insufficient for projects that propose to derive new hES cell lines. And research must conform to the highest ethical and scientific standards and be conducted sensitively and in accordance with all regulatory requirements of the nation or state. For example, even under its relatively liberal policy, the United Kingdom, in its Code of Practice for the Use of Human Stem Cell Lines, requires that all hES cell research be conducted under special licenses obtained from the government. The rationale is, in part, to ensure protection of the status of the human embryo:

The special regulations which govern the creation and use of human embryonic stem cells reflect the fact that the human embryo has a special moral status. The position taken by many (perhaps most) is that the embryo, unlike an infant, does not have the full rights of a person; however, its human potential gives it an intrinsic value which implies that neither its creation nor its destruction are to be treated casually, as reflected in law. A research license will not be granted unless the HFEA [Human Fertilisation and Embryology Authority] is satisfied that any proposed use of the embryos is necessary for the research and that the research is necessary or desirable for the purposes specified in the 1990 HFE Act and the 2001 Regulations…. Although the use of embryos for these purposes is now permitted under the law, researchers in this field should be sensitive to the fact that some people believe this practice to be morally unacceptable [MRC, 2004].

Many other sets of guidelines also contain provisions to ensure voluntary embryo donation—with a requirement of informed consent—and requirements that the confidentiality of donors be protected. Because there is no federal support in the United States for hES cell research in which new cell lines are derived, the most applicable guidelines come from the Ethics Committee of the American Society for Reproductive Medicine (ASRM, 2000; 2004b). Canada and the United Kingdom also have substantive procedural requirements regarding the recruitment of donors and informed consent. (Those and other approaches are addressed in detail in Chapter 5.) Most guidelines also call for some special oversight body for hES cell research to review documentation of compliance with the guidelines of various government agencies, both domestic and foreign (see Chapters 4 and 5). Oversight is in some cases folded into the evaluation of scientific merit; in others, it is performed by stand-alone ethics review bodies. Finally, most forms of laboratory and clinical research in the United States are subject to substantial local regulation, including provision of protections for human subjects in research, protections for laboratory animals, and the many considerations that must be addressed for research and testing of new drugs and medical devices. (The applicability of those regulatory systems to hES cell research is addressed in Chapter 4.)

In considering the ethical and policy issues that arise in connection with hES cell research, the committee subscribes to the consensus of many bioethics bodies throughout the world that a system of oversight of hES cell research should be in place. Examples of current and former national bioethics bodies taking such a view are the 1994 National Institutes of Health Human Embryo Research Panel, the National Bioethics Advisory Commission, the U.K. Human Fertilisation and Em-



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