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

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


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.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antioxidants / economics
  • Antioxidants / therapeutic use
  • Biomedical Research / ethics
  • Double-Blind Method
  • Ethics Committees, Research / economics*
  • Ethics Committees, Research / ethics*
  • Ethics Committees, Research / organization & administration
  • Humans
  • Multicenter Studies as Topic / economics*
  • Multicenter Studies as Topic / ethics
  • Parkinson Disease / drug therapy
  • Randomized Controlled Trials as Topic
  • Ubiquinone / analogs & derivatives
  • Ubiquinone / economics
  • Ubiquinone / therapeutic use
  • United States
  • Vitamin E / economics
  • Vitamin E / therapeutic use


  • Antioxidants
  • Ubiquinone
  • Vitamin E
  • coenzyme Q10