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Proposed federal IRB rule changes open for public comment

July 26, 2011

Yesterday when I posted about IRB regulation and free speech, I had no idea that the NY Times was running a story about new IRB rule changes possibly in the works. (I’m too cheap to pony up for the Times, and too guilt-prone to circumvent the paywall.)

It sounds like someone’s been listening to behavioral scientists. From the proposed changes in the Federal Register (found via a commenter on scatterplot):

Questions have been raised about the appropriateness of the review process for social and behavioral research.\15\ \16\ \17\ \18\ The nature of the possible risks to subjects is often significantly different in many social and behavioral research studies as compared to biomedical research, and critics contend that the difference is not adequately reflected in the current rules. While physical risks generally are the greatest concern in biomedical research, social and behavioral studies rarely pose physical risk but may pose psychological or informational risks. Some have argued that, particularly given the paucity of information suggesting significant risks to subjects in certain types of survey and interview-based research, the current system over-regulates such research.\19\ \20\ \21\ Further, many critics see little evidence that most IRB review of social and behavioral research effectively does much to protect research subjects from psychological or informational risks.\22\ Over-regulating social and behavioral research in general may serve to distract attention from attempts to identify those social and behavioral research studies that do pose threats to the welfare of subjects and thus do merit significant oversight.

There are lots of other proposed changes, including streamlining review of multi-site studies and updates to data security regulations. It’s quite a long document — I’m just starting to wade through the proposed rule changes myself. The proposed changes are open for public comment through September 26. Read them over and then submit your comments.

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