research. It is generally agreed that the Asilomar conference and the measures that followed helped to reassure Congress and the public that the scientific community took its responsibilities seriously and allowed the research to go forward.

Although the recombinant DNA debate and its results have achieved a sort of iconic status in the annals of science’s self-regulation, less spectacular examples have also arisen in the absence of or as a complement to government regulation of science and medicine. The government often relies on the private sector to regulate itself and supports it with the threat of sanctions. An example is the Joint Commission for the Accreditation of Health Care Organizations; failure to meet its standards can result in the loss of Medicare reimbursement. In the field of assisted reproduction, the lack of government funding has resulted in professional efforts to generate standards, such as those promulgated by the American Society for Reproductive Medicine (ASRM) and the Society for Assisted Reproductive Technologies.

Because there is no current federal support of hES cell research in which new cell lines are derived, the most applicable sets of guidelines in the United States for this purpose come from the Ethics Committee of the ASRM (ASRM, 2000, 2004b). Most international guidelines also call for some special oversight body for stem cell research to review documentation of compliance with the guidelines of various government agencies, both domestic and foreign. Such evaluation is in some cases folded into the evaluation of scientific merit; in others it is performed by stand-alone ethics review bodies. In the United States, review of scientific merit is typically conducted by the funding agency, which is often a federal agency. That will not be the case, for the time being, for most hES cell research conducted in this country.

There are clear advantages to government action, especially with regard to the legal standing of industry standards. Outstanding examples relevant to this report and to cultural environments that are similar to the United States are the British Human Fertilisation and Embryology Authority and the more recent Canadian Assisted Human Reproduction Agency. But in the absence of such arrangements, our proposals for a system of local review combined with a national oversight panel would go far toward consolidating and monitoring the policies and practices of hES cell research.

CONCLUSION

In the absence of federal guidelines broadly governing the generation and research use of hES cells, the scientific community and its institutions should step forward to develop and implement its own, much in the spirit of Asilomar, which resulted in the RAC guidelines in use today. Such guidelines are needed by the scientific community as a framework for hES cell research and would reassure the public and Congress that the scientific community is attentive to ethical concerns and is capable of self-regulation while moving forward with this important research. The premise is not to advocate that the work be done—that has already been debated with some consensus reached in the scientific community and elsewhere—



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