For-profit research ethics committees: How are they performing?

An important mechanism for protecting human research participants is the prior approval of a study by a research ethics board, known in the United States as an institutional review board, or IRB. Traditionally, IRBs have been run by volunteer committees of scientists and clinicians working in the academic medical centers where the studies they review are being conducted, but for-profit organizations are increasingly being hired to conduct ethics reviews. A provocative "for and against" debate in PLoS Medicine looks at the benefits and risks of using for-profit IRBs.

Ezekiel Emanuel, Chair of the Department of Clinical Bioethics, Clinical Center, National Institutes of Health, argues that "the crucial question is whether an IRB, regardless of its tax status, is performing at a high level of quality." We should, he says, "dump the outdated ideology of 'for-profit bad, not-for-profit good'" and focus instead on how the IRB is performing in its ethics reviews.

Emanuel argues that there are several examples of for-profit IRBs that are performing reviews just as well as, or better than, non-profit academic centers.

"The first IRBs to receive 'full accreditation'--the highest level of accreditation awarded by the Association for the Accreditation of Human Research Protection Programs-- were one for-profit IRB, Western Institutional Review Board (WIRB), and one not-for-profit IRB, University of Iowa," says Emanuel. "And so it continued: of the first eight organizations to receive full accreditation, four were for-profit IRBs."

However, Trudo Lemmens (Associate Professor, Faculty of Law, University of Toronto) and Carl Elliot (Professor, Center for Bioethics, University of Minnesota) argue that commercial IRBs have a fundamental conflict of interest, because "they are in a clientprovider business relationship with the commercial entities whose studies they review. Because commercial IRBs generate their income from clients with a di

Contact: Andrew Hyde
Public Library of Science

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