The Role of Local Institutional Review Boards in Protecting Human Research Subjects

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 al would relieve local IRBs from part of the unmanageable paperwork burden of the review of individual adverse events in multicenter trials but retain the rest of their responsibilities. Independent review by an IRB of the DMC report from an ongoing trial is an important part of protecting patients, but there is no evidence that patient safety would be improved by duplicating this review at multiple local IRBs. The responsibility for protecting patients in clinical trials should be focused, not diffused across many overburdened local IRBs. We suggest that a DMC and a centralized IRB be given a clear mandate to review patient safety in an ongoing multicenter trial, and that local IRBs be explicitly relieved of this responsibility.

The role of IRBs in multicenter trials needs to be completely reevaluated,² and we applaud the draft recommendations of the National Bioethics Advisory Commission proposing a comprehensive overhaul of the present system.³ The current trend of trying to fix every perceived problem in clinical investigation by mandating that local IRBs increase their paperwork collection is as likely to worsen the oversight of clinical investigation as it is to help it. Requiring that more filing cabinets be filled at local IRBs only adds to the underbrush in the forest; it does not make the forest safer for patients or more navigable by investigators.