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To the Editor: Dr Morse and colleagues¹ propose that the initial review of adverse event reports in clinical trials be the responsibility of a data monitoring committee (DMC), and that institutional review boards (IRBs) only receive collated summaries. This would prevent local IRBs from being overwhelmed with the need to review thousands of individual adverse event reports from multicenter trials. Local IRBs have neither the context (eg, denominators, study assignments) nor the resources to do so. However, we are still concerned about the role envisioned for the local IRB.

The focal point of the human subjects protection system is the local IRB, and it is generally assumed that participants will be better protected if the local IRB of each participating site is involved in nearly every aspect of the trial. This superficially appealing notion runs counter to a central tenet of management—that diffusion of responsibility produces managerial paralysis. Morse et . . . [Full Text of this Article]

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