Behind Closed Doors: IRBs and the Making of Ethical Research (Morality and Society Series) - Softcover

Stark, Laura

Softcover

ISBN 10: 0226770877 ISBN 13: 9780226770871

Publisher: University of Chicago Press, 2012

Synopsis

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.

About this title

About the Author:

Laura Stark is assistant professor in the Center for Medicine, Health, and Society and affiliated professor of history at Vanderbilt University.

Review:

“[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. It deserves to be widely read by social scientists, applied ethicists who seek to comment on research ethics in the social and natural sciences and, perhaps most importantly, the academic and non-academic bureaucrats who are involved with the ethical governance of academic research.”

(Nathan Emmerich Times Higher Education)

“Behind Closed Doors makes an important contribution to our understanding of IRBs and the ethical regulation of research.” (Charles W. Lidz Science)

“Stark’s book combines lively and entertaining writing about the historical development of IRBs with careful research on their current operation. All in all, her account provides a good resource for both lay and expert readers.”

(Health Affairs)

“Behind Closed Doors: IRBs and the Making of Ethical Research is actually two books in one. The first is a revelatory look at how instructional review boards (IRBs) actually operate in practice, based on the author’s experience watching three IRBs in action. The second is a startling analysis of the origin of the first ethics review board, the National Institutes of Health (NIH) Clinical Research Committee, and the spread of IRBs, starting in 1966, to other research institutions.” (Norman M. Goldfarb Journal of Clinical Research Best Practices)

“[L]ucid and engaging. . . . [A] wonderfully stimulating book that should be widely read and included on the syllabi of many graduate seminars to come.” (Carla Nappi New Books in Science, Technology, and Society)

“[S]ignificant and fascinating.” (Journal of American History)

"Recommended."
(M. M. Gillis, Florida International University Choice)

“Stark provides a fascinating account of how ethics for human subject research has become organized in the United States; its short chapters and careful arguments make Behind Closed Doors a very teachable book. . . . [T]his is a real contribution to our understanding of IRBs and why change is now necessary. Even those who know this history will have much to learn here.” (Susan M. Reverby Isis)

“I make notes in the margins of books I'm reviewing, and in the series I created when reading Laura Stark’s study of Institutional Review Boards (IRBs), a pattern quickly emerged: ‘nice!’ began alternating with ‘nice.’. . . Her unusual combination of first-hand ethnography and original historical research is one of the ‘Nice!’ features of the study. . . . [T]his is a creatively designed, sensitively analyzed, reliably documented, and elegantly terse study.” (Jack Katz Symbolic Interaction)

“Stark’s exploration of the history and workings of IRBs should appeal to anyone with an interest in research ethics.” (Medical Writing)

About this edition

• Publisher: University of Chicago Press
• Publication date: 2012
• ISBN 10: 0226770877
• ISBN 13: 9780226770871
• Binding: Paperback
• Number of pages: 229