Variability in Institutional Board Review for a Multisite Assessment of Resident Professionalism. (April 2019)

• Record Type: Journal Article
• Authors: Linden, Judith A.; Schneider, Jeffrey I.; Cotter, Andrea; Drexel, Sabrina; Frosch, Emily; Martin, Niels D.; Canavan, Colleen; Holtman, Matthew; Mitchell, Patricia M.; Feldman, James A.
• Is Part Of: Journal of empirical research on human research ethics. Volume 14:Number 2(2019)
• Page Start: 117
• Page End: 125
• Publication Date: 2019-04
• Subjects: research ethics committees -- institutional review boards -- graduate medical education -- medical professionalism; Medical ethics -- Research -- Periodicals; Research -- Moral and ethical aspects -- Periodicals; 174.205
• DOI: 10.1177/1556264619831895
• Languages: English
• ISSNs: 1556-2646

Abstract

Residents serve as both trainees and employees and can be considered potentially vulnerable research participants. This can lead to variation in the institutional review board (IRB) review. We studied sites participating in the Assessment of Professional Behaviors Study sponsored by the National Board of Medical Examiners (2009-2011). Of the 19 sites, all but one were university affiliated. IRB review varied; 2/19 did not submit to a local IRB, 4/17 (23%) were exempt, 11/17 (65%) were expedited, and 2/17 (12%) required full Board review; 12/17 (71%) required written informed consent. The interval from submission to approval was 1 to 2 months (8/17); the range was 1 to 7 months. Although most stated there were no major barriers to approval, the most common concern was resident coercion and loss of confidentiality. Local IRB review of this educational research study varied.