The Niche

hES Cell guidelines need input, not hysteria

NOTE: The original posting of this blog contained an error about the 1999 NIH draft guidelines. That has been corrected.

All of you reading the hysteria about the decline of U.S. federal funding for human embryonic stem cells, please take a deep breath. Okay?

The NIH is seeking comment on draft guidelines, not seeking to stop embryonic stem cell research on all old lines. It’s even unclear whether the draft guidelines would prohibit research on all the old Presidential lines, as the headlines state.

I’ve been reading the most recent media coverage (Here’s Wired and the Scientist ) in the wake of the commentary by Patrick Taylor in Cell Stem Cell, and I’ve yet to find a researcher who says explicitly that she or he thinks the majority of already extant cell lines will actually be excluded in the final guidelines because researchers didn’t have up-to snuff consent forms. Instead, my guess is, the NIH and stem cell community will have to either 1) laboriously work out whether the consent process used well in the past is sufficiently consistent with that in place now or 2) grandfather in the lines which the NIH had determined in 2001 to have been obtained with proper informed consent. (An analysis published last year found that not all of these lines met such standards and sent institutional review boards into disarray. Read more about that .)

My guess is that people want the NIH to say explicitly which lines can be used so that individual institutions don’t have to hash this through individually, a situation that will cause many people to do redundant work and could result in chaos. In fact, such explictness is one of the requests made explicitly in the template letter provided by the ISSCR.

The broader issues, of course, are whether the NIH will allow funding for lines derived from unfertilized eggs or from embryos created by nuclear transfer, or cloning. The first time the NIH drew up draft guidelines was for President Bill Clinton. Those guidelines did not allow research on embryos, but did allow research on embryonic stem cells created from embryos originally created for purposes of reproduction. (There were some other restrictions as well; see the 1999 draft guidelines). Then there was public comment, then the NIH changed the guidelines to restrict funding to lines from embryos created for reproductive purposes. The upshot of all this, tell the NIH what you think about human embryonic stem cell research by May 26, when the time for public comments close. (You can do that here . I wrote up a summary of the guidelines here.)

Taylor’s commentary is not about whether a specific line should or shouldn’t be used but about the approach that should be taken to informed consent. Put simply, he says, standards evolve constantly, so materials collected in the past should be evaluated according to the standards of that time. He then sets out a thought experiment to show what could happen if standards are applied retrospectively.

Another relevant thought experiment might be what could happen if the scientific community does not weigh in on setting the guidelines that it will need to live by. Hopefully that is not an experiment that will play out in real life. The comment form is here .


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