National Bioethics Advisory Commission

1996-1997 Annual Report

Rockville, Maryland

March 1998

National Bioethics Advisory Commission

1996-1997 Annual Report
National Bioethics Advisory Commission

6100 Executive Boulevard,

Suite 5B01

Rockville, MD 20892-7508

Telephone: 301-402-4242

Fax: 301-480-6900

Website: http://www.bioethics.gov
Table of Contents

Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i

Roster of NBAC Members (1996-1997) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii

NBAC Staff (1997) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv

Executive Order 12975 of October 3, 1995 

and Amendments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Establishment of the 

National Bioethics Advisory Commission . . . . . . . . . . . . . . . . . . . . . . . . . 3

A Brief History of 

U.S. Bioethics Commissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

NBAC’S First Year: 1996-1997 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Activities of the 

Human Subjects Subcommittee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Activities of the 

Human Genetics Subcommittee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Response to the President’s Request: 

Cloning Human Beings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Plans for 1998 and Beyond . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Further Information about NBAC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Appendix A: NBAC Staff (1998) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Appendix B: Executive Summary: 

Cloning Human Beings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Appendix C: Meeting Dates of the Commission, 

1996-1997 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Appendix D: Expert and Public Testimony 

Presented to NBAC, 1996-1997 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

i

Preface

The purpose of this report is to make available to the public a brief description of the work of the

National Bioethics Advisory Commission during 1996-1997, and its ongoing agenda.

The National Bioethics Advisory Commission, appointed by President Clinton in the later half of 1996,

has had a rather eventful first year. Our initial agenda, which focused both on the protection of human

subjects and the ethical issues surrounding the use of an individual’s genetic information,

perhaps drawn from existing tissue banks, was “interrupted” or temporarily displaced by a new,

urgent request from President Clinton. This Presidential request, prompted by the apparent success 

of the “Dolly Experiment”— the cloning of an animal from an adult or specialized cell using somatic

cell nuclear transfer technique—and the resulting widespread public excitement, fear, concern,

and awe — effectively put our initial agenda on hold for a number of months. We turned our attention

instead to the challenge of providing, in ninety days, advice on the ethical and legal issues involved 

if using this technique to clone human beings. Our report on this issue was delivered to the President 

in early June 1997, after which we returned to the items on our initial agenda. These items and the 

ongoing work of the Commission are more fully described in this report.

Finally, I would like to take this occasion to extend my appreciation to all the Commissioners for 

their dedication to the work of the Commission, to our small but very hard working staff, the 

many scholars who responded to our request for help, the leadership of the Department of Health 

and Human Services, and the Office of Science and Technology Policy, which in many ways 

supported the work of the Commission. I would also like to thank Dr. William F. Raub for his 

leadership and guidance as Acting Executive Director during 1997, which he provided in addition to 

his full time duties as Deputy Assistant Secretary for Science Policy at the Department of Health 

and Human Services. As Dr. Raub’s day-to-day responsibilities come to a close, NBAC welcomes 

Dr. Eric M. Meslin as its new Executive Director, beginning February 1998.

Harold T. Shapiro, Chair

March 1998
ii

Roster of NBAC Members (1996-1997)

Patricia Backlar

Research Associate Professor of Bioethics

Department of Philosophy

Portland State University

Senior Scholar

Center for Ethics in Health Care

Oregon Health Sciences University

Portland, Oregon

Arturo Brito, M.D.

Assistant Professor of Clinical Pediatrics

University of Miami School of Medicine

Miami, Florida

Alexander M. Capron, LL.B.

Henry W. Bruce Professor of Law

University Professor of Law and Medicine 

Co-Director, Pacific Center for 

Health Policy and Ethics

University of Southern California

Los Angeles, California

Eric J. Cassell, M.D.

Clinical Professor of Public Health

Cornell University Medical College

New York, New York

R. Alta Charo, J.D.

Associate Professor of Law and Medical Ethics

School of Law and Medicine

University of Wisconsin

Madison, Wisconsin

(From Jan. 1, 1998 to Aug. 1, 1998

Senior Fellow

Program in Genomics, Ethics, and Society

Stanford Center for Biomedical Ethics

Palo Alto, California)

James F. Childress, Ph.D.

Kyle Professor of Religious Studies

Professor of Medical Education

Department of Religious Studies

University of Virginia

Charlottesville, Virginia

David R. Cox, M.D., Ph.D.

Professor of Genetics and Pediatrics

Stanford University School of Medicine

Department of Genetics

Stanford, California

Rhetaugh Graves Dumas, Ph.D., R.N.

Vice Provost Emerita and Dean Emerita

Lucille Cole Professor of Nursing

The University of Michigan 

Ann Arbor, Michigan

Harold T. Shapiro, Ph.D.—Chair

President

Princeton University

Princeton, New Jersey
iii

Ezekiel J. Emanuel, M.D., Ph.D.

Associate Professor of Medical Ethics 

Department of Social Medicine

Harvard Medical School

Boston, Massachusetts

(resigned February 1998)

Laurie M. Flynn

Executive Director

National Alliance for the Mentally Ill

Arlington, Virginia

Carol W. Greider, Ph.D.

Associate Professor

Department of Molecular Biology and Genetics

Johns Hopkins University School of Medicine

Baltimore, Maryland

Steven H. Holtzman

Chief Business Officer

Millennium Pharmaceuticals Inc.

Cambridge, Massachusetts

Bette O. Kramer

Founding President

Richmond Bioethics Consortium

Richmond, Virginia

Bernard Lo, M.D.

Director

Program in Medical Ethics

University of California, San Francisco

San Francisco, California

Lawrence H. Miike, M.D., J.D.

Director

State Department of Health

Honolulu, Hawaii

Thomas H. Murray, Ph.D.

Director, Center for Biomedical Ethics

School of Medicine

Case Western Reserve University

Cleveland, Ohio

Diane Scott-Jones, Ph.D.

Professor 

Department of Psychology

Temple University

Philadelphia, Pennsylvania
iv

NBAC Staff (1997)

Executive Director, Acting

William F. Raub, Ph.D

Deputy Executive Director

Henrietta D. Hyatt-Knorr, M.A.

Senior Consultants

Kathi Hanna, M.S., Ph.D.

Jonathan Moreno, Ph.D.

Research Staff

William L. Freeman, M.D., M.P.H.

Sheri Alpert, M.A., M.P.A.

Emily C. Feinstein 

E. Randolph Hull, Jr.

Sean A. Simon

Robert Tanner

Joel Mangel, J.D.

Administrative Staff

Patricia Norris 

Margaret C. Quinlan

LaShell Gaskins

Robin Dorsey

Includes full-time, part-time and volunteer staff in 1997; 

for current (1998) staff, please see Appendix A
v

Executive Order 12975 of October 3, 1995

Federal Register: October 5, 1995 (Volume 60, Number 193) Page 5206352065

Protection of Human Research Subjects and Creation of National Bioethics Advisory Commission

By the authority vested in me as President by the Constitution and the laws of the United States of 

America, it is hereby ordered as follows:

Section 1. Review of Policies and Procedures. 

(a) Each executive branch department and agency that conducts, supports, or regulates research involving human

subjects shall promptly review the protections of the rights and welfare of human research subjects that 

are afforded by the department’s or agency’s existing policies and procedures. In conducting this review,

departments and agencies shall take account of the recommendations contained in the report of the Advisory

Committee on Human Radiation Experiments.

(b) Within 120 days of the date of this order, each department and agency that conducts, supports, or regulates

research involving human subjects shall report the results of the review required by paragraph (a) of this section

to the National Bioethics Advisory Commission, created pursuant to this order. The report shall include an 

identification of measures that the department or agency plans or proposes to implement to enhance human 

subject protections. As set forth in section 5 of this order, the National Bioethics Advisory Commission 

shall pursue, as its first priority, protection of the rights and welfare of human research subjects. 

(c) For purposes of this order, the terms “research” and “human subject” shall have the meaning set forth in the

1991 Federal Policy for the Protection of Human Subjects. 

Sec. 2. Research Ethics. 

Each executive branch department and agency that conducts, supports, or regulates research involving human

subjects shall, to the extent practicable and appropriate, develop professional and public educational programs

to enhance activities related to human subjects protection, provide forums for addressing ongoing and emerging

issues in human subjects research, and familiarize professionals engaged in nonfederally-funded research with

the ethical considerations associated with conducting research involving human subjects. Where appropriate,

such professional and educational programs should be organized and conducted with the participation of 

medical schools, universities, scientific societies, voluntary health organizations, or other interested parties.

Sec. 3. Establishment of National Bioethics Advisory Commission. 

(a) There is hereby established a National Bioethics Advisory Commission (“NBAC”). NBAC shall be 

composed of not more than 15 members to be appointed by the President. NBAC shall be subject to the Federal

Advisory Committee Act, as amended (5 U.S.C. App.). 

(b) The President shall designate a Chairperson from among the members of NBAC.
vi

Sec. 4. Functions. 

(a) NBAC shall provide advice and make recommendations to the National Science and Technology Council and

to other appropriate government entities regarding the following matters:

1. the appropriateness of departmental, agency, or other governmental programs, policies, assignments,

missions, guidelines, and regulations as they relate to bioethical issues arising from research on human 

biology and behavior; and 

2. applications, including the clinical applications, of that research. 

(b) NBAC shall identify broad principles to govern the ethical conduct of research, citing specific projects only

as illustrations for such principles. 

(c) NBAC shall not be responsible for the review and approval of specific projects. 

(d) In addition to responding to requests for advice and recommendations from the National Science and

Technology Council, NBAC also may accept suggestions of issues for consideration from both the Congress 

and the public. NBAC also may identify other bioethical issues for the purpose of providing advice and 

recommendations, subject to the approval of the National Science and Technology Council. 

Sec. 5. Priorities. 

(a) As a first priority, NBAC shall direct its attention to consideration of: protection of the rights and welfare 

of human research subjects; and issues in the management and use of genetic information, including but not 

limited to, human gene patenting. 

(b) NBAC shall consider four criteria in establishing the other priorities for its activities:

1. the public health or public policy urgency of the bioethical issue;

2. the relation of the bioethical issue to the goals for Federal investment in science and technology;

3. the absence of another entity able to deliberate appropriately on the bioethical issue; and 

4. the extent of interest in the issue within the Federal Government. 

Sec. 6. Administration. 

(a) The heads of executive departments and agencies shall, to the extent permitted by law, provide NBAC with

such information as it may require for purposes of carrying out its functions. 

(b) NBAC may conduct inquiries, hold hearings, and establish subcommittees, as necessary. The Assistant to the

President for Science and Technology and the Secretary of Health and Human Services shall be notified upon

establishment of each subcommittee, and shall be provided information on the name, membership (including

chair), function, estimated duration, and estimated frequency of meetings of the subcommittee. 

(c) NBAC is authorized to conduct analyses and develop reports or other materials. In order to augment the

expertise present on NBAC, the Secretary of Health and Human Services may contract for the services of 

nongovernmental consultants who may conduct analyses, prepare reports and background papers, or prepare

other materials for consideration by NBAC, as appropriate. 
vii

(d) Members of NBAC shall be compensated in accordance with Federal law. Members of NBAC may be

allowed travel expenses, including per diem in lieu of subsistence, to the extent permitted by law for persons

serving intermittently in the government service (5 U.S.C. 57015707). 

(e) To the extent permitted by law, and subject to the availability of appropriations, the Department of Health and

Human Services shall provide NBAC with such funds as may be necessary for the performance of its functions.

The Secretary of Health and Human Services shall provide management and support services to NBAC. 

Sec. 7. General Provisions. 

(a) Notwithstanding the provisions of any other Executive order, the functions of the President under the Federal

Advisory Committee Act that are applicable to NBAC, except that of reporting annually to the Congress, shall

be performed by the Secretary of Health and Human Services, in accordance with the guidelines and procedures

established by the Administrator of General Services. 

(b) NBAC shall terminate two years from the date of this order unless extended prior to that date.

(c) This order is intended only to improve the internal management of the executive branch and it is not 

intended to create any right, benefit, trust, or responsibility, substantive or procedural, enforceable at law or 

equity by a party against the United States, its agencies, its officers, or any person. 

WILLIAM J. CLINTON

The White House

October 3, 1995 

Amending Executive Order No. 12975

By the authority vested in me as President by the Constitution and the laws of the United States of America, and

in order to add 3 members to the National Bioethics Advisory Commission, it is hereby ordered that the 

number “15” in the second sentence of section 3(a) of Executive Order No. 12975 is deleted and the number

“18” is inserted in lieu thereof.

WILLIAM J. CLINTON

The White House

September 16, 1996

Further Amending Executive Order No. 12975, Extension National Bioethics Advisory Commission

By the authority vested in me as President by the Constitution and the laws of the United States of America, and

in order to extend the term of the National Bioethics Advisory Commission, it is hereby ordered that 

section 7(b) of Executive Order No. 12975 further is amended to read, “NBAC shall terminate on 

October 3, 1999, unless extended by the President prior to that date.”

WILLIAM J. CLINTON

The White House

May 16, 1997

1

Introduction

The National Bioethics Advisory Commission (NBAC) was

established by Executive Order 19275 in October 1995 to advise

the National Science and Technology Council and other appropriate government entities regarding bioethical issues arising

from research on human biology and behavior. NBAC’s first 

priority, as directed in its Charter, was to “consider the protection

of the rights and welfare of human research subjects; and issues

in the management and use of genetic information.” The Charter

encouraged NBAC to identify other bioethical issues for the 

purpose of providing advice and recommendations. This Annual

Report will describe the establishment of the National Bioethics

Advisory Commission, briefly recount the history of federal

bioethics commissions in the United States, and offer a 

summary of NBAC’s activities in its first year, including the

activities of the two subcommittees and the publication of 

the Commission’s first report, Cloning Human Beings.

3

Establishment of the 

National Bioethics Advisory Commission

In the Fall of 1993, the White House Office of

Science and Technology Policy (OSTP) was

approached by the National Institutes of Health

(NIH), the Department of Energy (DOE), and 

other research-oriented agencies to consider supporting many longstanding calls for the United

States to establish a standing, expert, national 

commission on bioethics. The proposal stemmed in

part from a congressional request that NIH and

DOE establish an advisory committee on genetic

privacy, but was also responsive to a growing 

chorus of voices suggesting the need for such a

commission to address a wide and growing range of

other unsettled issues in the area of bioethics. One

recommendation, which came directly from the

Advisory Committee on Human Radiation

Experiments (ACHRE), called for the creation of a

committee to address more broadly the ethics of

research involving human subjects 1. As a result,

OSTP expressed a need for a high-level group to

serve as a shared resource to address a broad set 

of ethical issues, including genetic privacy and 

the protection of human subjects in research, and 

to complement specialized committees and boards

already supported by the various mission agencies. 

Other than a short-lived advisory committee

appointed by Congress in the late 1980’s, no such

standing body for addressing bioethical issues had

existed in the United States since 1983. Indeed,

the United States stood virtually alone among 

industrialized nations in not having established 

a permanent standing commission to address 

evolving bioethical issues. Instead, this country 

has relied on the work of highly qualified but 

time-limited commissions, which have deliberated

about specific topics. For example, ACHRE was

responsible for reviewing the protections of U.S.

citizens involved in radiation experiments several

decades ago, including American soldiers who 

were intentionally exposed to radiation during

atmospheric nuclear tests. Three ongoing issues

were raised by ACHRE: the need for a continuing

public forum on the interpretation and application

of ethics rules and principles for the conduct 

of human subjects research; the need to maintain

consistency in ethical standards for human 

subjects research across the federal agencies and 

departments that support such efforts; and finally

the need to review the current Institutional 

Review Board (IRB) system. The first of these 

concerns provided some of the initial impetus to 

create NBAC.

In August 1994, OSTP published in the Federal

Register a draft charter for a National Bioethics

Advisory Commission (NBAC) to provide advice

and make recommendations to the National 

Science and Technology Council and to other

appropriate government entities on relevant 

bioethical issues. The NBAC charter that was

signed by John H. Gibbons, the Assistant to the

President for Science and Technology Policy, on

July 26, 1996, reflected public comments received

as well as bipartisan input from Congress. In addition to establishing NBAC, the President also

charged the executive branch agencies that conduct,

support, or regulate research involving human subjects to review their policies and procedures for 

protection of research subjects. This directive was a

direct response to the recommendations contained

in the ACHRE report. The President’s Executive

Order 12975 of October 3, 1995, required federal

agencies to report the results of their review to

NBAC, which was to pursue, as its first priority,

protection of the rights and welfare of human

research subjects. 

1Advisory Committe on Human Radiation Experiments, Final Report (Washington, DC: U.S. Government

Printing Office, October 1995), pg. 817.
4

2 Federal Advisory Committee Act, Pub. L. 92-463, Oct. 6, 1972, 86 Stat. 770

A Brief History of U.S. Bioethics Commissions

In the decades since the end of World War II,

advances in biomedical science increasingly

focused attention on both the opportunities and

challenges posed by biomedical research and 

medical practice. As a nation, the United States 

has enjoyed great success in utilizing innovative

technologies for medical purposes. However,

technology and the needs of medical researchers

have, at times, found themselves in juxtaposition

with deeply held social values, such as respect 

for human dignity, and the right to privacy. Just 

as complex ethical, legal, and social issues 

motivated society’s interest in decision making at

the end of life, equitable access to health care,

and the use of medically assisted reproduction, we

now find a similar motivation arising, for example,

from research in the Human Genome Project —

the international effort to determine our genetic

blueprint. Consideration of research ethics continues to be an important part of public policy in a

system in which the Federal Government has a

direct responsibility for the research activities it

conducts, sponsors or regulates.

In the past, American society has found it useful 

to promote a national discussion of those complex

bioethical issues that have arisen and to develop

appropriate public policies where necessary. To

carry out this task, the Federal Government has,

in the last three decades, convened a number 

of bioethics commissions to promote national 

deliberation. Indeed, the United States took the 

lead in developing a forum for “public bioethics.”

These government commissions have functioned as

mechanisms to develop public policies, to articulate

common values, and to foster understanding in the

face of growing cultural and religious heterogeneity, evolving moral sensibilities and the rapidly

advancing scientific frontier. The establishment of

these deliberative bodies signaled the increasing

importance of medical and biological technologies

in our national life and the pressing need for the

global consideration of these issues in a public

forum. The work of these commissions has been

used by courts, legislatures, academic and research

institutions, and the public media, each helping to

shape and inform public dialogue. 

NBAC was established more than a decade after 

the expiration of the last federal bioethics commission, the President’s Commission for the Study

of Ethical Problems in Medicine and Biomedical 

The charter requires that NBAC consider “issues 

in the management and use of genetic information,

including but not limited to human gene patenting.”

The Commission also may consider additional

issues suggested by executive branch agencies,

Congress, and the public, or issues which originate

within the Commission itself. 

NBAC is not a regulatory body and does not review

or approve individual projects. Rather, it is designed

to identify broad overarching principles to govern

the ethical conduct of research. 

It is an 18-person body, appointed by the President,

the membership of which is drawn from the fields 

of ethics, philosophy, law, medicine, theology,

economics, psychology, science, and the public.

Meetings of NBAC are public and are announced 15

working days in advance in the Federal Register.

These meetings provide an opportunity for the 

public to comment either in person (see Appendix

D) or by submitting written testimony. These and

other specific requirements are described in the

Federal Advisory Committee Act (FACA)2 to which

NBAC adheres.
5

and Behavioral Research. To date, Congress has 

created five deliberative bodies devoted to bioethics.

In order to understand the challenges and opportunities facing it, NBAC’s contribution to a national

(and indeed international) dialogue 

on bioethics issues must be seen in the context 

of the four national bioethics commissions that 

preceded it. NBAC is part of an important history 

of federal bioethics commissions in the 

United States.3

The National Commission for the Protection of

Human Subjects of Biomedical and Behavioral

Research (National Commission) (1974-1978)

was established under the National Research Act

(Public Law 93-348), following a congressional

debate dating back to 1968 concerning the protection of human research participants. A series 

of controversial cases, including the Tuskegee

syphilis study and the Willowbrook hepatitis 

experiments, signaled a need for some form of 

additional national oversight and review of 

human subjects research.

Congress created the National Commission as part

of the then Department of Health, Education, and

Welfare and gave it a specific task-to articulate 

the principles of ethics to guide research involving

human subjects, and to use those principles to 

recommend actions by the Federal Government.

The Commission issued 10 reports, many of which

were later translated by the Department into what

remain today the core regulations for research

involving human subjects (45 CFR 46). In perhaps

its most influential and enduring report, the Belmont

Report, the Commission articulated three basic 

principles to guide research with human subjects:

respect for persons, beneficence, and justice. These

principles have been adopted by research ethic

statements and codes in many parts of the world.

The Belmont Report placed an emphasis on autonomy, elaborated and extended the notion of

informed consent, recognized the vulnerability of

specific populations (children, prisoners, those

institutionalized as mentally infirm), and fleshed 

out details of review by the Institutional Review

Boards (IRBs) now embodied in federal research

regulations.

Based upon the first set of recommendations 

from the National Commission, the Department

announced in 1975 that no proposal for research 

on human embryos or on in vitro fertilization (IVF)

of human eggs would be funded until it was

reviewed and approved by a Federal ethics 

advisory board. In 1978, the Secretary of HEW

appointed an Ethics Advisory Board (EAB) which

issued a report on in vitro fertilization in May 1979

that stipulated several criteria for approval of 

such experiments. The Office of the Secretary has

never responded to the EAB’s report on IVF

research, thus resulting in a de facto moratorium on

human IVF research. The EAB was dissolved in

1980, because the Secretary concluded it had

become redundant due to the appointment of a new

bioethics commission.

The President’s Commission for the Study of

Ethical Problems in Medicine and Biomedical

and Behavioral Research (President’s

Commission) (1980-1983) was authorized in 1978

by Section III of Public Law 95-622. The language

of the statute specified several tasks, but also gave

the President’s Commission the authority to 

undertake studies at the request of the President 

or upon its own initiative. The President’s

Commission issued 11 reports. It continued some of

the work of the National Commission in several

reports on the federal regulations of research with

human subjects and compensation for research

injuries. Its report Defining Death became the 

foundation for statutory changes adopted by a

majority of U.S. states. The Commission addressed

“whistleblowing” in biomedical research, and

issued prescient reports on genetic screening and

counseling. The Commission also confronted 

controversies about termination of treatment in its

reports on making health care decisions, and even

more directly in Deciding to Forego Life-Sustaining

Treatment. Another report, Securing Access to

3 U.S. Congress, Office of Technology Assessment, Biomedical Ethics in U.S. Public Policy-Background

Paper, OTA-BP-BBS-105 (Washington, DC: U.S. Government Printing Office, June, 1993.)
6

Health Care was a foray into mainstream American

health policy, addressing a central issue, equitable

access to health care. Splicing Life emphasized the

distinction between genetically altering somatic

cells, which would not lead to inherited changes,

and germ cells (sperm, egg cells, and their precursors), which would induce inherited changes.

The Biomedical Ethics Advisory Committee

(BEAC) (1988-1989) was a 14-member group

whose membership was appointed by the

Biomedical Ethics Board (BEB), comprised of 12

Members of Congress — three each from the majority and minority parties of the House and Senate. It

took almost a year for the four party leaders of the

House and Senate to appoint the 12 members of the

congressional Board, which then took on the

responsibility of appointing the 14 members of

BEAC, the operational arm. BEAC met for the first

time in September 1988, less than a week before 

its authorization expired. BEAC was required to

prepare at least three reports on specified topics, as

well as to provide annual reports. The first mandated report concerned the implications of human

genetic engineering. The deadline for the second

report, on fetal research, expired before BEAC

members were appointed. The third mandate,

feeding and nutrition of dying patients, also was 

not addressed. Caught in political crossfire within

BEB, BEAC was ordered to cease meeting after 

its second session and closed its doors in October

1989, having issued no reports.

NBAC met for its inaugural meeting on 

October 4, 1996. Following this initial meeting,

two subcommittees were formed to address 

the two mandated issues of human subjects 

protections and issues in the management and 

use of genetic information4. They were named 

the Human Subjects Subcommittee (HSSC) and the

Human Genetics Subcommittee (HGSC). The

subcommittees were established to allow the

Commission to work more efficiently. On most

occasions, the subcommittees met on or within 

one day of the full Commission’s meeting, and 

then would convene jointly as a full Commission.

There were 17 meetings held between October 1996

and December 1997. Of those, seven were devoted 

to the Human Subjects Subcommittee, and 

seven were devoted to the Human Genetics

Subcommittee. NBAC met as a full commission

eight times (see Appendix C).

In November 1996, NBAC sponsored an

International Summit on bioethics in conjunction

with the III. World Congress of Bioethics held 

by the International Association of Bioethics in 

San Francisco. Representatives of 25 nations 

gathered to discuss organized bioethics activities 

in their countries (see Table 1). There are bioethics

commissions and institutes in the Americas, Africa,

Asia, Australia, and Europe. Existing commissions

vary in their scope and sponsorship. Several have

been formed in response to concerns about human

rights. Although drawn to what they do because 

of a common concern about the course of modern

science in society, the international commissions

reflect diversity in moral beliefs based on 

nationality, culture, history, and religious tradition.

Beginning in December 1997, the Subcommittees

met independently to advance their work on the use 

NBAC’s First Year: 1996-1997

4 Memo to John H. Gibbons, Assistant to the President for Science and Technology, signed November 6, 1996

by F. William Dommel, Jr., J.D., Executive Director (Acting)
7

International Bioethics Organizations Attending November 1996 Summit 

of National Bioethics Advisory Bodies, San Francisco, California

Association of Bioethics, Brazil

Association for Bioethics, Japan

Comision Nacional de Bioetica, Mexico

Comite Consultatif National d’Ethique, France

Committee of Medical Ethics and Health Law, Health Council of the Netherlands

Consejo Asesor de Sanidad, Spain

Council of Ethics, Denmark

East Asian Association for Bioethics

Escuela Latinamericana de Bioetica, Argentina

Ethics Committee of the Human Genome Organization

European Commission on Ethical Implications of Biotechnology

Groupe de Conseillers, Italy

Health Ethics Committee, Australia

International Associations of Bioethics

Japan Society of Bioethics

Law Commission for the Family Code and Transsexualism, Croatia

National Council on Bioethics in Human Research, Canada

National Committee for Medical Ethics, Slovenia

Nuffield Council on Bioethics, United Kingdom

Program in Bioethics, Chinese Academy of Social Sciences

Russian National Committee on Bioethics

Swiss Academy of Medical Sciences, Switzerland

The International Bioethics Committee, UNESCO

The Steering Committee on Bioethics, Council of Europe

Table 1

of genetic information and human subjects 

protection. These subcommittees functioned as

semi-independent working groups that reported

their progress and ideas to the full commission at

each joint meeting. This enabled the work of the

commission as a whole to progress more rapidly.

The subcommittees each commissioned papers on

subjects germane to their deliberations, and invited

testimony from both experts and members of the

public. Meetings were open to the public and

announced in the Federal Register as required by

FACA. Despite the existence of these distinct 

subcommittees, NBAC issues all of its reports 

as a full commission; all conclusions and recommendations come before the entire group for 

discussion and vote.
8

Activities of the Human Subjects Subcommittee

James F. Childress, Ph.D., Chair

Arturo Brito, M.D.

Alexander M. Capron, LL.B.

Eric J. Cassell, M.D.

R. Alta Charo, J.D.

Rhetaugh Graves Dumas, Ph.D., R.N.

Laurie M. Flynn

Diane Scott-Jones, Ph.D.

Federal Agency Compliance with Rules

Governing Research with Human Subjects

The first task of the Human Subjects Subcommittee

was to review the federal agency reports on human

subjects protections, required by Executive Order

12975. In response to those reports, NBAC undertook a survey of the federal agencies to determine

the extent to which agencies protect human subjects

according to the Common Rule, the name given to

the regulations promulgated jointly by relevant 

federal departments and agencies in 1991 to govern

the conduct of federally supported research involving human subjects (45 CFR 46). Once this study is

complete, the Commission will recommend actions

to be taken to ensure that all federal agencies 

conducting or supporting research with human 

subjects understand and implement the regulations.

The Commission will likely issue its findings as part

of a more comprehensive report on federal oversight

of human subjects research. 

Federal Oversight of Research

In the course of its deliberations, the Commission

recognized the importance of understanding the

oversight functions exercised by the Office for

Protection from Research Risks and the extension

of this oversignt only to federally funded research.

The Commission devoted some of its meeting 

time to this subject, and intends to pursue this more

thoroughly in 1998 and 1999. The subcommittee

commissioned three papers on this subject in 1997

(see Table 2). It heard testimony from 6 experts and

10 members of the public, and discussed the topic at

6 meetings.

Research Involving Subjects with Disorders

Affecting Decisionmaking Capacity

The ethical conduct of research with persons 

who suffer from disorders affecting their decision 

making capacity presents a significant challenge for

public policy. The National Commission’s Report

Research Involving Those Institutionalized as

Mentally Infirm (1978) identified many of these

challenges, but limited its focus to those persons

who were patients in mental health facilities. 

This report, unlike others focusing on potential subjects whose ability to consent was limited in some

way, was never translated into federal regulation.

Recent discussions about research conducted with

these individuals has been stimulated by several

incidents, including the tragic suicide of a former

subject in a schizophrenia relapse study conducted

at the University of California, Los Angeles and a

court case regarding the legality of restrictions on

the participation of subjects with decisional 

incapacity issued by the Office of Mental Health in

New York. Several organizations and individuals

have proposed additional guidance for research with

persons with decisional impairments, because of

concern about unclear areas in current regulations

or about perceived abuses. Although the

Commission does not have the authority to investigate specific complaints, it was persuaded that
9

there is substantial public concern about actual,

perceived, or potential failures to protect those 

with decisional impairments in research. The

Subcommittee commissioned three papers on this

subject in 1997 (see Table 2) and heard 

testimony from 10 experts and 13 members of 

the public. The subject was discussed at all 7 HSSC

meetings. NBAC’s report and recommendations on

this topic will be issued in 1998.

Papers Commissioned by the Human Subjects Subcommittee

Decisional Impairment

Research Involving Persons With Mental Disabilities:

A Review of Policy Issues and Proposals

Rebecca Dresser, J.D., Case Western Reserve University

Relational Ethics and Research with Vulnerable Populations 

Celia B. Fisher, Ph.D., Fordham University

Critical Issues Concerning Research Involving Decisionally Impaired Persons

Jonathan Moreno, Ph.D., SUNY Health Science at Brooklyn

Oversight of Federal Research 

Examination of the Location of the Office for Protection from Research Risks

John C. Fletcher, Ph.D., University of Virginia

Standard Models for Human Subjects Oversight

C. K. Gunsalus, J.D., Associate Provost, University of Illinois, Urbana-Champaign

Examination of the Location of the Office for Protection from Research Risks

Charles R. McCarthy, Ph.D., Georgetown University

Table 2
10

Activities of the Human Genetics Subcommittee

Thomas H. Murray, Ph.D., Chair

Patricia Backlar

David R. Cox, M.D., Ph.D.

Ezekiel Emanuel, M.D., Ph.D.

Carol W. Greider, Ph.D.

Steven H. Holtzman

Bette O. Kramer

Bernard Lo, M.D.

Lawrence H. Miike, M.D., J.D

In response to its charge, NBAC formed the 

Human Genetics Subcommittee to address issues in

the management and use of genetic information.

The subcommittee met for the first time in

December 1996 to set priorities for 1997. It decided

to pursue three topics: the use of tissue samples in

DNA analysis; genetic privacy and genetic discrimination; and gene patenting.

The use of tissue samples in genetic research 

was chosen as the first topic because the issue 

is well-defined, clearly important, and a matter 

of considerable current interest to professional

organizations, government agencies, and the

research community.

The Research of Human Biological Materials

NBAC estimates that there are more than 282 

million human tissue samples in storage in hospitals

and research facilities in the United States5. Many

important advances made in medical science 

would have been impossible were it not for the

analysis of collected and stored human tissues.

However, the increasingly common practice of 

performing genetic analyses on these materials is

triggering a renewed interest in examining how

these samples have been (and will be) collected,

stored, used, and shared, and how the results of the

research performed will be disseminated. A matter

of concern is how to handle consent for the use of 

samples collected in the past for diagnostic or

research purposes, especially when the research

purposes for which the samples might be used was

not foreseen. 

An additional concern centers on the relationship

between a person who provides a sample for

research and the particular community of which 

the person may be a member. Research conducted

on an individual identified as belonging to an ethnic

community is sometimes conducted or presented in

a way that suggests the community shares certain

genetic traits. The findings of the research may thus

have repercussions for the whole community that

must be considered before returning to previously

collected samples for analyses. There has been

ongoing discussion within the scientific community

as to whether consent can and should be obtained 

to use human samples that have been previously

collected and stored (in some instances for

decades). At issue is whether the samples were collected with identifiers that would link the sample to

the person from which it came. The subcommittee

recognized that one of the difficulties in resolving

this issue is the lack of consensus regarding the 

concept of anonymity. For example, if samples can

be collected with certain personal identifiers 

(e.g., aspects of the medical record), is the ability to

“anonymize” these tissues sufficient protection

from risk to the donor to waive the requirement to

obtain informed consent?

5 Elisa Eiseman, Ph.D., Stored Tissue Samples: An Inventory of Sources in the United States,

RAND, MR-954.0-CTI, December 1997
11

The subcommittee commissioned 6 papers to

inform its deliberations (see Table 3) and one report

summarizing seven “mini-hearings” across the

country to ascertain the views of the American 

public about uses of samples, the ethical obligations

of those who may learn significant health risk information from samples, and privacy protections.

NBAC will issue its report on this topic in 1998.

The Human Genetics Subcommittee met 7 

times (including meetings that involved the full

Commission) and heard testimony from 19 experts

and from 8 members of the public.

Papers and Report Commissioned by the Genetics Subcommittee

Privacy and the Analysis of Stored Tissues

Sheri Alpert, M.A., M.P.A.

Research on Human Tissue: Religious Perspectives

Courtney Campbell, Ph.D., Oregon State University

Stored Tissue Samples: An Inventory of Sources in the United States

Elisa Eiseman, Ph.D., and Jennifer Brower,

Critical Technologies Institute, Rand Corporation

Evaluation of Tissue Sample Storage Focus Group Methodology

Regina Kenen, Ph.D., M.P.H., The College of New Jersey

Genetic Tissue Storage: International, Comparative Positions

Bartha M. Knoppers, LL.D., University of Montreal

The Ongoing Debate about Stored Tissue Samples and Informed Consent

Robert Weir, Ph.D., University of Iowa 

Report of National Mini Hearings on Issues in Genetic Tissue Storage

James Wells, Ph.D., Center for Health Policy Studies

Table 3
12

In February 1997, the work of the Commission was

diverted toward an unexpected development. Within

days of the published report by Dr. Ian Wilmut and

his colleagues of the apparently 

successful cloning of a sheep6 using a technique

called somatic cell nuclear transfer President

Clinton instituted a ban on federal funding for

research directed at cloning human beings. In 

addition, the President asked NBAC to address 

the ethical and legal issues raised by cloning human

beings and to report back within ninety days with

recommendations on what steps should be taken 

to prevent the abuse of this technology. The

Commission quickly commissioned eight papers 

on the scientific, legal, ethical, religious, and 

policy aspects of the prospect of human cloning 

(see Table 4) and met five times over the following

three months. It delivered its report, Cloning

Human Beings: Report and Recommendations of

the National Bioethics Advisory Commission, to 

the President at a White House ceremony on 

June 9, 1997. 

NBAC recognized that resolution of the ethical,

scientific and legal issues associated with the

cloning of human beings would be difficult to

achieve, particularly because they evoked many

deeply held beliefs and values. Nevertheless, NBAC

attempted to consolidate its assessment of the risks

and benefits of this new technology and the public’s

concerns regarding the moral acceptability of the

practice into a cohesive set of recommendations that

could serve the scientific community, the public,

and policy makers. Due to the diversity and intensity of opinions heard and held by the Commission,

and the limited time period in which 

it had to reach conclusions, the Commission 

made recommendations that it hoped would serve 

as the foundation for further deliberation. NBAC

recommended that the Federal Government take

advantage of this opportunity to encourage a continuing public deliberation of the issues. Copies of

the Executive Summary, the full report (Vol. I), and

the commissioned papers (Vol.II) are available on

the NBAC website (http://www.bioethics.gov).

6 I. Wilmut, A.E. Schnieke, J. McWhir, A.J. Kind & K.H.S. Campbell Roslin Institute (Edinburgh), Roslin,

Midlothian EH25 9PS, UK PPL Therapeutics, Roslin, Midlothian EH25 9PP, UK; “Viable offspring derived

from fetal and adult mammalian cells” Nature, Volume 385, 810-813, Febraury 27,1997

Response to the President’s Request:

Cloning Human Beings
13

Papers Commissioned for the Report: Cloning Human Beings

Legal Status of Cloning in the United States

Lori B. Andrews, J.D., Chicago-Kent College of Law

Cloning Human Beings: An Assessment of the Ethical Issues Pro and Con

Dan W. Brock, Ph.D., Brown University 

Religious Perspectives on Human Cloning

Courtney S. Campbell, Ph.D., Oregon State University

Do Research Moratoria Work? A Review of Fetal Research, Gene Therapy, and

Recombinant DNA Research

Robert Mullan Cook-Deegan, M.D.

Views of Scientific Societies and Professional Associations on Human Nuclear Transfer

Cloning Research

Elisa Eiseman, Ph.D., Critical Technologies Institute, Rand Corporation

Cloning: An International Comparative Overview

Bartha M. Knoppers, LL.D., University of Montreal

Animal Cloning and Related Embryo Research: Implications for Medicine

Stuart H. Orkin, M.D., Dana Farber Cancer Institute

The Science of Animal Cloning

Janet Rossant, Ph.D., Mount Sinai Hospital, Toronto

Table 4
14

Plans for 1998 and Beyond

As 1997 came to a close, NBAC devoted portions 

of two meetings to discussions of the research activities in which it will engage. The Commission will

prepare the reports requested within the Executive

Order No. 12975, including the “protection of the

rights and welfare of human research subjects; and

issues in the management and use of genetic information, including but not limited to, human gene

patenting.”7 The Commission has identified several

important topics to which it intends to turn its attention in 1998 including the scope of federal oversight

of human subjects research; Institutional Review

Boards; and ethical and legal issues in international

research. NBAC also recognizes that an important

opportunity exists to reflect on how the research

paradigm, so effectively articulated in the National

Commission’s Belmont Report, has been used and

interpreted over the past two decades. One commissioned paper has already been developed on this

subject, by Dr. Charles Weijer. Following further

consultation with the National Science and

Technology Council, the Congress and the public,

the Commission will publish its research agenda 

for 1998.

Further Information About NBAC

Early in 1998, the NBAC homepage was updated at http://www.bioethics.gov. Eventually, all NBAC reports,

documents, agendas, and transcripts will be available at this site. For other requests, contact NBAC at 

(301) 402-4242 (telephone) or (301) 480-6900 (facsimile).

7 Executive Order 12975 of October 3, 1995, Sec. 5 (a)
15

Appendix A: NBAC Staff (1998)

Executive Director

Eric M. Meslin, Ph.D.

Deputy Executive Director

Henrietta D. Hyatt-Knorr, M.A.

Senior Consultants

Kathi Hanna, M.S., Ph.D.

Jonathan Moreno, Ph.D.

Research Staff

William L. Freeman, M.D., M.P.H.

Melissa Goldstein, J.D.

Debra McCurry

Emily Feinstein

Everson R. Hull, Jr.

Sean Simon

Robert Tanner

Joel Mangel, J.D.

Administrative Staff

Patricia Norris

Margaret Quinlan

Evadne Hammett

LaShell Gaskins

Emma Codrington

Claudia Ansah

Includes full-time, part-time and volunteer staff.
16

The idea that humans might someday be cloned —

created from a single somatic cell without sexual

reproduction-moved further away from science 

fiction and closer to a genuine scientific possibility

on February 23, 1997. On that date, The Observer

broke the news that Ian Wilmut, a Scottish 

scientist, and his colleagues at the Roslin Institute

were about to announce the successful cloning 

of a sheep by a new technique which had never

before been fully successful in mammals. The technique involved transplanting the genetic material 

of an adult sheep, apparently obtained from a 

differentiated somatic cell, into an egg from which

the nucleus had been removed. The resulting birth

of the sheep, named Dolly, on July 5, 1996, was 

different from prior attempts to create identical 

offspring since Dolly contained the genetic 

material of only one parent, and was, therefore, a

“delayed” genetic twin of a single adult sheep.

This cloning technique is an extension of research

that had been ongoing for over 40 years using nuclei

derived from non-human embryonic and fetal cells.

The demonstration that nuclei from cells derived

from an adult animal could be “reprogrammed,” or

that the full genetic complement of such a cell could

be reactivated well into the chronological life of 

the cell, is what sets the results of this experiment

apart from prior work. In this report we refer to 

the technique, first described by Wilmut, of nuclear

transplantation using nuclei derived from somatic

cells other than those of an embryo or fetus as

“somatic cell nuclear transfer.”

Within days of the published report of Dolly,

President Clinton instituted a ban on federal 

funding related to attempts to clone human beings

in this manner. In addition, the President asked the

recently appointed National Bioethics Advisory

Commission (NBAC) to address within ninety days

the ethical and legal issues that surround the subject

of cloning human beings. This provided a welcome

opportunity for initiating a thoughtful analysis of

the many dimensions of the issue, including a careful consideration of the potential risks and benefits.

It also presented an occasion to review the current

legal status of cloning and the potential constitutional challenges that might be raised if new

legislation were enacted to restrict the creation of a

child through somatic cell nuclear transfer cloning.

The Commission began its discussions fully 

recognizing that any effort in humans to transfer 

a somatic cell nucleus into an enucleated egg

involves the creation of an embryo, with the 

apparent potential to be implanted in utero and

developed to term. Ethical concerns surrounding

issues of embryo research have recently received

extensive analysis and deliberation in our country.

Indeed, federal funding for human embryo research

is severely restricted, although there are few restrictions on human embryo research carried out in the

private sector. Thus, under current law, the use of

somatic cell nuclear transfer to create an embryo

solely for research purposes is already restricted in

cases involving federal funds. There are, however,

no current federal regulations on the use of private

funds for this purpose. 

The unique prospect, vividly raised by Dolly, is 

the creation of a new individual genetically 

identical to an existing (or previously existing) 

person — a “delayed” genetic twin. This prospect 

has been the source of the overwhelming public

concern about such cloning. While the creation 

of embryos for research purposes alone always 

raises serious ethical questions, the use of somatic

cell nuclear transfer to create embryos raises no 

new issues in this respect. The unique and distinctive ethical issues raised by the use of somatic cell

nuclear transfer to create children relate to, for

example, serious safety concerns, individuality,

Appendix B:

Executive Summary: Cloning Human Beings
17

family integrity, and treating children as objects.

Consequently, the Commission focused its attention

on the use of such techniques for the purpose of 

creating an embryo which would then be implanted

in a woman’s uterus and brought to term. It also

expanded its analysis of this particular issue to

encompass activities in both the public and 

private sector.

In its deliberations, NBAC reviewed the scientific

developments which preceded the Roslin announcement, as well as those likely to follow in its path. It

also considered the many moral concerns raised by

the possibility that this technique could be used to

clone human beings. Much of the initial reaction to

this possibility was negative. Careful assessment 

of that response revealed fears about harms to the

children who may be created in this manner,

particularly psychological harms associated with 

a possibly diminished sense of individuality and

personal autonomy. Others expressed concern 

about a degradation in the quality of parenting and 

family life.

In addition to concerns about specific harms to 

children, people have frequently expressed fears

that the widespread practice of somatic cell nuclear

transfer cloning would undermine important social

values by opening the door to a form of eugenics or

by tempting some to manipulate others as if they

were objects instead of persons. Arrayed against

these concerns are other important social values,

such as protecting the widest possible sphere of 

personal choice, particularly in matters pertaining 

to procreation and child rearing, maintaining privacy and the freedom of scientific inquiry, and

encouraging the possible development of new 

biomedical breakthroughs. 

To arrive at its recommendations concerning the 

use of somatic cell nuclear transfer techniques 

to create children, NBAC also examined longstanding religious traditions that guide many 

citizens’ responses to new technologies and found

that religious positions on human cloning are 

pluralistic in their premises, modes of argument,

and conclusions. Some religious thinkers argue 

that the use of somatic cell nuclear transfer 

cloning to create a child would be intrinsically

immoral and thus could never be morally justified.

Other religious thinkers contend that human cloning

to create a child could be morally justified under

some circumstances, but hold that it should be

strictly regulated in order to prevent abuses.

The public policies recommended with respect to

the creation of a child using somatic cell nuclear

transfer reflect the Commission’s best judgments

about both the ethics of attempting such an 

experiment and our view of traditions regarding

limitations on individual actions in the name of 

the common good. At present, the use of this 

technique to create a child would be a premature

experiment that would expose the fetus and the

developing child to unacceptable risks. This in 

itself might be sufficient to justify a prohibition 

on cloning human beings at this time, even if such

efforts were to be characterized as the exercise of 

a fundamental right to attempt to procreate.

Beyond the issue of the safety of the procedure,

however, NBAC found that concerns relating to the

potential psychological harms to children and

effects on the moral, religious, and cultural values

of society merited further reflection and deliberation. Whether upon such further deliberation 

our nation will conclude that the use of cloning

techniques to create children should be allowed or

permanently banned is, for the moment, an open

question. Time is an ally in this regard, allowing for

the accrual of further data from animal experimentation, enabling an assessment of the prospective

safety and efficacy of the procedure in humans, as

well as granting a period of fuller national debate 

on ethical and social concerns. The Commission

therefore concluded that there should be imposed 

a period of time in which no attempt is made to 

create a child using somatic cell nuclear transfer.8

Within this overall framework the Commission

came to the following conclusions and 

recommendations.
18

Recommendation One

The Commission concludes that at this time it is

morally unacceptable for anyone in the public or

private sector, whether in a research or clinical 

setting, to attempt to create a child using somatic

cell nuclear transfer cloning. We have reached a

consensus on this point because current scientific

information indicates that this technique is not 

safe to use in humans at this point. Indeed, we

believe it would violate important ethical obligations were clinicians or researchers to attempt to

create a child using these particular technologies,

which are likely to involve unacceptable risks to the

fetus and/or potential child. Moreover, in addition to

safety concerns, many other serious ethical concerns have been identified, which require much

more widespread and careful public deliberation

before this technology may be used.

The Commission, therefore, recommends the 

following for immediate action:

A continuation of the current moratorium on the 

use of federal funding in support of any attempt to

create a child by somatic cell nuclear transfer.

An immediate request to all firms, clinicians, investigators, and professional societies in the private and

non-federally funded sectors to comply voluntarily

with the intent of the federal moratorium.

Professional and scientific societies should make

clear that any attempt to create a child by somatic

cell nuclear transfer and implantation into a

woman’s body would at this time be an irresponsible, unethical, and unprofessional act.

Recommendation Two

Federal legislation should be enacted to prohibit

anyone from attempting, whether in a research or

clinical setting, to create a child through somatic

cell nuclear transfer cloning. It is critical, however,

that such legislation include a sunset clause to

ensure that Congress will review the issue after a

specified time period (three to five years) in order to

decide whether the prohibition continues to be

needed. If state legislation is enacted, it should also

contain such a sunset provision. Any such legislation or associated regulation also ought to require

that at some point prior to the expiration of the 

sunset period, an appropriate oversight body will

evaluate and report on the current status of somatic

cell nuclear transfer technology and on the ethical

and social issues that its potential use to create

human beings would raise in light of public understandings at that time.

Recommendation Three

Any regulatory or legislative actions undertaken 

to effect the foregoing prohibition on creating a 

child by somatic cell nuclear transfer should be

carefully written so as not to interfere with other

important areas of scientific research. In particular,

no new regulations are required regarding the

cloning of human DNA sequences and cell lines,

since neither activity raises the scientific and 

ethical issues that arise from the attempt to create

children through somatic cell nuclear transfer,

and these fields of research have already provided

important scientific and biomedical advances.

Likewise, research on cloning animals by somatic

cell nuclear transfer does not raise the issues 

implicated in attempting to use this technique for

human cloning, and its continuation should only 

be subject to existing regulations regarding the

humane use of animals and review by institutionbased animal protection committees.

If a legislative ban is not enacted, or if a legislative

ban is ever lifted, clinical use of somatic cell nuclear

transfer techniques to create a child should be preceded by research trials that are governed 

by the twin protections of independent review and

informed consent, consistent with existing norms of

human subjects protection.

8 The Commission also observes that the use of any other technique to create a child genetically identical to

an existing (or previously existing) individual would raise many, if not all, of the same non-safety-related

ethical concerns raised by the creation of a child by somatic cell nuclear transfer.
19

The United States Government should cooperate

with other nations and international organizations to

enforce any common aspects of their respective

policies on the cloning of human beings.

Recommendation Four

The Commission also concludes that different 

ethical and religious perspectives and traditions 

are divided on many of the important moral issues

that surround any attempt to create a child using

somatic cell nuclear transfer techniques. Therefore,

we recommend that:

The federal government, and all interested and 

concerned parties, encourage widespread and continuing deliberation on these issues in order 

to further our understanding of the ethical and 

social implications of this technology and to enable

society to produce appropriate long-term policies

regarding this technology should the time come

when present concerns about safety have been

addressed.

Finally, because scientific knowledge is essential

for all citizens to participate in a full and informed

fashion in the governance of our complex society,

the Commission recommends that:

Federal departments and agencies concerned 

with science should cooperate in seeking out and

supporting opportunities to provide information and

education to the public in the area of genetics, and

on other developments in the biomedical sciences,

especially where these affect important cultural

practices, values, and beliefs.

Recommendation Five

Finally, because scientific knowledge is essential

for all citizens to participate in a full and informed

fashion in the governance of our complex society,

the Commission recommends that:

Federal departments and agencies concerned with

science should cooperate in seeking out and 

supporting opportunities to provide information and

education to the public in the area of genetics, and

on other developments in the biomedical sciences,

especially where these affect important cultural

practices, values, and beliefs.
20

1. October 4, 1996 

Full Commission

Inaugural Meeting 

Bethesda, Maryland

2. November 21, 1996

Full Commission

International Bioethics Summit 

San Francisco, California

3. December 13, 1996

Genetics Subcommittee 

Bethesda, Maryland

4. December 16, 1996 

Human Subjects Subcommittee 

Bethesda, Maryland

5. January 9, 1997

Full Commission

Washington, D.C.

and

January 10, 1997 

Genetics Subcommittee

Washington, D.C.

and

January 10, 1997 

Human Subjects Subcommittee

Washington, D.C.

6. February 24, 1997

Human Subjects Subcommittee 

Bethesda, Maryland

7. March 5, 1997 

Genetics Subcommittee

Bethesda, Maryland

8. March 13-14, 1997 

Full Commission

Washington, D.C.

9. April 12, 1997

Human Subjects Subcommittee 

Arlington, Virginia

and

April 13, 1997

Full Commission

Arlington, Virginia

10. May 2, 1997 

Full Commission

Arlington, Virginia

11. May 17, 1997

Full Commission

Arlington, Virginia

12. June 7, 1997

Full Commission

Arlington, Virginia

13. July 14, 1997 

Genetics Subcommittee 

Bethesda, Maryland

and

July 15, 1997

Human Subjects

Subcommittee 

Bethesda, Maryland

14. September 18, 1997

Human Subjects

Subcommittee

Bethesda, Maryland

and

Genetics Subcommittee 

Bethesda, Maryland

and

September 19, 1997

Genetics Subcommittee 

Bethesda, Maryland

15. October 19, 1997

Human Subjects

Subcommittee

and 

Genetics Subcommittee

Bethesda, Maryland

16. November 23, 1997

Genetics Subcommittee 

Bethesda, Maryland

17. December 9, 1997

Genetics Subcommittee

Arlington, Virginia

Appendix C:

Meeting Dates of the Commission, 1996-1997
21

Expert Testimony for the 

National Bioethics Advisory Commission

October 4, 1996

John H. Gibbons, Assistant to the President for Science and Technology

Francis S. Collins, National Center on Human Genome Research

Gary B. Ellis, Office for Protection from Research Risks

Aaron Meinkoff, Legislative Assistant to Sen. Mark O. Hatfield

Leonard Weiss, Minority Staff Director, U.S. Senate Committee on Governmental Affairs

Michelle Russell-Einhorn, National Institutes of Health

November 21, 1996*

Jean-Pierre Changeux, President, Comite Consultatif National d’ Ethique, France

Michael Abrams, Steering Committee on Bioethics, Council of Europe

Norio Fujiki, Vice President, International Bioethics Committee, United Nations Educational,

Scientific and Cultural Organization

Bartha M. Knoppers, Chair, Ethics Committee of The Human Genome Organization

Donald Chalmers, Chair, Health Ethics Committee, Australia

Abbyann Lynch, Chair, Consent Panel Task Force, National Council on Bioethics in 

Human Research, Canada

Manuel Velasco-Suarez, President, Comision Nacional de Bioetica, Mexico

Joze V. Trontelj, Chair, National Committee for Medical Ethics, Slovenia

Robert Levine, Council for International Organizations of Medical Sciences

Nenad Hlaca, Law Commission for the Family Code and Transsexualism, Croatia

Amy Gutman, Princeton University**

Daniel Winkler, President, International Association of Bioethics

Stephano Rodota, Ethics Advisor, European Commission on Ethical Implications of Biotechnology

December 13, 1996

Robert Gellman, National Committee of Vital Health Statistics

Karen Rothenberg, University of Maryland Law School

Rebecca Eisenberg, University of Michigan Law School

Appendix D: Expert and Public Testimony 

Presented to NBAC, 1996-1997

* Participants at the Summit of National Bioethics Advisory Bodies, San Francisco, California

** Luncheon Address
22

January 10, 1997

David Korn, American Association of Medical Colleges

Debra Saslow, National Action Plan on Breast Cancer

Mark Guyer, National Center for Human Genome Research

Rebecca Dresser, Case Western Reserve University

Robert J. Levine, Yale University

February 24, 1997

Jack Schwartz, Chief Counsel, Office of the Attorney General, State of Maryland

Celia B. Fisher, Fordham University

Jeffrey Kahn, University of Minnesota

Anna C. Mastroianni, University of Washington

Jeremy Sugarman, Duke University

March 5, 1997

Dorothy Wertz, Shriver Center for Mental Retardation

Chuck Denk, Mathematica Policy Research

Ronald Cole-Turner, Pittsburgh Theological Seminary

March 13-14, 1997

Lisa Cahill, Boston College, Department of Theology

Rabbi Elliot Dorff, University of Judaism, Los Angeles

Nancy Duff, Princeton Theological Seminary

Leon R. Kass, University of Chicago

Ruth Macklin, Albert Einstein College of Medicine

Gilbert C. Meilaender, Jr., Valparaiso University

Father Albert S. Moraczewski, Pope John Center

James L. Nelson, University of Tennessee

Professor John Robertson, University of Texas Law School

Abdulaziz Sachedina, University of Virginia

Rabbi Moshe Tendler, Yeshiva University

Shirley Tilghman, Princeton University

April 12-13, 1997

Ruth Faden, Chair, Advisory Committee on Human Radiation Experiments

Helen McGough, Applied Research Ethics National Association (ARENA)

Stuart Orkin, Dana Farber Cancer Institute

Janet Roussant, Samuel Lunenfield Research Institute
23

May 2, 1997

Elisa Eiseman, Critical Technologies Institute, RAND Corporation

July 14-15, 1997

Rebecca Dresser, Case Western University

Rex Cowdry, National Institute of Mental Health

Nina Schooler, University of Pittsburgh Medical Center 

Adil Shamoo, Citizens for Responsible Care in Psychiatry and Research

Paul Applebaum, University of Massachusetts Medical School

September 18-19, 1997

Robert Temple, Center for Drug Evaluation and Research, Food and Drug Administration

James Wells, Center for Health Policy Studies

Bartha M. Knoppers, University of Montreal

Courtney Campbell, Oregon State University

October 19, 1997

James Wells, Center for Health Policy Studies

Robert Weir, University of Iowa

November 23, 1997

Carol Tamminga, Psychiatric Research Institute

Trey Sunderland, National Institute of Mental Health

Charles R. McCarthy, Georgetown University

John C. Fletcher, University of Virginia

Elisa Eiseman, Critical Technologies Institute, RAND Corporation

James Wells, Center for Health Policy Studies

Robert Weir, University of Iowa

Mark Sobel, National Cancer Institute

Frances Pitlick, American Society for Investigative Pathology

December 9, 1997

John Y. Killen, National Institute of Allergy and Infectious Diseases

Debra Saslow, National Action Plan for Breast Cancer
24

October 4, 1996

Gwendon Plair

Jeffery Cossman

Charles MacKay

Suzanne Tomlinson

Acie Byrd 

Robert McMurrough 

November 21, 1996 

Norman Daniels

John Cavanaugh O’Keefe

Laura Bishop

December 13, 1996 

George Gasparis

Susan Pollin

December 16, 1996

Joan Rachlin

Susan Rose

January 9-10 1997 

Chris Kline

Adil Shamoo

Carol Isaacson-Barash

Nancy Reame

February 24, 1997

Jim Shelton

March 5, 1997

Mark Sobel

March 13, 1997 

Nancy Reame

Judith Lamb-Lion

Robert W. Weise

Michelle Theiman

March 14, 1997

Daniel B. McGee

Gladys White

Claire Nader

John Cavanaugh O’Keefe

Dan Crow

J. D. Hanson

April 13, 1997 

John Cavanaugh O’Keefe

May 2, 1997 

Mary Lyman Jackson

Paulette Roseboro

Sheena Talbot

Lisa Tennant

Audria Williams

May 17, 1997

Gail Youness

John Cavanaugh O’Keefe

June 7, 1997 

Randolfe Wicker

Alan Grayson

July 15, 1997

Sidney Wolfe

John Cavanaugh O’Keefe

September 18, 1997 

Robert Aller

Janice Becker

Joseph Friend

Arlis Neason

Shalmah Lee Prince

Stephen Post

Beverly Post

Maggie Scheie-Lurie

Vera Hassner Sharav

Arun K. Guha

September 19, 1997

John Cavanaugh O’Keefe

October 19, 1997 

W. Truxton Boyce

Ron Thompson

Harlan Girard

Adil Shamoo

November 23, 1997

Allen Barker

December 9, 1997 

Mark Sobel

Public Testimony Before the 

National Bioethics Advisory Commission