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How Single Institutional Review Boards Manage Their Own Conflicts of Interest: Findings From a National Interview
Ekaterina Pivovarova1, Robert L Klitzman, Alexandra Murray
1E. 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.
Conflicts of interest (COIs) in single Institutional Review Boards (sIRBs) vary by type. Commercial and government sIRBs have specific COI management processes, while academic sIRBs do not, highlighting a need for policy development.
Area of Science:
- Bioethics
- Research Integrity
- Regulatory Science
Background:
- Conflicts of interest (COIs) pose ethical challenges in scientific research, impacting decision-making, integrity, and participant safety.
- Single Institutional Review Boards (sIRBs) are increasingly mandated for multisite research, yet their internal COIs remain unexamined.
- Understanding sIRB COI management is crucial for ethical oversight in collaborative research.
Purpose of the Study:
- To investigate and compare the Conflict of Interest (COI) management processes across different types of single Institutional Review Boards (sIRBs).
- To document existing COI handling procedures within commercial, government, and academic sIRBs.
- To provide insights into the ethical considerations of sIRB implementation in multisite research.
Main Methods:
- Conducted semistructured interviews with 103 personnel from 20 commercial, government, and academic sIRBs.
- Gathered data on their experiences and processes for managing COIs during multisite research review.
- Analyzed qualitative data to identify variations in COI management strategies.
Main Results:
- Significant variability in COI management policies was observed among different sIRB types.
- Commercial sIRBs utilize firewalls, external reviewers, and client refusal to manage COIs inherent to their for-profit model.
- Government sIRBs address funding-related COIs through discussion, firewalls, nonaffiliated reviewers, and broad policies.
- Academic sIRBs reported no specific policies for managing their COIs, similar to local IRBs.
Conclusions:
- As sIRBs become more prevalent, researchers must consider the unique COIs associated with each type.
- Academic sIRBs should consider developing and implementing specific policies for managing their internal COIs.
- Standardizing COI management across sIRB types could enhance research integrity and ethical oversight.
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