Letter of Transmittal
The President's Council on Bioethics
1801 Pennsylvania Avenue, N.W., Suite 700
Washington, D.C. 20006
March 31, 2004
The White House
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
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.
Leon R. Kass, M.D.
Members of the Council
Leon R. Kass,
Addie Clark Harding Professor, The College and the
Committee on Social Thought, University of Chicago.
Hertog Fellow, American Enterprise Institute.
Carson, Sr., M.D.* Professor and Director
of Pediatric Neurosurgery, Johns Hopkins Medical
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.
Ph.D. Dean of the Faculty, Bernard Schwartz
Professor of International Political Economy, Paul
H. Nitze School of Advanced International Studies,
Johns Hopkins University.
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.
Gómez-Lobo, Dr. phil. Ryan Family
Professor of Metaphysics and Moral Philosophy, Georgetown
Hurlbut, M.D. Consulting Professor in Human
Biology, Stanford University.
Krauthammer, M.D. Syndicated Columnist.
Peter A. Lawler,
Ph.D.* Chairman of the Department of Government
and International Studies, Dana Professor of Government,
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.
C. Meilaender, Ph.D. Phyllis & Richard
Duesenberg Professor of Christian Ethics, Valparaiso
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.
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,
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
Deputy Executive Director
Senior Research Consultant
Diane M. Gianelli
Director of Communications
Laura Harmon, Esq.
Senior Aide to the Chairman
Richard Roblin, Ph.D.
O. Carter Snead, Esq.
Audrea R. Vann
Information Tech. Specialist
Rachel Flick Wildavsky
Director, Education Project
Lee L. Zwanziger, Ph.D.
Senior Research Analyst
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
- 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
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
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:
- The need for some system of regulation
has been widely felt around the world.
- Most countries focus their debate and regulation
on questions of assisted reproduction and genetics.
- The experience of other countries shows
that diverse approaches are possible, each in
line with the character and history of the particular
- Designing and establishing systems of regulation
takes a great deal of time and effort.
- 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
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.
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.
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).
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).
The President’s Council on Bioethics, “Call for
submissions,” Federal Register 68, no.
56 (March 24, 2003): 14239.
See the Acknowledgments for a list of individuals
and organizations that aided the Council in preparing
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
Lee Rubin Collins, J.D.
National Board of Directors, RESOLVE: The National
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
Director of Government Affairs, RESOLVE: The National
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)
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
James S. Benson
Former Acting Commissioner, Food and Drug Administration
Robert Bryzski, M.D., Ph.D.
President (2003), Society for Assisted Reproductive
Francis S. Collins, M.D., Ph.D.
Director, National Human Genome Research Institute
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,
Kathy Hudson, Ph.D.
Director, Genetics and Public Policy Center, Johns
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
Lori Knowles, L.L.B., B.C.L., L.L.M.
Former Associate for Law and Policy, Director, Education
and Outreach, The Hastings Center
Chairman, The Bioethics Project
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
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
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
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
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
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
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
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
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
- 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
- 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
- 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”
- 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
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
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
- 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
- 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
- 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
- Gene transfer research, by contrast, is regulated
- 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.
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
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
- 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
- Strengthen and augment the Fertility Clinic
Success Rate and Certification Act to better protect
consumers and patients:
- Provide more user-friendly reporting of
- 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
- 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
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
- 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
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
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.
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
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).
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.
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.