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Jul 7, 2009

NIH Sets Guidelines for Funding Research on Human Stem Cells

  • NIH published guidelines for embryonic stem cell funding called “National Institutes of Health Guidelines for Human Stem Cell Research.” It establishes rules for informed consent and evaluation of eligible human embryonic stem cell (hESC) lines. Once accepted, lines become part of a registry and eligible for NIH funding.

    “With a registry of cell lines available for NIH funding, California scientists and their colleagues outside the state can benefit from CIRM and NIH funding while working with the best embryonic stem cell lines,” says Robert Klein, chair of the governing board of the California Institute for Regenerative Medicine (CIRM). “We can expect the pace of discovery to move even faster toward new cures for patients.”

    The guidelines allow for funding research using hESCs derived from embryos created using in vitro fertilization (IVF) for reproductive purposes but no longer needed for these purposes, assuming the research has scientific merit and the embryos were donated after proper informed consent was obtained. The guidelines do not support research using hESC lines from embryos created expressly for research purposes and lines created or pluripotent cells derived following parthenogenesis or somatic cell nuclear transfer (SCNT).

    “In terms of extending the classical embryonic stem cell lines that can be used with federal funding, this is an important step forward,” remarks Stanford University School of Medicine stem cell researcher Irving Weissman, M.D. “However, the policy banning funding of other stem cell lines produced by transferring the genetic material from a patient to an egg is a terrible disappointment. It seems inconsistent with the president’s promise to allow scientific facts to determine science policy.”

    And while Klein gave NIH’s guidelines a thumbs up, he is also looking forward to working with the NIH to evaluate the inclusion of parthenogenesis and SCNT lines in the future. CIRM says that it will continue to uphold the highest standards of oversight for hESC derivation and research not currently eligible for federal funding.

    This will enable NIH to leverage current efforts in its future programs. The NIH says that it will periodically re-evaluate the scope of these guidelines in light of medical and scientific advances.

    NIH states that the guidelines reflect the broad public support for federal funding of research using hESCs created from embryos obtained through IVF. The use of parthenogenesis and SCNT involve complex ethical and scientific issues on which a similar consensus has not emerged, the institute notes. For example, the embryo-like entities created by parthenogenesis and SCNT require women to donate oocytes, a procedure that has health and ethical implications.

    “They could have said that they would evaluate these stem cell lines when and if they are derived to determine whether they met the appropriate ethical standards,” says Dr. Weissman, who directs Stanford’s Stem Cell Biology and Regenerative Medicine Institute. “Instead, their only justification for not funding research on these lines was that SCNT didn’t have public support.”

    Some other restrictions include research in which hESCs, even when derived as per the guidelines, are introduced into nonhuman primate blastocysts as well as research involving the breeding of animals where the introduction of hESCs or human induced pluripotent stem cells may contribute to the germ line.

    The guidelines also establish specific and different rules for gaining eligibility for lines derived in the U.S. as well as outside the country before, on, or after the effective date, which is July 7. In general, if created in the U.S., all lines must comply to the same set of rules related to informed consent even if produced before the publication of these guidelines. This is also the case with hESCs derived outside the U.S., but the NIH will take into consideration each country’s guidelines and ask applicants to prove at least equivalent protections.

     



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