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Letters
October 22/29, 2003

Local vs Central Institutional Review Boards for Multicenter Studies—Reply

Author Affiliations
 

Letters Section Editor: Stephen J. Lurie, MD, PhD, Senior Editor.

JAMA. 2003;290(16):2126-2127. doi:10.1001/jama.290.16.2126-a

To the Editor: Dr McWilliams and colleagues1 found that review of a protocol for a multicenter genetic epidemiology study by local institutional review boards (IRBs) was highly variable. They concluded that multiple-site IRB review is inconsistent and inefficient, and thus they recommended centralized review for such studies.

The data, however, also reveal considerable consistency between IRBs, judging by the 94% of sites that refused to waive written consent, and by the 77% that found the protocol "nonexpeditable." The data also suggest that there is variability in resources available to IRBs, as well as in standards that address the readability of consent documents. The latter factor appears to result in cycles of revisions and rebuttals, thereby lengthening time to approval.

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