Cover of Regulating Human Research by Sarah Babb
Regulating Human Research
IRBs from Peer Review to Compliance Bureaucracy
Sarah Babb


January 2020
208 pages.
from $22.00

Cloth ISBN: 9781503610149
Paper ISBN: 9781503611221



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 Researchprovides 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.

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.

"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