Local institutional review board (IRB) review of a multicenter trial: local costs without local context.
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.
Ravina
Bernard
B
Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Bernard.ravina@ctcc.rochester.edu
Deuel
Lisa
L
Siderowf
Andrew
A
Dorsey
E Ray
ER
D000975:Antioxidants / Q000191:economics / Q000627:therapeutic use; D035843:Biomedical Research / Q000941:ethics; D004311:Double-Blind Method; D028744:Ethics Committees, Research / Q000191:economics* / Q000941:ethics* / Q000458:organization & administration; D006801:Humans; D015337:Multicenter Studies as Topic / Q000191:economics* / Q000941:ethics; D010300:Parkinson Disease / Q000188:drug therapy; D016032:Randomized Controlled Trials as Topic; D014451:Ubiquinone / Q000031:analogs & derivatives / Q000191:economics / Q000627:therapeutic use; D014481:United States; D014810:Vitamin E / Q000191:economics / Q000627:therapeutic use
D000975:Antioxidants; D014451:Ubiquinone; D014810:Vitamin E; C024989:coenzyme Q10