Reproduction and Responsibility:
The Regulation of New Biotechnologies
The President's Council on Bioethics
Washington, D.C.
March 2004
www.bioethics.gov
Acknowledgments
The Council would like to extend special thanks to two former
Council Members, Elizabeth H. Blackburn, Ph.D., and William
F. May, Ph.D., who participated in some of the discussions leading
to this report and offered very helpful comments during its
drafting.
Special recognition is also due the following outside experts who
provided helpful comment on certain portions of the report in draft
form. (They do not bear any responsibility for the final report nor do
they necessarily endorse its contents.):
Sandra Carson, M.D.
President (2003), American Society for Reproductive Medicine
(ASRM)
Lee Rubin Collins, J.D.
National Board of Directors, RESOLVE: The National Infertility
Association
Marian D. Damewood, M.D.
President (2004), ASRM
Theodore Friedmann, M.D.
Professor, Center for Molecular Genetics, University of California,
San Diego; former Chair, National Institutes of Health (NIH)
Recombinant DNA Advisory Committee
Erin Kramer
Director of Government Affairs, RESOLVE: The National Infertility
Association
Pamela L. Madsen
Executive Director, The American Infertility Association
Richard A. Merrill, L.L.B, J.D., M.A.
Professor of Law, University of Virginia
Phillip D. Noguchi, M.D.
Director, Division of Cellular and Gene Therapies, Center
for Biologics Evaluation and Research, Food and Drug Administration
(FDA)
Sean Tipton
Director of Public Affairs, ASRM
Daniel E. Troy, J.D.
Chief Counsel, FDA
The Honorable Ron Wyden
United States Senator, Oregon
Judith A. Yost
Director, Division of Laboratories, Centers for Medicare and
Medicaid Services
The Council would also like to extend its gratitude to the following
individuals who provided valuable testimony used in the production of
this report:
George J. Annas, J.D., M.P.H.
Chairman, Department of Health Law, Bioethics and Human Rights,
Boston University
Patricia A. Baird, OC., OBC., FRSC., M.D., C.M., FRCPC., FCCMG,
University Distinguished Professor, Department of Medical Genetics,
University of British Columbia, Canada
James S. Benson
Former Acting Commissioner, Food and Drug Administration
Robert Bryzski, M.D., Ph.D.
President (2003), Society for Assisted Reproductive Technology
(SART)
Francis S. Collins, M.D., Ph.D.
Director, National Human Genome Research Institute (NHGRI),
NIH
Richard M. Doerflinger, Ph.D.
Deputy Director, Secretariat for Pro-Life Activities, U. S.
Conference of Catholic Bishops
Ezekiel J. Emanuel, M.D., Ph.D.
Chief, Center for Clinical Bioethics, NIH
Karen Hauda, J.D.
Office of Legislative and International Affairs, U. S. Patent
and Trademark Office
Steve H. Holtzman
President, Infinity Pharmaceuticals, Inc., Cambridge, Massachusetts
Kathy Hudson, Ph.D.
Director, Genetics and Public Policy Center, Johns Hopkins
University
Baroness Helena Kennedy QC
Chair, U. K. Human Genetics Commission
Daniel J. Kevles, Ph.D.
Department of History, Yale University
Andrew Kimbrell, J.D.
President, International Center for Technology Assessment (ICTA)
Lori Knowles, L.L.B., B.C.L., L.L.M.
Former Associate for Law and Policy, Director, Education and
Outreach, The Hastings Center
William Kristol
Chairman, The Bioethics Project
Suzi Leather
Chair, U.K. Human Fertilisation and Embryology Authority
Pamela L. Madsen
Executive Director, The American Infertility Association
Mary Briody Mahowald, Ph.D.
Professor Emerita, Department of Obstetrics and Gynecology,
MacLean Center for Clinical Medical Ethics, Committee on Genetics,
and The College, University of Chicago
Michael Manganiello
President (2003), Coalition for the Advancement of Medical
Research; Senior Vice President, Christopher Reeve Paralysis
Foundation
Arti Rai, J.D.
Assistant Professor (2002), University of Pennsylvania Law
School
Gerald P. Schatten, Ph.D.
Vice-Chair, Obstetrics-Gynecology & Reproductive Sciences
and Cell Biology-Physiology, University of Pittsburgh School
of Medicine; Director, Pittsburgh Development Center; Deputy
Director, Magee-Women's Research Institute
Spiros Simitis, Prof. Dr. Drs. h.c.
Chairman, German National Ethics Council
Maxine F. Singer, Ph.D.
Chair, Committee on Science, Engineering, and Public Policy,
National Academy of Sciences
David H. Smith, Ph.D.
Director (2003), The Poynter Center for the Study of Ethics
and American Institutions, Indiana University
Michael J. Werner, J.D.
Vice President, Biotechnology Industry Organization
Finally, the Council would like to thank those that answered its call
for public comment on the issues touched on in this report:
American Association for the Advancement of Science
American Association of Bioanalysts
American Bar Association
American Board of Bioanalysis
American College of Obstetricians and Gynecologists
American Infertility Association
American Life League
American Medical Association
American Society for Reproductive Medicine
American Society of Human Genetics
Assemblies of God U.S.A.
Biotechnology Industry Organization
Center for Applied Reproductive Science
Center for Bioethics and Human Dignity
William P. Cheshire, Jr., M.D.
Christian Legal Society
Christian Medical and Dental Associations
Church of Jesus Christ of Latter-day Saints
Coalition for the Advancement of Medical Research
College of Reproductive Biology
Concerned Clergy for Choice
Concerned Women for America
Council for Responsible Genetics
Evangelical Lutheran Church of America
Family Planning Advocates of New York State
Family Research Council
Federation of American Societies for Experimental Biology
Focus on the Family
Genetics and Public Policy Center
Greek Orthodox Church of America
Ronald M. Green, Ph.D., Institute for the Study of Applied and
Professional Ethics, Dartmouth College
The Hastings Center
Institute for Women's Policy Research
International Center for Technology Assessment
Journal of Assisted Reproduction and Genetics
Lutheran Church - Missouri Synod
Lynne Millican, R.N., B.S.N.
Medical and Health Research Association of New York
City, Inc.
Michael J. Fox Foundation for Parkinson's Research
The National Academies
National Catholic Bioethics Center
National Science Foundation
National Women's Law Center
Northwest Women's Law Center
Planned Parenthood
Reproductive Health Technologies Project
RESOLVE: The National Infertility Association
Society for Assisted Reproductive Technology
Society for Reproductive Endocrinology and Infertility
Craig H. Syrop, M.D.
Union of Orthodox Jewish Congregations of America
Yates Family Planning Services
