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Acad Med. 2012 Jul;87(7):975-81. doi: 10.1097/ACM.0b013e3182578b54.

Institutional review board community members: who are they, what do they do, and whom do they represent?

Author information

  • 1Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York, NY 10032, USA. rlk2@columbia.edu

Abstract

PURPOSE:

The roles of nonaffiliated and nonscientific institutional review board (IRB) members at academic medical centers have received some attention, but questions remain-Who are they, what do they do, and whom, if anyone, do they represent?

METHOD:

The author interviewed 46 IRB chairs, directors, administrators, and members in 2007-2009. He contacted the leadership of 60 IRBs (every fourth one in the list of the top 240 institutions by National Institutes of Health funding), interviewed IRB leaders from 34 of these institutions, then recruited 7 additional members from these IRBs to interview.

RESULTS:

Regular IRB members often called these individuals community members and were confused as to who these members were, or should be, and whether they did, or should, represent anyone and, if so, whom. IRBs encountered challenges in finding, training, and retaining these community members. Tensions emerged because nonscientific members, by definition, have no scientific training, so they have difficulty understanding key aspects of protocols, making them feel unempowered to contribute to reviews. IRBs varied in how much they encouraged these members to participate, in what ways, and with what success.

CONCLUSIONS:

At academic medical centers, IRBs struggled with how to view, choose, employ, and retain nonaffiliated and nonscientific members, and they varied widely in these regards. Some IRBs had these members review entire protocols, others only limited parts (particularly reading consent forms for comprehension), pro forma. Yet, at times, these members' input proved very important. These findings have critical implications for policy, practice, and research.

PMID:
22622206
[PubMed - indexed for MEDLINE]
PMCID:
PMC3549463
Free PMC Article
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