federal funds would be available only for work with hES cell lines that had been developed prior to that date.13 The impact of this new policy was widely debated in the scholarly and disease advocacy communities.14 In fact, because NIH was unable to take the lead in this area, the National Academies convened a committee to draft voluntary guidelines for hES cell research (NRC and IOM, 2005).

In March 2009, shortly after taking office, President Obama issued an executive order allowing NIH support for hES cell research to the extent permitted by law. Executive Order 13505—Removing Barriers to Responsible Scientific Research Involving Human Stem Cells—states that the Secretary of Health and Human Services, through the director of NIH, “may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law.”15 Recognizing the controversial ethical issues involved, the new guidelines, issued in July 2009, contain provisions designed to ensure informed consent from donors, address potential conflicts of interest, and limit federal funding to research on hES cell lines derived from embryos originally created for reproductive purposes. Specifically, the guidelines state that, to be eligible for federal funding, hES cell lines must be created from embryos that were produced for reproductive purposes and are no longer needed for that purpose, that the embryos used to produce the lines must be donated by individuals who sought reproductive treatment and who have given voluntary consent for the embryos to be used for research purposes, and that no payments—cash or in kind—must be offered for the donated embryos. NIH also established a stem cell working group to formulate recommendations for the NIH Advisory Committee to present to the director regarding the acceptability of lines that predate the new guidelines. With the new guidelines in place, 178 hES cell lines have been approved by NIH as being eligible for federal funding (as of August 30, 2012).

In August 2009, a suit was filed in U.S. District Court to block the Department of Health and Human Services (HHS) from implementing the new guidelines on the grounds that they were in violation of the Dickey-

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13Address to the Nation on Stem Cell Research from Crawford, Texas (37 Weekly Comp. Pres. Doc. 1149 [August 9, 2001]).

14Approximately 1 month after the President’s announcement, an NAS report and an unpublished NIH analysis both stated that additional hES cell lines would have to be available to federally funded researchers to fulfill the promise of research announced in 2001 (NRC, 2002). In addition, several studies have examined the geographic distribution of publications in the field (e.g., Levine, 2008; Owen-Smith and McCormick, 2006).

15Removing Barriers to Responsible Scientific Research Involving Human Stem Cells (74 Fed. Reg. 10667 [2009]).



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