Supporters of embryonic stem cell research have expressed concern about the impact on existing research efforts under the Obama administration's draft guidelines outlining criteria for federal funding of stem cell research, the Washington Post reports. The public comment period for the guidelines ends Tuesday and has generated more than 20,000 comments addressing nearly every element of the proposal. The guidelines, which NIH issued in April, propose limiting federal funding for the research to stem cells derived from unused embryos created for fertility treatments and willingly donated by patients who have given written consent. Former President George W. Bush in August 2001 enacted restrictions limiting federal funding for the research to the 21 stem cell lines existing at the time. Although President Obama in March signed an executive order lifting Bush's restrictions, some proponents of embryonic stem cell research have suggested that Obama's plan could actually jeopardize many existing research efforts. The Obama administration is expected to issue its final version of the guidelines by July 7, the Post reports.

After Bush restricted federal funding to the embryonic stem cell lines already in existence, many researchers turned to private donors and state governments for the financial support to create hundreds of new lines. Although supporters of the research initially were pleased that the Obama administration's guidelines would allow federal funding for research on these new existing lines, some are now concerned that certain stipulations in the new guidelines could actually disqualify these research efforts from receiving federal funding. For example, NIH's proposal requires that couples who wish to donate unused embryos for research sign a consent form indicating that they were fully informed of their alternatives. Although many fertility clinics provide information for couples about their other options, few clinics note these details in written consent forms, according to the Post. Therefore, existing stem cell lines derived from embryos donated by couples who did not sign the required consent forms could be ineligible under NIH's draft proposal, the Post reports. In addition, many stem cell research supporters also expressed disappointment that only unused embryos created for fertility treatments would be eligible for federal funding.

George Daley of the Harvard Stem Cell Institute said that the Obama administration's guidelines "take 2009 standards and attempt to apply them retroactively, which isn't really a standard that would allow most of the pre-existing lines to be acceptable for NIH funding." Lawrence Goldstein, director of the University of California-San Diego's stem cell program, said, "It's not that past practices were shoddy. But they don't necessarily meet every letter of the new guidelines moving forward." Goldstein added that researchers would "have to throw everything out and start all over again" under the new proposed guidelines. Amy Comstock Rick, CEO of the Coalition for the Advancement of Medical Research, said that her group is "very concerned" about the funding prospects for existing research efforts, adding that if NIH officials do not modify the guidelines, "very little current research would be eligible" to receive federal funds.

However, Raynard Kington, acting NIH director, said the agency is aware of the concerns and "will take them into consideration." He added that "it's unambiguous that the intent of the president was to expand opportunities and research in this area," as long as such research is "scientifically worthy" and "ethically responsible" (Stein, Washington Post, 5/25).

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