Regulating Human Research: IRBs from Peer Review to Compliance Bureaucracy

by Sarah Babb

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 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.

184 pages, Paperback

Published January 21, 2020

About the author

Sarah Babb is an Associate Professor in the Department of Sociology at Boston College. Her research focuses on the sociology of economic policy. Some of her early work focused on debates and social movements surrounding monetary policy in the U.S. in the decades immediately following the Civil War. Her first book Managing Mexico, taken from her doctoral dissertation, examine historical changes in the economics profession in Mexico. With Bruce Carruthers, she co-authored a textbook on economic sociology entitled Economy/Society: Markets, Meanings, and Social Structure. She has been awarded a prestigious Woodrow Wilson Fellowship for academic year 2005/06.

Reviews

[Kim · Rating 4 out of 5]

Read this book in one sitting to inform my dissertation (and because I genuinely wanted to read it; it’s lauded in my field).

A must read for any IRB professional or member. Very informative, clear, and useful background on the evolution of the field of human research protection programs over the last 20 years.

[Gregg · Rating 4 out of 5]

Interesting, important, readable, short. This is a history of human subjects protection committees in the US and their evolution over time. Apparently, I'm not alone in my experiences with IRBs. Reports of "hyper compliance" and excessive paperwork driven by a philosophy that "if it's not documented it didn't happen." Vague federal rules allowing inconsistent decisions by local (university) IRBs staffed by professional administrators who are not professional researchers ans who promote the philosophy the rules are "a floor not a ceiling." Raises ongoing concerns IRBs are as, if not more, interested in protecting their university than human subjects. If you have to deal with IRBs, this is a worthwhile read.

[Tim Badmington · Rating 4 out of 5]

Feels broadly correct about the structures and ideas that made the research reg scene what it is today.