Local institutional review board (IRB) review of a multicenter trial: Local costs without local context
- 11 August 2009
- journal article
- review article
- Published by Wiley in Annals of Neurology
- Vol. 67 (2), 258-260
- https://doi.org/10.1002/ana.21831
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. ANN NEUROL 2010;67:258–260This publication has 12 references indexed in Scilit:
- Coast IRB hits treacherous watersNature Medicine, 2009
- Ontario Cancer Research Ethics Board: Lessons Learned From Developing a Multicenter Regional Institutional Review BoardJournal of Clinical Oncology, 2008
- Clinical trials: rising costs limit innovationAnnals of Neurology, 2007
- Regulatory challenges: Lessons from recent West Nile virus trials in the United StatesContemporary Clinical Trials, 2006
- The Cost of Institutional Review Boards in Academic Medical CentersThe New England Journal of Medicine, 2005
- The price of innovation: new estimates of drug development costsJournal of Health Economics, 2003
- Readability Standards for Informed-Consent Forms as Compared with Actual ReadabilityThe New England Journal of Medicine, 2003
- A Central Institutional Review Board for Multi-Institutional TrialsThe New England Journal of Medicine, 2002
- Regulatory approvals in a large multinational clinical trial: the ESPRIT experienceControlled Clinical Trials, 2002
- Breaking the Camel's Back: Multicenter Clinical Trials and Local Institutional Review BoardsAnnals of Internal Medicine, 2001