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September 8, 2010

Do IRBs Protect Human Research Participants?

Author Affiliations

Author Affiliations: Department of Bioethics, National Institutes of Health Clinical Center, Bethesda, Maryland.

JAMA. 2010;304(10):1122-1123. doi:10.1001/jama.2010.1304

Institutional review boards (IRBs) are the core of the well-established US system for the protection of human research participants. Institutional review boards were initially created to provide independent review of research conducted by researchers at their own institutions, impartial assessment of the ethical acceptability of proposed research, and a check on investigators' interests.1 Subsequently, advances in knowledge, technology, and resources have changed the face of research. Pharmaceutical industry research spending exceeds the National Institutes of Health (NIH) budget, which increased from approximately $1 billion in 1970 to $30 billion in 2010.2 Multisite research, expansion into international and community settings, novel scientific opportunities, freezers of stored samples, expanded categories of researchers, and entities including contract research organizations, data and safety monitoring committees, clinical trial coordinating centers, and commercial IRBs have transformed the clinical research enterprise.

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