Institutional Review Board Review of Multicenter Studies
- Gregory K. Sobolski, BA, BS;
- Leonardo Flores, BA; and
- Ezekiel J. Emanuel, MD, PhD
- From the National Institutes of Health, Bethesda, MD 20892.
Background: Consensus suggests that institutional review boards (IRBs) are operating beyond their capacities (1). For example, multicenter studies require assessment of the same protocol at each participating site's IRB, which can lead to variation in the review of individual protocols (2). Proposed reforms of the IRB system seek centralized (3) and regional (4) review of multicenter studies to improve the quality of review, reduce repetition, and increase efficiency. Although the precise number of multicenter reviews nationally is uncertain, it is growing (1). But data are lacking to estimate the …
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