Should society allow research ethics boards to be run as for-profit enterprises?
- PMID: 16848618
- PMCID: PMC1518668
- DOI: 10.1371/journal.pmed.0030309
Should society allow research ethics boards to be run as for-profit enterprises?
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.
Conflict of interest statement
Comment in
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Research ethics boards: size, not money.PLoS Med. 2006 Oct;3(10):e457; author reply e460, e471. doi: 10.1371/journal.pmed.0030457. PLoS Med. 2006. PMID: 17076570 Free PMC article. No abstract available.
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Research ethics boards: error and misconception.PLoS Med. 2006 Oct;3(10):e458; author reply e460, e471. doi: 10.1371/journal.pmed.0030458. PLoS Med. 2006. PMID: 17076571 Free PMC article. No abstract available.
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Research ethics boards: no data on quality of for-profit or non-profit IRBs.PLoS Med. 2006 Oct;3(10):e459; author reply e460, e471. doi: 10.1371/journal.pmed.0030459. PLoS Med. 2006. PMID: 17076572 Free PMC article. No abstract available.
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Research ethics boards: the protection of human subjects.PLoS Med. 2006 Oct;3(10):e472; author reply e471. doi: 10.1371/journal.pmed.0030472. PLoS Med. 2006. PMID: 17076582 Free PMC article. No abstract available.
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References
-
- Steinbrook M. Gag clauses in clinical-trial agreements. N Engl J Med. 2005;352:2160–2162. - PubMed
-
- Krimsky S. Science in the private interest: Has the lure of profits corrupted biomedical research? Lanham (Maryland): Rowman and Littlefield; 2003. 247 pp.
-
- Bekelman J, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: A systematic review. JAMA. 2003;289:454–465. - PubMed
-
- Bodenheimer T. Uneasy alliance—Clinical investigators and the pharmaceutical industry. N Engl J Med. 2000;342:1539–1544. - PubMed
-
- Lemmens T. Leopards in the temple: Restoring scientific integrity to the commercialized research scene. J Law Med Ethics. 2004;32:641–657. - PubMed
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