Stem cell lines eligible for US federal research dollars must be derived from embryos created for reproductive purposes that are no longer needed for those purposes, the National Institutes of Health (NIH) announced this afternoon (April 17).
The agency will not fund research on cell lines derived from embryos created via in vitro fertilization for research rather than reproductive purposes, nor those created using somatic cell nuclear transfer or parthenogenesis.
"This represents unequivocally a great expansion in opportunity" for scientists in the US to conduct federally funded stem cell research, said acting NIH director Raynard Kington at a press teleconference announcing the agency's awaited draft guidance on stem cell research.
Kington defended the agency's decision not to fund research on embryos created explicitly for research or work involving somatic cell nuclear transfer. "We don't believe there is consensus yet, even within scientific community," on whether the type of research the guidelines forbid should be conducted, he said. Also, he noted, "we do not know of any human embryonic stem cell lines that were created from somatic nuclear transfer, or that were created just for stem cell purposes."
The draft guidelines come almost six weeks after President Barack Obama's executive order lifting a 2001 policy that restricted federal funding to 21 already-extant lines. According to President Obama's directive on March 9, the agency had 120 days to lay out the rules for what would constitute "scientifically worthy and ethically responsible" stem cell research.
In addition to specifying the types of lines that will and won't be eligible for funding, the guidelines also define requirements and procedures for informed consent for funded projects. Individuals who have undergone reproductive therapies such as IVF who choose to donate their leftover embryos must sign a consent form releasing the embryos to research use, and the facility where the donation takes place must have an explicit policy stating that the quality of care won't be affected by the decision to donate embryos to science. Also, researchers are not allowed to provide incentives encouraging individuals to donate their embryos to research, and when possible, the physician providing reproductive treatment should not be the same person as the scientist who intends to conduct the research.
According to the California Institute of Regenerative Medicine, thousands of leftover embryos from IVF are discarded every year.
Consent forms used in accepting embryo donations for research must include several features, according to the policy. Specifically, donors must state that their donation is voluntary, and the consent form must state that the research will not provide direct medical benefits, that stem cell lines created from the tissue may exist for many years, and that the resulting research may later be commercialized.
It will be up to researchers and their institutions to provide assurances that the stem cell lines they propose to use comply with the NIH guidelines, said Kington. The NIH's embryonic stem cell bank, located in Wisconsin, will continue to exist through 2010, but the agency has not yet decided whether the facility will exist beyond that time.
Kington declined to estimate how many stem cell lines created after 2001 would qualify under the new guidelines. He said that there were about 700 stem cell lines reported in the literature, but that it was "impossible to estimate how many" would meet the criteria. Many of these lines, he said, offer unprecedented research opportunities because they contain disease-specific mutations.
Though the new guidelines should increase the number of cell lines available, the ban on using federal funds to derive new lines will remain in place. That process would violate what's known as the Dickey Wicker amendment, a law which prohibits federal funding of research involving the creation or destruction of a human embryo.
The draft guidelines will be published next week in the Federal Register, and open for public comment for 30 days, said Kington. The agency expects to release a final version of the guidelines on or before July 7, 2009.
"Until the guidelines are final, no new uses for embryonic stem cells will be allowed," Kington said. Grant proposals that include embryonic stem cell work based on lines now okayed by the new plan may be submitted before then, but they won't be reviewed until the guidelines are final. Researchers who have already submitted proposals at that time will be able to modify them at that time to make sure they comply with the final guidelines.
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