and presents comparisons with regulations in other nations that have substantial hES cell research programs. Recommendations about the application of existing regulatory conventions to hES cell research are offered.

Finally, 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. In the context of privately funded research it is particularly difficult to explore mechanisms by which discoveries made using hES cells can be made widely accessible for the benefit of human health. However, the committee believes that best practices can be developed and followed. Several policy statements developed regarding patenting and licensing issues more generally applied in biomedical science can serve as aspirational goals for the hES cell research community. In particular, in 2004 NIH issued Best Practices for the Licensing of Genomic Inventions.1 This document aims to maximize the public benefit whenever Public Health Service-owned or -funded technologies are transferred to the commercial sector. In this document NIH recommends that “whenever possible, non-exclusive licensing should be pursued as a best practice. A non-exclusive licensing approach favors and facilitates making broad enabling technologies and research uses of inventions widely available and accessible to the scientific community.” In addition, the National Academies is developing recommendations for NIH on intellectual property rights in genomic- and protein-related innovation (forthcoming, 2005). The reader is encouraged to review these documents, which aim to facilitate responsible patenting and licensing practices by the scientific community.


Whether it involves receiving donated blastocysts that would otherwise be discarded after infertility treatment or procuring gametes and somatic cells to make blastocysts specifically for research purposes, the procurement process often requires oversight by an Institutional Review Board (IRB), whose membership and functions are described in Department of Health and Human Service (DHHS) regulations at 45 CFR 46.107-115 and in FDA regulations at 21 CFR 56.107-115.2 IRB



DHHS has codified its human subjects protection regulations at 45 CFR 46, Subparts A through D. Other federal research agencies have signed onto Subpart A, which is referred to as the Common Rule. In this report, the DHHS regulations are cited in discussing the protection of human subjects of research because they are more inclusive than the Common Rule alone. The DHHS regulations extend additional protections to vulnerable populations, such as pregnant women, viable fetuses, prisoners, and children. FDA also has codified Subpart A of the regulations at 21 CFR 50 and 56, although with slightly different interpretations. In some cases, FDA regulations and HHS regulations might apply to research.

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