Ekaterina Pivovarova1, Robert L Klitzman, Alexandra Murray, Deborah F Stiles, Paul S Appelbaum, Charles W Lidz. 1. 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.
Abstract
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.
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.
Authors: Eric G Campbell; Joel S Weissman; Christine Vogeli; Brian R Clarridge; Melissa Abraham; Jessica E Marder; Greg Koski Journal: N Engl J Med Date: 2006-11-30 Impact factor: 91.245
Authors: David R Holmes; Brian G Firth; Astrid James; Ron Winslow; Patricia K Hodgson; Gail L Gamble; Richard L Popp; Robert A Harrington Journal: Am Heart J Date: 2004-02 Impact factor: 4.749
Authors: Robert Klitzman; Paul S Appelbaum; Alexandra Murray; Ekaterina Pivovarova; Deborah F Stiles; Charles W Lidz Journal: Ethics Hum Res Date: 2020-01