Stem-Cell Guidelines Are a Good Start

Wednesday, June 3, 2009

The storm raised by stem-cell scientists about the failure of the National Institutes of Health draft guidelines to grandfather in stem-cell lines already in use is overshadowing other important issues raised by these guidelines ["New Rules on Stem Cells Threaten Current Research," news story, May 25].

The guidelines admirably add certain protections for those who make the difficult decision to donate, for stem-cell research, embryos remaining after in vitro fertilization treatment. Such protections did not appear in the Bush-era guidelines. While the protections complicate the informed-consent process, the grandfathering issue they raise can be remedied by adopting sections of the National Academy of Sciences guidelines addressing it.

What has been lost in the grandfathering brouhaha is that the NIH draft guidelines do not provide for oversight of stem-cell research at the institutional or national levels.

In contrast, such oversight is called for by the National Academies, the 2000 NIH stem-cell task force and the 1999 report of the National Bioethics Advisory Commission. Oversight of stem-cell research has been generally appreciated by scientists in Canada (whose Stem Cell Oversight Committee I served on for three years), because it has enabled them to avoid ethical and policy pitfalls that could delay their research.

Although the NIH draft guidelines address the issue of informed consent in more detail than the guidelines in use up to now, they do not take into account recent studies showing that embryo donors want more opportunities during treatment to consider what to do with spare embryos and greater assurances that their decisions will not be subjected to undue influence by their doctors.

The NIH draft guidelines make a good first stab at developing more complete guidelines for stem-cell research, but these and other sorts of ethical and policy concerns will need to be addressed in the final NIH guidelines due to appear in July.


Faculty Affiliate

Kennedy Institute of Ethics

Georgetown University


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