Pros and Cons of the New NIH Guidelines

In a letter to the editor of The Washington Post, Cynthia Cohen, Ph.D., J.D., Senior Research Fellow at the Kennedy Institute of Ethics at Georgetwon University in Washington, D.C., points out a few pros and cons of the recently proposed NIH guidelines.

Among other things, Dr. Cohen addresses "the grandfathering brouhaha", as she calls it, or in other words, "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". Under the initial draft of the proposed NIH guidelines, certain conditions would render ineligible for federal funding many of embryonic stem cell lines that already exist, which has caused a loud uproar among embryonic stem cell scientists. (Please see the related news article on this website, entitled, "Embryonic Stem Cell Advocates Protest NIH Guidelines", dated May 25, 2009).

According to Dr. Cohen, she does not see this as an irreconcilable problem, but instead points out that, "The guidelines admirably add certain protections for those who make the difficult decision to donate, for stem-cell research, embyros 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."

Of greater concern, Dr. Cohen explains, "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, by the 2000 NIH stem-cell task force and by the 1999 report of the National Bioethics Advisory Commission." Having served as a member of Canada’s Stem Cell Oversight Committee, Dr. Cohen is speaking from personal experience when she points out that, "Oversight of stem-cell research has been generally appreciated by scientists in Canada, because it has enabled them to avoid ethical and policy pitfalls that could delay their research." Indeed, such a concept is hardlly new in the U.S., as Dr. Cohen cites the formal requirement of such oversight even in 1999 by the National Bioethics Advisory Commission which existed under the Clinton administration.

Although Dr. Cohen concedes that the NIH draft guidelines make "a good first stab" at addressing a variety of complex issues, she also points out that "these and other sorts of ethical and policy concerns will need to be addressed in the final NIH guidelines".

Dr. Cohen has written extensively on issues of medical bioethics over the years, including "The Interests of Egg Donors: Who is Deceiving Whom?" which was published in the Fall 2001 issue of The American Journal of Bioethics, "Creating Human-Nonhuman Chimeras: Of Mice and Men" which was published in the Summer 2003 issue of The American Journal of Bioethics, and her latest book, "Renewing the Stuff of Life – Stem Cells, Ethics, and Public Policy", which was published in 2007 by Oxford University Press.

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