Regulating Human Research: IRBs from Peer Review to Compliance Bureaucracy

Institutional review boards (IRBs) are panels charged with protecting the rights of humans who participate in research studies ranging from biomedicine to social science. Regulating Human Research provides a fresh look at these influential and sometimes controversial boards, tracing their historic transformation from academic committees to compliance bureaucracies: non-governmental offices where specialized staff define and apply federal regulations. In opening the black box of contemporary IRB decision-making, author Sarah Babb argues that compliance bureaucracy is an adaptive response to the dynamics and dysfunctions of American governance. Yet this solution has had unforeseen consequences, including the rise of a profitable ethics review industry.

Table of Contents:
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

About the Author :
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.

Review :
"Beautifully done. Sarah Babb adroitly explains IRBs as but one expression of a general feature of distributed governance in the United States. Like it or not, this is what happens to ethics in complex systems."—Mitchell Stevens, Stanford University "Scientific research has long been portrayed as self-regulating, governed by practices of peer review and professionalism. But in recent decades, this self-regulation has been brought into question by research gone drastically wrong and transformed by federal policy. Focusing on institutional review boards, Regulating Human Research uses this case to document how the American state relies on private organizations to interpret and implement policy. In this succinct and insightful account, Sarah Babb illuminates policy developments and organizational changes that have been felt by a wide range of researchers, in academic and commercial institutions alike."—Elisabeth S. Clemens, Civic Gifts: Voluntarism and the Making of the American Nation-State "It sounded so good: colleagues reviewing each others' projects to ensure that human research subjects were properly protected. And yet that project, like many, went badly off the rails. Sarah Babb's exceptionally lucid book explains how a flexible, locally controlled system morphed into a quasi-legal body of arcane rules, spawned a new profession, and split into private and for-profit branches that do more to protect research institutions than research subjects. Rounding out her story and seamlessly stitching together several fields, Babb explains why the pressures of ambiguous federal rules nevertheless led to quite different compliance bureaucracies in other fields such as financial services and equal employment law. If you have time for only one piece on IRBs—or indeed on responses to federal regulation—this book should be your hands-down choice. Or you could just read it because it's a fantastic and elegant piece of scholarship."—Carol A. Heimer, Northwestern University and American Bar Foundation "[An] outstanding volume....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. Highly recommended."—K. E. Murphy, CHOICE