The Niche

Comments on the NIH Draft Guidelines

The Interstate Alliance on Stem Cell Research has posted its comments on the NIH draft guidelines as a ppt presentation.

Here’s a twelve-word summary: The language in the draft guidelines could interfere with the guidelines’ intentions.

You want to look at the 3rd slide, which summarizes 5 pitfalls and remedies, the 5th slide which shows which lines are being used to study which diseases, and the 7th slide, which summarizes which pitfalls other submitting organizations are emphasizing. In particular, researchers want to make sure that if couples donated their embryos for stem-cell research, those intentions can be respected, even if the informed consent forms used at the time of donation don’t match criteria outlined in the 2009 guidelines.

Informed consent procedures around embryo and gamete donation is more sophisticated now than it was a decade and a half ago, leading some to question how best to use materials collected then. See When the past catches up with the present

Several organizations have put together responses to the guidelines.

The International Society for Stem Cell Research restates its support of the study of pluripotent stem cell lines derived via somatic cell nuclear transfer (SCNT) and parthenogenesis (currently not eligible for funding in the guidelines) and urges the NIH to reconsider supporting them as science progresses. It also asks the NIH to re-review existing lines to make sure embryos were obtained with informed consent, without undue inducement, and with sufficient oversight, even if the details of those criteria do not match exactly with those set forth in the 2009 guidelines. Finally, it asks the NIH to keep a list of the embryonic stem cell lines eligible for funding, to avoid confusion across different regions in the U.S.

The Genetics Policy Institute , proposed how the NIH can track, review, and solicit public input for its policies. It also provides a framework to compare guidelines from the NIH, ISSCR, NAS, and other sources.

In its comments, the U.S. Conference of Catholic Bishops says that embryos should be considered human beings.

The American Association of Universities says the NIH guidelines should cover lines derived from unfertilized eggs or embryos cloned through nuclear transfer.

In addition to its praise for the guidelines in its comments, the Center for Genetics and Society (which supports embryonic stem cell research using donated IVF embryos but opposes egg donation or cloning human embryos) has compiled a good sampling of diverse reaction to the guidelines.

There are many, many more.

See also previous coverage from Nature:

The Niche: Stem cell guidelines need input, not hysteria

News story in Nature: NIH draft guidelines criticized

Editorial in Nature: Stem-cell clarity


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