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December 15, 2010

Institutional Review Boards and Protecting Human Research Participants

JAMA. 2010;304(23):2591-2592. doi:10.1001/jama.2010.1822

To the Editor: In her Commentary, Dr Grady1 argued that there is a need to develop objective metrics that can determine how effective institutional review boards (IRBs) are at protecting human participants from research risks. Framed within this suggestion are complaints about IRB focus on regulations, interest in protecting institutions rather than research participants, inconsistency in judgments, and lack of evidence that IRB oversight has any measureable benefit. The critique of IRBs by Bledsoe et al,2 which was cited as evidence that they stifle research without protecting participants, is based on a single-site report of the results of an e-mail survey mailed to 3 social science departments with a total of 27 respondents. The evidence that IRBs have “disrupted student careers [and] set back tenure clocks” should also meet a reasonable standard of evidence.