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Behind Closed Doors

IRBs and the Making of Ethical Research

Behind Closed Doors

IRBs and the Making of Ethical Research

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.


240 pages | 13 halftones, 1 line drawing, 1 table | 6 x 9 | © 2011

Morality and Society Series

History: General History

Law and Legal Studies: Law and Society

Reviews

“[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

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 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

Table of Contents

Introduction: Behind Closed Doors

Part  1. IRBs in Action

Chapter 1. Everyone’s an Expert? Warrants for Expertise
Chapter 2. Local Precedents
Chapter 3. Documents and Deliberations: An Anticipatory Perspective

Part 2. Setting IRBs in Motion in Cold War America

Chapter 4. An Ethics of Place
Chapter 5. The Many Forms of Consent
Chapter 6. Deflecting Responsibility
Conclusion: The Making of Ethical Research

Acknowledgments
Appendix: Ethnographic Methods
Abbreviations
Notes
Bibliography
Index

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