Human Cloning and Human Dignity: An Ethical Inquiry

Transmittal ~ Members ~ Staff ~ Preface ~ Executive Summary
Chapters: 1 ~ 2 ~ 3 ~ 4 ~ 5 ~ 6 ~ 7 ~ 8
Bibliography ~ Glossary ~ Appendix

Pre-Publication Version

The President's Council on Bioethics
Washington, D.C.
July 2002
www.bioethics.gov

Members of the President's Council on Bioethics

Council Staff and Consultants

Preface

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 (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

Human Cloning: What is at Stake?

The Inquiry: Our Point of Departure

Fair and Accurate Terminology

• 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.

Scientific Background

• 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 purposes.
  
  
• 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 animal experimental results are indeed quite 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.

The Ethics of Cloning-to-Produce-Children

• 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 individualized 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.

The Ethics of Cloning-for-Biomedical-Research

1. The Moral Case for Cloning-for-Biomedical-Research
   
   The moral case for proceeding with the 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 the 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 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.
   
   
2. The Moral Case against Cloning-for-Biomedical-Research
   
   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.

Public Policy Options

The Council's Policy Recommendations

• 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 problems with 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.

• 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.
  
  

The Meaning of Human Cloning: An Overview

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 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

Cloning and Human Procreation

Cloning and Biomedical Science

Cloning and Public Policy

The Report

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.
   
   
2. Cloning Human Beings, Rockville, MD: National Bioethics Advisory Commission, 1997. Human embry-onic 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.
   
   
3. Chapter Two summarizes selected historical aspects of the emergence of cloning research and public reac-tions to the prospect of human cloning. Chapter Four summarizes selected aspects of the current state of the relevant science and technology.
   
   
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.
   
   
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 con-ception 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 re-production." 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.
   
   
6. The apparent exception of identical twins is discussed in Chapter Five.
   
   
7. Pluripotent cells are those that can give rise to many different types of differentiated cells. See Glossary of Terms.

Historical Aspects of Cloning

Scientific Milestones

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 with its 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." But Spemann did not know how to achieve such an experiment.

Experiments 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 an embryo, and then became a tadpole. 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 will 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. 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.ⁱⁱ Experiments with amphibians did, however, show that the nucleus retained its full complement of genetic information and encouraged later investigators to explore mammalian cloning.

The birth of Louise Brown in 1978, the first baby conceived through in vitro fertilization (IVF), was also an important milestone, because it demonstrated that human birth was possible from eggs that were fertilized outside the body and then implanted into the womb. As for the possibility of cloning animals from adult cells�especially mammals�the work in the intervening years focused largely on the reprogramming in gene expression of somatic cells, the transfer of nuclei taken from embryos in mammals (beginning with mice in the 1980s), and finally the work of Ian Wilmut and his colleagues at the Roslin Institute with adult nuclei, which led to the birth of Dolly on July 5, 1996. Since then, similar success has been achieved in cloning other mammalian species, including cattle, goats, pigs, mice, cats, and rabbits (see Chapter Four).

The animal cloners did not set out to develop techniques for cloning humans. Wilmut�s goal was to replicate or perpetuate animals carrying a valuable genome; for example, sheep that had been genetically modified to produce medically valuable proteins in their milk. Others, such as the cloners of the kitten CC, were interested in commercial ventures for the cloning of pets.¹ Yet the techniques developed in animals have encouraged a small number of infertility therapists to contemplate and explore efforts to clone human children. And, following the announcement in 1998 by James Thomson and his associates of their isolation of human embryonic stem cells, there emerged an interest in cloned human embryos, not for reproductive uses but as a powerful tool for research into the nature and treatment of human disease.

Human Cloning from Popular Literature to Public Policy:
From Brave New World to the Birth of Dolly

One egg, one embryo, one adult�normality. But a bokanovskified egg will bud, will proliferate, will divide . . . becoming anywhere from eight to ninety-six embryos�a prodigious improvement, you will agree, on nature. Identical twins�but not in piddling twos and threes . . . Standard men and women; in uniform batches.

While Lederberg concluded his essay by exhorting his readers not to "mistake comment for advocacy," he clearly believed that clonal reproduction might offer a number of human benefits or improvements. "If a superior individual (and presumably then genotype) is identified, why not copy it directly, rather than suffer all the risks of recombinational disruption, including those of sex," he asked. "The same solace is accorded the carrier of genetic disease: why not be sure of an exact copy of yourself rather than risk a homozygous segregant,ⁱⁱⁱ or at worst copy your spouse and allow some degree of biological parenthood." He described other possibilities�such as "the free exchange of organ transplants with no concern for graft rejection" and more efficient communication between individuals in "stressed occupations.:

In the end, Lederberg argued that "tempered clonality" -- a mix of clonal and sexual reproduction�might, at least from a biological standpoint, "allow the best of both worlds�we would at least enjoy being able to observe the experiment of discovering whether a second Einstein would outdo the first one." Nevertheless, he acknowledged the possibility for "social frictions" and ethical dilemmas that might result from clonal reproduction�including whether "anyone could conscientiously risk the crucial experiment, the first attempt to clone a man." He suggested that the "mingling of individual human chromosomes with other mammals assures the gradualistic enlargement of the field and lowers the threshold of optimism or arrogance, particularly if cloning in other mammals gives incompletely predictable results." And he feared that social policy might become based on "the accidents of the first advertised examples" rather than "well-debated principles."

In 1970, the theologian and ethicist Paul Ramsey responded to Lederberg�s portrait of human cloning�and, more generally, the prospects for human self-modification�in a book called Fabricated Man: The Ethics of Genetic Control. He argued that human cloning would violate the ethical responsibilities of both science and parenthood: it would involve experiments on the child-to-be; it would transform parenthood into manufacture; and it would burden children with the genetic predisposition of their "maker" and so deny the cloned child a unique independence in the very act of bringing him or her to life. "To attempt to soar so high above an eminently human parenthood," Ramsey wrote, "is inevitably to fall far below�into a vast technological alienation of man �. The entire rationalization of procreation�its replacement by replication�can only mean the abolition of man�s embodied personhood."

Ramsey believed that such a willingness to experiment on human life�or to create sub-humans�showed how the effort to perfect and improve humankind through genetic control leads in fact to an ethical coarsening and to disregard for actual human beings for the hypothetical sake of the species. "In the present age," he wrote, "the attempt will be made to deprive us of our wits by comparing objections to schemes of progressive genetic engineering or cloning men to earlier opposition to inoculations, blood transfusions, or the control of malaria. These things are by no means to be compared: the practice of medicine in the service of life is one thing; man�s unlimited self-modification of the genetic conditions of life would be quite another matter."

The debate over human cloning and genetic manipulation continued in the early 1970s. The Nobel laureate geneticist James D. Watson testified before Congress in 1971 on the subject of human cloning. He described the science that was taking us there, including John Gurdon�s success in cloning frogs and the work of R. G. Edwards and P. S. Steptoe "in working out the conditions for routine test-tube conception of human eggs."

"Human embryological development," Watson observed, "need no longer be a process shrouded in secrecy. It can become instead an event wide-open to a variety of experimental manipulations." Watson called for the creation of national and international committees to promote "wide-ranging discussion � at the informal as well as formal legislative level, about the manifold problems which are bound to arise if test-tube conception becomes a common occurrence."

"This is not a decision for the scientists at all," he said. "It is a decision of the general public�do you want this or not?" and something that "if we do not think about it now, the possibility of our having a free choice will, one day, suddenly be gone."

In 1972, Willard Gaylin, a psychiatrist and co-founder of the newly formed Institute of Society, Ethics, and the Life Sciences (later called the Hastings Center), made James Watson�s warnings about cloning even more dramatic�with a New York Times Magazine article titled "The Frankenstein Myth Becomes a Reality�We Have the Awful Knowledge to Make Exact Copies of Human Beings." Gaylin hoped that the prospect of human cloning would awaken the public�and the scientific community�to the larger ethical implications of the life sciences. The same year, biologist and ethicist Leon R. Kass published an essay in The Public Interest called "Making Babies�The New Biology and the �Old� Morality," which addressed the prospect of both in vitro fertilization and human cloning, and wondered whether "by tampering with and confounding [our] origins, we are involved in nothing less than creating a new conception of what it means to be human."

In stark contrast to Gaylin and Kass, ethicist Joseph Fletcher argued that human cloning would not be dehumanizing at all, but would, in a number of circumstances, serve the good of both society and individuals. In his 1974 book The Ethics of Genetic Control: Ending Reproductive Roulette, he argued that "Good reasons in general for cloning are that it avoids genetic diseases, bypasses sterility, predetermines an individual�s gender, and preserves family likenesses. It wastes time to argue over whether we should do it or not; the real moral question is when and why." For Fletcher�unlike Ramsey, Gaylin, and Kass�genetic control would serve the human end of self-mastery and self-improvement, it would improve the quality of life for individuals, and it would aid the progress of the human species. Gunther Stent, a molecular biologist at the University of California at Berkeley, echoed this view that human cloning would contribute to human perfection. As he wrote in a 1974 article in Nature: "To oppose human cloning is to betray the Western dream of the City of God. All utopian visionaries, from Thomas More to Karl Marx, think of their perfect societies as being populated not by men but by angels that embody all of the best and none of the worst human attributes." With cloning, he suggested, such a city might one day be possible.

For several years, cloning remained a topic for fiction and philosophy, but fantasy had yet to turn into fact. In 1978, in a book titled In His Image: The Cloning of a Man, science writer David Rorvik claimed that he was involved in a secret project to clone a millionaire in Montana named "Max." The book caused a flurry of reaction�ranging from horror to amusement to nearly universal skepticism and denunciation in the scientific community�and eventually led to hearings before Congress on May 31, 1978. Robert Briggs, who with Thomas King cloned the first frog embryo from blastula frog cells in 1952, declared that the work in frogs demonstrated not that human cloning is now or imminently possible, but that "cloning in man or any other animal is not just a technical problem to be solved soon but may, in fact, never occur." James Watson, who just a few years earlier had urged a national conversation and possible legislation on human cloning because of the rapid advances in the science, declared that we would "certainly not [see the cloning of a man] in any of our lifetimes. I wouldn�t be able to predict when we might see the cloning of a mouse, much less a man." Rorvik eventually admitted that the book was a hoax.

In the years that followed, claims and counter-claims of scientific advances in mammalian cloning�including the controversy beginning in 1981 over whether any of several independent laboratories had actually cloned mice�prompted more public reaction and discussion about the issue. But there was no sustained or widespread public interest, and cloning lost its prominent place within the bioethics literature. The President�s Bioethics Commission, in its 1982 report Splicing Life, briefly discussed human cloning as well as IVF, but held that both were beyond the scope of that report because they could be considered reproductive technologies that did not necessarily involve modifying the genome (pp. 9-10). With regard to human cloning in particular, the report added that the possibility had received a good deal of public attention and it was therefore important to emphasize that even if it ever did become possible in humans, it would not result in an identical being.

The National Institutes of Health Human Embryo Research Panel, which issued a report in 1994 on federal funding for research involving preimplantation human embryos, deemed research involving nuclear transplantation, without transfer of the resulting cloned embryo to a uterus, as one type of research that was acceptable for federal support. The report noted that the majority on this point was narrow, with nearly as many panel members concluding that the ethical implications of nuclear transplantation should be studied further before any such research could be acceptable for federal funding (Exec. Summ., p. xvii). In its discussion of cloning techniques, the panel noted that many different procedures are all called "cloning," and said in a footnote (on page 28 of the report), "Popular notions of cloning derive from science fiction books and films that have more to do with cultural fantasies than actual scientific experiments."

Of course, there had been, in the meantime, continued scientific work in nuclear transplantation in animals�including mammals. And with the 1997 announcement of the cloning of Dolly, the prospect of human cloning once again became a prominent issue in public discussion, debate, and public life.

The Human Cloning Debate: From Dolly to the Present

Most ethicists agreed, though for different reasons. All agreed that cloning attempts on human beings "at this time" would be reckless experiments on the child-to-be and therefore totally unjustified. Many stressed, as Ramsey, Gaylin, and Kass had done in the 1970s, the ways that human cloning would undermine the human meaning of parenthood and identity; that it would mean a giant step toward genetic engineering, creating the first children whose genetic predisposition was known and selected in advance; and that it would turn procreation increasingly into a form of manufacture. In contrast, some bioethicists, including John Robertson and Ruth Macklin, believed that human cloning presented no inherent threat to public or private morality, that government had no legal authority or justification for banning clonal reproduction, and that it must be judged in terms of its particular uses, not dismissed outright.

In June 1997, NBAC released its report Cloning Human Beings, which concluded that

At present, the use of this technique to create a child would be a premature experiment that would expose the fetus and the developing child to unacceptable risks. This in itself might be sufficient to justify a prohibition on cloning human beings at this time, even if such efforts were to be characterized as the exercise of a fundamental right to attempt to procreate.³

In early 1998, the United States Senate considered legislation, proposed by Republican Senators Christopher Bond of Missouri, Bill Frist of Tennessee, and Judd Gregg of New Hampshire, to ban all human cloning permanently. Nearly all senators denounced clonal reproduction, but many believed that the proposed ban, which would have made it illegal to create human embryos by means of somatic cell nuclear transfer, would undermine potentially valuable scientific research. Democratic Senators Edward Kennedy of Mas- sachusetts and Tom Harkin of Iowa led the opposition, with the widespread support of patient advocacy groups, scientific and medical organizations, and the biotechnology industry. As Senator Kennedy put it:

Every scientist in America understands the threat this legislation poses to critical medical research. Every American should understand it, too. . . . Congress can and should act to ban cloning of human beings during this session. But it should not act in haste, and it should not pass legislation that goes far beyond what the American people want or what the scientific and medical community understands is necessary or appropriate.

On July 31, 2001, the House of Representatives passed the Weldon-Stupak bill (the ban on human cloning) by a vote of 265 to 162. In November 2001, scientists at Advanced Cell Technology, Inc., of Worcester, Massachusetts, one of the leading commercial advocates of cloning-for-biomedical-research, reported what they claimed were the first cloned human embryos. The announcement�along with continued debate on the possible use of cloned human embryos for stem cell research�left the issue in the United States Senate, where it stands as of this writing.

Meanwhile, the general public has consistently expressed the view that human cloning is wrong�most recently, a Gallup poll from May 2002 that showed opposition to cloning to produce a child at 90 percent, and opposition to "cloning of human embryos for use in medical research" at 61 percent. Asked about medical research using stem cells obtained from human embryos (with no mention of how the embryo was generated), 52 percent found it morally acceptable, while 51 percent found acceptable the "cloning of human cells from adults for use in medical research."⁵

In addition to activity at the federal level, many states have been active. As of this writing, twenty-two states have considered various policy alternatives on cloning, and six have passed legislation.^iv

Several nations, including Denmark, France, Norway, Spain, and Canada have passed or sought either partial or total bans. For example, in the United Kingdom, cloning-to-pro-duce-children is forbidden but cloned embryos up to fourteen days old may be used in biomedical research. In Germany, all human cloning is forbidden by law. There are also efforts now at the United Nations and other international organizations to pass a world-wide ban on human cloning�with many of the same disagreements internationally as there are nationally about what kind of ban to pass.

ENDNOTES

1. Regalado, A. "Only Nine Lives for Kitty? Not if She Is Cloned" Wall Street Journal, February 14, 2002, p. B1. Kluger, J. "Here Kitty Kitty!" Time, February 17, 2002.
   
   
2. Annas, G.J. "Human Cloning: A Choice or an Echo?" University of Dayton Law Review, 23 (2): 1-19, Winter 1998.
   
   
3. NBAC, Cloning Human Beings, 1997, p. 104.
   
   
4. Jaenisch, R., and I. Wilmut, "Don't clone humans!" Science 291: 5513, March 30, 2001.
   
   
5. Saad, L. "Cloning Humans Is a Turn-Off to Most Americans" Gallup Poll Analyses, May 16, 2002.

On Terminology

• Human cloning.
• Cloning-to-produce-children.
• Cloning-for-biomedical-research.
• Cloned human embryo.

Introduction: The Importance of Careful Use of Names

What exactly is meant by the term "cloning"? What criterion justifies naming an entity a "clone"? How is the term "cloning" related to what scientists call "somatic cell nuclear transfer (SCNT)" or "nuclear transplantation"? What should we call the single-cell entity that results from SCNT, and what should we call it once it starts to divide and develop? How, if at all, should our names for such activities or such entities be affected by the purposes we have for engaging in the activities or for using the entities?

As these questions imply, there is much confusion today about the terms used in discussing human cloning. There is honest disagreement about what names should be used, and there are also attempts to select and use terms in order to gain advantage for a particular moral or policy position. One difficulty is the difference between the perspective of science and the perspective of lived human experience. People who look at the phenomena of human reproduction and development through the lens of science will see and describe things in terms that often differ widely from those in ordinary usage; moreover, when an ordinary term is used in scientific parlance, it sometimes is given a different meaning. Similar divergences are possible also for people who look at these matters through the lens of different cultural, philosophical, or religious beliefs. Yet at the same time, all of us -- scientists or not, believers or not -- encounter these same matters on the plane of lived human experience, for which the terms of everyday speech may well be more suitable. Because this same common (nonscientific) discourse is also the medium of discourse for the ethical and policy discussions, we shall strive to stay close to common speech, while at the same time making the best use we can of scientific findings to avoid mistakes and misconceptions.

Advisers to decision makers should strive not only for accuracy, but also for fairness, especially because the choice of names can decisively affect the way questions are posed and, hence, how answers are given. The issue is not a matter of semantics; it is a matter of trying fairly to call things by names that correctly describe them, of trying to fit speech to fact as best one can. For the sake of clarity, we should at least stipulate clearly the meanings we intend by our use of terms. But we should also try to choose terms that most accurately convey the descriptive reality of the matter at hand. If this is well done, the moral arguments can then proceed on the merits, without distortion by linguistic sloppiness or chicanery.

Many of the terms that appear in the debate about cloning are confusing or are used in a confused manner.

First, there are difficulties concerning the terms that seek to name the activity or activities involved: cloning, asexual reproduction, reproductive cloning, nonreproductive cloning, research cloning, therapeutic cloning, somatic cell nuclear transfer (or nuclear transplantation), nuclear transfer for stem cell research, nuclear transplantation to produce stem cells, nuclear transfer for regenerative medicine. At stake are such questions as whether all acts of SCNT should be called cloning. Some worry that the term "cloning" unfairly prejudices people against the activity when it is used to describe research activities.

Second, there are difficulties concerning the terms that seek to name the entity or entities that result from human cloning (or human SCNT): cell, egg, activated cell, totipotent cell, clonote, reconstituted (or reconstructed) egg, zygote, clump of cells, embryo, human embryo, human organism, blastocyst, clonocyst, potential human being, human being, human clone, person. At stake here is the nature�and the possible moral status�of the entities that are involved in the subsequent manipulations, whether for producing a child or for use in biomedical research. Some worry that use of any term but "embryo" will unfairly prejudice people in favor of embryo-destructive activities by hiding from view the full import of the activity.

Third, there are difficulties concerning the terms that seek to describe the relation between the cloned entity and the person whose somatic cell nucleus was transferred to produce the cloned entity: genetic copy, replica, genetically virtually identical, noncontemporary twin, delayed genetic twin, clone.

Tools of Analysis

To illustrate: in vitro fertilization (IVF: the merging of egg and sperm outside the human body [in vitro = "in glass"], yielding a zygote that is the beginning stage of a new living being) is the deed (what). It is an act of "fertilization," of making fertile, of making the egg cell ready and able to develop into a human organism. This fertilization may be accomplished in at least two ways (how): by merely mixing egg and sperm, allowing the sperm to find and penetrate the egg, or by the technique of injecting individual sperm directly into the egg (a technique known as intracytoplasmic sperm injection, ICSI). And it may be done for the (proximate) purpose (why) of initiating a pregnancy, in turn for the (ultimate) purpose of providing a child for an infertile couple; or it may be done for the (proximate) purpose of providing living human embryos for basic research on normal and abnormal embryological development, in turn for the (ultimate) purposes of understanding human development or of discovering cures for diseases and producing tissues for regenerative medicine. Though the technique used or the purposes served may differ, in one crucial respect the deed (IVF) remains the same and bears a common intrinsic meaning: a human zygote, the first stage of a new human being, is intentionally produced outside the body and exists in human hands and subject to human manipulation.

As it happens, this fact is more or less accurately reflected in the descriptive terminology used for IVF. Interestingly enough, unlike the situation with cloning, no one distinguishes between "reproductive IVF" and "therapeutic IVF" or "research IVF," naming the activity or deed after the motive or purpose of the agent. This may reflect the historical fact that IVF was initiated by people who were interested in using it to produce live-born children for infertile couples; the research use of "surplus" embryos produced by IVF came only later. But it happens that this common name is also descriptively apt and remains so regardless of why IVF was done in a particular case: the deed is fertilization of egg by sperm, producing a living human zygote, the first stage of the development of a new human being.

It should be noted that, although we began by trying to describe the deed rather than the product of the deed, the two aspects merged necessarily. The meaning of the act of "fertilization" falls forward onto the nature of the "object" that fertilization produces: the fertilized egg or zygote or earliest embryo.ⁱ (By contrast, there is nothing in the name of the technique "intracytoplasmic sperm injection", that even hints at the immediate result or goal of the intended injection.) Similar attention to the nature of the product may turn out to be indispensable for a proper characterization of the activity of cloning.

Cloning: Toward an Appropriate Terminology

In the sense relevant here, "cloning" is a form of asexual reproduction (parthenogenesisⁱⁱ is another), the production of a new individual not by the chance union of egg and sperm but by some form of replication of the genetic makeup of a single existing or previously existing individual. (In biological or functional terms, the core of sexual reproduction is not bodily intercourse but the fusion of male and female germ cells; thus IVF, though it takes place outside the body, is�biologically speaking�a form of sexual reproduction.) Cloning is the activity of producing a clone, an individual or group of individuals genetically virtually identical to the precursor that is being "replicated."ⁱⁱⁱ

Cloning-to-Produce-Children; Cloning-for-Biomedical-Research

Some object to the term "reproductive cloning" used as a term of distinction, because they argue that all cloning is reproductive. Their reason: all human cloning intends and issues in the production of a cloned human embryo, a being distinct from the components used to generate it, a new human being in the earliest stage of development or "reproduction." (This claim, we would suggest, is at this stage a descriptive point, not yet a normative one; it does not necessarily imply that such a being is fully human or "one of us," hence deserving of the moral and social protection accorded "persons.") The fact that only some of these embryonic cloned humans are wanted for baby-producing purposes does not, in the view of these critics, alter this fact about their being. In support of their claim that cloning occurs (only) at the beginning, they note that once the cloning act of nuclear transfer has occurred, all new influences that act upon the new human organism cease to be "genetic" (nature) and are now "environmental" (nurture). Instead of "reproductive cloning," we shall speak of "cloning-to-produce-children."

Others object to the term "therapeutic cloning" for related reasons. The act of cloning embryos may be undertaken with healing motives. But it is not itself an act of healing or therapy.^iv The beneficiaries of any such acts of cloning are, at the moment, hypothetical and in the future. And if medical treatments do eventually result, the embryonic clone from which the treatment was derived will not itself be the beneficiary of any therapy. On the contrary, this sort of cloning actually takes apart (or destroys) the embryonic being that results from the act of cloning.

To avoid the misleading implications of calling any cloning "therapeutic," we prefer the terms "research cloning" or "cloning for research," which also more accurately indicate the purpose of the activity. Yet some may find fault with this replacement. Because it appears to be a deliberate substitution for "therapeutic cloning," it may seem to imply that the scientists have abandoned the pursuit of medical cure in favor of research as an end in itself. Believing that producing cloned embryos just for research would seem to be less justifiable than producing them with healing motives, these critics of the term "research cloning" want to avoid giving the impression that scientists want to experiment on new life just to satisfy their curiosity. We believe that this legitimate concern can be addressed by appending the adjective "biomedical" to make clear that the aim of the research is to seek cures and treatments for human diseases. We therefore opt to use the term "cloning-for-biomedical-research."

Some proponents of the activity called "therapeutic cloning" also now object to the term, but not because of the adjective. Though it was proponents who originally coined and used the term, some of them now want to shed the term "cloning," fearing that the bad or distressing connotations of the latter will weigh against the activity itself. Cloning, they insist, should be reserved for the activity that produces live-born cloned babies; it should not apply to the initial act that starts the process, which they would rather call "somatic cell nuclear transfer" or "nuclear transplantation."¹ The reason for such re-description is not wholly cosmetic and rhetorical; because the researchers are primarily interested in obtaining pluripotent^v stem cells, their focus is on the somatic cell nucleus and what must be done to it (transfer or transplantation) in order for it to revert to the undifferentiated condition of the primordial stem cell stage. Nevertheless, such terminological substitution is problematic, for the following reasons.

Although as a scientific matter "somatic cell nuclear transfer" or "nuclear transplantation" may accurately describe the technique that is used to produce the embryonic clone, these terms fail to convey the nature of the deed itself, and they hide its human significance. The deed, fully described, is the production of a living human entity (or "embryo" or "organism"; of the right name for the product, more later) that is genetically virtually identical to the donor organism, a fact or meaning not captured in the name for the technique or method, the transfer of a somatic cell nucleus (into an unfertilized egg whose own nucleus has been removed or inactivated).^vi As a name, SCNT is not a fully accurate description even of the technique itself. It makes no reference to the intended and direct result of the deed of nuclear transfer. It also omits mention of the fact that the recipient of the transferred nucleus is an (enucleated) egg cell (rather than another kind of cell), which then can be made to initiate cell division as if it were just like a zygote produced by fertilization. The further amendments, "somatic cell nuclear transfer for stem cell research" or "nuclear transplantation for regenerative medicine" or "nuclear transplantation to produce stem cells" only compound the difficulty, mixing in the purpose of the activity with its technique, thus further obscuring the immediate meaning of the act itself, the production of a living cloned human embryo.

Cloned Human Embryo: The Product of SCNT

The initial product of SCNT is a single cell, but it is no ordinary cell. It is also an "egg" and a "reconstituted egg." But even that is not the whole story. The "reconstituted" egg is more than reconstituted; it has been capacitated for development. Because the egg now has a diploid nucleus, it has become something beyond what it was before: it now contains in a single nucleus the full complement of genetic material necessary for producing a new organism.^vii And being an egg cell, it uniquely offers the cytoplasmic environment that can support this development. The product of SCNT thus resembles and can be made to act like a fertilized egg, a cell that not only has the full complement of chromosomes but also is capable (in animals) or may be capable (in humans) of developing into a new organism. In other words, in terms of its future prospects, it is a "zygote-like entity" or a (cloned) "zygote equivalent."^viii

The initial product of SCNT is, to be sure, not just a cell but an active cell. (More precisely, it is a cell that can be activated by electric stimulation.) But "activated cell" is much too vague to describe the activity of which it is capable. For, once stimulated, the activity of this "cell" produced by SCNT is nothing other than human embryological development, initiated and directed by the cell itself. The processes of cellular growth, chromosomal replication, cell division, and (ultimately) differentiation into the tissues and organs of the organism are coordinated processes under the governance of the immanent developmental plan encoded in the cell�s genetic material. In other words, the product of SCNT is an organism in its germinal stage, and its activities are those of an integrated and self-developing whole.^ix

Another suggested name, better than "activated cell," is "totipotent cell"�a cell that is "capable of all." But this too is ambiguous. If what is meant is that it can (and will, should it be stimulated to do so) become "any and all" of the different kinds of cells in the body, then it is an insufficient meaning. For, as explained in the previous paragraph, this totipotent cell may also become the "all" that is the integrated whole (cloned) mature organism itself (along with a portion of the placenta that would give it nourishment). In this second and fuller meaning of "totipotent," a totipotent cell is then just a functional synonym for the "zygote": "zygote" etymologically reminds one of the cell�s origins in egg-joined-to-sperm; "totipotency" describes what it is capable of. A fertilized egg is precisely a "totipotent" cell; the product of human SCNT is, we assume, its equivalent.

In some discussions, the next few stages of the developing cloned human entity have been described as "clumps of cells." Yet, for reasons already given, this is only partially accurate. Viewed externally, under the microscope, the developing embryo will appear as two, then four, then eight cells "clumped" together, and the 100-to-200-cell blastocyst stage will indeed appear as a "ball of cells." Yet there is more here than meets the eye, for the "clump" is governed by an internal principle of development that shapes and directs its transformations. Thus, this ball or clump is not a mere heap or aggregate; it is a primordial and unfolding whole that functions as a whole and that is in the process of developing (or attempting to develop) into a mature whole being. Of course, if development is not pursued or not allowed to happen because of disruption, then the "clump of cells" description may be rendered accurate not just microscopically but also biologically. But as long as development continues and the developing entity is intact, that is not the case.

It would seem, then, that�whatever the reason for producing it�the initial product of somatic cell nuclear transfer is a living (one-celled) cloned human embryo. The immediate intention of transferring the nucleus is precisely to produce just such an entity: one that is alive (rather than nonliving), one that is human (rather than nonhuman or animal), and one that is an embryo, an entity capable of developing into an articulated organismic whole (rather than just a somatic cell capable only of replication into more of the same cell type). This is the intended primary product of performing SCNT, whether the ultimate motive or purpose is producing a live-born child from the cloned embryo or conducting scientific research on the cloned embryo. Also, the blastocyst stage that develops from this one-celled cloned embryo will be the same being, whether it is then transferred to a woman�s uterus to begin a pregnancy or is used as a source of stem cells for research and possible therapy for others.

Yet, not surprisingly, objections have been raised to calling this cloned entity an "embryo," objections having to do both with its origins and with the uncertainty about the extent of its developmental potential. There are also objections having to do not with the facts but with public connotations and perceptions: for some members of the public, the word "embryos" apparently conjures images of miniature babies. If "nuclear transplantation to produce stem cells" seems to some people to be unfairly morally neutered terminology, "embryo" seems to other people to be unfairly morally loaded terminology, especially when used to describe an entity barely visible to the naked eye. We acknowledge this problem and recognize that, despite our best efforts, such difficulties in public perception probably cannot be simply corrected. But we do not regard this as sufficient reason to scrap the use of a term if it is in fact most appropriate. The other objections to calling the product of SCNT an "embryo" are not about rhetoric and politics, but about the thing itself. They should be addressed.

First, "human embryo," in the traditional scientific definition of this term, refers to the earliest stages of human development, from the zygote through roughly eight weeks of gestation, after which time it is called a fetus. Because the product of SCNT is technically not a zygote, not having come from egg and sperm, it is argued that it cannot therefore be an embryo. Second, it is said that it cannot be an embryo because it is an "artifact," something produced entirely by human artifice, "made" rather than "begotten." Third, we do not yet know for sure whether this entity can in fact develop into a baby; hence, we do not know whether it has the full developmental potential of a human embryo formed by fertilization.

There are, however, good responses to these objections. The first product of SCNT is, on good biological grounds, quite properly regarded as the equivalent of a zygote, and its subsequent stages as embryonic stages in development. True, it is not technically "zygotic" in origin, and it owes its existence to human artifice. But these objections, dealing only with origins, ignore the organization and powers of this entity, and the crucially important fact of its capacity to undergo future embryological development -- just like a sexually produced embryo. True, it originates as a result of human artifice, and it lacks the natural bi-parental (male-plus-female) precursors. But this particular "artifact" is alive and self-developing, and should it eventually give rise to a baby, that child would in its being and its capacities be indistinguishable from any other human being -- hardly an artifact -- in the same way that Dolly is a sheep. True, regarding its developmental potential, we do not yet have incontrovertible proof that a cloned human embryo can in fact do what embryos are "supposed" to do and what animal cloned embryos have already done, namely, develop into all the later stages of the organism, up to its full maturity (à la Dolly). But if we do not assume this last possibility -- an assumption based on the biological continuity of all mammals^x -- there would be nothing to talk about in this whole matter of human cloning. As we emphasized in the first chapter of this report, this entire inquiry assumes that cloned human embryos can someday be developed into live-born human beings.

Once we make this assumption, neither its artificial nor its uni-parental source alters the decisive point: the product of SCNT is an entity that is the first stage of a developing organism�of a determinate species (human), with a full genetic complement, and its own (albeit near-replicated) individual genetic identity. It hence deserves on functional grounds to be called an embryo. And that is the heart of the reason why we in this report shall call it an "embryo" (actually, for reasons soon to be discussed, a "cloned embryo"): because the decisive questions to be addressed in our moral reflections have to do not with the origin of the entity but with its developmental potential, its embryonic character must be kept centrally in mind.

This decision, based on what we believe comes closest to the truth about the product of SCNT, is supported by other, more practical considerations. We are disinclined to introduce other words to describe the early product of human cloning that might deprive discussion of the ethics of human cloning of its humanly significant context. Despite the novelty of cloning and its products, their considerable kinship to elements of normal reproduction and development means that we enter upon the discussion equipped with existing and relevant terms and notions. We do not start in a terminological vacuum or with an empty dictionary. We observe that even people who prefer not to call the one-celled product of SCNT a zygote or embryo use terms like "blastocyst" and "embryo" to name the product a few cell divisions later.^xi We think that using or coining other words will be more confusing to members of the public as they try to follow and contribute to the ethical discussion. And we clearly assume, as already stated, that the product of human SCNT could someday be shown (were it legal to attempt such a showing) to be capable of developing into a later-stage embryo, fetus, or live human being, even though such capacity has yet to be documented.

There are also very important ethical reasons that support our choice. We want to be very careful not to make matters easy for ourselves. We do not want to define away the moral questions of cloning-for-biomedical-research by denying to the morally crucial element a name that makes clear that there is a moral question to be faced. Yes, there is some ground for uncertainty about the being of the product of SCNT. Yet because something is ambiguous to us does not mean that it is ambiguous in itself. Where the moral stakes are high, we should not allow our uncertainty to lead us to regard the subject in question as being anything less than it might truly be.

The product of "SCNT" is not only an embryo; it is also a clone; genetically virtually identical to the individual that was the source of the transferred nucleus, hence an embryonic clone of the donor.^xii There is, to be sure, much discussion about how close the genetic relation is between donor and embryonic clone, and about the phenotypic similarity of the clone to the donor. Yet the goal in this process is in fact a blastocyst-stage cloned embryo (in the case of cloning-for-biomedical-research) or (in the case of cloning-to-produce-children) a child who is genetically virtually identical to the donor; otherwise there would be no reason to produce the cloned embryo by SCNT rather than by ordinary IVF. A full and fitting name of the developing entity produced by human SCNT is "cloned human embryo," a term that also allows us to remember that, thanks to its peculiar origins, this embryo is not in all respects identical to an embryo produced by fertilization of egg by sperm.

As if things were not difficult enough, a further complication may soon arise, following reports of successful SCNT experiments in which human somatic cells were fused with animal oocytes, and the resulting product grown to the blastocyst stage of development. What are we to call the product of this kind of cloning? And what kind of species identity does it have? According to the advance reports (based on a presentation at a scientific meeting), the stem cells extracted from the blastocyst stage were demonstrated to be human stem cells (somewhat surprisingly, the mitochondria were also human in genotype). Is this, therefore, a cloned human embryo? The only test that could settle the question�implantation into a woman�s uterus for attempted gestation to see if a human child results�cannot ethically even be contemplated without already assuming a positive answer. In the face of uncertainty, therefore, and lest we err by overconfidence, there is prima facie reason to include even these cross-species entities in the category of "cloned human embryos." (When we come to the ethical issues of cloning-for-biomedical-research, we can consider whether this terminological judgment is matched by an ethical one.)

Conclusion

Human cloning (what it is): 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.

Human cloning (how it is done): 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" (SCNT).

Human cloning (why it is done): This same activity may be undertaken for purposes of producing children or for purposes of scientific and medical investigation and use, a distinction represented in the popular discussion by 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) The immediate and developing product of the initial act of cloning, accomplished by SCNT. (b) A human embryo resulting from the somatic cell nuclear transfer process (as contrasted with a human embryo arising from the union of egg and sperm).

ENDNOTES

1. Vogelstein, B., et al. "Please don't call it cloning!" Science, 295: 1237, 2002.

2. Leggett, K. and A. Regalado. "China Stem Cell Research Surges as Western Nations Ponder Ethics" Wall Street Journal, March 6, 2002, p. A1.

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1. A more careful analysis of the what of this activity would distinguish between the activity itself and the product that results from it. Unlike nonproductive activities, such as dancing ("How can we know the dancer from the dance?"), the work (activity) of making or producing results in separable objects or works (products). Although shoemaking completes itself in the production of a shoe, the shoe as result is distinct from the activity of shoemaking. Similarly, though fertilization is an activity that is intelligible only as issuing in a fertilized egg, the now-fertile egg as result or product stands apart from the deed of IVF. One reason that the word "fertilization" works so well in describing IVF is that it is a very rich term, pointing both to cause and effect, backward to the deed and forward to the future pros-pects of the product.

2. Parthenogenesis (see Glossary of Terms), the development of an organism directly from an unfertilized egg that has been artificially induced to undergo development, is, in principle, another method of asexual reproduction. Although parthenogenetic reproduction has been successfully achieved in amphibians, in mammalian species there are as yet no reports of live births following parthenogenesis. Thus, there is at present little reason to believe that live-born human beings can be produced via parthenogenesis. It is therefore not the subject of this report, although many of the things said about cloning via somatic cell nuclear transfer would be applicable to asexual reproduction through parthenogenesis.

3. Although cloning, like fertilization, is responsible for bringing forth a new organism, the activities are named in very different ways, yet in each case emphasizing the fundamental intention of the activity. "Fertilization" describes the activity in terms of the capacitation of the egg, as a result of which development begins. "Cloning" describes the activity in terms of the relation between the progenitor and the product. In cloning by somatic cell nuclear transfer, the egg, though it is activated as if it were fertilized, is not cloned; cloned rather is the donor from whom the nucleus was taken, and the resulting organism (at all stages of development) is a clone of the donor. The name of the activ-ity, "cloning," even more than "in vitro fertilization," refers to the product of the activity, an identical (or nearly identical) entity.

4. Compare, in this respect, what used to be called "therapeutic abortion," an abortion undertaken in cases in which pregnancy threatened the life of the pregnant woman and where abortion was therefore intended to save the woman's life. Similarly, we might call the removal of a cancerous kidney a "therapeutic nephrectomy"; we would never use the term to refer to the removal of a kidney for donation to another person in transplantation.

5. Pluripotent cells are those that can give rise to many different types of differentiated cells. See Glossary of Terms.

6. This reduction of an act to its mechanism is roughly analogous to describing walking as "sequential alternate leg advancement" (SALA).

7. The original egg had a haploid nucleus, containing only half the chromosomes necessary for development. The diploid nucleus contains the full amount. See Chapter Four.

8. Technically, the term "zygote" (from a Greek root meaning "yoke") refers to the primordial cell that forms from the union of egg and sperm and the fusion (the yoking together) of their nuclei as the first step in the development of a new life that has come from the joining of its two parents. It is for this reason technically inappropriate to call the product of an asexual initiation a "zygote," though it may be its functional equivalent. The term "clonote" has been suggested as the strict analogue of "zygote," identifying the primordial cell formed in cloning by its special origin: just as a zygote arises from the "yoking together" of two elements, so a "clonote" arises from the act of clonal propagation from a single, already existing organism. (Similarly, the term "parthenote" for the primary product of parthenogenesis would accurately indicate that it arises from the "virgin" [unfertilized] egg alone; parthenos, Greek for "virgin.") The term "clonote" also has the merit of carrying the clonal character of the entity in its name.

9. For the reasons given in this paragraph, we reject the suggestion that the immediate product of SCNT and the cells it gives rise to should be considered "cells in tissue culture." Unlike somatic cells grown in laboratory culture, the immediate product of SCNT, although (like cultured tissues) it grows in culture media outside the body, is the germ of a new organism, not merely of other cells just like itself.

10. A recent press report indicates that as-yet-unpublished work in China by Sheng Huizhen involved insertion of human somatic cell nuclei into enucleated rabbit eggs, and that the resulting cloned embryos developed to a stage where human embryonic stem cells could be isolated.² And, of course, in other mammals the product of SCNT has been grown all the way to live-born young that grow up to be able to produce young of their own.

11. Thus, for example, the report on Scientific and Medical Aspects of Human Reproductive Cloning, released by the National Academy of Sciences in January 2002, describes "nuclear transplantation to produce stem cells" as "a very different procedure" from what it calls "human reproductive cloning." Nevertheless, the report falls quite naturally into our normal way of speaking, a way that recognizes that the cloned product is, indeed, a human embryo and that any stem cells obtained from it would be embryonic stem cells. Thus, for example, the authors of the report can write a sentence such as the following (p. 2-6): "The experimental procedures required to produce stem cells through nuclear transplantation would consist of the transfer of a somatic cell nucleus from a patient into an enucleated egg, the in vitro culture of the embryo to the blastocyst stage, and the derivation of a pluripotent ES cell line from the inner cell mass of this blastocyst." Other scientists clearly insist that the primary product of SCNT is an embryo (see, for example, Dr. John Gearhart's presentation to the Council on embryonic stem cells, March 25, 2002; transcript on the Council's website, www.bioethics.gov).

12. The environment in which the donor came to be and lives surely differs from the one in which the cloned embryo may develop (if it does develop). There may be imprinting or epigenetic reprogramming differences in gene expression early on that may affect the physical and mental characteristics of the clone. There is also the matter of the mitochondrial genes (see Glossary of Terms), a small number of protein-producing genes out of a total of some 30,000 to 60,000, which are inherited from the female source of the egg (the clone would be genetically identical only in those cases in which the same woman donated both egg and somatic cell nucleus, to produce an embryonic clone of herself).

Scientific Background

Introduction

This review is based largely on scientific research papers published through June 2002, supplemented by references to several articles in the popular press. However, the research areas of cloning and stem cell research are being very actively investigated, and significant new developments are published frequently. Publication of new results could change some of the interpretations and emphases in this review.

Use of unfamiliar technical terms has been avoided wherever possible. Scientific names and terms used are described and defined in the Glossary of Terms.

Some Basic Facts about Human Cell Biology and Sexual Reproduction

Normal human cells with nuclei contain forty-six chromosomes, twenty-two pairs plus two X chromosomes if the individual is female, or twenty-two pairs plus one X and one Y chromosome if the individual is male. These chromosomes contain nearly all of the cell's DNA and, therefore, the genes of the cell. During formation of sperm cells, a process of specialized cell division produces mature sperm cells containing twenty-three chromosomes (twenty-two unpaired chromosomes plus either X or Y). During the formation of eggs (oocytes), a process of specialized cell division produces a cell containing two pronuclei, each of which contains twenty-two unpaired chromosomes plus an X. During fertilization, a polar body containing one of these pronuclei is ejected from the egg.

Fusion of egg and sperm cells and the subsequent fusion of their nuclei (the defining acts of all sexual reproduction) produce a zygote that again contains a nucleus with the adult cell complement of forty-six chromosomes, half from each parent [See Figure 1]. The zygote then begins the gradual process of cell division, growth, and differentiation. After four to five days, the developing embryo attains the 100-200 cell (blastocyst) stage. In normal reproduction, the blastocyst implants into the wall of the uterus, where, suitably nourished, it continues the process of coordinated cell, tissue, and organ differentiation that eventually produces the organized, articulated, and integrated whole that is the newborn infant. According to some estimates, about half of all early human embryos fail to implant, and are expelled with the menses during the next menstrual cycle.

Not quite all the DNA of a human cell resides in its nucleus. All human cells, including eggs and sperm, contain small, energy-producing organelles called mitochondria. Mitochondria contain a small piece of DNA that specifies the genetic instructions for making several essential mitochondrial proteins. When additional mitochondria are produced in the cell, the mitochondrial DNA is replicated, and a copy of it is passed along to the new mitochondria that are formed. During fertilization, sperm mitochondria are selectively degraded inside the zygote. Thus, the developing embryo inherits solely or principally mitochondria (and mitochondrial DNA) from the egg.

Human reproduction has also been accomplished with the help of in vitro fertilization (IVF) of eggs by sperm, and the subsequent transfer of one or more early embryos to a woman for gestation and birth. Even though such union of egg and sperm requires laboratory assistance and takes place outside of the body, human reproduction using IVF is still sexual in the biological sense: the new human being arises from two biological parents through the union of egg and sperm.

Egg and sperm cells combined in vitro have also been used to start the process of animal development. Transfer of the resulting blastocysts into the uterus of a female of the appropriate animal species is widely used in animal husbandry with resulting successful live births.

Cloning (Asexual Reproduction) of Mammals

1. Obtain an egg cell from a female of a mammalian species.

2. Remove the nuclear DNA from the egg cell, to produce an enucleated egg.

3. Insert the nucleus of a donor adult cell into the enucleated egg, to produce a reconstructed egg.

4. Activate the reconstructed egg with chemicals or electric current, to stimulate the reconstructed egg to commence cell division.
   
   
   [Reserved for Figure 1]
   
   
   
5. Sustain development of the cloned embryo to a suitable stage in vitro, and then transfer the resulting cloned embryo to the uterus of a female host that has been suitably prepared to receive it.

6. 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.

Cloning to produce live offspring carries with it several possibilities not available through sexual reproduction. Because the number of presumably identical donor cells is very large, this process could produce a very large number of genetically virtually identical individuals, limited only by the supply of eggs and female animals that could bear the young. In principle, any animal, male or female, newborn or adult, could be cloned, and in any quantity. Because mammalian cells can be frozen and stored for prolonged periods at low temperature and grown again for use as donor cells in cloning, one may even clone individuals who have died. In theory, a clone could be cloned again, on and on, without limit. In mice, such "cloning of clones" has extended out to six generations (Wakayama et al., 2000).

Since the report by Wilmut et al. (1997), attempts have been made to clone at least nine other mammalian species. As summarized in Table 1, live offspring have been produced in a low percentage of cloned embryo transfer experiments with sheep, cattle, goats, mice, pigs, cats (Shin et al., 2002) and rabbits (Chesne et al., 2002). According to a press report (Kolata, 2001), attempts to clone rats, dogs, and primates using adult cell DNA have not yet yielded live offspring. In experiments to clone different mammalian species, many of the transferred cloned embryos fail to develop normally and abort spontaneously in utero. In addition, a variety of health problems have been reported in many of the cloned animals that survived to live birth (NAS Report, 2002, Table 2). However, some surviving cloned cattle appear physiologically similar to their uncloned counterparts, and two cloned cows have given birth to their own offspring (Lanza et al., 2001; see also Cibelli et al., 2002a).

Why is production of live cloned mammalian offspring a relatively rare event? Several factors may play a role. Enucleation of the egg may (variably from one attempt to the next) remove or damage its "epigenetic reprogramming" (see Glossary of Terms) capabilities. Isolating a nucleus from the donor cell and manipulating it to insert it into the egg is also a traumatic process that may damage the nucleus. An optimal in vitro nutritive environment for the development of cloned animal embryos may not yet have been determined. One interpretation (Rideout et al., 2001) attributes the early death of many cloned embryos to complete failure or incompleteness of epigenetic reprogramming.

Epigenetic Modification and Reprogramming

During cloning, factors in the egg cell reprogram the chromosomal DNA of the somatic cell. In rare cases, this reprogramming is sufficient to enable embryonic development to proceed all the way to the birth of a live animal (for examples, see Table 1). In many cloning experiments, epigenetic reprogramming fails or is abnormal, and the developing animal dies (Rideout et al., 2001). Incomplete epigenetic reprogramming could also explain why some live-born cloned animals suffer from subtle defects that sometimes do not appear for years (Ogonuki et al., 2002).

The completeness of epigenetic reprogramming is crucial for successful cloning-to-produce-children. It will also be important to assess the impact of variation in epigenetic reprogramming on the biological properties of cloned stem cell preparations. If the extent of epigenetic reprogramming varies from one cloning event to the next, the protein expression pattern and thus the biological properties of cloned stem cell preparations may also vary. Thus, it may be necessary to produce and test multiple cloned stem cell preparations before preparations that are informative about human disease or useful in cellular transplantation therapies can be identified.

Cloning-to-Produce-Children

Stem Cells and Regenerative Medicine

Stem cells are undifferentiated multipotent precursor cells that are capable both of perpetuating themselves as stem cells and of undergoing differentiation into one or more specialized types of cells (for example, kidney, muscle). Human embryonic stem cells have been isolated from embryos at the blastocyst stage (Thomson et al., 1998) or from the germinal tissue of fetuses (Shamblott et al., 1998). Multipotent adult progenitor cells have been isolated from sources such as human (Reyes et al., 2002) and rodent (Jiang et al., 2002) bone marrow. Such cell populations can be differentiated in vitro into a number of different cell types, and thus are the subject of much current research into their possible uses in regenerative medicine. Cloned human embryonic stem cell preparations could be produced using somatic cell nuclear transfer to produce a cloned human embryo, and then taking it apart at the (100-200 cell) blastocyst stage and isolating stem cells (see Figure 2). These stem cells would be genetically virtually identical to cells from the nucleus donor.

Scientists are pursuing the development of therapies based on transplantation of cells for several human diseases, Parkinson's disease and Type I diabetes. In Parkinson's disease, particular brain cells that produce the essential neurotransmitter dopamine die selectively. Experimental clinical treatment involving transplantation of human fetal brain cell populations, in which a small fraction of the cells produce dopamine, has improved the condition of some Parkinson's disease patients (Hagell and Brundin, 2001). Dopamine-producing neurons derived from mouse embryonic stem cells have been shown to function in an animal model of Parkinson's disease (Kim et al., 2002). Thus, there is a possibility that transplantation of dopamine-producing neural cells derived from embryonic or adult stem cell populations might be a useful treatment for Parkinson's disease in the future.

However, to be effective as long-term treatments of Parkinson's disease, Type I diabetes, and other diseases, cell transplantation therapies will have to overcome the immune rejection problem. Cells from one person transplanted into the body of another are usually recognized as foreign and killed by the immune system. If cells derived from stem cell preparations are to be broadly useful in transplantation therapies for human diseases, some way or ways around this problem will have to be found. For example, if the cells were isolated from a cloned human embryo at the blastocyst stage, in which the donor nucleus came from a patient with Parkinson's disease, in theory these stem cells would produce the same proteins as the patient. The hope is that dopamine-producing cells derived from these "individualized" stem cell preparations would not be immunologically rejected upon transplantation back into the Parkinson's disease patient. Alternatively, if dopamine-producing cells could be derived from adult stem cell or multipotent adult precursor cell populations, they could also be used in such therapies. Another possibility is mentioned in a press report (Weiss, 2002) about work with a single Parkinson's disease patient, in which brain cells were removed from the patient, expanded by growth in vitro, stimulated to increase dopamine production, and transplanted back into the brain of the same patient with an observed reduction in disease symptoms.

By combining specific gene modification and cloned stem cell procedures, Rideout et al. (2002), have provided a remarkable example of how some human genetic diseases might someday be treated. Starting with a mouse strain that was deficient in immune system function because of a gene mutation, these investigators (1) produced a cloned stem cell line carrying the gene mutation, (2) specifically repaired the gene mutation in vitro, (3) differentiated the repaired cloned stem cell preparation in vitro into bone marrow precursor cells, and (4) treated the mutant mice with the repaired bone marrow precursor cells and observed a restoration of immune cell function.


[Reserved for Figure 2]


Although remarkably successful, the experimental results included a caveat. The investigators also observed a tendency of even these cloned bone marrow precursor cells to be recognized as foreign by the recipient mice. Rideout et al. were led to conclude: "Our results raise the provocative possibility that even genetically matched cells derived by therapeutic cloning may still face barriers to effective transplantation for some disorders."

Lanza et al. (2002) have also evaluated the potential for immune rejection of cloned stem cell materials. Cloned cattle embryos at the blastocyst stage were transferred to the uteri of surrogate mothers and allowed to develop for five to eight weeks. Fetal heart, kidney, and skeletal muscle tissues were isolated, and degradable polymer vehicles containing these cloned cells were then transplanted back into the animals that donated the nuclei for cloning. The investigators observed no rejection reaction to the transplanted cloned cells using two different immunological tests. More investigations with cloned stem cell materials involving different stem cell preparations of varying sizes, different sites of implantation, and sensitive tests to detect low levels of immunological rejection will be required for a complete assessment of the possibility of using cloned stem cell populations to solve the immune rejection problem.

Human Cloning-for-Biomedical-Research

One attempt at human cloning-for-biomedical-research has been published in the scientific literature (Cibelli et al., 2001) as of the end of June 2002.ⁱⁱ It involved the following steps (see Figure 1):

1. Obtain human eggs from informed and consenting female volunteers.

2. Remove the nuclear DNA from the egg cell to produce an enucleated egg.

3. Insert the nucleus of a cell from an informed and consenting adult donor into the enucleated egg, to produce a reconstituted egg.

4. Activate the reconstituted egg with chemicals or electricity to stimulate it to commence cell division in vitro, producing a cloned embryo.

5. Use a microscope to follow the early cell divisions of the cloned embryo.

In the experiments described by Cibelli et al. (2001), the stated intent was to create cloned human embryos that would progress to the 100-200 cell stage, at which point the cloned embryo would be taken apart, stem cells would be isolated from the inner cell mass, and an attempt would be made to grow and preserve "individualized" human stem cells (see Figure 2) for the possible future medical benefit of the somatic cell donor. Because the cloned human embryos stopped dividing and died at the six-cell stage, no stem cells were isolated in these experiments. In light of results in other animal species and the variable completeness of "epigenetic reprogramming," it is perhaps not surprising that sixteen of the nineteen cloned human embryos did not undergo cell division and none of the other three divided beyond the six-cell stage (Cibelli et al., 2001).

Although the steps Cibelli et al. (2001) followed in these experiments were the same as those that would be used by those attempting human cloning-to-produce-children, Cibelli et al. (2001) distinguished their intent from such cloning by stating: "Strict guidelines for the conduct of this research have been established by Advanced Cell Technology's independent Ethics Advisory Board (EAB). In order to prevent any possibility of reproductive cloning, the EAB requires careful accounting of all eggs and embryos used in the research. No embryo created by means of NT [nuclear transfer] technology may be maintained beyond 14 days of development."

Parthenogenesis (Another Form of Asexual Reproduction)

Cibelli et al. (2001) activated human eggs (obtained from informed and consenting donors) by parthenogenesis, and obtained multiple cell divisions up to the early embryo stage in six out of twenty-two attempts. Although there was no report that stem cells were isolated in these experiments, it is possible that parthenogenesis of human eggs could induce them to develop to a stage where parthenogenetic stem cells could be isolated. For example, Cibelli et al. (2002b) derived a monkey parthenogenetic stem cell preparation from Macaca fasicularis eggs activated by parthenogenesis. Whether cloned stem cells resulting from parthenogenesis have been completely and correctly epigenetically reprogrammed remains to be determined.

REFERENCES

Brown, D. "Human Clone's Birth Predicted; Delivery Outside U.S. May Come By 2003, Researcher Says" The Washington Post, May 16, 2002, p. A8.

Chesne, P., et al. "Cloned rabbits produced by nuclear transfer from adult somatic cells" Nature Biotechnology, 20: 366-369, 2002.

Cibelli, J.B., et al. "Somatic cell nuclear transfer in humans: Pronuclear and early embryonic development" e-biomed: The Journal of Regenerative Medicine, 2: 25-31, 2001.

Cibelli, J.B., et al. "The health profile of cloned animals" Nature Biotechnology, 20: 13-14, 2002a.

Cibelli, J.B., et al. "Parthenogenetic stem cells in nonhuman primates" Science, 295: 819, 2002b.

Hagell, P., and P. Brundin, "Cell survival and clinical outcome following intrastriatal transplantation in Parkinson's disease" J Neuropathol Exp Neurol, 60: 741-752, 2001.

Hall, C.T. "UCSF Admits Human Clone Research; Work to Duplicate Embryos for Medical Purposes on Hold" San Francisco Chronicle, May 25, 2002, p. A1.

Jiang, Y., et al. "Pluripotency of mesenchymal stem cells derived from adult marrow," Nature, 418: 41-49, 2002 (doi:10.1038/nature00870).

Kim, J-H. et al. "Dopamine neurons derived from embryonic stem cells function in an animal model of Parkinson's disease" Nature 418: 50-56, 2002 (doi:10.1038/nature00900).

Kolata, G. "In Cloning, Failure Far Exceeds Success" New York Times, December 11, 2001, page D1.

Lanza, R.P., et al. "Human therapeutic cloning" Nature Medicine, 5: 975-977, 1999.

Lanza, R.P., et al. "Cloned cattle can be healthy and normal," Science, 294: 1893-1894, 2001.

Lanza, R.P., et al. "Generation of histocompatible tissues using nuclear transplantation" Nature Biotechnology, 00: 1-8, 2002.

Leggett, K., and A. Regalado. "China Stem Cell Research Surges as Western Nations Ponder Ethics" Wall Street Journal, March 6, 2002, p. A1.

National Academy of Sciences (NAS). Scientific and Medical Aspects of Human Reproductive Cloning, Washington, DC. National Academy Press, 2002.

National Research Council/Institute of Medicine (NRC/IOM). Stem Cells and the Future of Regenerative Medicine. Washington DC. National Academy Press, 2001.

Ogonuki, N., et al. "Early death of mice cloned from somatic cells" Nature Genetics, 30: 253-254, 2002.

Reyes, M., et al. "Origin of endothelial progenitors in human postnatal bone marrow" Journal of Clinical Investigation, 109: 337-346, 2002.

Rideout III, W.M., et al. "Nuclear cloning and epigenetic reprogramming of the genome" Science, 293: 1093-1098, 2001.

Rideout III, W.M., et al. "Correction of a genetic defect by nuclear transplantation and combined cell and gene therapy" Cell, 109: 17-27, 2002.

Rougier, N., and Z. Werb. "Minireview: Parthenogenesis in mammals" Mol Reprod Devel 59: 468-474, 2001.

Shamblott, M.J., et al. "Derivation of pluripotent stem cells from cultured human primordial germ cells" Pro Nat Acad Sci U.S.A., 95: 13726-13731, 1998.

Shin, T., et al. "A cat cloned by nuclear transplantation" Nature, 415: 859, 2002.

Thomson, J.A., et al. "Embryonic stem cell lines derived from human blastocysts" Science, 282: 1145-1147, 1998.

Wakayama, T., et al. "Cloning of mice to six generations" Nature, 407: 318-319, 2000.

Weiss, R. "Human Cloning Bid Stirs Experts' Anger; Problems in Animal Cases Noted" The Washington Post, April 11, 2001, page A1.

Weiss, R. "Stem Cell Transplant Works in Calif. Case, Parkinson's Traits Largely Disappear," The Washington Post, April 9, 2002, p. A8.

Wilmut, I., et al. "Viable offspring derived from fetal and adult mammalian cells" Nature, 385: 810-813, 1997.

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1. Previous experiments dating from the 1950s had shown that it was possible to clone amphibians. Earlier experiments had also produced clones of animals using embryonic donor cells. What made the report of Dolly's birth stand out was the fact that a mammal had been cloned, and from cells taken from an adult.

2. According to a press report (Hall, 2002), other attempts to clone human cells for biomedical research were carried out at the University of California-San Francisco by Roger Pedersen and coworkers in 1999 and 2001. Another press report (Leggett and Regalado, 2002) indicates that as-yet-unpublished work in China by Sheng Huizhen involved insertion of human somatic cell nuclei into enucleated rabbit eggs, and that the resulting cloned embryos developed to a stage where human embryonic stem cells could be isolated.

The Ethics of Cloning-to-Produce-Children

Our present opposition to human reproductive cloning is based on science and medicine, irrespective of broader considerations. The panel stresses, however, that a broad ethical debate must be encouraged so that the public can be prepared to make decisions if human reproductive cloning is some day considered medically safe for mothers and offspring.³

In this chapter we attempt to take up this charge to engage in a broad ethical consideration of the merits of cloning-to-produce-children.

The prospect of cloning-to-produce-children raises a host of moral questions, among them the following: Could the first attempts to clone a human child be made without violating accepted moral norms governing experimentation on human subjects? What harms might be inflicted on the cloned child as a consequence of having been made a clone? Is it significant that the cloned child would inherit a genetic identity lived in advance by another -- and, in some cases, the genetic identity of the cloned child's rearing parent? Is it significant that cloned children would be the first human beings whose genetic identity was entirely known and selected in advance? How might cloning-to-produce-children affect relationships within the cloning families? More generally, how might it affect the relationship between the generations? How might it affect the way society comes to view children? What other prospects would we be tacitly approving in advance by accepting this practice? What important human goods might be enhanced or sacrificed were we to permit cloning-to-produce-children?

In what follows, we shall explicitly consider many of these questions. But as we do so, we shall not lose sight of the larger and fundamental human contexts discussed in Chapter One -- namely, the meaning of human procreation and care of children, the means and ends of biotechnology, and the relation between science and society. Indeed, overarching our entire discussion of the specific ethical issues is our concern for the human significance of procreation as a whole and our desire to protect what is valuable in it from erosion and degradation -- not just from cloning but from other possible technological and nontechnological dangers. Readers of this report are encouraged to consider the discussion that follows in a similar light.

We will begin by formulating the best moral case for cloning-to-produce-children -- describing both the specific purposes it might serve and the philosophic and moral arguments made in its favor. From there we will move to the moral case against cloning-to-produce-children. Beginning with the safety objections that have dominated the debate thus far, we will show how these concerns ultimately point beyond themselves toward broader ethical concerns. Chief among these is how cloning-to-produce-children would challenge the basic nature of human procreation and the meaning of having children. We shall also consider cloning's effects on human identity, how it might move procreation toward a form of manufacture or toward eugenics, and how it could distort family relations and affect society as a whole.

A. Purposes

In recent years, in anticipation of cloning-to-produce-children, proponents have articulated a variety of possible uses of a perfected technology: providing a "biologically related child" for an infertile couple; permitting reproduction for individuals or same-sex couples; avoiding the risk of genetic disease; securing a genetically identical source of organs or tissues perfectly suitable for transplantation; "replacing" a loved spouse or child who is dying or has died; obtaining a child with a genotype of one's own choosing (including one's own genotype); replicating individuals of great genius, talent, or beauty, or individuals possessing traits that are for other reasons attractive to the cloners; and creating sets of genetically identical humans who might have special advantages in highly cooperative ventures in both war and peace.⁴ The desire to control or select the genomes of children-to-be through cloning has charmed more than a few prospective users, in the United States and around the world.

Although we appreciate that a perfected technology, once introduced for one purpose, might then be used for any of these purposes, we shall examine further only those stated purposes that seem to us to merit serious consideration.

1. Purpose #1: To Produce Biologically Related Children

   Human cloning would allow individuals or couples with fertility problems to have biologically related children. For example, if a man could not produce sperm, cloning would allow him to have a child who is "biologically related" to him. In addition, it would allow married couples with fertility problems to avoid using donor gametes, and therefore avoid raising children with genetic inheritances from outside the marriage.

2. Purpose #2: To Avoid Genetic Disease

   Human cloning could allow couples at risk of generating children with genetic disease to have healthy children. For example, if both parents carried one copy of a recessive gene for the same heritable disorder, cloning might allow them to ensure that their child does not inherit the known genetic disease (without having to resort to using donor gametes or practicing preimplantation or prenatal genetic diagnosis and elimination of afflicted embryos or fetuses).

3. Purpose #3: For "Rejection-Proof" Transplants

   Human cloning could produce ideal transplant donors for people who are sick or dying. For example, if no genetic match could be found for a sick child needing a kidney or bone marrow transplant, and the parents had planned to have another child, cloning could potentially serve the human goods of beginning a new life and saving an existing one.

4. Purpose #4: To "Replicate" a Loved One

   Human cloning would allow parents to "replicate" a dead or dying child or relative. For example, one can imagine a case in which a family -- mother, father, and child -- is involved in a terrible car accident in which the father dies instantly and the child is critically injured. The mother, told that her child will soon die, decides that the best way to redeem the tragedy is to clone her dying child. This would allow her to preserve a connection with both her dead husband and her dying child, to create new life as a partial human answer to the grievous misfortune of her child's untimely death, and to continue the name and biological lineage of her deceased husband.

5. Purpose #5: To Reproduce Individuals of Great Genius, Talent, or Beauty

   Human cloning would allow families or society to reproduce individuals of great genius, talent, or beauty, where these traits are presumed to be based on the individuals' desirable or superior genetic makeups. For example, some admirers of great athletes, musicians, or mathematicians, believing that the admired attributes are the result of a superior genetic endowment, might want to clone these distinguished individuals. Just as the cloning of cattle is being promoted as a means of perpetuating champion milk- or meat-producing cows, so cloning-to-produce-children has been touted as a means of perpetuating certain "superior" human exemplars.

B. Arguments

The purposes or reasons for cloning-to-produce-children are, as they are stated, clearly intelligible on their face. When challenged, the defenders of these purposes often appeal to larger moral and political goods. These typically fall within the following three categories: human freedom, existence, and well-being.

1. The Goodness of Human Freedom

   Strictly speaking, the appeal to human freedom is not so much a defense of cloning itself as it is of the right to practice it, asserted against those who seek to prohibit it. No one, we suspect, would say that he wanted to clone himself or any one else in order to be free or to vindicate the goodness of liberty. Nevertheless, human freedom is a defense often heard in support of a "right" to clone.

   Those who defend cloning-to-produce-children on the grounds of human freedom make two kinds of arguments. The first is that because individuals in pluralistic societies have different definitions of the good life and of right and wrong, society must protect individual freedom to choose against the possible tyranny of the majority. This means securing and even expanding the rights of individuals to make choices so long as their choices do not directly infringe on the rights (and especially the physical safety) of other rights-bearing citizens. In Eisenstadt v. Baird (1972), the United States Supreme Court enunciated what has been called a principle of reproductive freedom: "If the right to privacy means anything, it is the right of the individual, married or single, to be free from unwarranted governmental intrusion into matters so affecting a person as a decision whether to bear or beget a child."⁵ Defenders of cloning-to-produce-children argue that, in the event that the physical risks to mother and future child were shown to be ethically acceptable, the use of this new reproductive technology would fall under the protective umbrella of reproductive freedom.

   A second defense of human cloning on the grounds of freedom is the claim that human existence is by its very nature "open-ended," "indeterminate," and "unpredictable." Human beings are always remaking themselves, their values, and their ways of interacting with one another. New technologies are central to this open-ended idea of human life, and to shut down such technologies simply because they change the "traditional" ways of doing things is unjustifiable. As constitutional scholar Laurence Tribe has argued in reference to human cloning: "A society that bans acts of human creation that reflect unconventional sex roles or parenting models (surrogate motherhood, in vitro fertilization, artificial insemination, and the like) for no better reason than that such acts dare to defy 'nature' and tradition (and to risk adding to life's complexity) is a society that risks cutting itself off from vital experimentation and risks sterilizing a significant part of its capacity to grow."⁶

2. The Goodness of Existence

   Like the appeal to freedom, the appeal to the goodness of existence is not an argument for cloning, but an argument against opponents who speak up in the name of protecting the cloned child-to-be against the harms connected with its risky and strange origins as a clone. This argument asserts that attempts to produce children through cloning, like any attempt to produce a child, will directly benefit the cloned-child-to-be, since without the act of cloning the child in question would not exist. Existence itself, it is argued, is the first "interest" that makes all other interests -- including the interests of safety and well-being -- possible. Even taking into account the possibility of serious genetic or developmental disorders, this position holds that a cloned individual, once born, would prefer existence as a clone to no existence at all. There is also a serious corollary about how, in the absence of a principle that values existence as such, we will and should regard and treat people born with disabilities or deformities: opponents of cloning might appear in a position of intolerance -- of saying to cloned individuals, "Better for us (and for you) had you never existed."

3. The Goodness of Well-Being

   The third moral argument for cloning-to-produce-children is that it would contribute in certain cases to the fulfillment of human goods that are widely honored and deeply rooted in modern democratic society. These human goods include the health of newborn and existing children; reproductive possibilities for infertile couples, and the possibility of having a biologically related child. In all these circumstances, human cloning could relieve existing suffering and sorrow or prevent them in the future. Those who take this position do not necessarily defend human cloning-to-produce-children as such. Rather, they argue that a moral and practical line can be drawn between cloning-to-produce-children that serves the "therapeutic" aims of health (for the cloned child-to-be, for the infertile couple, or for an existing child) and the "eugenic" aims of producing or mass-producing superior people.

   Underlying this argument is the belief that an existing generation has a responsibility to ensure, to the extent possible, the genetic quality and fitness of the next generation. Human cloning, they argue, offers a new method for human control and self-improvement, by allowing families to have children free of specific genetic diseases or society to reproduce children with superior genetic endowments. It also provides a new means for gaining knowledge about the age-old question of nature versus nurture in contributing to human achievement and human flourishing, and to see how clones of great geniuses measure up against the "originals."

C. Critique and Conclusion

While we as a Council acknowledge merit in some of the arguments made for cloning-to-produce-children, we are generally not persuaded by them. The fundamental weakness of the proponents' case is found in their incomplete view of human procreation and families, and especially the place of children therein. Proponents of cloning tend to see procreation primarily as the free exercise of a parental right -- to satisfy parental desires for self-fulfillment or for a child who is healthy or "superior." Parents seek to overcome obstacles to reproduction, to keep their children free of genetic disease or disorder, and to provide them with the best possible genetic endowment. The principles guiding such prospective parents are freedom (for themselves), control (over their child), and well-being (both for themselves and what they imagine is best for their child). Even taken together, these principles provide at best only a partial understanding of the meaning and entailments of human procreation and child-rearing. In practice, they may prove to undermine the very goods that the proponents of cloning aim to serve, by undermining the unconditional acceptance of one's offspring that is so central to parenthood.

There are a number of objections -- or at the very least limitations -- to viewing cloning-to-produce-children through the prism of rights. Basic human rights are usually asserted on behalf of the human individual agent: for example, a meaningful right not to be prevented from bearing a child can be asserted for each individual against state-supported involuntary sterilization programs. But the act of procreation is not an act involving a single individual. Indeed, until human cloning arrives, it continues to be impossible for any one person to procreate alone. More important, there is a crucial third party involved: the child, whose centrality to the activity exposes the insufficiency of thinking about procreation in terms of rights.

In addition, rights are limited in the following crucial way: they cannot be ethically exercised at the expense of the rights of another. But the "right to reproduce" cannot be ethically exercised without at least considering the child that such exercise will bring into being and who is at risk of harm and injustice from the exercise. This obligation cannot be waived by an appeal to the absolutist argument of the goodness of existence. Yes, existence is a primary good, but that does not diminish the ethical significance of knowingly and willfully putting a child in grave physical danger in the very act of giving that child existence. It is certainly true that a life with even severe disability may well be judged worth living by its bearer: "It is better to have been born as I am than not to be here at all." But if his or her disability was caused by behavior that could have been avoided by parents (for example, by not drinking or using drugs during pregnancy, or, arguably, by not cloning), many would argue that they should have avoided it. A postfacto affirmation of existence by the harmed child would not retroactively excuse any parental misconduct that caused the child's disability, nor would it justify their failure to think of the child's well-being as they went about exercising their "right to procreate." Indeed, procreation is, by its very nature, a limitation of absolute rights, since it brings into existence another human being toward whom we have responsibilities and duties.

In short, the right to decide "whether to bear or beget a child" does not include a right to have a child by whatever means. Nor can this right be said to imply a corollary -- the right to decide what kind of child one is going to have. There are at least some circumstances where reproductive freedom must be limited to protect the good of the child (as, for instance, with the ban on incest). Our society's commitment to freedom and parental authority by no means implies that all innovative procedures and practices should be allowed or accepted, no matter how bizarre or dangerous.

Proponents of cloning, when they do take into account the interests of the child, sometimes argue that this interest justifies and even requires thoroughgoing parental control over the procreative process. Yet this approach, even when well-intentioned, may undermine the good of the child more than it serves the child's best interests. For one thing, cloning-to-produce-children of a desired or worthy sort overlooks the need to restrain the parental temptation to total mastery over children. It is especially morally dubious for this project to go forward when we know so little about the unforeseen and unintended consequences of exercising such genetic control. For example, in trying by cloning to circumvent the risk of genetic disease or to promote particular traits, what different risks to health and fitness would be inadvertently produced for the child by having forgone its chance at genetic novelty, a known asset in the constant struggle against microbial and parasitic diseases? Parental control is a double-edged sword, and proponents seem not to acknowledge the harms, both physical and psychological, that may befall the child whose genetic identity is selected in advance.

The case for cloning in the name of the child's health and well-being is certainly the strongest and most compelling. The desire that one's child be free from a given genetic disease is a worthy aspiration. We recognize there may be some unusual or extreme cases in which cloning might be the best means to serve this moral good, if other ethical obstacles could somehow be overcome. (A few of us also believe that the desire to give a child "improved" or "superior" genetic equipment is not necessarily to be condemned.) However, such aspirations could endanger the personal, familial, and societal goods supported by the character of human procreation. We are willing to grant that that there may be exceptional cases in which cloning-to-produce-children is morally defensible; however, that being said, we would also argue that such cases do not justify the harmful experiments and social problems that might be entailed by engaging in human cloning. Hard cases are said to make bad law. The same would be true for succumbing to the rare, sentimentally appealing case in which cloning seems morally plausible.ⁱ

Finally, proponents do not adequately face up to the difficulty of how "well-being" is to be defined. Generally, they argue that these matters are to be left up to the free choices of parents and doctors. But this means that the judgments of "proper" and "improper" will be made according to subjective criteria alone, and under such circumstances, it will be almost impossible to rule out certain "improvements" as unacceptable.

In the sections that follow, we shall explain more fully why Members of the Council are not convinced by the arguments for cloning-to-produce-children, even in the most defensible cases. To see why this is so, we need to consider cloning-to-produce-children from the broadest possible moral perspective, beginning with ethical questions regarding experiments on human subjects. What we hope to show is that the frequently made safety arguments strike deeper than we usually realize, and that they point beyond themselves toward more fundamental moral objections to cloning-to-produce-children.

We begin with concerns regarding the safety of the cloning procedure and the health of the participants. We do so for several reasons. First, these concerns are widely, indeed nearly unanimously, shared. Second, they lend themselves readily to familiar modes of ethical analysis -- including concerns about harming the innocent, protecting human rights, and ensuring the consent of all research subjects. Finally, if carefully considered, these concerns begin to reveal the important ethical principles that must guide our broader assessment of cloning-to-produce-children. They suggest that human beings, unlike inanimate matter or even animals, are in some way inviolable, and therefore challenge us to reflect on what it is about human beings that makes them inviolable, and whether cloning-to-produce-children threatens these distinctly human goods.

In initiating this analysis, there is perhaps no better place to start than the long-standing international practice of regulating experiments on human subjects. After all, the cloning of a human being, as well as all the research and trials required before such a procedure could be expected to succeed, would constitute experiments on the individuals involved -- the egg donor, the birthing mother, and especially the child-to-be. It therefore makes sense to consider the safety and health concerns that arise from cloning-to-produce-children in light of the widely shared ethical principles that govern experimentation on human subjects.

Since the Second World War, various codes for the ethical conduct of human experimentation have been adopted around the world. These codes and regulations were formulated in direct response to serious ethical lapses and violations committed by research scientists against the rights and dignity of individual human beings. Among the most important and widely accepted documents to emerge were the Nuremberg Code of 1947⁷ and the Helsinki Declaration of 1964.⁸ Influential in the United States is also the Belmont Report, published in 1978 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.⁹

The Nuremberg Code laid out ten principles for the ethical conduct of experiments, focusing especially on voluntary consent of research subjects, the principle that experiments should be conducted only with the aim of providing a concrete good for society that is unprocurable by other methods, and with the avoidance of physical or mental harm. The Helsinki Declaration stated, among other things, that research should be undertaken only when the prospective benefit clearly outweighs the expected risk, when the research subject has been fully informed of all risks, and when the research-subject population is itself likely to benefit from the results of the experiment.

Finally, the Belmont Report proposed three basic ethical principles that were to guide the treatment of individuals involved as subjects of scientific research. The first of these is respect for persons, which requires researchers to acknowledge the autonomy and individual rights of research subjects and to offer special protection to those with diminished autonomy and capacity. The second principle is beneficence. Scientific research must not only refrain from harming those involved but must also be aimed at helping them, or others, in concrete and important ways. The third principle is justice, which involves just distribution of potential benefits and harms and fair selection of research subjects. When applied, these general principles lead to both a requirement for informed consent of human research subjects and a requirement for a careful assessment of risks and benefits before proceeding with research. Safety, consent, and the rights of research subjects are thus given the highest priority.

It would be a mistake to view these codes in narrow or procedural terms, when in fact they embody society's profound sense that human beings are not to be treated as experimental guinea pigs for scientific research. Each of the codes was created to address a specific disaster involving research science -- whether the experiments conducted by Nazi doctors on concentration camp prisoners, or the Willowbrook scandal in which mentally retarded children were infected with hepatitis, or the Tuskegee scandal in which underprivileged African-American men suffering from syphilis were observed but not treated by medical researchers -- and each of the codes was an attempt to defend the inviolability and dignity of all human beings in the face of such threats and abuses. More simply stated, the codes attempt to defend the weak against the strong and to uphold the equal dignity of all human beings. In taking up the application of these codes to the case of cloning-to-produce-children, we would suggest that the proper approach is not simply to discover specific places where human cloning violates this or that stipulation of this or that code, but to grapple with how such cloning offends the spirit of these codes and what they seek to defend.

The ethics of research on human subjects suggest three sorts of problems that would arise in cloning-to-produce-children: (1) problems of safety; (2) a special problem of consent; and (3) problems of exploitation of women and the just distribution of risk. We shall consider each in turn.

1. Problems of Safety

   First, cloning-to-produce-children is not now safe. Concerns about the safety of the individuals involved in a cloning procedure are shared by nearly everyone on all sides of the cloning debate. Even most proponents of cloning-to-produce-children generally qualify their support with a caveat about the safety of the procedure. Cloning experiments in other mammals strongly suggest that cloning-to-produce-children is, at least for now, far too risky to attempt.¹⁰ Safety concerns revolve around potential dangers to the cloned child, as well as to the egg donor and the woman who would carry the cloned child to birth.

   1. Risks to the child. Risks to the cloned child-to-be must be taken especially seriously, both because they are most numerous and most serious and because -- unlike the risks to the egg donor and birth mother -- they cannot be accepted knowingly and freely by the person who will bear them. In animal experiments to date, only a small percentage of implanted clones have resulted in live births, and a substantial portion of those live-born clones have suffered complications that proved fatal fairly quickly. Some serious though nonfatal abnormalities in cloned animals have also been observed, including substantially increased birth-size, liver and brain defects, and lung, kidney, and cardiovascular problems.¹¹

      Longer-term consequences are of course not known, as the oldest successfully cloned mammal is only six years of age. Medium-term consequences, including premature aging, immune system failure, and sudden unexplained death, have already become apparent in some cloned mammals. Some researchers have also expressed concerns that a donor nucleus from an individual who has lived for some years may have accumulated genetic mutations that -- if the nucleus were used in the cloning of a new human life -- may predispose the new individual to certain sorts of cancer and other diseases.¹²

   2. Risks to egg donor and birth mother. Accompanying the threats to the cloned child's health and well-being are risks to the health of the egg donors. These include risks to her future reproductive health caused by the hormonal treatments required for egg retrieval and general health risks resulting from the necessary superovulation.¹³

      Animal studies also suggest the likelihood of health risks to the woman who carries the cloned fetus to term. The animal data suggest that late-term fetal losses and spontaneous abortions occur substantially more often with cloned fetuses than in natural pregnancies. In humans, such late-term fetal losses may lead to substantially increased maternal morbidity and mortality. In addition, animal studies have shown that many pregnancies involving cloned fetuses result in serious complications, including toxemia and excessive fluid accumulation in the uterus, both of which pose risks to the pregnant animal's health.¹⁴ In one prominent cattle cloning study, just under one-third of the pregnant cows died from complications late in pregnancy.¹⁵

      Reflecting on the dangers to birth mothers in animal cloning studies, the National Academy report concluded:

      Results of animal studies suggest that reproductive cloning of humans would similarly pose a high risk to the health of both fetus or infant and mother and lead to associated psychological risks for the mother as a consequence of late spontaneous abortions or the birth of a stillborn child or a child with severe health problems.¹⁶

   3. An abiding moral concern. Because of these risks, there is widespread agreement that, at least for now, attempts at cloning-to-produce-children would constitute unethical experimentation on human subjects and are therefore impermissible. These safety considerations were alone enough to lead the National Bioethics Advisory Commission in June 1997 to call for a prohibition of human cloning-to-produce-children. Similar concerns, based on almost five more years of animal experimentation, convinced the panel of the National Academy of Sciences in January 2002 that the United States should ban such cloning for at least five years.

   Past discussions of this subject have often given the impression that the safety concern is a purely temporary one that can be allayed in the near future, as scientific advances and improvements in technique reduce the risks to an ethically acceptable level. But this impression is mistaken, for considerable safety risks are likely to be enduring, perhaps permanent. If so, there will be abiding ethical difficulties even with efforts aimed at making human cloning safe.

   The reason is clear: experiments to develop new reproductive technologies are necessarily intergenerational, undertaken to serve the reproductive desires of prospective parents but practiced also and always upon prospective children. Any such experiment unavoidably involves risks to the child-to-be, a being who is both the product and also the most vulnerable human subject of the research. Exposed to risk during the extremely sensitive life-shaping processes of his or her embryological development, any child-to-be is a singularly vulnerable creature, one maximally deserving of protection against risk of experimental (and other) harm. If experiments to learn how to clone a child are ever to be ethical, the degree of risk to that child-to-be would have to be extremely low, arguably no greater than for children-to-be who are conceived from union of egg and sperm. It is extremely unlikely that this moral burden can be met, not for decades if at all.

   In multiple experiments involving six of the mammalian species cloned to date, more than 89 per cent of the cloned embryos transferred to recipient females did not come to birth, and many of the live-born cloned animals are or become abnormal (NAS Report, Figure 3). If success means achieving normal and healthy development not just at birth but throughout the life span, there is even less reason for confidence. The oldest cloned mammal (Dolly) is only six years old and has exhibited unusually early arthritis. The reasons for failure in animal cloning are not well understood. Also, no nonhuman primates have been cloned. It will be decades (at least) before we could obtain positive evidence that cloned primates might live a normal healthy (primate) life.

   Even a high success rate in animals would not suffice by itself to make human trials morally acceptable. In addition to the usual uncertainties in jumping the gap from animal to human research, cloning is likely to present particularly difficult problems of interspecies difference. Animal experiments have already shown substantial differences in the reproductive success of identical cloning techniques used in different species.ⁱⁱ If these results represent species-specific differences in, for example, the ease of epigenetic reprogramming and imprinting of the donor DNA, the magnitude of the risks to the child-to-be of the first human cloning experiments would be unknown and potentially large, no matter how much success had been achieved in animals. There can in principle be no direct experimental evidence sufficient for assessing the degree of such risk.ⁱⁱⁱ

   Can a highly reduced risk of deformity, disease, and premature death in animal cloning, coupled with the inherently unpredictable risk of moving from animals to humans, ever be low enough to meet the ethically acceptable standard set by reproduction begun with egg and sperm? The answer, as a matter of necessity, can never be better than "Just possibly." Given the severity of the possible harms involved in human cloning, and given that those harms fall on the very vulnerable child-to-be, such an answer would seem to be enduringly inadequate.

   Similar arguments, it is worth noting, were made before the first attempts at human in vitro fertilization. People suggested that it would be unethical experimentation even to try to determine whether IVF could be safely done. And then, of course, IVF was accomplished. Eventually, it became a common procedure, and today the moral argument about its safety seems to many people beside the point. Yet the fact of success in that case does not establish precedent in this one, nor does it mean that the first attempts at IVF were not in fact unethical experiments upon the unborn, despite the fortunate results.^iv

   Be this as it may, the case of cloning is genuinely different. With IVF, assisted fertilization of egg by sperm immediately releases a developmental process, linked to the sexual union of the two gametes, that nature has selected over millions of years for the entire mammalian line. But in cloning experiments to produce children, researchers would be transforming a sexual system into an asexual one, a change that requires major and "unnatural" reprogramming of donor DNA if there is to be any chance of success. They are neither enabling nor restoring a natural process, and the alterations involved are such that success in one species cannot be presumed to predict success in another. Moreover, any new somatic mutations in the donor cell's chromosomal DNA would be passed along to the cloned child-to-be and its offspring. Here we can see even more the truly intergenerational character of cloning experimentation, and this should justify placing the highest moral burden of persuasion on those who would like to proceed with efforts to make cloning safe for producing children. (By reminding us of the need to protect the lives and well-being of our children and our children's children, this broader analysis of the safety question points toward larger moral objections to producing cloned children, objections that we shall consider shortly.)

   It therefore appears to us that, given the dangers involved and the relatively limited goods to be gained from cloning-to-produce-children, conducting experiments in an effort to make cloning-to-produce-children safer would itself be an unacceptable violation of the norms of the ethics of research. There seems to be no ethical way to try to discover whether cloning-to-produce-children can become safe, now or in the future.

2. A Special Problem of Consent

   A further concern relating to the ethics of human research revolves around the question of consent. Consent from the cloned child-to-be is of course impossible to obtain, and because no one consents to his or her own birth, it may be argued that concerns about consent are misplaced when applied to the unborn. But the issue is not so simple. For reasons having to do both with the safety concerns raised above and with the social, psychological, and moral concerns to be addressed below, an attempt to clone a human being would potentially expose a cloned individual-to-be to great risks of harm, quite distinct from those accompanying other sorts of reproduction. Given the risks, and the fact that consent cannot be obtained, the ethically correct choice may be to avoid the experiment. The fact that those engaged in cloning cannot ask an unconceived child for permission places a burden on the cloners, not on the child. Given that anyone considering creating a cloned child must know that he or she is putting a newly created human life at exceptional risk, the burden on the would-be cloners seems clear: they must make a compelling case why the procedure should not be avoided altogether.

   Reflections on the purpose and meaning of seeking consent support this point. Why, after all, does society insist upon consent as an essential principle of the ethics of scientific research? Along with honoring the free will of the subject, we insist on consent to protect the weak and the vulnerable, and in particular to protect them from the powerful. It would therefore be morally questionable, at the very least, to choose to impose potentially grave harm on an individual, especially in the very act of giving that individual life. Giving existence to a human being does not grant one the right to maim or harm that human being in research.

3. Problems of Exploitation of Women and Just Distribution of Risk

   Cloning-to-produce-children may also lead to the exploitation of women who would be called upon to donate oocytes. Widespread use of the techniques of cloning-to-produce-children would require large numbers of eggs. Animal models suggest that several hundred eggs may be required before one attempt at cloning can be successful. The required oocytes would have to be donated, and the process of making them available would involve hormonal treatments to induce superovulation. If financial incentives are offered, they might lead poor women especially to place themselves at risk in this way (and might also compromise the voluntariness of their "choice" to make donations). Thus, research on cloning-to-produce-children could impose disproportionate burdens on women, particularly low-income women.

4. Conclusion

   These questions of the ethics of research -- particularly the issue of physical safety -- point clearly to the conclusion that cloning-to-produce-children is unacceptable. In reaching this conclusion, we join the National Bioethics Advisory Commission and the National Academy of Sciences. But we go beyond the findings of those distinguished bodies in also pointing to the dangers that will always be inherent in the very process of trying to make cloning-to-produce-children safer. On this ground, we conclude that the problem of safety is not a temporary ethical concern. It is rather an enduring moral concern that might not be surmountable and should thus preclude work toward the development of cloning techniques to produce children. In light of the risks and other ethical concerns raised by this form of human experimentation, we therefore conclude that cloning-to-produce-children should not be attempted.

For some people, the discussion of ethical objections to cloning-to-produce-children could end here. Our society's established codes and practices in regard to human experimentation by themselves offer compelling reasons to oppose indefinitely attempts to produce a human child by cloning. But there is more to be said.

First, many people who are repelled by or opposed to the prospect of cloning human beings are concerned not simply or primarily because the procedure is unsafe. To the contrary, their objection is to the use of a perfected cloning technology and to a society that would embrace or permit the production of cloned children. The ethical objection based on lack of safety is not really an objection to cloning as such. Indeed, it may in time become a vanishing objection should people be allowed to proceed -- despite insuperable ethical objections such as the ones we have just offered -- with experiments to perfect the technique.^v Should this occur, the ethical assessment of cloning-to-produce-children would need to address itself to the merits (and demerits) of cloning itself, beyond the safety questions tied to the techniques used to produce cloned children. Thus, anticipating the possibility of a perfected and usable technology, it is important to delineate the case against the practice itself.

Moreover, because the Council is considering cloning within a broad context of present and projected techniques that can affect human procreation or alter the genetic makeup of our children, it is important that we consider the full range and depth of ethical issues raised by such efforts.

How should these issues be raised, and within what moral framework? Some, but by no means all, of the deepest moral concerns connected to human cloning could be handled by developing a richer consideration of the ethics of human experimentation. Usually -- and regrettably -- we apply the ethical principles governing research on human subjects in a utilitarian spirit, weighing benefits versus harms, and moreover using only a very narrow notion of "harm." The calculus that weighs benefits versus harms too often takes stock only of bodily harm or violations of patient autonomy, though some serious efforts have been made in recent years to consider broader issues. In addition, we often hold a rather narrow view of what constitutes "an experiment." Yet cloning-to-produce-children would be a "human experiment" in many senses, and risks of bodily harm and inadequate consent do not exhaust the ways in which cloning might do damage. As we have described, cloning-to-produce-children would be a biological experiment -- with necessary uncertainties about the safety of the technique and the possibility of physical harm. But it would also be an experiment in human procreation -- substituting asexual for sexual reproduction and treating children not as gifts but as our self-designed products. It would be an experiment in human identity -- creating the first human beings to inherit a genetic identity lived in advance by another. It would be an experiment in genetic choice and design -- producing the first children whose entire genetic makeup was selected in advance. It would be an experiment in family and social life -- altering the relationships within the family and between the generations, for example, by turning "mothers" into "twin sisters" and "grandparents" into "parents," and by having children asymmetrically linked biologically to only one parent. And it would represent a social experiment for the entire society, insofar as the society accepted, even if only as a minority practice, this unprecedented and novel mode of producing our offspring.

By considering these other ways in which cloning would constitute an experiment, we could enlarge our analysis of the ethics of research with human subjects to assess possible nonbodily harms of cloning-to-produce-children. But valuable as this effort might be, we have not chosen to proceed in this way. Not all the important issues can be squeezed into the categories of harms and benefits. People can be mistreated or done an injustice whether they know it or not and quite apart from any experienced harm. Important human goods can be traduced, violated, or sacrificed without being registered in anyone's catalogue of harms. The form of bioethical inquiry we are attempting here will make every effort not to truncate the moral meaning of our actions and practices by placing them on the Procrustean bed of utilitarianism. To be sure, the ethical principles governing human research are highly useful in efforts to protect vulnerable individuals against the misconduct or indifference of the powerful. But a different frame of reference is needed to evaluate the human meaning of innovations that may affect the lives and humanity of everyone, vulnerable or not.

Of the arguments developed below, some are supported by most Council Members, while other arguments are shared by only some Members. Even among the arguments they share, different Members find different concerns to be weightier. Yet we all believe that the arguments presented in the sections that follow are worthy of consideration in the course of trying to assess fully the ethical issues involved. We have chosen to err on the side of inclusion rather than exclusion of arguments because we acknowledge that concerns now expressed by only a few may turn out in the future to be more important than those now shared by all. Our fuller assessment begins with an attempt to fathom the deepest meaning of human procreation and thus necessarily the meaning of raising children. Our analysis will then move onto questions dealing with the effects of cloning on individuals, family life, and society more generally.

B. The Human Context: Procreation and Child-Rearing

Were it to take place, cloning-to-produce-children would represent a challenge to the nature of human procreation and child-rearing. Cloning is, of course, not only a means of procreation. It is also a technology, a human experiment, and an exercise of freedom, among other things. But cloning would be most unusual, consequential, and most morally significant as a new way of bringing children into the world and a new way of viewing their moral significance.

In Chapter One we outlined some morally significant features of human procreation and raised questions about how these would be altered by human cloning. We will now attempt to deepen that analysis, and begin with the salient fact that a child is not made, but begotten. Procreation is not making but the outgrowth of doing. A man and woman give themselves in love to each other, setting their projects aside in order to do just that. Yet a child results, arriving on its own, mysterious, independent, yet the fruit of the embrace.^vi Even were the child wished for, and consciously so, he or she is the issue of their love, not the product of their wills; the man and woman in no way produce or choose a particular child, as they might buy a particular car. Sexual reproduction can, of course, be assisted (as with IVF). In such cases, it may become harder to see the child solely as a gift bestowed upon the parents' mutual self-giving and not to some degree as a product of their parental wills. Nonetheless, because it is still sexual reproduction, the children born with the help of IVF begin -- as do all other children -- with a certain genetic independence of their parents. They replicate neither their fathers nor their mothers, and this is a salutary reminder to parents of the independence they must one day grant their children and for which it is their duty to prepare them.

Gifts and blessings we learn to accept as gratefully as we can. Products of our wills we try to shape in accord with our desires. Hence, procreation as traditionally understood invites acceptance, rather than reshaping, engineering, or designing the next generation. It invites us to accept limits to our control over the next generation. It invites us even -- to put the point most strongly -- to think of the child as one who is not simply our own, our possession. Certainly, it invites us to remember that the child does not exist simply for the happiness or fulfillment of the parents.

To be sure, parents do and must try to form and mold their children in various ways as they inure them to the demands of family life, prepare them for adulthood, and initiate them into the human community. But, even then, it is only our sense that these children are not our possessions that makes such parental nurture -- which always threatens not to nourish but to stifle the child -- safe.

This concern can be expressed not only in language about the relation between the generations but also in the language of equality. The things we make are not just like ourselves; they are the products of our wills, and their point and purpose are ours to determine. But a begotten child comes into the world just as its parents once did, and is therefore their equal in dignity and humanity.

The character of sexual procreation shapes the lives of children as well as parents. By giving rise to genetically new individuals, sexual reproduction imbues all human beings with a sense of individual identity and of occupying a place in this world that has never belonged to another. Our novel genetic identity symbolizes and foreshadows the unique, never-to-be-repeated character of each human life. At the same time, our emergence from the union of two individuals, themselves conceived and generated as we were, locates us immediately in a network of relation and natural affection.

Social identity, like genetic identity, is in significant measure tied to these biological facts. Societies around the world have structured social and economic responsibilities around the relationship between the generations established through sexual procreation, and have developed modes of child-rearing, family responsibility, and kinship behavior that revolve around the natural facts of begetting.

There is much more to be said about these matters, and they are vastly more complicated than we have indicated. There are, in addition, cultural differences in the way societies around the world regard the human significance of procreation or the way children are to be regarded and cared for. Yet we have said enough to indicate that the character and nature of human procreation matter deeply. They affect human life in endless subtle ways, and they shape families and communities. A proper regard for the profundity of human procreation (including child-rearing and parent-child relations) is, in our view, indispensable for a full assessment of the ethical implications of cloning-to-produce-children.

C. Identity, Manufacture, Eugenics, Family, and Society

Beyond the matter of procreation itself, we think it important to examine the possible psychological and emotional state of individuals produced by cloning, the well-being of their families, and the likely effects on society of permitting human cloning. These concerns would apply even if cloning-to-produce-children were conducted on a small scale; and they would apply in even the more innocent-seeming cloning scenarios, such as efforts to overcome infertility or to avoid the risk of genetic disease. Admittedly, these matters are necessarily speculative, for empirical evidence is lacking. Nevertheless, the importance of the various goods at stake justifies trying to think matters through in advance.

Keeping in mind our general observations about procreation, we proceed to examine a series of specific ethical issues and objections to cloning human children: (1) problems of identity and individuality; (2) concerns regarding manufacture; (3) the prospects of a new eugenics; (4) troubled family relations; and (5) effects on society.

1. Problems of Identity and Individuality

   Cloning-to-produce-children could create serious problems of identity and individuality. This would be especially true if it were used to produce multiple "copies" of any single individual, as in one or another of the seemingly far-fetched futuristic scenarios in which cloning is often presented to the popular imagination. Yet questions of identity and individuality could arise even in small-scale cloning, even in the (supposedly) most innocent of cases, such as the production of a single cloned child within an intact family. Personal identity is, we would emphasize, a complex and subtle psychological phenomenon, shaped ultimately by the interaction of many diverse factors. But it does seem reasonably clear that cloning would at the very least present a unique and possibly disabling challenge to the formation of individual identity.

   Cloned children may experience concerns about their distinctive identity not only because each will be genetically essentially identical to another human being, but also because they may resemble in appearance younger versions of the person who is their "father" or "mother." Of course, our genetic makeup does not by itself determine our identities. But our genetic uniqueness is an important source of our sense of who we are and how we regard ourselves. It is an emblem of independence and individuality. It endows us with a sense of life as a never-before-enacted possibility. Knowing and feeling that nobody has previously possessed our particular gift of natural characteristics, we go forward as genetically unique individuals into relatively indeterminate futures.

   These new and unique genetic identities are rooted in the natural procreative process. A cloned child, by contrast, is at risk of living out a life overshadowed in important ways by the life of the "original" -- general appearance being only the most obvious. Indeed, one of the reasons some people are interested in cloning is that the technique promises to produce in each case a particular individual whose traits and characteristics are already known. And however much or little one's genotype actually shapes one's natural capacities, it could mean a great deal to an individual's experience of life and the expectations that those who cloned him or her might have. The cloned child may be constantly compared to "the original," and may consciously or unconsciously hold himself or herself up to the genetic twin that came before. If the two individuals turned out to lead similar lives, the cloned person's achievements may be seen as derivative. If, as is perhaps more likely, the cloned person departed from the life of his or her progenitor, this very fact could be a source of constant scrutiny, especially in circumstances in which parents produced their cloned child to become something in particular. Living up to parental hopes and expectations is frequently a burden for children; it could be a far greater burden for a cloned individual. The shadow of the cloned child's "original" might be hard for the child to escape, as would parental attitudes that sought in the child's very existence to replicate, imitate, or replace the "original."

   It may reasonably be argued that genetic individuality is not an indispensable human good, since identical twins share a common genotype and seem not to be harmed by it. But this argument misses the context and environment into which even a single human clone would be born. Identical twins have as progenitors two biological parents and are born together, before either one has developed and shown what his or her potential -- natural or otherwise -- may be. Each is largely free of the burden of measuring up to or even knowing in advance the genetic traits of the other, because both begin life together and neither is yet known to the world. But a clone is a genetic near-copy of a person who is already living or has already lived. This might constrain the clone's sense of self in ways that differ in kind from the experience of identical twins. Everything about the predecessor -- from physical height and facial appearance, balding patterns and inherited diseases, to temperament and native talents, to shape of life and length of days, and even cause of death -- will appear before the expectant eyes of the cloned person, always with at least the nagging concern that there, notwithstanding the grace of God, go I. The crucial matter, again, is not simply the truth regarding the extent to which genetic identity actually shapes us -- though it surely does shape us to some extent. What matters above all is the cloned individual's perception of the significance of the "precedent life" and the way that perception cramps and limits a sense of self and independence.

2. Concerns Regarding Manufacture

   The likely impact of cloning on identity suggests an additional moral and social concern: the transformation of human procreation into human manufacture, of begetting into making. By using the terms "making" and "manufacture" we are not claiming that cloned children would be artifacts made altogether "by hand" or produced in factories. Rather, we are suggesting that they would, like other human "products," be brought into being in accordance with some pre-selected genetic pattern or design, and therefore in some sense "made to order" by their producers or progenitors.

   Unlike natural procreation -- or even most forms of assisted reproduction -- cloning-to-produce-children would set out to create a child with a very particular genotype -- namely, that of the somatic cell donor. Cloned children would thus be the first human beings whose entire genetic makeup is selected in advance. True, selection from among existing genotypes is not yet design of new ones. But the principle that would be established by human cloning is both far-reaching and completely novel: parents, with the help of science and technology, may determine in advance the genetic endowment of their children. To this point, parents have the right and the power to decide whether to have a child. With cloning, parents acquire the power, and presumably the right, to decide what kind of a child to have. Cloning would thus extend the power of one generation over the next -- and the power of parents over their offspring -- in ways that open the door, unintentionally or not, to a future project of genetic manipulation and genetic control.

   Of course, there is no denying that we have already taken steps in the direction of such control. Preimplantation genetic diagnosis of embryos and prenatal diagnosis of fetuses -- both now used to prevent the birth of individuals carrying genes for genetic diseases -- reflect an only conditional acceptance of the next generation. With regard to positive selection for desired traits, there is some practice of sex selection, another example of conditional acceptance of offspring. But these precedents do not thereby provide a license to proceed with cloning. It is far from clear that it would be wise to proceed still farther in our attempts at control.

   The problem with cloning-to-produce-children is not that artificial technique is used to assist reproduction. Neither is it that genes are being manipulated. We raise no objection to the use of the coming genetic technologies to treat individuals with genetic diseases, even in utero -- though there would be issues regarding the protection of human subjects in research and the need to find boundaries between therapy and so-called enhancement (of this, more below). The problem has to do with the control of the entire genotype and the production of children to selected specifications.

   Why does this matter? It matters because human dignity is at stake. In natural procreation, two individuals give life to a new human being whose endowments are not shaped deliberately by human will, whose being remains mysterious, and the open-endedness of whose future is ratified and embraced. Parents beget a child who enters the world exactly as they did -- as an unmade gift, not as a product. Children born of this process stand equally beside their progenitors as fellow human beings, not beneath them as made objects. In this way, the uncontrolled beginnings of human procreation endow each new generation and each new individual with the dignity and freedom enjoyed by all who came before.

   Most present forms of assisted reproduction imitate this natural process. While they do begin to introduce characteristics of manufacture and industrial technique, placing nascent human life for the first time in human hands, they do not control the final outcome. The end served by IVF is still the same as natural reproduction -- the birth of a child from the union of gametes from two progenitors. Reproduction with the aid of such techniques still implicitly expresses a willingness to accept as a gift the product of a process we do not control. In IVF children emerge out of the same mysterious process from which their parents came, and are therefore not mere creatures of their parents.

   By contrast, cloning-to-produce-children -- and the forms of human manufacture it might make more possible in the future -- seems quite different. Here, the process begins with a very specific final product in mind and would be tailored to produce that product. Even were cloning to be used solely to remedy infertility, the decision to clone the (sterile) father would be a decision, willy-nilly, that the child-to-be should be the near-twin of his "father." Anyone who would clone merely to ensure a "biologically related child" would be dictating a very specific form of biological relation: genetic virtual identity. In any case of cloning-to-produce-children, scientists or parents would set out to produce specific individuals for particular reasons. The procreative process could come to be seen increasingly as a means of meeting specific ends, and the resulting children would be products of a designed manufacturing process, products over whom we might think it proper to exercise "quality control." Even if, in any given case, we were to continue to think of the cloned child as a gift, the act itself teaches a different lesson, as the child becomes the continuation of a parental project. We would learn to receive the next generation less with gratitude and surprise than with control and mastery.

   One possible result would be the industrialization and commercialization of human reproduction. Manufactured objects become commodities in the marketplace, and their manufacture comes to be guided by market principles and financial concerns. When the "products" are human beings, the "market" could become a profoundly dehumanizing force. Already there is commerce in egg donation for IVF, with ads offering large sums of money for egg donors with high SAT scores and particular physical features.

   The concerns expressed here do not depend on cloning becoming a widespread practice. The introduction of the terms and ideas of production into the realm of human procreation would be troubling regardless of the scale involved; and the adoption of a market mentality in these matters could blind us to the deep moral character of bringing forth new life. Even were cloning children to be rare, the moral harms to a society that accepted it could be serious.

3. Prospect of a New Eugenics

   For some of us, cloning-to-produce-children also raises concerns about the prospect of eugenics or, more modestly, about genetic "enhancement." We recognize that the term "eugenics" generally refers to attempts to improve the genetic constitution of a particular political community or of the human race through general policies such as population control, forced sterilization, directed mating, or the like. It does not ordinarily refer to actions of particular individuals attempting to improve the genetic endowment of their own descendants. Yet, although cloning does not in itself point to public policies by which the state would become involved in directing the development of the human gene pool, this might happen in illiberal regimes, like China, where the government already regulates procreation.^vii And, in liberal societies, cloning-to-produce-children could come to be used privately for individualized eugenic or "enhancement" purposes: in attempts to alter (with the aim of improving) the genetic constitution of one's own descendants -- and, indirectly, of future generations.

   Some people, in fact, see enhancement as the major purpose of cloning-to-produce-children. Those who favor eugenics and genetic enhancement were once far more open regarding their intentions to enable future generations to enjoy more advantageous genotypes. Toward these ends, they promoted the benefits of cloning: escape from the uncertain lottery of sex, controlled and humanly directed reproduction. In the present debate about cloning-to-produce-children, the case for eugenics and enhancement is not made openly, but it nonetheless remains an important motivation for some advocates. Should cloning-to-produce-children be introduced successfully, and should it turn out that the cloned humans do in fact inherit many of the natural talents of the "originals," some people may become interested in the prospects of using it to produce "enhanced children" -- especially if other people's children were receiving comparable advantages.

   Cloning can serve the ends of individualized 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. In the future, if techniques of genetic enhancement through more precise genetic engineering became available, cloning could be useful for perpetuating the enhanced traits and for keeping any "superior" manmade genotype free of the flaws that sexual reproduction might otherwise introduce.

   "Private eugenics" does not carry with it the dark implications of state despotism or political control of the gene pool that characterized earlier eugenic proposals and the racist eugenic practices of the twentieth century. Nonetheless, it could prove dangerous to our humanity. Besides the dehumanizing prospects of the turn toward manufacture that such programs of enhancement would require, there is the further difficulty of the lack of standards to guide the choices for "improvement." To this point, biomedical technology has been applied to treating diseases in patients and has been governed, on the whole, by a commonsense view of health and disease. To be sure, there are differing views about how to define "health." And certain cosmetic, performance-enhancing, or hedonistic uses of biomedical techniques may already have crossed any plausible boundary between therapy and enhancement, between healing the sick and "improving" our powers.^viii Yet, for the most part, it is by some commonsense views of health that we judge who is in need of medical treatment and what sort of treatment might be most appropriate. Even today's practice of a kind of "negative" eugenics -- through prenatal genetic diagnosis and abortion of fetuses with certain genetic abnormalities -- is informed by the desire to promote health.

   The "positive" eugenics that could receive a great boost from human cloning, especially were it to be coupled with techniques of precise genetic modification, would not seek to restore sick human beings to natural health. Instead, it would seek to alter humanity, based upon arbitrary ideas of excellence. The effort may be guided by apparently good intentions: to improve the next generation and to enhance the quality of life of our descendants. But in the process of altering human nature, we would be abandoning the standard by which to judge the goodness or the wisdom of the particular aims. We would stand to lose the sense of what is and is not human.

   The fear of a new eugenics is not, as is sometimes alleged, a concern born of some irrational fear of the future or the unknown. Neither is it born of hostility to technology or nostalgia for some premodern pseudo-golden age of superior naturalness. It is rather born of the rational recognition that once we move beyond therapy into efforts at enhancement, we are in uncharted waters without a map, without a compass, and without a clear destination that can tell us whether we are making improvements or the reverse. The time-honored and time-tested goods of human life, which we know to be good, would be put in jeopardy for the alleged and unknowable goods of a post-human future.

4. Troubled Family Relations

   Cloning-to-produce-children could also prove damaging to family relations, despite the best of intentions. We do not assume that cloned children, once produced, would not be accepted, loved, or nurtured by their parents and relatives. On the contrary, we freely admit that, like any child born of woman, they might be welcomed into the cloning family. Nevertheless, the cloned child's place in the scheme of family relations might well be uncertain and confused. The usually clear designations of father and brother, mother and sister would be confounded. The cloned child's relation to his or her grandparents would span one and two generations at once. Every other family relation would be similarly confused. There is, of course, the valid counter-argument that holds that the "mother" could easily be defined as the person who gives birth to the child, regardless of the child's genetic origins, and for social purposes that may serve to eliminate some problems. But because of the special nature of cloning-to-produce-children, difficulties may be expected.

   The crucial point is not the absence of the natural biological connections between parents and children. The crucial point is, on the contrary, the presence of a unique, one-sided, and replicative biological connection to only one progenitor. As a result, family relations involving cloning would differ from all existing family arrangements, including those formed through adoption or with the aid of IVF. A great many children, after all, are adopted, and live happy lives in loving families, in the absence of any biological connections with their parents. Children conceived by artificial insemination using donor sperm and by various IVF techniques may have unusual relationships with their genetic parents, or no genetic relationships at all. But all of these existing arrangements attempt in important ways to emulate the model of the natural family (at least in its arrangement of the generations), while cloning runs contrary to that model.

   What the exact effects of cloning-to-produce-children might be for families is highly speculative, to be sure, but it is still worth flagging certain troubling possibilities and risks. The fact that the cloned child bears a special tie to only one parent may complicate family dynamics. As the child developed, it could not help but be regarded as specially akin to only one of his or her parents. The sins or failings of the father (or mother), if reappearing in the cloned child, might be blamed on the progenitor, adding to the chances of domestic turmoil. The problems of being and rearing an adolescent could become complicated should the teenage clone of the mother "reappear" as the double of the woman the father once fell in love with. Risks of competition, rivalry, jealousy, and parental tension could become heightened.^ix

   Even if the child were cloned from someone who is not a member of the family in which the child is raised, the fact would remain that he or she has been produced in the nearly precise genetic image of another and for some particular reason, with some particular design in mind. Should this become known to the child, as most likely it would, a desire to seek out connection to the "original" could complicate his or her relation to the rearing family, as would living consciously "under the reason" for this extra-familial choice of progenitor. Though many people make light of the importance of biological kinship (compared to the bonds formed through rearing and experienced family life), many adopted children and children conceived by artificial insemination or IVF using donor sperm show by their actions that they do not agree. They make great efforts to locate their "biological parents," even where paternity consists in nothing more than the donation of sperm. Where the progenitor is a genetic near-twin, surely the urge of the cloned child to connect with the unknown "parent" would be still greater.

   For all these reasons, the cloning family differs from the "natural family" or the "adoptive family." By breaking through the natural boundaries between generations, cloning could strain the social ties between them.

5. Effects on Society

   The hazards and costs of cloning-to-produce-children may not be confined to the direct participants. The rest of society may also be at risk. The impact of human cloning on society at large may be the least appreciated, but among the most important, factors to consider in contemplating the morality of this activity.

   Cloning is a human activity affecting not only those who are cloned or those who are clones, but also the entire society that allows or supports such activity. For insofar as the society accepts cloning-to-produce-children, to that extent the society may be said to engage in it. A society that allows dehumanizing practices -- especially when given an opportunity to try to prevent them -- risks becoming an accomplice in those practices. (The same could be said of a society that allowed even a few of its members to practice incest or polygamy.) Thus the question before us is whether cloning-to-produce-children is an activity that we, as a society, should engage in. In addressing this question, we must reach well beyond the rights of individuals and the difficulties or benefits that cloned children or their families might encounter. We must consider what kind of a society we wish to be, and, in particular, what forms of bringing children into the world we want to encourage and what sorts of relations between the generations we want to preserve.

   Cloning-to-produce children could distort the way we raise and view children, by carrying to full expression many regrettable tendencies already present in our culture. We are already liable to regard children largely as vehicles for our own fulfillment and ambitions. The impulse to created "esigner children" is present today -- as temptation and social practice. The notion of life as a gift, mysterious and limited, is under siege. Cloning-to-produce-children would carry these tendencies and temptations to an extreme expression. It advances the notion that the child is but an object of our sovereign mastery.

   A society that clones human beings thinks about human beings (and especially children) differently than does a society that refuses to do so. It could easily be argued that we have already in myriad ways begun to show signs of regarding our children as projects on which we may work our wills. Further, it could be argued that we have been so desensitized by our earlier steps in this direction that we do not recognize this tendency as a corruption. While some people contend that cloning-to-produce-children would not take us much further down a path we have already been traveling, we would emphasize that the precedent of treating children as projects cuts two ways in the moral argument. Instead of using this precedent to justify taking the next step of cloning, the next step might rather serve as a warning and a mirror in which we may discover reasons to reconsider what we are already doing. Precisely because the stakes are so high, precisely because the new biotechnologies touch not only our bodies and minds but also the very idea of our humanity, we should ask ourselves how we as a society want to approach questions of human dignity and flourishing.

D. Conclusion

It is not only a matter of prudence. Cloning-to-produce-children would also be an injustice to the cloned child -- from the imposition of the chromosomes of someone else, to the intentional deprivation of biological parents, to all of the possible bodily and psychological harms that we have enumerated in this chapter. It is ultimately the claim that the cloned child would be seriously wronged -- and not only harmed in body -- that would justify government intervention. It is to this question -- the public policy question of what the government should and can do to prevent such injustice -- that we will turn in Chapter Seven. But, regarding the ethical assessment, Members of the Council are in agreement that cloning-to-produce-children is not only unsafe but also morally unacceptable and ought not to be attempted.^x

ENDNOTES

1. National Bioethics Advisory Commission, Cloning Human Beings Bethesda, MD, 1997.

2. National Academy of Sciences (NAS) Scientific and Medical Aspects of Human Reproductive Cloning Washington, DC. National Academy Press, 2002. (Referred to in subsequent citations as NAS Report.)

3. NAS Report, pp. 6-7.

4. Lederberg, J. "Experimental Genetics and Human Evolution" The American Naturalist, September-October, 1966.

5. Supreme Court of the United States. Eisenstadt v. Baird, 405 US 438, 1972.

6. Tribe, L. "On Not Banning Cloning for the Wrong Reasons" in Nussbaum, M., and C. R. Sunstein. Clones and Clones: Facts and Fantasies about Human Cloning. New York: Norton, 1998, p. 321.

7. Nuremberg Report Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181-182. Washington, DC: Government Printing Office, 1949.

8. Helsinki Declaration. 18th World Medical Association General Assembly Ethical Principles for Medical Research Involving Human Subjects, adopted in Helsinki, Finland, June 1964, and amended in October 1975, October 1983, September 1989, October 1996, and October 2000.

9. Belmont Report. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Bethesda, MD: Government Printing Office, 1978.

10. See, for instance, Chapter Four of the present report, as well as Chapter 3 of the NAS Report.

11. These issues are discussed in the NAS Report (3-2) as well as in Wilmut, I., Roslin Institute, Scotland. "Application of animal cloning data to human cloning," paper presented at Workshop: Scientific and Medical Aspects of Human Cloning, National Academy of Sciences, Washington, DC August 7, 2001; and Hill, J., Cornell University. "Placental defects in nuclear transfer (cloned) animals," paper presented at Workshop: Scientific and Medical Aspects of Human Cloning, National Academy of Sciences, Washington, DC August 7, 2001.

12. See, for instance, Chapter 3 of the NAS Report, and Kolata, G. "In Cloning, Failure Far Exceeds Success" New York Times, December 11, 2001, p. D1.

13. See, for instance, Rimington, M., et al. "Counseling patients undergoing ovarian stimulation about the risks of ovarian hyper-stimulation syndrome." Human Reproduction, 14: 2921-2922, 1999; and Wakeley, K., and E. Grendys. "Reproductive technologies and risk of ovarian cancer." Current Opinion in Obstetrics and Gynecology, 12: 43-47, 2000.

14. These issues are discussed in greater detail in Chapter 3 of the NAS Report.

15. Hill J.R., et al. "Clinical and pathologic features of cloned transgenic calves and fetuses (13 case studies)" Theriogenology 8: 1451-1465, 1999.

16. NAS Report, 3-2.

17. Hansen, M., et al., "The Risk of Major Birth Defects after Intracytoplasmic Sperm Injection and In Vitro Fertilization," New Eng. J. Med. 346: 725-30 (2002).

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1. Consider the following analogy: We would not allow a rare sympathetic case for brother-sister marriage-where, say, the two children were separated at birth and later fell in love, ignorant of their kinship-to overturn the taboo on incest. Whatever their merit, the goals of well-being and health do not outweigh the moral and social harms that cloning would entail.

2. See for instance the NAS Report, Appendix B, tables 1, 3, and 4.

3. It is of course true that there is always uncertainty about moving from animal to human experimentation or therapy. But in the usual case, what justifies the assumption of this added unknown risk is that the experimental subject is a likely beneficiary of the research, either directly or indirectly. And where this is not the case, risk may be assumed if there is informed and voluntary consent. Neither of these conditions applies for the child-to-be in human cloning experiments.

4. Surprisingly, there has been very little systematic study of the offspring of in vitro fertilization. One recently published study has suggested that IVF (and especially intracytoplasmic sperm injection [ICSI]) may not be as benign as we had thought.¹⁷

5. Such improvements in technique could result in part from the practice of cloning-for-biomedical-research, were it to be allowed to go forward. This possibility is one of the issues we shall consider in evaluating the ethics of cloning-for-biomedical-research in Chapter Six.

6. We are, of course, well aware that many children are conceived in casual, loveless, or even brutal acts of sexual concourse, including rape and incest.

7. According to official Chinese census figures for 2000, more than 116 male births were recorded for every 100 female births. It is generally believed that this is the result of the widespread use of prenatal sex selection and China's one-child policy, though it should be noted that even in a country such as South Korea, which has no such policy, the use of prenatal sex selection has skewed the sex ratio in favor of males.

8. One thinks of certain forms of plastic surgery or recreational uses of euphoriant drugs, and the uses in athletics and schools of performance-enhancing drugs, such as anabolic steroids, erythropoietin, and Ritalin.

9. And there might be special complications in the event of divorce. Does the child rightfully or more naturally belong to the "genetic parent"? How would a single parent deal with a child who shares none of her genes but carries 100 percent of the genes of the person she chose to divorce? Whether such foreseeable complications would in fact emerge is, of course, an empirical question that cannot be answered in advance. But knowledge of the complexities of family life lead us not to want to dismiss them.

10. Not surprisingly, some of us feel more strongly than others about this conclusion. One or two of us might someday be willing to see cloning-to-produce-children occur in the rare defensible case, but then only if means were available to confine its use to such cases.

The Ethics of Cloning-for-Biomedical-Research

I. The Manner and Spirit of This Inquiry

Yet despite this general agreement, it is difficult to know how best to proceed in the present case. There are multiple questions about the right context for considering the ethics of cloning-for-biomedical-research. First, we must weigh whether to take up this matter in the context of deciding what to do about cloning-to-produce-children or in the somewhat different context of the ethics of embryo and stem cell research more generally. The issue has in fact emerged in the public moral debate over anti-cloning legislation, as a complication in the effort to stop cloning-to-produce-children. Generally speaking, the most effective way to prevent cloning-to-produce-children would arguably be to stop the process at the initial act of cloning, the production (by an act of somatic cell nuclear transfer [SCNT]) of the embryonic human clone. Yet such a measure would rule out cloning-for-biomedical-research, and scientists and patient advocacy groups have argued that the human and moral costs of doing so are too great. Alternatively, we could take up this matter in what seems philosophically to be its more natural context, namely, as a sub-species of a larger inquiry into the ethics of embryo and stem cell research.

Each of these contexts -- what to do about cloning-to-produce-children and what to do about embryo research -- is certainly plausible. Yet each, by itself, is less than satisfactory. The first risks giving excessive weight to the fact that the embryos wanted for research are cloned embryos; the second, ignoring the aspect (central to cloning) of genetic manipulation, risks the opposite error by requiring that the ethics of cloning-for-biomedical-research be argued entirely in terms of what it is proper to do with embryos as such. We can imagine, in advance of any discussion, a variety of moral opinions that would emerge, influenced in part by how the question is formulated: one person could defend stem cell research performed using embryos produced by IVF but oppose research using cloned embryos for reasons of prudence (such as decreasing the likelihood of cloning-to-produce-children). Another person, holding IVF embryos in higher regard than cloned embryos, could reach precisely the opposite conclusion. Other people will hold that research on any human embryo, cloned or not, is either morally acceptable or morally unacceptable, regardless of what ethical or legal guidelines may or may not be in place, while still others will judge one way or another depending on whether there are appropriate guidelines and effective regulations in place.

We have decided to discuss the ethics of cloning-for-biomedical-research in the broader moral-philosophical context, rather than the narrower moral-political one that has taken shape around the current debate over anti-cloning legislation. Though we are mindful of the importance of these public policy debates -- and will consider them in the following chapter -- we do not want our moral analysis to be skewed by the specific legal or policy questions at issue, especially as the moral questions discussed here have implications beyond the current political debate and even beyond the question of human cloning itself. We opt to take up the moral questions in their fullness.

A second question about context is even more difficult to assess. Should we regard cloning-for-biomedical-research as just the latest -- and continuous -- step in trying to unlock the secrets of human development and to discover cures for diseases? Or should it be seen -- instead or also -- as the earliest stage of a revolutionary new science of enhancement or eugenics, which will go beyond treating individuals with disease and disability and actually engineer improvements in human genetic endowments? Because innovations like cloning come to us gradually and piecemeal, and because it cannot be known in advance how exactly they will be used or where they might lead, there is a temptation to stay close to the present and to ignore possible future implications.

Yet the alleged perils of going ahead with the research are arguably no more speculative than the promised benefits. And it would be morally and prudently shortsighted for this Council, charged with investigating "the human and moral significance of advances in biomedical science and technology," to refuse to think about where this research might lead. We will therefore consider, even if we cannot know in advance, whether and how the sort of genetic manipulation of embryos exemplified by cloning-for-biomedical-research is new or "revolutionary." Genetic therapy for existing diseases and non-therapeutic modifications of our genetic endowments raise profoundly different questions. Accordingly, we will keep in sight not only the moral questions surrounding the means of cloning-for-biomedical-research -- which is to say, the significance of using or not using nascent human life as a resource -- but also the possible ends to which our expanding knowledge and capacities might be put. At the same time, we will be careful not to equate genetic medicine that is truly in the service of human life with genetic manipulation that is not, and to avoid both the unjustified fear and misguided triumphalism that sometimes accompany biomedical progress.

A third difficulty concerns the relation between the ethics of research on embryos (cloned or not) and the ethics of abortion. For many people, these issues are linked, and there is doubtless an overlap in the moral questions involved. Yet the issues are, in important respects, quite distinct. In the case of abortion, the fetuses whose fate is at issue are unwanted and (usually) the result of unintended conception. The embryos produced for research are wanted, indeed deliberately created, with certain knowledge and intent that they will be used and destroyed. More important perhaps, the extra-corporeal embryo (whether produced specially for research or left-over in IVF procedures) does not exist in conflict with the wishes, interests, or rights of a woman who is pregnant. Also, although abortion is widely practiced, each decision to abort is made one at a time, case by case. In contrast, to embark on creating cloned embryos only for purposes of research is to countenance at one stroke large-scale production for routinized use and destruction. For these reasons, we shall try to consider the question of the ethics of research on embryos in its own terms, distinct from the ethical questions about abortion.

Finally, there is the question of the spirit in which this examination should be conducted. Reflecting the situation in American society, there are major differences within the Council regarding the morality of research involving early human (cloned) embryos. These differences turn largely, though not exclusively, on different judgments regarding the nature and moral status of the early human (cloned) embryo: namely, to what extent is it, or is it not, "one of us," a human life in pro-cess? Having explored these questions collegially among ourselves, we have come to think that all parties to this debate have something vital to defend, something vital not only to themselves but also to their opponents in the debate, and indeed to all human beings. No human being and no human society can afford to be callous to the needs of suffering humanity, cavalier regarding the treatment of nascent human life, or indifferent to the social effects of adopting in these matters one course of action rather than another. We believe, therefore, that we can make our best contribution to a truthful and appropriate moral understanding of the issue by developing, in a single document, the moral cases both for and against proceeding with cloning-for-biomedical-research (and also articulating, where necessary and as clearly as possible, important differences within each of these cases). Each Member of the Council has been asked to help strengthen the case made for both sides, regardless of which side he or she inclines toward. By proceeding in this way, we hope to make clear to the President and the nation exactly what is morally and humanly at stake in the controversy and what may be gained and lost in whatever choice is finally made.

Thus, notwithstanding our differences, we stand together as the authors of the entire chapter, hoping by this means to shed light rather than heat on this most vexing of moral and policy questions. At the same time, we have tried fully and fairly to articulate our differences, and to do so by speaking, in the first person, as members of a deliberative body called upon to make our best judgments. This means that the "we" that now embraces all Members of the Council will stand in the particular sections presenting the moral cases for and against cloning-for-biomedical-research (Parts III and IV, respectively) only for those among us who subscribe to the specific arguments being made in those sections. In other words, each opinion is a self-contained brief, representing not the Council as a whole but only a portion of the Council. And even within the cases for and against, Members of the Council disagree over matters of substance and emphasis. But while the Council has strong differences of opinion, as delineated in the sections that follow, the Council speaks in a single voice in its affirmation that the debate must not be won by dismissing, ridiculing, or demonizing the other side. Important human goods are to be found on all sides of the debate, a fact too often lost sight of.

We begin, in Part II, with a discussion of the human meaning of healing, for it is only by an analysis of this uniquely human activity that the contours of the debate over cloning-for-biomedical-research can be properly traced and understood. Here the Council speaks as one. What follows this framing discussion are two separate opinions: in Part III, a portion of Council Members make the moral case for biomedical research; in Part IV, a portion make the opposing moral case against. Going beyond just listing the arguments, pro and con, each opinion is a sustained attempt at moral suasion. Yet each opinion, by self-imposed stricture, has tried to respect and respond to the legitimate moral concerns of the other side and to indicate how it means to do them justice. Each has tried to address what is owed to embryonic human life, what is owed to suffering humanity, and what is owed to the moral well-being of society. This approach to public moral discourse is, we are well aware, an experiment. Whether it is successful or not is for the reader to judge.

To be human is to be mortal. To be alive is to be vulnerable to suffering. No one is better situated to appreciate these truths than the physician. To understand what it means to heal, one must therefore understand the doctor's special encounter with human suffering -- as both an experience (a crying out) of the patient who lies before him and as a central mystery of human existence. Why do human beings suffer? Why do they suffer in ways that cannot be explained -- entirely or perhaps at all -- with human notions of justice? In this role, the doctor is sometimes a messenger of human finitude. He must tell patients that their days are numbered or that their time has come; he must tell grieving family members that death is at the door. But the healer is also and more importantly -- in both the doctor's eyes and in the patient's eyes -- a deliverer. Not only is he well armed to deliver us from specific maladies and miseries. He is also a much-needed ally against the deadly disease -- traditionally regarded as a sin -- of despair. Because of the moral aspirations of his calling, the physician is a trusted source of hope that the living might yet still live and that in his skill and the powerful techniques of modern medicine might lie the possibility of renewal. The doctor is, at different times, a reminder of the intractable sadness of human life, but also explicitly a conqueror who beats back suffering and disease with the saving hand of medical knowledge and technique, and who inspirits us with hope to go forward even in the absence of cure and relief.

Until roughly the second half of the twentieth century, physicians delivered more hope than cure, and they conquered few diseases. Since then, their arsenal against disease (at least in technologically advanced nations) has grown enormously, and it promises to grow greater in the decades ahead. New healing powers will surely emerge from the work of medicine's ally, biomedical research, firmly grounded in the principles and methods of modern biomedical science. This noble field of human endeavor also has a context in the larger domain of human life. Celebrating its achievements and eager for its gifts to human welfare, modern societies embrace and invest heavily in medical research and grant scientists great freedom to inquire and experiment. Because of the way science advances, freedom is crucial to the successful realization of its goals.

Dr. William Osler, one of the founding figures of modern medicine, described the aspirations of biomedical research as follows:

To wrest from nature the secrets which have perplexed philosophers in all ages, to track to their sources the causes of disease, to correlate the vast stores of knowledge that they may be quickly available for the prevention and cure of disease -- These are our ambitions.¹

It is in the very nature of a "secret" that one cannot know in advance which areas of research and discovery will prove the most fruitful. One proceeds by trial and error. One makes hypotheses grounded in what is already known, in the effort to discover what remains a mystery. One begins with basic research into disease processes and mechanisms, in the hope that new knowledge will yield new medicines and new cures.

One motive for such research is simply the love of knowledge itself -- the distinctively human desire to know, to see, to understand more than one already does. But biomedical research is also guided, above all, by the humanitarian desire to apply new knowledge in the service of those who suffer, to correlate knowledge that it "may be quickly available for the prevention and cure of disease." Biomedical scientists aim to weld the virtues of charity, beneficence, and responsibility to the human ambition to "wrest from nature" her secrets. This is the moral heart of both the medical profession and the research tradition that supports it: to do everything in our power, consistent with law and morals, to provide cures, amelioration, and relief to those who need them.

"Consistent with law and morals": this requirement qualifies "everything in our power." This limitation has been traditionally understood to be part of the healing vocation. Moral philosophers and philosophers of medicine have long held that the duty to heal is an "imperfect duty," meaning that it does not trump all other considerations. Physicians perhaps understand this best of all, learning their limits empirically from their encounters with patients whom they cannot save or even comfort. The duty to heal this patient, at this time, is also an imperfect one. After all, a cure for one person at the direct expense of another -- for example, harvesting a vital organ from someone who is living to save someone else who is dying -- would violate the first principle of medicine to "do no harm."

It is also true that scientific freedom and medical progress are not the only human goods worthy of our commitment and protection. Research must be judged both by the means it employs and by the ends it serves (both those that were intended and those that were not). The Nuremberg Code, the Helsinki Declaration, and the Belmont Report, discussed in the last chapter, are all efforts to set moral limits on biomedical research and to ensure that science serves human beings rather than the other way around. Among other things, these ethical codes embody the recognition that those who do research about human beings can never escape (nor should they) their status as human beings. Those who investigate human biology are always both the knowers and the subject that is known, both the potential healers and the potentially afflicted. And therefore they must never treat that which is their equal -- their fellow human beings -- as something less than human.

But in the end, however imperfect it is as a duty and whatever its less than supreme place among all other human goods, the obligation to heal and to seek remedies is a powerful one. It is a mark both of man's natural limits (as the being in need of healing) and his capacity for goodness (as the being who heals). And so, the freedom of inquiry that makes biomedical research possible should be restricted only for the most important reasons, lest we do damage to the entire enterprise, or to the human beings and the society that benefit from the "vast stores of knowledge" it creates.

At the same time, however, those who have accepted the "healer's covenant" -- and those who defend, engage in, and benefit from the research that improves and expands the human capacity to heal -- must avoid the seduction of medical triumphalism: the belief that all human suffering, both physical and psychic, can be conquered by modern technique, and therefore that no form of biomedical research should be opposed. Doctors and scientists must not become partial human beings who evade moral responsibility by claiming that they are not qualified to judge the moral implications of their own medical research or, worse, that medically beneficial research is always self-justifying, and hence that there are no real moral dilemmas at all. In addition, they must avoid the cruelty of creating false hopes among patients and their loved ones, and the folly of creating messianic or utopian visions of what science and medicine can accomplish. And patients, even as they heroically fight against suffering, must not forget their own mortality -- including the often unpredictable nature of how and when death comes.

These reflections point to the following conclusions: In judging the moral beneficence and moral hazards of medical research, we must remember that suffering should not be opposed by any means possible. We would be less than human if we did not desire to alleviate such suffering, but we would be imagining ourselves to be more than human if we thought and acted as if we could alleviate it once and for all. Rather, we must acknowledge that as human beings we live in a difficult "in-between." Whether as doctors, scientists, or as patients, we all wish for the possible renewal of life through medicine, but also acknowledge that suffering and mortality are part of being alive. We are morally obliged to seek relief of suffering, but only in ways that preserve our humanity.

With these realities in mind, this chapter will now take up the ethics of cloning-for-biomedical-research, and specifically the moral and human questions raised above: What is owed to those who suffer from debilitating injuries and diseases? What is owed to nascent human life? And what is owed to the moral well-being of society? These are the central questions in the debate, questions that Members of the Council over the past year struggled to answer, and that indeed every member of society must ponder when considering the ethics of cloning-for-biomedical-research.

A note about how the remainder of the chapter proceeds: Part III, delivered in the voice of some Members of Council, makes the case for going forward with cloning-for-biomedical-research. Part IV, delivered in the voice of other Members of the Council, presents the opposing case, the argument against cloning-for-biomedical-research.

It is true that human cloning-for-biomedical-research raises ethical questions, mainly because it involves the production, use, and destruction of cloned human embryos. It is also true that cloned embryos produced for research could be used in attempts to produce cloned human children, and the availability of such cloned embryos for research and the perfection of cloning techniques might increase the likelihood that people will succeed in cloning children. We appreciate the concerns of people who voice these objections and risks, and we are prepared to accept certain limits and safeguards against possible abuses. Yet we believe that, on balance, the objections to cloning-for-biomedical-research are outweighed by the good that can be done for current and future individuals who suffer. The moral balance lies on the side of endorsing and encouraging this activity.

We who endorse cloning-for-biomedical-research will attempt to make a version of this case here. But we will do so, for the most part, in a somewhat different spirit, one that is informed by the discussion of healing just concluded. In moral debates about these matters, people often speak as if saving lives is the only value that counts and that everything else must be sacrificed to advancing potentially beneficial research. Others speak as if any failure to prevent death or suffering from disease is sinful. Our defense of cloning-for-biomedical-research is more complex and nuanced and, we believe, more true to the merits of the case in question. As we make our case, we will also confront -- and accept -- the burden of what it means to proceed with such research, just as those who oppose it must accept the burden of what it means not to proceed.

In making our case, we begin in Section A by summarizing the specific medical benefits that might be achieved by proceeding with this avenue of research. We then consider in Section B the moral dilemmas of this research. However, among those of us who believe the research should go forward there is disagreement about how seriously to take certain moral objections, and thus two distinct positions for proceeding are presented.

A. The Medical Promise of Cloning-for-Biomedical-Research

Many people suffer from chronic debilitating diseases and disabilities, including, among others, juvenile diabetes, Parkinson's disease, Alzheimer's disease, spinal cord injuries, heart disease, and amyotrophic lateral sclerosis. These terrible diseases shorten life, limit activity (often severely), and cause great suffering both for the afflicted and their families. The inspiring example of exceptional persons who bear bravely the great burdens of illness or injury should not blind us to the powerful warrants for research and therapy that might lift these burdens. The likelihood of premature death, in particular, can shadow the life of the patient and the patient's family even before it arrives, and its advent can impoverish and devastate families, dash hopes, and cast a chill on the lives of survivors. It is certainly admirable to confront, endure, and redeem these unchosen afflictions. But it is also admirable, where possible, to ameliorate through research and medicine the diseases and injuries that cause them.

Cloning-for-biomedical-research may offer unique ways of investigating and possibly treating several of these diseases. To unlock the secrets of a disease, scientists must explore its specific molecular and cellular mechanisms, carefully observing both normal and pathological development. This research could be greatly facilitated by in vitro cellular models of human disease. It is here that the potentially most valuable and unique benefits of research on cloned human embryos may lie. This section summarizes some of these benefits, with specific examples.

1. Cloning to Improve Understanding of Human Disease

   The creation of cloned embryos using nuclei from individuals carrying genetic mutations -- specifically, genes that predispose them to particular diseases -- might be used to better understand and treat those diseases. Consider, for example, Parkinson's disease. A characteristic of Parkinson's disease is the aggregation in dying brain cells of a protein called alpha-synuclein. Two different mutations in the alpha-synuclein gene produce forms of the protein that aggregate more readily. Individuals carrying these gene mutations suffer from early-onset Parkinson's disease.

   To study how genetic disease develops, scientists look for suitable laboratory models. One strategy for producing such disease models is to inject the disease-causing human genes into human or animal cells in tissue culture to produce a cell-system expressing the abnormality. Although it has been possible to introduce copies of mutant genes into various kinds of human and animal cells, the resulting in vitro cell-systems imperfectly model the human disease. In part this is because the behavior of specific proteins within cells is influenced by their interactions with other cellular proteins. For example, human alpha-synuclein in a mouse cell cytoplasm interacting with mouse proteins is unlikely to behave the same way that it does in a human cell surrounded by human proteins. To study human disease, it is generally preferable to work with human cells and tissues.

   A preferable alternative to introducing mutant genes into normal cells is to begin with human cells that are already abnormal -- in this case, cells carrying the mutant genes that predispose their bearers to Parkinson's disease. If one could obtain embryonic stem cells derived from cloned embryos produced using nuclei from individuals carrying these mutant genes, one could then stimulate them to differentiate into dopamine-producing nerve cells in vitro. These cells would provide a vastly improved model for understanding the metabolism of alpha-synuclein and its role in the development of Parkinson's disease.ⁱ In this example, the availability of improved in vitro models for genetic and neurodegenerative diseases could shorten the time required to understand and devise new treatments for devastating diseases.

   It is true that adult stem cells (or multipotent adult progenitor cells³), isolated from patients carrying the mutant genes that predispose them to Parkinson's disease, might also be stimulated to become dopamine-producing neurons in vitro. But there are unanswered questions about the ease of culture and long-term viability of such cells, and the likelihood of success with cellular models of disease derived from adult stem cells remains unknown. In the absence of a certain and superior alternative, it would be wrong to forgo the possibly unique benefits of cloning for disease research.

2. Cloning to Devise New Treatments for Human Diseases

   The same cellular model systems used to study disease processes are also potentially useful for assessing and developing chemical or pharmaceutical treatments for the disease in question. To continue with the Parkinson's disease example, neurons derived from stem cells containing the alpha-synuclein aggregation mutations would be very useful for testing compounds that might prevent aggregation of this protein. Chemicals that effectively prevented aggregation in this model system could be useful starting points for the development of new drugs for the specific treatment of Parkinson's disease. Here, too, neuronal cell-systems derived from adult stem cells carrying the mutations might serve as well as those derived from cloned embryonic stem cells. But there is no way of knowing in advance which of the alternative routes is more promising. From a medical and scientific point of view, research on cloned embryos may offer unique benefits.

3. Cloning to Produce Immune-Compatible Tissues for Transplantation

   Some animal studies suggest that tissues derived from embryonic stem cells can, if injected under certain conditions, populate disease-stricken areas and differentiate so as to compensate for the loss of function caused by the diseased tissue. For example, liver or heart muscle cells injected into an animal with liver or heart disease could help regenerate the diseased tissues and restore normal function. But these cells would have a chance to do this only if they can survive the normal immunological rejection response to foreign material. Cloning-for-biomedical-research offers the possibility that scientists could someday generate individualized, "rejection-proof" replacement cells and tissues to help patients fight disease and restore health. Stem cells and tissues derived from an embryonic clone of the patient would have the same genes as the patient, and so, hypothetically, would not be rejected by the patient's body as foreign.

   It is true that this possibility (what is sometimes called "therapeutic cloning") remains unproved.ⁱⁱ As before, there may be alternative (nonembryonic or adult) sources of such "rejection-proof" stem cells and tissues derived from them. And there is ongoing research to circumvent the rejection problem altogether, by, for example, modifying the surface of an unrelated (embryonic) stem cell so as to enable it to escape detection as "foreign" tissue when transferred to patients for therapy. But, once again, it is too early to say which approach will work, and therefore it is important, from a medical and scientific perspective, not to close off any avenue of promise. The only way to verify this hypothesis is to try it -- first in animals, then in human volunteers.

4. Cloning to Assist in Gene Therapy

   Cloning techniques could also be combined with precise genetic manipulation to devise genetic treatments for genetic diseases. For example, a cloned embryo produced from a patient with severe combined immunodeficiency could be genetically modified to correct and repair the disease-causing mutation. Stem cells taken from the genetically modified cloned embryo might then be used to develop bone marrow stem cells to transplant back into the patient. This combined approach to gene therapy has shown early promise in one attempt to correct a genetic abnormality in the immune system of mice.⁴

B. Possible Moral Dilemmas of Proceeding

The potentially unique medical benefits of cloning-for-biomedical-research are, to those of us who favor it, abundantly clear. Yet the moral meaning of proceeding, still to be considered, is the subject of some debate among us. Most of us who favor proceeding believe that this area of promising research is nonetheless fraught with moral quandaries and ethical trade-offs; a minority of us do not share these concerns. The minority view, labeled Position Number Two, follows the principal moral case for cloning-for-biomedical-research under strict limits, designated here as Position Number One. Each opinion is presented in turn.

1. Position Number One

   What makes this research morally controversial is that it involves the production, use, and intentional destruction of cloned human embryos. To determine whether or not the science should proceed -- or, if it does, what limits should be placed on this research -- it must be asked what, if anything, is owed this nascent form of human life. Only then can an evaluation be made of whether the possible benefits of this research justify its potential human cost. Other moral hazards must be considered that are either inherent in, or possible consequences of, this line of research. These hazards include the following: the possibility that cloned embryos will be developed and experimented upon beyond the blastocyst stage (the stage from which stem cells are taken); the possible exploitation of women who would be donors of eggs; the possibility that the production of cloned human embryos will lead -- intentionally or unintentionally -- to cloning-to-produce-children; and the possibility that engaging in such research will weaken or undermine society's respect for human life, and therefore undermine the very good (life) that it is meant to serve. Each of these moral challenges will now be addressed.

   1. What is owed to the cloned embryo? The subject of the moral status of developing human life is a difficult and controversial matter, one about which American society is and appears likely to remain deeply divided. We are well aware of the fact that we cannot do it full justice in the present context. Yet we believe that the moral defense of cloning-for-biomedical-research requires a consideration of what is owed nascent human life (cloned or not). There is also the question -- considered at great length in Chapter Three -- of whether cloned embryos are the moral equivalent of fertilized embryos, or whether the different nature of their origins and the uncertainty of their capacity to become full human beings means that our moral duties to them are somehow different.

      Nevertheless, those who wish to defend cloning-for-biomedical-research -- as we do here -- must consider what is owed to embryos as such as well as the significance of the fact that the embryos in question would be cloned. That said, the relevant arguments, especially in this sub-section and the next, are in most crucial respects the same as those regarding the treatment of embryos produced by IVF.

      Let us be clear about what we are talking about when we speak of cloned embryos. We are talking about the very earliest stages in development, from the single cell product of SCNT, through the early cleavage stages, up to the blastocyst stage. This is a structure comprising some 100 to 200 cells not yet differentiated into specific tissues, let alone organs (though there is differentiation into inner cell mass and trophoblast; see Chapter Four). It is true that the embryos at the blastocyst stage, if implanted in a woman's uterus or (hypothetically) an animal or artificial womb, could be made to develop to later stages, and this potentiality must be taken into account. But it is important to keep in mind the primitive and undifferentiated condition of the embryonic stage that is relevant for the research in question.

      We begin with a series of questions: Is destroying an embryo or cloned embryo at the blastocyst stage morally the same as killing a child? Is it the same as clipping a fingernail? Is it more like one of these acts than the other? Is it like neither? Does the moral status of an embryo depend on whether it is implanted in a woman's uterus or remains in a laboratory? Does the moral status of an embryo depend on its origins, or how it was produced? Does it depend on the motives of those who create it?

      In our view, embryos have a developing and intermediate moral worth, such that the early human embryo has a moral status somewhere between that of ordinary human cells and that of a full human person. We acknowledge the difficulty of setting perfectly clear lines marking when an embryo's moral status goes from "less than a human person" to "like a human person" to "fully a human person." But we believe there are sound moral reasons for not regarding the embryo in its earliest stages (certainly in the first fourteen days) as the moral equivalent of a human person, though it does command significantly more respect than other human cells. We also hold that the embryo can be used for life-saving or potentially life-saving research while still being accorded the "special respect" it deserves, and while still preventing abuses such as research on later-stage embryos or fetuses or the production of cloned children. We will develop this view by taking up the significance of (i) twinning, (ii) implantation, (iii) the human form, and (iv) the notion of "special respect."

      1. The possibility of twinning. First, it is still unclear in the initial fourteen-day period whether an embryo will develop into one or more human beings. The possibility for "twinning" is still present, suggesting that the earliest-stage embryo is either not yet an individual or is a being that is not confined to becoming only one individual. There are continuing philosophical debates about how to understand what happens in twinning: for example, whether one individual embryo "clones" itself to produce a second, or whether an organism that resembles (but is not yet) an individual embryo divides into two truly individual beings.ⁱⁱⁱ Nevertheless, the biological -- and we believe moral -- significance of the possibility for twinning is clear: after fourteen days (or after the primitive streak is formed), the being in question can no longer be anything but a single being -- that is to say, no embryo after this stage, and thus no fetus or live-born baby can replicate or divide to form another identical being. Before fourteen days, this possibility remains.

      2. The moral significance of pregnancy and implantation. Both IVF embryos and cloned embryos in vitro differ from comparable embryos conceived through sexual intercourse for two reasons. First, the possibility for pregnancy with IVF or cloned embryos requires human assistance -- that is, it requires the medical procedure of implanting an embryo into the woman's uterus. There is thus no possibility of the IVF or cloned embryo becoming a human child in its original in vitro environment. Second, embryos that are conceived through sexual intercourse have a direct physical connection with the individual women who carry them, whereas an in vitro embryo (cloned or not) has no such connection unless it is transferred into a woman's uterus. Thus, transfer of cloned or IVF embryos into a woman's uterus is a significant moral step, insofar as such embryos cannot be removed -- they can never again be held in human hands -- without a direct physical intrusion or violation of the pregnant woman. Of course, it might become technologically possible in the future for in vitro embryos to develop beyond the blastocyst stage (that is, in an artificial womb) -- and perhaps even to birth -- without implantation into a woman's uterus. Moreover, just because those embryos (cloned or not) that exist in vitro cannot continue to develop in a self-directed way beyond the blastocyst stage -- that is, they require human artifice of some kind to develop further -- does not mean that the preimplantation embryo is morally insignificant. But implantation does mark a significant point in these two respects: after implantation, self-direction toward birth (without external human artifice) becomes possible and external human control of embryos becomes impossible without intruding upon or violating the pregnant woman.

      3. The significance of the developed human form. Generally speaking, our moral sentiments respond very differently to the prospect -- or the sight -- of the destruction of an embryo and the murder of a child. In other words, there is a difference between what we respect and what we consider inviolable. The destruction of embryos might inspire concern or solemnity. In contrast, our reaction to the murder of a child would be one of horror, outrage, grief, and violation. James Q. Wilson has discussed how these two fundamentally different moral reactions change as the embryo develops into a fetus and then into a child -- and correspondingly, how our concern and solemnity transform into horror and outrage.⁵ Specifically, human beings exhibit a distinctly different moral sympathy for, and therefore greater willingness to protect, those organisms that have begun to resemble human beings in their developed form. The practice of sacrificing the life of the unborn in order to save the life of the pregnant woman -- while not a moral parallel to the case of using cloned embryos for biomedical research -- shows that there is some moral precedent for subordinating nascent human life to more developed human life. Of course, taken to an extreme, such a principle would justify the most grotesque uses of developing human fetuses for scientific experiments. Moreover, the case is not strictly analogous, for in the case of the pregnant woman, two lives are in conflict, a confrontation absent with free-standing embryos. We do not take the life of woman A's unborn fetus to save the life of woman B, not even with consent. But these difficulties notwithstanding, there is (again) a moral insight in this example. It demonstrates the important moral obligation of caring for those who already walk among us, and the inevitable moral complexity of weighing different forms of human life, especially nascent and developed human life, against one another. It also suggests ways in which the claim on our protection may increase with the emergence of powers of awareness and suffering. Of course, such examples -- and our moral sentiments in general -- are not by themselves decisive. They are the beginning, not the end, of reasoning about our moral responsibilities. But they should also not be ignored for what they reveal about the nature of particular beings and particular acts -- and in this case, for what they suggest about both the developing and intermediate status of the early human embryo.

      4. The meaning of "special respect." Finally, there is the question of whether it is possible to accord early-stage embryos "special respect" while still using them for biomedical research. We might reason here by an admittedly imperfect analogy. Various religions have rules governing the killing of animals for food. These exist in part to restrain cruelty. But they also serve to demonstrate respect for beings that command our affections and our wonder, because they are (like us) part of the mystery of existence. In a similar way, many hunters have a deep-rooted respect and even affection for the animals they kill. This is not to say that human embryos are the same as animals, because, in our opinion, they are indeed human organisms, if not fully developed human beings. But it is to show that there might be ways both to respect beings and to use them -- for serious, not frivolous, reasons and as part of our place in the order of being, not simply as an extension of our subjective will.

      For the above-stated reasons, we would assign an intermediate and developing status to the human embryo. Those who treat the developing early embryo as nothing more than "mere cells" (see Position Number Two below) are in danger of ignoring its direct and inherent connection to the profound mystery of the origins of human life and seem willing to ignore the fact that an embryo will (and a cloned embryo might) eventually become one (or more) human being(s). This view greatly underestimates the moral seriousness of the question of whether to proceed with research on nascent human life. And it gravely mischaracterizes the meaning of potentiality -- specifically, the difference between having the capacity to become anything at all (a pile of building materials, for example) and the capacity to become something in particular (an individuated human person or persons).

      At the same time, those who believe that early-stage embryos are the moral equivalent of a human person (see Part IV below) are also, we believe, misguided. Just as we must listen to -- and then articulate -- the moral meaning of our "repugnance" at the idea of cloning-to-produce-children, we must listen to and articulate our fundamentally different moral responses to the destruction of an embryo on the one hand and the murder of a child on the other. While no single criterion like "appearance," "self-consciousness," "the capacity to express needs and desires," or "the capacity to feel pain" can by itself be decisive in conferring human dignity, the absence of all such criteria in the early-stage embryo or cloned embryo suggests that it is not a truly human being, but something different, commanding our respect because of what it is and may become, but yet not fully one of us.

      In sum, what is owed the embryo is not the same protections, attachments, and rights as a human person; nor is it no respect at all. In making the decision to proceed with research on embryos or cloned embryos, we must do so only for the most compelling reasons -- namely, the reasonable expectation that such research will save human lives -- and only with eyes open to the moral burden of doing what we believe to be morally best. Even as we establish the biological and moral grounds for using human embryos in certain forms of research, we must face and accept the solemnity of what we propose. Finally, we must proceed with the paradox that accompanies all human suffering and human imperfection in full view: that sometimes we seem morally obligated to do morally troubling things, and that sometimes doing what is good means living with a heavy heart in doing it.

   2. The problem of deliberate creation for use in research. We next address whether the creation of embryos explicitly for the purposes of biomedical research presents additional ethical problems, beyond those just examined. In the case of research on cloned embryos, this form of deliberate production and destruction -- rather than the use of leftover embryos initially created for reproductive purposes -- is the only means of proceeding, if, at the same time, cloning-to-produce-children is prohibited. It is one thing to overcome the respect owed to an already existing embryo that would die even if not used for research. It is, some argue, quite another thing to bring the embryo into being solely for use and exploitation in research. Willing to accept the first, they reject the second.^iv In this connection, three issues seem worth considering.

      First, the fundamental moral judgment about whether to proceed with cloning-for-biomedical-research must be grounded in our judgment about the moral status of the embryos themselves, not the purpose of their creation. If an embryo or a cloned embryo had no moral standing, then creation for research and eventual destruction would present no moral problem. If the embryo or cloned embryo were morally the equivalent of a child, then regardless of how or why it was produced, experiments upon it would be morally abhorrent. But if, as we have just argued, an embryo or a cloned embryo has a developing and intermediate moral status, certain worthy uses of them may be justified regardless of how and why they were produced. Because the use of stem cells from cloned embryos may in the future provide treatment for serious human diseases, the creation of cloned embryos and their subsequent disaggregation to isolate stem cells can be justified.

      Second, the moral responsibilities for producing new embryos solely for research and for producing extra IVF embryos later used in research are not really so different. In the case of IVF and leftover embryos, the individuals who create them for reproductive purposes typically and deliberately create more embryos than they are likely to use, and therefore know in advance that some will probably be destroyed. It is true that they are produced with the intent of initiating a pregnancy and that the embryo wastage is not all that different from what obtains in efforts to conceive in vivo. But the moral responsibility for production, use, and destruction of leftover embryos are finally no less than for deliberate production for use (and subsequent destruction). (We acknowledge that some who accept this logic come to the opposite conclusion -- namely, not that cloning-for-biomedical-research is morally permissible but that IVF should be morally restricted to creating one embryo at a time, if permitted at all.)

      Third, in both cases -- creating embryos to aid fertility or creating embryos for biomedical research -- the ultimate goal is something humanly good: a child for an infertile couple or research that holds promise for curing debilitating diseases and easing suffering. Thus, in the case of cloning-for-biomedical-research, it is wrong to argue, as some do, that embryos are being "created for destruction." Certainly, their destruction is a known and unavoidable effect, but the embryos are ultimately created for research in the service of life and medicine.

      In the end, while we acknowledge the risk of turning nascent human life into a "resource" -- fully separate from its intrinsic connection to human procreation -- we hold that the concern over deliberate creation and destruction is misplaced. What matters instead is whether a proper regard is shown for the created embryos, and therefore whether a proper moral and legal framework can be established that limits and governs their use in accordance with the respect they are owed as human cloned embryos.

   3. Development and use of cloned embryos beyond the earliest stages. A perceived danger of allowing cloning-for-biomedical-research is that some researchers will develop cloned embryos beyond the blastocyst stage for research purposes. There are good scientific reasons and even moral arguments for doing so: one could learn much more about development, normal and abnormal, by going to later stages; differentiated tissues taken from cloned fetuses would likely be more useful in regenerative medicine than stem cells. There is already at least one animal study showing the potential of this approach.⁶ Transplantable functioning kidney tissue has been attained from six-week-old cloned cow fetuses, developed from cloned cow embryos transferred into a cow's uterus for partial gestation. Cloned human embryos might be developed past the blastocyst stage by implantation into an animal or human uterus, by the development of artificial wombs, or by advances in sustaining nascent human life in vitro.

      This is a serious concern for those of us who believe that the cloned embryo has only an intermediate moral status and who also recognize the difficulty of drawing bright lines for when developing human life changes from "less than a human person" to "like a human person" to a "fully developed person." Clearly, the longer cloned embryos are allowed to develop, the more severe the moral burden in using them. And at some point, the moral burden of proceeding becomes a moral obligation not to proceed -- even if significant medical benefits might be gained from doing so. In such circumstances, the medical principle of "do no harm" must override the researcher's desire to do good, lest we undermine the humanistic principles and spirit of the entire medical enterprise.

      The moral tradition of "erecting a fence around the law"^v may provide a useful guide in this case. We recommend that research on cloned embryos be strictly limited to the first fourteen days of development -- a point just about when the primitive streak is formed and before organ differentiation occurs. We acknowledge that by erecting the fence more widely, we might be more certain to prevent this particular abuse (developing cloned embryos beyond the blastocyst stage). We also acknowledge that relaxing this limit to permit research beyond fourteen days might yield additional medical benefits. There is a moral burden in both directions. But we hold that there is a point of development beyond which research on nascent human life is morally intolerable no matter what the potential medical benefits. By raising a permanent fence at fourteen days, the dignity of human life will be sufficiently protected.

   4. Exploitation of women who are egg donors. Additional concerns in proceeding with cloning-for-biomedical-research are the possible dangers to, and exploitation of, women who are egg donors. The removal of eggs remains an unpleasant and (owing to the hormone treatments needed to hyperstimulate the ovaries) a risky medical procedure for women. It is therefore restricted mostly to circumstances where such a procedure is necessary to treat infertility -- that is, where the women themselves are the beneficiaries of the procedure. Moreover, one possible avenue of cloning-for-biomedical-research -- namely, the creation and future use of individualized stem cells -- would potentially require, if it became feasible, a very large and indefinite number of eggs.

      These are genuine concerns. But they can be addressed by strictly adhering to the established body of ethics for research on human subjects. These ethical codes suggest the following requirements: regulation to prevent the creation of improper financial incentives for participating in such research; full disclosure by the users of human eggs of their practices; a commitment to consider using nonhuman eggs, so as to decrease the need for human egg donors;^vi and strict limits on the uses of cloned embryos for only those investigations that uniquely require them.

   5. The connection to cloning-to-produce-children. The final moral concern is that cloning-for-biomedical-research will lead -- intentionally or not -- to cloning-to-produce-children. For the reasons described in Chapter Five, we believe that the creation of cloned human children would be unethical and that society has a moral responsibility to ensure that this does not happen. Thus we are obliged to consider whether the pursuit of cloning-for-biomedical-research is consistent with a serious commitment to stopping cloning-to-produce-children. A number of points must be considered.

      First, the production of cloned embryos, even for research purposes, crosses a new line by bringing into existence for the first time forms of nascent human life that are asexually produced. Second, experience with producing cloned embryos for biomedical research might well improve the technique of cloning itself, and therefore result in the greater perfection of the first step toward cloning-to-produce-children. Third, cloning-for-biomedical-research means that cloned embryos would exist in laboratories where they could be available for efforts to initiate a pregnancy. Finally, a society that allows cloning-for-biomedical-research, while setting strict legal limits on cloning-to-produce-children, will likely require the mandatory destruction of nascent human life.

      The first concern is intrinsic to cloning-for-biomedical-research in itself. Are we a different society because we have brought asexually produced human embryos into existence? In some ways, perhaps we are. We are confronted by the scope of our powers to change human life, to alter human procreation, and to modify the nature of human origins and the genetic makeup of new life. But we are also reminded of what should be the animating purpose of that power: to cure disease and relieve suffering. We are reminded of both new and unique possibilities for human harm (from the production of human clones) and new and unique possibilities for human benefit (from research on cloned embryos). This is, we suggest, the meaning of crossing this line.

      The second and third concerns are connected to where this research might lead: namely, to a perfected cloning technique and to the intentional production of cloned children. This is indeed a genuine concern. It is perhaps the case that the best way to prevent the production of cloned children is to prohibit the creation of cloned embryos. But in the end, we are not convinced that cloning-for-biomedical-research will inevitably lead to cloning-to-produce-children; rather, we believe that the best approach is a system of regulation that prevents such an abuse. Such a system would include: a legal ban on the implantation of cloned embryos in any uterus (human, animal, or artificial); a prohibition on developing cloned embryos beyond fourteen days; a requirement that any individual or group engaging in cloning-for-biomedical-research register with proper regulatory authorities; prior scientific review of the proposed uses of cloned embryos to judge their medical and scientific benefits; and strict accounting of all cloned embryos that are produced to prevent their removal from the lab of origin or their use in attempts at cloning-to-produce-children.

      Of course, no system of regulation is perfect. There is always the possibility of malfeasance or error. The prudential question in this case is whether the likelihood of cloning-to-produce-children is increased -- at all, slightly, or significantly -- by allowing the production and use of cloned embryos for biomedical research. But there is also the question of whether some additional risk of cloning-to-produce-children is justified or tolerable given the human goods that might be achieved through cloning-for-biomedical-research. In our view, it is.

      The final concern is that to pursue research on cloned embryos while preventing cloning-to-produce-children would require laws that mandated the destruction of nascent human life. In assessing the moral significance of this fact, we return to our judgment about the moral status of cloned embryos, what is owed to them, and whether the human goods that can be achieved by cloning-for-biomedical-research justify the real and potential human costs. In our view, the possible existence of a law requiring the destruction of cloned embryos at or before fourteen days of development would force moral clarity about what we are doing -- and the burdens of doing it. Such a law might remind society of the ambiguity and limits of the efforts to "heal the world," and therefore the dangers of trying to do so by any means possible. The need for such a law requiring the destruction of nascent human life would also remind that there is a burden in acting just as there is a burden in not acting.

   6. Conclusion. The case for cloning-for-biomedical-research -- as with all research that involves the use of nascent human life -- should not consist simply of guessing how many people might be saved and how many embryos might be lost. The moral concerns cannot so simply be taken up, addressed, and retired. They are permanent concerns and permanent burdens.

      We believe, in this particular case, that the promise of cloning-for-biomedical-research justifies proceeding, but that the genuine possibility of moral harm requires strict regulations of how we proceed. We have tried to articulate what such a system of regulation might include: (1) a legal requirement not to develop cloned embryos beyond fourteen days of development and not to implant cloned embryos in any uterus, human, animal, or artificial; (2) the creation of a governmental oversight body to regulate individuals and groups who engage in this research, and to account for all cloned embryos that are produced so as to prevent their removal from the lab of origin or their use in cloning-to-produce-children; (3) a ban on commerce in living cloned human embryos; (4) adherence to the highest standards of the ethics of research on human subjects, especially when it comes to procuring eggs; (5) a prior scientific review of the proposed uses of cloned embryos to judge their unique medical and scientific benefits; and (6) continued research into possible non-embryonic sources of stem cells and tissues for developmental studies, and ways other than cloning to solve the immune rejection problem. Such regulations amount to much more than mere bureaucratic red tape. They embody a profound ethical insight -- namely, that the means of serving human beings must never corrupt our responsibilities to human beings.

2. Position Number Two

   A few of us who favor proceeding with cloning-for-biomedical-research have few of the ethical qualms expressed by our colleagues in Position Number One. It is our view that this research, at least in the forms and 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, we believe that the moral issues involved in this research are no different from those that accompany many existing forms of biomedical research, requiring mainly the usual commitment to high standards for the quality of research, scientific integrity, and the need to obtain informed consent from, and to protect the health of, donors of the eggs and somatic cells used in nuclear transfer.

   It is also our view that there are no sound reasons for treating the early-stage human embryo or cloned human embryo as anything special, or as having moral status greater than human somatic cells in tissue culture. A blastocyst (cloned or not), because it lacks any trace of a nervous system, has no capacity for suffering or conscious experience in any form -- the special properties that, in our view, spell the difference between biological tissue and a human life worthy of respect and rights. Additional biological facts suggest that a blastocyst should not be identified with a unique individual person, even if the argument that it lacks sentience is set aside. A single blastocyst may, until the primitive streak is formed at around fourteen days, split into twins; conversely, two blastocysts may fuse to form a single (chimeric) organism. Moreover, most early-stage embryos that are produced naturally (that is, through the union of egg and sperm resulting from sexual intercourse) fail to implant and are therefore wasted or destroyed.

   There is a moral precedent for using materials from early human embryos in the widely accepted practice of using organs from brain-dead human beings. Upon determination of death, and with permission from the next of kin, surgeons routinely harvest organs to save the lives of sick or dying patients. In a similar way, donors of somatic cells and human oocytes could justifiably grant a biomedical scientist permission to use cells derived from the resulting cloned five-to-six-day-old blastocyst, which also completely lacks a brain and a capacity for consciousness.

   Some argue that the transplantation analogy is misleading, because a blastocyst has the potential to become a fetus and ultimately a child, whereas the brain-dead individual does not. But the potential to become something (or someone) is hardly the same as being something (or someone), any more than a pile of building materials is the same as a house. A cloned embryo's potential to become a human person can be realized, if at all, only by the further human act of implanting the cloned blastocyst into the uterus of a woman. Such implantation is not a part of cloning-for-biomedical-research, whose aims and actual practice do not require it.

   Moreover, thanks to the results of nuclear transplantation research, there is reason to believe that every human cell has the genetic potential to develop into a complete human being, if used in cloning efforts to produce a child. If mere potentiality to develop into a human being is enough to make something morally human, then every human cell has a special or inviolable moral status, a view that is patently absurd.

   "Slippery slope" warnings that the use of early-stage cloned embryos for research would lead necessarily either to the production of cloned children or to research on later-stage cloned fetuses should be treated with skepticism. Appropriate regulations can easily be established and enforced to prevent any such abuses. Although the continuity of biological development means that there is no naturally given moment after which an embryo or fetus becomes a person, defensible boundaries can be set. It is perfectly possible to treat a blastocyst as a clump of cells usable for lifesaving research, while prohibiting any such use of a later-stage embryo or fetus.

   Where to set the boundary is a matter for prudent judgment. For the foreseeable future, the moral line might be safely drawn at fourteen days of development, when no nervous system has developed and when a distinct identity as a single individual has not yet been preordained. Also, derivation of the valuable stem cells can be accomplished well before fourteen days. Whether society will be faced, in the future, with reason to reconsider such a line is for now a matter of speculation. If such an occasion ever arose, it would require an evaluation of the proposed scientific use and its likely medical benefits and a moral consideration of whether the research in question justified using embryos beyond the fourteen-day point.

We also observe, however, that the realization of these medical benefits -- like all speculative research and all wagers about the future -- remains uncertain. There are grounds for questioning whether the proposed benefits of cloning-for-biomedical-research will be realized. And there may be other morally unproblematic ways to achieve similar scientific results and medical benefits. For example, promising results in research with non-embryonic and adult stem cells suggest that scientists may be able to make progress in regenerative medicine without engaging in cloning-for-biomedical-research. We can move forward with other, more developed forms of human stem cell research and with animal cloning. We can explore other routes for solving the immune rejection problem or to finding valuable cellular models of human disease. Where such morally innocent alternatives exist, one could argue that the burden of persuasion lies on proponents to show not only that cloned embryo research is promising or desirable but that it is necessary to gain the sought-for medical benefits. Indeed, the Nuremberg Code of research ethics enunciates precisely this principle -- that experimentation should be "such as to yield fruitful results for the good of society, unprocurable by other methods or means of study." Because of all the scientific uncertainties -- and the many possible avenues of research -- that burden cannot at present be met.

But these same uncertainties mean that no one -- not the scientists, not the moralists, and not the patients whose suffering we all hope to ameliorate -- can know for certain which avenues of research will prove most successful. Research using cloned embryos may in fact, as we said above, yield knowledge and benefits unobtainable by any other means.

With such possible benefits in view, what reasons could we have for saying "no" to cloning-for-biomedical-research? Why not leave this possible avenue of medical progress open? Why not put the cup to our lips? In The Winter's Tale, Shakespeare has Leontes, King of Silicia, explain why one might not.⁷

There may be in the cup
A spider steep'd, and one may drink, depart,
And yet partake no venom, for his knowledge
Is not infected; but if one present
The abhorr'd ingredient to his eye, make known
How he hath drunk, he cracks his gorge, his sides
With violent hefts. I have drunk, and seen the spider.

To discern the spider in the cup is to see the moral reality of cloning-for-biomedical-research differently. It is to move beyond questions of immediately evident benefits or harms alone toward deeper questions about what an ongoing program of cloning-for-biomedical-research would mean. In part, this approach compels us to think about embryo research generally, but cloning (even for research purposes alone) raises its own special concerns, since only cloned embryos could one day become cloned children. We need to consider and articulate the reasons why, despite the possibility of great benefits, society should nevertheless turn away and not drink from this cup, and why the reasons for "drinking with limits" (offered by our colleagues in Position Number One above) are finally not persuasive.

Our analysis proceeds along three pathways: what we owe to the embryo; what we owe to society; and what we owe to the suffering. We differ, among ourselves, on the relative importance of the various arguments presented below. But we all agree that moral objections to the research itself and prudential considerations about where it is likely to lead suggest that we should oppose cloning-for-biomedical-research, albeit with regret.

A. What We Owe to the Embryo

The embryo is, and perhaps will always be, something of a puzzle to us. In its rudimentary beginnings, it is so unlike the human beings we know and live with that it hardly seems to be one of us; yet, the fact of our own embryonic origin evokes in us respect for the wonder of emerging new human life. Even in the midst of much that is puzzling and uncertain, we would not want to lose that respect or ignore what we owe to the embryo.

The cell synthesized by somatic cell nuclear transfer, no less than the fertilized egg, is a human organism in its germinal stage.^vii It is not just a "clump of cells" but is an integrated, self-developing whole, capable (if all goes well) of the continued organic development characteristic of human beings. To be sure, the embryo does not yet have, except in potential, the full range of characteristics that distinguish the human species from others, but one need not have those characteristics in evidence in order to belong to the species. And of course human beings at some other stages of development -- early in life, late in life, at any stage of life if severely disabled -- do not forfeit their humanity simply for want of these distinguishing characteristics. We may observe different points in the life story of any human being -- a beginning filled mostly with potential, a zenith at which the organism is in full flower, a decline in which only a residue remains of what is most distinctively human. But none of these points is itself the human being. That being is, rather, an organism with a continuous history. From zygote to irreversible coma, each human life is a single personal history.

But this fact still leaves unanswered the question of whether all stages of a human being's life have equal moral standing. Might there be sound biological or moral reasons for according the early-stage embryo only partial human worth or even none at all? If so, should such embryos be made available or even explicitly created for research that necessarily requires their destruction -- especially if very real human good might come from it? Some of us who oppose cloning-for-biomedical-research hold that efforts to assign to the embryo a merely intermediate and developing moral status -- that is, more humanly significant than other human cells, but less deserving of respect and protection than a human fetus or infant -- are both biologically and morally unsustainable, and that the embryo is in fact fully "one of us": a human life in process, an equal member of the species Homo sapiens in the embryonic stage of his or her natural development. Moreover, all of us who oppose going forward with cloning-for-biomedical-research believe that it is incoherent and self-contradictory for our colleagues (in Position Number One) to claim that human embryos deserve "special respect" and to endorse nonetheless research that requires the creation, use, and destruction of these organisms, especially when done routinely and on a large scale.

The case for treating the early-stage embryo as simply the moral equivalent of all other human cells (Position Number Two, above) is entirely unconvincing: it denies the continuous history of human individuals from zygote to fetus to infant to child; it misunderstands the meaning of potentiality -- and, specifically, the difference between a "being-on-the-way" (such as a developing human embryo) and a "pile of raw materials," which has no definite potential and which might become anything at all; and it ignores the hazardous moral precedent that the routinized creation, use, and destruction of nascent human life would establish for other areas of scientific research and social life.

The more serious questions are raised -- about individuality, potentiality, and "special respect" -- by those who assign an intermediate and developing moral status to the human embryo, and who believe that cloned embryos can be used (and destroyed) for biomedical research while still according them special human worth (Position Number One, above). But the arguments for this position -- both biological and moral -- are not convincing. For attempts to ground the special 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 once one sees what those who take this position are willing to countenance.

We are not persuaded by the argument that fourteen days marks a significant difference in moral status. Because the embryo's human and individual genetic identity is present from the start, nothing that happens later during the continuous development that follows -- at fourteen days or any other time -- is responsible for suddenly conferring a novel human individuality or identity. The scientific evidence suggests that the fourteen-day marker does not represent a biological event of moral significance; rather, changes that occur at fourteen days are merely the visibly evident culmination of more subtle changes that have taken place earlier and that are driving the organism toward maturity. Indeed, many advocates of cloning-for-biomedical-research implicitly recognize the arbitrariness of the fourteen-day line. The medical benefits to be gained by conducting research beyond the fourteen-day line are widely appreciated, and some people have already hinted that this supposed moral and biological boundary can be moved should the medical benefits warrant doing so (see Position Number Two, above).

There are also problems with the claim that its capacity for "twinning" proves that the early embryo is not yet an individual or that the embryo's moral status is more significant after the capacity for twinning is gone. There is the obvious rejoinder that if one locus of moral status can become two, its moral standing does not thereby diminish but rather increases. More specifically, the possibility of twinning does not rebut the individuality of the early embryo from its beginning. The fact that where "John" alone once was there are now both "John" and "Jim," or where what we thought was "John" alone there now are "Jim" and "Tim," does not call into question the presence of "John" at the outset. Hence, we need not doubt that even the earliest cloned embryo is an individual human organism in its germinal stage. Also, from a developmental science perspective, twinning may not turn out to be an intrinsic process within embryogenesis. Rather, it may be a response to a disruption of normal development from which the embryo recovers and then forms two. Twinning would thus be a testament to the resilience of self-regulation and compensatory repair within early life, not the lack of individuation in the early embryo. From this perspective, twinning is further testimony to the potency of the individual (in this case two) to fullness of form.

We are also not persuaded by the claim that in vitro embryos (whether created through IVF or cloning) have a lesser moral status than embryos that have been implanted into a woman's uterus, because they cannot develop without further human assistance. The suggestion that extra-corporeal embryos are not yet individual human organisms-on-the-way, but rather special human cells that acquire only through implantation the potential to become individual human organisms-on-the-way, rests on a misunderstanding of the meaning and significance of potentiality. An embryo is, by definition and by its nature, potentially a fully developed human person; its potential for maturation is a characteristic it actually has, and from the start. The fact that embryos have been created outside their natural environment -- which is to say, outside the woman's body -- and are therefore limited in their ability to realize their natural capacities, does not affect either the potential or the moral status of the beings themselves. A bird forced to live in a cage its entire life may never learn to fly. But this does not mean it is less of a bird, or that it lacks the immanent potentiality to fly on feathered wings. It means only that a caged bird -- like an in vitro human embryo -- has been deprived of its proper environment. There may, of course, be good human reasons to create embryos outside their natural environments -- most obviously, to aid infertile couples. But doing so does not obliterate the moral status of the embryos themselves.

As we have noted, many proponents of cloning-for-biomedical-research (and for embryo research more generally) do not deny that we owe the human embryo special moral respect. Indeed, they have wanted positively to affirm it.^viii But we do not understand what it means to claim that one is treating cloned embryos with special respect when one decides to create them intentionally for research that necessarily leads to their destruction. This respect is allegedly demonstrated by limiting such research -- and therefore limiting the numbers of embryos that may be created, used, and destroyed -- to only the most serious purposes: namely, scientific investigations that hold out the potential for curing diseases or relieving suffering. But this self-limitation shows only that our purposes are steadfastly high-minded; it does not show that the means of pursuing these purposes are respectful of the cloned embryos that are necessarily violated, exploited, and destroyed in the process. To the contrary, a true respect for a being would nurture and encourage it toward its own flourishing.

It is, of course, possible to have reverence for a life that one kills. This is memorably displayed, for example, by the fisherman Santiago in Ernest Hemingway's The Old Man and the Sea, who wonders whether it is a sin to kill fish even if doing so would feed hungry people. But it seems difficult to claim -- even in theory but especially in practice -- the presence of reverence once we run a stockyard or raise calves for veal -- that is, once we treat the animals we kill (as we often do) simply as resources or commodities. In a similar way, we find it difficult to imagine that bio-technology companies or scientists who routinely engaged in cloning-for-biomedical-research would evince solemn respect for human life each time a cloned embryo was used and destroyed. Things we exploit even occasionally tend to lose their special value. It seems scarcely possible to preserve a spirit of humility and solemnity while engaging in routinized (and in many cases corporately competitive) research that creates, uses, and destroys them.

The mystery that surrounds the human embryo is undeniable. But so is the fact that each human person began as an embryo, and that this embryo, once formed, had the unique potential to become a unique human person. This is the meaning of our embodied condition and the biology that describes it. If we add to this description a commitment to equal treatment -- the moral principle that every human life deserves our equal respect -- we begin to see how difficult it must be to suggest that a human embryo, even in its most undeveloped and germinal stage, could simply be used for the good of others and then destroyed. Justifying our intention of using (and destroying) human embryos for the purpose of biomedical research would force us either to ignore the truth of our own continuing personal histories from their beginning in embryonic life or to weaken the commitment to human equality that has been so slowly and laboriously developed in our cultural history.

Equal treatment of human beings does not, of course, mean identical treatment, as all parents know who have more than one child. And from one perspective, the fact that the embryo seems to amount to so little -- seems to be little more than a clump of cells -- invites us to suppose that its claims upon us can also not amount to much. We are, many have noted, likely to grieve the death of an embryo less than the death of a newborn child. But, then, we are also likely to grieve the death of an eighty-five-year-old father less than the death of a forty-five-year-old father. Perhaps, even, we may grieve the death of a newborn child less than the death of a twelve-year-old. We might grieve differently at the death of a healthy eighty-year-old than at the death of a severely demented eighty-year-old. Put differently, we might note how even the researcher in the laboratory may react with excitement and anticipation as cell division begins. Thus, reproductive physiologist Robert Edwards, who, together with Dr. Patrick Steptoe, helped produce Louise Brown, the first test-tube baby, said of her: "The last time I saw her, she was just eight cells in a test-tube. She was beautiful then, and she's still beautiful now."⁸ The embryo seems to amount to little; yet it has the capacity to become what to all of us seems very much indeed. There is a trajectory to the life story of human beings, and it is inevitable -- and appropriate -- that our emotional responses should be different at different points in that trajectory. Nevertheless, these emotions, quite naturally and appropriately different, would be misused if we calibrated the degree of respect we owe each other on the basis of such responses. In fact, we are obligated to try to shape and form our emotional responses -- and our moral sentiments -- so that they are more in accord with the moral respect we owe to those whose capacities are least developed (or those whom society may have wrongly defined as "non-persons" or "nonentities").

In short, how we respond to the weakest among us, to those who are nowhere near the zenith of human flourishing, says much about our willingness to envision the boundaries of humanity expansively and inclusively. It challenges -- in the face of what we can know and what we cannot know about the human embryo -- the depth of our commitment to equality. If from one perspective the fact 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. This was once our own condition. From origins that seem so little came our kin, our friends, our fellow citizens, and all human beings, whether known to us or not. In fact, precisely because the embryo seems to amount to so little, our responsibility to respect and protect its life correspondingly increases. As Hans Jonas once remarked, a true humanism would recognize "the inflexible principle that utter helplessness demands utter protection."⁹

B. What We Owe to Society

Having acknowledged all that, we would miss something if we stopped with what is owed to the embryo -- with the language of respect, claims, or rights. An embryo may seem to amount to little or nothing, but that very insignificance tests not the embryo's humanity but our own. Even those who are uncertain about the precise moral status of the human embryo -- indeed, even those who believe that it has only intermediate and developing status -- have sound ethical-prudential reasons to refrain from using embryos for utilitarian purposes. Moreover, when the embryos to be used have been produced by cloning, there are additional moral dilemmas that go beyond the ethics of embryo research alone. There are principled reasons why people who accept research on leftover IVF embryos created initially for reproductive purposes should oppose the creation and use of cloned embryos explicitly for research. And there are powerful reasons to worry about where this research will lead us. All these objections have their ground not only in the embryo's character but also in our own, and in concern not only for the fate of nascent human life but for the moral well-being of society as a whole. One need not believe the embryo is fully human to object vigorously to cloning-for-biomedical-research.

We are concerned especially about three ways in which giving our moral approval to such research would harm the character of our common life and the way of life we want to transmit to future generations: (i) by crossing the boundary from sexual to asexual reproduction, in the process approving, whether recognized or not, genetic manipulation and control of nascent human life; (ii) by allowing and endorsing the complete instrumentalization of human embryos; and (iii) by opening the door to other -- for some of us, far greater -- moral hazards, such as cloning-to-produce-children or research on later-stage human embryos and fetuses.

1. Asexual Reproduction and the Genetic Manipulation of Embryos

   It is worth noting that human cloning -- including cloning-for-biomedical-research itself and not simply cloning-to-produce-children -- would cross a natural boundary between sexual and asexual reproduction, reducing the likelihood that we could either retrace our steps or keep from taking further steps. Cloning-for-biomedical-research and cloning-to-produce-children both begin with the same act of cloning: the production of a human embryo that is genetically virtually identical to its progenitor. The cloned embryo would therefore be the first human organism with a single genetic "parent" and, equally important, with a genetic constitution that is known and selected in advance. Both uses of cloning mark a significant leap in human power and human control over our genetic origins. Both involve deliberate genetic manipulation of nascent human life. It is, of course, precisely this genetic control that makes cloned embryos uniquely appealing and perhaps uniquely useful to those who seek to conduct research on them. But we should not be deceived about what we are agreeing to if we agree to start to clone: saying yes to cloned embryos in laboratories means saying yes in principle to an ever-expanding genetic mastery of one generation over the next.

2. The Complete Instrumentalization of Nascent Human Life

   By approving the production of cloned embryos for the sole purpose of research, society would transgress yet another moral boundary: that separating the different ways in which embryos might become available for human experimentation. It is one thing, as some have argued, to conduct research on leftover embryos from IVF procedures, which were created in attempts to have a child and, once no longer needed or wanted, are "destined" for destruction in any case. It is quite another to create embryos solely for research that will unavoidably and necessarily destroy them. Thus, for example, the National Bioethics Advisory Commission (in its report on stem cell research) reasoned that in circumstances where embryos were going to be discarded anyway, it did not undermine the moral respect owed to them if they were destroyed in one way (through research) rather than another (by being discarded when no longer wanted for IVF).¹⁰ By contrast, the Commission reasoned that it was much harder to embrace the language of respect for the embryo if it were produced solely for purposes of research and, having been used, then destroyed. This argument maintained the following moral and practical distinction: that embryos created for reproduction but no longer desired could, with proper consent, be used as research subjects, but that embryos ought not be produced solely in order to be used as research subjects. So long as we oppose morally and perhaps one day prohibit legally the production of cloned children, it is in the very nature of the case that cloned human embryos will not be acquirable as "spare" embryos left over from attempts at reproduction. To the contrary, they will have to be produced solely and explicitly for the purpose of biomedical research, with no other end in view.

   Some have argued that there is no significant moral difference between creating excess IVF embryos for reproduction knowing in advance that some will be discarded and creating cloned embryos for research that leads necessarily to their destruction. Because in both cases embryos are wittingly destroyed, there is, so the argument goes, no moral difference here.

   When viewed simply in terms of the fates of embryos once they are created, the distinction between using leftover embryos and creating embryos solely for research may indeed be morally insignificant. But when viewed in terms of the different effects these two activities might have on the moral fabric of society -- and the different moral dispositions of those who decide to produce embryos for these different purposes -- the issue is more complex. In the eyes of those who create IVF embryos to produce a child, every embryo, at the moment of its creation, is a potential child. Even though more eggs are fertilized than will be transferred to a woman, each embryo is brought into being as an end in itself, not simply as a means to other ends. Precisely because one cannot tell which IVF embryo is going to reach the blastocyst stage, implant itself in the uterine wall, and develop into a child, the embryo "wastage" in IVF is more analogous to the embryo wastage in natural sexual intercourse practiced by a couple trying to get pregnant than it is to the creation and use of embryos that requires (without exception) their destruction.

   Those who minimize or deny this distinction -- between producing embryos hoping that one of them will become a child and producing embryos so that they can be used (and destroyed) in research -- demonstrate the very problem we are worried about. Having become comfortable with seeing embryos as a means to noble ends (be it having a child or conducting biomedical research), they have lost sight of the fact that the embryos that we create as potential children are not means at all. Even those who remain agnostic about whether the human embryo is fully one of us should see the ways in which conducting such research would make us a different society: 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 that we have, ourselves, so recently established, once it appears to be in our own interests to do so. 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. Doing so would undermine the very prudence and humility to which defenders of limited embryo research often appeal: the idea that, while a human embryo may not be fully one of us, it is not humanly nothing and therefore should not be treated as a resource alone. But that is precisely what cloning-for-biomedical-research would do.

3. Opening the Door to Other Moral Hazards

   This leads directly to our third concern -- that the cloning of human embryos for research will open the door to additional (and to some of us, far greater) moral hazards. Human suffering from horrible diseases never comes to an end, and, likewise, our willingness to use embryonic life in the cause of research, once permitted, is also unlikely to find any natural stopping point. To set foot on this slope is to tempt ourselves to become people for whom the use of nascent human life as research material becomes routinized and everyday. That much is inherent in the very logic of what we would do in cloning-for-biomedical-research.

   In addition, the reasons justifying production of cloned embryos for research can be predicted to expand. Today, the demand is for stem cells; tomorrow it may be for embryonic and fetal organs. The recent experiments with cloned cow embryos implanted in a cow's uterus¹¹ already suggest that there may be greater therapeutic potential using differentiated tissues (for example, kidney primordia) harvested from early fetuses than using undifferentiated stem cells taken from the very early embryo. Should this prove to be the case, pressure will increase to grow cloned human blastocysts to later stages -- either in the uteruses of suitably prepared animal hosts or (eventually) using artificial placenta-like structures in the laboratory -- in order to obtain the more useful tissues. One can even imagine without difficulty how a mother might be willing to receive into her womb as a temporary resident the embryonic clone of her desperately ill child, in order to harvest for that child life-saving organs or tissues. In such ways the coarsening of our moral sensibilities can be the fruit of understandable desires. Indeed, to refuse such further steps in the name of moral wisdom might come to seem increasingly sentimental, and, even if we were reluctant to give our approval, we might be hard-pressed to say why.

   We should not be self-deceived about our ability to set limits on the exploitation of nascent life. What disturbs us today we quickly or eventually get used to; yesterday's repugnance gives way to tomorrow's endorsement. A society that already tolerates the destruction of fetuses in the second and third trimesters will hardly be horrified by embryo and fetus farming (including in animal wombs), if this should turn out to be helpful in the cure of dreaded diseases.

   We realize, of course, that many proponents of cloning-for-biomedical-research will recommend regulations designed to prevent just such abuses (that is, the expansion of research to later-stage cloned embryos and fetuses). But refusing to erect a red light to stop research cloning, they will propose various yellow lights intended to assure ourselves that we are proceeding with caution, limits, or tears. Paradoxically, however, the effect might actually be to encourage us to continue proceeding with new (or more hazardous) avenues of research; for, believing that we are being cautious, we have a good conscience about what we do, and we are unable to imagine ourselves as people who could take a morally disastrous next step. We are neither wise enough nor good enough to live without clear limits.

   Cloning-for-biomedical-research could require thousands of human eggs and would, as presently contemplated, give rise, as we have said, to a new industry of embryo manufacture. This industry would depend on eggs procured from women, themselves participants in the research, who would need to take drugs stimulating ovulation and to submit to the egg retrieval procedure. One might wonder whether their informed consent is sufficient to permit this in circumstances where, in the very nature of the case, the research is so preliminary that it cannot possibly provide effective therapies for patients. We might also worry lest women who are potential donors (because, for example, they have sought in vitro fertilization) might be vulnerable to pressure to participate in this research or financial inducements to do so. Even if such pressure does not rise to the level of coercion, we should acknowledge that there are inducements a just society would not offer and risks it would not ask potential research subjects -- themselves vulnerable for a variety of reasons -- to accept.

   To get around the shortage of human eggs and the ethical dilemmas it could produce, scientists are exploring the possibility of substituting animal eggs in the initial cloning step of SCNT. Experiments creating animal-human hybrid-embryos, produced by inserting human DNA into enucleated rabbit oocytes, have already been conducted in China, with development up to the blastocyst stage.¹² Yet far from solving our ethical dilemma, the use of animal eggs raises new concerns about animal-human hybrids. We have no idea where these and later interspecies experiments might lead. Yet the creation of such chimeras, even in embryonic form, shows how ready we seem to be to blur further the boundary -- biological and moral -- between human being and animal.

   As history so often demonstrates, powers gained for one purpose are often used for other, less noble ones. We are about to harness powers over our own (human) nature to be used for our own well-intentioned purposes. But the knowledge that provides this power does not teach us how to use it. And given our fallibility, that should give us pause. We should consider, in making our moral judgment about cloning-for-biomedical-research, not simply the origin of these cells, but their possible uses (and misuses), as well as their place in the larger story of our increasing technological powers. We must keep in mind not simply where we took these cells from, but where they might take us, and what might be done with them.

   Finally, if we accept even limited uses of cloning-for-biomedical-research, we significantly increase the likelihood of cloning-to-produce-children. The technique will gradually be perfected and the cloned embryos will become available, and those who would be interested in producing cloned children will find it much easier to do so. The only way to prevent this from happening would be to prohibit, by law, the implantation of cloned embryos for the purpose of producing children. To do so, however, the government would find itself in the unsavory position of designating a class of embryos that it would be a felony not to destroy. It would require, not just permit, the destruction of cloned embryos -- which seems to us the very opposite of showing such cloned embryos "special respect."

4. Conclusion: What Prudence Requires

   In light of these moral and prudential dangers -- namely, the crossing of the boundary from sexual to asexual reproduction; the possible misuse of our new genetic powers over embryonic life; the reduction of human embryos to nothing more than a resource and the coarsening of our moral sensibilities that would come with it; the prospect of a law that would mandate the destruction of nascent human life; and the prospect of other (greater) harms down the road, most notably the production of cloned children or research on later-stage fetuses -- we must take pause and resist. In trying to discern where a wise and prudent boundary must be drawn -- to protect those beings who are humanly inviolable, to prevent the dangers that most tempt us, and to protect the moral fabric of society -- we hold that the boundary must be drawn by prohibiting the production and use of cloned embryos. To cross this boundary or to set it further down the road -- that is, "with limits" -- is to invite (and perhaps ensure) that some (or all) of the dehumanizing possibilities described above will come to pass.

C. What We Owe to the Suffering

The final question to be considered is what we owe to the suffering. Like our colleagues who endorse cloning-for-biomedical-research, we believe it would be less than human to turn a blind eye to those who suffer and need relief, or to stand silent in the face (especially) of suffering and premature death. In saying "no" to cloning-for-biomedical-research, we are not closing the door on medical progress -- not in principle and not in practice. We are simply acknowledging that, for very strong moral reasons, progress must come by means that do not involve the production, use, and destruction of cloned embryos and that do not reduce nascent human life to a resource for our exploitation. This does mean, of course, that advances in basic research and progress in the cure of disease, though not halted, might be slowed (though, as described above, this is far from certain on scientific grounds). It is possible that some might suffer in the future because research proceeded more slowly. We cannot suppose that the moral life comes without cost. And honesty compels us not to offer guarantees where our human limits -- and the unpredictable nature of the future -- ensure that no such assurances are possible.

There may be occasions in life when the only means available for achieving a desired end is a means that it would be wrong to employ. This is especially true in circumstances such as those considered here; for to give our initial approval to cloning-for-biomedical-research is to set foot on a path whose deepest implications can scarcely be calculated. People sometimes imagine that human beings are responsible for all the harms they could prevent but do not; yet, this cannot be true. When we refuse to achieve a good outcome by doing what is wrong, and thereby perhaps accept some suffering that might have been avoided, we are not guilty of causing that suffering. To say otherwise would mean that sufficiently evil men could always hold us morally hostage. In order to obligate us to do an evil deed, they need only credibly threaten to do great harm unless we comply. Were we actually responsible for all the harm we might have prevented but did not, they would have us in their moral power. If our duty to prevent harm and suffering were always overriding, if it always held moral trump, we could not live nobly and justly.

We are not deaf to the voices of those who desperately want biomedical research to proceed. Indeed, we can feel the force of that desire ourselves, for all of us -- and those we love most -- are or could one day be patients desperate for a cure. But we are not only patients or potential patients. We are human beings and citizens, and we know that relief of suffering, though a great good, is not the greatest good. As highly as we value health and longer life, we know that life itself loses its value if we care only for how long we live, and not also for how we live.

Suppose, then, that we refrain from such research and that future sufferers say to us: "You might have helped us by approving cloning for research, but you declined to do so." What could we say to them? Something like the following: "Yes, perhaps so. But we could have done so only by destroying, in the present, the sort of world in which both we and you want to live -- a world in which, as best we can, we respect human life and human individuals, the weak and the strong. To have done it would have meant stepping across boundaries that are essential to our humanity. And, although we very much want to leave to our children a world in which suffering can be more effectively relieved, that is not all we want to leave them. We want to bequeath to them a world that honors moral limits, a world in which the good of some human lives is not entirely subordinated to the good of others, a world in which we seek to respect, as best we can, the time each human being has and the place each fills."

This understanding of what commitment to our shared humanity requires is not alien to the efforts of scientific researchers to make progress in the cure of disease and relief of suffering. Theirs is, after all, a moral mission, which serves us all and which we all support. But if history teaches anything, it is the danger of assuming that, because our motives are praiseworthy and our hope is to heal, our actions cannot possibly violate or diminish human well-being. Indeed, we may be least likely to see the dangers when we are most confident of the goodness of our cause.

Scientists already accept important moral boundaries in research on human subjects, and they do not regard such boundaries as unwarranted restrictions on the freedom of scientific research. More generally, the scientific enterprise is a moral one not only because of the goals scientists seek but also because of the limits they honor. Indeed, it is precisely the acceptance of limits that stimulates creative advance, that forces scientists to conceive of new and morally acceptable ways of conducting research. Surely, therefore, before society takes a step that cannot be undone, it should ponder soberly the moral implications of accepting cloning, even for research.

To approve cloning-for-biomedical-research, to drink from that cup, is an inviting prospect indeed, but there is a spider in the cup. When we consider what we owe to the embryo, to our society, and to the suffering, we can see it more clearly and can, perhaps, acquire the wisdom and even the courage not to put this cup to our lips.

ENDNOTES

1. Osler, W. "Chauvinism in Medicine" Aequanimitas, with Other Addresses to Medical Students, Nurses and Practitioners of Medicine Philadelphia: Blakiston, 1943, p. 267.

2. For more information about the scientific and medical case for cloning-for-biomedical-research, see the following two reports: (1) National Research Council/Institute of Medicine (NRC/IOM), Stem Cells and the Future of Regenerative Medicin, Washington DC, National Academy Press, 2001. (2) National Academy of Sciences (NAS), Scientific and Medical Aspects of Human Reproductive Cloning, Washington, DC, National Academy Press, 2002.

3. Reyes, M., et al. "Origin of endothelial progenitors in human postnatal bone marrow" Journal of Clinical Investigation, 109: 337-346, 2002.

4. Rideout III, W.M. et al. "Correction of a genetic defect by nuclear transplantation and combined cell and gene therapy" Cell, 109: 17-27, 2002.

5. Wilson, J.Q. "On Abortion" Commentary, 97(1): 21ff, 1994.

6. Lanza, R.P., et al. "Generation of histocompatible tissues using nuclear transplantation" Nature Biotechnology, 00: 1-8, 2002.

7. Brian Appleyard calls attention to this passage in his book, Brave New Worlds: Staying Human in the Genetic Future (New York: Viking, 1998).

8. Cited in Kass, L. "The Meaning of Life-in the Laboratory" The Public Interest, No. 146, pp. 45-46, Winter 2002.

9. Jonas, H. "Philosophical Reflections on Experimenting With Human Subjects" in Readings on Ethical and Social Issues in Biomedicine, ed. Richard W. Wertz (Prentice-Hall, 1973), p. 32.

10. National Bioethics Advisory Commission, Ethical Issues in Human Stem Cell Research, volume I, p. 53. Bethesda, MD: Government Printing Office, 1999.

11. See endnote 6, above.

12. Leggett, K., and A. Regalado. "China Stem Cell Research Surges as Western Nations Ponder Ethics" Wall Street Journal, March 6, 2002, p. A1.

1. Once such cells were produced in one laboratory, they could be stored at low temperatures and supplied to other labo-ratories for study. And so, for at least this particular area of cloning-for-biomedical-research, it might not be necessary to perform the cloning experiment more than a few times for each disease, making it possible that the number of cloned embryos required will be limited.

2. See Chapter Four, in the section on stem cells and regenerative medicine.

3. In the first case, human individuality would be present from the start, in the second case, not; and this distinction matters morally to some people.

4. See, for example, "The Ethics of Stem Cell Research," by Gene Outka, a paper presented and discussed at the Council's April 2002 meeting. Outka extends the principle "that nothing more be lost" to justify use of excess IVF embryos in research, but argues that this principle cannot be used to justify creating cloned (or IVF) embryos for research (available online at http://www.bioethics.gov).

5. To increase the chances of keeping people from a serious transgression (the law), a prohibition is imposed (the fence) on activities that might lead or tempt one to commit it. For example, if the goal is to keep people from engaging in commerce on the Sabbath, one makes it unlawful for them to handle money on the Sabbath.

6. This means of reducing demand for human oocytes would imply increased SCNT of human nuclei into animal eggs, a practice that may bring additional moral questions. It was unanimously opposed by the National Institutes of Health Human Embryo Research Panel in its 1994 report (p. 82).

7. That the embryo in question is produced by cloning and not by the fertilization of an egg should not, in our view, lead us to treat it differently. The cloned embryo is different in its origins, but not in its possible destiny, from a normal embryo. Were it brought to term it too would indisputably be a member of the human species. We caution against defining the cloned embryo into a "non-embryo" -- especially when science provides no warrant for doing so.

8. Thus, for example, the 1994 report of the National Institutes of Health Human Embryo Research Panel, even while endorsing embryo research under certain circumstances, spoke (p. xi) of "respect for the special character of the preim-plantation human embryo" and affirmed (p. x) that "the preimplantation human embryo warrants serious moral consideration as a developing form of human life" (though not, the report added, "the same moral status as infants and children"). Another report, Ethical Issues in Human Stem Cell Research, released in 1999 by the National Bioethics Advisory Commission, while declining to claim that the embryo should receive "the same level of respect accorded persons" (p. 50), spoke of and seemed to endorse the "ethical intuition" that "the act of creating an embryo for reproduction is respectful in a way that is commensurate with the moral status of embryos, while the act of creating an embryo for research is not" (p. 56).

Public Policy Options

These general remarks apply also to the case at hand. The moral assessments of the previous two chapters do not carry self-evident policy recommendations. Even a thoroughly developed moral position on either or both of the uses of human cloning still leaves open the question of what public policy would be appropriate, prudent, and effective. One can be morally opposed to cloning-to-produce-children, yet also oppose making it illegal, say, because of hesitation to increase the police power of the state in matters of reproduction. Or one can have no personal moral objection to cloning-for-biomedical-research, but still find practical reasons to favor a moratorium on such activity, say, because one wants to develop regulatory institutions before allowing the research to proceed. Moral principle and judgment, though necessary, are not sufficient for deliberating about what to do about human cloning. Prudence is also required.

In this chapter, we consider a broad range of public policy options. We assess and compare these options in the hope of seeing our way clear, in the eighth and final chapter of this report, to offer recommendations that comport, not only with our ethical judgments, but also with our sense as citizens of what is prudent, practical, and appropriate for this country at this time.

The policy debate about human cloning is a particularly vivid example of the tension between competing public goods, between the goods served by biomedical science and technology and other moral and social goods important to community life. The desire to ban human cloning, whether for producing children or for biomedical research, arises primarily from moral and social objections made in the name of human dignity, individuality, and respect for life. The opposition to a comprehensive ban on human cloning arises primarily from a belief that cloning research may lead to new remedies for human diseases and disabilities, backed also by appeals to the principle of freedom for scientific inquiry and technological innovation. Assumptions about the relative merits of these competing goods, as well as about the broader relation between science and society, lie just beneath the surface of this debate. Wittingly or not, these assumptions inform how people think about the various policy options proposed for dealing with human cloning. A brief examination of the more general question of the relation between science and society might clarify the principles that should guide our approach to a national policy on human cloning.

I. Science and Society

In exchange for the promise of great human benefits, the practice of science entered into an unprecedented relation to the larger society. Scientists gradually acquired a privileged standing in modern societies, first with protections against persecution and censorship, later with public recognition and financial support. But it deserves to be noted that, insofar as the public respect for science rests on its moral intention and its ability to deliver the goods that society wants, scientists tacitly subject themselves to public scrutiny and moral judgment of their work, both as to ends and to means. The tacit social contract between scientists and society -- freedom and support for scientists, benefits for all humanity -- is double-sided: on the one hand, the opportunity for scientists to be public benefactors and recognized as such; on the other hand, the need, in cases where values conflict, for scientists to defend what they do in terms of the community's judgments about the relation of scientific activity to other moral and social goods.

As we have noted in the previous chapters, in the twentieth century, biomedical science made tremendous advances, resulting in both greater knowledge of how the human body works and greater ability to affect its workings. The results have been so dramatic, and so beneficial, that in the United States today virtually no one questions the benefits of the modern scientific endeavor, especially in medicine. This consensus about benefits has expressed itself as consistently strong public support for public funding of basic research, as well as strong support for the freedom of scientists to set their own research agendas, limited only by their curiosity, their imaginations, and our commonly agreed-upon moral and ethical norms. The tacit "contract" or relationship between science and society recognizes and celebrates the great benefits of freedom for all involved.

But for all these great benefits and good purposes, there are also times when the activities of scientists or the products of scientific work can imperil society and its members. For one thing, the work of scientific research is by its nature experimental. Scientific inquiry involves action, not only observation or theory. For this reason, freedom of inquiry does not adequately describe the freedom that scientific work requires and is generally granted. It may be more accurate to say that scientists desire and often receive great freedom of action. Yet because scientists learn by doing, some of what scientists do can be dangerous or inappropriate. And because some of their actions may infringe on the rights, security, or dignity of individuals, or on the principles and interests of society as a whole, scientific freedom of action cannot be absolute.

In addition, many of the technological products of scientific research can be used to do harm as well as good. Just as society has moved in the past to restrict access to dangerous nuclear and biological agents, as well as to restrict public access to information about these things, so too will society be confronted with moral challenges by the new biomedical technologies. Technologies that disclose our genetic abnormalities or that alter the human genome, neurotropic drugs that can enhance (or destroy) memory or libido, computer implants in human brains -- these and many other technological possibilities now on the horizon may raise profound moral and social challenges to privacy, freedom, equality, dignity, and human self-understanding. As citizens we may -- indeed we must -- decide whether and where to limit potentially harmful research or technology even as we continue to desire and uphold free intellectual inquiry and technological innovation.

American society has done this in the past. The various codes of conduct for human experimentation, discussed at several points in this report, demonstrate some of the ways in which the polity has established important moral boundaries that biomedical researchers must respect. In addition, rules and restrictions governing the pharmaceutical industry, the practice of medicine, the sale of organs for transplantation, the handling of biohazards, the development of biological weapons, and numerous other areas of scientific and technological work show that even given our desire for scientific advance and our belief in the inherent value of freedom, the pursuit of research and technology has not been allowed to trump all other concerns.

Thus we conclude that in the realm of genetics and reproduction, as in many others, boundaries and regulations may be needed: lines may need to be drawn that none may cross, guidelines may need to be established that all must follow. Because the wisdom needed to decide how scientific knowledge and technology should be used is not something that science can provide by itself, these boundaries and regulations must be set by the whole community, democratically, through its representative institutions, and not only by those who are experts in the scientific work involved. Our analysis in Chapters Five and Six of the serious moral and social questions raised by human cloning has persuaded us that human cloning in both its forms is an appropriate area for public policy.

II. Public Policy Options: General Considerations

1. The Scope of Policy

   Having decided that human cloning is an activity fit for public policy decision, we still face many questions. Does it warrant legislative proscription, governmental regulation, professional oversight or self-regulation, or merely civil tort liability for bad results? And how broadly or narrowly should we delimit the domain in which human cloning is to be considered? Although the ethical analysis in this report has often concentrated on human cloning considered on its own, when considering public policy it is especially important to recall the larger contexts in which human cloning belongs. As we emphasized in Chapters One and Two, human cloning (in both its possible uses) would be but a special area of a larger domain of biotechnology, made possible by present and projected techniques of embryo research, assisted reproduction, genetic screening, and genetic engineering -- all of which are coming to be grouped under the field of "reprogenetics." As we contemplate possible policy options regarding human cloning, it behooves us to consider what cloning's place within this broader context might mean for public policy.

   Many other countries have in fact taken up cloning in this broader context. In Germany, for example, this broader approach has taken the form of a series of legal proscriptions and restrictions, centered on the Embryo Protection Act of 1990. The act treats all embryo research together and prohibits all interventions not undertaken for the well-being of the embryo (including the creation of embryos specifically for research). The German system also includes specific rules for IVF procedures, and in general treats all interventions involving the human embryo under one rubric. Human cloning, for whatever purposes, is legislatively prohibited.

   In the United Kingdom, too, policy on these subjects takes as its organizing principle the human embryo itself, though the approach here is regulative rather than proscriptive. The British system is centered around a regulatory body -- the Human Fertilization and Embryology Authority (HFEA), created in 1990 -- charged with monitoring and regulating essentially all of what has come to be called reprogenetics, including human cloning, both for producing children and for biomedical research. The HFEA regulates infertility treatment and clinical work; storage of gametes and embryos; and all embryo research, whether publicly or privately funded. It licenses these various activities, monitors compliance, sets standards of practice, establishes limits and requirements on the use of embryos for various purposes, and maintains a detailed information registry about both assisted reproduction and embryo research. Human cloning is treated within this broader regulatory scheme: cloning-to-produce-children is not permitted; cloning-for-biomedical-research is allowed, but only with cloned embryos no older than fourteen days.

   Canada is completing the process of establishing a national system, combining elements of legal proscription and governmental regulation, to govern all technological activities used to help people have children as well the use of embryos in research. Some activities would be permitted and regulated, others would be prohibited by law. The chosen point of departure is not the human embryo, but rather the goods of human health and dignity: to protect the health and safety of Canadians; to prevent commercial exploitation of reproduction; and to protect human individuality and diversity and the integrity of the human genome. A single broad regulatory body, the Assisted Human Reproduction Agency of Canada, would issue and renew licenses for assisted reproduction facilities, collect and analyze health information, set policies, and monitor compliance. Among the prohibited activities are all human cloning, whether to produce children or for biomedical research. Human embryos no longer needed for infertility may be used for stem cell research (with consent of the progenitors). But producing in vitro embryos for research purposes is prohibited, except for efforts to improve assisted reproduction procedures.¹

   Several other countries have approached this area of biotechnology with a similar broad outlook. The United States to date has not; indeed we lack any national monitoring, oversight, or regulatory system in this area. It may therefore be appropriate, in connection with thinking about specific policies for human cloning in the United States, to initiate discussions of a national policy for these related arenas. Doing so might allow us to regard the question of embryo research in its full scope, and to consider it together with the closely related issues that arise when the techniques of assisted reproduction come together with those of genetic diagnosis and potential genetic engineering. In putting forward its recommendations in the next chapter, the Council will take into account this broader context of related biotechnologies.

   Yet, much as it would be desirable to consider public policy regarding human cloning in its larger context, it is for us also necessary to consider it on its own. Owing to the immediate concern over the prospect of cloning-to-produce-children, legislative proposals and public debate have largely treated the subject of human cloning in isolation -- though for reasons we have noted, it has overlapped with the controversy about embryonic stem cell research. Accordingly, the policy options presented below are drawn for the most part from the ongoing public and legislative debate about human cloning, and therefore direct themselves to legislative alternatives regarding cloning in particular.

2. A Legislative Complication

   There is a complication that bedevils prospects for legislation regarding human cloning. Given that human cloning may be used for two very different purposes -- to produce children and for biomedical research -- one might think that these two different uses could be treated independently, just as we have done (for the most part) in the ethical analyses in Chapters Five and Six. The ethical issues of cloning-to-produce-children and cloning-for-biomedical-research differ considerably, and, as our own discussions have indicated, one's moral assessment of the second can be independent of one's moral assessment of the first. Some people who oppose cloning-to-produce-children may favor cloning-for-biomedical-research; some people who oppose producing embryos solely for research may object less forcefully to cloning-to-produce-children (should it ever become safe to attempt it). And people who oppose both uses may differ as to which they think is the worse. Given these variations, it would seem sensible to disaggregate the two forms of cloning and develop independent public policies for each.

   But this is easier said than done. The reason is simple: both forms begin in the same way with the act of cloning (by somatic cell nuclear transfer [SCNT]) that produces a cloned human embryo. It is therefore difficult -- perhaps impossible -- to craft a public policy regarding one use of cloned human embryos that does not, at least tacitly but usually explicitly, also affect the other. A thoroughgoing attempt to prevent cloning-to-produce-children by banning the first step would also prevent cloning-for-biomedical-research. An attempt to promote cloning-for-biomedical-research might well have consequences for cloning-to-produce-children (for example, by improving the technique or by increasing the likelihood of attempts to initiate a pregnancy). An attempt to prevent cloning-to-produce-children at the step of transfer of a cloned embryo to initiate a pregnancy would tacitly approve the initial creation of cloned embryos for other purposes. Moreover, by imposing penalties on implantation while sanctioning creation, a policy that banned only transfer to a uterus would in effect require, by law, that cloned human embryos be destroyed.

   Even if one thinks only of the task of statutory drafting, the difficulty persists. For if one wants to make a particular action illegal, one must specify precisely the act to be proscribed. It turns out to be very difficult to specify precisely and unambiguously the forbidden act of human cloning without touching both uses at once. "It shall be unlawful to attempt to clone a human being," is simple enough to say, but vexing to specify. The meaning of the term "human being" is contested: does it mean only a child or adult, or is an embryo too a human being, albeit in its primordial stage? The definition of "to clone" must specify either the initial act of somatic cell nuclear transfer or the birth of a cloned child. "Attempting to clone" will mean either somatic cell nuclear transfer itself or the transfer of the resulting cloned embryo to a woman's uterus.

   There is, of course, one possible policy approach that could disentangle the two uses of human cloning, but it would require dealing with cloning-for-biomedical-research in a different context. Since cloning-for-biomedical-research is one form of embryo research -- another is research that uses embryos produced by IVF -- one could have a broad policy on all embryo research, which would then necessarily apply to research with cloned embryos. Several states have separate laws that cover research on all human embryos, cloned or not. In these cases, a law to deal with the special practice of cloning-to-produce-children could then be added without difficulty. And, as we have indicated, in the United Kingdom and several other countries, there is a broad regulatory system for handling all activities involving human embryos -- both for research and for initiating pregnancies -- into which further regulations regarding cloned embryos may easily be fit. But the legislative debates in Congress, both in 1998 and in 2001-2002, have proceeded without the possibility of independent treatment. That fact shapes our examination of specific public policy options.

III. Public Policy Options: Specific Alternatives

First, given the seriousness of the subject, we favor a policy that makes an explicit and considered decision about whether to proceed. Should our society come to have no rules or guidelines regarding human cloning, it should do so deliberately, not by default.

Second, we need to decide whose decision and responsibility this should be. And while we may differ among ourselves on the answer to this question, we agree that whichever persons, institutions, or agencies of government have authority for the decision and any subsequent oversight, the responsible parties should be answerable to and held accountable by the people and their representatives. This is not an arena where secrecy or lack of accountability should be tolerated.

Third, whether one opts for permission with or without regulation or for legislative proscription, permanent or temporary, we believe that the following two balancing principles should be followed: (1) Because of the gravity of the issues at stake, whoever bears the power of decision needs to be persuaded that we should now proceed with human cloning, in either or both of its forms. (2) At the same time, we should not stand in the way of proceeding simply out of some vague fear of possible future harms of unknown magnitude; we should interfere only if the harms are deemed serious, important to the common good, and likely to occur.

1. Federal or State Jurisdiction?

   We begin, as we should in America, by examining human cloning in the context of our constitutional system and, in particular, of our special form of federalism. In short, we must consider which level of government has jurisdiction. Human cloning is not obviously a federal concern, nor is it plainly outside the jurisdiction of the states; thus it might be presumed to be a matter for regulation by the states alone. Certainly a number of states have moved to legislate in this area. As of this writing, twenty-two state legislatures have considered bills on cloning, and six of them have passed laws on the subject. Of these, five directly or indirectly prohibit both forms of human cloning, while one prohibits only cloning-to-produce-children.ⁱ It is possible to argue that human cloning is one of those many issues, essentially local in nature, that call more or less exclusively for the exercise of local self-government, which in the American system means primarily government by the states. And yet, a number of factors point to the need to consider a federal policy as well.

   For one thing, as we hope the foregoing chapters have made clear, human cloning-to-produce-children has nationwide implications, with potentially profound effects on individuals, families, and all of society. This view is reflected in the efforts in Congress to legislate on the subject, first in 1998 and again in 2001 and 2002. President Clinton made clear, in his executive order on human cloning,² that he regards it as a federal issue; and President Bush has done likewise in several public statements.³

   For another thing, the federal government plays an extensive role in funding and regulating scientific research. Insofar as there has been a role for government in the oversight of scientific work in America, it has generally been filled by the federal government, for reasons of scale and efficacy and also to some extent of historical accident. So long as this remains the case, questions relating to the funding and regulation of human cloning will, in practice, be addressed mostly or even solely at the federal level.

   Moreover, it can be assumed that, if they remain legally permissible, both forms of human cloning would tend to enter into interstate commerce, thus bringing them within the purview of Congress, at least as far as its power to regulate interstate commerce allows.

   Historically, when several or most of the states have proscribed some activity they regard as injurious to public health, safety, or morals (such as prostitution or the use of narcotic drugs), the federal government has tended to enact laws supportive of the states', or most of the states', moral proscriptions, either by restricting interstate commerce (as in the Mann Act relating to prostitution) or even by directly prohibiting the activity itself (as in the Federal Controlled Substances Act). Since the states have begun to act on human cloning, it has become valid therefore to ask whether federal legislation is also needed.

   Finally, human cloning has become a subject of international law. A number of nations have moved to prohibit one or both forms of human cloning, and the United Nations is currently debating whether to promulgate an international convention to ban cloning-to-produce-children. Since only the federal government can make treaties or conduct foreign policy for the whole nation, it seems likely that at some point the United -- and not merely the separate -- States will be under pressure to legislate on this subject.

   For some or all of these reasons, we think it reasonable to conclude that human cloning, of either variety, is a fit subject for debate and action at the federal level.ⁱⁱ

2. Seven Basic Policy Options

   With respect to each form of human cloning, cloning-to-produce-children and cloning-for-biomedical-research, there are two basic alternatives: permit or prohibit. For each of these alternatives, there are again two further possibilities: permit with or without regulation; prohibit indefinitely ("ban") or for a limited time ("moratorium"). (The alternative "permit with regulation" might or might not make permission contingent upon getting the regulatory system in place beforehand.) Among the numerous permutations and possibilities, we now take up seven basic policy options that have been publicly discussed and that appear to us worthy of consideration:

   • Policy Option 1: Professional self-regulation with no legislative action ("self-regulation").

   • Policy Option 2: A ban on cloning-to-produce-children, with neither endorsement nor restriction of cloning-for-biomedical-research ("ban plus silence").

   • Policy Option 3: A ban on cloning-to-produce-children, with regulation of the use of cloned embryos for biomedical research ("ban plus regulation").

   • Policy Option 4: Governmental regulation, perhaps by a new federal agency, with no legislative prohibitions ("regulation of both").

   • Policy Option 5: A ban on all human cloning, whether to produce children or for biomedical research ("ban on both").

   • Policy Option 6: A ban on cloning-to-produce-children, with a moratorium, or temporary ban, on cloning-for-biomedical-research ("ban plus moratorium").

   • Policy Option 7: A moratorium, or temporary ban, on all human cloning, whether to produce children or for biomedical research ("moratorium on both").

   In considering each of these options, we bear in mind four basic questions: (1) How would the policy be enforced and by whom? (2) On what moral opinions, and on what views of the role of government, is it based? (3) What are the arguments in favor? (4) What are the possible objections? To avoid needless repetition, where two options are very similar we refrain from repeating the same arguments at great length, and instead focus on the major new points worthy of note.

   *     *     *

   Policy Option 1: Professional self-regulation with no legislative action ("self-regulation").

   This option would enact no new legal restraints on human cloning, and rely instead on self-regulation and private decision making. Passing no law on the subject would maintain the legal status quo; it would leave in place the existing moratorium on federal funding for either form of human cloning, while also leaving private parties free to use private funds to conduct either form of human cloning, as they see fit, consistent with state law.

   This approach would let physicians and patients decide privately whether to engage in cloning-to-produce-children.ⁱⁱⁱ It would rely upon the people actually engaged in cloning-for-biomedical-research to establish a mechanism for self-regulation and to prevent abuses. And it could utilize tort liability to deter tragedies and mishaps, by holding people legally responsible for harms inflicted upon a cloned child or his or her mother.

   This approach assumes that neither form of human cloning poses moral or practical dangers sufficient to require public action. It assumes that the harms of cloning-to-produce-children are not so grave as to merit a legal restriction, and it sees no harm, or at least negligible harm, in cloning-for-biomedical-research. It also assumes that government's role in regulating scientific research and reproductive medicine should be minimal; that federal legislation may cause more harms than it prevents; that self-regulation provides sufficient safeguards against the worst abuses of cloning techniques; that the subject is so complex that the people best qualified to regulate it are the experts in the field themselves; or that any more restrictive policy is unlikely to succeed and likely to drive scientific talent overseas to more permissive jurisdictions.

   On the other hand, this hands-off approach would seem to ignore the widespread public and congressional support for a ban on cloning-to-produce-children, as evidenced in the July 31, 2001, vote in the House of Representatives, where nearly every member voted for some kind of federal ban on at least one form of human cloning. Of this option, it may be asked: Is cloning-to-produce-children so morally unproblematic that we could safely leave people free to try it? Would tort liability really be sufficient to deter abuses? And can we afford a laissez-faire policy on what is surely only the first of a series of powerful new genetic technologies? For those who answer "no" to any of these questions, it will be necessary to seek another option.

   Policy Option 2: A ban on cloning-to-produce-children, with neither endorsement nor restriction of cloning-for-biomedical-research ("ban plus silence").

   A second option would be to prohibit cloning-to-produce-children but remain silent on cloning-for-biomedical-research. Such a policy would prohibit the implantation rather than the creation of cloned human embryos. By remaining silent on the question of creating cloned human embryos, this approach would not establish an oversight mechanism or other means of keeping track of cloned embryos or otherwise preventing implantation before the act itself is undertaken. It would therefore probably not require a new enforcement agency; enforcement of the ban would presumably fall to the Department of Justice.

   This approach assumes that cloning-to-produce-children is sufficiently unacceptable as to merit legal prohibition, but minimizes or sets aside the disputed question of cloning-for-biomedical-research. It seeks to balance the responsibility for establishing public control over potential misuses of technology with public tolerance for competing worldviews and interests. It permits potentially valuable medical and scientific research to go forward. It preserves the current federal embryo-research policy, which (1) permits all embryo research to proceed unimpeded with private funds, (2) permits research on certain embryonic stem cell lines to proceed under federal guidance with public funds, and (3) leaves open, for continued debate, the question of whether there should be public funding for embryo and embryonic stem cell research.

   Against this option, it can be argued that it is not possible for the government to be neutral on the question of cloning-for-biomedical-research. It is difficult, if not impossible, to write a statute banning the act of implanting cloned embryos without tacitly sanctioning the creation of the cloned embryos in the first place. Thus, a ban on cloning-to-produce-children not accompanied by restrictions on cloning-for-biomedical-research could put the government in the position of allowing the creation of a class of (cloned) human embryos and then effectively mandating their destruction (or at least their perpetual preservation in cold storage), a class of (cloned) human embryos that it would be a felony to try to keep alive to birth. Also such a partial ban could arguably make cloning-to-produce-children more likely to occur. After all, without a regulatory system in place to keep track of and govern the use of cloned human embryos, the ban on implantation would be difficult to monitor and enforce. The commercial production of embryos for research would be protected by industrial secrecy. The transfer of cloned embryos to begin a pregnancy would be virtually undetectable and protected by doctor-patient confidentiality. Those charged with monitoring and enforcing the ban on cloning-to-produce-children would not know who is doing what with cloned human embryos. Moreover, actually enforcing the ban in the event of a violation would be nearly impossible. Once a clonal pregnancy has begun, there would be no real remedy except a forced abortion, an untenable option.

   Policy Option 3: A ban on cloning-to-produce-children, with regulation of the use of cloned embryos for biomedical research ("ban plus regulation").

   This option would be similar to Option 2 ("ban plus silence"), but in place of silence would require the establishment of a system of oversight and regulation of cloning-for-biomedical-research. These functions would be carried out by a regulatory agency (new or existing) authorized to do some or all of the following things:

   1. Establish what may and may not be done with cloned human embryos once they are created, including a prohibition on implantation of cloned human embryos into human, animal, or artificial wombs.

   2. License and conduct prior review of all research involving cloned embryos.

   3. Establish guidelines for the protection of all human subjects participating in the research, including donors of eggs and nuclei.

   4. Register and track each individual cloned human embryo.

   5. Establish the number of days beyond which a cloned human embryo may not be grown in vitro, and enforce this requirement.

   6. Monitor and regulate financial transactions regarding cloned embryos and human oocytes used in cloning-for-biomedical-research.

   7. Monitor corporate, academic, and industrial cloning-for-biomedical-research, check for compliance, and enforce sanctions against violations of regulations.

   To be effective, such a regulatory structure would have to be applied to both federally funded and privately funded research. Its first purpose would be to facilitate the ban on cloning-to-produce-children, by keeping close track of all research using cloned human embryos. Its second aim would be to enforce certain general standards for the handling and use of cloned human embryos, to ensure that they are not created for frivolous purposes, used irresponsibly, or treated in ways that go beyond what American society deems morally acceptable.

   This option assumes that neutrality on the question of cloning-for-biomedical-research is neither possible nor desirable. Instead, it assumes that a system is needed to regulate and limit the use of cloned embryos -- both in the interest of preventing cloning-to-produce-children, and in the interest of establishing a clear ethical framework for undertaking cloning-for-biomedical-research and allowing that research to flourish. At the same time, such a system would establish clear rules and limits to prevent abuses -- for example, experimentation on later-stage embryos and fetuses or attempts to produce cloned children.

   This new task could be assigned to an existing regulatory agency (or combination of agencies), such as the Food and Drug Administration or the National Institutes of Health, or, alternatively, it could be carried out by a new regulatory agency devised specifically for the purpose.

   Establishment of a regulatory structure may be aided by the study of models in other countries, such as the United Kingdom's Human Fertilization and Embryology Authority (HFEA) or the Assisted Human Reproduction Agency being brought into existence in Canada -- taking into account, of course, the important differences between their political, economic, and health-care systems and our own.

   Regulation, for these proponents, would limit the uses of cloned embryos to especially promising and worthy biomedical research and would set boundaries beyond which such embryos may not be grown or exploited. For some proponents of this option, such oversight and regulation would be aimed primarily at preventing the use of cloned embryos to produce children. For others, regulation is called for to ensure that cloned human embryos be treated not simply as a natural resource but with appropriate measures of respect owed them as human embryos.

   Against this option can be raised some of the same objections that were raised against Option 2 ("ban plus silence"), namely, that it puts the government in the new position of requiring the destruction of nascent human life, and that it could, by allowing the production of cloned human embryos, make cloning-to-produce-children more likely. It might also be argued against this option that setting up a workable regulatory structure is either impossible or impossible to do very quickly. After all, the IVF and assisted-reproduction industry is today largely unregulated in any way that could be called coordinated, comprehensive, or systematic. The federal government has no experience in regulating or keeping track of the number and fate of embryos produced in IVF clinics.^iv And the biotechnology industry has shown little enthusiasm for outside regulation. Establishing an effective regulatory regime could take several years of trial and error, during which time cloned embryos might be mishandled or implanted in an effort to produce children. There are also the dangers that regulatory bodies often prove ineffective and unaccountable and that they are vulnerable to capture by special interests that have a large stake, economic or other, in their regulatory decisions but little incentive to respect the permanent and aggregate interests of the nation. Establishing the regulatory body overseeing human cloning-for-biomedical-research within the National Institutes of Health, for example, would not be reassuring to those concerned lest the fate of the embryo be always subordinated to the imperative for research. In this view, regulation is not enough.

   Policy Option 4: Governmental regulation, perhaps by a new federal agency, with no legislative prohibitions ("regulation of both").

   This option is similar to the regulatory half of Option 3 ("ban plus regulation"), but the regulatory agency would also have authority to set policy and guidelines regarding cloning-to-produce-children. In addition to the functions listed in the description of Option 3, the regulatory body would determine if and when human cloning techniques were sufficiently safe to warrant attempts to produce children by human cloning. The entity might also function as a licensing agency, setting down clear guidelines delineating acceptable and unacceptable purposes for such a practice (for example, it might choose to permit cloning to "replace" a deceased child).

   The major argument for this option is flexibility: as the science and technology of human cloning proceeds in nonhuman animals, and as the public's views develop in response to new information and new debates, the nation will not be locked into a legislatively defined position that might later appear to have been misguided. Either a congressional ban or the refusal to enact a ban may prove to be a decision that will later look undesirable and very hard to undo.

   Against this option are many of the same objections raised against the regulatory part of Option 3. Also, it may be argued that, given our society's strong moral opposition to cloning-to-produce-children, any decision to permit such a practice, even in exceptional cases, should not be left to a regulatory body; it should rather require a decision by people directly accountable to the voters. This option fails that test.

   Policy Option 5: A ban on all human cloning, whether to produce children or for biomedical research ("ban on both").

   This option would ban the initial act of human cloning -- the production of cloned human embryos -- regardless of the intended purpose. It would thus prohibit both forms of human cloning.

   Specifically, this approach would proscribe the act of producing cloned human embryos by means of SCNT. Although enforcing the ban would be the responsibility of law enforcement agencies -- as would enforcing a ban on cloning-to-produce-children -- the "policing of laboratories" would hardly be necessary. Financial and criminal penalties, along with the inability to publish, patent, or profit from (the now illegal) work involving cloned human embryos, would by themselves eliminate nearly all incentive to clone. The ban would deter by subjecting to prosecution and social stigma any researchers or institutions whose efforts to create cloned human embryos came to public attention.

   As we have seen in previous chapters, some proponents of this option argue that the creation, use, and ultimate destruction of cloned human embryos solely for research is morally unacceptable, either in itself or because of its moral consequences. Others hold that a ban only on the transferring of cloned embryos to a woman's uterus, even with additional regulations, would fail to prevent the cloning of a child, and that human cloning must be comprehensively stopped before it starts. Also, any regulatory arrangements that allowed cloning-for-biomedical-research within legally established limits would put the federal government in the novel and morally troubling position of mandating the destruction of nascent life.

   In favor of this approach it can be argued that a "ban on both" would steer scientists toward less morally troubling (and, in the view of some, more medically promising) forms of biomedical research. Indeed, some argue that pursuing cloning-for-biomedical-research might actually hurt those whom it claims to help, by diverting valuable resources away from more promising areas of research or more urgent health-care needs. By taking this option, some proponents argue, America would send a strong signal of moral leadership to the rest of the world, where the human cloning question is also currently being debated. Besides, if scientists ever clearly demonstrated a unique, pressing, and morally powerful need for cloned embryos for research, the ban -- like any ban -- could always be revisited.

   Against this option it is frequently and vigorously argued that prohibiting cloning-for-biomedical-research would cut off a promising avenue of medical research. It is also argued that forbidding such research here may simply drive American talent overseas and thus diminish American scientific preeminence and economic strength.

   Policy Option 6: A permanent ban on cloning-to-produce-children, with a moratorium, or temporary ban, on cloning-for-biomedical-research ("ban plus moratorium").

   This option would impose a permanent legal prohibition on cloning-to-produce-children, by banning the creation and subsequent transfer of cloned embryos into a woman's uterus. At the same time, it would also prohibit the creation of cloned human embryos for any reason, but would require a mandatory review of that latter prohibition after a certain period of time (for example, five years). This option would lock in a permanent ban on the activity virtually everyone opposes (cloning-to-produce-children), while calling for continued and enlarged debate on a question about which people currently differ (cloning-for-biomedical-research).

   The main benefits of a moratorium on cloning-for-biomedical-research are that it would (1) allow time for research in related fields to proceed and perhaps clarify the potentially unique benefits of cloning-for-biomedical-research; (2) allow time for a regulatory structure -- whether narrow or broad in scope -- to be developed, if deemed desirable; and (3) allow time for further debate and deliberation about the moral questions, to determine if the prohibition on cloning-for-biomedical-research should be renewed, made permanent, or abandoned after the moratorium expires. Rightly understood, a moratorium should not be seen as an attempt to stall, but as an opportunity to figure out how to do things right. And for those interested in exploring and establishing regulatory arrangements, a moratorium, as a de jure halt, would provide prospective researchers with an incentive to recommend moral and legal guidelines before the moratorium would expire and be up for possible renewal.

   This option would also enable policymakers to take up the question of cloning-for-biomedical-research in the larger context of the embryo-research question, rather than in the narrower context of human cloning.

   This option captures much of the current public debate, in which there is general agreement on the need to prohibit cloning for producing children, but a great deal of uncertainty over the proper approach to cloning-for-biomedical-research.

   The arguments against this option are the same as those leveled against Option 5 ("ban on both"), namely, that prohibiting cloning-for-biomedical-research, even for a limited time, would cut off a promising avenue of medical research and simply drive American talent overseas. Others may object that the two uses of human cloning might hereafter be delinked, a prospect that troubles some for both practical and moral reasons (laid out in the discussion of the next option).

   Policy Option 7: A moratorium, or temporary ban, on all human cloning, whether to produce children or for biomedical research ("moratorium on both").

   The final option is a temporary form of Option 5 ("ban on both"), with a mandatory review of the policy after a certain period of time (for example, five years).

   The main benefits of this option are the same as those listed above for Option 6 ("ban plus moratorium"). But this option has what some consider the additional virtue of keeping the two uses of cloning linked in the policy arena. This has, they say, two major benefits.

   First, on practical grounds, the policy on cloning for research will bear heavily on the feasibility and efficacy of any ban on cloning-to-produce-children, and therefore there is an advantage in ensuring that the two are considered together. Because the availability of cloned embryos would make enforcement of the ban on cloning-to-produce-children more complicated and demanding, a ban on cloning-to-produce-children should never be de-coupled from an identical ban on cloning-for-biomedical-research.

   Second, on moral grounds, some argue that permitting the creation of cloned human embryos for research crosses an important line, and that one use of cloned embryos should not be separated fully from the other in public consideration. They hold that human cloning is a single thing, and therefore should be taken up whole. They are concerned that, at the end of the moratorium outlined in Option 6, the situation would be transformed into Option 2 ("ban plus silence") or Option 3 ("ban plus regulation"), with all the deficiencies that they think Option 3 holds. For this reason, these opponents argue, it is more appropriate for both forms to be considered together at the end of the moratorium period, even if the eventual resulting policy does not treat them equally.

   Once again, the arguments against this option are the same as those leveled against Option 5 ("ban on both") or Option 6 ("ban plus moratorium"); namely, that it would cut off, at least temporarily, a promising avenue of medical research and drive American talent overseas. In addition, some may object that linking the two uses of cloning misrepresents the state of the public discussion on the subject and places cloning-for-biomedical-research in the wrong context -- causing it to be considered always as a form of cloning, rather than as a form of embryo research.

   Finally, some do not want to forgo the present opportunity to enact a permanent ban on cloning-to-produce-children; failure to do so now, they argue, would seem to imply that cloning-to-produce-children is perfectly acceptable.

Having sketched out what we consider to be the most plausible options, we now proceed to offer our own policy recommendations and our reasons for them.

ENDNOTES

1. Presentation made by Dr. Patricia Baird, chair, Royal Commission on New Reproductive Technologies, at the June 2002 meeting of the President's Council. Transcript available at http://www.bioethics.gov.

2. Clinton, W.J., Memorandum on the Prohibition on Federal Funding for Cloning of Human Beings, March 4, 1997 In Weekly Compilation of Presidential Documents (Volume 33, Number 10), p. 281. Washington, DC: Government Printing Office, 1997.

3. Bush, G.W., Remarks on Human Cloning Legislation, April 10, 2002 In Weekly Compilation of Presidential Documents (Volume 38, Number 15), pp. 608-610. Washington, DC: Government Printing Office, 2002.

____________________

1. As of June 2002, three states (Iowa, Michigan, and Virginia) ban both cloning-to-produce-children and cloning-for-biomedical-research. Two states (Louisiana and Rhode Island) ban cloning-to-produce-children, but also have embryo-research laws that appear to prohibit cloning-for-biomedical-research. One state (California) has banned cloning-to-produce-children until December 31, 2002, but has no embryo-research law and thus effectively permits cloning-for-biomedical-research.

2. We prescind from trying to determine at length whether federal legislation limiting human cloning would infringe on what some believe is a fundamental constitutional right to attempt to procreate. Nor will we try to offer our own legal opinion about whether the Food and Drug Administration has existing authority that would enable it to regulate either form of human cloning, or both forms. These questions we are content to leave to others. Instead we proceed here on the assumption that, whatever the precise state of the law, Congress may (and we would argue, should) take the lead in determining federal cloning policy.

3. The Food and Drug Administration (FDA) claims that it has jurisdiction to regulate attempts to clone humans, because this would involve testing of a biologic, and it threatens to go after anyone who tries to create a cloned child in the United States. But the FDA's claim to such authority is disputed, it being at least doubtful whether a cloned human embryo is to be regarded, under the governing statute, as a medical product or device. The FDA has never attempted to regulate the human uses of IVF embryos.

4. The FDA has never attempted to regulate the practice of IVF, intracytoplasmic sperm injection, preimplantation genetic diagnosis, or embryo research conducted with IVF-produced embryos.

Policy Recommendations

First, our recognition of both the scientific and technological and the human and ethical contexts of human cloning, considered in Chapters One through Four.

Second, our awareness that human cloning is but a small part of a large and growing field of biomedical science and technology based on the convergence of developmental biology and genetics; and our awareness that this field offers relief for human disease and suffering while impinging also upon human procreation and family life, regard for nascent human life, and the relations between science and society.

Third, our ethical assessments of cloning-to-produce-children and cloning-for-biomedical-re-search, as presented in Chapters Five and Six.

Fourth, our ethical and prudential assessment of the strengths and weaknesses, benefits and harms, of the various policy options, as presented in Chapter Seven, including a serious effort to judge -- in the face of unavoidable ignorance about what the future may bring -- what will likely be gained and what will likely be lost should we pursue one path rather than another.

Fifth, our assessment of recent congressional efforts to develop national legislation on human cloning, and the reasons for their failures to date.

Sixth, our respect for the strongly held moral views of those with whom we do not agree, both on the Council and in the larger society.

Seventh, our desire to seek a wise and prudent course of action that does justice to our deepest moral concerns while preserving our nation's thriving biomedical science and technology.

1. The Council regards the country's public policy decision about human cloning as a matter of great moment. It is important not only for its effect on the prospects of human cloning but also for what it will say about our democratic society's ability to govern the course of technological innovation and use in the name of things we as a nation hold dear.

2. The Council is unanimous in opposing cloning-to-produce-children. We hold that the likely harms and injustices to prospective cloned offspring and the women involved, as well as to their families and the broader society, are sufficiently great and sufficiently likely as to justify governmental action to prevent cloning-to-produce-children.

3. Two general approaches have thus far been proposed by those seeking to prevent cloning-to-produce-children. The first would stop the process at the first step by banning the creation of any cloned embryos. The second would stop the process at the initiation of a pregnancy by banning the transfer of a cloned embryo into a woman's uterus (or other gestational environment). If the question of cloning-to-produce-children were considered in isolation, the first and stricter ban would be most prudent: if it were illegal to produce cloned embryos, they would be less likely to be created and hence less likely to be available for attempts at pregnancy. But such a comprehensive ban would preclude cloning-for-biomedical-research, research favored by most scientists and patient advocacy groups, but about which the public is deeply divided.

4. Regarding the ethics of cloning-for-biomedical-research, the Council is of many minds. Among Members who approve the practice -- all of whom strongly endorse the worthiness and importance of the research and its enormous potential for medical therapies -- a few approve it unconditionally and with enthusiasm, but more approve it with moral concern. Among the latter are a few Members who, though approving it in principle, are reluctant at this time to approve it in practice, for one or more of the following prudential reasons: the current lack of sufficient scientific evidence to sustain claims of the unique value of cloned embryos for the desired researches; the absence of proper regulatory institutions and mechanisms to enforce regulations, held by these Members to be a prerequisite for allowing the research to go forward; and an unwillingness to alienate large numbers of our fellow citizens who oppose this research on moral grounds.

   Among Members who disapprove of cloning-for-biomedical-research, most oppose it permanently because they think it is immoral to create human embryos for purposes that are foreign to the embryos' own well-being and that necessarily require their destruction. Others oppose such cloning permanently because they hold that society (and not only the embryos) will suffer irreversible moral harm by crossing the boundary that allows nascent human life routinely to be treated as a natural resource. Some Members oppose permitting the practice because they fear that it will greatly increase the likelihood that cloning-to-produce-children will occur or because they think that a law banning only the transfer of a cloned embryo into a woman's uterus would be unenforceable. Some Members oppose the practice also because they think that the scientific case for proceeding has not yet met the burden of showing why this research is necessary and of sufficient importance to justify crossing the moral barrier of creating nascent human life for the purpose of experimentation.

5. Were we to indicate where we stand on the ethical and prudential assessments of the two forms of human cloning, each considered independently, we would line up as follows:

   	Permit Now (with Regulation)	Moratorium	Ban
   To produce children	0	0	17
   For biomedical research	7	3	7

   Where we stand on the public policy options -- in which both cloning-to-produce-children and cloning-for-biomedical-research are necessarily considered together -- we shall indicate below, in our recommendations.

6. The Council notes that research on stem cells, both embryonic and adult, is still in its very early stages. Work with both embryonic and non-embryonic stem cells has led to some very promising results,ⁱ and it is impossible to predict which avenues of research will prove most successful in providing basic knowledge of disease processes and tools for regenerative medicine. It is also likely that different diseases or research problems will require different approaches. The Council also notes that the possible benefits of cloning-for-biomedical-research are, at the present time, uncertain and undemonstrated. There is little evidence from animal experimentation to indicate, one way or the other, whether work with embryonic stem cells derived from cloned embryos offers unique benefits not otherwise available. Only further research can answer these questions. These uncertainties about the future should cut in two directions. They should temper claims of medical miracles just around the corner, placing a high demand for cautious accumulation of evidence. They should also temper assertions that biomedical researchers can pursue their goals without using human embryos because other approaches that are morally nonproblematic will surely prove successful.

7. The Council notes, with special emphasis, that proposals to engage in cloning-for-biomedical-research necessarily endorse the creation of (cloned) human embryos solely for the purpose of such research. Public policy that specifically promoted this research would thus explicitly and officially approve crossing a moral boundary.ⁱⁱ

8. The Council also notes that, at the present time, human embryo research proceeds unregulated in commercial biotechnology companies and with local oversight in university-based laboratories (under the governance of institutional review boards [IRBs], whose oversight is generally stringent). In addition, federally funded research on human embryonic stem cell lines is now proceeding, under guidelines established by the National Institutes of Health pursuant to President Bush's decision of August 9, 2001. Any legislative action on human cloning, including cloning-for-biomedical-research, would not directly affect this other valuable research, including all research on embryonic stem cells derived from IVF embryos. In addition, a ban on cloning-for-biomedical-research would leave undisturbed the freedom that scientists (in the private sector) now have to create embryos solely for research by means of IVF, a practice that lacks official sanction and that has drawn public criticism but that is nonetheless legal (except in those few states that have banned this practice).

9. Finally, in viewing congressional efforts in 1998 and in 2001-2002 to enact a legislative ban on human cloning, the Council notes the failure to enact a ban on cloning-to-produce-children -- a ban that nearly everyone supports -- because of irreconcilable differences between the supporters of cloning-for-biomedical-research and the opponents of any research that destroys (cloned) human embryos. Failure to prohibit cloning-to-produce-children, especially after protracted debate on the issue, amounts tacitly to public willingness to allow this practice to remain legal. We are accordingly interested in seeking a policy proposal that would, among other things, overcome this impasse.

Below are the two alternative proposals to which Council Members have given their support.

Ban on Cloning-to-Produce-Children, Moratorium on Cloning-for-Biomedical-Research (Policy Option 6 of Chapter Seven).

Call for a federal review of current and projected practices of human embryo research, preimplantation genetic diagnosis, genetic modification of human embryos and gametes, and related matters, with a view to recommending and shaping ethically sound policies for the entire field.

We recommend a congressionally enacted ban on all attempts at cloning-to-produce-children and a four-year national moratorium (a temporary ban) on human cloning-for-biomedical-research.ⁱⁱⁱ These measures would apply everywhere in the United States and would govern the conduct of all researchers, physicians, institutions, or companies, whether or not they accept public funding. We also recommend that, during this moratorium, the federal government undertake a thoroughgoing review of present and projected practices of human embryo research, preimplantation genetic diagnosis, genetic modification of human embryos and gametes, and related matters, with a view to proposing, before the moratorium expires, an ethically acceptable public policy to govern these scientifically and medically promising but morally challenging activities. Several reasons converge to make this our recommended course of action at the present time. Members of the Council who support this recommendation do so for different reasons; some individual Members do not endorse all the concurring arguments given below.


Strengths of the Proposal

1. Bans Cloning-to-Produce-Children

   The strong ethical verdict against cloning-to-produce-children, unanimous in this Council (and in Congress) and widely supported by the American people, is hereby translated into clear and strong legal proscription. The nation's moral conviction is expressed with force of law through the people's representatives. To be sure, such a ban (like any proscription) could be violated, but it could not be violated with impunity. By reflecting the pervasive moral judgment of the community, this ban would also serve as a source of moral instruction and a sign that we can exercise some control over the direction and use of biotechnology. Moreover, were we at this time to settle for a mere moratorium on cloning-to-produce-children, we might lose what may be our society's best chance to get a permanent ban on this practice before it occurs and to declare our opposition to the idea of designing and manufacturing our children. We would lose this precious opportunity to demonstrate that we are able to practice democratic self-rule regarding biotechnology and that we can establish firm guidelines for the moral practice of science and technology.

2. Provides a Highly Effective Means of Preventing Cloning-to-Produce-Children

   The proposal's ban on all efforts to produce cloned children is a primary goal. The moratorium on cloning-for-biomedical-research (while desired by many for its own sake) would also provide an additional safeguard against cloning-to-produce-children during the next four years, beyond what would be available in a proposal that banned only the implantation of cloned embryos but left cloning-for-biomedical-research unregulated. By stopping all human cloning for four years, this proposal would prevent the creation of cloned embryos, thus decreasing the chances that anyone will be able to attempt to produce a cloned child. The moratorium would also permit time to explore other effective safeguards against this possibility that might be put in place should the moratorium not be reenacted after four years.

3. Calls For and Provides Time for Further Democratic Deliberation

   A true national discourse on cloning-for-biomedical-research has not yet taken place. Certainly it has begun. But no consensus has been reached, no clear majority has appeared, and only in rare cases have the various parties to the debate acknowledged (as we have attempted to do in this report) that their opponents are also defending important and shared values. The matters at stake are too significant to be settled now -- either by proceeding with the research with minimal delay or by banning the research outright -- when the nation is so divided and when the implications of proceeding or not proceeding are as yet unclear. Under these circumstances, the proper attitude is modesty, caution, and moderation, expressed in a temporary ban to be revisited when time and democratic argumentation have clarified the matter. By allowing the debate and deliberation to continue, a moratorium would offer the following specific benefits:

   1. Seeking consensus on crossing a major moral boundary. To decide to create nascent human life expressly for the purpose of experimentation and use is to cross a significant moral boundary. It goes beyond permitting the use of extra embryos, created for reproductive purposes, that are stored in IVF clinics and otherwise destined for destruction. Yet the meaning and moral propriety of crossing such a boundary are today hotly contested. Many people believe that even the earliest stages of a new human life should be protected against such use and destruction and would oppose such a practice at any time. Many others favor permitting the practice, but only under conditions of strict governmental regulation that would guard against abuses and reflect measured respect for the embryonic life that is being sacrificed. Our society needs more time to explore the full moral significance of taking such a step, to debate the moral and practical issues involved, and to seek a national consensus -- about all research on early human embryonic (and fetal) life (not just that formed through cloning techniques).

   2. Gaining needed scientific evidence. The moratorium on all human cloning will allow time for scientists to produce hard evidence from cloning research in animals and animal disease models -- evidence not available today. Such evidence, if available, would support their present claims regarding the value of cloning-for-biomedical-research, both for understanding normal and disease processes and for finding new treatments. The moratorium will also provide time to see whether cloning research will be indispensable for these goals or whether there are equally fruitful but morally nonproblematic alternatives to cloning, (such as, for example, work with adult stem cells or multipotent adult progenitor cells or work that would solve the transplant rejection problem for tissues derived from ordinary embryonic stem cell lines).

   3. Promoting fuller and focused public debate, leading to a better-informed decision. For people who believe that the human embryo must not be violated, and who would therefore advocate a permanent ban on cloning-for-biomedical-research, this moratorium offers a partial step in what they deem to be the right direction, and an opportunity to make further progress through moral persuasion and political action. By preventing cloning-for-biomedical-research for a while, this proposal takes seriously their warnings of possible harms from allowing such research. But it also calls on them to make those warnings more concrete and convincing, by arguing their case in the proper context of embryo research in general and not just that of cloning. Meanwhile, those who now do (or later might) support cloning-for-biomedical-research would also find benefits in this moratorium. It would allow them the opportunity to make their full case and win over new supporters, to prepare the ground properly (using new scientific evidence) for agreement on the merits of research when the time to decide comes, and to devise safeguards against likely abuse and misuse. The public decision made after the moratorium expires would be better informed and more fully considered as a result of such debate.

   4. Preserving a decent respect for deep moral concerns of our fellow citizens. A large number of Americans, perhaps even a majority, hold that it is deeply immoral to create what they regard as new human life for the purposes of experimental research that involves the destruction of that life. We should be very reluctant to ride roughshod over these views and to practice contempt for our fellow citizens, especially for the sake of promised benefits that are at this point highly uncertain and speculative, and especially when the necessity of this approach to the treatment of disease has not been demonstrated and when the public debate has been so brief. A moratorium will enable us to respect and assess these moral concerns while we look to science to provide alternatives that do not require crossing this moral boundary. Should the community decide, after the ongoing deliberation made possible by the moratorium, to cross it, no group would have grounds to complain that its views had been treated with contempt. Also, we could have in the meantime established new boundaries and devised effective regulations that could give genuine assurance that additional and more problematic practices would be forestalled or avoided altogether.

4. Provides Time and Incentive to Develop Adequate Regulation Regarding Human Cloning

   Because of the widespread concern to prevent cloning-to-produce-children, those who support cloning-for-biomedical-research bear the burden of devising and instituting adequate oversight and regulatory mechanisms that would effectively reduce the risk that embryos cloned for research might be used in efforts to produce cloned children. In addition, regulatory guidelines and mechanisms, devised and installed in advance, are called for regarding cloning-for-biomedical-research itself. Because everyone has a stake in how nascent human life is treated, serious efforts are necessary to protect the public interest. Cloning-for-biomedical-research, if and when it is to be allowed, must be preceded by the formulation of proper rules and the institution of effective safeguards.. Devising effective regulatory instruments takes time, and a moratorium could afford regulation proponents that time. Indeed, in the absence of a moratorium, few proponents of the research would have much incentive to help institute an effective regulatory system. And a governmental policy simply to withhold federal funding pending the development of a regulatory regimen would have no effect on the conduct of this research in the private sector. The following matters, at a minimum, would need to be considered by any serious program of regulation:

   1. Breadth of scope. Regulations that would cover all cloning research, whether done with public or private funds, whether done in universities, private research institutes, assisted reproduction clinics, or biotech companies.

   2. Protections for egg donors. Regulations governing the safety and consent of the oocyte donors, with safeguards against improper inducements and exploitation of poor or otherwise vulnerable women.

   3. Transparency and accountability. Regulations permitting full public knowledge and scrutiny of what is being done with cloned embryos produced for research purposes.^iv

   4. Equal access to benefits. Guidelines to promote equal access to the medical benefits that flow from such research.

      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, as well as how cloning-for-biomedical research relates to other areas of embryological, reproductive, and genetic experimentation.

5. Calls For and Provides Time for a More Comprehensive Review of the Entire Domain of Related Biotechnologies

   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 and genetics. The practices of human embryo research and preimplantation genetic diagnosis are largely unregulated by the federal government, or regulated in a haphazard, uncoordinated way. These practices, along with those of assisted reproduction, are largely unstudied: 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. To achieve this goal, the moratorium here proposed should be accompanied by a concerted review of the entire field, with the aim of establishing permanent institutions to advise and shape federal policy in this arena.

   The President's Council on Bioethics stands ready to undertake the preliminary steps of such a process and to provide advice on further steps. As part of our ongoing inquiry, we intend to continue to study various models of oversight and regulation of biomedical research and technology, both professional and governmental, that are used in the United States and abroad. As the necessary efforts will likely lead beyond the authority, scope, and perhaps also the duration of this advisory Council,^v we shall be especially interested in recommendations for devising a more permanent national agency or institution, with broad oversight, advisory, and decision-making authority,^vi that could emerge before the expiration of the four-year moratorium here proposed. Such a body could provide much-needed understanding and national guidance on these vitally important subjects. Progress toward creating such a body would ratify and perpetuate the deliberative goals of the moratorium.

6. Provides Time to Garner Long-Term Respect and Support for Biomedical Research and to Reaffirm the Social Contract between Science and Society

   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. By providing time to consider whether and how regulations might govern research in this morally troubling area, the moratorium invites the scientific, medical, and industrial communities into the activities of devising boundaries that they themselves would willingly respect. Such responsible behavior of biomedical researchers would go a long way to protect them against a public backlash should some less responsible scientists or technologists engage in practices repugnant to community standards or should some of their experiments result in great harm to some human subjects. It would reaffirm the principle that science can progress while upholding the community's moral norms. It would reassure researchers that any public moral restrictions on their activities will be rare, strictly limited, and carefully drawn. It would reassure the community that there is to be no slippery slope toward significant interference with the progress of beneficial biomedical research, the treatment of human diseases, or the moral uses of biomedical technologies. Friction between scientists and the wider community, aggravated by precipitate decision, would be reduced. The community's moral support for science and biomedical technology would be reaffirmed, and, as a result, the long-term interests of patients, families, and the entire society could be better served.

Some Specifics for the Legislation

Drafting the legislation that would give effect to this proposal lies beyond the scope and competence of the Council. Yet the following considerations would seem to be indispensable for a well-drafted and effective statute.

1. Broad Coverage

   The ban and moratorium should cover everyone, corporations as well as individuals, private as well as public institutions.

2. Narrowly Drafted

   The statute should be very narrowly drafted, making sure that only the human cloning actions in question are proscribed, and indicating explicitly other research and assisted-reproduction practices that will not be in any way affected by the ban or moratorium.

3. Temporary

   Regarding the moratorium on cloning-for-biomedical-research, in the event that Congress takes no further action after four years, the moratorium should lapse.

Conclusion

The proposal we recommend is, admittedly, a compromise, requiring some give on both sides of the national debate if it is to be enacted. But it is by no means merely a compromise. On the contrary, it is perfectly warranted by the state of public opinion and justified by the supreme value in our democracy of informed and deliberate decision in matters of great moment. If enacted, it would establish a permanent ban on cloning-to-produce-children, a practice that the nation overwhelmingly opposes. And it would not prematurely settle the equally important question of cloning-for-biomedical-research.

As already noted, this proposal accurately reflects the state of the public discussion of human cloning. There is broad agreement that cloning-to-produce-children should be banned, but there is deep disagreement and uncertainty regarding whether and how to proceed with cloning-for-biomedical-research. Such uncertainty calls for more discussion, more data, and more time -- things a moratorium would provide. In proposing the combination of a ban on cloning-to-produce-children and a moratorium on cloning-for-biomedical-research, we do not imply that we hold one form of cloning to be worse than the other, but rather that the state of the public debate is such that a clearly-agreed-upon course of action presents itself in the one case, but more time and deliberation are called for in the other. Even some of us who see merit in proceeding with cloning-for-biomedical-research worry that cloning-for-biomedical-research may turn out to be morally worse than cloning-to-produce-children, at least in magnitude, especially should it lead to a routinized practice of embryo cultivation and the growth of nascent human life for body parts. But given the present state of the public discussion and the dearth of scientific evidence, the Council has not reached consensus on how to formulate a permanent policy on this matter at this moment, and the American people are apparently divided on the subject.

The proposal we have offered is not just an acknowledgement of the current lack of consensus. It is intended to advance the discussion toward an informed decision by forcing both sides to argue for their positions clearly and openly. A moratorium means that neither side would be free to cling to the status quo and avoid presenting its full case for public discussion.

On the one hand, the moratorium would permit and require the research community to provide the public with more information about the desirability and necessity of the research, and to indicate how it can go forward within proper limits and respectful of communal norms. It will also provide time and incentive for researchers to seek out and invest in alternative technological approaches that are morally nonproblematic. It may well be that when Congress revisits the issue after the moratorium expires, the facts on the ground may show no unique or compelling need for cloning-for-biomedical-research. Yet the ban on cloning-to-produce-children would remain in place regardless of what happens on the research front.

On the other hand, the moratorium would permit and require the community concerned about defending the inviolability of embryonic human life to continue the moral argument in the hope of persuading the broader society to desist. That argument, we point out, has to be about embryo research in general, and not just about cloned embryos in particular. With cloning-to-produce-children prohibited and hence off the table, the debate could focus honestly and fully on this central question.

We acknowledge the concerns raised by opponents of this proposal, who worry that even a four-year moratorium on cloning-for-biomedical-research cuts off urgently needed investigation, and that prominent scientists may be tempted to leave the United States for countries without such restrictions on cloning research. These are understandable worries, but we believe they are misplaced and are not sufficient to force an immediate decision on this subject.

First, the promise of this research is for now purely speculative, and no significant evidence from animal research has presented itself that might demonstrate that this (to many people) morally disquieting or objectionable practice is in fact necessary for the goals that researchers aim to serve, and that, for example, adult stem cells cannot provide equally good models for studying inherited diseases, or that other routes are not more effective in addressing the transplant rejection problem.

Second, there is more to this matter than scientific and medical progress. We ask proponents to recognize the moral hazards that such research would be unleashing. Treating nascent human life as a natural resource (or even, more respectfully, as a human resource to which we ought to feel indebted) is morally troubling, and there is a clear and present danger that it could lead us down a path where our reverence for life may be imperiled. We would therefore ask proponents of this research and the public-at-large to keep these moral concerns in mind as we try to develop a sound public policy for the whole area of embryo research. We think that the moratorium provides needed time to do this right.

Finally, while it is possible that a few scientists will leave the country if a moratorium is enacted, the vast majority will not. We have examples at the state and national levels (for instance, Michigan and Germany) where highly restrictive laws banning all human cloning have been enacted yet where the biotechnology industry is thriving. We have confidence that this robust field will continue to grow, including the area of stem cell research from sources other than cloned embryos (Indeed, several other countries, including France, Norway, and Canada, permit work on embryonic stem cells but do not allow cloning-for-biomedical-research). Moreover, succumbing to the threat that some researchers might leave would not be a worthy way of making such a crucial moral decision. A scientist, like any other citizen, may choose to leave the United States for many different reasons. But there is no reason to assume that good scientists will not be able to work with and within the moral boundaries of the communities of which they are members and whose blessings and support they enjoy.

We believe that a permanent ban on cloning-to-produce-children coupled with a four-year moratorium on cloning-for-biomedical-research would be the best way for our society to express its firm position on the former, and to engage in a properly informed and open democratic deliberation on the latter. Moreover, combined with a systematic review at the federal level of the general field of embryo, reproductive, and genetic research and technology, this proposal would enable our society to think more comprehensively about how we should deal not just with human cloning but also with other vitally important areas of biotechnology. Ethical principles and boundaries need to be established; regulatory mechanisms need to be considered and devised; and ways must be found to give guidance to biomedical researchers and technological innovators such that beneficial research may proceed while respecting the moral and social norms of the community. The decision before us is of great moment and importance. Our society should take the time do to it right and to make a judgment that is well-informed, respectful of strongly held views, and representative of the priorities and principles of the American people. We believe this proposal offers the best available way to a wise and prudent policy.

Ban on Cloning-to-Produce-Children, with Regulation of the Use of Cloned Embryos for Biomedical Research (Policy Option 3 of Chapter Seven).

We recommend a congressionally enacted ban on all attempts at cloning-to-produce-children while preserving the freedom of cloning-for-biomedical-research. We recommend the establishment of a system of oversight and regulation that would permit cloning-for-biomedical-research to proceed promptly, but only under carefully prescribed limits. These measures would apply everywhere in the United States and would govern the conduct of all researchers, physicians, institutions, or companies, whether or not they accept public funding. In addition, we recommend that the federal government undertake a thoroughgoing review of present and projected practices of human embryo research. Several reasons converge to make this our recommended course of action at the present time. Members of the Council who support this recommendation do so for different reasons; some individual Members do not endorse all the concurring arguments given below.


Strengths of the Proposal

1. Bans Cloning-to-Produce-Children

   The strong ethical verdict against cloning-to-produce-children, unanimous in this Council (and in Congress) and widely supported by the American people, is hereby translated into clear and strong legal proscription. The nation's moral conviction is expressed with force of law through the people's representatives. To be sure, such a ban (like any proscription) could be violated, but it could not be violated with impunity. By reflecting the pervasive moral judgment of the community, this ban would also serve as a source of moral instruction and a sign that we can exercise some control over the direction and use of biotechnology. Moreover, were we at this time to settle for a mere moratorium on cloning-to-produce-children, we might lose what may be our society's best chance to get a permanent ban on this practice before it occurs and to declare our opposition to the idea of designing and manufacturing our children. We would lose this precious opportunity to demonstrate that we are able to practice democratic self-rule regarding biotechnology and that we can establish firm guidelines for the moral practice of science and technology.^vii

2. Provides an Effective Means of Preventing Cloning-to-Produce-Children

   Statutory prohibition on transfer of a cloned human embryo to a woman's uterus, backed by heavy penalties, would provide a sufficient deterrent. Cloned embryos created for research could, it is true, possibly get into the hands of those who would attempt to use them to produce cloned children. But the regulatory mechanisms and guidelines governing cloning-for-biomedical-research, provided for by this proposal (see below), will greatly minimize the likelihood of such an occurrence. And anyone who attempted to clone a child could not claim the credit for any successes without incurring prosecution. Even if slightly less foolproof than a ban that also blocked the creation of the cloned embryos, this is a sufficiently effective means for preventing cloning-to-produce-children.

3. Approves Cloning-for-Biomedical-Research and Permits It to Proceed without Substantial Delay

   Here are the major benefits to be obtained from this proposal (benefits foreclosed by the First Proposal). This proposal would provide clear congressional endorsement of the importance of proceeding with cloning-for-biomedical-research. This potentially very valuable research, promising for all the reasons enumerated in Chapter Six, Part III "The Moral Case for Cloning-for-Biomedical-Research," could now go forward without substantial delay using human cloned embryos and the stem cells and tissues derived therefrom. Uncertainty about the potential of this research can only be overcome by doing the research. It will be critically important to compare directly the advantages and disadvantages of adult stem cells, embryonic stem cells from IVF blastocysts, and embryonic stem cells from cloned blastocysts side by side in the same laboratory. Regardless of how much time we allow, no amount of experimentation with animal models could provide the essential and urgently needed understanding of human diseases. Moreover, the special and unique benefits of stem cell research using cloned embryos (see Chapter Six, Part III) cannot be obtained using embryos produced by in vitro fertilization. The possible benefits to potentially millions of patients are so great that we think they should be pursued as soon as possible (under proper guidelines and regulations; see next point). While not disturbing the current policy on embryo research (which permits federal funding for research only on certain designated stem cell lines), this proposal explicitly eschews federal legal bans on new approaches to the revolutionary possibilities of regenerative medicine.

4. Establishes Necessary Protections against Possible Misuses and Abuses, Thus Paying the Respect Owed to Embryos Sacrificed in the Research

   Unlike most of the more permissive human cloning legislation recently considered by Congress, this proposal takes seriously the special respect owed to nascent human life as well as the moral hazards involved in this research, and it proposes concrete steps to prevent or minimize them. While such regulation will not satisfy those who believe that all such research is morally wrong, it will give concrete expression to our view that human embryos are never merely a natural resource, and that the special respect owed to them as human resources must be reflected in limits on what we may do with them. In addition, such regulation may succeed in assuaging everyone's worst fears about where this research might lead.^viii

   Because of our concern to prevent cloning-to-produce-children, we call for adequate oversight and regulatory mechanisms to effectively reduce the risk that embryos cloned for research might be used in efforts to produce cloned children. In addition, we welcome regulatory guidelines and mechanisms, devised in advance, regarding cloning-for-biomedical-research itself. We agree that everyone has a stake in how nascent human life is treated, and that therefore serious efforts are necessary to protect the public interest. And although we want now to approve cloning-for-bio-medical-research, we agree that it shall not go forward in the absence of appropriate regulations and effective mechanisms for enforcing them.

   Although this is not the place to draft legislation, the regulatory mechanisms we favor would be based on the following principles:

   1. Prevent cloned embryos from being used to initiate pregnancies. To do this, regulations must register, inventory, and track the fate of individual cloned embryos; prohibit the shipping or sale of cloned embryos (but not stem cells or other tissues or products derived from these embryos).

   2. Provide enforceable ethical guidelines for the use of cloned embryos for research. To do this, regulations must license and conduct prior review of all research involving cloned human embryos; set a definite time limit and developmental stage beyond which a cloned human embryo may not be grown, either in vitro or in vivo (we suggest fourteen days, or the formation of the primitive streak); prohibit the transfer of a cloned human embryo into the womb (or other gestational environment) of a human being or an animal (or into an artificial equivalent of the same) for research purposes; and provide strong penalties to deter unlicensed or impermissible research.

   3. Protect the adult participants in this research. To do this, regulations must establish clear regulations for the protection of any human egg donors; set rules for financial compensation for egg donation; and establish other relevant measures designed to protect against the exploitation of women.

   4. Promote equal access to the medical benefits that flow from this research. To do this, guidelines must be developed that will keep down costs of medical therapies made available through this research, which would have been explicitly sanctioned by the community to serve the health needs of all.

5. Who Should Regulate This?

   Whether done by an existing agency or a new one devised for this purpose, the regulatory authority should include scientists, physicians, and representatives of the biotechnology and pharmaceutical industries, but also lawyers, ethicists, humanists, clergy, and members of the public. Persons involved in cloning-for-biomedical-research or with commercial interests in the same should be excluded from membership. Everything should be done to avoid even the appearance of conflict of interest, to prevent capture by special interests, and to ensure that the public's moral concerns are fully addressed in the devising of the regulations. A special Cloning Research Review Board, appointed by the President, might be one way to ensure high visibility and accountability.

6. Calls for a Comprehensive Review of the Entire Domain of Embryo Research

   The ethical and policy issues regarding cloning-for-biomedical-research deserve to be considered in the context of all human embryo research. Regulatory mechanisms for cloning-for-biomedical research should be part of a larger regulatory program governing all research involving human embryos. To achieve this goal, we recommend that the federal government undertake a thorough-going review of present and projected practices of human embryo research, with the aim of establishing appropriate institutions to advise and shape federal policy in this arena.

Some Specifics for the Legislation

Drafting the legislation that would give effect to this proposal lies beyond the scope and competence of the Council. Yet the following considerations would seem to be indispensable for a well-drafted and effective statute.

1. Broad Coverage

   The ban on cloning-to-produce-children, as well as the regulations devised for cloning-for-bio-medical-research, should cover everyone, corporations as well as individuals, private as well as public institutions.

2. Narrowly Drafted

   The statute should be very narrowly drafted, making sure that only the human cloning actions in question are proscribed and indicating explicitly other research and assisted-reproduction practices that will not be in any way affected by the ban or regulations.

Conclusion

This recommendation is above all grounded in the importance of not needlessly foreclosing or delaying a promising avenue of medical research. Permitting cloning-for-biomedical-research now, while governing it through a prudent and sensible regulatory regime, is the most appropriate way to allow this important research to proceed while ensuring that abuses are prevented. Combined with a firm ban on the transfer of cloned embryos into a woman's uterus, as we have recommended, such a policy would provide the balance of freedom and protection, medical progress and respect for moral standards, always sought in a free society. Most important, it would leave open and endorse an important new avenue of research that might help alleviate the suffering of millions of our fellow citizens.

We respect and recognize the concerns of many in the public and in this Council regarding cloning-for-biomedical-research, especially about the need for further deliberation and the necessary safeguards to prevent cloning-to-produce-children. But we do not believe that our proposal forecloses continued deliberation. On the contrary, the public process of designing a system to regulate cloning-for-biomedical-research is likely to generate public discussion about the difficult ethical issues posed by embryo research in general.

First, the ban we propose on cloning-to-produce-children would be a strong deterrent against a practice that the nation overwhelmingly opposes. By stopping, with the force of law, the transfer of cloned embryos into a uterus, this ban would effectively prevent the cloning of children. Like any law, the ban we propose could be violated, but so too could a more comprehensive ban on all cloning of embryos. Moreover, we believe that the sort of regulatory mechanisms we have proposed here would provide sufficient protection against the implantation of cloned embryos. Research scientists and fertility specialists are not out to break the law or violate the moral norms of their communities. They can in general be relied upon to abide by the ban we have proposed, and those who violate it can be penalized.

Second, we believe that the regulatory system we have proposed would address those concerns specific to cloning-for-biomedical-research itself. We do not discount these concerns. The moral seriousness of working with nascent human life and the larger public concern about where this research may lead make it imperative, even as a matter of enlightened self-interest, for the research community to welcome and participate in the regulation of this research. Because the issues at stake are not just those of safety and efficacy, but moral and social ones as well, the participation of other citizens in these decisions is entirely appropriate. Cooperation with the broader community in this matter of public moral concern can only advance the relations between science and technology and the broader society.

Third, we do not believe that cloning-for-biomedical-research is the place to settle the more general question of research on human embryos. That is why we have proposed that the federal government review in a systematic way the general field of embryo research, with an eye to devising a possible set of general policies or institutions. In the meantime, it seems inappropriate to halt promising embryo research in one arena (cloned embryos) while it proceeds essentially unregulated in others. A sensible system of regulation will allow this important research to continue safely, while the nation considers a possible general policy on all embryo research.

Last, in answer to the specific concern that our proposal may put the government in the position of mandating the destruction of human embryos, we point out that those who would be producing the cloned embryos for research would have absolutely no intention of keeping them alive beyond the limits needed for the research. Hence there would be no occasion when governmental interference might be called for to compel unwilling researchers to destroy the cloned embryos. Strictly speaking, it would be the researchers, not government officials, who would be responsible for the destruction of the embryos; the government would not be requiring anything that was not already implicit in the research activity itself. True, the government, by enacting this legislation, would be accepting the use of cloned embryos for research, but it would be doing so, fully mindful of the moral cost, for very good reason and under strict guidelines.

We therefore believe that the legitimate concerns about human cloning expressed throughout this report are sufficiently addressed by a ban on cloning-to-produce-children and the regulation of cloning-for-biomedical-research. And we believe that the nation should affirm and support the responsible effort to find treatments and cures that might help ameliorate or thwart diseases and disabilities that shorten life, limit activity (often severely), and cause great suffering for the afflicted and their families. Finding a way to support such valuable research while preserving moral standards is the challenge that confronts the federal government and the American public in the matter of cloning. We believe our approach offers the best means of achieving that goal.

The following ten Members of the Council form a majority in support of the First Proposal: Rebecca S. Dresser, Francis Fukuyama, Robert P. George, Mary Ann Glendon, Alfonso Gómez-Lobo, William B. Hurlbut, Leon R. Kass, Charles Krauthammer, Paul McHugh, Gilbert C. Meilaender.

The following seven Members of the Council form a minority in support of the Second Proposal: Elizabeth H. Blackburn, Daniel W. Foster, Michael S. Gazzaniga, William F. May, Janet D. Rowley, Michael J. Sandel, James Q. Wilson.

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1. The embryonic stem cells in these studies were obtained from non-cloned human embryos, produced by IVF.

2. The National Bioethics Advisory Commission recommended that federal agencies not fund research involving the derivation or use of human embryonic stem cells from embryos made solely for research purposes or using SCNT. (NBAC, Ethical Issues in Human Stem Cell Research, Vol. I, 1999, Recommendations 3 and 4, pp. 71-72.)

3. Operationally, the legislation could address separately the two uses of cloning and define the prohibited acts as follows. Cloning I: the creation of a cloned human embryo by somatic cell nuclear transfer. Cloning II: the creation of a cloned human embryo, produced by somatic cell nuclear transfer, followed by transfer into a woman.s (or animal's) uterus or into an artificial womb. It could then declare that: (1) Cloning I shall be unlawful for four years from the date of the enactment of this legislation. (2) Cloning II is hereby declared unlawful.

4. Careful consideration should be given to the following matters: licensing requirements to engage in such research; accurate inventory and reporting of the numbers, uses, and fates of all cloned embryos; decisions about whether to permit the buying and selling of cloned human embryos; rules governing commerce or traffic in cloned human embryos, should it be allowed; patent law questions regarding cloned human embryos, blastocysts, and later stages of cloned human organisms; age and stage of embryonic development beyond which it would be impermissible to maintain and experiment upon cloned embryos; rules regarding the permissibility of growing cloned human embryos in animal hosts or artificial substitutes for a human or animal uterus; regulations concerning cloned human-animal chimeras (for example, human nuclei placed in animal oocytes); guidelines specifying the kinds of experiments that may be performed on the cloned embryos; guidelines regarding production levels and storage of cloned embryos; and, finally, effective institutional designed to prevent easy capture by cloning researchers or biotech for monitoring cloning activities, enforcing the rules, and penalizing violators.

5. The President's Council on Bioethics is currently chartered through November 2003.

6. In thinking about this process we think it will be helpful to consult the work of the Canadian Royal Commission on New Reproductive Technologies. The process by which that Commission arrived at its final conclusions, and its manner of presenting those conclusions (carefully taking into account voluminous public testimony and dissenting opinions) strike us as providing an excellent model worthy of study and, to the extent appropriate, emulation. The scope, principles, structure, and functions of the proposed Assisted Human Reproduction Agency of Canada seem to us also worthy of special attention.

7. On this point and some others to follow, this policy proposal is identical to the First Proposal. To indicate this fact, the earlier argument will sometimes be repeated in this Second Proposal verbatim. We do so for symmetry and balance, and to allow each proposal to be read as a self-contained unit, without relying on the other.

8. See Position Number One of The Moral Case for Cloning-for-Biomedical-Research in Chapter Six and the discussion of Policy Option 3 in Chapter Seven for the details of the moral hazards and how specific regulations can deal with them.