The Cost of Institutional Review Board Procedures in Multicenter Observational Research
Authors: Keith Humphreys, Jodie Trafton, Todd H. Wagner
Journal: Annals of Internal Medicine (2003)

Letters1 July 2003The Cost of Institutional Review Board Procedures in Multicenter Observational ResearchKeith Humphreys, PhD, Jodie Trafton, PhD, and Todd H. Wagner, PhDKeith Humphreys, PhDPalo Alto Veterans Affairs Medical Center; Stanford University Medical Center (Humphreys, Trafton, Wagner), Jodie Trafton, PhDPalo Alto Veterans Affairs Medical Center; Stanford University Medical Center (Humphreys, Trafton, Wagner), and Todd H. Wagner, PhDPalo Alto Veterans Affairs Medical Center; Stanford University Medical Center (Humphreys, Trafton, Wagner)Author, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-139-1-200307010-00021 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:Background: In recent years, there has been significant controversy over how institutional review board (IRB) procedures are structured, administered, and balanced against other concerns (for example, the feasibility of multicenter research) (1). Formal economic analysis has been largely absent in these debates. With hospitals and research facilities under budgetary pressures, it is essential that cost-effective IRB systems be developed.Objective: To estimate the cost of IRB procedures in an eight-site observational substance abuse treatment study.Methods and Findings: We estimated the cost of each IRB action (initial reviews, continuing reviews, amendments, and adverse event reports) at each ...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. Wagner TH, Bhandari A, Chadwick GL, Nelson DK. The cost of operating institutional review boards (IRBs). Acad Med 2003; 178: [In press]. Google Scholar3. Christian MC, Goldberg JL, Killen J, Abrams JS, McCabe MS, Mauer JK, . A central institutional review board for multi-institutional trials. N Engl J Med. 2002;346:1405-8. [PMID: 11986418] CrossrefMedlineGoogle Scholar4. New beryllium IRB. Department of Energy. Protecting Human Subjects. 2001-02; Winter:1, 6-7. Accessed at www.science.doe.gov/ober/humsubj/winter01.pdf on 13 June 2002. Google Scholar5. Middle C, Johnson A, Petty T, Sims L, Macfarlane A. Ethics approval for a national postal survey: recent experience. BMJ. 1995;311:659-60. [PMID: 7549633] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: Palo Alto Veterans Affairs Medical Center; Stanford University Medical Center (Humphreys, Trafton, Wagner)Grant Support: By the Department of Veterans Affairs Health Services Research and Development Service. 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 Rise of Litigation in Human Subjects Research Michelle M. Mello , David M. Studdert , and Troyen A. Brennan Metrics Cited ByInternational mHealth Research: Old Tools and New ChallengesConsent in Biomedical ResearchIs mandatory research ethics reviewing ethical?How Variability in the Institutional Review Board Review Process Affects Minimal-Risk Multisite Health Services ResearchLaura A. Petersen, MD, MPH, Kate Simpson, MPH, Richard SoRelle, BS, Tracy Urech, MPH, and Supicha Sookanan Chitwood, MPHBurdens on Research Imposed by Institutional Review Boards: The State of the Evidence and Its Implications for Regulatory ReformViewpoint: A method to estimate the cost in lives of ethics board review of biomedical researchBureaucratic Ethics: IRBs and the Legal Regulation of Human Subjects ResearchEquipoise Lost: Ethics, Costs, and the Regulation of Cancer Clinical ResearchInstitutional Review Boards, Professionalism, and the InternetCosts and Benefits of the National Cancer Institute Central Institutional Review BoardCancer: The Road to AmiensHow valid is using cancer registries' data to identify acquired immunodeficiency syndrome-related non-Hodgkin's lymphoma?IRBs: Going Too Far or Not Far Enough?A review finds that multicenter studies face substantial challenges but strategies exist to achieve Institutional Review Board approvalU. S. Health Researchers Review Their Ethics Review Boards: A Qualitative StudyThe Canadian Agency for the Oversight of Research Involving Humans: A Reform ProposalFeasibility of a National Fatal Asthma Registry: More Evidence of IRB Variation in Evaluation of a Standard ProtocolVariation in Institutional Review processes for a multisite observational studyAnalgesia and anesthesia for neonates: Study design and ethical issuesMedical Schools' Attitudes and Perceptions Regarding the Use of Central Institutional Review BoardsMinimizing Risk in Clinical ResearchDaniel D. Federman, MDWorking with Boards and Committees: ECs, DSMBs, CABs 1 July 2003Volume 139, Issue 1Page: 77KeywordsDatabasesFearForecastingHealth services researchHospitalsInstitutional review boardsObservational studiesResearch facilitiesResearch grantsSubstance abuse ePublished: 1 July 2003 Issue Published: 1 July 2003 CopyrightCopyright © 2003 by American College of Physicians. All Rights Reserved.PDF DownloadLoading ...