effort. For better or worse,

professionals, Members of Congress, or State

legislators assign different weight to groups that

they have created than to other groups in operation. Nevertheless, private, professional, local,

and national approaches are not mutually exclusive; all are desirable.

Government-sanctioned commissions allow debates about contentious issues to go forward in a

somewhat less politicized way than is possible on

Chapter 3-Prospects for the Future I 27

the floors of Congress or a State legislature.

National commissions provide a vehicle to handle

issues that are amenable to consensus building, or

at least to an elaboration of conflicting views.

Ideally, they gamer the esteem of policymakers

and experts by serving as a forum to:

●

●

●

●

●

●

●

●

crystallize a consensus or delineate points of

disagreement;

identify emerging issues;

defuse controversy or delay decisionmaking;

propose regulations, develop guidelines, or

formulate policy options;

review implementation of existing law and

policies;

aid judicial decisionmaking;

educate professionals and the public; and

promote interdisciplinary research (15,18,

53,91).

Still, commissions tend not to be ground

breaking intellectually (13), although they can

summarize current thinking into a form meaningful for policymakers (13,15). Further, commissions can clarify issues and offer useful critiques

of public policy, but they lack the moral and political authority to decide what ought to be done (57).

Nevertheless, the process of convening a commission for the Federal Government can be an

opportunity to create the environment in which

political action becomes possible by gathering

policy relevant information and injecting it directly into the policy matrix. In doing so, commissions can often consider controversial issues

independent of the regular political process and

its constraints (72). Commissions cannot quiet all

bioethical concerns, but can provide a broadly

accepted basis for understanding the issues and

propose particular policies to cover most situations (15).

The history of regulations governing the participation of humans in research provides an example of the validating powers of national commissions. In 1973, the then Department of Health,

Education, and Welfare (DHEW) proposed rules

on research involving human fetuses. The rules,
28 I Biomedical Ethics in U.S. Public Policy

which were published in revised form in 1974,

generated a storm of controversy and resulted in

heated debate in Congress. The bureaucrats who

had prepared the rules had done a reasonable job

of examining the literature and putting together

thoughtful, well-articulated proposals, and they

were surprised by the ensuing debate (52).

Eventually, Congress created the National Commission and assigned it the task of addressing

fetal research, which it did in about the required

4 months (85). What the Commission recommended was similar to that originally proposed,

but this time the substance was received with

praise and approval from all sides (52). In politically sensitive areas of debate, sometimes the

messenger is more important than the message.

WHAT TYPES OF FORUMS SHOULD

BE CONSIDERED?

Before considering the specific elements of any

future effort, decisions about proposed structure

and function must be addressed. Past Federal

bioethics initiatives provide a guide should Congress decide to launch a new effort or efforts.

OTA identified three basic types of organizational models that should be considered:

. continuous/standing,

. term limited, and

. ad hoc.

Do certain topics or areas of inquiry lend

themselves to a particular structure? If so, then

the scope and issues Congress believes a

commission must address could drive the type

of policy body that would be most appropriate

to establish. Linking the class of issue to the

commission structure might help ensure optimal

consideration in a timely, effective, and economic

manner. Less than this could endanger patients or

research subjects, delay decisionmaking and lead

to gaps in policy implementation, or interfere

with vital research.

OTA identified two general classes of issues

for which bioethical analyses have been applied: specific classes of, or protocols in, biomedical or behavioral research involving human

subjects (table 3-1) versus broad-based issues

related to medical practices, health care, or the

social implications of research (table 3-2). The

following sections analyze these two categories

within the three general models: an ongoing body,

a term-limited commission, and an ad hoc effort.

■ Standing Bodies

As part of its work, the National Commission

concluded that ethical deliberations involving the

review of protocol-r classes of protocols—

arising from controversial biomedical and behavioral research (table 3-1) warranted a standing

body. Despite its demise, EAB was chartered for

this purpose and was the only Federal initiative

intended as a continuing body. OTA concurs

with the National Commission’s recommendation that a standing body is appropriate to

consider the ethical implications of certain

protocols or classes of federally funded biomedical and behavioral research. Researchrelated issues-e.g., AIDS vaccine protocols or

clinical trials using human growth hormone in

children without identifiable disease (2,69)-

are ongoing, and any single proposal that

raises novel ethical questions can appear suddenly.

An ongoing entity in the model of EAB would

be beneficial. Without an EAB-like body to

provide guidance, the Federal Government has

turned to separate ad hoc panels to perform

precisely the functions of an EAB—including the

Fetal Tissue Panel and the committee to examine

human growth hormone trials in children more

recently, as well as groups to evaluate other

protocols in children or prisoners in the past. In

fact, recognizing new questions can arise with

any proposal, NIH recently established standing

bodies called protocol implementation review

committees to identify potentially sensitive intramural research (68,69); the new panels do not,

however, examine extramural research.
Chapter 3-Prospects for the Future I 29

Table 3-l—Biomedical Research Topics That May

Raise Unresolved Ethical Issues

Clinical trials for anti-addictive medications

Clinical trials in children of synthetic human growth hormone

for cosmetic versus therapeutic uses

Clinical trials in women and minorities

Compassionate uses of gene therapy outside controlled

clinical trials

Conduct of AIDS vaccine trials

Drug trials and clinical studies of individuals with dementia

Drug trials and clinical studies of individuals with mental

illness, e.g., schizophrenia

Embryo research

Fetal research

Genome research on aboriginal human populations

Involvement of women of childbearing age in drug trials

Large family pedigree genetics research

Research involving RU 486

Rules governing research where patients pay for clinical

research through service fees

Update of what institutes “minimal risk,” “innovative therapy, “ “experimental treatment,” and other terms of art

embedded in current regulations

SOURCE: Office of Technology Assessment, 1993.

Nevertheless, the current climate to eliminate

nonmandated Federal advisory groups poses a

significant barrier to reconstituting an EAB-like

body; the Clinton Administration has mandated

the termination of not less than one-third of

bodies not required by statute (Executive Order

12838; 58 FR 8207). In the face of significantly

shrinking numbers of Federal advisory committees, the prospect of DHHS reviving a

former body seems unlikely. Thus, Congress

could require DHHS to establish an ongoing

panel to evaluate ethical issues raised by

federally funded biomedical and behavioral

research. A congressional mandate for an EAB

per se is not necessary, but a directive to establish

one and clarify its scope ultimately might be

needed. Without legislation, the future of a

standing body likely will be held in abeyancedespite the fact that a backlog of research-related

issues exists (table 3-1) and that the everaccelerating pace of biomedical research is sure to

generate more. Ironically, though the United

States no longer has

nature, it is the most

other countries.

an ongoing body of this

common type of effort in

 Term-Limited Commissions

The National Commission, the President’s

Commission, and BEAC were all bodies whose

terms were limited by Congress through sunset

provisions. As mentioned, the National Commission examined issues primarily related to human

subjects research. The President’s Commission’s

focus was largely policy analysis of broad-based

topics related to clinical practice, though it also

examined research-related issues. BEAC issued

no reports.

Thus, on the surface, commissions that have a

freed term appear appropriate for either class of

issue. Nonetheless, as just discussed, issues raised

by controversial research appear best suited to a

standing body. Term-limited entities could attend to the types of issues that were the focus

of most reports produced by the President's

Commission—broad-based topics arising from

Federal activities or interest in medicine,

health care, or research (table 3-2). Again,

however, establishing such an entity probably

would require congressional legislation because of the move to fewer Federal advisory

bodies (Executive Order 12838; 58 FR 8207).

Since the United States established the President’s Commission, similar bodies have been

created abroad—most notably in Denmark,

Table 3-2—Possible Bioethical Issues

for a Broad-Based Effort

Animal patents

Dilemmas arising in emergency care situations

Euthanasia

Genetic privacy

Health care providers’ equity Interests and self-referral

Organ transplantation issues, including availability and

xenografts

Patenting human tissues, cells, or DNA

Research collaboration and conflicts of interest

SOURCE: Office of Technology Assessment, 1993.
30 I Biomedical Ethics in U.S. Public Policy

France, and the United Kingdom (app. A)-but

all appear to be permanent bodies. Despite this,

OTA found little sentiment for establishing a

permanent, broad-based bioethics initiative modeled after international efforts or those in New

York and New Jersey. Of concern is allowing a

commission to become a self-perpetuating body

in search of a mission.

■ Ad Hoc Initiatives

By its nature, an ad hoc initiative is confined to

a single topic, and one may be convened at any

time (box 3-A). In these respects, integrating

bioethics into public policy decisionmaking in an

ad hoc manner offers the advantage of flexibility.

Another advantage is that members can be

selected for expertise on the specific topic at

hand. Similarly, convening several groups means

more people have an opportunity to closely

influence the process. And of course if no ad hoc

efforts are convened, no money will be spent.

However, OTA found consensus that ad hoc

initiatives are the least desirable mechanism to

address bioethical dilemmas. Each individual

initiative requires a certain critical energy, financial support, and personnel level before it becomes functional. Repeatedly starting committees or panels to review controversial protocols or

practices when commonalities among topics

exist-and could be analyzed by a single body—

not only results in a less than optimal use of time,

Box 3-A—Bioethics and the National Institutes of

Health Revitalization Act of 1993

Congress has pursued legislation to prevent the secretary of the Department of Health and Human

Services from making unilateral decisions that deny, based on ethical considerations, funding for

peer-reviewed, approved projects. Two events prompted this legislation: the secretary’s moratorium on

fetal tissue transplantation research and the decision to withhold funding of the adolescent sexual

behavior survey (59). The National Institutes of Health Revitalization Act of 1993 (S. 1 and H.R. 4)

contains language intended to prohibit the Secretary from withholding funds for research on “ethical

grounds” unless he or she convenes an ethics advisory board, or’’ethics board.” No definition of ethical

grounds is offered; what constitutes ethical grounds appears to be left to the Secretary.

Despite the confusing terminology created by using “EthicsAdvisory Boards’’ [sic] out of historical

context, the entities created by this Act would be wholly dissimilar to the original EAB. These bodies

would be implemented only if the Secretary refused to fund a successfully peer-reviewed proposal.

Thus, they are ad hoc in nature, and can be viewed as a subset of review panels because they are

instituted only in the rare instances in which funding is withheld or withdrawn on ethical grounds. A wide

range of research proposals that are funded-but might benefit from an EAB review-go unevaluated.

ln the event a Secretary withholds funds, he or she must appoint an ethics board after considering

nominations for 30 days; 180 days later, the body must submit a report to the Secretary and Congress.

The legislation directs that an ethics board shall be composed of 14 to 20 individuals and shall include

at least one attorney, one practicing physician, one ethicist, and one theologian. No fewer than one-third

and no more than one-half shall be biomedical or behavioral scientists. The board would be staffed by

the National Institutes of Health and would expire 30 days after it submits its report.

Should the majority of the ethics board recommend that the Secretary not withhold the monies for

the research on ethical grounds, the research shall be funded unless the Secretary finds that the board’s

recommendations were “arbitrary and capricious.”

SOURCE: Olf~ of Tmhnology Asaessman$ 1S93, basedon “S. 1:’ CoWressionalIUXXW13%:S1SOS-S1S 03, 1393; and “HR.4R

(%gredomdl?eootil%): H1?34-H11S5, 1893.
Chapter 3—Prospects for the Future I 31

money, and people, but does the public, policymakers, and other interested parties a disservice.

Additionally, the initial learning and acculturation process of any group requires time and effort

(23,52,92) and must be repeated each time an ad

hoc panel is convened. Later reports of the

President’s Commission, for example, were considered better by its executive director because of

this phenomenon (17). The work of the National

Commission also improved substantially over

time; its report on prisoners was much more

polished and sophisticated than its preceding

report on fetuses (48,49).

Continuity also can contribute to a body’s

credibility (53). Because ad hoc efforts cease to

exist after a topic is addressed, any credibility

gained with the passage of time or completion of

projects is immediately lost. That is, a standing or

fixed-term body, by doing a good job on one

topic, garners the respect of a variety of constituencies and can transfer that credibility to its

handling of new topics (52).

WHAT ELEMENTS ARE

IMPORTANT?

The experiences of the National Commission,

EAB, President’s Commission, and BEAC illuminate a variety of key considerations for any

future effort to create a national bioethics board or

commission. In devising a strategy for addressing bioethical issues in a national policy context, OTA found six factors predominate regardless of the type of body established:

●

●

●

●

●

●

budget, including staffing;

the charge (i.e., mandate and flexibility to

control the agenda);

appointment process;

bureaucratic location;

target audience(s); and

reporting and response requirements.

Absent from this list is politics; the very nature of

creating a new entity subjects each of these

factors to the pressures and whims inherent in the

political process. An inadequate or ill-suited

approach in any single area can undermine the

successful implementation of a new national

commission or board, and a deficiency in a single

aspect+. g., funding or the appointment process-can doom an effort to total failure.

■ Funding

Although each factor is important, funding

is foremost. A successful initiative begins with

adequate funding (box 3-B). Sufficient funds to

hire an adequate number of qualified, professional staff are essential; otherwise the entity is

staffed piecemeal or by castoffs. Also necessary

are monies for contract papers and public hearings or meetings beyond the Washington, DC

locus. Commissions are most successful when

they can weigh both empirical information and

conceptual analyses to derive useful policy options. Thus, they must have the capability to

gather data. Public meetings and hearings—

providing an educational function for both commissioners and the public-are imperative. Finally, providing funds for publication and dissemination of a commission’s work is essential.

The National Commission and the President’s

Commission had reasonable funds for staffing

and activities—as initially did BEAC. Likewise,

the commissions and their staffs had broad

contracting authority and funds to bring in

additional expertise, as well as to hear witnesses.

Both capabilities served the staff well by expanding their knowledge base; staffing can also

provide balance. For example, staff can weigh

and analyze the persuasiveness of particular

points of view without regard for the sophistication or eloquence of the defender of that position.

Without staff to mediate between the more and

less sophisticated presentations, a commission’s

policy documents run the risk of becoming

skewed (4,8,14,17).

The National Commission did not have a

specific appropriation, but during its 4-year

lifespan received about $5 million from DHEW

(93). Nevertheless, the need for specific appropri-
32 I Biomedical Ethics in U.S. Public Policy

Box 3-B—What Might a New Effort Cost?

Estimating a potential budget for a new bioethics entity depends on many factors, including the

number of members, staff, meetings, and reports. Start-up capital costs also will vary based on size and

whether anew body is housed within an existing Federal agency or office, or created as an independent

body. Despite these caveats, funding projections are possible. Budgets can be constructed by

examining current Federal commissions and agencies performing policy analysis. Examining the

expenditures of previous bioethics bodies is less useful bemuse of the significant changes in basic

business costs since their existence-e..g., rent, computer hardware and software, telecommunication

technologies, travel for commission members, and salaries.

Although a comprehensive survey of budgets for commissions, taskforces, or committees was not

possible, funding Ievels for a new standing body (like the Ethics Advisory Board (EAB)) and a new

term-limited commission (like the President’s Commission) are presented based on OTA’s experience

with producing policy reports and a brief inspection of a few other efforts. For each, certain assumptions

are described. Clearly, changes in any assumption would affect the funding required.

Standing Body: $744,000 annually. This budget assumes such a body will be located within an

existing agency. it assumes 20 members will be appointed; by comparison, the charter proposed in 1988

for a reconstituted EAB envisioned 21 members (53 FR35232). The cost also assumes five staff (i.e.,

five full time equivalents (FTEs) represented by four analytic and one support staff). Compared to the

initial EAB’s eight staff, this represents about a 40 percent reduction in FTEs. The cost also assumes

contracting authority at 30 percent of staff costs. As with the proposed charter, it assumes ten 1-day

meetings will be held-at least three outside of Washington, DC-and, thus, includes funds for travel

and per diem, as necessary. The annual budget assumes three small documents (on the order of

position papers, not full report and one full report per year, and includes printing and distribution costs.

Overhead costs of computer literature searches, books, and journal subscriptions are included.

However, because this body is assumed to be housed within an existing Federal agency or office, the

budget does not include costs such as rent or utilities. Nor are costs associated wlth personnel who

manage procurement, reimbursement, computer support or other general services included.

Term-limited Body: $1,920,000 per year for 4 years. This estimate assumes a new term-limited

body will operate as an independent commission. The budget assumes 15 members will be

appointed--4 more than the President’s Commission. it also assumes 12 FTEs (9 professional and 3

support positions) will staff the new effort-approximately 40 percent below that of the President’s

Commission. The cost includes six 2-day meetings in Washington, DC, and four l-day field hearings

outside Washington, DC, annually. Also included are initial outlays for equipment and annual costs for

rent, utilities, and other items (e.g., supplies, books, journals) and services (e.g., mail, photocopying,

and computer support). The budget also assumes six reports will be produced over the 4-year term, and

includes contracting authority-for papers and editing-equivalent to 40 percent of staff costs, as well

as printing and distribution costs. in the first year, funds will be needed for certain capital costs (e.g.,

computers, phones, facsimile machines, and photocopiers) that will not be needed in subsequent years.

However, contracting, meeting, and publication costs will be incurred chiefly in later years as the

commission begins its formal work. OTA’s calculations revealed the average annual cost would be

about the same between the first and later years, despite the shift in spending priorities.

SOURCE: Office of Technology Assessment, 1993.
Chapter 3—Prospects for the Future I 33

ations can be critical; EAB’s experience demonstrates this point. EAB was born from the

National Commission, which had anticipated that

EAB would be a continuing body. However, in

the course of congressional deliberations after the

National Commission’s conclusion, the President’s Commission was established with funds

initially diverted from the EAB because policymakers failed to distinguish their distinct purposes (17,18). On the other hand, fiscal support

could have been drawn from other U.S Department of Health and Human Services (DHHS)

funds after 1980--as presumably was intended

when plans to recharter EAB emerged in 1988 (53

FR 35232).

■ Mandate and Agenda Setting

The focus and mandate-global issues versus

research issues, regulatory or advisory-influence an initiative’s authority or lack thereof.

Additionally, as discussed earlier in this chapter,

the form a bioethics body takes-standing versus

limited term--can be linked to its agenda and

mandate. Thus, delineating a mechanism to set

the scope of topics also is a consideration for

Congress.

A commission’s charge should be structured to

provide guidance, if not requirements, for the

selection of topics or issues for study. Circumscribing too narrow a function obviates the

potential early warning benefit of bioethics commissions. Drawing too broad a boundary could

move a commission to examine issues-e. g.,

health care reform-that Congress or the President have tasked to others.

Since Federal regulation over medical practices or biomedical research is limited to federally

funded activities, Congress might restrict an

agenda to areas with clear Federal authority—

e.g., patenting animals. On the other hand, an

agenda need not be limited by current Federal

regulatory authority. Issues that are currently

entirely matters of State law--e. g., assisted suicide (32)-could fall under the Federal rubric

should they someday involve Federal reimbursement policies. Moreover, government deliberations can provide important information and

identify common ground in areas generally the

domain of States+. g., animal-to-human organ

transplants or assisted suicide-even when no

Federal regulatory or funding role exists.

Each of the three previous congressionally

created bioethics bodies was required to assess

certain specific topics, but their flexibility to

embark on analyses of other issues varied. A

combination of mandated studies and the

opportunity for commissioners and staff to

identify emerging issues maximizes the use of

talent, time, and money. No single best mechanism, however, clearly prevails.

One approach would be for the commission

itself--rather than the sponsor—to initiate studies of nonmandated topics, under the belief that

members and staff are in the best position to select

study topics because of their expertise and

detachment from political structures. That is, if

properly and appropriately appointed, a commission should embody the capacity to select topics

that are of shared concern to all (21). On the other

hand, federally funded commissions are public

bodies created by officials who will be held

accountable to the public. To address this conflict, Congress or the President could be permitted

to suggest or mandate topics—with the Commission retaining, or not retaining, the authority to

refuse such suggestions.

Congress struck a balance in the authority it

gave the President’s Commission. It required that

specific topics be addressed, but also provided an

elastic clause that allowed either the Commission

or the President to add additional topics. To

prevent the use of the President’s Commission for

special interests, Congress explicitly excluded

itself from being able to provide further topics; a

practice, however, that would seem unlikely to

work for a standing body. In fact, the President’s

Commission responded to a single additional

request by President Carter and his Science

Advisor and explored the ethics of gene therapy
34 I Biomedical Ethics in U.S. Public Policy

(17). Similarly, the President’s Commission

undertook the issue of foregoing life-sustaining

treatment on its own volition, and the report

became one of its most influential and lasting

(10,17,18,37). The National Commission also

initiated topics on its own (49).

Finally, depoliticizing a commission’s mandate is impossible (6), but a priori avoiding

extremely politicized issues, such as abortion,

enables a commission to be more efficient and

productive (as in the case of the New York State

Task Force (56)). The short life of BEAC—

caught in the abortion controversy crossfireprovides the most persuasive argument for this

approach (19).

■ Appointment Process and

Composition

A commission’s mandate affects the nominating process. In turn, commission (and staff)

structure and composition shape substance (62).

With a narrow scope and small size, the tendency

might be to select individuals with narrow,

predetermined ideologic views for membership,

thus diminishing the chances for success. On the

other hand, a mandate created for specific topical

needs, as for the National Commission, New

Jersey Bioethics Commission, and New York

State Task Force, can be executed effectively if

the body’s membership is balanced to reflect

diversity and specific areas of expertise.

Today’s explosive growth in the field of

bioethics and in the number of individuals described as bioethicists has enhanced the Nation’s

capacity to discuss bioethical issues. At the same

time, these developments increase the risk of

bodies rendering commentary that is ingrown or

out of touch with the real worlds of health care

providers, scientists, or the lay public. Thus, any

new organization must be representative of society at large.

Diversity in race, ethnicity, gender, and

professional experience is a paramount factor

in appointing commissioners and staff (17,44,66).

Ethics involves values, and a commission with

monolithic membership or stafffing cannot

hope to adequately represent the diverse range

of perspectives in American society. Additionally, the processes of a bioethics commission—

that of formulating guidelines or regulations-is

part social knowledge (appreciation of the problems rooted in experience) and part theory (ethical, legal, and philosophical). This means a

deliberative body should be comprised of both

practitioners and theoreticians.

The National Commission’s success, for example, has been credited to its multidisciplinary and

multiexperiential composition (44,66), although

whether it was stacked in favor of research has

been debated (3,38,61). Similarly, the success of

the President’s Commission has been attributed

to the broad range of professionals that comprised

it (17,62), although whether philosophy was

adequately integrated has been questioned (11);

on the other hand, questions also have been raised

about the role of philosophers in addressing

public policy issues (7,39,47,54,55).

Ideology is a destructive criterion in appointing a bioethics committee. While selecting

members solely on the basis of their stance on a

particular issue-such as abortion-might be

viewed by special interests as useful, such an

approach is shortsighted and likely to create

gridlock. There is no way of predicting which way

people will move on issues with which they are

unfamiliar. Focusing solely on the views of

potential panelists for one contentious issue, such

as abortion, can delay the actual work of a

committee, perhaps indefinitely; other issues, for

which there might be broad consensus, are not

given the floor.

The experience with BEAC illustrates this

point. When BEAC was formed, it was believed

that, although the membership was deliberately

and strategically split on abortion, the panel

would split in many different ways once it

addressed more general issues—such as genetics.

This supposition was apparent by the second

meeting. It never got the chance to develop,
Chapter 3-Prospects for the Future I 35

however, because the rancor over abortion-and

congressional focus on the prochoice/antiabortion makeup of BEAC members—prevented the

congressional Biomedical Ethics Board (BEB),

the oversight body comprised of Senators and

Representatives, from permitting further work to

proceed (18,20).

OTA found no consensus on the optimal size of

a commission, A smaller body, e.g., the National

Commission with 11 members, lends itself to

quicker development of the interpersonal dynamics and collegiality necessary for consensus

building; it is also easier to handle administratively, but might bog down in ideological demagoguery. In contrast, a larger body, such as the

current 41-member French commission, could be

more inclusive and might be less susceptible to

political line drawing (46). On the other hand, a

body this large might be unwieldy and require

subcommittees or task forces to work effectively,

which adds an additional layer of bureaucracy.

OTA also found no consensus on the ideal

mechanism to appoint members. Successful commissions have been appointed wholly by the

President, his agency designee, or by a statutorily

prescribed formula that usually involves the

President, the Speaker of the House, the House

Minority Leader, and the Senate Majority and

Minority Leaders (72). Another model is the

Advisory Panel for Alzheimer’s Disease. This

independent panel is congressionally mandated to

advise DHHS and is staffed by the National

Institute on Aging, but OTA appoints panel

members—a process viewed as both impartial

and expeditious (20). OTA also successfully

appoints members to the Prospective Payment

Assessment Commission and the Physician Payment Review Commission. BEAC’s members

were appointed solely by its congressional oversight board, the BEB, and BEAC expired due to

BEB’s infighting when a vacancy needed filling.

OTA did find general consensus on the merits

of rotating membership, With the National Commission, members were appointed and toiled for

the full 4 years of the commission’s life. One

former member of the National Commission

commented that by the conclusion of its work,

ideas had become less fresh and responses reflexive, rather than open and discursive (44). Infusing

new ideas and personalities by limiting members’

terms carries some cost, however. Commission

dynamics take time to develop; overly short term

lengths would strain a consensus building process. The membership of the President’s Commission was rotated and, on occasion, rotations

disrupted the process of completing reports in

progress (15,17). Nevertheless, rotating membership keeps a body from appearing to be politically

locked in and should be favored.

■ Location

Deciding where to locate a Federal bioethics

organization depends on its mission and purpose.

In some cases it might be best to locate an ethics

advisory group in the agency whose work it

reviews, thereby maximizing the chance that its

recommendations will be implemented. In other

cases, the work of the advisory body might be too

closely related to the work of the agency to

accomplish anything-i.e., an independent body

would be optimal.

The National Commission, for example, was

formed because of growing concern about the

treatment of human subjects in research. A

crucible of debate over fetal research forced the

issue, resulting in policy discussions on research

involving human subjects. Most of these issues

fell squarely in the domain of DHEW/DHHS, and

Congress placed the National Commission within

that agency in 1974. In retrospect, although the

National Commission operated with a good deal

of autonomy (63), one factor that contributed to

the Commission’s success was its close proximity

to the agency it was reviewing and to which it

made its recommendations (23,52). On the other

hand, locating a body within the concerned

agency could create a perception of conflict-i. e.,

that the ethics body is not wholly independent.

EAB was housed within DHEW/DHHS, and
36 I Biomedical Ethics in U.S. Public Policy

although the impact of this body was less than that

of the National Commission, it was significant

(51). Had it been given time, its effectiveness in

reviewing the Department’s work could have

been fully evaluated: Either its work would have

been successful in terms of departmental implementation or it would have been embedded in the

bureaucracy and ignored (52).

In contrast, the President’s Commission has

been deemed a success, in part due to its

independent standing and freedom from Congress

and the executive branch. Had it been integrated

within DHHS, it is uncertain whether the Commission would have survived political interference by Congress and the executive branch, given

the political climate of the early 1980s (17).

A prime example of location undermining a

body’s success was the failed 1985 attempt to

establish BEB and BEAC. BEB created a partisan

logjam along abortion lines that prevented the

deliberative committee—BEAC-from ever completely considering an issue, and BEAC’s demise

can be attributed directly to congressional wrangling and lack of independence (18-20).

Besides these models—within an agency of the

executive branch, an independent commission of

the Federal Government, and attached to Congress-proposals also have suggested that OTA

or IOM house a bioethics body (1 ,70). When such

proposals were under consideration 8 years ago,

OTA, as a congressional agency, was perceived

as potentially subject to excessive politicization

(l). IOM was criticized as a body ultimately

captured by medical interests (l), even though

IOM policy and membership includes nonmedical perspectives. The passage of time and the

increased experience and prominence of both

OTA and IOM might now mute these objections.

Notably, IOM is not subject to the Federal

Advisory Committee Act (5 U.S.C. Ap. 2, §1 et

seq.), which requires open meetings. IOM routinely reserves the right to conduct closed committee meetings, which is seen as a strength (30)

or a weakness (14,15,92). With the exception of

the New York State Task Force, all Federal and

State bioethics bodies that OTA examined did not

hold closed deliberations, though many international entities do.

Thus, in considering location, Congress can

look to a range of historical models and

proposals. It could also examine whether the

locus for a bioethics commission should be in the

Executive 0ffice of the President-e. g., attached

to the Office of Science and Technology Policy

(OSTP). OSTP, however, has limited familiarity

with biomedical ethics issues, although the legislation establishing the President’s Commission

mandated that OSTP’s director have a liaison

with the Commission (42 USC § 300v). Furthermore, while locating a commission in OSTP

might lend stature to the effort, Congress would

need to address the historical understaffing of this

office (24,45).

■ Client

Target audiences for the work of a new

bioethics entity include Congress, the executive

branch, the academic community, health care

providers, and the public. As just discussed, a

body’s bureaucratic location might define the

primary client, but any new effort will affect—

and hence should strive to serve-all parties. For

a bioethics entity to operate effectively, restraints

and controls must be in place to discourage or

prevent political meddling with the staff or the

conditions for operation-regardless of where the

body is housed or who the principal client is.

OTA found consensus on the need for autonomy and independence from both congressional interference and mischief from the

executive branch.

Through the 1970s, Members of Congress, the

President, and executive branch agency personnel—

regardless of political afffiation-largely viewed

commissions from the perspective of patrons of a

process, not players in it (23). This culture

reversed in the 1980s, resulting in executive

branch interference with Federal regulations—

e.g., the lack of an EAB to review protocols for
Chapter 3—Prospects for the Future I 37

human in vitro fertilization (IVF) (ch. 2; 77).

Also, if an EAB had been in place, the piecemeal

funding and staffing of the NIH Fetal Tissue

Transplantation Research Panel would have been

unnecessary. Similarly, intrusion by Congress

resulted in the failure of BEAC to ever initiate a

project (17,18).

Finally, as mentioned in chapter 2, the lay

public is increasingly interested in and involved

with resolving bioethical issues. The ability to

operate in relative obscurity in the early history of

biomedical ethics contributed to the success of

the National Commission (44,66,92). Such a

situation would be impossible today; intense

public scrutiny exacerbated the difficulties experienced by BEAC (16,20).

■ Reporting and Response

Requirements

To whom and how the group shall report, in

what manner, and what response should be

required are key factors for congressional consideration. In fact, to whom a group should report

its final work seems to raise little controversy;

what is problematic is injecting politics during

the deliberative process. In practice, a new

commission could be required to report to Congress, the executive branch, or both. For example,

a new body could be responsible primarily to the

executive branch, with Congress maintainingg its

traditional oversight role.

Even the most successful attempts to tackle

bioethical issues will be ineffective if the results

of those deliberations are censored or poorly

distributed. The National Commission published

its own work, which was inadequately distributed, and EAB’s work remains even more difficult to trace because of poor dissemination. In

contrast, the President’s Commission greatly

improved the manner in which findings were

reported and distributed; reports were published

and sold by the U.S. Government Printing Office.

Because one goal of bioethics commissions is

public and professional education, adequate funds

and a plan for widespread public dissemination

and reporting beyond the designated client are

vital.

Nevertheless, whether and how the client

must respond is probably more important

than how the commission must report and

disseminate (23,52). Should Congress create a

new commission or board, it could include a

forcing clause for accountability of the target

client(s). For example, EAB addressed such

controversial issues as fetoscopy, research with

the human embryo, and freedom of information

and the early release of clinical trial data. Its

recommendations, however, were largely ignored

by its client, the executive branch-even when

the report was unanimously approved (52). The

most glaring example of this was the 1979 report

on IVF (84). Yet, by using it as background for

professional practice guidelines, the American

Fertility Society and other organizations interested in conducting IVF research in a responsible

and ethical manner implicitly endorsed this

report.

In contrast, Congress included a “forcing

claus e in the legislation that created the National Commission. The clause did not require the

Secretary to accept every recommendation made,

but it did require the Secretary to accept recommendations within 180 days or publish reasons

for not accepting them in the Federal Register.

Such a clause forces some sort of decision or

action on the part of Federal officials in response

to a report. In fact, EAB was created as a result of

a National Commission recommendation. The

Secretary had to accept the recommendation or

publish reasons for not accepting it, and the

political untenability of rejecting an EAB was

greater than the risk of creating it (52). Ironically,

an unanticipated outcome was Secretarial censorship of EAB activities because the regulations

associated with chartering EAB, unlike the legislation creating the National Commission, forced

no response to EAB reports (52). Even so, a

forcing clause does not guarantee responsiveness:

In violation of the law (48), DHHS has failed to
38 I Biomedical Ethics in U.S. Public Policy

issue final regulations related to the National

Commission’s work on research involving the

“mentally infirm” (87).

Finally, an open question is whether a commission should be directed to achieve and report

consensus on an issue or to consider and articulate

the merits of competing values (1,41,89). Congress could look to three successful models: the

National Commission and President’s Commission for consensus and OTA for analyzing the

range of viewpoints.

SUMMATION AND PROSPECTUS

Does the United States need a governmentsanctioned body, or bodies, dedicated to deliberating about the ethical issues raised by biomedical

research, medical innovation, and health care?

What have past efforts accomplished?

In only two decades, the U.S. Government’s

forays into bioethics have had lasting, measurable

impacts (15,22,36,48,62). Federal regulations to

protect human research subjects owe their existence in their current form to the National

Commission-e.g., the National Commission’s

report on research involving children (86) raised

controversial issues, but the guidelines finally

proposed received praise and approval from all

sides (49). In clinical practice, for example, the

President’s Commission shaped subsequent public debate in health care settings, legislatures, and

courts about patient directives on life-sustaining

treatments.

If Congress decides to create a new bioethics

commission, it can look to the history of Government’s involvement in bioethics for a wealth of

experience and information. Although it is difficult to generalize whether a particular factor is

specifically associated with ultimate success or

failure-each commission had a slightly different

model or existed in a different political climate—

lessons can be learned from the National Commission, EAB, President’s Commission, and BEAC.

By examining this rich history of activity, OTA

found six specific elements contributed to the

success or failure of past efforts and so should be

considered in devising future strategies. Not

surprisingly, the budget is important, but mandate, appointment process, bureaucratic location,

targeted client, and reporting and response requirements are also key. Absent from the list is

politics, since creating a new body is inherently

political, and the system will affect each factor.

Whether a standing, term-limited, or ad hoc

commission should be established might depend

on the type of issues Congress would like

analyzed. An ongoing body in the model of EAB

appears superior for examining questions raised

by controversial research involving human subjects. A term-limited body like the President’s

Commission can address both research-related

issues and broad-based topics in bioethics, but

might be best for the latter if a standing body is

available to address research topics. Still, in an era

of shrinking numbers of Federal advisory bodies,

the barriers involved in creating two forums,

though for distinct purposes, could prove insurmountable. Ad hoc commissions can handle both

categories, but OTA found consensus that ad hoc

panels are less desirable-i.e., to be favored only

as a last resort.

Past Federal bioethics efforts have been varied,

innovative, and largely successful, but not enduring. Today, Congress stands at a crossroad. How

best to incorporate bioethical analyses into policy

decisionmaking is the issue currently facing

Congress-one made especially difficult as fiscal

realities mean fewer Federal advisory bodies and

fewer staff to support them. Congress must decide

what opportunities to seize, and when and how to

move forward. Regardless of whether it creates a

new, broad-based commission, directs DHHS to

establish an EAB with a new mandate, or both,

Congress should somehow provide a voice for

biomedical ethics in public policy.
Chapter 3-Prospects for the Future I 39

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In the past few years, bioethics has become a global

enterprise, with commissions or institutes in the

Americas, Africa, Asia, Australia, and Europe. Though

no federally sponsored forum exists in the United

States, other governments and multinational organizations increasingly are establishing working groups,

committees, or commissions to deal with bioethical

issues.

In November 1992, OTA conducted a mail survey

of bioethicists and individuals in government offices in

47 countries. Individuals and groups in 35 countries

generously responded to OTA’s inquiry, and approximately 40 persons active in national and international

bioethics committees abroad also contributed by

telephone or in-person interviews. This appendix

describes national bioethics commissions abroad—as

well as a sampling of bioethics activity in regional and

multinational groups-based on the survey and information collected through other reports and the literature. The appendix also notes some common themes

about the structure and operations of international

bioethics entities. Finally, although OTA attempted to

be as comprehensive as possible, the limits inherent in

a short-term survey are such that the absence of a

description for any country does not mean a lack of

interest or activity in that country.

Appendix A

International

Bioethics

Initiatives

COUNTRY-BY-COUNTRY

ACTIVITIES

Abroad range of bioethics initiatives occurs abroad.

This section summarizes the wealth of information

obtained on individual countries, with a particular

focus on national bodies. (See also table 2-l.) The

following section describes data on multinational

efforts,

■ Argentina

In December 1992, the Secretary of Health, National

Ministry of Health and Social Welfare, created the

National Bioethics Commission. Its mandate includes

establishment and oversight of research subject committees, assessment of research protocols, and consideration of other issues in bioethics. A National

Commission of Bioethics and Health Research to

enunciate policies and survey bioethics research programs has also been proposed (116).

■ Australia

A number of federal and state bioethics commissions have contributed to health policy development in

Australia. For example, the New South Wales Law

Reform Commission on Human Tissue Transplants

influenced practice and policy in that field in the 1970s

43
44 I Biomedical Ethics in U.S. Public Policy

(73). In 1982, the Medical Research Ethics Committee

(MREC) was established within the National Health

and Medical Research Council (NHMRC) (analogous

to the U.S. National Institutes of Health) to formulate

guidelines for medical research. Compliance with

these guidelines was a condition of Federal funding of

medical research (17,35).

A more general group, the National Bioethics

Consultative Committee (NBCC), was established in

1988 by the Joint Meeting of federal and state

Ministers of Health and Social Welfare. NBCC’s role

was to advise the Ministers, and it was composed of

professionals from a number of fields. Its reports,

primarily concerned with human reproduction, were

intended to stimulate debate rather than reflect conventional, mainstream views, While the NBCC’s work

provoked much public discussion, it was opposed by

influential groups including churches, feminist organizations, disability groups, right-to-life organizations,

and most bioethics centers. The federal and state

Ministers of Health and Social Welfare withdrew their

support (47,1 19).

The functions of MREC and NBCC were consolidated in 1991 into the Australian Health Ethics

Committee (AHEC) at the NHMRC (16,47,1 19). Like

its predecessors, AHEC is multidisciplinary in membership, and its duties include policy development and

public education, as well as monitoring institutional

ethics committees. In 1992, the federal Parliament

changed the status of AHEC to involve broader

membership; it will also undertake wider community

consultation and will no longer be subject to NHMRC

in regard to issuing guidelines. AHEC is not viewed as

representing the community, but rather challenging the

community (47,1 19). In fact, it has lobbied against

bioethical decisions made by state parliaments and

committees (47,1 19).

While AHEC operates at a national level, the

constitutional responsibility for regulating health care

practice and research belongs to Australian states.

Thus, it is at the state level that there has been the most

bioethics activity, including exhaustive public consultation, consensus seeking, policy development, and

legislation. Several committees of inquiry were established in states, and three states have on-going

statutory committees composed of a minority of health

professionals and a broad range of other professionals

and lay people. Most such committees have examined

single topics, such as genetic manipulation, informed

consent, or reproductive technologies (17,47,66,1 19).

■ Brazil

Brazil’s National Health Council considers bioethics in its deliberations. Established in 1937, but

reorganized extensively in 1990, participants include

government officials, health care providers, consumers, and researchers. Additionally, the Federal Council

of Medicine, which was created in 1957 as part of the

Professional Councils on Health, is a professional

organization of doctors that operates independently of

the government. It enforces an ethical code for doctors

and oversees several regional councils that provide

guidance to professionals (82,87).

■ Canada

Both the Canadian Government and several provinces have considered bioethical issues in the context

of potential legislation recommended by law reform

commissions. In particular, the work of the Canadian

Federal Law Reform Commission, which concluded

its work in 1992, contributed widely to discussions on

bioethical issues. In addition, the Science Council of

Canada, now disbanded, produced several bioethics

studies (83).

In July 1984, the Medical Research Council (MRC)

of Canada established a Standing Committee on Ethics

in Experimentation which, with its Working Group on

Research Involving Human Subjects, accepted outside

consultation and recommended guidelines on research

involving human subjects to the MRC. The MRC

accepted the report as official MRC guidelines and

required that all research it funds be in compliance with

them (80). The National Council on Bioethics in

Human Research was established in 1989 by the MRC,

National Health and Welfare Canada, and the Royal

College of Physicians and Surgeons. This body is an

advisory group that aims to encourage ethical standards in biomedical and health research involving

human subjects. The Council defines guidelines,

advises institutional research ethics boards, and promotes professional and public education in research

ethics (83).

Another effort is the legislatively established, singleissue Royal Commission on New Reproductive Technologies, which is responsible only to the privy council
Appendix A—International Bioethics Initiatives I 45

and the prime minister. It has been charged with

performing a comprehensive and authoritative review

of Canadian policies, attitudes, laws, and practices on

current and forthcoming reproductive technologies.

Like all Royal Commissions, it is well-tided; in fact,

it is reportedly the most well-funded bioethics commission in the world-over CN$20 million, or nearly

CN$l per citizen. The Commission is chaired by a

physician and has four other members and a large

professional staff. Through more than 100 outside

contracts, it has sponsored extensive research to review

existing data. It also has held hearings and open

meetings around Canada and expects to publish its

reports as required in 1993 (69,1 10). Royal Commissions examining other bioethical issues can also be

created on an ad hoc, time-limited basis (126).

■ China

China has no general bioethics commission, although the Ministry of Health created an Ad Hoc

Expert Advisory Committee to draft a eugenics law.

Membership consists of 20 scientists, physicians, and

bioethicists. The Ministry is reportedly planning to

create a standing committee on policy issues stemming

from technological innovations in health care. The

Chinese Academy of Social Sciences, an academic and

policy institute that advises the government, also has

an active program in bioethics. This program has

sponsored several national conferences on bioethical

issues, sometimes with support from the Ministry of

Health (95).

 Czech Republic

Czechoslovakia’s 1989 revolution enabled the Czech

Republic to create the Czech National Commission of

Medical Ethics (Centralni Eticka Komise, or CEC) in

1990. CEC oversees the activities of numerous Local

Commissions of Ethics, located in hospitals and other

health care units that had previously existed in the

former Czechoslovakia. CEC consists of 28 members

appointed by the President of the Scientific Council of

the Minister of Health Care and two staff. Members are

not required to represent particular professions or

ideologies and receive no payment. CEC meets once a

month with no rules excluding public attendance (56).

■ Denmark

Currently, Denmark has two national bioethics

commissions with overlapping areas of interest, and

sometimes disagreement. The Central ScientificEthical Committee (CSEC) has been in operation since

1978 (58). It was created in the wake of the Helsinki

II declaration on human subjects research and has been

chaired by one of its drafters. It has a well-defined

responsibility to oversee all clinical and laboratory

medical science research involving humans (98).

CSEC originally operated via a voluntary arrangement

of professional groups and a government ministry, but

in 1992 it was given statutory authority. Currently, it

consists of two representatives from each regional

human subjects research review board, a layperson,

and a researcher. CSEC acts on disputed proposals and

in cases where a matter of principle needs to be decided

(15). A 1989 report on research involving human

subjects by the Ministry of Health had a tangible

impact on the current laws on the research ethical

committee system (84,98). Also, in 1991, the Danish

Medical Research Council gathered a working group

to publish a report on scientific dishonesty (27).

In 1988, Parliament created the Danish Council of

Ethics to consider a broader range of bioethica1 issues.

The Council is the primary adviser to Parliament on

ethical problems in the health sciences, excluding the

research related questions handled by the CSEC (98).

The Council appears to be more grassroots than any

other in the world, making significant effort to

mobilize public discussion. The Council’s 17 members are predominately laypersons who are nearly

evenly divided by gender (26). Though reports are

written by Council members, the Council has a slightly

larger staff-three professionals-than is common in

Europe; the Council also includes academics for short

periods of service (26).

The Council’s public education efforts go far

beyond anything attempted elsewhere. For example, in

considering the definition of death and the ethical

issues of protecting human gametes, the Council not

only held public hearings, but financed local debates

on television. It also distributed elaborate educational

materials to high schools, produced award-winning

films shown on national television and in movie

theaters, produced booklets and brochures for public

libraries, and sponsored creative contests for young

people. One thousand articles have been published
46 I Biomedical Ethics in U.S. Public Policy

over 3 years, along with numerous editorials that drew

hundreds of letters to the editor. Although public

awareness of bioethics among the general population

has been successfully raised-probably due to the

small size and homogeneity of the population (108)-

it is interesting to note that, even after widespread

discussion among the public, the Council’s own

surveys revealed misunderstandings about brain death

(26,39,58,92,98,100,101).

The Council’s findings on the definition of death

drew criticism from CSEC members. The two commissions also disagreed on the propriety of preserving

brain tissue for research and teaching purposes; one of

the provisions in the 1992 law establishing the CSEC’s

legal status was a directive to the two councils to

cooperate.

, Finland

The Finnish National Research Ethics Committee

was established in 1991 as a permanent advisory body

of the government. Its mandate is to make proposals

and give expert statements to the government, function

as an expert body, promote research ethics, participate

in international research ethics cooperation, and inform the government about issues in research ethics.

The Committee consists of 10 members representing

the scientific fields and government authorities involved in research ethics. Members of the first

Committee have been appointed until 1995, when new

members will be appointed (70,77).

The Ethical Advisory Committee for the National

Agency for Welfare and Health was founded in 1991

by the Ministry of Social Affairs and Health. Twenty

members from various fields have been appointed to

serve until 1994 by the Director General of the

National Agency for Welfare and Health. The group

promotes bioethics and provides advice about ethical

issues. It has no formal power, but may propose

regulations or legislation (65).

■ France

The French National Consultative Ethics Committee on Life and Medical Sciences (Comite Consultatif National d’Et.hique Pour les Sciences de la Vie et

de la Sante, or CCNE) was created in 1983 by the

President (30). It is one of the first national bioethics

committees abroad and was created to play a central

role in the country’s deliberations over bioethical

issues (62). Additionally, France developed a system

of local ethics committees in the 1980s. These

committees focus mainly on human research, similar

to the function of institutional review boards in the

United States. The local ethics committees became

subject to national regulation in 1990, but are completely independent of CCNE (89).

CCNE’s 41 members are drawn from medicine, law,

biology, nursing, social science, ethics, philosophy,

and religion; 15 of 41 members are women (89).

Members are not paid, although many devote major

portions of their professional time to CCNE; staff size

is small. The committee is housed at the Institut

National de la Sante et de la Recherche Medicale

(INSERM) (analogous to the National Institutes of

Health) and meets in closed session. A 2-day public

symposium is held each year to bring bioethical issues

to the public’s attention.

CCNE’s mission, as defined by the decree establishing it, is to advise the government on questions of

bioethics; questions can be brought to CCNE by

members of the government, the presidents of the two

houses of Parliament, or by public institutions involved in research. To date, CCNE has issued over 30

reports or statements on topics that include research on

human subjects, embryo research, genetic testing, the

use of fetal tissue for medical procedures, surrogate

motherhood, testing of drug addicts in employment

settings, use of RU486, and sex determination procedures at the Olympics.

CCNE’s unusually large size permits wider representation of views and interests. It not only carries out

studies of major bioethical issues, but also involves

itself in day-to-day controversies arising in the hospitals and courts. High in visibility and prestige, its

annual public meetings have been addressed on several

occasions by the President of the Republic, and its

deliberations and findings are covered extensively by

the press,

Finally, the French Parliament currently is considering a wide ranging bioethics bill, which has cleared the

Assembly and is awaiting Senate action (89,91). A

National Center of Medical Ethics was created by

presidential degree in 1992, but has not yet been

assembled (12).
Appendix A—International Bioethics Initiatives I 47

■ Germany

The former West Germanyl has had a number of

inter-ministry ad hoc commissions and legislative ad

hoc commissions. In 1985, a joint commission with

representatives from several federal ministries and

academic institutions issued a report on in vitro

fertilization, genome analysis, and gene therapy.

Known as the Benda Commission, this body was

chaired by the President of the Constitutional Court.

The report led the federal Ministry of Justice to

introduce the Embryo Protection Law (45,103). The

federal Parliament has also created ad hoc commissions, known as Enquete commissions, on bioethical

issues. The Gentechnologie Enquete Commission

focused on biotechnology and produced a report in

1987 (46). Another Enquete commission focused on

technology assessment and the social acceptability of

technology; a third, established in 1988, focused on the

public health care system (102). Rather than simply

fostering anticipatory moral debate, the Benda Commission and the Enquete commissions generally used

worst case scenarios for determining the moral and

social acceptability of modem medical technology,

applied general principles such as “human dignity” to

specific cases, and recommended the criminalization

of future technological possibilities (103),

The Scientific Council of the Federal Chamber of

Physicians established two ethics commissions in

1985 that involved philosophers, theologians, and

health administrators; the Scientific Council examined

issues of in vitro fertilization and embryo research

(11). In 1986, the German Society for Medical Law

addressed the issue of withholding treatment from

severely handicapped newborns (33), and the German

Society for Anthropology and Human Genetics issued

guidelines concerning withholding information from

parents about the sex of their fetus (32,103).

The former West Germany also has had ethics

committees in medical schools, as well as chambers of

physicians that assist physicians in consultation on and

assessment of moral and legal issues of human

experimentation. In 1986, an association was formed

by these ethics committees to regulate their activities

and memberships; it meets once a year (4),

The role of bioethics in German public policy is

somewhat unusual in light of the Nazi era. In 1989, a

visiting British bioethicist’s lectures on bioengineering and mental retardation had to be canceled after

anti-biotechnology and disability rights groups accused him of advocating the rekindling of the Nazi’s

“euthanasia” program of persons with disabilities,

Subsequent to this, other public protests forced the

cancellation of lectures and courses on bioethics. The

anti-bioethics protesters feel that public discussion of

contemporary bioethics will make ‘‘despicable and

dangerous” views seem more respectable (125),

 Greece

In 1987, a nongovernmental group called the

Hellenic Society of Medical Ethics and Deontology

was created by individuals interested in medical ethics.

The Society then played a role in persuading the

Ministry of Public Health to begin to establish a

National Center of Medical Ethics and require an

ethics committee in every Greek hospital (12,67,71). It

also succeeded in obtaining legislation establishing a

National Medical Ethics and Deontology Board, consisting of professionals in health, law, and theology, all

to be appointed by the Minister of Health (67,71).

■ Hungary

The Hungarian Scientific Health Council established a Scientific and Research Ethics Committee in

1987. Comprised of 20 individuals, including physicians, theologians, ethicists, and lawyers, it is the

parent forum overseeing human subjects research in

Hungary. It coordinates the regional research ethics

committees and defines and publishes unified principles for research ethics.

The Parliament Committee on Social, Health, and

Family Welfare established a bioethics commission of

16 professionals, health officials, sociologists, and

philosophers in 1990. It seeks to be an advisory forum

for legislation and to advise lawmakers. Quarterly

meetings are not formally announced and consequently are unknown to the public (10,63).

1 Though OTA only has information on the former West Germany, this is not to imply that no bioethics activities took place in the former

East Germany.
48 I Biomedical Ethics in U.S. Public Policy

 Israel

The Director General of the Israeli Ministry of

Health convenes a Supreme Helsinki Committee-i.e.,

a human subjects review committee operating on

provisions of the Helsinki Declaration, which has been

incorporated into Israeli law—when research in sensitive areas is proposed. One such area has been

‘‘experiments regarding the human genetic code, and

its focus in recent years has been reproductive medicine. This same subject will also be addressed by a new

commission jointly created by the Ministries of Health

and Justice. In addition, the Israeli Society for Medical

Ethics has its own committee that has provided

testimony to various public agencies (106).

 Ital y

The President of the Council of Ministers created a

National Committee on Bioethics (Comitato Nazionale per le Bioetica) in 1990 to provide advice to the

Parliament. Its functions include formulating opinions

and proposing solutions to ethical and legal problems

that could arise in conjunction with advances in

research in the life and health sciences or in the

development of clinical therapies. It is also mandated

to promote the formation of codes of conduct for

individuals in the life and health sciences and to

promote the provision of accurate information to the

public. By decree, topics include genetic therapy and

safety of biological materials (127), Thirty-six members have been chosen based on disciplinary background, and four represent professional organizations,

including the Italian Medical Association. The Committee meets in closed sessions and has no professional

staff. The Committee strives for consensus, reserving

the use of voting if necessary, and has produced more

than 10 reports (107).

In 1990, the Prime Minister established a working

group of scientists, physicians, philosophers, and

legislators to produce legislation on the ethical and

legal problems involved in assisted procreation procedures and in scientific research concerning human

embryos (18). In addition, the Italian National Research Council has an 1 l-member Committee of

Bioethics, as do several medical specialty societies,

including the Italian Society of Neurology and the

Italian Society of Fertility and Sterility. A number of

local groups also exist (124).

■ Japan

Japan has no standing bioethics commission, but has

established the Prime Minister’s Ad Hoc Committee

on Brain Death and Organ Transplantation-a subject

that is highly controversial in Japan (59,78). Its

deliberations were closed to the public. In January

1992, the Committee issued a report-with dissentsthat endorsed a definition of brain death.

Additionally, Japan’s Human Genome Project has

granted funds for the study of ethical issues, and a

20-member Ethical, Legal, and Social Issues Working

Group has been established. To date, it has convened

two international conferences (50,1 14).

■ Luxembourg

In 1988, the government of Luxembourg established

a National Ethical Consultative Commission for the

Life and Health Sciences. The Commission is attached

to the Ministry of the State and serves as an advisory

agency to the government. It is responsible for the

multidisciplinary study, either at its own initiative or

at the request of the government, of the ethical aspects

of various problems arising in the life and health

sciences. It also examines the solutions and means to

be employed to address these problems (96).

 Malt a

In 1989, Malta’s Minister of Social Policy formed a

National Ethical Health Committee (12). The government is also interested in developing policies and

programs to enhance the lives of the elderly and to

mitigate any negative effects resulting from the aging

population’s impact on development (3).

■ Mexico

In Mexico, a federally sponsored National Bioethics

Commission (Comision Nacional de Bioetica) that

reports to the Ministry of Health was established in

1992. The Commission’s President is the Secretary of

Health, who appoints the 10 commission members and

an executive general secretary, all health professionals.

The body holds monthly meetings and additional

sessions when the need arises. Its goals include

research, education of the public, and recommendations for legislation. Besides medical issues, its

broad mandate includes oversight on environmental

matters (85).
Appendix A—International Bioethics Initiatives I 49

■ The Netherlands

The Netherlands has had a bioethics commission

since 1977. The Health Council, the scientific advisory

board of the government in the fields of public health

and environmental hygiene, sponsors a permanent

Commission on Health Ethics and Health Law

(CHEHL). CHEHL is a standing advisory group that

transmits findings to the government of subjectspecific ad hoc committees organized by the Health

Council. CHEHL’s 10 to 20 members, all scientists,

meet 6 times a year in closed sessions. Currently, the

vice president of the Health Council chairs CHEHL.

The staff consists of two lawyers and one ethicist.

Among national bioethics commissions, only CHEHL

is known to have undergone an evaluation, in this case

from the Parliament in 1991; the outcome was

favorable,

In 1989, the Minister of Health established the

Dutch Interim Central Committee on Ethical Aspects

of Medical Research (Kerncommissie Ethiek Medisch

Onderzoek, or KEMO) and located it at the premises

of the Health Council. KEMO is a national advisory

commission for the assessment of planned medical

research involving ethical, legal, and social issues. It

directly advises local medical ethics boards of health

care institutions, not the government; recommendations are nonbinding (18). From 1989 to 1990, KEMO

met bimonthly and responded by confidential letter to

requests for advice from four local ethics committees

(72,97). In 1991, KEMO published its first annual

report (1,36). The Federation of Health Care Organizations in the Netherlands and the Royal Dutch Medical

Association have also been active in bioethics (29,

121 ,122).

, New Zealand

New Zealand has a single governmental body

responsible for bioethical issues, the Health Research

Council Ethics Committee. Established in 1990, the

Committee advises the Health Research Council on

ethical issues related to research, It also advises ethics

committees established by other bodies (e.g., hospitals) on standards, procedures, and membership. In

New Zealand, the chair of an ethics committee and at

least 50 percent of members are not health care

professionals.

Other government activities include a review of

assisted reproduction and reports commissioned

through agencies such as the Medical Council and the

Core Health Services Committee. Establishment of a

National Health Ethics Committee is also under

consideration (14). The Law Reform Division of the

Department of Justice has also been active and, in

March 1985, released a paper on artificial reproductive

technologies (48).

■ Norway

In 1989, the Norwegian Parliament passed a law

establishing three national research ethics committees.

One, the National Committee for Medical Research

Ethics already existed on a nonstatutory basis, and two

were created to work in the fields of social sciences and

science and technology (43). The National Committee

for Medical Research Ethics has nine members,

including two Members of Parliament. In the past, the

Committee answered to the Medical Research Council, but it is now independent. Its professional staff

consists of a theologian-bioethicist, a secretary, and a

consultant. Additionally, a National Medical Ethics

Committee has been proposed to investigate patient

rights and health care rationing (75). Also in 1989, the

Parliament voted 16 million kroner for the Medical

Research Council to establish a Center for Biomedical

Ethics in Oslo (43).

■ The Philippines

In 1987, the Philippine Council for Health Research

and Development published National Guidelines for

Biomedical Research Involving Human Subjects which,

among other matters, created a National Ethics Committee and institutional review committees (93). These

committees are primarily concerned with the ethical

review of research activities, though they are expected

eventually to review other medical and health care

practices (28). The National Ethics Committee is

dominated by nonphysicians: By law, it includes one

homemaker, one attorney, one environmentalist, one

social scientist, one representative of the religious

community, one medical researcher, and one representative of the Philippine Medical Association. The

membership of the National Ethics Committee is

indicative of a trend in the Philippines toward greater

public involvement in a previously physician-centered

activity (28).
50 I Biomedical Ethics in U.S. Public Policy

■ Poland

The Ethics Review Committee in Biomedical Research was founded in 1977 by the Ministry of Health

and Social Welfare and has been active in bioethics. A

Commission for Supervising Research on Human

Subjects was also created in 1982 by the Ministry of

Health and Social Welfare to advance proper policy for

research involving human subjects; this commission is

chaired by a physician in the Ministry of Health and

Social Welfare, and the Minister appoints the members.

A Commission for Research Ethics was created in

1991 at the Scientific Council of the Ministry of Health

and Social Welfare. This commission meets once a

year in closed session to draft legal regulations for

human subjects research, review and inspect research

on human subjects, review local research ethics

committees, and publish its findings (88,1 15).

 Portugal

Following an initiative of the Parliament, the

national government created the National Council on

Ethics for the Life Sciences in 1990 (94). The group

presents annual reports to the Prime Minister on the

application of new technologies to human life and the

relevant clinical and social implications. The 20

members serve 5-year terms, and membership consists

of 10 medical professors or doctors of certain specialties, 4 jurists, 3 philosophers, 1 biologist, 1 engineer,

and 1 Catholic moralist (18). The Council’s chairperson is appointed by the Prime Minister six members

are elected by Parliament, and 14 others are appointed

by ministries and by scientific and professional

organizations. Monthly meetings are closed to the

public, but press conferences are held regularly. The

Council strives for consensus, but publishes dissents.

A single administrative officer staffs the Council

(105).

■ Romania

In 1990, the Academy of Medical Sciences established a Bioethics Committee out of a need to “correct

the numerous deficiencies left by the 45 years of

Communist regime” (79). It is independent of the

government and consists of 20 members, including

physicians, jurists, psychologists, and priests; the

current president is a geneticist. Members meet four

times a year and are not paid. The Committee has

played a role in the withdrawal of a Ministry of Health

draft law to legalize active euthanasia and in the

establishment of bioethics groups in several clinics of

pediatrics, surgery, and endocrinology (79). It has

organized conferences on medical ethics and bioethics,

and is currently attempting to develop ethics curricula

in each Romanian medical school (12).

■ Russia

In 1992, a Russian National Committee on Bioethics was formed on the initiative of the Russian

Academy of Sciences and the Russian Academy of

Medical Sciences (102). Its tasks include identifying

and defining ethical issues raised by recent advances in

biomedical research and practice. The Committee’s

role is advisory, though it can make arrangements for

examining and reporting on bioethical issues and

formulating new guidelines or laws. The Committee

recognizes the need to inform and promote public

debate and discussion on bioethical issues, and it is

expected to consult widely, publish reports, and make

recommendations (102). The Committee’s first act

was organizing the Commission on Protection of

Animals as Subjects of Scientific Experimentation

(118). In 1991, the Committee cosponsored, with the

United Nations Educational, Scientific, and Cultural

Organization (UNESCO), an international symposium

on bioethics (12).

Additionally, the Center of Biomedical Ethics and

Law was organized in Moscow in 1990. The center

conducts regular interdisciplinary debates on problems

in Russian medicine, and will submit a proposal to the

President of Russia to establish an all-Russian Committee on biomedical research. This committee would

be involved in ethical assessment and regulation, and

would not be controlled by medical or academic

authorities (118).

■ South Africa

The South African Medical Research Council prepares ethical guidelines for medical research; a revised

document will be issued in late 1993 (9). The South

African Law Commission recently issued a draft report

on surrogate motherhood (48).

■ Spain

The Ministry of Health has considered creating a

national committee on bioethics, however, these dis-
Appendix A—International Bioethics Initiatives I 51

cussions were recently suspended. The Ministry’s

multidisciplinary Advisory Council has examined

several bioethical issues (99), and numerous government-sponsored ad hoc commissions also have studied

bioethics (2). In 1990, legislation requiring that

clinical trials and research projects involving drugs be

approved by hospital ethics committees was enacted.

Thus, the number of hospital ethics committees is

rising in Spain. The Spanish Medical Association also

has dealt with bioethics through its Commission of

Deontology (99).

■ Sweden

Sweden’s National Council on Medical Ethics has

been functioning since 1985. It is advisory to the

government, and works under the Ministry of Health

and Social Affairs. The Council consists of 18

members, including 7 Members of Parliament and

experts in ethics, the arts, and religion, as well as

representatives of certain organizations. The Council’s

task is to shed light on fundamental medical ethics

issues, keep abreast of state-of-the-art research, and to

act as a link between science, the public, and political

decisionmakers. The Council has the ability to choose

topics on its own initiative. It meets in closed session,

but holds a “day of ethics” to brings bioethics to the

public’s attention. The Council does not carry out its

own investigations, but is designed to monitor trends

and analyze problems in medical ethics.

Additionally, numerous ad hoc, topic-specific committees have also been formed by the Swedish

government before it prepares a bill. These committees

have published reports and influenced legislation,

sometimes through the National Council on Medical

Ethics. In 1987, the Minister of Health and Social

Affairs appointed a special Swedish Committee on

Transplantation, which has written a number of reports

(1 11,112). Sweden’s Medical Research Council houses

a central committee that oversees local research ethics

committees concerned with individual research projects (64,1 13).

■ Switzerland

Currently, no broad bioethics commission exists,

but the Swiss Department of the Interior and Department of Justice and Police jointly created an Expert

Commission on Human Genetics and Reproductive

Medicine (the Arnstad Commission), which met from

1986 to 1988. Its mandate was to discuss new

reproductive technologies and their social, ethical, and

legal impacts, point out abuses, and write recommendations for the government. The 21-member group met

17 times in closed session and released its report in

1989 (117). In addition, the Swiss Academy of

Medical Sciences maintains a nongovernmental Central Ethics Commission that has issued guidelines to

clinicians on a number of ethical matters (57).

■ Turkey

The Higher Council of Health, established by

legislation in 1930, consists of nine health care

professionals chosen by the Minister of Health. Its

scope of activity includes some bioethics issues, but it

does not publish its work. In the near future, a Central

Ethics committee will be established in the Ministry of

Health to administer human subjects guidelines

through institutional review boards (90).

■ United Kingdom

In the United Kingdom, bioethics is incorporated

into policy in several ways and in many institutions.

The Medical Research Council publishes an ethics

series that primarily focuses on human research subject

issues. Most prominent among the bioethics councils

was the 1982-84 Warnock Committee on embryos and

reproductive technology under the auspices of the then

Department of Health and Social Security (31); its

recommendations were largely embodied in new

legislation. Recently, the House of Lords established

a Select Committee on Medical Ethics to consider a

number of issues. The British Medical Association has

a Medical Ethics Committee and the Royal Colleges

(e.g., of Physicians or Psychiatrists) have also issued

numerous guidelines and position papers. In addition,

the General Medical Council has issued guidelines on

the commerce of human organs (48),

Nevertheless, in contrast to other European nations,

the government has rejected suggestions to create a

national bioethics commission with a broader mandate

(13); it has preferred to establish multiple committees

that each offer advice on specific issues. Prominent

bioethicists in the United Kingdom have complained

that without a national commission, they cannot

identify and pursue the “British position” on important issues in pan-European councils and conferences

(123,124). Thus, with interest in a British commission
52 I Biomedical Ethics in U.S. Public Policy

rising, a private solution was pursued. Following

extensive consultation with professional, scientific,

legal, and consumer groups, the Nuffield Foundation,

an educational and charitable trust, founded a private

body in 1991. The Nuffield Council on Bioethics is

designed to function similarly to governmental bioethics bodies elsewhere in Europe. Its 15 members, 8 of

whom are women, do not represent constituencies, but

were chosen with diversity in mind. The Council aims

to stimulate coordination among the many parties now

contributing to bioethics policy, to anticipate new

problems, and to increase public awareness of the

issues and their importance. Several working groups

have been established. An executive secretary and two

administrative assistants comprise the staff (107).

The Nuffield Council on Bioethics, as a private

body, has no regulatory role; it is advisory only.

Nevertheless, the Foundation’s initiative was welcomed by the government. One staff member is

government salaried and the Council is regarded as the

national voice within the British bioethics community.

In fact, in composition and procedures, the Council

conducts business as if it had been created by the

government. Nevertheless, to date, many European

bioethics forums have been intergovernmental, and

government officials represent the United Kingdom.

Thus, whether the British government will accord the

Nuffield Council the same influence and authority in

intergovernmental deliberations over bioethical issues

as other European counterparts enjoy is uncertain

(53,54,68,76,107).

MULTINATIONAL ORGANIZATIONS

Beyond efforts tailored to individual countries,

ongoing efforts exist to address multinational, crosscultural, or shared concerns about bioethical issues.

This section briefly reviews some of the activities

sponsored by international groups.

■ United Nations System

In January 1993, the General Director of the United

Nations Educational, Scientific, and Cultural Organization (UNESCO) asked its Scientific and Technical

Group to submit proposals for establishing an International Consultative Committee of Bioethics (120). The

Committee will consist of 40 experts; its first task will

be considering whether an international convention on

the human genome should convene. The convention

would deal with subjects linked to bioethics and

human rights, especially problems stemming from

trade of human tissues and cells, the use of genetic

tests, eugenics, and cloning (120). The United Nations

Fund for Population Assistance (UNFPA) has also

provided funds for conferences that included bioethical issues (104).

In March 1993, the United Nations Commission on

Human Rights adopted a Decision on Human Rights

and Bioethics that seeks to ensure that the life sciences

develop in a manner respectful of human rights. The

Commission also promotes exchanges between national consultative bodies (48).

WHO has developed Guiding Principles on Human

Organ Transplantation (endorsed in 1991 by the

World Health Assembly). WHO’s Health Legislation

Unit also seines as a global clearinghouse for legislation, codes, and other measures in the field of

bioethics. WHO reports on legislation and associated

literature in a quarterly journal (48).

The Pan American Health Organization (PAHO)

serves as the regional office of WHO for the Americas.

Through publications and consultations, PAHO has

fostered the development of bioethics in Central and

South America. PAHO published the first regional

survey of Latin American bioethics (19). PAHO and

the University of Chile are also currently planning the

establishment of 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, will provide

a “permanent place for . . . discussion of bioethical

subjects,” and its primary mission will be to support

research and training in bioethics for the region (49).

■ Council for International

Organizations of Medical Sciences

The Council for International Organizations of

Medical Sciences (CIOMS) is an international, nongovernmental organization established in 1949 by two United

Nations agencies (WHO and UNESCO). It began as a

vehicle to facilitate the exchange of scientific information in the medical sciences through coordination of

international organizations of medical sciences and

support of international congresses on medical sciences. Since 1966, CIOMS has focused less on purely

scientific medical subjects and more on the social and

cultural impacts of medical science. The main activity

of CIOMS has become the convening of broadly
Appendix A—International Bioethics Initiatives I 53

based, multidisciplinary, and internationally representative conferences concerned with the impact of

progress in biomedical science on society, and in fields

such as bioethics, health policy, drug development,

and medical education, CIOMS, with WHO, has

published the proceedings of many conferences and

offered international ethical guidelines on a number of

topics (6,7,24,25,128). In 1985, CIOMS constituted a

steering committee on bioethics with representatives

from a range of professional backgrounds and geographical locales, which in turn has organized ‘‘international dialogues’ on ethical issues arising from

many subjects, including human genome research (5).

■ Council of Europe

The Council of Europe (CE), an intergovernmental

organization that seeks consensus among its 26

members on cultural and human rights issues, is active

in bioethics. Following a 1985 resolution presented by

the French Minister of Justice to the European

Ministerial Conference on Human Rights, CE created

an Ad Hoc Committee of Experts on Bioethics

(CAHBI) to further the interests of member states in

bioethical issues (42). In 1989, it held its First

Symposium on Bioethics (20,74). In 1992, CE elevated CAHBI to full legal status within CE and

changed its name to the Steering Committee on

Bioethics (Comite Directeur sur la Bioethique, or

CDBI).

CDBI consists of a diverse group of professionals

and civil servants from member states and has

delivered a number of reports from its working groups

to the CE Committee of Ministers. Its activities have

included a recommendation on international exchange

and transportation of human substances, an opinion

requested by the Netherlands government on voluntary

euthanasia, and a report on assisted human reproduction. CDBI also has been particularly interested in

issues of genetic screening, genetic testing, as well as

forensic applications of DNA tests (21,64).

CDBI aims “to fill the political and legal gaps that

may result from the rapid development of biomedical

sciences,” but to do this it must achieve the consensus

of member states. It deals with this challenge in several

ways: by ‘‘promoting] constructive dialogue between

the member states;” by attending to the “principles

and values which must guide any regulation in

bioethics;” and by making “special efforts in order to

identify the fundamental points on which the member

States are unanimous” (22).

In 1989, CAHBI considered a proposal to create a

European Bioethics Committee, but in 1992 it judged

this step premature (23). Nevertheless, the CE has held

meetings of the chairpersons of various national ethics

committees and special symposiums (64). CDBI is

currently preparing, pursuant to a 1990 request from

the Committee of Ministers, a Convention for Bioethics. The Convention will consist of a framework of

fundamental principles, based loosely on the European

Convention on Human Rights (86). The Convention

will incorporate general principles rather than detailed

regulations, though these statements of principles

could eventually become the basis for detailed protocols (109). Currently, protocols in organ transplantation, medical research involving humans and embryos,

and the use of genetic information for nonmedical

purposes are under preparation (23). The Convention

is expected to be ready in 1994 and will be open to

nonmember states (64).

 European Community

Bioethics has emerged as an important human rights

element of the European Community’s (EC) scientific

research policy (38). The Commission of the European

Community recently decided to undertake a number of

initiatives in bioethics and has established several

working groups, For example, the Working Group on

Human Embryos and Research intends to “determine] the area of consensus . . . and development of

a common [legal] code,” with the goal of pressuring

member states to enact legislation where regulations

are weak or nonexistent (44). In 1992, the EC formed

a working group on the ethics of biotechnology (44).

The Working Group on Ethical, Social, and Legal

Aspects (ESLA) of Human Genome Analysis has

educational functions, but has also been charged to

‘‘make recommendations for future Commission

initiatives-including legislation. Its charter requires

it to take account of specific documents on human

rights, including the Universal Declaration of Human

Rights issued by the United Nations in 1948. Following a call for proposals, ESLA has funded 18 studies

on ethical issues. The studies vary from applied to

theoretical and examine a variety of key issues in

human genetics (38,41).
54 I Biomedical Ethics in U.S. Public Policy

The EC also empaneled an international commission on ethical issues in reproductive technology,

called the Working Party on Ethical and Legal Issues

Raised by New Reproductive Technology, or the

Glover Commission. Despite cultural differences among

the members and very little staff, the Glover Commission produced a report that is distinctive in its

dissection of the moral arguments and premises on

which rival positions on these issues rely (124).

Though CE had no plans for publication, the Commission’s chair, on his own initiative, brought the Commission’s findings to public attention by arranging for

their publication by academic presses (54,55).

In 1991, the EC identified general biomedical ethics

as a fundamental research area in the Biomedical and

Health Specific Program (37,40), The EC has established a research program in bioethics that appears to

be the world’s sole general fund for investigatorinitiated general bioethics research. Proposals were

solicited, and grants were provided for work that

evaluates biomedical ethics issues and assesses the

social impact and risks of current biomedical and

health research programs. To date, eight projects have

been funded, including grants addressing organ transplantation, artificial procreation, and AIDS. Initial

funding for the eight grants was approximately 1.9

million ECU. Total funding under the program, approved for 1990-94, is slated at 4.67 million ECU (8).

■ European Parliament

The European Parliament seeks technical advice

from its Scientific and Technological Options Assessment (STOA) Programme. STOA recently commissioned a major study that provides an analysis of the

status of bioethics in Europe (42). The preliminary

report indicates that the goal of European bioethics is

regulation to ensure safety and to protect fundamental

human rights. The report finds that “generally the first

step toward the creation of successful regulation is the

constitution of ethics committees to study the consequences of the various biological and genetic technologies” (42). The report recognizes that not every

country has established a national ethics committee,

“so the theory of harmonization of regulation will be

difficult to put into practice,” though the report

nevertheless urges inter-European harmonization of

law and recommendations (42).

The STOA report also discuss bioethics in the CE

and EC and finds that the scope of these efforts largely

overlaps. According to one EC official, however, the

CE and EC have different roles to play in bioethics

(44). The former gives general recommendations; the

latter can submit proposals on specific regulations to

the European Parliament. The CE can inspire new law,

but it will be the law of member states. The CE and the

EC are now taking steps to ensure cooperative activity

in the field (70).

■ Other International

Organizations

Other multinational bioethics organizations also are

being created and include academic, governmentsponsored, and professional groups and societies.

With the support of two U.S. foundations-Ford

and Rockefeller-and WHO and UNFPA, the International Islamic Center for Population Studies and

Research, A1-Azhar University in Cairo, Egypt hosted

the first conference on the ethics of human reproduction research in the Muslim world in December 1991.

The conference resulted in the adoption of ethical

guidelines for human reproduction research in the

Muslim world and the creation of the first Ethics

Committee for Human Reproduction Research at

A1-Azhar University, Cairo, Egypt (60,61,104). Similarly, the Islamic Organization for Education, Sciences, and Culture collaborated with the Faculty of

Sciences at Qatar University to organize a meeting in

February 1993 on the ethical implications of and

guidelines for genetic research (104).

In 1987, the Medical Research Council of Canada

and Canada’s Department of National Health and

Welfare convened an International Summit Conference on Bioethics (81). In 1990, the International

Association of Human Biologists and the Japan

Society of Human Genetics convened an International

Panel Discussion on Education and Ethics in Medical

Genetics (51), Hosted by the National Health Council

of the Netherlands, with the support of the EC, the

International Association of Bioethics (IAB) held its

inaugural congress in 1992. JAB, headquartered in

Australia, provides a forum for diverse views on

bioethical issues, but it does not take positions. The

International Association of Law, Ethics, and Science

gathers individuals interested in bioethics and pub-
Appendix A—International Bioethics Initiatives I 55

lishes a journal partly devoted to the works of national

and international bioethics commissions (113).

International bioethics has also received the support

of the United States’ Hastings Center, which has held

international bioethics conferences in Eastern Europe

and other areas (34), The Eubios Ethics Institute in

Christchurch, New Zealand and Tsukuba, Japan is a

nonprofit group that holds international bioethics

conferences, and publishes proceedings and newsletters (52). Among other public and private international

bioethics groups are: the Fundacion Dr. Jose Maria

Mainetti Escuela Latinoamericana de Bioetica, the

European Association of the Centres of Medical

Ethics, the International Federation of Catholic Universities’ International Study Group on Bioethics, the

Nordic Council’s Bioethics Group, and the European

Society for Philosophy of Medicine and Health Care,

which has a Section for Medical Ethics in the Nordic

Countries (2,64,70,1 16).

COMMON THEMES

Existing international commissions vary, and it is

impossible to reach conclusions linking structure to

performance. Because the commissions of each country exist in a unique cultural, political, social, and

moral climate, it is dangerous to generalize too broadly

or to transfer specific details too directly. Nevertheless,

OTA’s survey revealed several common points among

international commissions: scope, sponsorship, public

access, professional dominance, evaluation and soundness, role, structure, and a national voice. In particular,

many countries’ activities in bioethics stem from their

interest in human rights.

Until recently, most bioethics commission abroad

have been topical-i. e., devoted to one or a small

number of issues-and temporary. Topics were selected, in advance, by the sponsor. The French

commission, however, is wide ranging and seemingly

permanent, with the freedom to choose its own topics.

Other commissions established in Europe since the

founding of the French commission also have been

general, self generating, and open ended. Among the

most influential commissions have been some singletopic efforts, such as the Wamock Committee in the

United Kingdom. The clear trend, however, is toward

a permanent bioethics commission that addresses new

issues as they arise (124).

The independence of the commission is regarded by

all observers as essential to its authority. Whether

based in the legislature or in the executive branch, all

but the United Kingdom’s commissions are public.

Most answer to, and are located in, the ministries of

health, in contrast to the United States’ President’s

Commission, which was located administratively outside the departmental structure of the executive branch.

Responses to OTA did not reveal that existing

commissions were perceived as overly beholden to

their ministries.

Most national commissions in other countries limit

public access, and meetings are generally closed. In

some cases, members of the public may offer their

views through periodic public symposia. One reason

offered for the lack of public access is that some

commissions rule on particular cases requiring confidentiality.

All governments have tried to ensure membership of

non-health care professionals. In some cases, physicians and scientists are a clear minority. No survey data

exist regarding public perceptions of the commissions

as independent versus captured by special interests, but

where separate committees exist to oversee human

subjects research, these tend to be perceived as

protective of the interests of physicians and scientistseven when lay members are present or even a majority

(124).

Though bioethics commissions can be evaluated for

productivity, influence, and soundness, little has been

done in any country to date. Fragmentary though the

responses to OTA’s questionnaire were, however, it

was striking that respondents’ academic credentials

were inversely related to their opinions about the

soundness of the bioethics commission reports (124).

Complaints that findings of various commissions are

poorly argued, or not argued at all, were common.

National bioethics commissions abroad differ in

their basic purpose. In some instances, they are directly

advisory to parliaments; their existence is justified by

their government’s perceived need to develop legislation on complex technological and scientific issues

through a slower and more deliberative process than

allowed by usual legislative procedures. Other commissions exist to stimulate and educate the public, and

still others assume the role of distilling and articulating

a national sensibility on bioethical matters.
56 I Biomedical Ethics in U.S. Public Policy

Particularly in international councils, national bioethics committees are increasingly seen as defining

their nation’s position on bioethics issues, To this

extent, committees, and sometimes their members, act

as or are viewed as national spokespersons (124).

All foreign bioethics bodies have a chair and

numerous members, though they vary in size by a

factor of four. Larger bodies can be more representative, but sacrifice working efficiency (65). More

striking is the difference in the size of the staff, and

complaints about lack of staff were frequent among

responses to OTA’s survey. Most have few-one to

two-though isolated initiatives have larger staffs and

more senior individuals. Only Canada has provided its

Royal commissions a staff comparable to that found in

the United States.

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69. Knoppers, B. M., University of Montreal Law

Facultyj Montreal, Canada, remarks at ‘Biomedical Ethics in U.S. Public Policy,” a workshop

sponsored by the Office of Technology Assessment, U.S. Congress, Dec. 4, 1992,

70. Kokkonen, P., National Agency for Welfare and

Health, Helsinki, Finland, personal communications, November 1992, January 1993.

71. Kontogeorgas, K., Patras, Greece, personal communication, November 1992.

72. Kuitert, H., Free University, Amstelveen, The

Netherlands, personal communication, January

1993.

73. Law Reform Commission, Human Tissue Transplants, Report Number 7, (Sydney, Australia:

Commonwealth of Australia, 1977).

74. Le Bris, S., “National Ethics Bodies,” contract

document for the Council of Europe, Ad Hoc

CornmitIee of Experts on Bioethics (CAHBI),

Round Table of Ethics Committees, Madrid,

Spain, Mar. 24, 1992.
Appendix A—International Bioethics Initiatives I 59

75.

76.

77.

78.

79.

80.

81.

82.

83,

84.

85.

86.

87.

88.

89.

90.

Lie, R., University of Oslo, Oslo, Norway, personal communications, December 1992, January

1993.

Lockwood, M., University of Oxford, Oxford,

United Kingdom, personal communication, November 1992.

Lopponen, P,, Academy of Finland, Helsinki,

Finland, personal communication, November 1992.

Macer, D., University of Tsukuba, Ibaraki, Japan,

personal communication, November 1992.

Maximilian, C., Academy of Medical Sciences,

Bucharest, Romania, personal communication,

December 1992.

Medical Research Council of Canada, Guidelines

on Research Involving Human Subjects 1987

(Ottawa, Canada: Minister of Supply and Services

Canada, 1987).

Medical Research Council of Canada, Towards an

International Ethic for Research with Human

Beings: Proceedings of the International Summit

Conference on Bioethics, April 5-10, 1987, Ottawa, Canaak, Sponsored by the Medical Research Council of Canada and the Department of

National Health and We~are (Ottawa, Canada:

Minister of Supply and Services Canada, 1988).

Meira, A. R., University of Sao Paulo, Sao Paulo,

Brazil, personal communication, March 1993.

Miller, J., National Council on Bioethics in

Human Research, Ottawa, Canada, personal communication, March 1993.

Ministry of Health, Research Involving Human

Subjects: Ethics/Luw (Copenhagen, Denmark:

Ministry of Health, 1989).

Moctezuma-Barragan, G,, Direccion de Asuntos

Juridicos de la Secretarial de Salud, Mexico,

personal communication, December 1993.

Mundell, I., “Bioethics: Europe Drafts a Convention,” Nature 356:368, 1992.

Neto, E. R., University of Brasilia, Brasilia, Brazil,

personal communication, March 1993.

Nielubowicz, J., Ethics Review Committee in

Biomedical Research, Warsaw, Poland, personal

communication, December 1992.

Novaes, S, B., Centre National de la Recherche

Scientifique, Paris, France, personal communication, March 1993.

Ors, Y., Ankara Medical Faculty, Ankara, Tbrkey,

personal communication, November 1992.

91.

92.

93.

94.

Patel, T., “France Takes the Lead on Medical

Ethics,” New Scientist 136(1850):8, 1992.

Petersen, U, H., Ministry of Health, Copenhagen,

Denmark, personal communication, November

1992.

Philippine Council for Health Research and Development, National Guidelines for Biomedical

Research Involving Human Subjects (Manila, The

Philippines: Philippine Council for Health Research and Development, 1987).

Portugal Law No. 14/90 of 9 June 1990 establishing the National Council on Ethics for the Life

Sciences, Diario de Republica, Series 1, 9 June

1990, No. 133.

95.

96.

97.

98.

99.

100.

101.

102.

103.

104.

Qiu, R.-Z,, Chinese Academy of Social Sciences,

Beijing, China, personal communications, December 1992, January 1993.

“Regulations of the Government in Council of 9

September 1988 Establishing a National Ethical

Consultative Commission for the Life and

Health Sciences,”Memorial: Journal Officiel

du Grand-Duche de Luxembourg, A-No 70, Dec.

27, 1988.

Rigter, H., Health Council of the Netherlands,

The Hague, The Netherlands, personal communications, November 1992, January 1993.

Riis, P., Herlev University Hospital, Herlev,

Denma.rL personal communications, November

1992, March 1993.

Rivero, A. P., Universidad de Alcala, Madrid,

Spain, personal communication, April 1993.

Rix, B. A.,“The Importance of Knowledge and

Trust in the Definition of Death,” Bioethics

4:232-236, 1990 .

Rix, B. A., The Danish Council of Ethics, Copenhagen, Denmark, personal communication, January 1993.

“Russian National Committee Set Up,’ Bulletin

of Medical Ethics, October 1989.

Sass, H. M.,“Blue-Ribbon Commissions and

Political Ethics in the Federal Republic of

Germany,’ Journal of Medicine and Philosophy

14465472, 1989.

Serour, G, I., A1-Azhar University, Cairo, Egypt,

persona.lcommunications, December 1992, March

1993.
60 I Biomedical Ethics in U.S. Public Policy

105. Serrao, D., University of Porto Medical School,

Porto, Portugal, personal communications, December 1992, January 1993, March 1993.

106. Shapira, A.“Public Control of Biomedical ,

Experiments,’The Use of Human Beings in

Research, A. de Vnes and T Engelhardt (eds.)

(Dordrecht, The Netherlands: Kluwer Academic

Publishers, 1988).

107. Shapiro, D., Nuffleld Council on Bioethics,

Lmdon, United Kingdom, personal communications, November 1992, March 1993.

108. Shapiro, D., Nuffield Council on Bioethics,

Imndon, United Kingdom, remarks at “Biomedical Ethics in U.S. Public Policy, ” a

workshop sponsored by the Office of Twhnology Assessment, U.S. Congress, Dec. 4, 1992.

109. Sirnons, H., Department of Health, The Hague,

The Netherlands, personal communication, January 1993.

110. Somerville, M. A., McGill Center for Medicine,

Ethics, and Law, Montreal, Canada, personal

communication, December 1992.

111. Swedish Committee on Transplantation, Transplantation — Ethical, Medical and Legal Aspects (Stockholm, Sweden: The Swedish Ministry of Health and Social Affairs, 1989).

112. Swedish Committee on Transplantation, The

Body Afier Death (Stockholm, Sweden: The

Swedish Ministry of Health and Social Affairs,

1992).

113. Swedish Ministry of Health and Social Affairs,

The National Council on Medical Ethics in

Sweden (Stockholm, Sweden: The Swedish Ministry of Health and Social Affairs, 1992).

114. Swinbanks, D., “Japan Bioethics: When Silence

Isn’t Golden,” Nature 356:368, 1992.

115. Szawarski, Z., University College of Swansea,

Swansea, Poland, personal communication, December 1992.

116. Tealdi, J. C., Fundacion Dr. JOS6 Maria Mainetti,

Gonnet, Argentina, personal communication,

December 1992.

117. Thevoz, J.-M., Foundation Imuis Jeantet, Geneva, Switzerland, personal communication, November 1992.

118. Tichtchenko, P.D. and Yudin, B.G., “Toward a

Bioethics in Post-Communist Russi~” Cambridge Quarterly of Healthcare Ethics 4:295-

303, 1992

119. Tonti-Filippini, N., Lower Templestone, AustraI.@ personal communication, December 1992.

120. UNESCOPRESSE, News Semice of the United

Nations Educational, Scientific and Cultural

Organization, press release 3(2), Jan. 22, 1993.

121. van Berkestijn, T. M. G., Borst-Eilers, E., Cohen,

H. S., et al., “Meeting at Maastricht,” Hastings

Center Report 23(2):45, 1993.

122. van der Kloot Meijburg, H.H., Federation of

Health Care Organizations in the Netherlands,

Utrecht, The Netherlands, personal communication, November 1992.

123. Vines, G.,“Research Ethics Face National

Scrutiny,” New Scientist 129(1758):14, 1991.

124. Wikler, D.,“Bioethics Commissions Abroad,”

contract document prepared for the U.S. Congress, Office of Twhnology Assessment, January 1993.

125. Wikler, D. and Barondess, J., “Bioethics and

Anti-Bioethics in Light of Nazi Medicine: What

Must We Remember,”Kennedy Institute of

Ethics Journal 3:39-55, 1993.

126. Williams, J.R.,“Commissions and Biomedical

Ethics: The Canadian Experience,” Journal of

Medicine and Philosophy 14:425444, 1989.

127. World Health Organization, “Italy,” international Digest of Health Legislation 42(4):671-

672,1991.

128. World Health Organization and Council of

International Organimations of Medical Sciences,

Proposed International Guidelines for Biomedical Research Involving Human Subjects (Geneva, Switzerland: Council of International Organizations of Medical Sciences, 1982).
Appendix B

Legislation, Regulations,

or Statutes for

Previous U.S.

Bioethics Initiatives

NATIONAL COMMISSION FOR THE PROTECTION OF HUMAN SUBJECTS OF

BIOMEDICAL AND BEHAVIORAL RESEARCH

Reprinted below is Public Law 93-348, which established the National Commission for the

Protection of Human Subjects of Biomedical and Behavioral Research. The National Commission

operated from 1974-78.

Title H-Protection of Human Subjects of Biomedical and Behavioral Research

Part A—National Commission for the Protection of Human Subjects of

Biomedical and Behavioral Research

Establishment of Commission

Section 201. (a) There is established a Commission to be known as the National Commission for the

Protection of Human Subjects of Biomedical and Behavioral Research (hereinafter in this title referred to as the

“Commission”).

(b)(1) The Commission shall be composed of eleven members appointed by the Secretary of Health,

Education, and Welfare (hereinafter in this title referred to as the ‘Secretary’ ‘). The Secretary shall select members

of the Commission from individuals distinguished in the fields of medicine, law, ethics, theology, the biological,

physical, behavioral and social sciences, philosophy, humanities, health administration, government, and public

affairs; but five (and not more than five) of the members of the Commission shall be individuals who are or who

have been engaged in biomedical or behavioral research involving human subjects. In appointing members of the

Commission, the Secretary shall give consideration to recommendations from the National Academy of Sciences

and other appropriate entities. Members of the Commission shall be appointed for the life of the Commission. The

Secretary shall appoint the members of the Commission within sixty days of the date of the enactment of this Act.

(2)(A) Except as provided in subparagraph (B), members of the Commission shall each be entitled to receive

the daily equivalent of the annual rate of the basic pay in effect for grade GS-18 if the General Schedule for each

day (including traveltime) during which they are engaged in the actual performance of the duties of the

Commission.

(B) Members of the Commission who are fall-time officers or employees of the United States shall receive

no additional pay on account of their service on the Commission.

61
62 I Biomedical Ethics in U.S. Public Policy

(C) While away from their homes or regular places of business in the performance of duties of the

Commission, members of the Commission shall be allowed travel expenses, including per diem in lieu of

subsistence, in the same manner as persons employed intermittently in the Government service are allowed

expenses under section 5703@) of Title 5 of the United States Code.

(c) The chairman of the Commission shall be selected by the members of the Commission from among their

number.

(d)(1) The Commission may appoint and fix the pay of such staff personnel as it deems desirable. Such

personnel shall be appointed subject to the provisions of Title 5, United States Code, governing appointments in

the competitive service, and shall be paid in accordance with the provisions of chapter 51 and subchapter III of

chapter 53 of such title relating to classification and General Schedule pay rates.

(2) The Commission may procure temporary and intermittent services to the same extent as is authorized by

section 3109(b) of Title 5 of the United States Code, but at rates for individuals not to exceed the daily equivalent

of the annual rate of basic pay in effect for grade GS-18 of the General Schedule.

Commission Duties

Sec. 202. (a) The Commission shall carry out the following:

(l)(A) The Commission shall (i) conduct a comprehensive investigation and study to identify the basic ethical

principles which should underlie the conduct of biomedical and behavioral research involving human subjects,

(ii) develop guidelines which should be followed in such research to assure that it is conducted in accordance with

such principles, and (iii) make recommendations to the Secretary (I) for such administrative action as may be

appropriate to apply such guidelines to biomedical and behavioral research conducted or supported under

programs administered by the Secretary, and (II) concerning any other matter pertaining to the protection of human

subjects of biomedical and behavioral research.

(B) In carrying out subparagraphs (A), the Commission shall consider at least the following:

(i) The boundaries between biomedical or behavioral research involving human subjects and the

accepted and routine practice of medicine.

(ii) The role of assessment of risk-benefit criteria in the determination of the appropriateness of research

involving human subjects.

(iii) Appropriate guidelines for the selection of human subjects for participation in biomedical and

behavioral research.

(iv) The nature and definition of informed consent in various research settings.

(v) Mechanisms for evaluating and monitoring the performance of Institutional Review Boards

established in accordance with section 474 of the Public Health Service Act and appropriate

enforcement mechanisms for carrying out their decisions.

(C) The Commission shall consider the appropriateness of applying the principles and guidelines identified

and developed under subparagraph (A) to the delivery of health services to patients under programs conducted or

supported by the Secretary.

(2) The Commission shall identify the requirements for informed consent to participation in biomedical and

behavioral research by children, prisoners, and the institutionalized mentally infirm. The Commission shall

investigate and study biomedical and behavioral research conducted or supported under programs administered

by the Secretary and involving children, prisoners, and the institutionalized mentally infirm to determine the nature

of the consent obtained from such persons or their legal representatives before such persons were involved in such

research; the adequacy of the information given them respecting the nature and purpose of the research, procedures

to be used, risks and discomforts, anticipated benefits from the research, and other matters necessary for informed

consent; and the competence and the freedom of the persons to make a choice for or against involvement in such

research. On the basis of such investigation and study the Commission shall make such recommendations to the

Secretary as it determines appropriate to assure that biomedical and behavioral research conducted or supported

under programs administered by him meets the requirements respecting informed consent identified by the

Commission. For purposes of this paragraph, the term ‘‘children” means individuals who have not attained the
Appendix B-Legislation, Regulations, and Statutes for Previous U.S. Bioethics Initiatives 163

legal age of consent to participate in research as determined under the applicable law of the jurisdiction in which

the research is to be conducted; the term “prisoner” means individuals involuntarily confined in correctional

institutions or facilities (as defined in section 601 of the Omnibus Crime Control and Safe Streets Act of 1968 (42

U.S.C. 3781)); and the term “institutionalized mentally infirm” includes individuals who are mentally ill,

mentally retarded, emotionally disturbed, psychotic, or senile, or who have other impairments of a similar nature

and who reside as patients in an institution.

(3) The Commission shall conduct an investigation and study to determine the needf or a mechanism to assure

that human subjects in biomedical and behavioral research not subject to regulation by the Secretary are protected.

If the Commission determines that such a mechanism is needed, it shall develop and recommend to the Congress

such a mechanism. The Commission may contract for the design of such a mechanism to be included in such

recommendations.

(b) The Commission shall conduct an investigation and study of the nature and extent of research involving

living fetuses, the purposes for which such research has been undertaken, and alternative means for achieving such

purposes. The Commission shall, not later than the expiration of the 4-month period beginning on the first day

of the first month that follows the date on which all the members of the Commission have taken office, recommend

to the Secretary policies defining the circumstances (if any) under which such research may be conducted or

supported.

(c) The Commission shall conduct an investigation and study of the use of psychosurgery in the United States

during the five-year period ending December 31, 1972. The Commission shall determine the appropriateness of

its use, evaluate the need for it, and recommend to the Secretary policies defining the circumstances (if any) under

which its use may be appropriate. For purposes of this paragraph, the term ‘psychosurgery’ means brain surgery

on (1) normal brain tissue of an individual, who does not suffer from any physical disease, for the purpose of

changing or controlling the behavior or emotions of such individual, or (2) diseased brain tissue of an individual,

if the sole object of the performance of such surgery is to control, change, or affect any behavioral or emotional

disturbance of such individual. Such term does not include brain surgery designed to cure or ameliorate the effects

of epilepsy and electric shock treatments.

(d) The Commission shall make recommendations to the Congress respecting the functions and authority of

the National Advisory Council for the Protection of Subjects of Biomedical and Behavioral Research to be

established under section 217(f) of the Public Health Service Act.

Special Study

Section 203. The Commission shall undertake a comprehensive study of the ethical, social, and legal

implications of advances in biomedical and behavioral research and technology. Such study shall include-

(1) an analysis and evaluation of scientific and technological advances in past, present, and projected

biomedical and behavioral research and services;

(2) an analysis and evaluation of the implementations of such advances, both for individuals and for society;

(3) an analysis and evaluation of laws and moral and ethical principles governing the use of technology in

medical practice;

(4) an analysis and evaluation of public understanding of and attitudes toward such implications and laws

and principles; and

(5) an analysis and evaluation of implications for public policy of such findings as are made by the

Commission with respect to advances in biomedical and behavioral research and technology and public

attitudes toward such advances.

Administrative Provisions

Section 204. (a) The Commission may for the purpose of carrying out its duties under sections 202 and 203

hold such hearings, sit and act at such times and places, take such testimony, and receive such evidence as the

Commission deems advisable.
64 I Biomedical Ethics in U.S. Public Policy

(b) The Commission may secure directly from any department or agency of the United States information

necessary to enable it to carry out its duties. Upon the request of the chairman of the Commission, the head of such

department or agency shall furnish such information to the Commission.

(c) The Commission shall not disclose any information reported to or otherwise obtained by it in carrying

out its duties which (1) identifies any individual who has been the subject of an activity studied and investigated

by the Commission, or (2) which concerns any information which contains or relates to a trade secret or other

matter referred to in section 1905 of Title 18 of the United States Code.

(d) Except as provided in subsection (b) of section 202, the Commission shall complete its duties under

sections 202 and 203 not later than the expiration of the 24-month period beginning on the first day of the first

month that follows the date on which all the members of the Commission have taken office. The Commission shall

make periodic reports to the President, the Congress, and the Secretary respecting its activities under sections 202

and 203 and shall, not later than ninety days after the expiration of such 24-month period, make a final report to

the President, the Congress, and the Secretary respecting such activities and including its recommendations for

administrative action and legislation.

(e) The Commission shall cease to exist thirty days following the submission of its final report pursuant to

subsection (d).

Duties of the Secretary

Section 205. Within 60 days of the receipt of any recommendation made by the Commission under section

202, the Secretary shall publish it in the Federal Register and provide opportunity for interested persons to submit

written data, views, and arguments with respect to such recommendation. The Secretary shall consider the

Commission’s recommendation and relevant matter submitted with respect to it and, within 180 days of the date

of its publication in the Federal Register, the Secretary shall (1) determine whether the administrative action

proposed by such recommendation is appropriate to assure the protection of human subjects of biomedical and

behavioral research conducted or supported under programs administered by him, and (2) if he determines that

such action is not so appropriate, publish in the Federal Register such determination together with an adequate

statement of the reasons for his determination. If the Secretary determines that administrative action recommended

by the Commission should be undertaken by him, he shall undertake such action as expeditiously as is feasible.

Part B—Miscellaneous

National Advisory Council for the Protection of Subjects of Biomedical and Behavioral Research

Section 211. (a) Section 217 of the Public Health Service Act is amended by adding at the end of the following

new subsection:

“(f)(l) There shall be established a National Advisory council for the Protection of Subjects of Biomedical

and Behavioral Research (hereinafter in this subsection referred to as the “Council”) which shall consist of the

Secretary who shall be Chairman and not less than seven nor more than fifteen other members who shall be

appointed by the Secretary without regard to the provisions of Title 5, United States Code, governing appointments

in the competitive service. The Secretary shall select members of the Council from individuals distinguished in

the fields of medicine, law, ethics, theology, the biological, physical, behavioral and social sciences, philosophy,

humanities, health administration, government, and public affairs; but three (and not more than three) of the

members of the Council shall be individuals who are or who have been engaged in biomedical or behavioral

research involving human subjects. No individual who was appointed to be a member of the National Commission

for the Protection of Human Subjects of Biomedical and Behavioral Research (established under Title II of the

National Research Act) may be appointed to be a member of the Council. The appointed members of the Council

shall have terms of office of four years, except that for the purposes of staggering the expiration of the terms of

office of the Council members, the Secretary shall, at the time of appointment, designate a term of office of less

than four years for members first appointed to the Council.
Appendix B-Legislation, Regulations, and Statutes for Previous U.S. Bioethics Initiatives 65

“(2) The Council shall—

“(A) advise, consult with, and make recommendations to, the Secretary concerning all matters

pertaining to the protection of human subjects of biomedical and behavioral research;

“(B) review policies, regulations, and other requirements of the Secretary governing such research to

determine the extent to which such policies, regulations, and requirements require and are effective

in requiring observance in such research of the basic ethical principles which should underlie the

conduct of such research and, to the extent such policies, regulations, or requirements do not require

or are not effective in requiring observance of such principles, make recommendations to the

Secretary respecting appropriate revision of such policies, regulations, or requirements; and

“(C) review periodically changes in the scope, purpose, and types of biomedical and behavioral research

being conducted and the impact such changes have on the policies, regulations, and other

requirements of the Secretary for the protection of human subjects of such research.

“(3) The Council may disseminate to the public such information, recommendations, and other matters

relating to its functions as it deems appropriate.

“(4) Section 14 of the Federal Advisory Committee Act shall not apply with respect to the Council.”

(b) The amendment made by subsection (a) shall take effect July 1,1976,

Institutional Review Boards; Ethics Guidance Program

Section 212. (a) Part I of Title IV of the Public Health Service Act, as amended by section 103 of this Act,

is amended by adding at the end the following new section:

“Institutional Review Boards; Ethics Guidance Program

“Section 474. (a) The Secretary shall by regulation require that each entity which applies for a grant or

contract under this Act for any project or program which involves the conduct of biomedical or behavioral research

involving human subjects submit in or with its application for such grantor contract assurances satisfactory to the

Secretary that it has established (in accordance with regulations which the Secretary shall prescribe) a board (to

be known as an ‘Institutional Review Board’) to review biomedical and behavioral research involving human

subjects conducted at or sponsored by such entity in order to protect the rights of the human subjects of such

research.

“(b) The Secretary shall establish a program within the Department under which requests for clarification

and guidance with respect to ethical issues raised in connection with biomedical or behavioral research involving

human subjects are responded to promptly and appropriately. ”

(b) The Secretary of Health, Education, and Welfare shall within 240 days of the date of the enactment of

this Act promulgate such regulations as maybe required to carry out section 474(a) of the Public Health Service

Act. Such regulations shall apply with respect to applications for grants and contracts under such Act submitted

after promulgation of such regulations.

Limitation on Research

Section 213. Until the Commission has made its recommendations to the Secretary pursuant to section

202(b), the Secretary may not conduct or support research in the United States or abroad on a living human fetus,

before or after the inducted abortion of such fetus unless such research is done for the purpose of assuring the

survival of such fetus.

Individual Rights

Section 214. (a) Subsection (c) of section 401 of the Health Programs Extension Act of 1973 is amended (1)

by inserting “(l)” after “(c)”, (2) by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B),

respectively, and (3) by adding at the end the following new paragraph:

‘‘(2) No entity which receives after the date of enactment of this paragraph a grant or contract for biomedical

or behavioral research under any program administered by the Secretary of Health, Education, and Welfare may—
66 I Biomedical Ethics in U.S. Public Policy

“(A) discriminate in the employment, promotion, or termination of employment of any physician or

other health care personnel, or

“(B) discriminate in the extension of staff or other privileges to any physician or other health care

personnel, because he performed or assisted in the performance of any lawful health service or

research activity, because he refused to perform or assist in the performance of any such service

or activity on the grounds that his performance or assistance in the performance of such service or

activity would be contrary to his religious beliefs or moral convictions, or because of his religious

beliefs or moral convictions respecting any such service or activity.”

(b) Section 401 of such Act is amended by adding at the end the following new subsection:

“(d) No individual shall be required to perform or assist in the performance of any part of a health service

program or research activity funded in whole or in part under a program administered by the Secretary of Health,

Education, and Welfare if his performance or assistance in the performance of such part of such program or activity

would be contrary to his religious beliefs or moral convictions. ”

Special Project Grants and Contracts

Section 215. Section 772(a)(7) of the Public Health Service Act is amended by inserting immediately before

the semicolon at the end thereof the following: “, or (C) providing increased emphasis on the ethical, social, legal,

and moral implications of advances in biomedical research and technology with respect to the effects of such

advances on individuals and society”.

Approved July 12, 1974.
Appendix B-Legislation, Regulations, and Statutes for Previous U.S. Bioethics Initiatives 67

ETHICS ADVISORY BOARD

Provisions governing the Ethics Advisory Board derive from volume 45, part 46, subpart B, of the

Code of Federal Regulations (CFR) and the two charters under which it operated from 1978-80. The

pertinent CFR sections and charters are reproduced below. (The regulations refer to ‘‘Ethical Advisory

Boards,’ but the body came to be known as the Ethics Advisory Board, as noted in the second charter.)

45 CFR, Subpart B—Additional Protections Pertaining to Research, Development, and Related Activities

Involving Fetuses, Pregnant Women, and Human In Vitro Fertilization

Section 46.201 Applicability.

(a) The regulations in this subpart are applicable to all Department of Health and Human Services grants and

contracts supporting research, development, and related activities involving: (1) The fetus, (2) pregnant women,

and (3) human in vitro fertilization.

(b) Nothing in this subpart shall be construed as indicating that compliance with the procedures set forth

herein will in an way render inapplicable pertinent State or local laws bearing upon activities covered by this

subpart.

(c) The requirements of this subpart are in addition to those imposed under the other subparts of this part.

Section 46.202 Purpose.

It is the purpose of this subpart to provide additional safeguards in reviewing activities to which this subpart

is applicable to assure that they conform to appropriate ethical standards and relate to important societal needs.

Section 46.203 Definitions.

As used in this subpart:

(a) “Secretary’ means the Secretary of Health and Human Services and any other officer or employee of the

Department of Health and Human Services to whom authority has been delegated.

(b) “Pregnancy” encompasses the period of time from confirmation of implantation (through any of the

presumptive signs of pregnancy, such as missed menses, or by a medically acceptable pregnancy test), until

expulsion or extraction of the fetus.

(c) “Fetus” means the product of conception from the time of implantation (as evidenced by any of the

presumptive signs of pregnancy, such as missed menses, or a medically acceptable pregnancy test), until a

determination is made, following expulsion or extraction of the fetus, that it is viable.

(d) “Viable” as it pertains to the fetus means being able, after either spontaneous or induced delivery, to

survive (given the benefit of available medical therapy) to the point of independently maintaining heart beat and

respiration. The Secretary may from time to time, taking into account medical advances, publish in the Federal

Register guidelines to assist in determining whether a fetus is viable for purposes of this subpart. If a fetus is viable

after delivery, it is a premature infant.

(e) “Nonviable fetus” means a fetus ex utero which, although living, is not viable.

(f) “Dead fetus” means a fetus ex utero which exhibits neither heartbeat, spontaneous respiratory activity,

spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord (if still attached).

(g) ‘‘h vitro fertilization” means any fertilization of human ova which occurs outside the body of a female,

either through admixture of donor human sperm and ova or by any other means.

Section 46.204 Ethical Advisory Boards.

(a) One or more Ethical Advisory Boards shall be established by the Secretary. Members of these board(s)

shall be so selected that the board(s) will be competent to deal with medical, legal, social, ethical, and related issues

and may include, for example, research scientists, physicians, psychologists, sociologists, educators, lawyers, and
68 I Biomedical Ethics in U.S. Public Policy

ethicists, as well as representatives of the general public. No board member maybe a regular, full-time employee

of the Department of Health and Human Services.

(b) At the request of the Secretary, the Ethical Advisory Board shall render advice consistent with the policies

and requirements of this part as to ethical issues, involving activities covered by this subpart, raised by individual

applications or proposals. In addition, upon request by the Secretary, the Board shall render advice as to classes

of applications or proposals and general policies, guidelines, and procedures.

(c) A Board may establish, with the approval of the Secretary, classes of applications or proposals which: (1)

Must be submitted to the Board, or (2) need not be submitted to the Board. Where the Board so establishes a class

of applications or proposals which must be submitted, no application or proposal within the class may be funded

by the Department or any component thereof until the application or proposal has been reviewed by the Board and

the Board has rendered advice as to its acceptability from an ethical standpoint.

(d) No application or proposal involving human in vitro fertilization maybe funded by the Department of

any component thereof until the application or proposal has been reviewed by the Ethical Advisory Board and the

Board has rendered advice as to its acceptability from an ethical standpoint.
Appendix B-Legisiation, Regulations, and Statutes for Previous U.S. Bioethics Initiatives 69

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ETHICAL ADVISORY BOARD

Purpose

In the Federal Register of August 8, 1975 (40 FR 33526) , the Secretary

of Health, Educaticn, and Welfare published regulations regarding

research, development, and related activities involving fetuses, pregnant women, and in vitro fertilization. The regulations, codified at

45 CFR Part 46, Subpart B, provide for the establishment by the

Secretary of one or more Ethical Advisory Boards. Review of the

current needs for such an advisory structure indicates that, for the

time being, a single Board may be sufficient to meet the Department's

needs. This Board will advise the Department regarding biomedical and

behavioral research activities covered by Subpart B, in accordance

with the provisions thereof. In addition, the Board will advise the

cSecretary, as requested, with respect to issues arising under Section 474 (b)

of the Public Health Service Act, as -amended (42 U.S.C. 2891-3) The

Board may also be assigned responsibility for advising with-respect to

ethical issues raised by other Departmental biomedical and behavioral

research activities subject to the provisions

Authority

of 45 CFR 46.

42 U.S. Code 217a. This Board is governed by

Law 92-463 which sets forth standards for the

advisory committees

Function

the provisions of Public

formation and use of

At the request of the Secretary or his designee, the Ethical Advisory

Board shall render advice consistent with the policies and requirements

of 45 CFR Part 4 6 Subpart B as to etihical issues, involving , activities

covered by that subpart, raised by individual applications or proposals.

In addition, upon request by the Secretary or his designee, the Board

shall render advice as to classes of applications or proposals and

general policies, guidelines, and procedures under Subpart B.
70 I Biomedical Ethics in U.S. Public Policy

The Board may establish, with the approval of the Secretary or his

designee, classes of applications or proposals involving activities

revered by Subpart B which: (1) must be submitted to the Board, or (2)

need not be submitted to the Board. Where the Board so establishes a

class of applications or proposals which must be submitted, no application

or proposal within the class may be funded by the Department of Health,

Education, and Welfare or any component thereof until the application or

proposal has been reviewed by the Board and the Board has rendered

advice as to its acceptability from an ethical standpoint.

No application or proposal involving human in vitro fertilization may be

funded by the Department of Health, Education , and Welfare or any component

thereof until the application or proposal has been reviewed by the

Ethical Advisory Board and the Board has rendered advice as to its

acceptability from an ethical standpoint.

The Board must approve a request by the applicant or

or waive requirements of Subpart B, in order for the

designee to grant such a request.

At the

advice

Healt h

request of the Secretary or his designee, the

offeror to modify

secretary or his

Board will provide

with respect to issues arising under Section 474 (b) of the Public

Service Act, as amended (42 U.S.C. 2891-3) . —

The Secretary or his designee may assign the Board responsibility for

advising the Department of Health, Education, and Welfare regarding

ethical issues raised by other Department of Health, Education, and

Welfare activities subject to the provisions of 45 CFR 46.

Structure

The Ethical Advisory Board shall consist of fourteen members , including

the Chairman, appointed by the Secretary or his designee. Members shall

be so selected that the Board will be competent to deal with medical,

legal, social, ethical, and related beomedical issues, provided that:

(1) no more than seven may be Scientists, of whom four shall be beomedical

scientists and three social or behavioral scientists; and (2) the remainder

shall be from other disciplines or representatives of the general public,

except that at least one shall be an attorney and one shall be an ethicist.

No Board member may be a regular, full-time employee of the Federal

government.

Members shall be invited to seine for overlapping four-year terms,

except that of these persons initially appointed to the Board, four

shall be appointed for four-year terms, four for three-year terms, three

for two-year terns, and three for one-year terns. Terms of more than

two years are contingent upon renewal of the Board by appropriate action

prior to its termination.
Appendix B-Legislation, Regulations, and Statutes for Previous U.S. Bioethics Initiatives 71

Management and staff services shall be provided by the Executive Secretary

of the Ethical Advisory Board, Office of the Director, National Institutes

of Health.

Meetings

Meetings will usually be held three tires a year or at the call of the

with the advance approval of a government official who shall

also approve the agenda. A government official shall be present at all

meetings .

Meetings shall be open to the public except as determined- otherwise by

the Secretary or his designee; notice of all meetings shall be given to

the public.

Meetings shall be conducted, and records of proceeding kept, as required

by applicable laws and Departmental regulations.

Decisions of the Board on matters of broad public interest shall be

published in such form and manner as the Secretary may approve.

Compensation

Members shall be paid at the rate of $100 per day plus per diem and

travel expenses in accordance with Standard Government Travel Regulations.

Annual Cost Estimate

Estimated annual cost for operating the Board, including compensation

and travel expenses but excluding staff support , is $50,000. Estimat e

of annual person years of staff support required is two, $40,000.

Report

An annual report shall be submitted to the Secretary and

at a cost of

the Assistant

Secretary for Health not later than 60 days following the beginning of

the next fisca1 year which shall contain, as a minimum, a list of members

and their business addresses, the Committee's functions, the dates and

places of meetings, and a summary of the Committee's activities and

recommendations made during the fiscal year. A copy of the report shall

be provided to the Department Committee Management Officer.
72 I Biomedical Ethics in U.S. Public Policy

Termination Date

Unless renewed by appropriate action prior to its expiration, the Ethical

Advisory Board will terminate two years from the date this charter is

approved, or, if earlier, the first day of the first month that follows

the date on which all the members of the National Advisory Council for

the Protection of Subjects of Biomedical and Behavioral Research (as

provided for by Section 211 of the National Research Act) are appointed.

APPROVED :

M*

e

DEC 271976 [

Date Secretary
Appendix B-Legislation, Regulations, and Statutes for Previous U.S. Bioethics Initiatives 73

T H E S E C R E TA R Y O F H E A LT H , E D U C AT I O N, A N D W E L FA R E

WA S H I N G T O N , D. C. 2020 [

CHARTER

ETHICS ADVISORY BOARD

Purpose

The Ethics Advisory Board will review and advise the Secretary, as

requested, with respect to the ethics of current and proposed

departmental research and other activities, and of the missions,

programs, agency assignments, or procedures that are proposed to,

or are reviewed, supported, conducted, sponsored, monitored, or

regulated by the Department or which may involve the Department

directly or indirectly through other Federal, domestic, foreign,

or international organizations, institutions, agencies or persons.

Department regulations (45 CFR 46) for the protection of human

subjects involved in research, development or related activities

conducted, supported, or sponsored by the Department provide for

the establishment of one or more Ethics Advisory Boards within

the Department. Review of the current needs for the prescribed

functions indicates that, for the time being, a single Board may

be sufficient to meet the Department’s needs. This Board will

advise the Department regarding research activities covered by

applicable subparts and sections of 45 CFR 46, in accordance

with the provisions thereof. In addition, the Board will advise

the Secretary, as requested, with respect to issues arising under

Section 474(b) of the Public Health Service Act, as amended (42

U.S.C. 2891-3). —

The Board may initiate inquiries, hold hearings and conduct public

meetings, symposia, or other means for the purpose of developing

appropriate recommendations and to advise the Secretary.

Authority

42 U.S. Code 217a. This Board is governed by the provisions of

Public Law 92-463 as amended which sets forth standards for the

formation and use of advisory committees.

Functions

1. At the request of the Secretary, the Ethics Advisory Board shall

advise, consult with, and make recommendations to the Secretary

regarding the ethics of any research or other policy, or any mission,

program, agency assignment, or activity.
74 Biomedical Ethics in U.S. Public Policy

2. The Board may conduct inquiries and hold hearings on proposed policies

and regulations and on the interpretation, applicability, administration,

and effectiveness of departmental regulations, policies or requirements

and on the implementation of safeguards and assurances by institutions

or by agencies within the Department for the purpose of protecting the

rights and welfare of human subjects, or on other ethical matters and

will report its findings and recommendations to the Secretary.

3. At the request of the Secretary, the Board will provide advice on

ethical issues addressed to the Secretary regarding research, development or related activities involving human subjects.

4. The Board may advise, consult with and make recommendations to the

Secretary on ethical issues that arise in regard to proposed or ongoing

research, development or related activities involving human subjects

that may be conducted, supported, sponsored or regulated by the

Department.

5. The Board may consider appeals, requests and inquiries from

Institutional Review Boards or comparable agency review committees

that are addressed to the Secretary for guidance on ethical or policy

questions regarding research activities or proposals involving human

subjects when such referrals, in the judgment of the Secretary, present

substantive ethical or related policy issues.

6. The Chairman of the Board shall report directly to the Secretary on

all proposed agenda subjects, actions and recommendations of the Board

on policy development or policy review matters.

Ethical reviews required by regulation or referred to or requested by

the Board on specific proposals or ongoing activities will be reported

through the Office of the Secretary to the head of the departmental

agency or agencies involved.

Structure

The Ethics Advisory Board shall consist of no less than fourteen nor

more than twenty members, including the Chairman, appointed by the

Secretary.

Selection of members shall be made for representation from the legal,

ethical, scientific, medical and social professions or from the general

public, with special qualifications and competence to deal effectively
Appendix B-Legislation, Regulations, and Statutes for Previous U.S. Bioethics Initiatives 75

with ethical issues of concern to the Department, provided that at least

one member shall be an attorney, at least one member shall be an ethicist,

at least one member shall be a practicing physician, at least one member

shall be a theologian, and that no less than one-third nor More than half

the total membership shall be career scientists with substantial research

accomplishments, each to be selected for competency in one or more of

the following categories; (a) basic biomedical and behavioral (e.g. ,

physiological, genetic, psychological, pathological or etiological)

research; (b) pediatrics, developmental human biology, obstetrical or

gynecological research; (c) epidemiology, population or health services

research; (d) psychiatric, clinical psychology, behavioral or sociological research; and (e) design and conduct of large scale clinical

research programs for improving the treatment of major diseases or

disorders. .

No Board member may be a regular, full time employee of the Federal

government.

Members shall be appointed for four year terms except that of the members

first appointed, approximately one fourth shall be appointed for terms

of one year, one fourth for terms of two years, one fourth for terms of

three years, and one fourth for terms of four years.

Any member appointed to fill a vacancy occurring prior to expiration of

the term for which his predecessor was appointed shall serve for the

remainder of such term. Appointed members shall be eligible for

reappointment for one additional four year term. Members may serve

after the expiration of their terms until their successors have taken

office.

A majority of the appointed members shall constitute a quorum of the

Board.

The Board may refer specific questions, problems, and issues to any

other Departmental committee, agency or staff for advice and counsel .

On recommendations by the Board, the Secretary may approve the issuance

of requests for proposals and make sole or multiple contracts for

personal or institutional services for consultants to the Board, to

sponsor or conduct appropriate meetings, workshops, symposia, studies

or investigations and for preparation of transcripts, reports, and

other documents to assist the Board in its assigned functions.

The Board is empowered to have access to all records within the

Department and to all records outside the Department available to the

Secretary under the provisions of 45 CFR 46, or as may be additionally

authorized by the Secretary or his designee.
76 Biomedical Ethics in U.S. Public Policy

Management and staff services shall be provided by the Office of the

Director, National Institutes of Health. The Chairman of the Board,

after consultation with the Board, shall appoint a Staff Director and

a Deputy Staff Director. Additional staff shall be appointed by the

Staff Director. The Office of the Secretary, HEW, will, as justified

and necessary, on request of the Chairman and with concurrence by the

Secretary, authorize detail assignments of staff from departmental

agencies to the staff of the Board. The Staff Director may enter into

contracts for the purpose of assisting the Board in the performance of

its functions.

Meetings

The Board may hold up to ten meetings a year or at the call of the

Chairman. Subcommittee meetings may also be held three to six times

a year. All meetings require advance approval by an authorized government official who shall also approve the agenda. An authorized government official shall be present at all meetings.

Meetings shall be conducted, and records of proceedings kept, as required

by applicable laws and departmental regulations.

Compensation

Members shall be paid at the rate of $182.72 per day plus per diem and

travel expenses in accordance with Standard Government Travel Regulations.

Annual Cost Estimate

The estimated annual cost for the operations and functions of the Board

including compensation, travel expenses and contract services but

excluding staff support is estimated at $1,000,000. The estimated annual

person years of staff support is ten, at a cost of approximately $270,000.

Report

An annual report shall be submitted to the Secretary no later than 60

days following the beginning of the next fiscal year which shall contain,

as a minimum, a list of members and their business addresses, the Board’s

functions, the dates and places of meetings, and a summary of the Board’s

activities and recommendations made during the fiscal year. A COPY Of

the report shall be provided to the Department Committee Management

Officer.
Appendix B-Legislation, Regulations, and Statutes for Previous U.S. Bioethics Initiatives 77

Termination Date

Unless renewed by appropriate action prior to its expiration, the

Ethics Advisory Board will terminate two years from the date this

Charter is approved.

APPROVED:

JAN 11 1979 &d ●

Date Secretary
78 Biomedical Ethics in U.S. Public Policy

PRESIDENT’S COMMISSION FOR THE STUDY OF ETHICAL PROBLEMS IN

MEDICINE AND BIOMEDICAL AND BEHAVIORAL RESEARCH

Public Law 95-622 authorized creation of the President’s Commission for the Study of Ethical

Problems in Medicine and Biomedical and Behavioral Research. Although not fully operational during

the entire period, the authority for the President’s Commission was 1978-83. Reprinted below is the

relevant section of the U.S. Code.

42 U.S.C. Subchapter XVI—Presiden's Commission for the Study of Ethical Problems in Medicine and

Biomedical and Behavioral Research

Section 300 v. Commission

(a) Establishment; composition; appointment of members; vacancies

(1) There is established the President’s Commission for the Study of Ethical Problems in Medicine and

Biomedical and Behavioral Research (hereinafter in this subchapter referred to as the ‘Commission’) which shall

be composed of eleven members appointed by the President. The members of the Commission shall be appointed

as follows:

(A) Three of the members shall be appointed from individuals who are distinguished in biomedical or

behavioral research.

(B) Three of the members shall be appointed from individuals who are distinguished in the practice of

medicine or otherwise distinguished in the provision of health care.

(C) Five of the members shall be appointed from individuals who are distinguished in one or more of

the fields of ethics, theology, law, the natural sciences (other than a biomedical or behavioral

science), the social sciences, the humanities, health administration, government, and public affairs.

(2) No individual who is a full-time officer or employee of the United States may be appointed as a member

of the Commission. The Secretary of Health and Human Services, the Secretary of Defense, the Director of Central

Intelligence, the Director of the Office of Science and Technology Policy, the Administrator of Veteran’s Affairs,

and the Director of the National Science Foundation shall each designate an individual to provide liaison with the

Commission.

(3) No individual maybe appointed to serve as a member of the Commission if the individual has served for

two terms of four years each as such a member.

(4) A vacancy in the Commission shall be filled in the manner in which the original appointment was made.

(b) Terms of members

(1) Except as provided in paragraphs (2) and (3), members shall be appointed for terms of four years.

(2) Of the members first appointed—

(A) four shall be appointed for terms of three years, and

(B) three shall be appointed for terms of two years, as designated by the President at the time of

appointment.

(3) Any member appointed to fill a vacancy occurring before the expiration of the term for which his

predecessor was appointed shall be appointed only for the remainder of such term. A member may serve after the

expiration of his term until his successor has taken office.

(c) Chairman

The chairman of the Commission shall be appointed by the President, by and with the advice and consent

of the Senate, from members of the Commission.
Appendix B-Legislation, Regulations, and Statutes for Previous U.S. Bioethics Initiatives 79

(d) Meetings

(1) Seven members of the Commission shall constitute a quorum for business, but a lesser number may

conduct hearings.

(2) The Commission shall meet at the call of the chairman or at the call of a majority of its members.

(e) Compensation; travel expenses, etc.

(1) Members of the Commission shall each be entitled to receive the daily equivalent of the annual rate of

basic pay in effect for grade GS-18 of the General Schedule for each day (including travel time) during which they

are engaged in the actual performance of duties vested in the Commission.

(2) While away from their homes or regular places of business in the performance of services for the

Commission, members of the Commission shall be allowed travel expenses, including per diem in lieu of

subsistence, in the same manner as persons employed intermittently in the Government service are allowed

expenses under section 5703 of Title 5.

Section 300 v-1. Duties of Commission

(a) Studies and investigation; priority and order; report to President and Congress

(1) The Commission shall undertake studies of the ethical and legal implications of—

(A) the requirements for informed consent to participation in research projects and to otherwise undergo

medical procedures;

(B) the matter of defining death, including the advisability of developing a uniform definition of death;

(C) voluntary testing, counseling, and information and education programs with respect to genetic

diseases and conditions, taking into account the essential quality of all human beings, born and

unborn;

(D) the differences in the availability of health services as determined by the income or residence of the

persons receiving the services;

(E) current procedures and mechanisms designed (i) to safeguard the privacy of human subjects of

behavioral and biomedical research, (ii) to ensure the confidentiality of individually identifiable

patient records, and (iii) to ensure appropriate access of patients to information continued [sic] in such

records, and

(F) such other matters relating to medicine or biomedical or behavioral research as the President may

designate for study by the Commission.

The Commission shall determine the priority and order of the studies required under this paragraph.

(2) The Commission may undertake an investigation or study of any other appropriate matter which relates

to medicine or biomedical or behavioral research (including the protection of human subjects of biomedical or

behavioral research) and which is consistent with the purposes of this subchapter on its own initiative or at the

request of the head of a Federal agency.

(3) In order to avoid duplication of effort, the Commission may, in lieu of, or as part of, any study or

investigation required or otherwise conducted under this subsection, use a study or investigation conducted by

another entity if the Commission sets forth its reasons for such use.

(4) Upon the completion of each investigation or study undertaken by the Commission under this subsection

(including a study or investigation which merely uses another study or investigation), it shall report its findings

(including any recommendations for legislation or administrative action) to the President and the Congress and

to each Federal agency to which a recommendation in the report applies.
80 Biomedical Ethics in U.S. Public Policy

(b) Recommendations to agencies; subsequent administrative requirements

(1) Within 60 days of the date a Federal agency receives a recommendation from the Commission that the

agency take any action with respect to its rules, policies, guidelines, or regulations, the agency shall publish such

recommendation in the Federal Register and shall provide opportunity for interested persons to submit written

data, views, and arguments with respect to adoption of the recommendation.

(2) Within the 180-day period beginning on the date of such publication, the agency shall determine whether

the action proposed by such recommendation is appropriate, and, to the extent that it determines that—

(A) such action is not appropriate, the agency shall, within such time period, provide the Commission

with, and publish in the Federal Register, a notice of such determination (including an adequate

statement of the reasons for the determination), or

(B) such action is appropriate, the agency shall undertake such action as expeditiously as feasible and

shall notify the Commission of the determination and the action undertaken.

(c) Report on protection of human subjects; scope; submission to President, etc.

The Commission shall biennially report to the President, the Congress, and appropriate Federal agencies on

the protection of human subjects of biomedical and behavioral research. Each such report shall include a review

of the adequacy and uniformity (1) of the rules, policies, guidelines, and regulations of all Federal agencies

regarding the protection of human subjects of biomedical or behavioral research which such agencies conduct or

support, and (2) of the implementation of such rules, policies, guidelines, and regulations by such agencies, and

may include such recommendations for legislation and administrative action as the Commission deems

appropriate.

(d) Annual report; scope; submission to President, etc.

Not later than December 15 of each year (beginning with 1979) the Commission shall report to the President,

the Congress, and appropriate Federal agencies on the activities of the Commission during the fiscal year ending

in such year. Each such report shall include a complete list of all recommendations described in subsection (b)(1)

of this section made to Federal agencies by the Commission during the fiscal year and the actions taken, pursant

[sic] to subsection (b)(2) of this section, by the agencies upon such recommendations, and may include such

recommendations for legislation and administrative action as the Commission deems appropriate.

(e) Publication and dissemination of reports

The Commission may at any time publish and disseminate to the public reports respecting its activities.

(f) Definitions

For purposes of this section:

(1) The term “Federal agency” means an authority of the government of the United States, but does not

include (A) the Congress, (B) the courts of the United States, and (C) the government of the Commonwealth of

Puerto Rico, the government of the District of Columbia, or the government of any territory or possession of the

United States.

(2) The term “protection of human subjects‘‘ includes the protection of the health, safety, and privacy of

individuals.

Section 300 v-2. Administrative provisions

(a) Hearings

The Commission may for the purpose of carrying out this subchapter hold such hearings, sit and act at such

times and places, take such testimony, and receive such evidence, as the Commission may deem advisable.
Appendix B-Legislation, Regulations, and Statutes for Previous U.S. Bioethics Initiatives 81

(b) Appointment and compensation of staff personnel; procurement and compensation of temporary and

intermittent services; detail of personnel from other Federal agencies

(1) The Commission may appoint and fix the pay of such staff personnel as it deems desirable. Such personnel

shall be appointed subject to the provisions of Title 5 governing appointments in the competitive service, and shall

be paid in accordance with the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to

classification and General Schedule pay rates.

(2) The Commission may procure temporary and intermittent services to the same extent as is authorized by

section 3109(b) of Title 5, but at rates for individuals not to exceed the daily equivalent of the annual rate of basic

pay in effect for grade GS-18 of the General Schedule.

(3) Upon request of the Commission, the head of any Federal agency is authorized to detail, on a reimbursable

basis, any of the personnel of such agency to the Commission to assist it in carrying out its duties under this

subchapter.

(c) Contracting authority

The Commission, in performing its duties and functions under this subchapter, may enter into contracts with

appropriate public or nonprofit private entities. The authority of the Commission to enter into such contracts is

effective for any fiscal year only to such extent or in such amounts as are provided in advance in appropriation

Acts.

(d) Information requirements and prohibitions

(1) The Commission may secure directly from any Federal agency information necessary to enable it to carry

out this subchapter. Upon request of the Chairman of the Commission, the head of such agency shall furnish such

information to the Commission.

(2) The Commission shall promptly arrange for such security clearances for its members and appropriate staff

as are necessary to obtain access to classified information needed to carry out its duties under this subchapter.

(3) The Commission shall not disclose any information reported to or otherwise obtained by the Commission

which is exempt from disclosure under subsection (a) of section 552 of Title 5 by reason of paragraphs (4) and

(6) of subsection (b) of such section.

(e) Support services from Administrator of General Services

The Administrator of General Services shall provide to the Commission on a reimbursable basis such

administrative support services as the Commission may request.

Section 300 v-3. Authorization of appropriations; termination of Commission

(a) To carry out this subchapter there are authorized to be appropriated $5,000,000 for the fiscal year ending

September 30, 1979, $5,000,000 for the fiscal year ending September 30, 1980, $5,000,000 for the fiscal year

ending September 30, 1981, and $5,000,000 for the fiscal year ending September 30, 1982.

(b) The Commission shall be subject to the Federal Advisory Committee Act, except that, under section

lo of such Act, the Commission shall terminate on December 31, 1982.
82 I Biomedical Ethics in U.S. Public Policy

BIOMEDICAL ETHICS BOARD AND BIOMEDICAL ETHICS ADVISORY

COMMllTEE

In 1985, Congress passed, and the President signed, Public Law 99-158, which included

establishment of a congressional Biomedical Ethics Board and the appointment of the Biomedical

Ethics Advisory Committee. Both entities ceased to exist in 1989, having been operational for

approximately 16 months. Reprinted below is the relevant section of the U.S. Code.

42 U.S.C. Section 275. Biomedical Ethics Board

(a) Establishment

There is established in the legislative branch of the Government the Biomedical Ethics Board (hereinafter

referred to as the “Board”).

(b) Membership; term of office; vacancies; chairman and vice chairman; meetings

(1) The Board shall consist of twelve members as follows:

(A) Six Members of the Senate appointed as follows: Three members appointed by the Majority Leader

of the Senate from the majority party and three members appointed by the Minority Leader from the

minority party.

(B) Six Members of the House of Representatives appointed by the Speaker of the House of

Representatives, three from the majority party and three from the minority party.

(2) The term of office of a member of the Board shall expire when the member leaves the office of Senator

or Representative; as the case may be, or upon the expiration of eight years after the date of the member’s

appointment to the Board, whichever occurs first.

(3) Vacancies in the membership of the Board shall not affect the power of the remaining members to execute

the functions of the Board and shall be filled in the same manner as in the case of the original appointment.

(4) The Board shall select a chairman and a vice chairman from among its members at the beginning of each

Congress. The vice chairman shall act as chairman in the absence of the chairman or in the event of the incapacity

of the chairman. The chairmanship and vice chairmanship shall alternate between the Senate and the House of

Representatives with each Congress. The chairman during each even-numbered Congress shall be selected by the

Members of the House of Representatives on the Board from among their number. The vice chairman during each

Congress shall be chosen in the same manner from that House of Congress other than the House of Congress of

which the chairman is a Member.

(5) The Board shall meet once every three months unless such meeting is dispensed with by the chairman,

and may meet at any time upon the request of four or more members of the Board or upon the call of the chairman.

(c) Functions; annual report to Congress; report to the Congress on research and developments in genetic

engineering

(1) The Board shall study and report to the Congress on a continuing basis on the ethical issues arising from

the delivery of health care and biomedical and behavioral research, including the protection of human subjects of

such research and developments in genetic engineering (including activities in recombinant DNA technology)

which have implications for human genetic engineering.

(2)(A) Except as provided in subparagraph (B), an annual report shall be transmitted to the Congress

identifying the issues which were the subject of the study conducted under paragraph (1) and identifying areas,

programs, and practices of medicine and biomedical and behavioral research which have significant ethical

implications and which would be appropriate subjects for study.

(B) A report on research and developments in genetic engineering (including activities in recombinant

DNA technology) which have implications for human genetic engineering shall be transmitted to the

Congress not later than eighteen months after the appointment of the Committee under subsection

(d) of this section.
Appendix B-Legislation, Regulations, and Statutes for Previous U.S. Bioethics Initiatives 83

(d) Biomedical Ethics Advisory Committee; appointment, membership, compensation, etc.; functions;

public hearings; availability of additional personnel and information; gifts and donations; use of mails

(1) To conduct the studies and make the reports required by subsection (c) of this section, the Board shall

appoint a Biomedical Ethics Advisory Committee (hereinafter referred to as the “Committee”). The Committee

shall consist of fourteen members as follows:

(A) Four of the members shall be appointed by the Board from individuals who are distinguished in

biomedical or behavioral research,

(B) Three of the members shall be appointed by the Board from individuals who are distinguished in the

practice of medicine or otherwise distinguished in the provision of health care.

(C) Five of the members shall be appointed by the Board from individuals who are distinguished in one

or more of the fields of ethics, theology, law, the natural sciences (other than the biomedical or

behavioral sciences), the social sciences, the humanities, health administration, government, and

public affairs.

(D) Two of the members shall be appointed by the Board from individuals who are representatives of

citizens with an interest in biomedical ethics but who possess no specific expertise.

(2)(A) The Committee, by majority vote, shall elect from its members a chairman and a vice chairman and

appoint an executive director who shall serve for such time and under such conditions as the Committee may

prescribe. In the absence of the chairman, or in the event of the incapacity of the chairman, the vice chairman shall

act as chairman.

(B) The term of office of each member of the Committee shall be four years, except that any such member

appointed to fill a vacancy occurring prior to the expiration of the term for which such member’s

predecessor was appointed shall be appointed for the remainder of such term. Terms of the members

shall be staggered so as to establish a rotating membership.

(C) The members of the Committee shall receive no pay for their services as members of the Committee,

but shall be allowed necessary travel expenses (or, in the alternative, mileage for use of privately

owned vehicles and a per diem of subsistence at not to exceed the rate prescribed in sections 5702

and 5704 of Title 5) and other necessary expenses incurred by them in the performance of duties as

a member of the Committee, without regard to the provisions of subchapter 1 [sic] of chapter 57 and

section 5731 of Title 5, and regulations promulgated thereunder.

(D) The executive director of the Committee, with the approval of the Committee, may employ such staff

and consultants as necessary to prepare studies and reports for the Committee.

(3)(A) The Committee may, for the purpose of carrying out its functions, hold such public hearings, sit and

act at such times and places, and take such testimony, as the Committee considers appropriate.

(B) Upon request of the Committee, the head of any Federal agency is authorized to detail, on a

reimbursable basis, any of the personnel of such agency to the Committee to assist the Committee

in carrying out its functions.

(C) The Committee may secure directly from any department or agency of the United States information

necessary to enable it to carry out its functions. Upon request of the chairman of the Committee, the

head of such department or agency shall furnish such information to the Committee.

(D) The Committee may accept, use, and dispose of gifts or donations or services or property.

(E) The Committee may use the United States mails in the same manner and under the same conditions

as other departments and agencies of the United States.

(e) Authorization of appropriations

To enable the Board and the Committee to carry out their functions there are authorized to be appropriated

$2,000,000 for fiscal year 1986,$2,500,000 for fiscal year 1987,$3,000,000 for fiscal year 1988,$2,000,000 for

fiscal year 1989, and $2,500,000 for fiscal year 1990.
Appendix C

Acknowledgments

OTA thanks the many individuals and organizations that generously supplied information for this study. In

addition, OTA acknowledges the following individuals for their review of drafts of this background paper:

J.G.M Aartsen S.R. Benatar

Health Council of the Netherlands University of Cape Town

The Hague, The Netherlands Cape Town, South Africa

Duane F. Alexander

National Institute of Child Health

and Human Development

Bethesda, MD

Margaret A. Anderson

American Public Health Association

Washington, DC

Paul W. Armstrong

Bridgewater, NJ

Christian Bardoux

Commission of the European Communities

Brussels, Belgium

Nora K. Bell

University of South Carolina

Columbia, SC

Bela Blasszauer

Medical University of Pees

Pecs, Hungary

Dan W. Brock

Brown University

Providence, RI

Christian Byk

Paris, France

Daniel Callahan

The Hastings Center

Briarcliff Manor, NY

Alastair V. Campbell

University of Otago

Dunedin, New Zealand

84
Arthur L. Caplan

University of Minnesota

Minneapolis, MN

Peter Carpenter

Stanford University

Atherton, CA

Max Charlesworth

North Carlton, Australia

R. Alta Charo

University of Wisconsin Law School

Madison, WI

James Childress

University of Virginia

Charlottesville, VA

Ellen Wright Clayton

The Vanderbilt Clinic

Nashville, TN

Robert M. Cook-Deegan

Institute of Medicine

Washington, DC

Jean Davies

World Federation of Right-to-Die Societies

Oxford, United Kingdom

Regis M. Dunne

Provincial Bioethics Center

South Brisbane, Australia

Gary B. Ellis

Office for Protection from Research Risks

Bethesda, MD

H. Tristram Englehardt, Jr.

Baylor College of Medicine

Houston, TX

Paolo Maria Fasella

Commission of the European Communities

Brussels, Belgium

Appendix C-Acknowledgments I 85

John 1, Fleming

Southern Cross Bioethics Institute

Plympton, Australia

John C. Fletcher

University of Virginia

Charlottesville, VA

S.S. Fluss

World Health Organization

Geneva, Switzerland

Patricia Anne Flynn

St. Mary’s College of California

Moraga, CA

Heman L. Fuenzalida

Pan American Health Organization

Washington, DC

K.W.M. Fulford

University of Oxford

Oxford, United Kingdom

Bradford H. Gray

Yale University

New Haven, CI’

Jiri F. Haderka

Palacky University

Havirov, Czech Republic

D.A. Henderson

Office of Science and Technology Policy

Washington, DC

Angela R. Holder

Yale University

New Haven, CT

Soren Helm

University of Copenhagen

Copenhagen, Denmark

Kathy Hudson

Office of the Assistant Secretary for Health

Washington, DC
86 I Biomedical Ethics in U.S. Public Policy

Ram Ishay

Israeli Society for Medical Ethics

Tel Aviv, Israel

Tibor Jakab

Medical University of Pees

Pecs, Hungary

Albert R. Jensen

University of Washington

Seattle, WA

Lena Jonsson

Ministry of Health and Social Affairs

Stockholm, Sweden

Eric T. Juengst

National Center for Human Genome Research

Bethesda, MD

Aristoteles G. Katsas

Evangelisms Hospital

Athens, Greece

George Kisch

Jestetten, Germany

Bartha Maria Knoppers

University of Montreal Law Faculty

Montreal, Canada

Walter Landesman

Sindicato Medico del Uruguay

Montevideo, Uruguay

Nicole Lery

Laboratoire de Medecine Legale et de Toxicologic

Medicale

Lyon, France

Robert J. Levine

Yale University School of Medicine

New Haven, CT

Roberto Llanos-Zuloaga

Clinica Ricardo Palma

Lima, Peru

Fernando Lolas

University of Chile

Santiago, Chile

Charles R. McCarthy

Kennedy Institute of Ethics

Washington, DC

Affonso Renato Meira

University of Sao Paulo

Sao Paulo, Brazil

Judith Miller

National Council on Bioethics in

Human Research

Ottawa, Canada

Gonzalo Moctezuma Barragan

Direccion de Asuntos Juridicos

Mexico City, Mexico

Maurizio Mori

Politeia

Milan, Italy

Ellen H. Moskowitz

The Hastings Center

Briarcliff Manor, NY

Amo G. Motulsky

University of Washington

Seattle, WA

Thomas H. Murray

Case Western Reserve University

Cleveland, OH

Simone B. Novaes

Centre National de La Recherche Scientifique

Paris, France

Robert S. Olick

Lowenstein, Sandler, Kohl, Fisher& Boylan

Roseland, NJ

Yaman Ors

Ankara Medical Faculty

Ankara Turkey
Appendix C-Acknowledgments I 87

Marian Osterweis

Association of Academic Health Centers

Washington, DC

Joan P. Porter

Office for Protection from Research Risks

Bethesda, MD

Gail J. Povar

George Washington University Medical Center

Washington, DC

Philip R. Reilly

Shriver Center for Mental Retardation, Inc.

Waltham, MA

Povl Riis

Herlev University Hospital

Herlev, Denmark

Eleuterio Rodriguez Neto

University of Brasilia

Brasilia, Brazil

Maria Teresa Rotondo

Sindicato Medico del Uruguay

Montevideo, Uruguay

Kenneth J. Ryan

Brigham and Women’s Hospital

Boston, MA

Gamal I. Serour

A1-Azhar University

Cairo, Egypt

Daniel Serrao

University of Porto Medical School

Porto, Portugal

David Shapiro

Nuffield Council on Bioethics

London, United Kingdom

Judith Swazey

The Acadia Institute

Bar Harbor, ME

Juan Carlos Tealdi

Fundacion Dr. JOSe Maria Mainetti

Gonnet, Argentina

Jean-Marie Thevoz

Fondation Louis Jeantet

Geneva, Switzerland

Nicholas Tonti-Filippini

Lower Templestowe, Australia

Harold Y. Vanderpool

University of Texas Medical Branch

Galveston, TX

LeRoy B. Walters

Kennedy Institute of Ethics

Washington, DC

Daniel J. Wikler

University of Wisconsin

Madison, WI

Susan M. Wolf

Harvard University

Cambridge, MA

Michael S. Yesley

Los Alamos National Laboratory

Los Alamos, NM

Amos Shapira

Tel Aviv University

Ramat Aviv, Israel
Index

Advisory Panel for Alzheimer’s Disease-U.S., 35 role of Federal commissions devoted to, 25-28

Africa, 43; see also individual countries State initiatives in, 13-15

Agenda. See Mandate use in OTA report of the term, 2

AIDS, 8-9, 10,28 Biomedical Ethics Advisory Committee (BEAC)

Alabama, 3 appointment process for, 13, 34-35, 83

American Academy of Pediatrics, 26 bureaucratic location of, 4, 12, 18,36,82

American Association of Bioethics, 26 establishment of, 4, 12-13

American College of Obstetricians and Gynecologists, 26 factors affecting demise of, 17, 18,32

American Fertility Society, 26,37 funding of, 31,83

American Medical Association, 26 mandate and scope of, 13, 82-83

American Society of Human Genetics, 26 membership composition of, 13, 82

Americans With Disabilities Act, 8 relationship to BEB of, 13

Appointment process reports by, 13, 29

as an important element for a new body, 34-35, 38 request for OTA report and, iii, 4, 7

for BEAC, 13, 34-35, 83 statute governing, 82-83

for EAB, 11, 67 Biomedical Ethics Board (BEB)

for National Commission, 10, 34, 61 composition of, 4, 13

for New Jersey Bioethics Commission, 13, 14 OTA Technology Assessment Board as a model for, 13

for New York State Task Force, 15 oversight of BEAC by, 4, 13, 82

for President’s Commission, 12,34,78 statute governing, 82-83

Argentina, 16,43 Botswana, 16

Army, Us., 3 Brazil, 16,44

Asia, 43; see also individual countries Budget. See Funding

Australia, 16,43-44, 54 Bush, George H. W., EAB and administration of, 11

Austria, 16

Cabot, Richard Clarke, 1

‘ ‘Baby Doe, ” 1 California, 13

‘‘Baby M,’ case of, 2, 14 Canada, 16,44-45,54,56

Belgium, 16 Carter, Jimmy, President’s Commission and, 33

Bioethics Central America, 43,52

congressional interest in, iii, 34, 7, 12-13 Charters

Federal initiatives in, 7-13, 17-18, 25 governing EAB, 7,67,69-77

international initiatives in, 15-17, 43-60 see also Legislation; Regulations; Statutes

issues in, 1-3, 28-29 Chile, 16

NIH reauthorization and, 3, 30 China, 16,45

origin of term, 2 Client, as an important element for a new body, 33-34,38

89
90 I Biomedical Ethics in U.S. Public Policy

Clinton, William J.

fetal tissue transplantation and, 9

reduction in Federal advisory bodies and, 29

Colorado, 13

Columbia, 16

Commission

factors to consider in creating new, 31-38

potential cost of new, 32

potential organizational model of new, 28-31,38

potential role of new, 25-28,38

see also Appointment process; Biomedical Ethics Advisory Committee; Client; Ethics Advisory Board;

Funding; Location; Mandate; National Commission;

President’s Commission; Reporting requirement; Response requirement

Congress, U.S.

as a bureaucratic location for new body, 36

commission structures for consideration by, 28-31, 38

establishment of BEAC and BEB by, 4, 12-13

establishment of National Commission by, 4, 10

establishment of President’s Coremission by, 4, 12, 25

interest in bioethics of, iii, 3-4, 7, 12-13

role in appointing coremission members, 35

role in setting coremission agenda, 33-34

Cost, 32

Council for International Organizations of Medical Sciences,

52-53

Council of Europe, 17,54

Croatia, 16

Cruzan, Nancy, case of, 2

Cyprus, 16

Czech Republic, 16,45

DeConcini, Senator Dennis, iii, 3

Denmark, 16, 17, 18,29,4546

Department of Energy (DOE), U. S., ELSI program of, 4,8,

10,26

Department of Health and Human Services (DHHS), U.S.

EAB and, 4, 11,33,35-36

Organ Transplantation Task Force of, 9

reestablishing EAB-like body and, 29

Department of Health, Education, and Welfare (DHEW),

Us.

EAB and, 4, 11,35-36

National Coremission and, 4, 10-11, 12, 27-28

Egypt, 16,54

Ethical, Legal, and Social Issues (ELSI) programs-NIH/

DOE, 4,8, 10,26

Ethical, Legal, and Social Issues Working Group-NIH/

DOE, 4,8

Ethics Advisory Board (EAB)

advisability of reestablishing, 28

bureaucratic location of, 4, 11,35-36,67

demise of 11, 12,33,37

establishment of, 4, 10-11

factors affecting success of, 18

forcing clause and, 37

funding of, 12,33

mandate and scope of, 11, 18, 68

membership composition of, 11, 67

regulations and charters governing, 11, 67-77

relationship to National Coremission of, 10-11, 28, 33,

37-38

relationship to President’s Commission of, 12, 33

relationship to proposed ethical advisory boards in NIH

reauthorization of, 30

reporting and dissemination by, 37

reports by, 11

request for OTA report and, iii, 4, 7

Ethics advisory boards, relationship to EAB of, 30

Ethics and Values in Science and Technology Program—

NSF, 10

Eubios Ethics Institute, 55

Europe, 43; see also individual countries

European Association of the Centres of Medical Ethics, 55

European Community, 17,53-54

European Parliament, 54

European Society for Philosophy of Medicine and Health

Care, Section for Medical Ethics in Nordic Countries,

55

Federal Advisory Committee Act

exemption of IOM to, 36

requirement for open meetings by, 18, 36

Federal Government

interest in bioethics of, 7-10, 25-28

legislation, statutes, or regulations for bioethics initiatives

of, 61-83

past bioethics initiatives of, iii, 4,7-13,25

see also Biomedical Ethics Advisory Committee; Ethics

Advisory Board; National Commission; President’s

Commission

Finland, 16,46

France, 16, 17, 18,30,35,46,55

Fundacion Dr. Jose Maria Mainetti, 55

Funding, as an important element for a new body, 31-33,38

Germany, 16,47

Ghana, 16

Gibbons, John H., 5

Greece, 16,47

Hastings Center, 55

Hatfield, Senator Mark O., iii, 3,4-5

Herdman, Roger C., iii

Holy See, 16

Human Fetal Tissue Transplantation Research Panel (Fetal

Tissue Panel)-NIH, 8,9, 10,28,37

Human Genome Project, 8

Hungary, 16,47

Iceland, 16

Institute of Medicine (IOM)

as a bureaucratic location for new body, 36
Index I 91

forthcoming document on bioethics and policy decisionmaking of, 26

reports including bioethical analyses of, 26

Institutional ethics committees, 2

Institutional Review Boards, 2

International

efforts in bioethics, 15-17, 43-60

see also specific countries

International Association of Bioethics, 26, 54

International Association of Law, Ethics, and Science, 54-55

International Federation of Catholic Universities, International Study Group on Bioethics, 55

International Islamic Center for Population Studies, 54

Ireland, 16

Islamic Organization for Education, Sciences, and Culture,

54

Israel, 16,47

Issues

broad-based, 28,29

in bioethics generally, 1-3, 28

research-related, 28, 29

Italy, 16,48

Japan, 16,48, 55

Jewish Chronic Disease Hospital-Brooklyn, New York, 2

Kennedy, Senator Edward M., iii, 3

Kevorkian, Jack, 2

Kuwait, 16

Latin America, 43,52,55

Legislation

establishing National Commmission, 61-66

establishing U.S. bioethics initiatives, 4

see also Charters; Regulations; Statutes

Liechtenstein, 16

Location

as an important element for a new body, 35-36, 38

of BEAC, 4, 12, 18, 82

of EAB, 4, 11, 67

of National Coremission, 4, 10, 12, 18

of New Jersey Bioethics Commission, 13

of New York State Task Force, 15

of President’s Commission, 4, 12, 78

of U.S. bioethics initiatives, 4

Luxembourg, 16,48

Malta, 16,48

Mandate

as an important element for a new body, 33-34, 38

of BEAC, 13, 82-83

of EAB, 11, 18, 68

of National Commission, 10, 18, 29, 34, 61-63

of New Jersey Bioethics Coremission, 13

of New York State Task Force, 15

of President’s Commission, 12, 29, 33-34, 79, 80

Mexico, 16,48

Minnesota, 13

National Academy of Sciences, 26

National Advisory Board on Ethics in Reproduction, 26

National Commission for the Protection of Human Subjects

of Biomedical and Behavioral Research (National

Commission)-U.S.

appointment process for, 10, 34, 61

bureaucratic location of, 4, 10, 12, 18,35-36

establishment of, 4, 10

factors affecting success of, 18,37

forcing clause of, 10-11,37-38,64

funding of, 31-32

legislation establishing, 61-66

mandate and scope of, 10, 18, 29, 34, 61-63

membership composition of, 10, 34, 35, 61-62

relationship to EAB of, 10-11, 28, 33, 37-38

reporting and disseminating by 37

reports by, 9, 10, 31, 38

request for OTA report and, iii, 34, 7

National Commission on Acquired Immune Deficiency

Syndrome-U. S., 8-9

National Commission on Health Science and Society—

proposed U.S., 7

National Endowment for the Humanities-U. S., 10

National Institute on Aging, 35

National Institutes of Health (NIH)

Ethical, Legal, and Social Issues program of, 4,8, 10,26

ethics advisory boards and reauthorization of, 30

Human Fetal Tissue Transplantation Panel of, 8,9,10,28,

37

reauthorization of, 3, 30

Recombinant DNA Advisory Committee of, 9, 12

research on human in vitro fertilization and, 11

Science Policy Studies Center of, 8

National Institutes of Health Revitalization Act of 1993, 30

National Science Foundation-U. S., 10

The Netherlands, 16,49,54

New Jersey Commission on Legal and Ethical Problems in

the Delivery of Health Care, 13-14, 17, 18, 30, 34

New York

Jewish Chronic Disease Hospital-Brooklyn, 2

Task Force on Life and the Law, 14-15, 17, 18,30,34,36

New Zealand, 16,49,55

Nordic Council Bioethics Group, 55

North America, 43; see also individual countries

Nonway, 16,49

Office of Science and Technology Policy (OSTP)

as a bureaucratic location for new body, 36

disbanding of EAB by, 11

Science Advisor and President’s Commission, 33

Office of Technology Assessment (OTA)

as a bureaucratic location for new body, 36, 38

BEB compared to Technology Assessment Board of, 13

organization of this report, 4-5

origins of this report, 2-4

reports including bioethica1 analyses of, 9, 26

role in appointing certain bodies, 35

terminology used by, 2
92 I Biomedical Ethics in U.S. Public Policy

Oregon, 13

Organ Transplantation Task Force—DHHS, 9

Pan American Health Organization (PAHO), 52

Peru, 16

The Philippines, 16,49

Physician Payment Review Commission, 35

Poland, 16,50

Portugal, 16,50

Potter, Van Rensselaer, 2

President—U.S.

bioethics and Executive Office of the, 36

Bush, 11

Carter, 33

Clinton, 9

Reagan, 11

President Commission for the Study of Ethical Problems in

Medicine and Biomedical and Behavioral Research

(President’s Commission)-U.S.

appointment process for, 12, 34, 35, 78

bureaucratic location of, 4, 12, 36, 78

establishment of, 4, 12

factors affecting success of, 18

forcing clause and, 12,80

funding of, 18, 81

mandate and scope of, 12, 29, 33-34,79, 80

membership composition of, 12, 34, 35, 78

relationship to EAB of, 12, 33

reporting and dissemination by, 37

reports by, 12, 31, 38

request for OTA report and, iii, 4, 7

statute governing, 78-81

Presidential Commission on the Human Immunodeficiency

Virus Epidemic-U. S., 8

Prospective Payment Assessment Coremission, 35

Public Health Service, U. S., 3

Quinlan, Karen Ann, 2, 13

Reagan, Ronald, EAB and administration of, 11

Recombinant DNA Advisory Committee (RAC)-NIH, 9,

12

Regulations

governing EAB, 7,67-68

see also Charters; Legislation; Statutes

Reporting requirement, as an important element for a new

body, 37-38

Response requirement

as an important element for a new body, 37-38

National Commission and, 10-11,37-38,64

President’s Commission and, 12, 80

Romania, 16,50

Russia, 16,50

Scope. See Mandate

Scotland, 17

South Africa, 17,50

South America, 43, 52; see also individual countries

Spain, 17,50-51

States, bioethics initiatives of, 13-15

Statutes

governing BEAC, 82-83

governing President’s Commission, 78-81

see also Charters; Legislation; Regulations

Sweden, 17,51

Switzerland, 17,51

Turkey, 15,51

Tuskegee syphilis study, 2,3

United Kingdom, 17, 18,30,51-52,55

United Nations Educational, Scientific, and Cultural Organization (UNESCO), 50, 52

United Nations Fund for Population Assistance (UNFPA),

52,54

United Nations system, 52

United States. See Federal Government; States

Uruguay, 17

Vermont, 13

Willowbrook State School for the Retarded, 2

Wisconsin, 2

World Health Organization (WHO), 52,54