NIH Announces New Embryonic Stem Cell Research Guidelines

A month after the Obama Administration lifted Bush era restrictions on federal funding for human embryonic stem cell (hESC) research, the NIH has now announced its new draft guidelines for such research. The new guidelines will greatly expand the scope of federally-funded research by allowing funds to be used for work on stem cell lines derived from excess fertility clinic embryos.

However, federal funds will not be available for work on hESC lines derived from embryos that have been generated specifically for the purpose of stem cell work. This is a pretty severe limitation, actually, and the rules basically ensure that if a cell line was derived from an embryo that was not left over from a fertility clinic, work on that cell line can never be funded by federal dollars. Ever.

(The actual derivation of an embryonic stem cell line also cannot be funded with federal dollars, regardless of the source of the embryo, but that is due to an act of Congress and has nothing to do with these NIH guidelines.)

So, it appears that the NIH, under Obama, will retain the same basic framework with respect to hESCs used within the Bush Administration, but will expand the number of lines eligible for funding substantially. It's unfortunate, though, that the Administration has chosen to restrict federally-funded research in such a way, as the ability to generate specific hESC lines will be very important--likely essential--for therapeutic cloning to be possible and even just for scientists to be able to use hESCs for the study of a wide variety of diseases.

Despite all of that, this is still a significant step forward.

Note: these are "draft" guidelines, and there will be a 30-day period during which public comments will be accepted before the guidelines are finalized:

COMMENTS: The NIH welcomes public comment on the draft Guidelines. Comments must be submitted within 30 days of publication of the Guidelines in the Federal Register. The Guidelines are expected to be published in the Federal Register by April 24th. Comments may be mailed to: NIH Stem Cell Guidelines, MSC 7997, 9000 Rockville Pike, Bethesda, Maryland, 20892-7997. At the time of publication in the Federal Register, the NIH will make available a URL where comments may be submitted electronically. In submitting comments, please note that comments will be made publicly available, including any personally identifiable or confidential business information they contain.

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While I have no idea if the Obama Administration is interested in lifting the ban on funding for research on research-derived hESCs, the ban is one of federal law (the Dickey-Wicker Amendment). In other words, it couldn't be nullified by executive order, but would require an act of Congress.

By David Bruggeman (not verified) on 22 Apr 2009 #permalink

Actually, as far as I know, the Dickey-Wicker Amendment only covers the actual derivation of hESCs, but it does not effect the funding of research on a hESC line once it has been created.