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The NIH Draft Guidelines on Human Stem Cell Research

New guidelines have positive aspects, but challenges remain in relation to previously approved stem cell lines, informed consent, oversight, and research embryos. With new draft guidelines to govern federal funding of human stem cell research, including human embryonic stem cell (hESC) research, the National Institutes of Health (NIH) have again taken on one of the most contentious endeavors of the day (1). There are positive aspects of the guidelines (2), but concern is growing that prior approvals of many widely used cell lines may not be in accord with specific wording requirements in the draft guidelines; such cell lines would need to be “grandfathered in” if research is to continue unimpeded (3). There are also several surprising omissions, surprising because they come in areas that are thoroughly addressed in the guidelines of the U.S. National Academies of Sciences (NAS) (4–6), which have become the gold standard for the conduct of stem cell research in the United States. Further, there has been little comment on the kind of initiative that would support future policy development.