The Roles and Experiences of Nonaffiliated and Non-scientist Members of Institutional Review Boards

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PurposeLittle is known about the roles and experiences of non-scientist and nonaffiliated institutional review board (IRB) members (also known as lay members), and what contributions they are making to IRBs. This study investigated the experiences of IRB lay members from leading academic medical institutions in the United States and presents their recommendations for future education and training.MethodIn 2000, the authors randomly selected and contacted 20 IRBs. From the 11 IRBs that agreed to participate, a total of 32 lay members participated in telephone interviews in which they were asked open-ended questions about the types of initial and ongoing education they had received, their interactions with scientific members, their contributions, the problems they experienced on the IRB, and recommendations for future education and training.ResultsParticipants believed their role was to represent the community of human subjects, and 94% reported that their main contribution was simplifying the consent forms. Although 94% of participants had positive experiences working with scientist IRB members, 88% occasionally had been intimidated and felt disrespected by them. Forty-seven percent of participants identified lack of education and training as a problem, and 78% wanted more intensive education and training for future non-scientist/nonaffiliated members.ConclusionIRB reform should include better training for non-scientist and nonaffiliated members so that they can take on more active roles. In addition, measures are needed to strengthen the relationships between scientist and non-scientist and nonaffiliated members.

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