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Key protections for human research subjects often overlooked

NEWS IN BRIEF — Posted June 11, 2012

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Institutional review boards frequently fail to follow federal regulations meant to protect human research subjects, said a study published online in Academic Medicine.

Researchers sat in on 20 IRB research-protocol meetings at 10 leading academic medical centers and reviewed audio recordings of the discussions. Nearly 60% of the time, the review boards failed to cover the risk-benefit comparison for patients. About half the time, the IRBs did not discuss how data from the trial would be monitored. Meanwhile, 21% of meetings failed to address how risks to human research subjects would be minimized, said the study, published May 22 (link).

The IRBs did place a great emphasis on informed consent, the study found. The boards reviewed, raised questions about or requested changes to informed consent for the protocols 98% of the time.

Note: This item originally appeared at http://www.ama-assn.org/amednews/2012/06/11/prbf0611.htm.

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