Thursday, July 5, 2012

Article of Note: How Closely Do Institutional Review Boards Follow the Common Rule?

In a recent article appearing in Academic Medicine, Lidz and Applebaum, et al., describe how closely institutional review board discussions reflect the criteria for approval of research specified in the federal regulations to protect human research subjects (45 CFR 46). The authors observed, audio-recorded, transcribed, and coded protocol reviews from 20 IRB meetings at 10 leading academic medical centers.

The study found that the IRBs frequently failed to discuss many of the regulatory criteria for approval of research. For example, in more than 21 percent of the protocols reviewed, the IRB did not consider whether the risks associated with the proposed research were minimized using sound research designs and the relationship between risks and potential benefits in 57 percent of the protocols, equity of subject selection was not considered in 60 percent, data monitoring was not considered in 54 percent, provisions to protect privacy interests and maintain confidentiality of data in 25 percent and protection of vulnerable populations in 13 percent of the protocols reviewed.

By contrast, the IRBs rarely neglected to pay attention to consent documents and processes.

The authors conclude that a mechanism for ensuring that consideration is given to each of the seven key regulatory criteria of approval of research might help improve the reliability of IRB determinations and ensure that IRBs use all the criteria in their review of proposed research.

This Article of Note may be found at Acad Med. 2012; 87:1-5.

Published online doi:10.1097/ACM.0b013e3!82575e2e

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