Executive Summary -- Cloning Human Beings

EXECUTIVE SUMMARY

The idea that humans might someday be cloned—created from a single somatic cell without sexual reproduction—moved further away from science fiction and closer to a genuine scientific possibility on February 23, 1997. On that date, The Observer broke the news that Ian Wilmut, a Scottish scientist, and his colleagues at the Roslin Institute were about to announce the successful cloning of a sheep by a new technique which had never before been fully successful in mammals. The technique involved transplanting the genetic material of an adult sheep, apparently obtained from a differentiated somatic cell, into an egg from which the nucleus had been removed. The resulting birth of the sheep, named Dolly, on July 5, 1996, was different from prior attempts to create identical offspring since Dolly contained the genetic material of only one parent, and was, therefore, a "delayed" genetic twin of a single adult sheep.

This cloning technique is an extension of research that had been ongoing for over 40 years using nuclei derived from non-human embryonic and fetal cells. The demonstration that nuclei from cells derived from an adult animal could be "reprogrammed," or that the full genetic complement of such a cell could be reactivated well into the chronological life of the cell, is what sets the results of this experiment apart from prior work. In this report the technique, first described by Wilmut, of nuclear transplantation using nuclei derived from somatic cells other than those of an embryo or fetus is referred to as "somatic cell nuclear transfer."

Within days of the published report of Dolly, President Clinton instituted a ban on federal funding related to attempts to clone human beings in this manner. In addition, the President asked the recently appointed National Bioethics Advisory Commission (NBAC) to address within ninety days the ethical and legal issues that surround the subject of cloning human beings. This provided a welcome opportunity for initiating a thoughtful analysis of the many dimensions of the issue, including a careful consideration of the potential risks and benefits. It also presented an occasion to review the current legal status of cloning and the potential constitutional challenges that might be raised if new legislation were enacted to restrict the creation of a child through somatic cell nuclear transfer cloning.

The Commission began its discussions fully recognizing that any effort in humans to transfer a somatic cell nucleus into an enucleated egg involves the creation of an embryo, with the apparent potential to be implanted in utero and developed to term. Ethical concerns surrounding issues of embryo research have recently received extensive analysis and deliberation in the United States. Indeed, federal funding for human embryo research is severely restricted, although there are few restrictions on human embryo research carried out in the private sector. Thus, under current law, the use of somatic cell nuclear transfer to create an embryo solely for research purposes is already restricted in cases involving federal funds. There are, however, no current federal regulations on the use of private funds for this purpose.

The unique prospect, vividly raised by Dolly, is the creation of a new individual genetically identical to an existing (or previously existing) person—a "delayed" genetic twin. This prospect has been the source of the overwhelming public concern about such cloning. While the creation of embryos for research purposes alone always raises serious ethical questions, the use of somatic cell nuclear transfer to create embryos raises no new issues in this respect. The unique and distinctive ethical issues raised by the use of somatic cell nuclear transfer to create children relate to, for example, serious safety concerns, individuality, family integrity, and treating children as objects. Consequently, the Commission focused its attention on the use of such techniques for the purpose of creating an embryo which would then be implanted in a woman's uterus and brought to term. It also expanded its analysis of this particular issue to encompass activities in both the public and private sector.

In its deliberations, NBAC reviewed the scientific developments which preceded the Roslin announcement, as well as those likely to follow in its path. It also considered the many moral concerns raised by the possibility that this technique could be used to clone human beings. Much of the initial reaction to this possibility was negative. Careful assessment of that response revealed fears about harms to the children who may be created in this manner, particularly psychological harms associated with a possibly diminished sense of individuality and personal autonomy. Others expressed concern about a degradation in the quality of parenting and family life.

In addition to concerns about specific harms to children, people have frequently expressed fears that the widespread practice of somatic cell nuclear transfer cloning would undermine important social values by opening the door to a form of eugenics or by tempting some to manipulate others as if they were objects instead of persons. Arrayed against these concerns are other important social values, such as protecting the widest possible sphere of personal choice, particularly in matters pertaining to procreation and child rearing, maintaining privacy and the freedom of scientific inquiry, and encouraging the possible development of new biomedical breakthroughs.

To arrive at its recommendations concerning the use of somatic cell nuclear transfer techniques to create children, NBAC also examined long-standing religious traditions that guide many citizens' responses to new technologies and found that religious positions on human cloning are pluralistic in their premises, modes of argument, and conclusions. Some religious thinkers argue that the use of somatic cell nuclear transfer cloning to create a child would be intrinsically immoral and thus could never be morally justified. Other religious thinkers contend that human cloning to create a child could be morally justified under some circumstances, but hold that it should be strictly regulated in order to prevent abuses.

The public policies recommended with respect to the creation of a child using somatic cell nuclear transfer reflect the Commission's best judgments about both the ethics of attempting such an experiment and its view of traditions regarding limitations on individual actions in the name of the common good. 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.

Beyond the issue of the safety of the procedure, however, NBAC found that concerns relating to the potential psychological harms to children and effects on the moral, religious, and cultural values of society merited further reflection and deliberation. Whether upon such further deliberation our nation will conclude that the use of cloning techniques to create children should be allowed or permanently banned is, for the moment, an open question. Time is an ally in this regard, allowing for the accrual of further data from animal experimentation, enabling an assessment of the prospective safety and efficacy of the procedure in humans, as well as granting a period of fuller national debate on ethical and social concerns. The Commission therefore concluded that there should be imposed a period of time in which no attempt is made to create a child using somatic cell nuclear transfer. ¹

Within this overall framework the Commission came to the following conclusions and recommendations:

I. The Commission concludes that at this time it is morally unacceptable for anyone in the public or private sector, whether in a research or clinical setting, to attempt to create a child using somatic cell nuclear transfer cloning. The Commission reached a consensus on this point because current scientific information indicates that this technique is not safe to use in humans at this point. Indeed, the Commission believes it would violate important ethical obligations were clinicians or researchers to attempt to create a child using these particular technologies, which are likely to involve unacceptable risks to the fetus and/or potential child. Moreover, in addition to safety concerns, many other serious ethical concerns have been identified, which require much more widespread and careful public deliberation before this technology may be used.

The Commission, therefore, recommends the following for immediate action:

A continuation of the current moratorium on the use of federal funding in support of any attempt to create a child by somatic cell nuclear transfer.

An immediate request to all firms, clinicians, investigators, and professional societies in the private and non-federally funded sectors to comply voluntarily with the intent of the federal moratorium. Professional and scientific societies should make clear that any attempt to create a child by somatic cell nuclear transfer and implantation into a woman's body would at this time be an irresponsible, unethical, and unprofessional act.

II. The Commission further recommends that:

Federal legislation should be enacted to prohibit anyone from attempting, whether in a research or clinical setting, to create a child through somatic cell nuclear transfer cloning. It is critical, however, that such legislation include a sunset clause to ensure that Congress will review the issue after a specified time period (three to five years) in order to decide whether the prohibition continues to be needed. If state legislation is enacted, it should also contain such a sunset provision. Any such legislation or associated regulation also ought to require that at some point prior to the expiration of the sunset period, an appropriate oversight body will evaluate and report on the current status of somatic cell nuclear transfer technology and on the ethical and social issues that its potential use to create human beings would raise in light of public understandings at that time.

III. The Commission also concludes that:

Any regulatory or legislative actions undertaken to effect the foregoing prohibition on creating a child by somatic cell nuclear transfer should be carefully written so as not to interfere with other important areas of scientific research. In particular, no new regulations are required regarding the cloning of human DNA sequences and cell lines, since neither activity raises the scientific and ethical issues that arise from the attempt to create children through somatic cell nuclear transfer, and these fields of research have already provided important scientific and biomedical advances. Likewise, research on cloning animals by somatic cell nuclear transfer does not raise the issues implicated in attempting to use this technique for human cloning, and its continuation should only be subject to existing regulations regarding the humane use of animals and review by institution-based animal protection committees.
If a legislative ban is not enacted, or if a legislative ban is ever lifted, clinical use of somatic cell nuclear transfer techniques to create a child should be preceded by research trials that are governed by the twin protections of independent review and informed consent, consistent with existing norms of human subjects protection.
The United States Government should cooperate with other nations and international organizations to enforce any common aspects of their respective policies on the cloning of human beings.

IV. The Commission also concludes that different ethical and religious perspectives and traditions are divided on many of the important moral issues that surround any attempt to create a child using somatic cell nuclear transfer techniques. Therefore, the Commission recommends that:

The federal government, and all interested and concerned parties, encourage widespread and continuing deliberation on these issues 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.

V. Finally, because scientific knowledge is essential for all citizens to participate in a full and informed fashion in the governance of our complex society, the Commission recommends that:

Federal departments and agencies concerned with science should cooperate in seeking out and supporting opportunities to provide information and education to the public in the area of genetics, and on other developments in the biomedical sciences, especially where these affect important cultural practices, values, and beliefs.

Note:

¹ The Commission also observes that the use of any other technique to create a child genetically identical to an existing (or previously existing) individual would raise many, if not all, of the same non-safety-related ethical concerns raised by the creation of a child by somatic cell nuclear transfer.