Behind closed doors: IRBs and the making of ethical research

Abstract

Although the subject of federally mandated Institutional Review Boards (IRBs) has been extensively debated, we actually do not know much about what takes place when they convene. The story of how IRBs work today is a story about their past as well as their present, and Behind Closed Doors is the first book to meld firsthand observations of IRB meetings with the history of how rules for the treatment of human subjects were formalized in the United States in the decades after World War II. Drawing on extensive archival sources, Laura Stark reconstructs the daily lives of scientists, lawyers, administrators, and research subjects working - and warring - on the campus of the National Institutes of Health, where they first wrote the rules for the treatment of human subjects. Stark argues that the model of group deliberation that gradually crystallized during this period reflected contemporary legal and medical conceptions of what it meant to be human, what political rights human subjects deserved, and which stakeholders were best suited to decide. She then explains how the historical contingencies that shaped rules for the treatment of human subjects in the postwar era guide decision making today - within hospitals, universities, health departments, and other institutions in the United States and across the globe. Meticulously researched and gracefully argued, Behind Closed Doors will be essential reading for sociologists and historians of science and medicine, as well as policy makers and IRB administrators.