This Mentored Scientist Development Award in Research Ethics will support detailed, comparative ethnographic research of Institutional Review Boards. The research has two aims: 1) to promote the development of the applicant as a scholar in the ethics of research on human subjects, and 2) to address an important problem in the field of research ethics: the behavior and effectiveness of Institutional Review Boards (IRBs). Institutional Review Boards were created to protect humans from exploitation as research subjects. Although there is near universal agreement that IRBs have been an important tool for the protection of human subjects. Although there is near universal agreement that IRBs have been an important tool for the protection of human subjects, continuing reports about research abuses have created concern about failures in the review process. Improvement of the IRB review process requires empirical knowledge of the variables that shape the conduct of IRBs, that affect the content and style of their deliberations, and that determine levels of compliance with their recommendations. The formal rules and regulations that govern IRBs are well publicized, but the internal processes of decision making remain a mystery. There has been a plethora of research surveying members of IRBs and recording and analyzing the number of proposals considered, numbered approved., or recommendations made. But a thorough understanding of the operation and effect of Institutional Review Boards requires careful consideration of the day-to-day work of these groups. This research uses ethnographic and historical research methods to examine the inner workings of IRBs, the negotiations and patterns of interaction that characterize their meetings, the factors that explain their role, and effectiveness of IRBs in the larger institution. In-depth qualitative analysis of three IRBs will be done allowing important variables that explain the behavior of review boards to be isolated. This study, with its use of ethnographic and historical research methods and its careful consideration of several sources of data, will allow description of the social influences on IRBs and the decisions generated there. These findings will improve our understanding of the ethics review process and will allow us to better realize the goal of protecting human subjects.
