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Table of Contents: Letter of Transmittal to the President     Members of the President's Council on Bioethics     Council Staff and Consultants Preface Executive Summary Chapter One: The Meaning of Human Cloning: An Overview Chapter Two: Historical Aspects of Cloning Chapter Three: On Terminology Chapter Four: Scientific Background Chapter Five: The Ethics of Cloning-to-Produce-Children Chapter Six: The Ethics of Cloning-for-Biomedical-Research Chapter Seven: Public Policy Options Chapter Eight: Policy Recommendations Bibliography Glossary of Terms Appendix: Personal Statements

Letter of Transmittal

The President
The White House
Washington, D.C.

Dear Mr. President:

I am pleased to present to you the first report of the President's Council on Bioethics, Human Cloning and Human Dignity: An Ethical Inquiry. The product of six months of discussion, research, reflection, and deliberation, we hope that it will prove a worthy contribution to public understanding of this momentous question.

Man's biotechnological powers are expanding in scope, at what seems an accelerating pace. Many of these powers are double-edged, offering help for human suffering, yet threatening harm to human dignity. Human cloning, we are confident, is but a foretaste – the herald of many dazzling genetic and reproductive technologies that will raise profound moral questions well into the future. It is crucial that we try to understand its full human significance.

We have tried to conduct our inquiry into human cloning unblinkered, with our eyes open not only to the benefits of the new biotechnologies but also to their challenges – moral, social, and political. We have not suppressed differences but sought rather to illuminate them, that all might better appreciate what is at stake. We have eschewed a thin utilitarian calculus of costs and benefits, or a narrow analysis based only on individual "rights." Rather, we have tried to ground our reflections on the broader plane of human procreation and human healing, with their deeper meanings. Seen in this way, we find that the power to clone human beings is not just another in a series of powerful tools for overcoming unwanted infertility or treating disease. Rather, cloning represents a turning point in human history – the crossing of an important line separating sexual from asexual procreation and the first step toward genetic control over the next generation. It thus carries with it a number of troubling consequences for children, family, and society.

Although the Council is not unanimous, either in some of its ethical conclusions or its policy recommendations, we are unanimous in submitting the entire report as a fair and accurate reflection both of our views and of the state of the question. To summarize our findings briefly:

First. The Council holds unanimously that cloning-to-produce-children is unethical, ought not to be attempted, and should be indefinitely banned by federal law, regardless of who performs the act or whether federal funds are involved.

Second. On the related question of the ethics of cloning-for-biomedical research, the Council is of several minds and is divided in its policy preferences:

• Seven Members (a minority), eager to see the research proceed, recommend permitting cloning-for-biomedical-research to go forward, but only under strict federal regulation.

• Ten Members (a majority), convinced that no human cloning should be permitted at least for the time being, recommend instituting, by law, a four-year ban on cloning-for-biomedical-research, applicable to all researchers regardless of whether federal funds are involved.

Third. The same ten-Member majority recommends a federal review of current and projected practices of human embryo research, pre-implantation 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. A thorough federal review, during the moratorium, could help to clarify the issues and foster a public consensus about how to proceed, not just on cloning-for-biomedical-research but on all the related reproductive and genetic technologies. We think this Council is well situated to initiate such a review, and we have already begun it. But we also stand ready to assist any other body that may be established to take up this large and complex subject.

The extensive reasoning underlying these recommendations is given at length in the report and is well summarized in the Executive Summary, and so I shall not rehearse it here.

On behalf of my Council colleagues, and our fine staff, allow me to thank you, Mr. President, for the opportunity you have given us to serve the nation on this weighty subject.

Members of the President's Council on Bioethics

Council Staff and Consultants

Preface

Human Cloning and Human Dignity: An Ethical Inquiry is the first publication 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.
  
  
• To explore possibilities for useful international collaboration on bioethical issues.

President Bush left the Council free to establish its own priorities among the many issues encompassed within its charter, based on the urgency and gravity of those issues and the public need for practical guidance about them.

The Council had little difficulty in choosing its first topic of inquiry. The ethics of human cloning has been the subject of intense discussion in the United States and throughout the world for more than five years, and it remains the subject of heated debate in Congress. On the surface, discussion has focused on the safety of cloning techniques, the hoped-for medical benefits of cloning research, and the morality of experimenting on human embryos. But driving the conversations are deeper concerns about where biotechnology may be taking us and what it might mean for human freedom, equality, and dignity.

Human cloning, were it to succeed, would enable parents for the first time to determine the entire genetic makeup of their children. Bypassing sexual reproduction, it would move procreation increasingly under artful human control and in the direction of manufacture. Seen as a forerunner of possible future genetic engineering, it raises for many people concerns also about eugenics, the project to "improve" the human race. A world that practiced human cloning, we sense, could be a very different world, perhaps radically different, from the one we know. It is crucial that we try to understand, before it happens, whether, how, and why this may be so.

Investigating human cloning also provides the Council an important opportunity to illustrate how bioethics can and should deal with those technological innovations that touch deeply our humanity. Here, as elsewhere, the most profound issues go beyond the commonplace and utilitarian concerns of feasibility, safety, and efficacy. In addition, on the policy side, cloning offers us a test case for considering whether public control of biotechnology is possible and desirable, and if so, by what means and at what cost.

The Council commenced deliberations on the topic of human cloning at its first meeting in January 2002, and continued the discussion at its February, April, and June meetings, all held in Washington, D.C. We heard presentations on the recent cloning report of the National Academy of Sciences; on human stem cell research, embryonic and adult; on the ethics of embryo research; and on international systems of regulation of embryo research and assisted reproductive technologies. We received a great deal of public comment, oral and written. All told, we held twelve ninety-minute conversations on the subject.

Recognizing "the complex and often competing moral positions" on biomedical issues, President Bush specified in creating the Council that it need not be constrained by "an overriding concern to find consensus." In this report we have chosen not to be so constrained. We have not suppressed disagreements in search of a single, watered-down position. Instead, we have presented clear arguments for the relevant moral and policy positions on multiple sides of these difficult questions, representing each as fairly and fully as we can. As a result, the reader will notice that, on some of the matters discussed in the report, Members of the Council are not all of one mind. Members are united, though, in endorsing the worthiness of the approach taken and the importance of the separate arguments made. Accordingly, the Council is unanimous in owning the entire report and in recommending all its discussions and arguments for serious consideration.

Readers interested in delving further into this subject may wish to consult the Bibliography, which includes all of the documents referred to within the report, as well as the verbatim transcripts of our meetings, which are posted at our website (www.bioethics.gov).

It was in his remarks to the nation on federal funding of embryonic stem cell research, on August 9, 2001, that President Bush first declared his intention to create this Council. At the end of that speech, the President said:

I will also name a President's council to monitor stem cell research, to recommend appropriate guidelines and regulations, and to 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 these pages – and shall remain our goal in the future – to live up to the President's high hopes and noble aspirations.

Executive Summary

For the past five years, the prospect of human cloning has been the subject of considerable public attention and sharp moral debate, both in the United States and around the world. Since the announcement in February 1997 of the first successful cloning of a mammal (Dolly the sheep), several other species of mammals have been cloned. Although a cloned human child has yet to be born, and although the animal experiments have had low rates of success, the production of functioning mammalian cloned offspring suggests that the eventual cloning of humans must be considered a serious possibility.

In November 2001, American researchers claimed to have produced the first cloned human embryos, though they reportedly reached only a six-cell stage before they stopped dividing and died. In addition, several fertility specialists, both here and abroad, have announced their intention to clone human beings. The United States Congress has twice taken up the matter, in 1998 and again in 2001-2002, with the House of Representatives in July 2001 passing a strict ban on all human cloning, including the production of cloned human embryos. As of this writing, several cloning-related bills are under consideration in the Senate. Many other nations have banned human cloning, and the United Nations is considering an international convention on the subject. Finally, two major national reports have been issued on human reproductive cloning, one by the National Bioethics Advisory Commission (NBAC) in 1997, the other by the National Academy of Sciences (NAS) in January 2002. Both the NBAC and the NAS reports called for further consideration of the ethical and social questions raised by cloning.

The debate over human cloning became further complicated in 1998 when researchers were able, for the first time, to isolate human embryonic stem cells. Many scientists believe that these versatile cells, capable of becoming any type of cell in the body, hold great promise for understanding and treating many chronic diseases and conditions. Some scientists also believe that stem cells derived from cloned human embryos, produced explicitly for such research, might prove uniquely useful for studying many genetic diseases and devising novel therapies. Public reaction to the prospect of cloning-for-biomedical-research has been mixed: some Americans support it for its medical promise; others oppose it because it requires the exploitation and destruction of nascent human life, which would be created solely for research purposes.

The intense attention given to human cloning in both its potential uses, for reproduction as well as for research, strongly suggests that people do not regard it as just another new technology. Instead, we see it as something quite different, something that touches fundamental aspects of our humanity. The notion of cloning raises issues about identity and individuality, the meaning of having children, the difference between procreation and manufacture, and the relationship between the generations. It also raises new questions about the manipulation of some human beings for the benefit of others, the freedom and value of biomedical inquiry, our obligation to heal the sick (and its limits), and the respect and protection owed to nascent human life.

Finally, the legislative debates over human cloning raise large questions about the relationship between science and society, especially about whether society can or should exercise ethical and prudential control over biomedical technology and the conduct of biomedical research. Rarely has such a seemingly small innovation raised such big questions.

The Inquiry: Our Point of Departure

As Members of the President's Council on Bioethics, we have taken up the larger ethical and social inquiry called for in the NBAC and NAS reports, with the aim of advancing public understanding and informing public policy on the matter. We have attempted to consider human cloning (both for producing children and for biomedical research) within its larger human, technological, and ethical contexts, rather than to view it as an isolated technical development. We focus first on the broad human goods that it may serve as well as threaten, rather than on the immediate impact of the technique itself. By our broad approach, our starting on the plane of human goods, and our open spirit of inquiry, we hope to contribute to a richer and deeper understanding of what human cloning means, how we should think about it, and what we should do about it.

On some matters discussed in this report, Members of the Council are not of one mind. Rather than bury these differences in search of a spurious consensus, we have sought to present all views fully and fairly, while recording our agreements as well as our genuine diversity of perspectives, including our differences on the final recommendations to be made. By this means, we hope to help policymakers and the general public appreciate more thoroughly the difficulty of the issues and the competing goods that are at stake.

There is today much confusion about the terms used to discuss human cloning, regarding both the activity involved and the entities that result. The Council stresses the importance of striving not only for accuracy but also for fairness, especially because the choice of terms can decisively affect the way questions are posed, and hence how answers are given. We have sought terminology that most accurately conveys the descriptive reality of the matter, in order that the moral arguments can then proceed on the merits. We have resisted the temptation to solve the moral questions by artful redefinition or by denying to some morally crucial element a name that makes clear that there is a moral question to be faced.

On the basis of (1) a careful analysis of the act of cloning, and its relation to the means by which it is accomplished and the purposes it may serve, and (2) an extensive critical examination of alternative terminologies, the Council has adopted the following definitions for the most important terms in the matter of human cloning:

• Cloning: A form of reproduction in which offspring result not from the chance union of egg and sperm (sexual reproduction) but from the deliberate replication of the genetic makeup of another single individual (asexual reproduction).
  
  
• Human cloning: The asexual production of a new human organism that is, at all stages of development, genetically virtually identical to a currently existing or previously existing human being. It would be accomplished by introducing the nuclear material of a human somatic cell (donor) into an oocyte (egg) whose own nucleus has been removed or inactivated, yielding a product that has a human genetic constitution virtually identical to the donor of the somatic cell. (This procedure is known as "somatic cell nuclear transfer," or SCNT). We have declined to use the terms "reproductive cloning" and "therapeutic cloning." We have chosen instead to use the following designations:
  
  
• Cloning-to-produce-children: Production of a cloned human embryo, formed for the (proximate) purpose of initiating a pregnancy, with the (ultimate) goal of producing a child who will be genetically virtually identical to a currently existing or previously existing individual.
  
  
• Cloning-for-biomedical-research: Production of a cloned human embryo, formed for the (proximate) purpose of using it in research or for extracting its stem cells, with the (ultimate) goals of gaining scientific knowledge of normal and abnormal development and of developing cures for human diseases.
  
  
• Cloned human embryo: (a) A human embryo resulting from the nuclear transfer process (as contrasted with a human embryo arising from the union of egg and sperm). (b) The immediate (and developing) product of the initial act of cloning, accomplished by successful SCNT, whether used subsequently in attempts to produce children or in biomedical research.

Cloning research and stem cell research are being actively investigated and the state of the science is changing rapidly; significant new developments could change some of the interpretations in our report. At present, however, a few general points may be highlighted.

• The technique of cloning. The following steps have been used to produce live offspring in the mammalian species that have been successfully cloned. Obtain an egg cell from a female of a mammalian species. Remove its nuclear DNA, to produce an enucleated egg. Insert the nucleus of a donor adult cell into the enucleated egg, to produce a reconstructed egg. Activate the reconstructed egg with chemicals or electric current, to stimulate it to commence cell division. Sustain development of the cloned embryo to a suitable stage in vitro, and then transfer it to the uterus of a female host that has been suitably prepared to receive it. Bring to live birth a cloned animal that is genetically virtually identical (except for the mitochondrial DNA) to the animal that donated the adult cell nucleus.
  
  
• Animal cloning: low success rates, high morbidity. At least seven species of mammals (none of them primates) have been successfully cloned to produce live births. Yet the production of live cloned offspring is rare and the failure rate is high: more than 90 percent of attempts to initiate a clonal pregnancy do not result in successful live birth. Moreover, the live-born cloned animals suffer high rates of deformity and disability, both at birth and later on. Some biologists attribute these failures to errors or incompleteness of epigenetic reprogramming of the somatic cell nucleus.
  
  
• Attempts at human cloning. At this writing, it is uncertain whether anyone has attempted cloning-to-produce-children (although at least one physician is now claiming to have initiated several active clonal pregnancies, and others are reportedly working on it). We do not know whether a transferred cloned human embryo can progress all the way to live birth.
  
  
• Stem cell research. Human embryonic stem cells have been isolated from embryos (produced by IVF) at the blastocyst stage or from the germinal tissue of fetuses. Human adult stem (or multipotent) cells have been isolated from a variety of tissues. Such cell populations can be differentiated in vitro into a number of different cell types, and are currently being studied intensely for their possible uses in regenerative medicine. Most scientists working in the field believe that stem cells (both embryonic and adult) hold great promise as routes toward cures and treatments for many human diseases and disabilities. All stem cell research is at a very early stage, and it is too soon to tell which approaches will prove most useful, and for which diseases.
  
  
• The transplant rejection problem. To be effective as long-term treatments, cell transplantation therapies will have to overcome the immune rejection problem. Cells and tissues derived from adult stem cells and returned to the patient from whom they were taken would not be subject (at least in principle) to immune rejection.
  
  
• Stem cells from cloned embryos. Human embryonic stem cell preparations could potentially be produced by using somatic cell nuclear transfer to produce a cloned human embryo, and then taking it apart at the blastocyst stage and isolating stem cells. These stem cells would be genetically virtually identical to cells from the nucleus donor, and thus could potentially be of great value in biomedical research. Very little work of this sort has been done to date in animals, and there are as yet no published reports of cloned human embryos grown to the blastocyst stage. Although the promise of such research is at this time unknown, most researchers believe it will yield very useful and important knowledge, pointing toward new therapies and offering one of several possible routes to circumvent the immune rejection problem. Although some experimental results in animals are indeed encouraging, they also demonstrate some tendency even of cloned stem cells to stimulate an immune response.
  
  
• The fate of embryos used in research. All extractions of stem cells from human embryos, cloned or not, involve the destruction of these embryos.

Two separate national-level reports on human cloning (NBAC, 1997; NAS, 2002) concluded that attempts to clone a human being would be unethical at this time due to safety concerns and the likelihood of harm to those involved. The Council concurs in this conclusion. But we have extended the work of these distinguished bodies by undertaking a broad ethical examination of the merits of, and difficulties with, cloning-to-produce-children.

Cloning-to-produce-children might serve several purposes. It might allow infertile couples or others to have genetically-related children; permit couples at risk of conceiving a child with a genetic disease to avoid having an afflicted child; allow the bearing of a child who could become an ideal transplant donor for a particular patient in need; enable a parent to keep a living connection with a dead or dying child or spouse; or enable individuals or society to try to "replicate" individuals of great talent or beauty. These purposes have been defended by appeals to the goods of freedom, existence (as opposed to nonexistence), and well-being – all vitally important ideals.

A major weakness in these arguments supporting cloning-to-produce-children is that they overemphasize the freedom, desires, and control of parents, and pay insufficient attention to the well-being of the cloned child-to-be. The Council holds that, once the child-to-be is carefully considered, these arguments are not sufficient to overcome the powerful case against engaging in cloning-to-produce-children.

First, cloning-to-produce-children would violate the principles of the ethics of human research. Given the high rates of morbidity and mortality in the cloning of other mammals, we believe that cloning-to-produce-children would be extremely unsafe, and that attempts to produce a cloned child would be highly unethical. Indeed, our moral analysis of this matter leads us to conclude that this is not, as is sometimes implied, a merely temporary objection, easily removed by the improvement of technique. We offer reasons for believing that the safety risks might be enduring, and offer arguments in support of a strong conclusion: that conducting experiments in an effort to make cloning-to-produce-children less dangerous would itself be an unacceptable violation of the norms of research ethics. There seems to be no ethical way to try to discover whether cloning-to-produce-children can become safe, now or in the future.

If carefully considered, the concerns about safety also begin to reveal the ethical principles that should guide a broader assessment of cloning-to-produce-children: the principles of freedom, equality, and human dignity. To appreciate the broader human significance of cloning-to-produce-children, one needs first to reflect on the meaning of having children; the meaning of asexual, as opposed to sexual, reproduction; the importance of origins and genetic endowment for identity and sense of self; the meaning of exercising greater human control over the processes and "products" of human reproduction; and the difference between begetting and making. Reflecting on these topics, the Council has identified five categories of concern regarding cloning-to-produce-children. (Different Council Members give varying moral weight to these different concerns.)

• Problems of identity and individuality. Cloned children may experience serious problems of identity both because each will be genetically virtually identical to a human being who has already lived and because the expectations for their lives may be shadowed by constant comparisons to the life of the "original."
  
  
• Concerns regarding manufacture. Cloned children would be the first human beings whose entire genetic makeup is selected in advance. They might come to be considered more like products of a designed manufacturing process than "gifts" whom their parents are prepared to accept as they are. Such an attitude toward children could also contribute to increased commercialization and industrialization of human procreation.
  
  
• The prospect of a new eugenics. Cloning, if successful, might serve the ends of privately pursued eugenic enhancement, either by avoiding the genetic defects that may arise when human reproduction is left to chance, or by preserving and perpetuating outstanding genetic traits, including the possibility, someday in the future, of using cloning to perpetuate genetically engineered enhancements.
  
  
• Troubled family relations. By confounding and transgressing the natural boundaries between generations, cloning could strain the social ties between them. Fathers could become "twin brothers" to their "sons"; mothers could give birth to their genetic twins; and grandparents would also be the "genetic parents" of their grandchildren. Genetic relation to only one parent might produce special difficulties for family life.
  
  
• Effects on society. Cloning-to-produce-children would affect not only the direct participants but also the entire society that allows or supports this activity. Even if practiced on a small scale, it could affect the way society looks at children and set a precedent for future nontherapeutic interventions into the human genetic endowment or novel forms of control by one generation over the next. In the absence of wisdom regarding these matters, prudence dictates caution and restraint.

Ethical assessment of cloning-for-biomedical-research is far more vexing. On the one hand, such research could lead to important knowledge about human embryological development and gene action, both normal and abnormal, ultimately resulting in treatments and cures for many dreaded illnesses and disabilities. On the other hand, the research is morally controversial because it involves the deliberate production, use, and ultimate destruction of cloned human embryos, and because the cloned embryos produced for research are no different from those that could be implanted in attempts to produce cloned children. The difficulty is compounded by what are, for now, unanswerable questions as to whether the research will in fact yield the benefits hoped for, and whether other promising and morally nonproblematic approaches might yield comparable benefits. The Council, reflecting the differences of opinion in American society, is divided regarding the ethics of research involving (cloned) embryos. Yet we agree that all parties to the debate have concerns vital to defend, vital not only to themselves but to all of us. No human being and no society can afford to be callous to the needs of suffering humanity, or cavalier about the treatment of nascent human life, or indifferent to the social effects of adopting one course of action rather than another.

To make clear to all what is at stake in the decision, Council Members have presented, as strongly as possible, the competing ethical cases for and against cloning-for-biomedical-research in the form of first-person attempts at moral suasion. Each case has tried to address what is owed to suffering humanity, to the human embryo, and to the broader society. Within each case, supporters of the position in question speak only for themselves, and not for the Council as a whole.

The moral case for cloning-for-biomedical-research rests on our obligation to try to relieve human suffering, an obligation that falls most powerfully on medical practitioners and biomedical researchers. We who support cloning-for-biomedical-research all agree that it may offer uniquely useful ways of investigating and possibly treating many chronic debilitating diseases and disabilities, providing aid and relief to millions. We also believe that the moral objections to this research are outweighed by the great good that may come from it. Up to this point, we who support this research all agree. But we differ among ourselves regarding the weight of the moral objections, owing to differences about the moral status of the cloned embryo. These differences of opinion are sufficient to warrant distinguishing two different moral positions within the moral case for cloning-for-biomedical-research:

Position Number One. Most Council Members who favor cloning-for-biomedical-research do so with serious moral concerns. Speaking only for ourselves, we acknowledge the following difficulties, but think that they can be addressed by setting proper boundaries.

• Intermediate moral status. While we take seriously concerns about the treatment of nascent human life, we believe there are sound moral reasons for not regarding the embryo in its earliest stages as the moral equivalent of a human person. We believe the embryo has a developing and intermediate moral worth that commands our special respect, but that it is morally permissible to use early-stage cloned human embryos in important research under strict regulation.
  
  
• Deliberate creation for use. We believe that concerns over the problem of deliberate creation of cloned embryos for use in research have merit, but when properly understood should not preclude cloning-for-biomedical-research. These embryos would not be "created for destruction," but for use in the service of life and medicine. They would be destroyed in the service of a great good, and this should not be obscured.
  
  
• Going too far. We acknowledge the concern that some researchers might seek to develop cloned embryos beyond the blastocyst stage, and for those of us who believe that the cloned embryo has a developing and intermediate moral status, this is a very real worry. We approve, therefore, only of research on cloned embryos that is strictly limited to the first fourteen days of development – a point near when the primitive streak is formed and before organ differentiation occurs.
  
  
• Other moral hazards. We believe that concerns about the exploitation of women and about the risk that cloning-for-biomedical-research could lead to cloning-to-produce-children can be adequately addressed by appropriate rules and regulations. These concerns need not frighten us into abandoning an important avenue of research.

Position Number Two. A few Council Members who favor cloning-for-biomedical-research do not share all the ethical qualms expressed above. Speaking only for ourselves, we hold that this research, at least for the purposes presently contemplated, presents no special moral problems, and therefore should be endorsed with enthusiasm as a potential new means of gaining knowledge to serve humankind. Because we accord no special moral status to the early-stage cloned embryo and believe it should be treated essentially like all other human cells, we believe that the moral issues involved in this research are no different from those that accompany any biomedical research. What is required is the usual commitment to high standards for the quality of research, scientific integrity, and the need to obtain informed consent from donors of the eggs and somatic cells used in nuclear transfer.

The moral case against cloning-for-biomedical-research acknowledges the possibility – though purely speculative at the moment – that medical benefits might come from this particular avenue of experimentation. But we believe it is morally wrong to exploit and destroy developing human life, even for good reasons, and that it is unwise to open the door to the many undesirable consequences that are likely to result from this research. We find it disquieting, even somewhat ignoble, to treat what are in fact seeds of the next generation as mere raw material for satisfying the needs of our own. Only for very serious reasons should progress toward increased knowledge and medical advances be slowed. But we believe that in this case such reasons are apparent.

• Moral status of the cloned embryo. We hold that the case for treating the early-stage embryo as simply the moral equivalent of all other human cells (Position Number Two, above) is simply mistaken: it denies the continuous history of human individuals from the embryonic to fetal to infant stages of existence; it misunderstands the meaning of potentiality; and it ignores the hazardous moral precedent that the routinized creation, use, and destruction of nascent human life would establish. We hold that the case for according the human embryo "intermediate and developing moral status" (Position Number One, above) is also unconvincing, for reasons both biological and moral. Attempts to ground the limited measure of respect owed to a maturing embryo in certain of its developmental features do not succeed, and the invoking of a "special respect" owed to nascent human life seems to have little or no operative meaning if cloned embryos may be created in bulk and used routinely with impunity. If from one perspective the view that the embryo seems to amount to little may invite a weakening of our respect, from another perspective its seeming insignificance should awaken in us a sense of shared humanity and a special obligation to protect it.
  
  
• The exploitation of developing human life. To engage in cloning-for-biomedical-research requires the irreversible crossing of a very significant moral boundary: the creation of human life expressly and exclusively for the purpose of its use in research, research that necessarily involves its deliberate destruction. If we permit this research to proceed, we will effectively be endorsing the complete transformation of nascent human life into nothing more than a resource or a tool. Doing so would coarsen our moral sensibilities and make us a different society: one less humble toward that which we cannot fully understand, less willing to extend the boundaries of human respect ever outward, and more willing to transgress moral boundaries once it appears to be in our own interests to do so.
  
  
• Moral harm to society. Even those who are uncertain about the precise moral status of the human embryo have sound ethical-prudential reasons to oppose cloning-for-biomedical-research. Giving moral approval to such research risks significant moral harm to our society by (1) crossing the boundary from sexual to asexual reproduction, thus approving in principle the genetic manipulation and control of nascent human life; (2) opening the door to other moral hazards, such as cloning-to-produce-children or research on later-stage human embryos and fetuses; and (3) potentially putting the federal government in the novel and unsavory position of mandating the destruction of nascent human life. Because we are concerned not only with the fate of the cloned embryos but also with where this research will lead our society, we think prudence requires us not to engage in this research.
  
  
• What we owe the suffering. We are certainly not deaf to the voices of suffering patients; after all, each of us already shares or will share in the hardships of mortal life. We and our loved ones are all patients or potential patients. But we are not only patients, and easing suffering is not our only moral obligation. As much as we wish to alleviate suffering now and to leave our children a world where suffering can be more effectively relieved, we also want to leave them a world in which we and they want to live – a world that honors moral limits, that respects all life whether strong or weak, and that refuses to secure the good of some human beings by sacrificing the lives of others.

The Council recognizes the challenges and risks of moving from moral assessment to public policy. Reflections on the "social contract" between science and society highlight both the importance of scientific freedom and the need for boundaries. We note that other countries often treat human cloning in the context of a broad area of biomedical technology, at the intersection of reproductive technology, embryo research, and genetics, while the public policy debate in the United States has treated cloning largely on its own. We recognize the special difficulty in formulating sound public policy in this area, given that the two ethically distinct matters-cloning-to-produce-children and cloning-for-biomedical-research-will be mutually affected or implicated in any attempts to legislate about either. Nevertheless, our ethical and policy analysis leads us to the conclusion that some deliberate public policy at the federal level is needed in the area of human cloning.

We reviewed the following seven possible policy options and considered their relative strengths and weaknesses: (1) Professional self-regulation but no federal legislative action ("self-regulation"); (2) A ban on cloning-to-produce-children, with neither endorsement nor restriction of cloning-for-biomedical-research ("ban plus silence"); (3) A ban on cloning-to-produce-children, with regulation of the use of cloned embryos for biomedical research ("ban plus regulation"); (4) Governmental regulation, with no legislative prohibitions ("regulation of both"); (5) A ban on all human cloning, whether to produce children or for biomedical research ("ban on both"); (6) A ban on cloning-to-produce-children, with a moratorium or temporary ban on cloning-for-biomedical-research ("ban plus moratorium"); or (7) A moratorium or temporary ban on all human cloning, whether to produce children or for biomedical research ("moratorium on both").

Having considered the benefits and drawbacks of each of these options, and taken into account our discussions and reflections throughout this report, the Council recommends two possible policy alternatives, each supported by a portion of the Members.

Majority Recommendation: Ten Members of the Council recommend a ban on cloning-to-produce-children combined with a four-year moratorium on cloning-for-biomedical-research. We also call for a federal review of current and projected practices of human embryo research, pre-implantation 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. Speaking only for ourselves, those of us who support this recommendation do so for some or all of the following reasons:

• By permanently banning cloning-to-produce-children, this policy gives force to the strong ethical verdict against cloning-to-produce-children, unanimous in this Council (and in Congress) and widely supported by the American people. And by enacting a four-year moratorium on the creation of cloned embryos, it establishes an additional safeguard not afforded by policies that would allow the production of cloned embryos to proceed without delay.
  
  
• It calls for and provides time for further democratic deliberation about cloning-for-biomedical research, a subject about which the nation is divided and where there remains great uncertainty. A national discourse on this subject has not yet taken place in full, and a moratorium, by making it impossible for either side to cling to the status-quo, would force both to make their full case before the public. By banning all cloning for a time, it allows us to seek moral consensus on whether or not we should cross a major moral boundary (creating nascent cloned human life solely for research) and prevents our crossing it without deliberate decision. It would afford time for scientific evidence, now sorely lacking, to be gathered – from animal models and other avenues of human research – that might give us a better sense of whether cloning-for-biomedical-research would work as promised, and whether other morally nonproblematic approaches might be available. It would promote a fuller and better-informed public debate. And it would show respect for the deep moral concerns of the large number of Americans who have serious ethical objections to this research.
  
  
• Some of us hold that cloning-for-biomedical-research can never be ethically pursued, and endorse a moratorium to enable us to continue to make our case in a democratic way. Others of us support the moratorium because it would provide the time and incentive required to develop a system of national regulation that might come into use if, at the end of the four-year period, the moratorium were not reinstated or made permanent. Such a system could not be developed overnight, and therefore even those who support the research but want it regulated should see that at the very least a pause is required. In the absence of a moratorium, few proponents of the research would have much incentive to institute an effective regulatory system. Moreover, the very process of proposing such regulations would clarify the moral and prudential judgments involved in deciding whether and how to proceed with this research.
  
  
• A moratorium on cloning-for-biomedical-research would enable us to consider this activity in the larger context of research and technology in the areas of developmental biology, embryo research, and genetics, and to pursue a more comprehensive federal regulatory system for setting and executing policy in the entire area.
  
  
• Finally, we believe that a moratorium, rather than a lasting ban, signals a high regard for the value of biomedical research and an enduring concern for patients and families whose suffering such research may help alleviate. It would reaffirm the principle that science can progress while upholding the community's moral norms, and would therefore reaffirm the community's moral support for science and biomedical technology.

The decision before us is of great importance. Creating cloned embryos for any purpose requires crossing a major moral boundary, with grave risks and likely harms, and once we cross it there will be no turning back. Our society should take the time to make a judgment that is well-informed and morally sound, respectful of strongly held views, and representative of the priorities and principles of the American people. We believe this ban-plus-moratorium proposal offers the best means of achieving these goals.

This position is supported by Council Members Rebecca S. Dresser, Francis Fukuyama, Robert P. George, Mary Ann Glendon, Alfonso Gómez-Lobo, William B. Hurlbut, Leon R. Kass, Charles Krauthammer, Paul McHugh, and Gilbert C. Meilaender.

Minority Recommendation: Seven Members of the Council recommend a ban on cloning-to-produce-children, with regulation of the use of cloned embryos for biomedical research. Speaking only for ourselves, those of us who support this recommendation do so for some or all of the following reasons:

• By permanently banning cloning-to-produce-children, this policy gives force to the strong ethical verdict against cloning-to-produce-children, unanimous in this Council (and in Congress) and widely supported by the American people. We believe that a ban on the transfer of cloned embryos to a woman's uterus would be a sufficient and effective legal safeguard against the practice.
  
  
• It approves cloning-for-biomedical-research and permits it to proceed without substantial delay. This is the most important advantage of this proposal. The research shows great promise, and its actual value can only be determined by allowing it to go forward now. Regardless of how much time we allow it, no amount of experimentation with animal models can provide the needed understanding of human diseases. The special benefits from working with stem cells from cloned human embryos cannot be obtained using embryos obtained by IVF. We believe this research could provide relief to millions of Americans, and that the government should therefore support it, within sensible limits imposed by regulation.
  
  
• It would establish, as a condition of proceeding, the necessary regulatory protections to avoid abuses and misuses of cloned embryos. These regulations might touch on the secure handling of embryos, licensing and prior review of research projects, the protection of egg donors, and the provision of equal access to benefits.
  
  
• Some of us also believe that mechanisms to regulate cloning-for-biomedical-research should be part of a larger regulatory program governing all research involving human embryos, and that the federal government should initiate a review of present and projected practices of human embryo research, with the aim of establishing reasonable policies on the matter.

Permitting cloning-for-biomedical-research now, while governing it through a prudent and sensible regulatory regime, is the most appropriate way to allow important research to proceed while insuring that abuses are prevented. We believe that the legitimate concerns about human cloning expressed throughout this report are sufficiently addressed by this ban-plus-regulation proposal, and that the nation should affirm and support the responsible effort to find treatments and cures that might help many who are suffering.

This position is supported by Council Members Elizabeth H. Blackburn, Daniel W. Foster, Michael S. Gazzaniga, William F. May, Janet D. Rowley, Michael J. Sandel, and James Q. Wilson.

The Meaning of Human Cloning: An Overview

The prospect of human cloningⁱ burst into the public consciousness in 1997, following the announcement of the successful cloning of Dolly the sheep. It has since captured much attention and generated great debate, both in the United States and around the world. Many are repelled by the idea of producing children who would be genetically virtually identical to pre-existing individuals, and believe such a practice unethical. But some see in such cloning the possibility to do good for infertile couples and the broader society. Some want to outlaw it, and many nations have done so. Others believe the benefits outweigh the risks and the moral concerns, or they oppose legislative interference with science and technology in the name of freedom and progress.

Complicating the national dialogue about human cloning is the isolation in 1998 of human embryonic stem cells, which many scientists believe to hold great promise for understanding and treating many chronic diseases and conditions. Some scientists also believe that stem cells derived from cloned human embryos, produced explicitly for such research, might prove to be uniquely useful for studying many genetic diseases and devising novel therapies. Public reaction to this prospect has been mixed, with some Americans supporting it in the hope of advancing biomedical research and helping the sick and the suffering, while others are concerned about the instrumentalization or abuse of nascent human life and the resulting danger of moral insensitivity and degradation.

In the United States, several attempts have been made to initiate a comprehensive public review of the significance of human cloning and to formulate appropriate policies. Most notably, the National Bioethics Advisory Commission (NBAC) released a report on the subject of cloning-to-produce-children in 1997.ⁱⁱ The Commission concluded that cloning-to-produce-children was, at least for the time being, unethical on safety grounds, and that the deeper and more permanent moral concerns surrounding the practice should be the subject of continuing deliberation "in order to further our understanding of the ethical and social implications of this technology and to enable society to produce appropriate long-term policies regarding this technology" (p. 106).

In this report, the President's Council on Bioethics takes up this important charge, and considers the ethical and social implications of human cloning (both for producing children and for biomedical research) in their full scope, with the aim of informing public policy on the matter.

Our work toward this end is guided by a number of explicit methodological choices about modes of approach, points of departure, and spirit of inquiry. We locate human cloning within its larger human and technological context, rather than consider it in isolation. We focus first on the broad human goods that it may serve or threaten, rather than on the immediate impact of the technique itself. And we present the strongest arguments for the relevant moral and policy positions, rather than frame the arguments in order to seek consensus. By our broad approach, our starting on the plane of human goods, and our open spirit of inquiry, we hope to contribute to a richer and deeper understanding of what human cloning entails, how we should think about it, and what we should do about it.

Two points of clarification before we proceed. First, all of our considerations and arguments assume that cloning techniques, both for producing children and for providing embryos useful in biomedical research, could succeed in human beings as they have with other mammals. Cloning-to-produce-children has never been successfully carried out in humans, and cloning embryos for biomedical research has not progressed beyond the earliest experiments. We consider it part of our task to judge whether even attempts at human cloning would be ethical or should be lawful. To conduct the analysis and assessment needed for such judgment, we necessarily proceed on the assumption, which we believe is supported by evidence from animal experiments, that human cloning is indeed a possibility – that sooner or later, if it were allowed and attempted, human cloning could be successfully carried out. Practically all public discussion of the ethics of human cloning has, whether expressly or not, proceeded on this same premise, and rightly so.

Second, on some of the matters discussed in this report, Members of the Council are not of one mind. Given that competing goods are at stake, and different people regard them differently, this is not at all surprising. Rather than bury these differences in search of a spurious consensus, we have sought to present all views fairly and fully. Yet transcending these differences is a more fundamental agreement about the worthiness of the approach we have adopted and the arguments we have made. Accordingly, the Council is unanimous in owning the entire report and in recommending, to all, the report's discussions and arguments for serious consideration.

In the remainder of this overview, we describe the context of human cloning and the discussions it has generated. In the course of doing so, we identify the kinds of questions and concerns that would permit a full assessment of the meaning of human cloning. These questions and concerns will guide us throughout the report.

Human Cloning in Context

It is useful to begin by observing how it is that the question of human cloning has come before us. The prospect of cloning human beings confronts us now not as the result of a strong public demand or a long-standing need. Unlike sought-for medical therapies, it was not at the outset pursued as a cure for disease. Neither has it been sought explicitly as a tool for genetic control or "enhancement" of human offspring. Cloning has arisen not so much because it was actively sought for its own sake, but because it is a natural extension of certain biotechnological advances of the past several decades.ⁱⁱⁱ

For more than half a century, and at an accelerating pace, biomedical scientists have been gaining wondrous new knowledge of the workings of living beings, from small to great. Increasingly, they also are providing precise and sophisticated knowledge of the workings of the human body and mind. Such knowledge of how things work often leads to new technological powers to control or alter these workings, powers ordinarily sought in order to treat human disease and relieve suffering.

Questions regarding the meaning of acquiring such powers – both the promise and the peril – have attracted scholarly and public attention. For more than thirty years, ethical issues related to biomedical advance have occupied the growing field of bioethics. Increasingly, these ethical issues have spawned public discussion and debates. A growing number of people sense that something new and momentous is happening; that the accelerating waves of biotechnical advances touch deeply on our most human concerns; and that the centuries-old project for human mastery of nature may now be, so to speak, coming home, giving humanity the power to alter and "master" itself.

One important aspect of human life already affected by new biotechnologies is human reproduction. For several decades now, building on advances in genetics, cell biology, and developmental biology, and on technologies used first in animal husbandry, scientists around the world have been adapting techniques and developing tools to study, influence, and manipulate the origins of human life. Beginning with techniques of artificial insemination and progressing through in vitro fertilization (IVF) and intracytoplasmic sperm injection, artificial aids to reproduction have come into standard medical use.

Cloning is, in one sense, another step along this path. It developed as the result of research into mammalian reproduction and development, where it is desired also as a means of replicating animals especially useful to human beings. It is also proposed as an additional means to overcome infertility in humans.

But the controversy surrounding human cloning, and the widespread sense of disquiet and concern with which the prospect has been received around the world, make it clear that cloning is not just another reproductive technology, to be easily assimilated into ordinary life. Nearly all participants in the public debate over human cloning appear to agree that the subject touches upon some of the most fundamental questions regarding the nature of our humanity and the character of our society. In addition, it raises questions about the aims of biomedical science and about the relation between science and society, including the possibility and desirability of exercising public control over the uses of biomedical technology and the conduct of biomedical research. It is because we sense these larger entailments that the subject of cloning matters so much to us. It is these considerations that give the present debate its force and prominence. Thus only through a serious reflection on these broader questions can the full meaning of human cloning be discovered. The prospect of human cloning may have been brought before us by the march of biotechnology, but now that it is here it is incumbent upon us to look well beyond its technical and medical aspects, if we are to appreciate its significance in full.

Three areas of inquiry in particular seem essential to any understanding of the full meaning of human cloning: the nature and meaning of human procreation; the aims, ends, and means of biomedical science and technology; and the relation of science and technology to the larger society.

Cloning and Human Procreation

Human procreation provides the major context for considering the prospect of cloning, especially cloning-to-produce-children. Much of the time, most of us tend to take for granted this central aspect of human life, through which all of us come to be and through which we give birth to our posterity. But the prospect of creating children by cloning brings this subject sharply before us and compels us to examine the nature and meaning of human procreation. For cloning-to-produce-children, while it may be a potential aid to human reproduction, appears also to be a substitute for it, or at least for its natural, un-programmed, sexual character. Properly to assess the meaning of producing cloned children, one must first of all consider the meaning of human procreation in all its aspects and entailments.^iv

Human procreation, though seemingly an exclusively private act, has a profoundly public meaning. It determines the relations between one generation and the next, shapes identities, creates attachments, and sets up responsibilities for the care and rearing of children (and the care of aging parents or other needy kin). Thus, in considering proposals to clone children, we must ask ourselves what cloning would mean not only for the individual parents and children involved, but also for the surrounding families and for all of society. Opinions on this subject will of course differ, sometimes widely, as they rest on possibly differing perceptions of human procreation and family life. Yet the following basic observations, concerns, and questions seem pertinent, notwithstanding possible differences of opinion among us about how much weight to give them.

Among the important aspects of the topic are these: the meaning of having children; the meaning of sexual, as opposed to asexual, reproduction; the meaning of origins and genetic endowment for identity and sense of self; the meaning of exercising greater human control over the processes and "products" of human reproduction; and the difference between begetting and making.

To understand what it would mean to clone a child, we do well to consider most generally what it means to bring a child into the world, and with what attitude we should regard his or her arrival and presence. Our children are, to begin with, our replacements, those who will one day stand in our place. They are, as Hans Jonas has remarked, "life's own answer to mortality." Though their conception is the fruit of our activity, and though we are responsible for saying "yes" to their arrival, we do not, in normal procreation, command their conception, control their makeup, or rule over their development and birth. They are, in an important sense, "given" to us. Though they are our children, they are not our property. Though they are our flesh and blood, and deeply kin, they are also independent "strangers" who arrive suddenly out of the darkness and whom we must struggle to get to know. Though we may seek to have them for our own self-fulfillment, they exist also and especially for their own sakes. Though we seek to educate them, they are not like our other projects, determined strictly according to our plans and serving only our desires.

If these observations are correct, certain things follow regarding the attitudes we should have toward our children. We treat them rightly when we treat them as gifts rather than as products, and when we treat them as independent beings whom we are duty-bound to protect and nurture rather than as extensions of ourselves subject only to our wills and whims. Might these attitudes toward children be altered by cloning, and, if so, how? Would social attitudes toward children change, even if cloning were not practiced widely? What might these changes mean?

To understand how the introduction of asexual reproduction might affect human life, we must first seek the intrinsic meaning of the sexual character of human reproduction and what it implies for individuals, for families, and for the relation between the generations. Once again, the following observations – while hardly exhaustive – seem pertinent and important.

In sexual reproduction,^v each child has two complementary biological progenitors. Each child thus stems from and unites exactly two lineages, lines that trace backward in similar branching fashion for ages. Moreover, the precise genetic endowment of each child is determined by a combination of nature and chance, not by human design: each human child naturally acquires and shares the common human species genotype, each child is genetically (equally) kin to each (both) parent(s), yet each child is also genetically unique.^vi Cloning-to-produce-children departs from this pattern. A cloned child has unilineal, not bilineal, descent; he or she is genetically kin to only one progenitor. What is more, the genetic kinship is near-total: the cloned child is not genetically unique, but shares almost completely the genetic endowment of the "original" progenitor. Finally, this endowment comes to the cloned child not by chance but by human choice and decision. What do these differences mean for the cloned child, for family relations, and for relations across the generations?

Origins and genetic endowment are significant aspects of who one is and how one regards oneself, of one's "identity," individuality, and place in the social order. The biological linkages and prospects implicit in sexual reproduction help to define us, though, it should go without saying, they do not define us completely. While we are more "what we choose to become" than we are "where we came from," our human beginnings matter, biologically, psychically, and socially. Because of the way we are generated, each of us is at once (1) equally human, (2) equally marked by and from birth as mortal, (3) equally enmeshed in a particular familial nexus of origin, (4) equally individuated in our trajectory from the beginning to the end of our lives – and, if all goes well, (5) equally capable (despite our mortality) of participating with a complementary other in the very same renewal of human possibility through procreation. Our genetic identity – manifest, for instance, in our distinctive appearance by which we are recognized by others and in our immune system by which we maintain our integrity against "foreign invasions" – also symbolizes and foreshadows exactly the unique, never-to-be-repeated character of each human life. In addition, human societies virtually everywhere have structured child-rearing responsibilities and systems of identity and relationships on the bases of these natural facts of begetting. Kinship is tied to origins, and identity, at least in part, is tied to kinship. It is against this background that we must consider the implications of clonal reproduction, and the alterations it might produce in how cloned children would regard themselves and how they would be regarded by others. What would cloning-to-produce-children mean for individual identity, for kinship, and for sense of self, not only for the cloned child but also for his or her family?

Unaided sexual procreation is an activity at once natural, private, mysterious, unmediated, unpredictable, and undesigned. With the arrival of techniques such as IVF to assist procreation in the face of infertility, the process becomes less private and more mediated. But although technique is used, the basic structure of sexual reproduction – the combination of genetic material from father and mother resulting in a genetically unique child – is unaltered, the outcome is still unpredictable, and the genetic endowment of the child remains uncontrolled and undesigned. Cloning-to-produce-children would seem to bring procreation under human control and direction. What would this mean? What are the implications of allowing reproductive activities to become increasingly technological and commercialized? Cloning would be the first instance in which parents could select in advance the precise (or nearly precise) genetic makeup of their child, by selecting the donor to be cloned. It therefore forces us to ask what might be the difference between begetting and making, to wonder whether cloning somehow crosses the line between them, and, if so, to consider whether and why that should worry us.

Though admittedly sketchy and incomplete, these preliminary reflections on the nature and meaning of human procreation should enable us to see cloning – and especially cloning-to-produce-children-in its most important human context and to understand its deepest implications for its practitioners and for society.

Cloning and Biomedical Science

Human procreation is not the only context for evaluating the prospect of human cloning. As a product of biotechnology, a potential means of assisted reproduction, and a possible source of cloned embryos for research and medical use, human cloning also points us to questions about the aims, ends, and means of biomedical science and technology. Ordinarily, we are not prompted to much reflection about what science is for and what goals technology should serve. Our society tacitly accepts the self-directing and self-augmenting character of these activities, and the vast majority of us support them because we esteem and benefit from their contributions to human understanding and human welfare. However, when developments such as cloning raise profound questions affecting fundamental moral values and social institutions, we are forced to consider the ends and means of science and technology, and to explore their standing in the scheme of human goods.

To provide a context for assessing human cloning and its possible benefits, we do well to remember the goals of medicine and modern science: the great value and importance of treating disease and relieving suffering, including the sorrows of infertility; and the great value and importance of gaining knowledge about the workings of nature, our own nature emphatically included. No one can doubt the merit of these noble aims. Yet there has always been some disagreement about the lengths to which we should allow ourselves to go in serving them. Questions therefore arise about the need for limits on scientific pursuits and technological activities, and, conversely, about the meaning of such limits for the scientific and technological enterprises.

To address these questions, we must appreciate the human good of biomedical science in its fullness, and we must ask about the necessary and sufficient conditions for its flourishing. We must recognize, among other things, the unpredictability of scientific discovery and technological innovation, and the importance, therefore, of keeping open lines of inquiry and experimentation regardless of current estimates of their likelihood of success. Although serendipity often favors the prepared mind, nature guards her secrets well, and even the best scientists are regularly surprised by where the keys to the locks are ultimately found.

But precisely because so much of biomedical science is exploratory and experimental, scientific inquiry is not just thought but also action, action often involving research on living subjects, including human beings. And precisely because the use of technologies often has unintended or undesirable side effects, affecting many human goods in addition to health, safety, and the relief of suffering, large questions are necessarily raised when the goods promoted by technology come into conflict with others. For example, is the need to discover new cures for the sick a moral imperative that should trump all other goods and values? If not, then on what basis can it be limited? What moral boundaries should scientists and technologists respect as they continue their quests for knowledge and cures, whether or not they receive public funding? How can society establish and enforce such boundaries? And, on the other hand, how can science and technology be protected against unreasonable limitations imposed by excessively fearful legislators or overzealous regulators?

To be sure, these large questions are hard to answer in the abstract. As a result, they do not recommend themselves for much deliberation. Yet they are very close to the surface of the current debate about human cloning. Moreover, implicit answers to these questions, seldom articulated and rarely defended save by mere assertion, at least color and may even determine what people think should be done about human cloning. A clearer and more thoughtful awareness of the aims of biomedical science could help us assess whether and how human cloning might serve the ends of science and medicine and could help us more fully consider its possible benefits and potential drawbacks.

But we must consider not only the ends of science, but also the means it employs. Cloning, after all, is a technique, a means of reaching some desired end. Even if the purposes it might serve are worthy, it must still be evaluated as a means. Not every means employed in the pursuit of worthy ends can pass ethical muster. This truth is widely recognized in the establishment of canons of ethics regarding the use of human subjects in research. It is also recognized in the established practice of technology assessment, which seeks to find the least problematic and least dangerous means for achieving a desirable end.

For instance, as a means of treating infertility or of providing a suitable source of compatible organs for transplantation, cloning raises difficulties having to do with human dignity and the costs of "manufacture" of the sort discussed earlier. Human cloning also raises questions about the ethics of research with human subjects, with risks of harm to the child-to-be, the egg donor, and the woman who would bring the cloned child to birth, questions that we shall take up in some detail in Chapter Five. Yet the most highly controverted moral argument about human cloning research involves a human subject not always considered when the ethics of research is discussed: the early human embryo. Because all cloning begins with the production of embryonic clones, and because such clones are potentially highly useful in biomedical research, questions of the ethics of means are absolutely central to the debate about the morality of cloning.

Ethical questions regarding the use of human embryos in research are, of course, not unique to cloning. They have been central to the recent and continuing controversy about federal funding of research on human embryonic stem cells, because human embryos produced by IVF offer possibilities for medical advances, beyond their use in assisted reproduction. The use of embryos has aided research on early human development. These embryos are also the source of human embryonic stem cells, pluripotent cells^vii that may be induced to develop into all the tissues of the body. These stem cells thus may hold great promise for future treatment of chronic degenerative diseases and disabilities.

The difficulty arises because the embryos put to use in these ways are themselves destroyed. This fact raises serious and troubling questions about the proper way to regard these nascent human organisms and the morally appropriate way to treat them. Cloning techniques might provide an even more useful source of embryos for biomedical research than current IVF techniques. Human cloning could yield numerous identical embryos, could provide for the study of stem cells derived from individuals known to possess genetic diseases, and might eventually yield transplantable tissues for regenerative medicine that would escape immune rejection. Human cloning-for-biomedical-research therefore brings the moral question of means before us with even greater force. It calls on us to think of the good of medical advances and the relief of human suffering while at the same time considering our responsibilities to nascent human life and the possible harms to ourselves and future generations that may result from coming to regard the beginning stages of human life as raw material for use and exploitation.

While there is almost universal opposition to cloning-to-produce-children, the prospect of using cloned embryos in biomedical research has attracted significant support in the general public and among many scientists, patient advocacy groups, and policymakers. It therefore presents more complicated moral and policy challenges, and requires serious reflection on the duty of society to those of its members who are suffering, as well as its responsibility for nascent life. The precise character of both that duty and that responsibility is a subject of long-standing dispute, giving rise to a contentious but very important public debate.

Cloning and Public Policy

Beneath the current debate about human cloning lie major questions about the relation between science and technology and the larger society. Valuing freedom and innovation, our society allows scientists to inquire as they wish, to explore freely, and to develop techniques and technologies based on the knowledge they find, and on the whole we all benefit greatly as a result. We limit what scientists can do only in certain cases, as when their research requires the use of human subjects, in which case we erect rules and procedures to protect the health, safety, and dignity of the weak from possible encroachments by the strong. In more pervasive ways, we also shape what science does through public decisions about financial support and scientific education. With the uses of technology, we are sometimes more intrusive, establishing regulations to protect public health and safety or to preserve the environment. In rare cases, we even ban certain practices, such as the buying and selling of organs for transplantation. Yet, on the whole, the spirit of laissez-faire governs technological research, development, and use.

But when innovations arise that appear to challenge basic goods that we hold dear, or when the desirability of scientific and technological progress runs up against concerns for the protection of human life and well-being, we are forced to consider the tacit social contract between science and technology and the larger society. The current public and political deliberation about whether and how to restrict or prohibit human cloning forces us to do so in a most powerful way.

In addition, the current deliberation confronts us with the task of balancing important and commonly defended freedoms – the freedom of scientists to inquire, of technologists to invent, of individuals to reproduce, of entrepreneurs to invest and to profit – with the well-being of our society and its members. Circumstances in which otherwise beneficent freedoms can endanger paramount moral and social goods present serious challenges for free societies, and the prospect of cloning presents us with just such a challenge.

This is not an altogether unfamiliar challenge. There are other circumstances in which the freedom to explore, inquire, research, and develop technologies has been constrained. Biomedical science, as we have said, is restricted in its use of human subjects for research, and scientists are required to obtain informed consent and take great care to secure research subjects from harm. Scientific work is also restricted from activities that might harm the health of the general public, and from producing products that may endanger consumers. For example, the federal Food and Drug Administration sits at the juncture between development and marketing of medical products, regulating their introduction and use according to criteria of safety and efficacy. Our society has come to a near-total agreement on the need for such an agency and the importance of its work.

Human cloning, however, does not easily fall into any of the familiar classes of our experience with science. Nor do the ethical challenges it raises fit neatly into the categories of risks to health and safety that are ordinarily the basis of public oversight of science and technology. Raising ethical questions about ends as well as means, cloning is at once a potential human experiment, a possible aid to reproduction, an altogether new sort of procreative technique, a prospective means of human design, and a source of embryos and embryonic stem cells for research. It points back to familiar dilemmas of bioethics – including the ethics of human experimentation and embryo research – and it points forward to the sorts of challenges that will face us as biology gains greater technical prowess. It therefore invites us to think anew about the relationship between society and biomedical science and to evaluate the sufficiency of current institutions and practices that govern that relationship.

The potential dangers we face do not result from ill intent or bad faith. Neither of the prevailing caricatures in the cloning debate – the mad scientist on a blind quest for an inhuman immortality or the puritanical Luddite seeking to keep the future at bay – is accurate, appropriate, helpful, or fair. The challenge we face is not as easy as that. The challenge we face involves the conflict of competing sets of concerns and priorities, each in the service of vital human goods, and each driven by a desire to improve the human condition and to protect essential principles. The widely shared desire to cure disease, relieve suffering, understand human biology, and provide humankind with new and more powerful means of control can conflict, in this case, with the widely shared desire to respect life, individual identity, the dignity of human procreation, and other institutions and principles that keep our society healthy and strong. The challenge for our society is to determine, through public deliberation and thoughtful reflection, how best to adjudicate between these two desires and to determine what form to give to the tacit agreement between society and science, by which society promises freedom within bounds, and science affords us innovation, knowledge, and power while respecting reasonable limits.

The new and distinct challenges that confront us through cloning call upon us to consider the character of that tacit agreement, and to determine whether, and in what way, it might need to be amended and supplemented, especially in the face of the rapidly arriving new biomedical technologies that touch so directly upon our humanity. It is our hope in this report to contribute to just such a thoughtful consideration of the question.

The Report

In Chapter One we present a brief history of human cloning. We summarize the scientific developments, the various public and political debates, and the actions of earlier panels and government bodies.

In Chapter Three we discuss the terminology of the cloning debate. We analyze the controversy over cloning terms, state the terms we intend to use, and lay out the rationale behind our choice of terms.

In Chapter Four we present a survey of the scientific aspects of human and animal cloning. We attempt to clarify what cloning is, where the science stands, and where it may be going.

In Chapter Five we discuss the ethical arguments for and against human cloning-to-produce-children. We consider reasons to create cloned children, concerns over safety and consent, and a series of moral objections.

In Chapter Six we discuss the ethical arguments for and against cloning-for-biomedical-research. We consider the likely medical benefits, the potential social and ethical difficulties, and the concern over the treatment of human embryos.

In Chapter Seven we discuss the public policy alternatives. We consider various options for government action, and present arguments for and against each.

In Chapter Eight, we present the Council's conclusions and offer our recommendations.

1. The term "human cloning" is used in this chapter to refer to all human cloning: cloning-to-produce-children and cloning-for-biomedical-research. When only one particular use of human cloning is intended, we use the more specific term. A full discussion of our choice of terminology is provided in Chapter Three. Back to Text
   
   
2. Cloning Human Beings, Rockville, MD: National Bioethics Advisory Commission, 1997. Human embryonic stem cells had not yet been isolated at the time of the NBAC report, so the Commission did not offer any recommendations on cloning-for-biomedical-research. Back to Text
   
   
3. Chapter One summarizes selected historical aspects of the emergence of cloning research and public reactions to the prospect of human cloning. Chapter Four summarizes selected aspects of the current state of the relevant science and technology. Back to Text
   
   
4. In order to be sure that we explore fully the human meaning of cloning, we shall examine it in comparison with natural unaided human reproduction, rather than assisted reproduction, say, with in vitro fertilization. The established reproductive technologies do provide some useful points of comparison, but they cannot be taken as the most helpful baseline for understanding the significance of cloning. For that, normal sexual reproduction is the appropriate basis of comparison. Back to Text
   
   
5. The term "sexual reproduction" has two related meanings: the first refers to the act of sexual intercourse that initiates conception by introducing sperm into a woman's generative tract; the second refers to the conception itself, the combination of genetic material from egg and sperm that results in a new organism with a unique genotype. Assisted reproduction techniques like IVF do not involve the former, but do involve the latter and are therefore still rightly considered sexual reproduction. (Likewise, children who are adopted are the fruit of sexual reproduction.) Cloning involves neither, and is therefore described as "asexual reproduction." The second and more fundamental meaning of "sexual reproduction," the union of egg and sperm that results in a new genetically unique organism, is the basis of our discussion in this section. Back to Text
   
   
6. The apparent exception of identical twins is discussed in Chapter Five. Back to Text
   
   
7. Pluripotent cells are those that can give rise to many different types of differentiated cells. See Glossary of Terms. Back to Text

Historical Aspects of Cloning

The previous chapter located human cloning in its larger human context. This chapter provides a brief history of human cloning, both as a scientific matter and as a subject of public discussion, debate, and legislation.¹ Although we present only selected highlights, rather than a comprehensive account, we seek to enable the reader to place the present debate about cloning and this report into their proper historical setting. Until recently, all discussion of human cloning concentrated exclusively on the prospect of clonal reproduction, the production of individuals genetically virtually identical to previously existing ones. Our historical account here reflects that emphasis. Yet we will also consider the emerging interest in cloning-for-biomedical-research, a prospect connected to the recent isolation of embryonic stem cells and their potential for the understanding and treatment of human disease and disability.

Scientific Milestones

As a scientific and technical possibility, human cloning has emerged as an outgrowth of discoveries or innovations in developmental biology, genetics, assisted reproductive technologies, animal breeding, and, most recently, research on embryonic stem cells. Assisted reproductive techniques in humans accomplished the in vitro fertilization of a human egg, yielding a zygote and developing embryo that could be successfully implanted into a woman's uterus to give rise to a live-born child. Animal breeders developed and refined these techniques with a view to perpetuating particularly valuable animals and maintaining laboriously identified genomes. Most recently, the isolation of embryonic stem cells and their subsequent in vitro differentiation into many different cell types have opened up possibilities for repairing and replacing diseased or nonfunctioning tissue, and thus possible research uses for cloned human embryos.

The German embryologist Hans Spemann conducted what many consider to be the earliest "cloning" experiments on animals. Spemann was interested in answering a fundamental question of biological development: does each differentiated cell retain the full complement of genetic information present initially in the zygote? In the late 1920s, he tied off part of a cell containing the nucleus from a salamander embryo at the sixteen-cell stage and allowed the single cell to divide, showing that the nucleus of that early embryo could, in effect, "start over." In a 1938 book, Embryonic Development and Induction, Spemann wondered whether more completely differentiated cells had the same capacity and speculated about the possibility of transferring the nucleus from a differentiated cell – taken from either a later-stage embryo or an adult organism – into an enucleated egg. As he explained it: "Decisive information about this question may perhaps be afforded by an experiment which appears, at first sight, to be somewhat fantastical. This experiment might possibly show that even nuclei of differentiated cells can initiate normal development in the egg protoplasms." ² But Spemann did not know how to conduct such an experiment.

Research with frogs fourteen years later encouraged progress toward the "fantastical experiment." In 1952, the American embryologists Robert Briggs and Thomas J. King first successfully transferred nuclei from early embryonic cells of leopard frogs to enucleated leopard frog eggs. The "activated egg" began to divide and develop, became a multicellular embryo, and then became a tadpole. ³ Embryologists in other laboratories successfully repeated these initial experiments on different species of frogs. But additional experience also showed that the older and more differentiated a donor cell becomes, the less likely it is that its nucleus would be able to direct development.

In 1962, the British developmental biologist John Gurdon reported that he had produced sexually mature frogs by transferring nuclei from intestinal cells of tadpoles into enucleated frog eggs.⁴ The experiments had a low success rate and remained controversial. Gurdon continued this work in the 1970s, and he was able to produce tadpoles by transferring the nucleus of adult frog skin cells into enucleated frog eggs. Later experiments established that many factors in addition to the intact nucleus are crucial to success (see Chapter Four for further discussion). In retrospect, it is surprising that any of these earlier experiments produced positive results.⁵ But despite their low success rates, these experiments demonstrated that the nucleus retained its full complement of genetic information and encouraged later investigators to explore mammalian cloning.