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In Reply: Although we appreciate Dr Rosé's argument for diversity, we contend that there is a point of diminishing returns when diverse and redundant review interferes with uniform participant protection. For instance, 23% of local IRBs deemed the same protocol to be eligible for expedited review, while the others did not. This variability reveals serious differences in the review process, not simply diversity. Differences in the review process can manifest in several ways. For example, revisions mandated by the different language requirements of local IRBs could have produced consent forms that did not articulate the intended study protocol. Thus, we remain concerned that the current system does not ensure equal protection of the rights and welfare of human participants in large multicenter studies.

The "healthy price to keep applied ethics outside of super-committees" alluded to by Dr Rosé may be a hefty price indeed. Humphreys et al estimated the cost . . . [Full Text of this Article]

Rita McWilliams, MPH; Julie Hoover-Fong, MD; Ada Hamosh, MD, MPH; Suzanne Beck, MD; Terri Beaty, PhD; Garry R. Cutting, MD
Johns Hopkins Medical Institutions
Baltimore, Md

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