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Local institutional review board (IRB) review of a multicenter trial: Local costs without local context
Author(s) -
Ravina Bernard,
Deuel Lisa,
Siderowf Andrew,
Dorsey E. Ray
Publication year - 2010
Publication title -
annals of neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 4.764
H-Index - 296
eISSN - 1531-8249
pISSN - 0364-5134
DOI - 10.1002/ana.21831
Subject(s) - institutional review board , clinical trial , informed consent , protocol (science) , context (archaeology) , medicine , clinical research , premise , family medicine , alternative medicine , psychiatry , pathology , linguistics , philosophy , paleontology , biology
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. ANN NEUROL 2010;67:258–260