1. Prerequisites to hES cell research (such as examination of alternative approaches), appropriate uses of hES cells in research or therapy, and limitations on the use of hES cells.

  2. Safeguards against misuse.

In accordance with the stated position of the National Academies that there should be a global ban on NT for human reproduction (NRC, 2002), the guidelines developed by this committee focus exclusively on research and therapeutic uses of hES cells and NT.

To conduct its work, the committee surveyed the current state of science in this field and likely pending developments, reviewed the policy and ethical issues posed by the research, examined professional and international regulations and guidelines affecting hES cell research, and conducted a 2-day workshop with speakers who represented many scientific, ethical, and public policy perspectives. It did not revisit the debate about whether hES cell research should be pursued; rather it assumed that both hES cell and adult stem cell research would continue in parallel with federal and nonfederal funding. In addition, although the committee recognizes that successful resolution of intellectual property issues will be critically important in this evolving area of research, it was beyond its charge and beyond its capabilities to address adequately all of the legal issues that will arise. Chapter 4 briefly addresses ongoing efforts to ensure that intellectual property issues do not impede new developments in biomedical research.

The guidelines presented in Chapter 6 focus on the procurement of embryos and gametes and the derivation, banking, and use of hES cell lines. They provide an oversight process that will help to ensure that research is conducted in a responsible and ethically sensitive manner and in compliance with all regulatory requirements pertaining to biomedical research in general. These guidelines are being issued for use by the scientific community, including researchers in university, industry, or other private sector research organizations, as well as practitioners of assisted reproduction, which will be one of the sources of donated embryos and gametes.

PRECEDENTS FOR SCIENTIFIC SELF-REGULATION

Perhaps the archetype of modern scientific self-regulation in the life sciences—although primarily focused initially on safety rather than ethical issues—was the moratorium on recombinant DNA research that emerged from a meeting of several hundred scientists at the Asilomar Conference Center in California. A controversy had erupted in 1971 about an experiment that involved inserting genes from a monkey virus, SV40, which can make rodent cells cancerous, into an E. coli bacterial cell. Prominent scientists called for a halt to recombinant DNA research until the matter could be resolved. The 1975 Asilomar conference concluded that safeguards should be introduced into recombinant DNA work, ultimately including the creation of the NIH RAC and guidelines for federally funded recombinant DNA



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