Regulating Human Research : IRBs from Peer Review to Compliance Bureaucracy.

By: Babb, SarahMaterial type: TextTextSeries: eBooks on DemandPublisher: Redwood City : Stanford University Press, 2020Copyright date: ©2020Description: 1 online resource (185 pages)Content type: text Media type: computer Carrier type: online resourceISBN: 9781503611238Subject(s): Institutional review boards (Medicine)-United States | Human experimentation in medicine-Law and legislation-United States | Medical ethics committees-United States | Bureaucracy-United StatesGenre/Form: Electronic books.Additional physical formats: Print version:: Regulating Human Research : IRBs from Peer Review to Compliance BureaucracyDDC classification: 174.28 LOC classification: R852.5 .B333 2020Online resources: Click here to view this ebook.
Contents:
Cover -- Contents -- Acknowledgments -- Introduction -- 1 The Federal Crackdown and the Twilight of Approximate Compliance -- 2 Leaving It to the Professionals -- 3 Organizing for Efficiency -- 4 Ethics Review, Inc. -- 5 The Common Rule and Social Research -- 6 Varieties of Compliance -- Conclusion -- Appendix: Research Informants -- Notes -- Bibliography -- Index -- A -- B -- C -- D -- E -- F -- G -- H -- I -- J -- K -- L -- M -- N -- O -- P -- Q -- R -- S -- T -- U -- V -- W.
Summary: This book traces the historic transformation of institutional review boards (IRBs) from academic committees to compliance bureaucracies. Sarah Babb opens the black box of contemporary IRB decision-making, which is increasingly outsourced to specialized private firms.
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Cover -- Contents -- Acknowledgments -- Introduction -- 1 The Federal Crackdown and the Twilight of Approximate Compliance -- 2 Leaving It to the Professionals -- 3 Organizing for Efficiency -- 4 Ethics Review, Inc. -- 5 The Common Rule and Social Research -- 6 Varieties of Compliance -- Conclusion -- Appendix: Research Informants -- Notes -- Bibliography -- Index -- A -- B -- C -- D -- E -- F -- G -- H -- I -- J -- K -- L -- M -- N -- O -- P -- Q -- R -- S -- T -- U -- V -- W.

This book traces the historic transformation of institutional review boards (IRBs) from academic committees to compliance bureaucracies. Sarah Babb opens the black box of contemporary IRB decision-making, which is increasingly outsourced to specialized private firms.

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Reviews provided by Syndetics

CHOICE Review

As an institutional review board (IRB) professional, this reviewer was skeptical that anyone from the "outside" could capture the essence of IRB work. Babb (Boston College) overturns those fears with this outstanding volume. Having interviewed 50 individuals from the IRB world, she expertly describes IRB work from the early days of "approximate compliance," run largely by boards of volunteer academic faculty, to what has become a full-on compliance bureaucracy. She has captured the why and the how models of IRB review's evolution into an industry where the master's-trained IRB professional has become essential to helping organizations conform to complex and ambiguous regulatory rules. The author discusses both the upside and the downside of the professionalization and commercialization of the IRB complex and how the social sciences have been rolled into what had largely been a process with a biomedical focus. Comparing three different models of compliance bureaucracies, Babb's discussion of the differences between the ways equal employment opportunity, IRBs, and financial services approach compliance is compelling, particularly her consideration for the reliance of IRBs and financial services on efficiency goals. Thoughtful and readable. Summing Up: Highly recommended. All readership levels. --Kathleen E. Murphy, Northwestern University

Author notes provided by Syndetics

Sarah Babb is Professor of Sociology at Boston College, and author of many published works exploring the connections among organizations, professions, and the state. She served on the Boston College IRB for three years.

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