ABOUT THIS BOOK
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.
REVIEWS
“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
“Behind Closed Doors makes an important contribution to our understanding of IRBs and the ethical regulation of research.”
— Charles W. Lidz, Science
“[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
“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
"Recommended."
— M. M. Gillis, Florida International University, Choice
“[S]ignificant and fascinating.”
— Journal of American History
“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
TABLE OF CONTENTS
Introduction - Laura Stark
DOI: 10.7208/chicago/9780226770888.003.0001
[institutional review boards, human subjects, United States, review procedures, ethics principles, IRB meetings, moral authority]
This introductory chapter discusses the theme of this volume which is about the role of institutional review boards (IRBs) in designing the U.S. government rules for the treatment of human subjects in research after World War II and the present-day consequences of their choice to adopt review procedures rather than ethics principles. This volume is divided into two main sections. The first section offers an analysis of actual IRB meetings and the second explains how the moral authority to decide how to treat research participants was relocated from professions to the state and reinvested in procedures rather than ethics principles. (pages 1 - 8)
This chapter is available at:
https://academic.oup.com/chica...
Part I: IRBS in Action
Everyone’s an Expert? Warrants for Expertise - Laura Stark
DOI: 10.7208/chicago/9780226770888.003.0002
[warrants for expertise, IRB meetings, group decision making, warranting process]
This chapter examines the issue of warrants for expertise based on analysis of actual meeting of an institutional review board (IRB). It suggests that IRB decisions were in part the product of a warranting process, through which members decided who had the most persuasive claim to knowledge on the matter at hand. It also highlights the importance of attention to warrants in providing a fuller explanation of group decision making. (pages 21 - 40)
This chapter is available at:
https://academic.oup.com/chica...
Local Precedents - Laura Stark
DOI: 10.7208/chicago/9780226770888.003.0003
[institutional review boards, local precedents, decision making process, warrants, experts, analogical reasoning, Anglo-American law, medicine]
This chapter examines the importance of local precedents in the decision making process of institutional review boards (IRBs) based on a survey of the chairman of IRBs in major research universities in the United States. It explains that IRB members identify new problems somewhat idiosyncratically and they develop remedies for these problems by drawing on warrants of experts. It suggests that the way the IRB works resonates with what it called analogical reasoning which was developed in Anglo-American law and medicine during the late nineteenth century. (pages 41 - 56)
This chapter is available at:
https://academic.oup.com/chica...
Documents and Deliberations: An Anticipatory Perspective - Laura Stark
DOI: 10.7208/chicago/9780226770888.003.0004
[IRB meeting, decision making process, documentation, unitary social actors, consensus-building]
This chapter focuses on the documentation of the decision making process of institutional review boards (IRBs). It examines the ethics review of two studies and looks at decisions both as they took place over time and as these events were formally documented afterward. It suggests that these meetings portrayed the IRBs as unitary social actors who evaluated studies, and highlights the individual board members' successful attempts at consensus-building during board deliberations. (pages 57 - 74)
This chapter is available at:
https://academic.oup.com/chica...
Part II: Setting IRBS in Motion in Cold War America
An Ethics of Place - Laura Stark
DOI: 10.7208/chicago/9780226770888.003.0005
[institutional review boards, NIH Clinical Center, group consideration, human subjects, professional discretion, United States, incoherence]
This chapter examines the history of institutional view boards (IRBs) in the context of the National Institutes of Health (NIH) Clinical Center in the U.S. It explains that when the center opened in July 1953 its medical board wrote the group consideration guidelines, which created a procedure in which a committee uninvolved in the research would judge whether an investigator had planned to protect his human subjects. It explains that advantages of group consideration in terms of accommodating the tremendous incoherence of the institutes and retaining the professional discretion researchers had traditionally enjoyed. (pages 81 - 112)
This chapter is available at:
https://academic.oup.com/chica...
The Many Forms of Consent - Laura Stark
DOI: 10.7208/chicago/9780226770888.003.0006
[forms of consents, United States, proof of consent, NIH researchers, FDA Drug Act, patient-generation documentation, group review]
This chapter examines the history of the forms of consents in the United States. It discusses the rules for proof of consent during the 1950s and 1960s and the opposition of National Institutes of Health (NIH) researchers to patient-generation documentation, even after the passage of the 1962 FDA Drug Act which placed the NIH under the regulatory purview of the Food and Drug Administration (FDA). It also describes the NIH designed group review to allow researchers to avoid consent documents. (pages 113 - 136)
This chapter is available at:
https://academic.oup.com/chica...
Deflecting Responsibility - Laura Stark
DOI: 10.7208/chicago/9780226770888.003.0007
[National Institutes of Health, human-subjects protections, lawsuits, research sites, expert groups, research institutions, United States]
This chapter examines the work of the U.S. National Institutes of Health (NIH) in relation to human-subjects protections. It suggests that the leadership of the NIH on this front can be understood as an effort to deflect lawsuits away from Bethesda and toward other research sites. It also discusses the role of the NIH in creating the so-called expert groups and in the leading spread of human-subjects review committees to research institutions across the U.S. and abroad. (pages 137 - 158)
This chapter is available at:
https://academic.oup.com/chica...
The Making of Ethical Research - Laura Stark
DOI: 10.7208/chicago/9780226770888.003.0008
[institutional review boards, human subjects, United States, National Institutes of Health, decision making process, warrants]
This chapter sums up the key findings of this study on the role of institutional review boards (IRBs) in designing the U.S. government rules for the treatment of human subjects in research after World War II. It highlights the influence of the National Institutes of Health's (NIH) postwar strategy on the way clinical and social science is regulated today. It also suggests that the decision making process of the IRBs can be considered systematic because they offer warrants, apply precedents, scrutinize documents, and produce records of their own. (pages 159 - 166)
This chapter is available at:
https://academic.oup.com/chica...
Acknowledgments
Appendix: Ethnographic Methods
Abbreviations
Notes
Bibliography
Index
