front cover of Behind Closed Doors
Behind Closed Doors
IRBs and the Making of Ethical Research
Laura Stark
University of Chicago Press, 2011
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.
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front cover of The Normals
The Normals
A People’s History of Modern America in Five Human Experiments
Laura Stark
University of Chicago Press, 2027

How healthy control subjects in clinical research transformed the practice and labor of science, as told by the Normals themselves.

In the 1950s, the National Institutes of Health were in search of a large, replenishing stream of healthy people to participate in clinical studies. To establish legal sources of test subjects, the NIH signed unprecedented contracts with American colleges, church organizations, and other government agencies, and in the process gave rise to a new type of test subject: the “normal patient.” Thousands of them eventually moved into the NIH Clinical Center to live in hospital rooms, eat food prepared in a metabolic kitchen, and follow—or flout—the rules.

The Normals is a groundbreaking account of the NIH Normal Volunteer Patient Program, which has lasted into the twenty-first century. This program harnessed outside organizations in all areas of postwar American life—colleges and universities, labor unions, civic groups, federal prisons, and churches—to recruit research subjects for human experiments. Drawing on thousands of pages of unearthed government documents, oral histories, and personal materials shared by the patients themselves (collected in a new archive), Laura Stark follows five experiments and the people involved, delving into their biographies, their time at the Clinical Center, and the thorny problem of determining who counts as “normal.” The “Normals” were not passive objects of study, Stark shows, but active research participants who collaborated with scientists, maintained the laboratories where they served, informed official ethics policies, and bargained to meet their needs.

By taking seriously the pillow fights and the first kisses, the bible clubs and the movie nights that animated the Clinical Center as much as the medical experiments, The Normals brings to life a surprising true story of the origins of our present-day system of human experiment, one that at once explores what it means to work, to serve, to volunteer.

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