Stephen J.LurieMD, PhD, Senior EditorIndividualAuthorJody W.ZylkeMD, Contributing EditorIndividualAuthor
Copyright 2001 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2001
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.
Burman WJ, Schooley RT. The Role of Local Institutional Review Boards in Protecting Human Research Subjects. JAMA. 2001;285(21):2713. doi:10.1001/jama.285.21.2713