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NIH Policy on Single-IRB Review — A New Era in Multicenter Studies
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NIH Policy on Single-IRB Review — A New Era in Multicenter Studies
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Journal Article
NIH Policy on Single-IRB Review — A New Era in Multicenter Studies
2016
Overview
The new National Institutes of Health policy on review of multicenter studies by a single institutional review board ushers in new responsibilities for investigators. Public comments have highlighted several challenges to streamlining ethics review in this way.
Review of the ethics of multicenter clinical studies is typically conducted by the institutional review board (IRB) of each participating center. Extensive evidence suggests that the current practice is costly, is unnecessarily duplicative, and delays commencement of research.
1
The U.S. government has permitted single-IRB review and other streamlined review models since 1991, but few investigators have taken advantage of those options.
2
In June 2016, the National Institutes of Health (NIH) issued new guidance on single-IRB review of multicenter studies.
3
The policy was introduced as a means to increase the efficiency of multicenter studies, reduce the time to study initiation, promote . . .
Publisher
Massachusetts Medical Society
