A Proposal by the U.S. Food and Drug Administration for Reliance on Single Institutional Review Boards: Proceed Only With Caution
Authors: Ryan Spellecy, Nathan Thompson, Ann B. Nattinger
Journal: Annals of Internal Medicine (2024)

Ideas and Opinions13 February 2024A Proposal by the U.S. Food and Drug Administration for Reliance on Single Institutional Review Boards: Proceed Only With CautionRyan Spellecy, PhD, Nathan Thompson, MD, PharmD, MS, and Ann B. Nattinger, MD, MPHRyan Spellecy, PhDCenter for Bioethics and Medical Humanities, Medical College of Wisconsin, Milwaukee, Wisconsin (R.S.)Search for more papers by this author, Nathan Thompson, MD, PharmD, MSDepartment of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin (N.T.)Search for more papers by this author, and Ann B. Nattinger, MD, MPHDepartment of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin (A.B.N.).Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M23-2152 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Several U.S. senators called on the U.S. Government Accountability Office (GAO) to investigate commercial institutional review boards (IRBs) over concerns that their business model “could undercut the ethical mission of IRBs to protect and promote the rights and welfare of research participants” (1). Soon after, Fernandez Lynch and Rosenfeld (1) noted that for-profit status is not incompatible with the mission of IRBs. However, they also noted that the business model of commercial IRBs favors compliance with regulations yet offers few incentives to address ethical issues not covered by regulations. This is important because the regulations cannot anticipate all ethical issues. ...References1. Fernandez Lynch H, Rosenfeld S. Institutional review board quality, private equity, and promoting ethical human subjects research. Ann Intern Med. 2020;173:558-562. [PMID: 32687743] doi:10.7326/M20-1674 LinkGoogle Scholar2. U.S. Government Accountability Office. Institutional review boards: actions needed to improve federal oversight and examine effectiveness. 17 January 2023. Accessed at www.gao.gov/products/gao-23-104721 on 23 June 2023. Google Scholar3. Regulations.gov. Institutional review boards; cooperative research. 2022. Accessed at www.regulations.gov/document/FDA-2019-N-2175-0001/comment on 25 October 2023. Google Scholar4. Nichols C, Kunkel LE, Baker R, et al. Use of single IRBs for multi-site studies: a case report and commentary from a National Drug Abuse Treatment Clinical Trials Network study. Contemp Clin Trials Commun. 2019;14:100319. 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Accessed at www.science.org/content/article/fda-s-own-documents-reveal-agency-s-lax-slow-and-secretive-oversight-clinical-research on 3 February 2023. Google Scholar9. Fernandez Lynch H, Hurley EA, Taylor HA. Responding to the call to meaningfully assess institutional review board effectiveness. JAMA. 2023;330:221-222. [PMID: 37351871] doi:10.1001/jama.2023.8457 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: Ryan Spellecy, PhD; Nathan Thompson, MD, PharmD, MS; Ann B. Nattinger, MD, MPHAffiliations: Center for Bioethics and Medical Humanities, Medical College of Wisconsin, Milwaukee, Wisconsin (R.S.)Department of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin (N.T.)Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin (A.B.N.).Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M23-2152.Corresponding Author: Ryan Spellecy, PhD, 8701 Watertown Plank Road, Milwaukee, WI, 53226; e-mail, rspellecy@mcw.edu.Author Contributions: Conception and design: R. Spellecy, N. Thompson, A.B. Nattinger.Analysis and interpretation of the data: R. Spellecy, N. Thompson.Drafting of the article: R. Spellecy, N. Thompson.Critical revision of the article for important intellectual content: R. Spellecy, N. Thompson, A.B. Nattinger.Final approval of the article: R. Spellecy, N. Thompson, A.B. Nattinger.Administrative, technical, or logistic support: R. Spellecy.This article was published at Annals.org on 13 February 2024. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics LatestKeywordsClinical trialsConflicts of interestDrugsFood and Drug AdministrationInstitutional review boardsRisk assessmentsSafetyVaccines ePublished: 13 February 2024 Copyright & PermissionsCopyright © 2024 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...