Institutional Review Board Review of Multicenter Studies
Authors: Gregory K. Sobolski, Leonardo Flores, Ezekiel J. Emanuel
Journal: Annals of Internal Medicine (2007)

Letters15 May 2007Institutional Review Board Review of Multicenter StudiesGregory K. Sobolski, BA, BS, Leonardo Flores, BA, and Ezekiel J. Emanuel, MD, PhDGregory K. Sobolski, BA, BSFrom the National Institutes of Health, Bethesda, MD 20892., Leonardo Flores, BAFrom the National Institutes of Health, Bethesda, MD 20892., and Ezekiel J. Emanuel, MD, PhDFrom the National Institutes of Health, Bethesda, MD 20892.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-146-10-200705150-00019 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Background: Consensus suggests that institutional review boards (IRBs) are operating beyond their capacities (1). For example, multicenter studies require assessment of the same protocol at each participating site's IRB, which can lead to variation in the review of individual protocols (2). Proposed reforms of the IRB system seek centralized (3) and regional (4) review of multicenter studies to improve the quality of review, reduce repetition, and increase efficiency. Although the precise number of multicenter reviews nationally is uncertain, it is growing (1). But data are lacking to estimate the potential benefits and cost savings of centralized review.Methods: We surveyed ...References1. Burman WJ, Reves RR, Cohn DL, Schooley RT. Breaking the camel's back: multicenter clinical trials and local institutional review boards. Ann Intern Med. 2001;134:152-7. [PMID: 11177319] LinkGoogle Scholar2. McWilliams R, Hoover-Fong J, Hamosh A, Beck S, Beaty T, Cutting G. Problematic variation in local institutional review of a multicenter genetic epidemiology study. JAMA. 2003;290:360-6. [PMID: 12865377] CrossrefMedlineGoogle Scholar3. Christian MC, Goldberg JL, Killen J, Abrams JS, McCabe MS, Mauer JK, et al. A central institutional review board for multi-institutional trials. N Engl J Med. 2002;346:1405-8. [PMID: 11986418] CrossrefMedlineGoogle Scholar4. Wood A, Grady C, Emanuel EJ. Regional ethics organizations for protection of human research participants. Nat Med. 2004;10:1283-8. [PMID: 15580245] CrossrefMedlineGoogle Scholar5. Sugarman J, Getz K, Speckman JL, Byrne MM, Gerson J, Emanuel EJ, et al. The cost of institutional review boards in academic medical centers [Letter]. N Engl J Med. 2005;352:1825-7. [PMID: 15858200] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: Gregory K. Sobolski, BA, BS; Leonardo Flores, BA; Ezekiel J. Emanuel, MD, PhDAffiliations: From the National Institutes of Health, Bethesda, MD 20892.Disclaimer: The views contained herein are those of the authors and do not necessarily represent the views of the National Institutes of Health, U.S. Public Health Service, or U.S. Department of Health and Human Services.Acknowledgment: The authors thank Amy Reid for careful assistance with collection of the data.Disclosures: None disclosed. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoBreaking the Camel's Back: Multicenter Clinical Trials and Local Institutional Review Boards William J. Burman , Randall R. Reves , David L. Cohn , and Robert T. Schooley Metrics Cited bySystems approach to assessing and improving local human research Institutional Review Board performanceTime to institutional review board approval with local versus central review in a multicenter pragmatic trialUse of central institutional review boards for multicenter clinical trials in the United States: A review of the literatureBurdens on Research Imposed by Institutional Review Boards: The State of the Evidence and Its Implications for Regulatory ReformA Systematic Review of the Empirical Literature Evaluating IRBs: What We Know and What We Still Need to LearnEquipoise Lost: Ethics, Costs, and the Regulation of Cancer Clinical Research 15 May 2007Volume 146, Issue 10Page: 759KeywordsAdverse eventsConflicts of interestInstitutional review boardsMedical services ePublished: 15 May 2007 Issue Published: 15 May 2007 Copyright & PermissionsCopyright © 2007 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...