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Reproduction and Responsibility: The Regulation of New Biotechnologies

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

 

TABLE OF CONTENTS

Letter of Transmittal

The President's Council on Bioethics
1801 Pennsylvania Avenue, N.W., Suite 700
Washington, D.C. 20006
March 31, 2004

The President
The White House
Washington, D.C.

Dear Mr. President:

I am pleased to present to you Reproduction and Responsibility: The Regulation of New Biotechnologies, the latest report of the President's Council on Bioethics, and one that contains a set of unanimous policy recommendations. The product of two years of research, reflection, and deliberation, we hope that it will prove a worthy contribution to understanding and addressing important ethical and social issues arising at the intersection of assisted reproduction and genetic knowledge.

This report differs from, yet complements, the Council’s work in its previous publications. In Human Cloning and Human Dignity, we addressed the limited topic of human cloning—what to think and what to do about it—and offered specific legislative recommendations. In Monitoring Stem Cell Research, we answered your request for an update on developments concerning human stem cell research, both in basic and clinical research and in the ethical and policy debates, as these have emerged under the current federal policy. In Beyond Therapy: Biotechnology and the Pursuit of Happiness, we surveyed growing capacities that biotechnologies are providing to serve non-medical goals—such as the desires for “better children,” “superior performance,” “ageless bodies,” and “happy souls”—and sought to raise public awareness of the challenges such pursuits might pose to the meaning of our humanity. And in Being Human, we offered a rich anthology of readings to help the nation better appreciate and promote those aspects of our humanity affected by the coming age of biotechnology. Only in this report do we address the large social and political question: how can we monitor, oversee, and regulate these burgeoning new technologies, so as to reap their benefits while avoiding their harms, both overt and subtle? How can we exercise responsible control over where biotechnology may be taking us, in order to both serve and preserve our humanity?

In investigating the general subject of the regulation of biotechnology, we have taken as our specific focus the intersection of the technologies of assisted reproduction, human genomic knowledge and technique, and human embryo research. Advances in biotechnology are providing new capacities for altering and influencing the beginnings of human life, especially life initiated outside the body, in the clinic, or in the laboratory. The well-established procedures of in vitro fertilization are being rapidly augmented by abilities to test the genetic make-up of embryos, to screen them for genetic diseases, to select them for their sex or (in the future) for some other desired traits, and to alter them in many other ways. These new capacities increase the variety and complexity of the options facing infertile couples and others seeking assisted reproduction, and they raise the prospect of changes in human reproduction that may have great significance not only for the parents and children involved, but also for society as a whole.

The Council has sought to understand the public policy implications of these developments in human reproduction and, in particular, the ways in which the technologies in question are currently monitored and regulated. Surveying this domain in our report on human cloning, we noted that we lack comprehensive knowledge about what is being done, with what success, at what risk, under what ethical guidelines, respecting which moral boundaries, subject to what oversight and regulation, and with what sanctions for misconduct or abuse. If we are to have wise public policy regarding these scientifically and medically promising but morally challenging activities, we need careful study and sustained public moral discourse on this general subject, and not only on specific narrowly defined pieces of the field.

Since the release of that report, the Council has conducted a comprehensive inquiry into the current regulation of those biotechnologies that touch on human reproduction. This report is the fruit of that inquiry.

The Council finds that our regulatory institutions have not kept pace with our rapid technological advance. Indeed, there is today no public authority responsible for monitoring or overseeing how these technologies make their way from the experimental to the clinical stage, from novel approach to widespread practice. There is no authority, public or private, that monitors how or to what extent these new technologies are being or will be used, or that is responsible for attending to the ways they affect the health and well-being of the participants or the character of human reproduction more generally. Our existing regulatory institutions, such as the Food and Drug Administration or local institutional review boards, do not at the present time oversee this area, and the welcome ethical standards promulgated by the professional societies are somewhat limited in scope and not binding on individual member practitioners.

Yet the Council has refrained, at least for the time being, from proposing major new regulatory institutions. Gaps in our current information make doing so premature, and our deep differences over the moral status of human embryos make it problematic. Before either policymakers or the public can address the need for institutional change, we first need much more additional information. What are the true health effects of assisted reproductive technologies on children, mothers, and egg-donors? Are assisted-reproduction patients able to make fully informed choices in the current environment? Could federal intervention be rendered unnecessary by better professional self-regulation? What would be the benefits and the costs of each of the various alternatives either for expanding the responsibilities of our current regulatory institutions or for designing new ones, so as to provide oversight and guidance for responsible practices in reproductive medicine and research? The Council presents a series of recommendations—addressed both to government and to the relevant scientific and medical practitioners—for data gathering, reporting, and professional self-scrutiny. These recommendations are designed to help us get answers to those and other such questions.

But even as we seek answers to these questions and ponder the need for institutional reforms, we do think that the nation would benefit from a series of targeted interim legislative measures that would safeguard certain important ethical boundaries. Accordingly, we propose a series of modest yet precise legislative proposals targeting certain unethical or disquieting practices in human reproduction—for example, attempts to conceive children other than by the union of egg and sperm, to produce a hybrid animal-human embryo, to initiate a human pregnancy for any purpose other than to produce a live-born child, or to try to grow human embryos in the bodies of animals. (The full list of the targeted legislative measures—and of all the other recommendations—is provided in the Executive Summary.) Based on our deliberations to date, we believe these targeted measures will find support on all sides—pro-choice as well as pro-life, secular as well as religious, scientist as well as humanist, left as well as right. Like the nation at large, our members hold differing views about certain foundational questions, especially the moral standing of human embryos. Yet despite our great differences, we all support these proposals and urge their swift adoption.

The issues surrounding the beginnings of human life are notoriously controversial in our country, as they are on the Council. By design, this Council consists of Members with strongly held yet divergent views on these subjects. Yet precisely because of these differences, we have sought in this report—and especially in its recommendations—to find a common ground in certain aims and formulations that all sides could accept, without anyone having to compromise on a matter of principle or having to repudiate what they have said in previous reports. Rather than allow continuing disagreements to blind us to possible significant points of agreement, we have sought precisely to find those goods we all hold dear and to highlight them for the country, so that some progress might be made where it is possible, while public debate and attempts at persuasion continue on the issues that still divide us.

The Council stands behind these recommendations unanimously, even though different members come to them from different premises and with different aims and hopes—as they articulate in their personal statements in the appendix to this document. This discernment of practical common ground in the midst of meaningful disagreement and debate is an accomplishment of which the Council is very proud. We hope it might point the way for others to seek and find the responsible way forward in this vexing arena of public policy.

As with our past reports, so in this one we have sought to be—and we hope you will find us—fair in our approach, precise in our language, accurate in our presentation, and thoughtful in our recommendations. 

And as always, Mr. President, I send you this report with the good wishes of my Council colleagues and our fine staff. Once again, we thank you for the opportunity to serve.

Sincerely,

Leon R. Kass, M.D.

Chairman

 

 

Members of the Council

Leon R. Kass, M.D., Ph.D., Addie Clark Harding Professor, The College and the Committee on Social Thought, University of Chicago. Hertog Fellow, American Enterprise Institute.

Benjamin S. Carson, Sr., M.D.* Professor and Director of Pediatric Neurosurgery, Johns Hopkins Medical Institutions.

Rebecca S. Dresser, J.D., M.S. Daniel Noyes Kirby Professor of Law and Professor of Ethics in Medicine, Washington University, St. Louis.

Daniel W. Foster, M.D. John Denis McGarry, Ph.D. Distinguished Chair in Diabetes and Metabolic Reasearch, University of Texas Southwestern Medical School.

Francis Fukuyama, Ph.D. Dean of the Faculty, Bernard Schwartz Professor of International Political Economy, Paul H. Nitze School of Advanced International Studies, Johns Hopkins University.

Michael S. Gazzaniga, Ph.D. Dean of the Faculty, David T. McLaughlin Distinguished Professor, Professor of Psychological and Brain Sciences, Dartmouth College.

Robert P. George, J.D., D.Phil. McCormick Professor of Jurisprudence, Director of the James Madison Program in American Ideals and Institutions, Princeton University.

Mary Ann Glendon, J.D., M. Comp. L. Learned Hand Professor of Law, Harvard University.

Alfonso Gómez-Lobo, Dr. phil. Ryan Family Professor of Metaphysics and Moral Philosophy, Georgetown University.

William B. Hurlbut, M.D. Consulting Professor in Human Biology, Stanford University.

Charles Krauthammer, M.D. Syndicated Columnist.

Peter A. Lawler, Ph.D.* Chairman of the Department of Government and International Studies, Dana Professor of Government, Berry College.

Paul McHugh, M.D. University Distinguished Service Professor of Psychiatry, Johns Hopkins School of Medicine. Professor, Department of Mental Health, Bloomberg School of Public Health, Johns Hopkins University.

Gilbert C. Meilaender, Ph.D. Phyllis & Richard Duesenberg Professor of Christian Ethics, Valparaiso University.

Janet D. Rowley, M.D. Blum-Riese Distinguished Service Professor of Medicine, Molecular Genetics and Cell Biology, and Human Genetics, Pritzker School of Medicine, University of Chicago.

Michael J. Sandel, D.Phil. Anne T. and Robert M. Bass Professor of Government, Harvard University.

Diana J. Schaub, Ph.D.* Chairman of the Department of Political Science, Loyola College, Maryland.

James Q. Wilson, Ph.D.
James A. Collins Professor of Management and Public Policy Emeritus, University of California-Los Angeles. Reagan Professor of Public Policy, Pepperdine University.

 

Council Staff and Consultants

Dean Clancy
Executive Director

Yuval Levin
Deputy Executive Director

Eric Cohen
Senior Research Consultant

Judith Crawford
Administrative Director

Diane M. Gianelli
Director of Communications

Laura Harmon, Esq.
Senior Aide to the Chairman

Emily Jones
Executive Administrator

Michelle Powers
Law Clerk

Richard Roblin, Ph.D.
Scientific Director

Adam Schulman
Research Consultant

O. Carter Snead, Esq.
General Counsel

Catherine Thorp
Receptionist/Staff Assistant

Audrea R. Vann
Information Tech. Specialist

Rachel Flick Wildavsky
Director, Education Project

Lee L. Zwanziger, Ph.D.
Senior Research Analyst

 

Preface

Reproduction and Responsibility: The Regulation of New Biotechnologies is a report of the President's Council on Bioethics, which was created by President George W. Bush on November 28, 2001, by means of Executive Order 13237.

The Council's purpose is to advise the President on bioethical issues related to advances in biomedical science and technology. In connection with its advisory role, the mission of the Council includes the following functions:

  • To undertake fundamental inquiry into the human and moral significance of developments in biomedical and behavioral science and technology.
  • To explore specific ethical and policy questions related to these developments.
  • To provide a forum for a national discussion of bioethical issues.
  • To facilitate a greater understanding of bioethical issues.

In his executive order, the President specified several areas for possible attention by the Council, including “embryo and stem cell research, assisted reproduction, cloning, uses of knowledge and techniques derived from human genetics or the neurosciences, and end of life issues,” and added that the Council may “study broader ethical and social issues not tied to a specific technology, such as questions regarding the protection of human subjects in research, the appropriate uses of biomedical technologies, the moral implications of biomedical technologies, and the consequences of limiting scientific research.” The President left the Council free to establish its own priorities among the many issues encompassed within its charter, and to determine its own modes of proceeding.

The inquiry that led to the present report began at the first Council meeting in January of 2002, when, in his maiden comments to the Council, Professor Francis Fukuyama proposed that the group pursue a study of how new biotechnologies are currently regulated, in hopes of advising the President on new regulatory institutions and principles that might outlive the Council.

In a memo to the Council dated April 10, 2002, Professor Fukuyama argued that

broad legislative bans will not be an appropriate approach for dealing with a number of foreseeable future technologies. For this, a regulatory model (that is, where Congress delegates authority to a regulatory body under broad guidelines) will be necessary. But the current regulatory system in the United States for human biotechnology is inadequate to make some of the decisions that will have to be made.i

Detailing what he regarded as the gaps in the U.S. regulatory system, Fukuyama suggested that new institutions are necessary, but added that “a great deal may be achievable through self-regulation,” citing as an example the Recombinant DNA Advisory Committee (RAC), created as a tool for self-policing by scientists after the Asilomar Conference of 1975. And he named five specific areas for possible regulation: preimplantation genetic diagnosis (PGD); germ-line engineering; the creation of human-animal hybrids and chimeras; novel research techniques (as, for example, research cloning or creating female embryos in order to harvest eggs from their ovaries); and security against bioterrorism.

The Council’s interest in the general topic of the regulation of biotechnology soon became focused on the area of human reproduction, and in particular, on the intersection of assisted reproduction, genetic testing and selection, and embryo research. In its July 2002 report on human cloning, in addition to recommending a permanent nationwide ban on cloning-to-produce-children and a four-year moratorium on cloning-for-biomedical-research, a majority of the Council called for “a federal review of current and projected practices of human embryo research, preimplantation genetic diagnosis, genetic modification of human embryos and gametes, and related matters, with a view to recommending and shaping ethically sound policies for the entire field.” And it offered itself to “undertake the preliminary steps of such a process and to provide advice on further steps.”ii

In October 2002, staff produced a memo that set forth some tentative findings to date:

  1. The need for some system of regulation has been widely felt around the world.
  2. Most countries focus their debate and regulation on questions of assisted reproduction and genetics.
  3. The experience of other countries shows that diverse approaches are possible, each in line with the character and history of the particular society.
  4. Designing and establishing systems of regulation takes a great deal of time and effort.
  5. In the United States, existing institutions appear to be insufficient to handle the questions raised by the new biotechnologies.iii

After discussing the memo, the Council charged staff with the task of coming back in six months with a thorough description of the entire range of regulatory institutions and activities—governmental and professional—that monitor, oversee, and regulate the uses of biotechnologies touching the beginnings of human life, and perhaps also with some policy options for consideration. In addition, the Council continued to hear invited presentations on various aspects of the subject, including, among others, the activities of the Food and Drug Administration and institutional review boards (IRBs); the patenting of living organisms; professional self-regulation; the concerns of patients with infertility or with children suffering genetic diseases; and the regulatory activities of other countries, with special presentations regarding institutional arrangements in Canada, Germany, and Great Britain. And the Council also received and considered voluminous written submissions in response to its call for public comment, posted in the Federal Register.iv

At the June 2003 meeting, staff presented the requested diagnostic overview of all current oversight and regulatory activities, in the form of a 132-page discussion document. Further discussion documents were subsequently produced: a summary of the diagnostic findings and an overview of some possible policy options (July); draft recommendations covering data collection, monitoring, oversight, professional self-regulation, and targeted legislative measures (September); revised recommendations for the targeted legislative measures (October); and all recommendations, revised once more (January 2004). All told, twenty-six sessions, of ninety minutes each, were devoted to this topic at public meetings. Transcripts are available on-line at www.bioethics.gov. The present report draws directly upon those transcripts, as well as on writings of Council members, staff, and invited consultants; comments by interested members of the public and outside expertsv; and the written submissions responding to the Council’s call for public comment.

As noted in Chapter 1, this report does not go so far as Professor Fukuyama had originally recommended. It does not advocate new regulatory structures or institutions; neither does it recommend any major changes or increased responsibility for existing regulatory institutions. It does, however, set forth detailed findings about the regulatory status quo. It lays out possible policy options, for future examination and study. And it makes interim recommendations, to be followed as the investigation seeking improved regulatory institutions and activities proceeds. We view this report as a first step in a continuing national conversation.

We hope this document, with its detailed diagnostic survey of the regulatory status quo, will serve as a source of clear, intelligible, and useful information for both policymakers and the general public. We also hope that policymakers will take action soon to implement the interim recommendations, set forth in Chapter 10, even as that conversation continues.

In creating this Council, President Bush expressed his desire to see us

consider all of the medical and ethical ramifications of biomedical innovation. . . . This council will keep us apprised of new developments and give our nation a forum to continue to discuss and evaluate these important issues. As we go forward, I hope we will always be guided by both intellect and heart, by both our capabilities and our conscience.

It has been our goal in the present report, as in all of our work, to live up to these high hopes and noble aspirations.

 

Leon R. Kass, M.D.

Chairman

 

_________________

Footnotes

i. Fukuyama, F., “An Overview of Biotech Regulation,” Memo to the Members of the President’s Council on Bioethics, discussed at session 6 of the Council’s meeting on April 26, 2002. For more on this theme, see his book Our Posthuman Future: Consequences of the Biotechnology Revolution, New York: Farrar, Strauss and Giroux, 2002.

ii. The President’s Council on Bioethics, Human Cloning and Human Dignity: An Ethical Inquiry, Washington, D.C.: Government Printing Office, 2002, p. 205 (also pp. x and xxxvi).

iii. The President’s Council on Bioethics, “Regulating the New Biotechnologies: Observations and Procedural Options for the Council,” Staff Working Paper discussed at session 7 of the Council’s meeting on October 18, 2002 (available at www.bioethics.gov).

iv. The President’s Council on Bioethics, “Call for submissions,” Federal Register 68, no. 56 (March 24, 2003): 14239.

v. See the Acknowledgments for a list of individuals and organizations that aided the Council in preparing the report.

 

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

Executive Summary

 

Executive Summary

Advances in biotechnology in recent decades have made available an increasing capacity to intervene in the beginnings of human life, especially life initiated outside the body, whether in the clinic or in the laboratory. This capacity emerges from a confluence of work in reproductive biology, developmental biology, and human genetics, and raises ethical issues involving a number of important human goods. There is little question that the way these new technologies are used could have far-reaching consequences, not only for the individuals involved but also for society as a whole.

Yet it is not clear just how the interests of those individuals and of the public at large can best be served as these new technologies are developed and applied. What challenges and public policy concerns arise together with the use of new technologies affecting human reproduction? Whose responsibility is it to monitor, review, and offer guidance where guidance is needed, in order to safeguard the diverse human goods at stake? Should there be more or less oversight and regulation? Should there be any? Just how much is there now? Only partial answers are available to these questions, and much basic data remain to be gathered before they could be answered.

Since its very first meeting, in January of 2002, the President’s Council on Bioethics has taken an interest in these subjects, and the Council has sought a way to advance public understanding of the challenges that confront us in this arena—beginning with the most basic information regarding what is being done and with what results. In the Council’s report, Human Cloning and Human Dignity (2002), members observed that, with regard to assisted reproduction, genetic testing, and human embryo research,

we lack comprehensive knowledge about what is being done, with what success, at what risk, under what ethical guidelines, respecting which moral boundaries, subject to what oversight and regulation, and with what sanctions for misconduct or abuse. If we are to have wise public policy regarding these scientifically and medically promising but morally challenging activities, we need careful study and sustained public moral discourse on this general subject, and not only on specific narrowly defined pieces of the field.

Following the release of that report, the Council decided to undertake a thoroughgoing inquiry into the current regulation of those biotechnologies that touch on human reproduction. This report is the fruit of that inquiry. Its principal aim is to describe and critically assess the various oversight and regulatory measures that now govern the biotechnologies and practices at the intersection of assisted reproduction, human genetics, and human embryo research.

I. WHAT IS AT STAKE?

The Council saw a number of powerful reasons for taking up this subject. It involves some of the key concerns of bioethics and is likely to be an area of increasing importance, one in which both public understanding and public policy lag well behind the rapid advance of technological developments. Among the goods and ideals that are at stake, and that led the Council to point the public’s attention toward this subject, are the following:

  • The health and well-being of the human subjects directly affected by these technologies, not only the individuals or couples seeking their use, but also and especially the children who may be born with their aid.
  • Relief of the suffering and sorrow of those afflicted with infertility.
  • Compassion for children with serious genetic diseases, and relief of the sorrows and burdens that they and those who love and care for them must bear.
  • The intrinsic value of new knowledge of human development and genetic function in addition to the inestimable practical value of new treatments for diseases and disabilities.
  • Privacy of genetic information and reproductive practice.
  • The foundational value of human life and the respect owed to it in its various stages.
  • Several expressions and avenues of human freedom, including the freedom of parents to make their own reproductive decisions or to use or refuse genetic screening, and the freedom of scientists to conduct research. As important, as well, is the necessity to protect the freedom of children from improper attempts to manipulate their lives through control of their genetic make-up or from unreasonable expectations that could accompany such manipulations.
  • The promotion of justice and equality, including equitable access to the use and benefits of new technologies, equal respect and opportunity in a world that places great emphasis on genetic distinctions, and the prevention of discrimination against or contempt for genetic “defectiveness” or “inferiority.”
  • The protection of human dignity, including the dignity of the human body and its parts, the dignity of important human relationships (parent and child, one generation and the next), and the humanity of human procreation.

The Council’s review of the field has been guided and motivated by these concerns.

II. A DIAGNOSTIC OVERVIEW

This report is fundamentally a diagnostic document, and even most of the recommendations with which it concludes aim largely at improving the nation’s capacity for future diagnosis of the state of this field.  The diagnosis begins by examining policies and practices related to assisted reproduction. This is our starting point because assisted reproduction is, in practice, the necessary gateway to all the newer technologies—present and projected—that affect human reproduction. Preimplantation genetic diagnosis (including sex selection), germ-line genetic modification, human embryo research, and similar techniques all presuppose in vitro fertilization and the existence of developing human life in vitro. As a consequence, any oversight or regulation of the use of genetic technologies in human reproduction will necessarily depend on the systems that oversee and regulate assisted reproduction itself. Also, the addition of genetic technologies to existing techniques of assisted reproduction has made it clear—if it had not been clear before—that we are dealing here with a most unusual branch of medicine. In no other area of medicine does the treatment of an ailment—in this case, infertility—call for the creation of another human being. Our deep concern for the safety and well-being of children suggests to us the need for special attention to the uses and outcomes of these new biotechnologies.

The report then proceeds to review the regulatory policies and practices involved in screening and selecting for genetic conditions and traits; modification of traits and characteristics; research involving in vitro human embryos; and commercial and financial interests in this arena.

In discussing each area we review the relevant techniques and practices, the principal ethical issues, and (especially) the existing regulatory activities. This extended diagnostic discussion explores in detail precisely who currently provides oversight and guidance in each area, pursuant to what authority, according to what principles and values, and with what ultimate practical effect.

III. THE COUNCIL’S FINDINGS

The Council’s diagnostic review of these areas has led us to several general conclusions:

  • The fields of assisted reproduction, human genetics, and embryo research are increasingly converging with one another.
  • There is no uniform, comprehensive, and enforceable system of data collection, monitoring, or oversight for the biotechnologies affecting human reproduction.
  • There is minimal direct governmental regulation of the practice of assisted reproduction.
  • There is extensive professional self-regulation of the practice of assisted reproduction, but compliance with the standards invoked is purely voluntary.
  • There is no comprehensive, uniform, and enforceable mechanism for data collection, monitoring, or oversight of how the new reproductive biotechnologies affect the well-being of the children conceived with their aid, the egg donors, or the gestational mothers.
  • There are no nationally uniform laws or policies relating to access to assisted reproduction.
  • Given the present framework of regulation, novel technologies and practices that are successful move from the experimental context to clinical practice with relatively little oversight or deliberation. Once in practice, these techniques are used at clinicians’ discretion, with little or no external oversight. Use of effective technologies becomes widespread rapidly.
  • As in other areas of medicine, there is no uniform system for public review and deliberation regarding the larger human or social significance of new reproductive biotechnologies.
  • Preimplantation genetic diagnosis is an unregulated practice.
  • Gene transfer research, by contrast, is regulated robustly.
  • There is no comprehensive, uniform, and enforceable mechanism for data collection, monitoring, or oversight regarding the use and disposition of in vitro human embryos in the context of clinical practice or research.
  • There is no comprehensive mechanism for regulation of commerce in gametes, embryos, and assisted reproductive technology services.
  • Patenting of embryonic or fetal human organisms is prohibited for the fiscal year 2004.

The Council does not take these findings in and of themselves to mean that any public policy response is called for, but any consideration of potential public policies in this area must take these basic facts into account.

IV. POLICY OPTIONS AND RECOMMENDATIONS

The Council’s findings, combined with the concerns that animate our interest in this area, point toward a fairly wide array of possible regulatory approaches. In this report, the Council considers these options in some detail, laying out a range of potential institutional options—from doing nothing to developing entirely new regulatory institutions—and offering a number of possible aims and principles that might guide future regulators.

However, given the preliminary character of this report, and the fact that our review of the field has turned up a number of areas where crucial data are simply lacking, the Council was not prepared to recommend any sweeping institutional reform or innovation. Rather, members agreed upon a series of modest measures to alleviate some clear and significant present problems, including especially the lack of information on certain key practices and their consequences.

The report concludes, therefore, with a set of recommendations that the Council agrees should be adopted immediately. These recommendations are not for structural or institutional changes; we do not propose the wholesale creation of new regulatory institutions or even the reform of existing ones.  Rather, we offer these recommendations as interim measures with two goals in mind: first, to strengthen existing legislation and regulatory mechanisms in order to gather more complete and useful information; and, second, to erect certain legislative safeguards against a small number of boundary-crossing practices, at least until there can be further deliberation and debate about both the human goods at stake and the best way to protect them.

The recommendations fall into three general categories: studies and data collection, oversight and self-regulation by professional societies, and targeted legislative measures. In each case, the Council has detailed its precise recommendations in the report and has offered extensive supporting arguments and reasons. The recommendations are as follows.

A. Federal Studies, Data Collection, Reporting, and Monitoring Regarding the Uses and Effects of These Technologies

As the Council’s findings demonstrate, the incompleteness of basic information on the uses and impact of new reproductive technologies makes any conclusive policy judgments very difficult to formulate. The Council therefore recommends that the federal government take a number of specific steps to improve our knowledge and understanding:

  • Undertake a federally funded longitudinal study of the impact of assisted reproductive technologies on the health and development of children born with their aid.
  • Undertake federally funded studies on the impact of assisted reproductive technologies on the health and well-being of women.
  • Undertake federally funded comprehensive studies on the uses of reproductive genetic technologies, and on their effects on children born with their aid.
  • Strengthen and augment the Fertility Clinic Success Rate and Certification Act to better protect consumers and patients:
    • Provide more user-friendly reporting of data.
    • Require the publication of all reported adverse health effects.
    • Require the reporting of the average prices of the procedures and the average cost (to patients) of a successful assisted pregnancy.
    • Include information on novel and experimental procedures.
    • Require more specific reporting and publication of the frequency of, and reasons for, uses of specialized techniques such as ICSI, preimplantation genetic diagnosis, and sperm sorting for sex-selection.
    • Provide model forms for decision-making.
    • Provide stronger penalties to enhance compliance with the Act’s reporting requirements.
    • Increase funding for implementation of the Act.

B. Increased Oversight by Professional Societies and Practitioners

Most oversight in this area currently takes the form of self-regulation by professional societies, and as far as the Council can determine the vast majority of practitioners abide by these guidelines and standards and are dedicated to the welfare of their patients. Yet the Council has identified a few ways in which self-regulation could be meaningfully improved:

  • Strengthen informed patient decision-making.
  • Treat the child born with the aid of assisted reproductive procedures as a patient.
  • Improve enforcement of existing guidelines.
  • Improve procedures for movement of experimental procedures into clinical practice.
  • Create and enforce minimum uniform standards for the protection of human subjects affected by assisted reproduction.
  • Develop additional self-imposed ethical boundaries.

C. Targeted Legislative Measures

In the course of its review, discussion, and findings, the Council encountered and highlighted several particular practices and techniques (some already in use, others likely to be tried in the foreseeable future) touching human reproduction that raise new and distinctive challenges. Given the importance of the matter, we believe these require special attention, and we therefore recommend that Congress should consider some limited targeted measures that might institute a moratorium on certain particularly questionable practices. The report includes an extensive discussion of the reasons for these recommendations as well as the aims we hope they might serve. The Council recommends that the Congress should, at least for a limited time:

  • Prohibit the transfer, for any purpose, of any human embryo into the body of any member of a non-human species.
  • Prohibit the production of a hybrid human-animal embryo by fertilization of human egg by animal sperm or of animal egg by human sperm.i
  • Prohibit the transfer of a human embryo (produced ex vivo) to a woman’s uterus for any purpose other than to attempt to produce a live-born child.
  • Prohibit attempts to conceive a child by any means other than the union of egg and sperm.ii
  • Prohibit attempts to conceive a child by using gametes obtained from a human fetus or derived from human embryonic stem cells.ii
  • Prohibit attempts to conceive a child by fusing blastomeres from two or more embryos.ii
  • Prohibit the use of human embryos in research beyond a designated stage in their development (between 10 and 14 days after fertilization).iii
  • Prohibit the buying and selling of human embryos.iv
  • Prohibit the issuing of patents on claims directed to or encompassing human embryos or fetuses at any stage of development; and amend Title 35, United States Code, section 271(g) (which extends patent protections to products resulting from a patented process) to exclude these items from patentability.v

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Footnotes

i. It bears noting that, in testing for male-factor infertility, practitioners of assisted reproduction now use hamster eggs to test the capacity of human sperm to penetrate an egg; yet there is no intent to produce a human-animal hybrid embryo, and there is negligible likelihood that one might be formed, given the wide genetic gap between the species. Thus, we do not believe that such procedures run afoul of the letter or spirit of the above recommendations.

ii. Operationally, in each of the three cases listed, the prohibited act comprises the creation ex vivo of any such human embryo with the intent to transfer it to a woman’s body to initiate a pregnancy.

iii. Some members of the Council are opposed to any experimentation that harms or destroys human embryos, but, recognizing that it is legal and active, they see the value in limiting the practice. Other members of the Council favor allowing such experimentation during the early stages of embryonic development, but nonetheless recognize the need to establish an upper age limit beyond which such research should not proceed. Some Council members believe that this upper limit should be 14 days after the first cell division; others favor 10 (or less).

iv. This provision is not intended to preclude patients who receive donated embryos from reimbursing donors for reasonable expenses, storage costs, and the like. Also, because the compensated giving of sperm is a long-established practice, and because payment to egg donors is now also fairly common, efforts to ban payment to gamete providers would likely prove controversial and untenable for purposes of actual legislation. Thus, we decline to recommend such a ban here. That is not to say, however, that the Council approves of the buying and selling of gametes. Indeed, many Council members have raised serious concerns regarding this species of commercialization in the domain of human reproduction.

v. The language of any such statute would in our view need to take some care not to exclude from patentability the processes that result in these items, but only the products themselves. Similar language has been included in a component of the federal budget for fiscal year 2004 (the Consolidated Appropriations Act of 2004, H.R. 2673, 108th Congress [January 23, 2004], Division B, §634), but we believe this provision should also be made a clear and permanent element of the patent law.

To Chapter 1

 


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