program of funding extramural hES cell research according to its own new guidelines on eligibility for funding.

The NIH Guidelines on Human Stem Cell Research were issued on July 7, 2009 (Appendix A). They establish mechanisms to determine the eligibility of hES cell lines for federal research funding based on the principles that (1) responsible research with hES cells has the potential to improve our understanding of human health and illness and discover new ways to prevent and/or treat illness; and (2) individuals donating embryos for research purposes should do so freely, with voluntary and informed consent. Many of the provisions defining informed consent in the NIH guidelines closely resemble those of the National Academies, ISSCR, and others that predate the new NIH requirements. Thus, the NIH guidelines address both the evaluation of lines already in existence, derived under a variety of rules and guidelines, as well as lines yet to be derived. NIH has established a Working Group of the Advisory Committee to the Director of NIH to determine which hES cell lines were derived under conditions that meet the requirements of the NIH guidelines.2

It should be noted that the NIH guidelines prohibit the use of federal funding for research using hES cell lines derived from any source other than excess in vitro fertilization (IVF) embryos created for reproductive purposes. Thus research on lines that may, in the future, be derived by somatic cell nuclear transfer (SCNT), parthenogenesis, or from IVF embryos created specifically for research purposes is not currently eligible for federal funding. As a consequence, they would not be subject to the NIH guidelines, including its standards for ensuring voluntary, informed consent for donated materials.

The NIH has also established a new Registry of hES cell lines eligible for NIH funding, containing those lines that its Working Group deems to conform with the requirements of the guidelines.3 The NIH approved the first list of hES cell lines for NIH funding on December 2, 2009, a second set on December 14, 2009, and additional lines in the first half of 2010 and indicated that it anticipated a continuing flow of approved hES cell lines to be listed on the NIH Registry. Use of those lines with federal funding will henceforth be governed by the NIH guidelines.

This letter report sets out an updated version of the National Academies’ Guidelines, one that takes into account the new, expanded role of the NIH in overseeing hES cell research. It also identifies those avenues of continuing National Academies’ involvement deemed most valuable by the research community and other significant stakeholders.

2

See <http://www.nih.gov/news/health/sep2009/od-21.htm> for information about the Working Group.

3

The Registry is available at <http://grants.nih.gov/stem_cells/registry/current.htm>.



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