Reproduction and Responsibility:
The Regulation of New Biotechnologies
The President's Council on Bioethics
Washington, D.C.
March 2004
www.bioethics.gov
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
