The Crisis in Local Institutional Review Boards TO THE EDITOR: As members of the institutional review board

(IRB) committee that reviews adverse events for the clinical studies at our institution, we read the perspective by Burman and colleagues (1) with interest. We agree that ideally local IRBs cannot and should not be responsible for the detailed review of all safety reports in multicenter trials. However, we do not agree that we are presently exempt from the responsibility to review and question the clinical events that occur in these trials. At our institution, we have set up a computer tracking system of all events and have reorganized our adverse event submission form. This allows our committee to review the hundreds of events in an organized format. We are thus able to detect trends of concern. If a trend is detected, we ask the investigator to obtain more information from his or her sponsor and often ask that the consent form be modified. We also plan to use this tracking system to provide a complete list of adverse events for each protocol in order to assess risk and benefit when performing the continuing review of ongoing studies. We agree that all multicenter studies should be required to set up data and safety monitoring boards that will function without bias. The reports of these boards can be reviewed by the local investigator and then sent to the local IRB. Until independent boards are re-quired for all multicenter studies, we believe that we must continue our own detailed review, despite the inordinate amount of time de-voted to the process by our IRB office staff and committees