Thursday, January 1, 2009

Happy New Year, OHRP

In February 2007, the New York Times reported on scholars' frustration with IRB review of social research. OHRP assured reporter Patricia Cohen that it was working on the problem:

Bernard A. Schwetz, director of the federal Office for Human Research Protections, which administers the regulations, acknowledges that the guidelines covering the boards’ actions have not been clear enough and says he intends to make public new proposed guidelines before the end of the year.

Later in the article, Schwetz "said the new guidelines 'will give a lot of examples and will give more guidance on how to make the decision on what is research and what is not.'" This makes it clear that the 2007 call for comments on expedited review is not what he had in mind.

With the end of 2008, the promised guidelines are more than a year late.

This may be for the best. Schwetz seemed determined to continue OHRP's history of trying to regulate everything, while under Menikoff, we might expect better results. But OHRP and its predecessors have made a lot of empty promises over the years, and it's frustrating to see that tradition continued.

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