Regulating Human Research

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Institutional review boards (IRBs) are panels charged with protecting the rights of humans who participate in research studies ranging from biomedicine to social science. Regulatin g 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. Show more