University of Chicago Press Behind Closed Doors – IRBs and the Making of Ethical Research (Morality and Society Series)

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. Review ""Behind Closed Doors "is a novel and important addition to the literature on the governance of experimentation on human subjects. It will appeal to academic scholars in the history of science and medicine, sociology, bioethics, and post-war American history."--Gerald Kutcher, author of "Contested Medicine: Cancer Research and the Military"""Behind Closed Doors "is a novel and important addition to the literature on the governance of experimentation on human subjects. It will appeal to academic scholars in the history of science and medicine, sociology, bioethics, and postwar American history."--Gerald Kutcher, author of "Contested Medicine: Cancer Research and the Military" "Laura Stark, as her book title promises, takes us behind closed doors to better understand how IRBs do their work. Comfortable both in meeting rooms and archives, she skillfully analyzes the many barriers to the ethical and legal conduct of human experimentation. Everyone seeking to improve the system will be grateful for her insights."--David J. Rothman, Columbia University""Behind Closed Doors" is a novel and important addition to the literature on the governance of experimentation on human subjects. It will appeal to academic scholars in the history of science and medicine, sociology, bioethics, and postwar American history."--Gerald Kutcher, author of Contested Medicine: Cancer Research and the Military""Behind Closed Doors" looks closely and candidly at the apparatus of institutional review boards and their role in creating norms and conventions of acceptable human experimentation. The writing is lucid, the analysis sharp, and the observations keen. This will be a book to be reckoned with in the decades to come."--Susan E. Lederer, University of Wisconsin-Madison""Behind Closed Doors" makes an important contribution to our understanding of IRBs and the ethical regulation of research."--Charles W. Lidz "Science """Behind Closed Doors" is a novel and important addition to the literature on the governance of experimentation on human subjects. It will appeal to academic scholars in the history of science and medicine, sociology, bioethics, and postwar American history."--Gerald Kutcher, author of Contested Medicine: Cancer Research and the Military"[T]his is one of the most important books concerned with the governance of research ethics, particularly in the social sciences, to have appeared in recent times