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How Single Institutional Review Boards Manage Their Own Conflicts of Interest: Findings From a National Interview Study

Pivovarova, Ekaterina PhD; Klitzman, Robert L. MD; Murray, Alexandra MPA; Stiles, Deborah F. JD; Appelbaum, Paul S. MD; Lidz, Charles W. PhD

doi: 10.1097/ACM.0000000000002762
Research Reports
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Purpose Conflicts of interest (COIs) are important ethical concerns because they may affect scientific decision making, research integrity, and the safety and fairness of studies. No research to date has examined COIs of single institutional review boards (sIRBs), which are now mandated by the National Institutes of Health, and will be by the revised Common Rule in 2020, for all multisite research. This study investigated how different types of sIRBs manage their own COIs by documenting existing processes for and comparing commercial, government, and academic sIRBs.

Method One hundred three personnel from 20 commercial, government, or academic sIRBs participated in semistructured interviews about their processes for and experiences with managing COIs when conducting multisite research review.

Results Variability in COI management policies exist across types of sIRBs. Commercial sIRBs were aware of their own COIs given their for-profit model, and managed them by using firewalls, relying on external reviewers, and turning down potential clients. Government sIRBs described unique COIs stemming from the same agency funding the sIRB and the research being reviewed. They addressed these by discussing concerns about COIs, using firewalls, relying on nonaffiliated reviewers, and having broad COI policies. In contrast to commercial and government sIRBs, academic sIRBs did not report any specific policies to manage their COIs, which are similar to those of local IRBs.

Conclusions As sIRBs become increasingly common, researchers will need to weigh the different COIs inherent to each type of sIRB. Additionally, academic sIRBs may consider implementing specific policies for managing their COIs.

E. Pivovarova is assistant professor, Department of Psychiatry, University of Massachusetts Medical School and Massachusetts Center of Excellence for Specialty Courts, Worcester, Massachusetts.

R.L. Klitzman is professor of psychiatry and director, Master of Science in Bioethics Program, Columbia University, New York, New York.

A. Murray is research coordinator II, Department of Psychiatry, University of Massachusetts Medical School, Worcester, Massachusetts.

D.F. Stiles is vice president of research operations and policy and chief operating officer, Office of the Executive Vice President for Research, Columbia University, New York, New York.

P.S. Appelbaum is professor of psychiatry, medicine, and law; director, Division of Law, Ethics, and Psychiatry; and director, Center for Research on Ethical, Legal and Social Implications of Psychiatric, Neurological and Behavioral Genetics, Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York, New York.

C.W. Lidz is professor emeritus, Department of Psychiatry, University of Massachusetts Medical School, Worcester, Massachusetts.

Funding/Support: This study was funded through the National Institute of General Medicine grant 1R01GM 113640: Central IRBs: Enhanced Protections for Human Research Participants.

Other disclosures: None reported.

Ethical approval: This study was approved by the University of Massachusetts Medical School (ID: H00005752 Dates: 09/23/14 to 09/22/19) and New York State Psychiatric Institute (ID: 7045 Dates: 10/26/14 to 10/25/19) institutional review boards.

Previous presentations: Portions of this manuscript were presented at the annual American Society for Bioethics and Humanities conference in 2017 in a symposium titled The Challenges and Solutions in Centralizing Multi-site Research IRB Review: Lessons Learned From the Field About Making a Single IRB (sIRB) Policy Work.

Supplemental digital content for this article is available at http://links.lww.com/ACADMED/A676.

Correspondence should be addressed to Ekaterina Pivovarova, University of Massachusetts Medical School, Department of Psychiatry, 222 Maple Ave., Chang Building, Shrewsbury, MA 01545; telephone: (508) 856-7816; email: ekaterina.pivovarova@umassmed.edu.

Copyright © 2019 by the Association of American Medical Colleges