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Reproduction and Responsibility:

The Regulation of New Biotechnologies


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

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.


Leon R. Kass, M.D.



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