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NIH Draft Guidelines on Stem Cell Research: A Work in Progress?

As promised, President Obama has loosened up federal funding constraints on human embryonic stem cell research. But when the NIH published its draft guidelines on stem-cell research last month, it emerged that the constraints weren’t quite as loose as many Obama supporters had hoped they might be. We are nearing the end of the 30-day comment period on the draft guidelines. Two potentially controversial features of the NIH draft are nonfundable research and informed consent requirements.

Nonfundable Research

What kinds of research are not federally fundable under the new NIH draft guidelines is the only issue to have received much press coverage. The draft guidelines permit federal funding of research on “excess” human embryos from fertility clinics, and of stem cell lines developed from such embryos. That is a vast expansion over the funding available under President Bush. But the new guidelines also prohibit federal funding of research on lines derived “from any other sources.” Nonfundable lines include, without limitation, those produced from somatic cell nuclear transfer (SCNT), from parthenogenesis, and from IVF embryos that were specifically created for research, rather than for reproductive, purposes.

SCNT is a method of creating an embryo by removing the nuclear genetic material from an egg and replacing it with the nuclear material taken from an adult, donor cell. The resultant cell is like a fertilized egg, but one whose nuclear genetic material is identical to the donor’s. If permitted to develop, it would be the adult donor’s clone. (Dolly the sheep was cloned in just this fashion.) Researchers think that SCNT is a promising way of creating embryos—and from them lines of embryonic stem cells—with particular genetic diseases. Such lines might be used to develop therapies for those diseases.

Parthenogenesis involves stimulating an egg to produce an embryo without any genetic contribution from a male. While mammalian parthenote embryos seem incapable of developing into healthy offspring, they can be used to create stem-cell lines. (The fact that they cannot develop into healthy offspring is sometimes cited as a reason why their destruction in research is less problematic ethically than the destruction of embryos with better developmental potential.) Scientists have already succeeded in producing human stem cell lines via parthenogenesis. One reason for creating such lines is that they might be a perfect match for the egg donor, permitting transplantation without rejection. Parthenogenesis might also produce stem cell lines that are easier to match to nondonor patients. Having been derived from an embryo with only one “parent,” they inherit only one set of histocompatiblity antigens. This means fewer opportunities for incompatibility in transplant.

Thus, the NIH draft guidelines prohibit federal funding of work on at least two kinds of stem cell lines that have theoretical therapeutic potential beyond that of cell lines derived from “excess” IVF embryos. This feature of the guidelines—particularly the ban on SCNT—has already been publicly denounced by various researchers, including the former head of a National Academies of Science (NAS) panel, Scientific and Medical Aspects of Human Reproductive Cloning, which supported a reproductive cloning ban but wanted to permit SCNT for research purposes. We can expect critical comments, also, from the International Society of Stem Cell Researchers (ISSCR).

Informed Consent

The NIH draft guidelines include specific requirements for obtaining the informed consent of embryo donors. Two problems arise from these requirements. First, unlike the widely used NAS guidelines, the NIH draft guidelines apply these requirements to the stem cell lines that had been eligible for funding under President Bush’s policy—namely, those that were in existence before August 9, 2001. For about a quarter of these, adequate informed consent documentation is lacking. Problems include failure to inform donors about the nature of stem cell research. Researchers who’ve been federally funded for work on those lines, and who have come to know their characteristics and potential, will have to stop working with them if these NIH draft guidelines go forward unaltered. Expect a debate over whether a grandfather clause should be permitted, or whether informed consent requirements should be enforced without regard to the disruption of research.

Second, the NIH informed consent requirements differ in other ways from the NAS guidelines, as well as from the ISSCR guidelines. Because many research institutions and state research-funding authorities worldwide have adopted one of these guidelines, research institutions will have to spend some time parsing the differences between them and the new NIH requirements and determining whether the lines they’ve been using, or lines they are considering obtaining from abroad, are eligible for federal funding. Just to sample a few potentially problematic differences:

  • Like NAS guidelines, NIH draft guidelines prohibit any inducement for embryo donation. ISSCR guidelines prohibit only “undue” inducement.
  • The draft guidelines ask for documentation that “[a] policy was in place at the health care facility where the embryos were donated,” to the effect that a potential donor’s decision to give or to withhold consent would not affect the quality of care provided to that potential donor. NAS and ISSCR guidelines require that the consent decision not affect quality of care, but do not require written evidence of a facility’s existing policy to that effect.
  • The draft guidelines require that there be written evidence that “all options pertaining to use of embryos no longer needed for reproductive purposes were explained to the potential donor(s).” NAS guidelines include no such requirement.

The 30-day comment period exists so that researchers and others can bring exactly such problems to the attention of NIH regulators. NIH’s response may be a substantial amendment, a refusal to budge, or anything in between. The response may not come until weeks after the comment period has closed, but there is substantial pressure on NIH to get its standards set so that the research money can begin to flow—so don’t expect too long a wait. When the final guidelines come out, we’ll know whether the draft guidelines were, or were not, only a work in progress.

[This essay was edited on May 14, 2009.]

Published on: May 13, 2009
Published in: Clinical Trials and Human Subjects Research, Emerging Biotechnology

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