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Reproduction and Responsibility:

The Regulation of New Biotechnologies


The President's Council on Bioethics
Washington, D.C.
March 2004



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

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