Jamie Ellen Siegel, MD; Ann Vaughn; Elaine Baszczewski
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Siegel JE, Vaughn A, Baszczewski E. The Crisis in Local Institutional Review Boards. Ann Intern Med. 2002;136:410. doi: 10.7326/0003-4819-136-5-200203050-00018
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Published: Ann Intern Med. 2002;136(5):410.
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.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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