Institutional review boards (IRBs) are committees that protect human research subjects from ethical abuses. 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 oversee, define, and apply ambiguous federal regulations. In opening the black box of contemporary IRB decision-making, increasingly organized like an assembly line, author Sarah Babb argues that compliance bureaucracy is an adaptive response to the dynamics and dysfunctions of American governance. Yet this solution of outsourcing has unintended consequences, including the creation of profitable compliance industries.
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