Local IRB Review of a Multicenter Trial: Local Costs without Local Context

摘要

Multicenter clinical research involves parallel 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's 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 and NCI to facilitate centralized reviews. This may be an opportune time for NINDS to adopt a central review model.