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美全国卫生研究所发行干细胞研究基金指导方案
http://www.100md.com 2000年8月28日 Westport Newsroom
     WASHINGTON, DC, Aug 24 (Reuters Health) - US researchers could receive federal funding to study the potential uses of stem cells derived from human embryos under final guidelines unveiled by the National Institutes of Health on Wednesday. The new guidelines, however, which will be published in Friday's Federal Register, are certain to touch off another round of debate in Congress when it returns from its summer recess in 2 weeks.

    Advocates and opponents of federal funding for research using human pluripotent stem cells have been battling for months over the moral and ethical propriety of using embryonic stem cells, which researchers believe hold promise for the treatment of conditions such as diabetes, Parkinson's disease, Alzheimer's disease and spinal cord injuries.
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    The guidelines, the first version of which were published in 1999, attempt to steer a middle course in the ethically loaded debate. Under the rules, federal funds could not be used to actually remove stem cells from human embryos. Federal funding also could not be used to create embryos for the purpose of using stem cells. Funding is limited to cells derived from embryos created, but no longer needed, for in vitro fertilization.

    Donors could not be paid for providing embryos. The guidelines also require strict informed consent procedures, including informing donors that donated embryos will not survive the process by which the stem cells are removed, and that donors will not benefit from any potential commercial developments using the stem cells.
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    Researchers hailed the guidelines as a needed boost for a promising area of research. The guidelines "will enable this critical research to advance without offending the moral and ethical sensibilities of the American people," said Dr. Paul Berg, a Nobel Laureate from Stanford University and chairman of the Public Policy Committee of the American Society for Cell Biology.

    Dr. John Gearhart of Johns Hopkins University, one of the researchers who first isolated human pluripotent stem cells, said that the guidelines would speed up research that has shown promise in animal studies. "This is significant. It's terrific," said Dr. Gearhart, who spoke to reporters on a conference call with Dr. Berg.
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    But right-to-life groups continue to maintain that the guidelines are in direct contravention with the 5-year-old Congressional ban on research using human embryos. "This is clearly a violation of current law," said Douglas Johnson of the National Right to Life Committee. Richard Doerflinger of the National Conference of Catholic Bishops added that "this is falsification of science in the name of politics."

    NIH has maintained that the Congressional ban does not apply to stem cell research "because such cells are not embryos," according to an NIH fact sheet.
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    Both Johnson and Doerflinger said that by publishing the guidelines that allow the use of embryonic stem cells, NIH has ignored research findings showing that adult stem cells also show promise in treating disease and disability. "The argument that [using embryonic cells] is the only way to reach a therapeutic result becomes less convincing every week," Johnson said.

    Doerflinger said, "We could greatly expand funding of these alternatives that have no moral problem and enormous promise."
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    But Drs. Berg and Gearhart said that while they support more funding of research on adult stem cells, research also needs to go forward simultaneously on embryonic cells. Research on adult cells "is still in its infancy," Dr. Berg said. "Whether they are as able as the embryonic stem cells in terms of the range of differentiation is yet to be determined...I think what scientists are saying is: We ought to explore both."

    Even before the NIH action, Congress was scheduled to resume its debate over the stem cell issue. Senate Majority Leader Trent Lott, R-Miss., had previously promised Sen. Arlen Specter, R-Pa., a vote on Specter's bill to clarify that federal funding of embryonic stem cell research is allowed. In exchange for Lott's promise, Specter, who chairs the appropriations subcommittee that funds NIH, agreed not to insert similar language into the 2001 funding bill. As approved by the House and Senate, the spending bill continues the language banning embryo research, but does not specifically address the stem cell issue.

    Even if Congress does not act to block the new rules, Gearhart said that it will likely take at least a year for the first grants to be approved, and 3 to 5 years before the first human clinical trials will likely begin.

    

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