One cause of delay can be multiple institutional review board (IRB) reviews of the same protocol.įederal regulations require that every site engaged in human subjects research either (a) have a local IRB to approve that research or (b) delegate IRB review to an external IRB via a formal reliance agreement (RA). The translation of discoveries into therapeutics is often delayed by lengthy start-up periods in multicenter clinical research trials. The NINDS plans to promote CIRB use in future initiatives. They plan to collect data on timelines and costs associated with CIRB use. The authors anticipate that CIRB use will decrease NN trial start-up time and thus promote efficient trial implementation. The authors describe anticipated challenges related to institutional oversight responsibilities versus regulatory CIRB review as well as unanticipated challenges related to working with complex organizations that include multiple FWA-holding affiliates. The first NN protocol reviewed by the CIRB achieved full approval to allow participant enrollment within 56 days and went from grant award to the first patient visit in less than four months. To delineate roles and establish legal relationships between the NN sites and the CIRB, the CIRB executed reliance agreements with the sites and their affiliates that hold federalwide assurance for the protection of human subjects (FWA) this took, on average, 84 days. academic institutions, agreed to required CIRB use for NN trials. When developing the Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT hereafter, NN), the National Institute of Neurological Disorders and Stroke (NINDS) established a central IRB (CIRB) based at Massachusetts General Hospital, the academic medical center that received the NN clinical coordinating center grant. One cause of delay can be multiple institutional review board (IRB) reviews of the same protocol. Translating discoveries into therapeutics is often delayed by lengthy start-up periods for multicenter clinical trials. Kaufmann, Division of Clinical Innovation, National Center for Advancing Translational Sciences, 6701 Democracy Blvd., Room 934, Bethesda, MD 20892-9520 telephone: (301) 435-0178 e-mail. Neither author reported any potential or actual conflicts related to this report.Įthical approval: Reported as not applicable.Ĭorrespondence should be addressed to Dr. O’Rourke is a full-time employee of Partners HealthCare. Kaufmann is a full-time employee of the National Institutes of Health and holds an adjunct faculty appointment in the Department of Neurology at Columbia University in New York City. O’Rourke is director, Human Research Affairs, and director, Partners Human Embryonic Stem Cell Research Oversight, Partners HealthCare, Boston, Massachusetts.įunding/Support: The central institutional review board is funded through a grant to the NeuroNEXT Clinical Coordinating Center at Massachusetts General Hospital from the National Institute of Neurological Disorders and Stroke (NS-U01 NS077179) this includes salary support for Dr. Kaufmann is director, Division of Clinical Innovation, National Center for Advancing Translational Sciences, and former director, Office of Clinical Research, National Institute for Neurological Disorders and Stroke, Bethesda, Maryland.ĭr.
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