NIH Expands Embryonic Stem Cell Research
Special Report - July 8, 2009
The National Institutes of Health (NIH) has released its final guidelines for expanded federal funding of research involving human embryonic stem cells. The “Guidelines for Human Stem Cell Research,” which became effective on July 7, were issued in response to an executive order by President Barack Obama in March, in which the president directed the NIH to allow expanded taxpayer funding of research that involves the destruction of human embryos and the harvesting of their stem cells, and ordered the agency to issue guidelines for that purpose. According to the NIH, the guidelines are intended to help ensure “that NIH-funded research in this area is ethically responsible, scientifically worthy and conducted in accordance with applicable law.” The NIH guidelines also create an online federal registry of eligible stem cell lines.
Under the guidelines, federal funds can only be used for research involving stem cell lines that have: 1) been derived from human embryos created through in vitro fertilization (IVF) for reproductive purposes that are no longer needed by the donors and 2) that have been voluntarily donated for research with written informed consent. The NIH specifies the procedures for obtaining documentation of informed consent from donors who wish to donate their unused embryos for research, and prohibits payment for donated embryos. In addition, the guidelines require documentation of “a clear separation between the prospective donor(s)’s decision to create human embryos for reproductive purposes and the prospective donor(s)'s decision to donate human embryos for research purposes.”
Research that involves introducing human stem cells into “nonhuman primate blastocysts” and “the breeding of animals where the introduction of human embryonic-stem cells or human-induced pluripotent stem cells may have contributed to the germ line” is ineligible for federal funding. In addition, the NIH will not fund research that uses human embryonic stem cells obtained from other sources, “including somatic cell nuclear transfer, parthenogenesis, and/or IVF embryos created for research purposes.”
During the open public comment period that was held from April 23 through May 26, 2009, the NIH says it received approximately 49,000 comments about the proposed guidelines, including responses from religious organizations, Congressional leaders, and scientists. Raynard Kington, acting director of the NIH, told members of the media that 30,000 of the 49,000 responses the NIH received expressed opposition to any federal funding for human embryonic stem cell research.
According to the U.S Conference of Catholic Bishops, the NIH guidelines ignore the wishes of the majority of Americans who submitted comments. “The 30,000 individuals or organizations that made comments in opposition to federal funding of embryonic stem-cell research were saying, ‘You’re not responding to what the American people want. Start over,’” said Richard M. Doerflinger, associate director of the U.S. bishops’ Secretariat of Pro-Life Activities.
Tony Perkins, president of the Family Research Council, also criticized the NIH guidelines. “The guidelines purport to have tight informed consent requirements, but don’t even require the IVF doctor and the stem cell researcher to be separate persons, opening a gaping loophole for researchers to increase embryo production for their own purposes,” Perkins said in a press release. “Instead of funding more life-destroying experiments, federal funding should go toward life-saving treatments and clinical trials using adult stem cells, which are on the cutting edge of treating patients for diabetes, spinal cord injury, heart disease, multiple sclerosis, and other diseases.”
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