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This staff working paper was discussed at the Council's January 2002 meeting. It was prepared by staff solely to aid discussion, and does not represent the official views of the Council or of the United States Government.

Staff Working Paper

The President has authorized the Council to look at the scientific, medical, and ethical issues relating to human cloning as one of its first priorities. Anticipating the possibility of this assignment and mindful of the importance of the topic, the Council's staff has prepared working papers for the Council's first discussions of human cloning. This is the first of four.

Biotechnology, Procreation, and the Meaning of Human Cloning

This working paper, prepared for the first of our three sessions on human cloning, has three major purposes: First, it aims to set human cloning in the larger contexts of biotechnology and human procreation and the bioethical discussions these subjects have generated. Second, it presents the importance of human cloning as the first project for the Council. Finally, but most important, it seeks to articulate the kinds of questions that might lead to a rich exploration of the meaning of cloning human beings.

1. Biotechnology and Human Procreation: A Matter of Moral and Political Concern.
For roughly half a century, and at an ever-accelerating pace, biomedical science has been gaining wondrous new knowledge of the workings of living beings, from small to great. Increasingly, it is providing precise and sophisticated knowledge of the workings also of the human body and mind. Such knowledge of how things work often leads to new technological powers to control or alter these workings, powers generally sought in order to treat human disease and relieve suffering. But, once available, powers sought for one purpose are frequently usable for others. The same technological capacity to influence and control bodily processes for medical ends may lead (wittingly or unwittingly) to non-therapeutic uses, including "enhancements" of normal life processes or even alterations in "human nature." Moreover, as a result of anticipated knowledge of genetics and developmental biology, these transforming powers may soon be able to transmit such alterations to future generations.

Concern over the meaning of acquiring such powers -- both the promise and the peril -- has attracted scholarly and public attention. For over thirty years, ethical issues related to biomedical advance have occupied the growing field of bioethics. Increasingly, these ethical issues have entered public discussion and spawned debates about what we should do about them. A growing number of people sense that something new and momentous is happening: that the accelerating waves of biotechnical advances touch deeply on our most human concerns and the things that make us human; and that the four-centuries-old project for human mastery of nature may now be, so to speak, coming home, giving man the power to alter and "master" himself.

One important aspect of human life already affected by new biotechnologies is human reproduction. Even before we have seen the potential fruits of the human genome project, powers to manipulate the origins of human life have been gathering, the result of the confluence of work in genetics, cell biology, and developmental biology. Negatively, we have acquired powers to prevent conception and to block embryo implantation and gestation. Positively, we have acquired powers to overcome various forms of infertility, both female and male. Beginning with techniques of artificial insemination (sperm from husband or donor) and progressing through in vitro fertilization (IVF) and intra-cytoplasmic sperm injection, artificial aids to sexual reproduction have come into standard medical use. In addition, we are gradually acquiring powers to affect in a deliberate way the genetic endowment of the next generation. Genetic screening, amniocentesis to test for genetic disease (and sex of offspring), and pre-implantation genetic diagnosis of in vitro embryos -- as well as demonstrated abilities to do embryo twinning or to produce chimeric embryonic hybrids -- have opened possibilities for choosing (and someday altering) the genetic makeup of the resulting offspring. The new technologies of laboratory-assisted reproduction have also opened up possibilities for non-reproductive uses of nascent human life. The availability of human embryos, produced in excess in IVF clinics (or produced-to-order by IVF techniques in research laboratories), has facilitated research on early human development and has led to the extraction and growth of human embryonic stem cells, the pluripotent precursor cells that may hold great promise for future treatment of chronic degenerative diseases.

Finally, we may be on the threshold of a more radical departure in human procreation: human cloning, the asexual reproduction of a new human organism that is genetically virtually identical to an already existing or previously existing organism. The first successful cloning of a mammal (Dolly the sheep) was announced in February 1997; since then, cows, mice, pigs, and goats have also been cloned. Several fertility specialists in the United States and abroad have announced, to great fanfare, their intention to clone human beings, and their efforts may already be well under way. In November 2001, American researchers claimed to have produced the first cloned human embryo, a being that grew only to a 6-cell stage before it died. Public concern about the prospect of human cloning, triggered by the cloning of Dolly, has remained high and legislative efforts to ban human cloning proceed at home and abroad. In the United States, six states have banned human cloning. In July 2001, the House of Representatives passed a strict ban on all human cloning, including the creation of embryonic human clones. President Bush has expressed his opposition to all human cloning and has strongly supported the House-passed ban. As of this writing the Senate has not taken any action on the subject, though at least two competing bills have been introduced to ban cloning. What to think and what to do about human cloning and embryo research cloning, or both, remain topics of lively public discussion and debate.

2. Human Cloning: The Importance of Studying It Now
We accept the President's charge to study human cloning and concur in the view that it is important that we do so as our first project. With the public debate swirling and with the Senate soon to consider the matter of a legislative ban, it would be most irresponsible for the Council to avoid what is today the first public issue of bioethics on the national agenda. We have an obligation to be prepared to participate in the discussion, to clarify the issues, evaluate the arguments, and to offer whatever help we can.

The subject of cloning is not only timely, it is also important in itself, and quite apart from the scale on which it may be practiced. Clonal reproduction represents the first instance of assisted baby-making in which the genetic endowment of the resulting (cloned) child would be specifically determined and known in advance. It may therefore represent a first step toward normalizing the genetic design of children or, more ambitiously, the project of eugenic "improvement" of the human race. Bypassing sexual reproduction, it moves procreation increasingly under artful human control and perhaps toward a form of manufacture. These facts are important for the resulting children and their families, as well as for the society at large: A world that practices human cloning would seem to be a very different world, perhaps radically different, from the one we know. It is part of our task to understand whether, how, and why this is so.

An investigation of human cloning also provides this Council with an important opportunity to illustrate how a rich and deep bioethics can and should deal with technological innovations that implicate our humanity. The most profound issues, here as elsewhere, go beyond the commonplace and utilitarian concerns of feasibility, safety, and efficacy.

In addition, on the policy side, cloning offers a test case for considering whether public control of biotechnology is possible and desirable, and by what means and at what cost. The issue has high public visibility, and public opposition to clonal reproduction is strong. At the same time, there are keen proponents of research on cloned human embryos and others who oppose any governmental interference with the freedom of scientists and biotech companies to conduct such research.

Human cloning was once before the subject of a report by a federal bioethics commission, the National Bioethics Advisory Commission (NBAC), established in 1995. Published in 1997, Cloning Human Beings declared that attempts "t this time" to clone a human being were unethical, owing to questions about the safety of the technique and the likelihood of harm to the resulting offspring. The NBAC report explored other ethical and social issues about which it did not reach consensus. About these it recommended that they be the subject of widespread and 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 should the time come when present concerns about safety have been addressed." In a recent letter to President Bush, dated September 26, 2001, NBAC Chairman Harold Shapiro listed human cloning among the "Outstanding Ethical and Public Policy Issues" that the outgoing Commission believes require serious and sustained attention at the federal level. He stressed the need to take up again the "ethical, social, and legal issues associated with human cloning in the event that the risks to the fetus and mother were someday to be considered acceptable." Our Council is eager to carry to the next stage the work that NBAC so ably began.

3. How to Proceed?
The Council begins its work on human cloning mindful of the immediate public policy challenge: the need for a decision regarding the desirability (or lack thereof) of a legislative ban on human cloning. We plan in due course to consider the various policy options and assess their relative merits. But in keeping with our mission to examine fully and deeply the human and moral significance of any scientific or technical innovation, we shall begin by considering the meaning of human cloning, seen especially as an important challenge to the character of human procreation and its personal, familial, and social significance. We intend to consider in the fullest way possible the range of scientific, moral, and practical questions raised by human cloning: among them, the history and science of human cloning; the ethical arguments for and against the creation of cloned human beings; the relationship between "reproductive" cloning and research cloning (more often called "therapeutic" cloning); and the question of what is the wisest public policy. But to properly ground these inquiries and judgments, we believe that we must start from the human activities or aspects of our humanity that are at stake or in conflict. We seek to understand what they are and why we do (or should) care about their survival.

We suggest that proper points of departure for the discussion of clonal baby-making (and indeed for many of the new biomedical technologies) are the character of human procreation, the character of human freedom, and the goals of biomedical science.

On the one side, we have various questions connected with the nature and moral meaning of human procreation and the relationships and responsibilities connected with it. For it is human procreation in all its aspects that provides the major human context for considering proposals to clone a human being. What does it mean to bring a child into the world, and with what attitude should we regard its arrival? What is the human difference between sexual and asexual reproduction and what does this difference mean for the relation between the generations? What is the significance of one's origins and one's genetic make-up to who one is and how one regards oneself, to one's "identity," individuality, and sense of self? What does it mean if reproductive activities become increasingly technological and commercialized? May or should one generation be permitted to design, redesign, "improve," or select in advance the genetic characteristics of the next generation, and if so, on the basis of what goals and standards? What is the moral status of nascent human life, created in the process of trying to assist human procreation? What does it mean to regard nascent human life as a natural resource, to be used for the benefit of others?

On the other side, and raising novel challenges to human procreation, we have the pursuit of two other (and often allied) human goods. First is freedom: of scientists to inquire, of technologists to invent, of individuals to reproduce, of entrepreneurs to invest and make money. Second is the desire to relieve man’s estate: negatively, to prevent and treat disease and alleviate suffering; positively, to engineer "improvements" in heritable human potentialities and capacities. The pursuit of knowledge and the healing of illness are indeed high human callings. But what are the necessary and sufficient conditions for their flourishing? Should those who exercise these various freedoms accept certain limits? Is the need to find new cures for the sick a moral imperative that should trump all other goods and values? If not, what are the moral boundaries that scientists and technologists should respect as they continue their quests for knowledge and cures?

The fact that there are deep and fundamental disagreements about these issues cannot be ignored. There is a need both for sobriety and for a full hearing of all arguments in this debate, and it is in this spirit of open inquiry that the Council shall do its work. But there is also the need for responsible judgments and policies, and for recognition of the fact that these are inescapably moral matters, to be decided on not by scientists or techno-entrepreneurs acting alone but by all of us conversing and deliberating in the public square. We enter into the discussion of human cloning guided both by this desire for wisdom and by the need for prudence.

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