Tuesday, April 21, 2009

Deregulation "Is Not Going to Happen"

Linda Shopes kindly alerts me to the April 20 issue of COSSA Washington Update, the newsletter of the Consortium of Social Science Organizations, which reports on an April 1 meeting of the National Academies’ Board on Behavioral, Cognitive, and Sensory Sciences, at which IRBs were discussed.

Here's the key passage:

Philip Rubin, CEO of Haskins Laboratories in New Haven, CT, and former director of the National Science Foundation’s (NSF) Division of Behavioral and Cognitive Sciences, chairs the Board. He began the session with a review highlighting the difficulties social/behavioral researchers have had with the current system under the Common Rule regulation and its interpretation by campus Institutional Review Boards (IRBs). Complaints have been loud, but mostly anecdotal . . . Once again the bottom line is that despite efforts by Joan Sieber and the Journal of Empirical Research on Human Ethics, which she edits, there are still large gaps in our empirical knowledge of how the system works for social and behavioral scientists.

Rubin was followed by Jerry Menikoff, new head of the U.S. government’s Office of Human Research Protections (OHRP). Menikoff announced that he was all for “flexibility” in the system and that “changes can be made.” He also endorsed conducting more research. He rejected the arguments of the American Association of University Professors and Philip Hamburger of Northwestern University Law School that IRBs violate researchers’ first amendment rights. He acknowledged the importance of expedited review, but stated quite clearly that “removing minimal risk research from the system is not going to happen.”

I don't want to make too much of these comments; an OHRP spokesperson tells me that they were an extemporaneous response to Rubin, and not prepared remarks. Still, I am disappointed. Menikoff's comments suggest a retreat from his earlier concession that "flexibility" often can be code for arbitrary power. And it's a pity for a public official to insist that a given policy "is not going to happen" even as he endorses more research. Wise governance depends on making policies after finding facts, not before.

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