The participation of community members on medical institutional review boards.

The goal of this study was to describe the contributions of community members (unaffiliated members) who serve on institutional review boards (IRBs) at large medical research centers and to compare their contributions to those of other IRB members. We observed and audiotaped 17 panel meetings attended by community members and interviewed 15 community members, as well as 152 other members and staff. The authors coded transcripts of the panel meetings and reviewed the interviews of the community members. Community members played a lesser role as designated reviewers than other members. They were infrequently primary reviewers and expressed hesitation about the role. As secondary or tertiary reviewers, they were less active participants than other members in those roles. Community members were more likely to focus on issues related to confidentiality when reviewing an application than other reviewers. When they were not designated reviewers, however, they played a markedly greater role and their discussion focused more on consent disclosures than other reviewers. They did not appear to represent the community so much as to provide a nonscientific view of the protocol and the consent form.