Are NIH’S Stem Cell Rules a 'Tectonic Shift'? And a Plea to Speak Out on Science Policy

The 26 May deadline for commenting on the National Institutes of Health's draft guidelines for human embryonic stem cell research is fast approaching, and scientists are fretting that NIH's rules for informed consent will disqualify many existing cell lines. Patrick Taylor, deputy general counsel at Children's Hospital Boston, in a commentary published online today in Cell Stem Cell, argues in general that new rules should not be applied retroactively to science, because it is always evolving.

Here’s part of Taylor's take on the proposed stem cell guidelines:

Prospectively applied, the proposed NIH rules as they stand would present a challenge to the field. But retroactively applied, the draft regulations would create a tectonic shift: previously, only certain old lines were fundable, and now—conceivably—only certain new lines will be, and there will continue to be no federal funding available for research using cells created ethically since 2001. Important research will need to be repeated, and assays and data rebuilt. As currently outlined, it’s as if the last 8 years of cell line creation and ethical self-regulation have just vanished, to be replaced by a new funding structure that does not give weight to the existing science, ethics, self-regulation, donor intentions, or diverse cell lines.

Like other proposed federal rules, the draft guidelines appeared in the Federal Register—a daily compendium of notices from federal agencies. Its most devoted readers tend to be Washington, D.C., policy-wonk types who follow it for their respective interest groups or agencies. Scientific societies usually comment on proposals that affect their membership. 

But individual scientists aren’t participating enough, according to an article, also appearing today, in the journal Cell (subscription required). Science writer Amy Maxmen lists recent Federal Register requests for comment involving transgenic organisms, gene patents, and stem cells. It's easy to stay informed, she says: "Scientists can choose to be alerted by e-mail as rules … appear on the Federal Register by signing up at http://www.regulations.gov."

So add that to your list of things to do this week. But it’s this science writer's observation that any federal proposal as important as NIH's stem cell policy will draw plenty of comments. Like most of us, scientists tend to wait until the deadline, however.