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Ann Neurol. 2010 Feb;67(2):258-60. doi: 10.1002/ana.21831.

Local institutional review board (IRB) review of a multicenter trial: local costs without local context.

Author information

1
Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Bernard.ravina@ctcc.rochester.edu

Abstract

Multicenter clinical research involves parallel Institutional Review Board (IRB) reviews based on the premise that local review reflects aspects of the research environment. We examined the costs and effects of local IRB review of the consent and protocol in a multicenter clinical trial in Parkinson disease. Seventy-six percent of changes to the consent reflected standard institutional language, with no substantive changes to the protocol. The costs of this process exceeded $100,000. These findings support initiatives by the Office of Human Research Protections (OHRP) and the National Cancer Institute (NCI) to facilitate centralized reviews. This may be an opportune time for the National Institute of Neurological Disorders and Stroke (NINDS) to adopt a central review model.

PMID:
20225291
PMCID:
PMC2848288
DOI:
10.1002/ana.21831
[Indexed for MEDLINE]
Free PMC Article

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