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. 2006 Jul;3(7):e309.
doi: 10.1371/journal.pmed.0030309. Epub 2006 Jul 25.

Should society allow research ethics boards to be run as for-profit enterprises?

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Should society allow research ethics boards to be run as for-profit enterprises?

Ezekiel J Emanuel et al. PLoS Med. 2006 Jul.

Abstract

An important mechanism for protecting human research participants is the prior approval of a clinical study by a research ethics board, known in the United States as an institutional review board (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 carried out. However, for-profit organizations are increasingly being hired to conduct ethics reviews. Proponents of for-profit IRBs argue that these IRBs are just as capable as academic IRBs at providing high-quality ethics reviews. Critics argue that for-profit IRBs have a conflict of interest because they generate their income from clients who have a direct financial interest in obtaining approval.

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Conflict of interest statement

Competing Interests: EJE has spoken at and received an honorarium from many different not-for-profit academic medical centers, some that review their own protocols and others, including the University of Iowa and Johns Hopkins University, that have outsourced their protocols to a for-profit institutional review board (IRB). He has served on a subcommittee of the Dana-Farber IRB and on both commercial and noncommercial data safety monitoring boards. He was a member of the Consortium to Examine Clinical Research Ethics, which is financed by the Doris Duke Charitable Foundation to collect primary data on and critically examine human subject protection (members of the consortium are listed at http://www.ddcf.org/page.asp?pageId=302). TL and CE have both served on academic IRBs.

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