National Bioethics Advisory Commission

National Bioethics Advisory Commission

National Bioethics Advisory Commission

National Bioethics Advisory Commission

National Bioethics Advisory Commission

National Bioethics Advisory Commission

National Bioethics Advisory Commission

National Bioethics Advisory Commission

National Bioethics Advisory Commission

National Bioethics Advisory Commission

National Bioethics Advisory Commission

National Bioethics Advisory Commission

1998–1999 Biennial Report

National Bioethics Advisory Commission

National Bioethics Advisory Commission

National Bioethics Advisory Commission
National Bioethics Advisory Commission

6705 Rockledge Drive, Suite 700, Bethesda, Maryland 20892-7979

Telephone: 301-402-4242 • Fax: 301-480-6900 • Website: www.bioethics.gov
National Bioethics Advisory Commission

National Bioethics Advisory Commission

National Bioethics Advisory Commission

National Bioethics Advisory Commission

National Bioethics Advisory Commission

National Bioethics Advisory Commission

National Bioethics Advisory Commission

National Bioethics Advisory Commission

National Bioethics Advisory Commission

National Bioethics Advisory Commission

National Bioethics Advisory Commission

National Bioethics Advisory Commission

1998–1999 Biennial Report

National Bioethics Advisory Commission

National Bioethics Advisory Commission

ISBN 1-931022-12-7
The past two years have been productive for the Commission. We have completed three reports and initiated two new projects related to the protection

of human subjects in research. As the new millennium approached, we met

for the 36th time in December 1999, in Baltimore, Maryland, continuing a trend of

convening our regular meetings in different locations around the country.

This second biennial report provides a summary of our accomplishments and

describes our ongoing agenda, which has always been centered on issues surrounding

the protection of human subjects in research and ethical issues in the use of genetic

and other medical information. In 1998–1999, two of the three reports we completed

were in these areas: one on the ethical conduct of research involving 

persons whose decisionmaking capacity is limited by mental illness, and a second

report on the ethical and policy issues concerning the research use of human 

biological materials. In addition, as in the past, the Commission was asked by

President Clinton to temporarily put its agenda on hold to deliberate and issue 

recommendations on an emerging area of research—in this case, human embryonic

stem cell research. That report, undertaken in the midst of the Commission’s ongoing

work, was completed in September 1999.

Over this period, the Commission staff have established important and fruitful

relationships with many groups that have a vital stake in our work, including international organizations, patient groups, scientific groups, academic institutions, health

care providers, federal agencies, and offices of Congress. Input from these groups

and consistent outreach from the Commission to them has enriched our work and has

made it more valuable. In addition to official outreach from Commission staff members, commissioners have served as emissaries, speaking to groups in their own communities and communicating in personal ways their experiences and views on some

of the nation’s most complex and important bioethical issues.

We increasingly have seen our work widely read and disseminated, which is especially gratifying, as we believe that an ongoing national conversation about these

issues is a critically important component of policy development. As in any complex

policy area, the views expressed by commissioners are diverse and frequently reflect

the range of perspectives to be found in our society.

In the next year we look forward to completing our discussions concerning ethics

in international research and our comprehensive review of the current system of

human subjects protections in the United States. As always, we could not complete

our assignments without the hard work and dedication of our staff and consultants

and the many scholars and experts who provide testimony and written materials in

support of our work. 

Harold T. Shapiro

Chair

iii

Preface
Harold T. Shapiro, Ph.D., Chair

President

Princeton University

Princeton, New Jersey

Patricia Backlar

Research Associate Professor of Bioethics

Department of Philosophy

Portland State University

Assistant Director

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 Morgan 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., M.A.C.P.

Clinical Professor of Public Health

Cornell University Medical College

New York, New York

R. Alta Charo, J.D.

Professor of Law and Medical Ethics

Schools of Law and Medicine

The University of Wisconsin

Madison, Wisconsin

James F. Childress, Ph.D.

Kyle Professor of Religious Studies

Professor of Medical Education

Co-Director, Virginia Health Policy Center

Department of Religious Studies

The University of Virginia

Charlottesville, Virginia

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

Professor of Genetics and Pediatrics

Stanford University School of Medicine

Stanford, California

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

Vice Provost Emerita, Dean Emerita, and 

Lucille Cole Professor of Nursing

The University of Michigan

Ann Arbor, Michigan

Laurie M. Flynn

Executive Director

National Alliance for the Mentally Ill

Arlington, Virginia

Carol W. Greider, Ph.D.

Professor of Molecular Biology and Genetics

Department of Molecular Biology and Genetics

The 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

The University of California, San Francisco

San Francisco, California

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

Kaneohe, Hawaii

Thomas H. Murray, Ph.D.

President

The Hastings Center

Garrison, New York

William C. Oldaker, LL.B

Senior Partner

Oldaker and Harris, L.L.P.

Washington, D.C.

Co-Founder and General Counsel

NeuralStem Biopharmaceuticals Ltd.

College Park, Maryland

Diane Scott-Jones, Ph.D.

Professor

Department of Psychology

Temple University

Philadelphia, Pennsylvania

v

National Bioethics Advisory Commission
Introduction

Since its last biennial report in 1997, the National Bioethics Advisory

Commission (NBAC) has met 19 times in various locations across the country.

The Commission also has completed three significant reports and has initiated

two new major projects that focus on the protection of human research subjects here

and abroad. NBAC was established in October 1995 to advise the White House

National Science and Technology Council and other federal agencies on bioethical

issues arising from research on human biology and behavior. The Commission’s

third and fourth years were prolific as it deliberated and reported on some of the

most complex ethical, legal, and scientific issues currently facing the nation. 

The three major reports submitted to the President in 1998 and 1999 offer 52 recommendations designed to improve the protection of human subjects in research.

(All NBAC reports are available at www.bioethics.gov.) (See Exhibits A, B, and C.)

In Research Involving Persons with Mental Disorders That May Affect Decisionmaking

Capacity (December 1998), NBAC recommended that additional regulations

are needed to govern this type of research in order to protect research subjects

from abuse and to ensure that important research is allowed to proceed.

In Research Involving Human Biological Materials: Ethical Issues and Policy Guidance

(August 1999), NBAC recommended ways to clarify current federal regulations to ensure that the nearly 300 million human biological specimens now

stored in various universities, laboratories, hospitals, and other repositories

throughout the country can be used in an ethically appropriate manner. The

report also makes recommendations about improving the processes by which

consent should be obtained when such materials are collected in the future.

In Ethical Issues in Human Stem Cell Research (September 1999), NBAC responded

to a request from President Clinton for recommendations outlining the conditions under which such research could be eligible for federal funding. 

In addition to issuing these reports, the Commission engaged in numerous other

activities critical to informing federal agencies, Congress, international groups, the

research community, and the public about the various dimensions of complex

bioethical issues and their importance in public policy development.

❖ NBAC commissioners and staff (see Appendix A for a listing of staff and consultants) testified five times before Congress, appearing before subcommittees of

the House and Senate to discuss completed projects or ongoing work. 

1

1998–1999 Biennial Report

continued on page 8
Research examining mental disorders has yielded many important and clinically relevant

scientific findings. But at the same time, some of these investigations have generated

public controversy and led to government sanctions—and occasionally lawsuits. 

Since the 1970s, a number of unsuccessful attempts have been made to extend more regulatory protections to people with mental disorders who serve as research subjects and whose

decisionmaking ability may be limited. In 1997, NBAC undertook an effort to explore the various dimensions of research conducted with this population to determine how ethically acceptable research could be conducted, whether additional protections are needed, and if so, what

those protections should be and how they should be applied.

After 18 months of study, NBAC produced an 88-page report entitled Research Involving

Persons with Mental Disorders That May Affect Decisionmaking Capacity. The Commission concluded

that research involving subjects with mental disorders that may affect their decisionmaking

capacity should be governed by specific further regulations to ensure that they are appropriately protected from harm. Current U.S. regulations promote ensuring ethical treatment of

human research subjects with mental disorders; however, the Commission noted that these

provide no specific guidance for Institutional Review Boards and investigators regarding 

vulnerable subjects, a gap that the Commission would like to see filled, especially concerning

informed consent and who may decide whether an individual with a mental disorder can or

should participate in research.

NBAC based its 21 recommendations in this report on testimony heard at more than a dozen

meetings convened around the country representing a range of views, including those from

legal scholars; philosophers; mental health advocates; scientists; former research subjects and

their families; and the general public. In addition, a number of papers were commissioned from

leading experts in law, medicine, psychiatry, and ethics and were published in a separate volume of the report (see below); a sampling of research protocols drawn from the field was analyzed; and 120 public comments that were received on a draft of the final report were reviewed.

NBAC’s recommendations are directed at the development of new federal regulations for the

protection of human subjects, while others are aimed at investigators and Institutional Review

Boards, state legislatures, the National Institutes of Health, health professionals, federal agencies subject to the 1991 Federal Policy for the Protection of Human Subjects in Research (the

Common Rule, or 45 CFR 46 Subpart A), and others responsible for human subjects protection. The report provides a set of requirements that NBAC believes must be met in all research

protocols involving persons with mental disorders, as well as several additional or optional 

protections that would be appropriate in certain circumstances. 

NBAC believes that the enhanced protections recommended in its report will augment

existing regulations and promote broader support for further research by engendering greater

Research Involving Persons with Mental Disorders That May

Affect Decisionmaking Capacity: Volume I (December 1998)

Exhibit A:

2
public trust and confidence that subjects’ rights and

interests are fully respected. Given that it will likely

take time for the needed protections to be 

codified in federal regulations, NBAC has encouraged

institutions, researchers, Institutional Review Boards,

and other investigators to adopt the spirit and 

substance of its recommendations in the interim. 

Volume II: Commissioned Papers

(May 1999)

Decisionally Impaired Research Subjects: 

Disorders and Research Promises

Paul S. Appelbaum

University of Massachusetts Medical Center

Research Involving Persons with Mental Disabilities: 

A Review of Policy Issues and Proposals

Rebecca Dresser

Washington University, St. Louis

Relational Ethics and Research with Vulnerable Populations

Celia B. Fisher

Fordham University

Critical Issues Concerning Research Involving Decisionally

Impaired Persons

Jonathan D. Moreno

University of Virginia

Competency to Decide on Treatment and Research: 

The MacArthur Capacity Instruments

Elyn R. Saks

University of Southern California Law School

“If the public is 

convinced that all

research will be done

under appropriate 

ethical restraints, this

will encourage greater

support for this kind

of research.”

NBAC Chair Harold Shapiro,

quoted in the Washington Post,

November 8, 1998

3
4

The medical and scientific practice of storing human biological materials is more than 

a century old. NBAC estimates that there are nearly 300 million human biological 

materials—including cells, tissues, and biopsy specimens obtained for diagnostic 

purposes—stored in the nation’s laboratories, tissue repositories, and health care institutions.

Recent advances in the biological sciences have provided tools that can be used to mine these

biological materials in research efforts directed toward improving health. But the very power

of these new research tools raises a number of important ethical questions: 

❖ How well does existing federal policy for the protection of human subjects meet the objective

of protecting human subjects from harm in research using their biological materials?

❖ Does current federal policy provide clear direction to research sponsors, investigators,

Institutional Review Boards, and others regarding the conduct of research using these

materials?

In addition, the growing availability to third parties of genetic and other medical information about individuals has raised concerns about medical privacy and discrimination. NBAC is

sensitive to the possibility that use of information obtained from human biological samples can

be harmful as well as beneficial. 

After nearly two years of study, the Commission produced a 113-page report entitled

Research Involving Human Biological Materials: Ethical Issues and Policy Guidance. NBAC found that

while the federal regulations are generally satisfactory, the Common Rule does not address a

number of issues and provides, in some cases, vague guidelines on how to conduct research

with human biological materials. NBAC also found that certain parts of current regulations fall

short of ensuring the ethical use of such material in research and require some modification.

Despite these shortfalls, NBAC believes it is critical that human biological materials continue

to be available to qualified researchers, with specific protections in place to protect the privacy

and confidentiality of those individuals whose materials are used. NBAC’s 23 recommendations

offer clarifications and interpretations of the current federal regulations; outline measures to be

taken to ensure that research involving human biological materials will continue to benefit from

appropriate oversight and Institutional Review Board review; provide investigators and

Institutional Review Boards with clear guidance regarding the use of human biological materials

in research; and present a coherent public policy for research in this area that will endure and

be responsive to new scientific developments. 

Research Involving Human Biological Materials: 

Ethical Issues and Policy Guidance: Volume I (August 1999)

Exhibit B:
5

Volume II: Commissioned Papers (January 2000)

Privacy and the Analysis of Stored Tissues

Sheri Alpert

Alexandria, Virginia

An Ethical Framework for Biological Samples Policy

Allen Buchanan

University of Arizona

Research on Human Tissue: Religious Perspectives

Courtney S. Campbell

Oregon State University

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

Elisa Eiseman

RAND Critical Technologies Institute

Control of DNA Samples and Information

Bartha Maria Knoppers, Marie Hirtle, Sébastien Lormeau, Claude M. Laberge, 

and Michelle Laflamme 

CRDP (Public Law Research Centre), Faculty of Law, Université de Montréal, Québec 

Contribution of the Human Tissue Archive to the Advancement of Medical Knowledge 

and the Public Health

David Korn

Stanford University School of Medicine

The Ongoing Debate About Stored Tissue Samples

Robert F. Weir

University of Iowa

Mini-Hearings on Tissue Samples and Informed Consent

James A. Wells and Dana Karr

Center for Health Policy Studies
On November 14, 1998, President Clinton asked NBAC to conduct a thorough review

of issues surrounding human stem cell research. This was the second time that the

President had called on NBAC to consider a highly charged bioethical issue (the first

was his request that NBAC review the ethics of cloning human beings1

). The President’s

request followed a series of reports that researchers had isolated and cultured human embryonic

stem (ES) cells and embryonic germ (EG) cells. These reports have generated considerable 

scientific and clinical interest because of the prospect these efforts pose for treating injuries or

debilitating conditions such as Alzheimer’s disease, Parkinson’s disease, or heart disease. But

this research also raises serious ethical concerns, mainly because the major current sources of

stem cells are cadaveric fetal tissue obtained following elective abortions and embryonic tissue

derived from embryos remaining after infertility treatments.

After nine months of study, the commission produced its 109-page report entitled Ethical

Issues in Human Stem Cell Research. This report makes 13 recommendations meant to offer a policy

framework to provide the public with assurance that important, potentially life-saving

research can be conducted with federal support within a publicly accountable and rigorous

system of oversight and review. 

The Commission recommended that federal sponsorship of research involving the derivation and use of human ES cells and human EG cells should be limited in two ways. First,

research should be limited to using only two sources of such cells, namely cadaveric fetal

material and embryos remaining after infertility treatments. Second, such sponsorship should

be contingent on an appropriate and open system of national oversight and review. The report

also addresses requirements related to the means of ensuring appropriate consent of women

or couples who donate cadaveric fetal tissue or embryos remaining after infertility treatments;

the need for restrictions on the sale of these materials and the designation of those who may

benefit from their use; the need for ethical oversight and review of such research at the national

and institutional levels; and the appropriateness of voluntary compliance by the private sector. 

NBAC noted that recent developments in human stem cell research have raised hopes that

new therapies will become available that will serve to relieve human suffering. These developments also have served to remind society of the deep moral concerns that are related to

research involving human embryos and cadaveric fetal tissue. Serious ethical discussion will

and should continue on these issues. But it is clear that the scientific and clinical benefits of

stem cell research should not be overlooked. The Commission strongly believes that carrying

out human stem cell research under federal sponsorship is important, but only if it is conducted in an ethically responsible manner.

Ethical Issues in Human Stem Cell Research: Volume I

(September 1999)

Exhibit C:

6

1 The report Cloning Human Beings was published by NBAC in June 1997 and is available at www.bioethics.gov.
Volume II: Commissioned Papers

(January 2000)

State Regulation of Embryo Stem Cell Research

Lori B. Andrews

Chicago-Kent College of Law

The Food and Drug Administration’s Statutory and

Regulatory Authority to Regulate Human Pluripotent Stem Cells 

Robert P. Brady, Molly S. Newberry, and 

Vicki W. Girard

Hogan & Hartson L.L.P.

Quick Response: Use of Human Fetal Tissue in Federally

Funded Research

Elisa Eiseman

RAND Science and Technology Policy Institute

Analysis of Federal Laws Pertaining to Funding of Human

Pluripotent Stem Cell Research

Ellen J. Flannery and Gail H. Javitt

Covington & Burling

Deliberating Incrementally on Human Pluripotential 

Stem Cell Research

John C. Fletcher

University of Virginia

Bioethical Regulation of Human Fetal Tissue and Embryonic

Germ Cellular Material: Legal Survey and Analysis 

J. Kyle Kinner, Presidential Management Intern

National Bioethics Advisory Commission

Regulating Embryonic Stem Cell Research: 

Biomedical Investigation of Human Embryos

J. Kyle Kinner, Presidential Management Intern

National Bioethics Advisory Commission

International Perspectives on Human Embryo and 

Fetal Tissue Research

Lori P. Knowles

The Hastings Center

What Has the President Asked of NBAC? On the Ethics and

Politics of Embryonic Stem Cell Research

Erik Parens

The Hastings Center

Locating Convergence: Ethics, Public Policy, and Human

Stem Cell Research

Andrew W. Siegel

The Johns Hopkins University

“Although the 

ethical issues have 

not diminished, it 

now appears that 

this research may

have real potential 

for treating such 

devastating illnesses

as cancer, heart 

disease, diabetes, and

Parkinson’s disease.

With this in mind, 

I am also requesting

that the Commission

undertake a thorough

review of the issues

associated with 

such human stem 

cell research, 

balancing all ethical

and medical 

considerations.”

President Clinton, 

November 14, 1998

7
❖ NBAC commissioners and staff were involved in

numerous public education activities domestically

and abroad to discuss the Commission’s recommendations or work in progress. Activities included

participation in public lectures, seminars, and conferences; consultations with the World Health

Organization, the United Nations Educational,

Scientific, and Cultural Organization (UNESCO),

and the Council on International Organizations

of Medical Sciences; and co-sponsorship of the

Second International Summit of National

Bioethics Commissions in Tokyo. (See Appendix C.)

❖ In January 1998, NBAC launched its website,

www.bioethics.gov, as a comprehensive source of

information, posting reports, meeting agendas,

transcripts, and related materials. Since its debut,

the website has received more than 300,000 “hits.”

Many national and international groups have

established links to NBAC’s website and rely on 

it for up-to-date information about bioethics

developments in the United States. Commission

staff have been working to upgrade the site and

improve site navigation. Later in 2000, a new,

improved website will be up and running. 

8

Neal F. Lane, Assistant to the President for Science 

and Technology, and Harold T. Shapiro, NBAC Chair

continued from page 1 “ We really 

appreciate the

Commission’s timely

and very important

contributions to the

national debate on

what are clearly 

some of the most 

controversial issues 

in science policy we

face today. Certainly

your work reflects 

well on the wisdom 

of establishing this

Commission.”

Dr. Neal F. Lane, Assistant to 

the President for Science and

Technology, Executive Office 

of the President, addressing the

Commission on October 22, 1999
NBAC’s contribution to national discussions on bioethics, science, and law has drawn praise

from many sources for its clarity, depth, scholarship, sensitivity to public views, and long-term

policy impact. NBAC’s recommendations and perspectives have been featured in many leading

national publications, including the Los Angeles Times, the New York Times, the Wall Street Journal,

and the Washington Post, as well as prominent medical and scientific journals such as the Journal

of the American Medical Association, the New England Journal of Medicine, Nature, and Science.

Follow-up and Impact of NBAC’s Reports

All NBAC reports are submitted to the President through the National Science and

Technology Council. In February 1998, NBAC was informed that its report Research Involving

Persons with Mental Disorders That May Affect Decisionmaking Capacity had been circulated to federal

departments and agencies for comment and that comments were to be received in May 1998.

To date, no action has been taken by federal agencies on any of the report’s 21 recommendations. However, the National Institutes of Health issued a guidance document and a set of

“points to consider” that addresses similar issues. Consistent with its Charter authority, NBAC

wrote to several federal departments in October 1999 to request a response within 180 days to

the recommendations that were made to them. 

NBAC’s report on research involving human biological materials has served as a useful

guide to research institutions aiming to establish ethical policies and practices regarding

research access to stored blood and tissue samples. The federal Office for Human Research

Protections cites NBAC’s recommendations regarding identifiability of samples when responding

to requests for clarification from investigators and research institutions.

NBAC reports have been widely circulated both domestically and internationally. All

reports can be obtained in hard copy format by contacting the Commission offices, or they can

be downloaded directly from NBAC’s website. NBAC’s report on human biological materials

has been translated into Japanese, and Germany’s Institut für Wissenschaft und Ethik is publishing two NBAC report summaries in its 2000 edition of the “Yearbook for Science and

Ethics.”

While it is difficult to assess the direct impact of NBAC’s recommendations, there is ample

indirect evidence that the Commission’s work has stimulated discussion and informed the public policy debate in this country and elsewhere. For example, Japan recently enacted legislation permitting federal funding for the derivation and use of embryonic stem cells from

embryos remaining after infertility treatments. Japan’s policy on stem cell research parallels

NBAC’s recommendations. Similarly, in a recent working paper on human stem cell research,

the Nuffield Council on Bioethics in the United Kingdom endorsed a number of NBAC’s 

recommendations. NBAC staff continue to monitor the literature and print media and will be

comprehensively assessing the impact of the Commission’s work.

9
Public Involvement

Historically, U.S. bioethics commissions have used

a variety of strategies to involve the public in their

debates. As a federal advisory committee, NBAC

must comply with the Federal Advisory Committee

Act (FACA), which requires that Commission

meetings be held in public, that its recommendations be agreed to in public, and that the public

must be able to access Commission materials. From

the outset, NBAC has embraced both the spirit 

and substance of FACA, upholding its obligation to

both engage and be accountable to the public. The

public is notified of the dates and sites for meetings

through the NBAC website, direct mail, and

announcements in the Federal Register. Drafts of recommendations and background papers that are

commissioned from outside experts or prepared by

staff also are available to the public. In addition,

NBAC makes available copies of all materials at its

regularly scheduled meetings, and regular updates

of the Commission’s work appear in the lay press

and scientific journals. 

At every NBAC meeting, 30 minutes are

reserved in 5-minute increments to permit public

testimony. Individuals need only inform NBAC

staff that they wish to testify, and they can do so

even on the day of the meeting. At several

Commission meetings, patients and former research

subjects have been given the opportunity to share

their experiences in research. Over the past two

years, 36 individuals have taken advantage of this

opportunity to offer their views on a range of 

subjects. To engage broader public participation,

many of NBAC’s 19 meetings in 1998–1999 have

been held in cities other than Washington D.C.,

including Miami, Florida; Northbrook, Illinois;

Cleveland, Ohio; and Portland Oregon. (See

Appendix B.) 

When time allows, NBAC employs a formal public

comment period to obtain critical and constructive

public input on draft reports and recommendations.

For the report Research Involving Persons with Mental

10

The National

Bioethics Advisory

Commission “has

demonstrated its

legitimate claim to

respect for its efforts

as a national body 

to promote public

input into social 

policy related 

to advances in 

biomedical research.”

American Association for 

the Advancement of Science

“Stem Cell Research and

Applications: Monitoring 

the Frontiers of Biomedical

Research,” November 1999 
Commissioner Activities

Exhibit D:

I

n 1998 and 1999, members of the Commission published more than 90 articles, chapters,

and books on issues specifically related to bioethics and health policy. In addition, commissioners spoke in a variety of venues on nearly 100 separate occasions about NBAC’s

work. Following are some examples:

❖ Commissioner R. Alta Charo addressed the Public Responsibility in Medicine and Research

1998 Annual Meeting, speaking on “A National Agenda for Human Subjects Protection.”

❖ Commissioner Bernard Lo presented the Ethics Grand Rounds, “Ethical Issues in Caring

for Patients from Different Cultures,” at the National Institutes of Health in February 1999.

❖ Commissioner Alexander Capron presented “Counting Sheep: Ethical, Legal and Social

Implications of Human Cloning,” at the California Institute of Technology in January 1998.

❖ Commissioner Rhetaugh Dumas provided “An Update on the Work of NBAC and My Role

and Experiences as the Only Nurse Member” to the National Advisory Committee for the

National Institute of Nursing Research, National Institutes of Health.

❖ Commissioner Thomas Murray presented “Genetics, Race and Bioethics” at the Center for

Bioethics Fall Conference at Tuskegee University in September 1998.

❖ Commissioner Patricia Backlar discussed “Research Advance Directives” at the National

Alliance for the Mentally Ill Annual Convention in July 1999.

❖ On a visit to West Africa in December 1999 as part of her work for the National Science

Foundation, Commissioner Diane Scott Jones discussed with West African investigators and

university officials NBAC’s ongoing work in the protection of subjects in international

research.

❖ Commissioner Bette Kramer, one of NBAC’s public members, has been a key contributor to

Bioethics 2000, a collaborative project with the University of Richmond, United Network

for Organ Sharing, Virginia Commonwealth University, Southern California Organ

Procurement Center, Virginia Transplant Council, and Mills Godwin High School.

Disorders That May Affect Decisionmaking Capacity, more than 120 comments from individuals and

organizations were received and analyzed by NBAC staff. Many of these comments helped

commissioners identify issues that ultimately led to revisions in the report’s final recommendations. Similarly, for the report Research Involving Human Biological Materials: Ethical Issues and

Policy Guidance, the Commission received 63 comments, many from professional and scientific

organizations.

National and International Outreach Activities

Over the course of the past two years, commissioners have been actively involved in public 

discussions about NBAC’s work. (See Exhibit D.) These activities include public and professional

11
lectures, media interviews, and publications and editorials in the scholarly literature and the

popular press. 

In addition, as NBAC has become a more visible deliberative body, it has been asked to

organize, consult, attend, or provide input to a variety of national and international meetings

and projects. In the past two years, the Commission has been involved in the activities

described below.

Second International Summit of National Bioethics Commissions, November 1998

As discussed in its 1996–1997 Report, NBAC was instrumental in convening the First

International Summit of National Bioethics Commissions, held in San Francisco in 1996. The

positive reaction to this Summit encouraged NBAC to collaborate in the organization of the

Second International Summit of National Bioethics Commissions, which was held in Tokyo,

Japan, November 4–5, 1998, in conjunction with the Fourth World Congress of the

International Association of Bioethics. As in San Francisco, NBAC Chair Harold T. Shapiro,

Ph.D., was one of the co-chairs. Dr. Shapiro, along with Dr. Hiroo Imura, Chair of the

Japanese Bioethics Commission, and Dr. Jean-Pierre Changeux, Chair of France’s national

bioethics committee, Comité Consultatif National d’Ethique (CCNE), convened a two-day

meeting that brought together Delegates and Observers from more than 30 countries and 

5 international organizations. Commissioners Alexander Capron, R. Alta Charo, and Thomas

Murray attended the Summit, as did NBAC Executive Director Eric Meslin. An important

outcome of the Summit was the “Tokyo Communiqué” (see Appendix C), which identified a

number of common issues of interest and resulted in an agreement that national bioethics commissions will continue to explore ways to work together. The Summit will reconvene in 2000 

in London, England. 

12

Left to Right:

Harold T. Shapiro,

NBAC Chair; Hiroo

Imura, Chair of the

Japanese Bioethics

Commission; 

Jean-Pierre Changeux,

Chair of the French

national bioethics 

committee (CCNE), at

the Second International

Summit of National

Bioethics Commissions

in Tokyo, November 1998.
Belmont Report 20th Anniversary Conference

NBAC co-sponsored a meeting in April 1999 at the University of Virginia in Charlottesville to

celebrate the 20th anniversary of the publication of the Belmont Report: Ethical Principles and

Guidelines for the Protection of Human Subjects of Research. This anniversary was an opportune time

for scholars and academics involved in the work to revisit one of the most influential documents

in bioethics. The Belmont Report was prepared by the National Commission for the Protection

of Human Subjects of Biomedical and Behavioral Research and has provided the ethical foundation for the current federal system of human subjects protections in the United States. The

conference was co-chaired by NBAC Chair Harold T. Shapiro and Commissioner James

Childress. Commissioners Alexander Capron, Eric Cassell, R. Alta Charo, and Thomas

Murray and NBAC Executive Director Eric Meslin presented papers, which will be published

in a book being edited by Harold Shapiro, James Childress, and Eric Meslin. 

Journees Annuelle (Annual Ethics Days): CCNE, France

In December 1999, NBAC was represented by Commissioners Alexander Capron and R. Alta

Charo and Executive Director Eric Meslin at the annual meeting of France’s CCNE. In 

contrast with NBAC, the CCNE is not bound by the requirement to hold all meetings in 

public. Thus, its annual ethics forum is an opportunity for the public to observe and participate

in the country’s biomedical ethics debates. Each year, the CCNE invites experts from around

the world to review its work and discuss a variety of French bioethics laws and issues. A 

constructive and helpful relationship has developed between the two national commissions. 

World Health Organization Consultation

In December 1999, the World Health Organization convened a meeting of 40 experts and

groups to seek advice on the direction it should take in addressing ethical issues in genetics and

related advances in medicine and biology. Commissioners Alexander Capron and R. Alta

Charo and Executive Director Eric Meslin participated in this consultation. 

Commission Functions and Operations

The Commission continues to function according to the original Executive Order. However,

there have been several administrative changes that have occurred since the last biennial

report. (See Appendix D.)

Extension of Executive Order and New Charter. As an indication of the value that NBAC offers

to the policymaking arena, President Clinton, on September 16, 1999, extended the

Commission’s term for two additional years, via Executive Order 13137. This Executive Order

expires on October 3, 2001. On October 20, 1999, a new Charter was signed by Department

of Health and Human Services Secretary Donna Shalala. 

New Member. William C. Oldaker, LL.B., of Potomac, Maryland, was appointed to the

Commission in September 1999. Mr. Oldaker is the co-founder of and general counsel to

NeuralStem Biopharmaceuticals Ltd., which conducts research into genetic therapies. He

replaced Ezekiel Emanuel, M.D., Ph.D., associate professor of medical ethics at Harvard

Medical School, who left NBAC in February 1998 to head the Department of Clinical

Bioethics at the National Institutes of Health. 

13
Budget. NBAC’s operating budget for FY 1998 

was $1.9 million. Its operating budget for FY 1999 

was $2 million. In contrast with previous years,

NBAC currently receives its budget from a single

federal agency, the Department of Health and

Human Services.

Subcommittees Disbanded. On September 15, 1999,

NBAC informed the White House and the

Department of Health and Human Services that it

was disbanding the Human Genetics Subcommittee

and the Human Subjects Subcommittee.

Work in Progress

With the Commission now extended until October

2001, additional reports are under way and nearing

completion.

Ethical and Policy Issues of International

Research

The adequate protection of the rights and welfare of

all individuals who participate in clinical trials,

regardless of nationality or the site of the research in

all countries involved, is emerging as a critical issue in

international research ethics. Over the past 10 years,

there has been a significant increase in the amount

of clinical research that the United States conducts

or sponsors in other countries, particularly in countries that are resource poor. By late fall 2000, NBAC

expects to produce a set of recommendations that

will address the ethical, legal, and policy issues that

arise when research subject to U.S. research regulations is sponsored or conducted in other countries. 

NBAC’s goal is to identify these issues and determine whether they are unique to international settings

and deserve attention from policymakers. NBAC will

be looking at recruitment of subjects, informed consent, and the risks and potential benefits of conducting research. The report also will analyze many

national and international guidelines and statements

to make recommendations about possible ways to

enhance international collaborative research. It also

will focus on the obligations of private and public

14

“NBAC finds that

the current federal

regulations have

served to prevent 

most recurrences of

the gross abuses

associated with 

biomedical research

in the earlier part 

of this century.

Nonetheless, some

abuses still occur, 

and the system is in

need of significant

revision.”

NBAC Summary of

Preliminary Findings:

Adequacy of Federal

Protections for Human

Subjects in Research, 

May 1999
sponsors of investigations to research participants,

communities, and countries throughout the research

process.

Ethical and Policy Issues in the Oversight 

of Human Subjects Research in the United

States

In September 1999, President Clinton asked NBAC 

to undertake a thorough examination of the federal 

system of human research subject protections. The

President’s request stems from concerns that the current decentralized system of oversight places too much

responsibility on individual investigators and their

sponsoring institutions. In May 1999, NBAC wrote to

the President indicating several areas of concern, noting

that federal protections for people serving as subjects 

in research do not yet extend to all Americans and that

many federal agencies find the interpretation and

implementation of the Common Rule confusing or

unnecessarily burdensome. The Commission’s effort 

in this area comes against a backdrop of intensifying 

public concern about the state of human research

oversight in the United States. 

NBAC’s charge is to assess the adequacy of the current federal system of protections; review relevant

statutes and regulations with particular attention to

the effectiveness of the Common Rule and its applicability to the full range of government-sponsored

research activities involving human subjects; and

examine the strengths and weaknesses of the infrastructure responsible for ensuring the entire system’s

integrity. The goal of the report, expected to be completed by early 2001, will be to offer recommendations

that ensure that all federal research involving humans

is conducted ethically. 

Archiving NBAC’s Work

Plans are now under way to ensure that all reports,

materials, and related documents from NBAC’s work

are accessible to scholars and the public in both hard

copy and electronic formats. By the end of 2000, it is

expected that an agreement will be reached with a

university to archive these materials.

15

“It took 10 long

years to promulgate

the Common Rule in

1991, and yet even 

at that time it was

agreed that additional

work needed to be

done to provide 

adequate coverage 

for every research

subject, including 

special populations.

One of the driving

forces behind NBAC’s

establishment was the

desire to accelerate

progress towards the

goal of ensuring such

coverage.”

Dr. Neal Lane, Assistant to 

the President for Science 

and Technology, Executive

Office of the President,

addressing the Commission 

on October 22, 1999
National Bioethics Advisory Commission Staff, 

Consultants, and Volunteers, 1998–1999

Executive Director

Eric M. Meslin, Ph.D. 

Research Staff

Elisa Eiseman, Ph.D., Senior Research Analyst

Emily C. Feinstein, Program Analyst (until May 1999)

Ellen L. Gadbois, Ph.D., Senior Policy Analyst

Melissa Goldstein, J.D., Research Analyst (until May 1999)

Kathi E. Hanna, M.S., Ph.D., Research Director (until October 1999)

Everson R. Hull, Program Analyst (until May 1999)

Stuart Kim, J.D., M.S., Research Analyst

Kyle Kinner, J.D., Presidential Management Intern (until July 1999)

Kerry Jo Lee, Research Assistant

Debra McCurry, M.S., Information Specialist

Alice Page, J.D., M.P.H., Senior Policy Analyst, Project Manager (International) 

Daniel J. Powell, Intern (Summer 1999)

Andrew Siegel, Ph.D., J.D., Staff Philosopher (until August 1999)

Sean A. Simon, Program Analyst (until May 1999)

Robert S. Tanner, J.D., Program Analyst (until February 2000)

Administrative Staff

Jody L. Crank, Assistant to the Executive Director

LaShell L. Gaskins, Administrative Technician (until July 1999)

Evadne M. Hammett, Administrative Officer

Henrietta Hyatt-Knorr, M.A., Acting Deputy Executive Director (until November 1998)

Patricia Norris, Public Affairs Officer (until October 1999)

Lisa N. Price, Secretary (until October 1999)

Margaret C. Quinlan, Office Manager

Sherrie D. Senior, Secretary

Consultants and Volunteers

Burness Communications, Communications Consultant

Sara Davidson, M.A., Editor

William F. Freeman, M.D., M.P.H., Volunteer (until September 1998)

Kathi E. Hanna, M.S., Ph.D., Editorial Consultant (from November 1999)

Jeffrey P. Kahn, Ph.D., M.P.H., Bioethics Consultant (until September 1999)

Tamara Lee, Graphic Designer

Ruth Macklin, Ph.D., Senior Consultant

Joel M. Mangel, J.D., Volunteer (until December 1998)

Jonathan D. Moreno, Ph.D., Senior Consultant (until October 1999)

LeRoy B.Walters, Ph.D., Bioethics Consultant (until October 1999)

17

Appendix A
Meeting Dates, Locations, and Testimony Provided

January 6–8, 1998

Arlington, Virginia

Public Testimony:

John Cavanaugh O’Keefe, American Bioethics Advisory Commission

Norman Carl Rabin, Long Island, New York

David Shore, National Institute of Mental Health

Mark Sobel, National Cancer Institute

Expert Testimony:

Patricia Barr, National Action Plan on Breast Cancer

Gary B. Ellis, Office for Protection from Research Risks

John C. Fletcher, University of Virginia

C.K. Gunsalus, University of Illinois

Rachel Levinson, Office of Science and Technology Policy

Susan E. Old, National Heart, Lung, and Blood Institute

Joan Porter, Office of Science and Technology Policy

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

February 5–6, 1998

Los Angeles, California

Public Testimony:

Art Ablin, University of California, San Francisco

Robert Aller, Patient Rights Network

Con Hopper, University of California System

Kathy Kasten, Los Angeles, California

Betsy Manning

Felicia McCarty, Mira Loma, California

David Shore, National Institute of Mental Health 

Joan Siegemund

Expert Testimony:

Rachel Levinson, Office of Science and Technology Policy

Elyn Saks, University of Southern California

March 3–4, 1998 

Tysons Corner, Virginia

Public Testimony:

Judith Brunden, Union City, New Jersey

John Cavanaugh O’Keefe, American Bioethics Advisory Commission

Karen Rothenberg, University of Maryland

Adil Shamoo, Citizens for Responsible Care in Psychiatry and Research

Expert Testimony:

Lisa Brooks, National Human Genome Research Institute

Bernard M. Dickens, University of Toronto

Mark Guyer, National Human Genome Research Institute

J. Thomas Puglisi, Office for Protection from Research Risks

19

Appendix B
May 19–20, 1998

Cleveland, Ohio

Public Testimony:

Tillman Bauknight, Cleveland, Ohio

Vicki Casagrande, West Bloomfield, Michigan

Expert Testimony: 

C. Christopher Hook, The Mayo Clinic

Ruth Macklin, Albert Einstein College of Medicine

Stuart L. Nightingale, Food and Drug Administration

Donald L. Rosenstein, National Institute of 

Mental Health

David Shore, National Institute of Mental Health

Marjorie A. Speers, Centers for Disease Control 

and Prevention

July 14–15, 1998

Portland, Oregon

Public Testimony:

Ted Falk, Portland, Oregon

Sid Glasser, San Francisco, California

Karen Hansen, Public Responsibility in Medicine 

and Research

Expert Testimony:

Allen Buchanan, University of Arizona

Frank C. Dukepoo, Northern Arizona University

Albert R. Jonsen, University of Washington

Mary-Claire King, University of Washington

September 16–17, 1998

Alexandria, Virginia

Public Testimony:

Irene Lynch, Colts Neck, New Jersey 

Marcia Pines, Baltimore, Maryland

David Shore, National Institute of Mental Health

October 20, 1998

Arlington, Virginia

Public Testimony:

Wesley Alcorn, National Alliance for the Mentally Ill

Catherine Clapp, Fragile X Research Foundation 

Kathy Mannion, Port Washington, New York

James McNulty, National Alliance for the 

Mentally Ill

Harold Pincus, American Psychiatric Association

Jaqueline Shannon, National Alliance for the

Mentally Ill

November 17–18, 1998

Miami, Florida

Public Testimony:

Michael Guarino, Autism Society of America

David Shore, National Institute of Mental Health

Michael West, Advanced Cell Technology

Expert Testimony:

Ralph Brinster, University of Pennsylvania

January 19–20, 1999 

Washington, D.C.

Public Testimony:

Kneale Ewing, Collegians Activated to Liberate Life

Olga Fairfax, Wheaton, Maryland

Will Goodman, Civil Rights and Antidefamation

League of Embryonic Life

John Price

Mark Sobel, American Society of Investigative Pathology

E.J. Suh, Collegians Activated to Liberate Life

Expert Testimony:

Françoise Baylis, Dalhousie University 

John Gearhart, The Johns Hopkins University 

Patricia King, Georgetown University School of Law

Karen Lebacqz, Pacific School of Religion

Erik Parens, The Hastings Center 

Daniel Perry, Alliance for Aging Research

Ted Peters, Center for Theology and the Natural

Sciences

John Robertson, University of Texas School of Law

Austin Smith, University of Edinburgh

James Thomson, University of Wisconsin 

Harold Varmus, National Institutes of Health

February 2–3, 1999

Princeton, New Jersey

Expert Testimony:

David Blumenthal, Massachusetts General Hospital

Robert Brady, Hogan & Hartson L.L.P.

Brigid Hogan, Vanderbilt University

Barbara Mishkin, Hogan & Hartson L.L.P.

March 2–3, 1999

Vienna, Virginia

Public Testimony:

Phil Noguchi, Food and Drug Administration

Expert Testimony:

John Fanning, Department of Health and Human

Services

John Fletcher, University of Virginia 

Nancy Kass, Johns Hopkins University

Lori Knowles, The Hastings Center 

Jeremy Sugarman, Duke University

LeRoy Walters, Georgetown University

April 15–16, 1999

Charlottesville, Virginia

Public Testimony:

Ida Chow, American Society of Developmental Biology

Richard Doerflinger, National Conference of Catholic

Bishops

Ethics and Religious Liberty Commission of the Southern

Baptist Convention (submitted written testimony)

Edward Furton, National Catholic Bioethics Center

Sidney Gunst, Jr., Richmond, Virginia

Karen Poehailos

Expert Testimony:

Patricia Marshall, Loyola University

20
May 7, 1999

Washington, D.C.

Public Testimony:

Dena Davis, Cleveland-Marshall College of Law

Richard Doerflinger, National Conference of Catholic

Bishops

Expert Testimony:

Ronald Cole-Turner, Pittsburgh Theological Seminary

Demetrios Demopulos, Holy Trinity Greek Orthodox

Church 

Elliot Dorff, University of Judaism

Nancy Duff, Princeton University Theological

Seminary

Margaret Farley, Yale University

Gilbert Meilaender, Jr., Valparaiso University

Edmund Pellegrino, Georgetown University

Abdulaziz Sachedina, University of Virginia

Moshe Tendler, Yeshiva University

Kevin Wildes, Georgetown University

Laurie Zoloth, San Francisco State University

May 11–12, 1999

Northbrook, Illinois

Public Testimony:

Peggy Connelly, Wheaton, Illinois

Daniel McConchie, Center of Bioethics and Human

Dignity

Expert Testimony:

Lori Andrews, Chicago-Kent College of Law

Sander Shapiro, University of Wisconsin-Madison

June 28–29, 1999

Washington, D.C.

Public Testimony:

Phil Noguchi, Food and Drug Administration

Expert Testimony:

Roger Cortesi, Environmental Protection Agency

Nancy Dubler, Albert Einstein College of Medicine

Paul Gatons, Department of Housing and Urban

Development

Timothy Gerrity, Department of Veterans Affairs

Renee M. Landers, Ropes & Gray

Edward M. Lane, Department of Defense

Barbara C. Levin, National Institute on Standards

and Technology

Beth McCormick, National Aeronautics and Space

Administration

Stuart Plattner, National Science Foundation

Blanca Rosa Rodriguez, U.S. Department of

Education

James D. Shelton, U.S. Agency for International

Development

Lana Skirboll, National Institutes of Health

Majorie Speers, Centers for Disease Control and

Prevention

July 13–14, 1999

Cambridge, Massachusetts

September 16–17, 1999

Arlington, Virginia

Public Testimony:

Peter Lurie, Public Citizen’s Health Research Group

Expert Testimony:

Donald S. Burke, Johns Hopkins School of Hygiene

& Public Health

Jack Killen, National Institute of Allergy and

Infectious Diseases

Alfred Sommer, Johns Hopkins School of Hygiene &

Public Health

October 21–22, 1999

Washington, D.C.

Public Testimony:

Adnan Hyder, Johns Hopkins School of Hygiene &

Public Health

Susan Poland, National Reference Center for

Bioethics Literature

Expert Testimony:

Lori B. Andrews, Chicago-Kent College of Law

Sam Avrett, AIDS Vaccine Advocacy Coalition

Neal F. Lane, Office of Science and Technology

Policy

Sana Loue, Case Western Reserve University

Mark Sagoff, University of Maryland

December 2–3, 1999

Baltimore, Maryland

Public Testimony:

Steven Gordon, The Johns Hopkins University

Kohar Jones, Yale University

Peter Lurie, Public Citizen’s Health Research Group

Terry Rhinehart

Expert Testimony:

Gary Chase, Henry Ford Health Sciences Center

Kay Dickersin, Brown University

Dennis Dixon, National Institute of Allergy and

Infectious Diseases

Stephen Lagakos, Harvard School of Public Health

David Lepay, Food and Drug Administration

Christopher C. Whalen, Case Western Reserve

University

Sidney M. Wolfe, Public Citizen’s Health Research 

Group

21
Second International Summit of National Bioethics

Commissions: Tokyo Communiqué

The Delegates to the Second International Summit of National Bioethics Commissions,

Representing more than 30 countries and every inhabited continent, who have gathered

for two days of open dialogue and exchange of ideas and experiences,

Recalling the history of international efforts in this century both to promote progress

in biology and medicine as a means of improving the human condition, and to safeguard the well-being and to respect the worth of all persons, particularly those made

vulnerable by disease,

Recognizing that developments in the life sciences and in the provision of health care

and public health services generate ever more complex issues for advisory bodies in

all nations concerning, for example:

❖ access to healthcare resources in the face of scarcity

❖ permissible means to reduce suffering in the process of dying 

❖ the prospect of creating human beings through cloning

❖ selecting the sex of children

❖ transgenic animals and genetically engineered foods

❖ molecular therapy for enhancement of human capacities rather than treatment of

disease

Bearing in mind that many issues have international ramifications concerning, for

example:

❖ the need for research leading to inexpensive pharmaceutical and nutritional 

interventions of great potential value in the poorest nations

❖ the need for sustainable development in light of the rapid increase in human

population and use of natural resources

❖ the standards for clinical trials of drugs and vaccines in developing nations

❖ intentional manipulation of the human genome 

❖ payment for human organs for transplantation

❖ ownership of DNA information derived from mapping and sequencing the

human genome

Aspiring to advance the field of bioethics, which attempts to analyze and understand

such issues, and to provide healthcare professionals, research scientists, citizens,

patients and families, and governmental policymaking bodies in healthcare, biotechnology, environment, population and related fields with ideas and recommendations

that may improve the way they carry out their responsibilities,

23

Appendix C
Taking into account the importance of working together to promote education and enlightenment on bioethics around the world, of increasing the know-how of national commissions in

dealing with difficult issues, and of developing the necessary information-gathering and policymaking capabilities, particularly in nations that now lack relevant academic and governmental

resources,

Realizing the need to learn from, and work closely with, experts in the social and natural

sciences and the humanities in order to address bioethical issues in an informed and productive

fashion,

Wishing to cooperate in ways that will effectively address and take action not only on the issues

of today but that will anticipate issues that will emerge tomorrow, and

Desiring to carry on the process begun at the First International Summit of National Bioethics

Advisory Bodies in San Francisco in November 1996 and continued at the present Second

International Summit in Tokyo, not only through such meetings but also on an on-going basis

in order to permit all our countries to learn from each other’s experiences and to explore topics

that may benefit from coordinated responses,

Do hereby establish the Global Summit of National Bioethics Commissions in order to foster

progress on subjects of mutual interest in this field,

Delegate to an Interim Working Committee, with members from all continents, the responsibility

(1) to make appropriate arrangements with the World Health Organization and other

national and international organizations which are willing to provide the secretariat and

documentation functions needed for our continued cooperation and coordination, with

the expectation that such arrangements will be concluded within three months,

(2) to assemble the reports of national bioethics commissions and organize their findings

by topic, with the assistance of the Comité Consultatif National d’Ethique pour les

Sciences de la Vie et de la Santé, and report the results back to the commissions, as a

means of moving forward with the process of exploring common interests,

(3) based upon this analysis and upon the discussion of topics at the Tokyo Summit (particularly such issues as the ethics of multicenter, international clinical trials, and the ethical

aspects of various types of healthcare reform), to circulate a list of possible topics where

coordinated examination by national advisory bodies working simultaneously might produce results that would not be as easily obtained through such bodies working alone, and

then to select one or two such topics on which the process of international collaboration

can begin, 

(4) to make appropriate arrangements for the next meeting of the Global Summit, 

(5) to consult with international organizations working on bioethics and establish appropriate collaborative ties with them, and

(6) through a process of consultation with the national commissions, to formulate a set of

basic by-laws for the Global Summit.

24
Signed, this 4th day of November 1998 in Tokyo, Japan

SIGNATORIES* TO THE GLOBAL SUMMIT OF NATIONAL BIOETHICS COMMISSIONS: 

TOKYO COMMUNIQUÉ, NOVEMBER 4, 1998

Summit Co-Chairs

Hiroo Imura, Japan

Jean-Pierre Changeux, France

Harold T. Shapiro, USA

Delegates

Argentina Juan Carlos Tealdi,

Australia Donald Chalmers, Australian Health Ethics Committee

Bangladesh Hasna Begum

Belgium Etienne Vermeersch 

Brazil Leo Passini, National Commission of Ethics in Research Involving Human Beings

Canada Neil MacDonald, Medical Research Council

Croatia Ivan Segota

Denmark Soren Holm, Danish Council on Ethics

Egypt Ibrahim Badran

Finland Tuija Takala 

Matti Hayry

Hungary Bela Blassauer

India Vasantha Muthuswamy, Indian Council of Medical Research

Ivory Coast Lazare Marcelin-Poame

Korea Song Sang-Yong

Mexico Horacio Garcia-Romero

Manuel Velasco-Suarez

The Netherlands Egbert Schroten, Standing Committee on Medical Ethics and Health Law, Health Council

of the Netherlands

New Zealand Ken R. Daniels 

Poland Zbigniew Szawarski

Portugal Daniel Serrao, Portugeuse National Ethics Committee for Life Sciences

Russia Boris Yudin

Scotland Donald Bruce, Genetic Engineering Working Group, Church of Scotland

South Africa Solomon Benatar

Sweden Stellan Welin 

United Kingdom Colin Campbell, Human Genetics Advisory Commission

Sandra M. Thomas, Nuffield Council on Bioethics

USA Alexander M. Capron, National Bioethics Advisory Commission

International Organizations

Council on International Organizations of Medical Sciences

John Bryant

European Group of Ethics, European Commission 

Octavi Quintana-Trias 

International Association of Bioethics

Alastair V. Campbell.

International Union of Biological Sciences

Darryl Macer

World Health Organization

Daniel Wikler

UNESCO, International Bioethics Committee

Michael Kirby

*Unless indicated, signatories are signing on behalf of themselves 

revised as of 7/27/1999

25
Executive Order 12975 of October 3, 1995

Federal Register: October 5, 1995 (Volume 60, Number 193) Page 52063-52065 

Presidential Documents

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. 

27

Appendix D
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. 

(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. 5701-5707). 

(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. 

28
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 Amendment to Executive Order 12975, Extension of The 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 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. 

Executive Order 13137

Further Amendment to Executive Order 12975, as Amended, 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 more accurately describe the expertise require-ments for members selected for

the National Bioethics Advisory Commission, it is hereby ordered that Executive Order 12975, as

amended (“Order”), is further amended as follows:

Section 1. Section 3 of the order shall read as follows: “Sec. 3. Establishment of National Bioethics

Advisory Commission. There is established in the Department of Health and Human Services a National

Bioethics Advisory Commission (NBAC). The NBAC shall be subject to the Federal Advisory

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

Sec. 2. A new section 4 shall be added to the order to read: “Sec. 4. Structure.

(a) The National Bioethics Advisory Commission shall be composed of not more than 18 non-government

members appointed by the President. At least one member shall be selected from each of the following

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categories of primary expertise: (1) philosophy/theology; 2) social/behavioral science; (3) law; (4) medicine/allied health professions; and (5) biological research. At least three members shall be selected from

the general public, bringing to the Commission expertise other than that listed. The membership shall be

approximately evenly balanced between scientists and non-scientists. Close attention will be given to

equitable geographic distribution and to ethnic and gender representation.

(b) Members of the Commission will serve for terms of 2 years and may continue to serve after the expiration of their term until a successor is appointed. A member appointed to fill an unexpired term will be

appointed to the remainder of such term.

(c) The President shall designate a Chairperson from among the members of the NBAC.”

Sec. 3. (a) “[S]ection 5” in the third sentence of section 1(b) of the order shall be deleted and “section 6”

shall be inserted in lieu thereof.

(b) Current sections 4 through 7 of Executive Order 12975 shall be renumbered sections 5 through 8.

(c) New section 8(b) is amended by deleting “October 3, 1999” and inserting “October 3, 2001” in lieu

thereof.

WILLIAM J. CLINTON

The White House,

September 15, 1999.

National Bioethics Advisory Commission Charter

Purpose

The National Bioethics Advisory Commission will provide advice and make recommendations to the

National Science and Technology Council, chaired by the President; other appropriate entities and the

public, on bioethical issues arising from research on human biology and behavior, and the applications,

including the clinical applications, of that research.

Authority

Executive Order 12975, as amended. This Commission is governed by the provisions of the Federal

Advisory Committee Act (FACA), Public Law 92-463, as amended (5 U. S.C. Appendix 2), which sets

forth standards for the formation of advisory committees, and implementing regulations (41C.F.R.

101.6.10).

Functions

The National Bioethics Advisory Commission shall advise, consult with, and make recommendations to

the National Science and Technology Council, chaired by the President; Federal agencies; and other

appropriate entities, and also make available to the public the Commission’s advice and recommendations.

The Commission’s purview includes 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 applications, including the clinical applications, of that research. The Commission shall identify broad, overarching principles to govern the ethical

conduct of research, citing individual projects only as illustrations for such principles. The Commission

shall not be responsible for the review and approval of individual projects.

As a first priority, the Commission will direct its attention to consideration of

A. Protection of the rights and welfare of human research subjects; and

B. Issues in the management and use of genetics information including but not limited to human

gene patenting.

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In addition to responding to requests for advice and recommendations from the National science and

Technology Council, the Commission also may accept suggestions for issues for consideration from both

the Congress and the public. The Commission 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. The Commission shall consider four criteria -in establishing priority for its activities:

A. The public health or public policy urgency of the bioethical issue.

B. The relation of the bioethical issue to the goals for Federal investment in science and technology.

C. The absence of another body able to deliberate fruitfully on the bioethical issue.

D. The extent of interest in the issue across the government. (The Commission ordinarily will not

deliberate on a bioethical issue of interest to just one department or agency.)

Structure

The National Bioethics Advisory Commission shall consist of not more than 18 members including the

Chairperson. Appointments shall be made by the President, who shall select from knowledgeable nonGovernment experts and community representatives with special qualifications and competence to deal

effectively with bioethical issues. At least one member shall be selected from each of the following categories of primary expertise: (1) philosophy/theology; (ii) social/behavioral science; (iii) law; (iv) medicine/allied health professions; and (v) biological research. At least three members shall be selected from

the general public, bringing to the Commission expertise other than that listed. The membership shall be

approximately evenly balanced between scientists and non-scientists. Close attention will be given to

equitable geographic distribution and to ethnic and gender representation.

Members of the Commission will serve for terms of 2 years and may continue to serve after the expiration of their term until a successor is appointed. A member appointed to fill an unexpired term will be

appointed to the remainder of such terms. The Chairperson shall be appointed by the President. The

term of office for the Chairperson shall be two years, renewable by appropriate action of the President.

If a vacancy occurs on the Commission, the President shall make an appointment to fulfill the term. Any

member appointed to fill a vacancy occurring prior to expiration of the term for which his or her predecessor was appointed shall serve for the remainder of such term. Members may serve after the expiration of their terms until their successors have taken office.

The heads of executive departments and agencies shall, to the extent permitted by law, provide the

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

The Commission may conduct inquiries, hold hearings and establish subcommittees, as necessary.

The Commission is authorized to solicit information form relevant human research subject groups.

The Commission is authorized to conduct analyses and develop reports or other materials. In order to

augment the expertise present on the Commission, the Secretary of Health and Human Services is also

authorized to contract for the services of non-governmental consultants who may conduct analyses, prepare reports and background papers or prepare other materials for consideration by the Commission, as

appropriate.

In order to avoid duplication of effort, the Commission is encouraged to review the deliberations of other

entities. The Commission may incorporate or otherwise use the results of the deliberations of other entities,

as it deems appropriate.

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 of the subcommittee, and estimated frequency of meetings.

To the extent permitted by law, the subject to the availability of appropriations, the Department of

Health and Human Services (DHHS) shall provide NBAC with such funds as may be necessary for the

performance of its functions. Management and support services shall be provided by the DHHS.
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Meetings

Meetings of the Commission shall be held up to 12 times a year at the call of the Chairperson. Meetings of

the subcommittee(s) shall be convened as necessary. A Federal Government official shall be present at all

meetings.

Meetings shall be open to the public except as determined otherwise by the Assistant to the President

for Science and Technology and the Secretary of Health and Human Services. Advance notice of all

meetings shall be given to the public.

Meetings shall be conducted, and records of proceedings kept, as required by applicable laws and

Federal regulations.

Compensation

Members may be compensated at a rate not to exceed the maximum pay authorized by 5 U. S.C. 3109,

plus per them and travel expenses as in accordance with standard government travel regulations,

Annual Cost Estimate

The estimated annual cost for operating the National Bioethics Advisory Commission is $3,000,000.

Reports

Reports by the National Bioethics Advisory Commission on specific issues shall be submitted to the

National Science and Technology Council, chaired by the President, and then to the appropriate committees of Congress, and other appropriate entities. The Commission may specifically identify the

Federal department, agency or other entity to which particular recommendations are directed and

request a response from the Federal department, agency or other entity within 180 days of publication

of such recommendation.

Executive summaries of each report of the Commission shall be published in the Federal Register or on

the World Wide Web. Such summaries shall specifically list the department, agency, or other entity to

which any recommendations are directed and the date by which such responses are expected.

An annual report shall be submitted to the National Science and Technology Council and the appropriate

committees of Congress. It shall contain, at a minimum, (1) the Commission’s function; (ii) a list of 

members and their business addresses; (iii) the dates and places of meetings; (iv) a summary of the

Commission’s activities during the year; (v) a summary of the Commission’s recommendations made during the year; and (vi) a summary of responses made by departments, agencies, or other entities to the

Commission’s recommendations during the year.

General Provisions

Notwithstanding the provisions of any other Executive Order, the functions of the President under the

Federal Advisory Committee Act that are applicable to the Commission, 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.

Termination Date

Unless renewed by Executive Order prior to its expiration, this National Bioethics Advisory

Commission will terminate on October 3, 2001.

Approved:

Donna E. Shalala, Secretary

October 20, 1999
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