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Stanford bioethicist speaks out about layers of stem cell regulations

Say you're a human embryonic stem cell researcher (odds are, that at least some of the readers of this blog fit this description). If so, you're familiar with the alphabet soup of regulations that govern this type of research in California and elsewhere. In particular, depending on the specifics of your proposed experiments, you may need to seek approval from your Institutional Review Board (the IRB), your Institutional Animal Care and Use Committee (the IACUC) and an Embryonic Stem Cell Research Oversight Committee, or ESCRO. That could change, however.

Stanford bioethicist Hank Greely, JD, spoke out yesterday in an article in Nature exploring whether all these layers of approval are really still necessary. (Greely published a commentary on the topic in the January issue of the American Journal of Bioethics.) As the article explains, ESCROs were implemented when embryonic stem cell research was still in its infancy:

To encourage responsible practices, the US National Academies issued a report in 2005 calling for the establishment of stand-alone institutional oversight committees, and within two years, at least 25 so-called 'embryonic stem cell research oversight committees', or ESCROs, cropped up across the country. Most of these were created voluntarily, except in the few states—California and Connecticut, as well as New York if the research is performed with state funding—that made the practice mandatory. Now, however, with hESC research widely practiced and accepted, some experts are questioning whether stand-alone ESCROs are still needed.

“As that early period of figuring out ways to implement good ethical guidelines has shifted into the more normal science of applying those concerns, the need for ESCROs has gotten smaller,” says Henry Greely, a bioethicist at the Stanford Law School and chair of California's Human Stem Cell Research Advisory Committee. “It's not rocket science any more. A lot of [hESC research] is pretty routine, and it doesn't necessarily need a unique institution to deal with it.”

Greely's no newcomer to the ethical and legal issues surrounding embryonic stem cell research. He's been a frequent commenter here on the topic. Not all experts agree with Greely in the case of the ESCROs, but it's an interesting discussion. As he argues:

Ultimately, the decision to maintain ESCROs or not all comes down to a cost-benefit ratio, says Greely. Streamlining committee structures won't bring “enormous benefits,” he admits, “but I don't think they're trivial benefits, and what are the benefits of continuing to have ESCROs after this breaking in and bureaucratization process has worked itself out? They're not very big.”

“It's not saying these guys have been failures and we should get rid of them,” he adds. “It's almost saying, 'These guys have been so successful that they worked themselves out of a job'—and that's not a bad thing.”

Previously: Supreme Court decision on human embryonic stem cell case ends research uncertainty, and Stanford law professor on embryonic stem cell ruling
Photo by Max Braun

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