Institutional Review Boards: A Crisis in Confidence

Editorials16 January 2001Institutional Review Boards: A Crisis in ConfidenceRobert J. Levine, MDRobert J. Levine, MDDr. Levine: Yale University School of Medicine; New Haven, CT 06520Author, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-134-2-200101160-00018 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail There is a sense of crisis in the country about the effectiveness of the nationwide system that protects the rights and welfare of human research subjects. Reports of problems appear on television or in newspapers almost weekly and focus attention on the system's centerpiece, the institutional review board (IRB). University hospitals' entire research programs have been suspended on grounds of inadequate IRB performance, and governmental agencies have found that the IRB system is incapable of coping with its workload.In this issue, Burman and coworkers (1) identify the enormous increase in the number and complexity of multicentered randomized clinical trials ...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. LinkGoogle Scholar2. . Protecting Human Research Subjects: Status of Recommendations. Department of Health and Human Services, Office of the Inspector General. Washington, DC: U.S. Department of Health and Human Services; 2000. Google Scholar3. OHRP compliance activities: common findings and guidance. Compliance Oversight Branch, Division of Human Subjects Protection, Office for Human Research Protections (OHRP). Available at ohrp.osophs.dhhs.gov/references/findings.pdf. Google Scholar4. Glass KC, Weijer C, Palmour RA, Lemmens TM, Shapiro S. Structuring the review of human genetics protocols: genetic diagnostic and screening studies. IRB: A Review of Human Subjects Research. 1997; 19(3-4):1-12. Google Scholar5. Office for Protection from Research Risks. Letter to Virginia Commonwealth University, 17 December 1999. Google Scholar6. Levine RJ. Ethics and Regulation of Clinical Research. 2nd ed. New Haven, CT: Yale Univ Pr; 1988. Google Scholar7. Levine RJ, Lasagna L. Demystifying central review boards: current options and future directions. IRB: A Review of Human Subjects Research. 2000;22:1-4. Google Scholar Author, Article, and Disclosure InformationAffiliations: Dr. Levine: Yale University School of Medicine; New Haven, CT 06520Grant Support: In part by the National Institute of Mental Health and the National Institute on Drug Abuse (PO1 MH/DA 56 826-01A1).Corresponding Author: Robert J. Levine, MD, Room 204 CLP, Yale University School of Medicine, 47 College Street, New Haven, CT 06520. 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 The Crisis in Local Institutional Review Boards Alan M. 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Federman, MDToward protecting the safety of participants in clinical trialsEthical Issues in Clinical Research on Fracture Prevention in Patients With OsteoporosisImpact of shared scientific or ethical review of multicentre clinical research on the quality of clinical research and the clinical research processEthics Committees in Italy: A Survey on a Sample of OncologistsTowards the regulation of research ethics boardsA Central Institutional Review Board for Multi-Institutional TrialsThe Crisis in Local Institutional Review BoardsAlan M. Sugar, MDThe Crisis in Local Institutional Review BoardsStephanie Nagy-Agren, MDOf scientific physicians and evidence-based medicine: in regard to glatstein, IJROBP 2001;49:619–621 16 January 2001Volume 134, Issue 2Page: 161-163KeywordsAdverse eventsData and safety monitoring boardsGeneticsInstitutional review boardsResearch reporting guidelinesSafetySurgeonsSurgerySurvey research ePublished: 16 January 2001 Issue Published: 16 January 2001 CopyrightCopyright © 2001 by American College of Physicians. All Rights Reserved.PDF DownloadLoading ...