| Literature DB >> 30866723 |
Judith A Linden1,2, Jeffrey I Schneider1,2, Andrea Cotter1,2, Sabrina Drexel1,2, Emily Frosch3, Niels D Martin4, Colleen Canavan5, Matthew Holtman5, Patricia M Mitchell1,2, James A Feldman1,2.
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.Entities:
Keywords: graduate medical education; institutional review boards; medical professionalism; research ethics committees
Mesh:
Year: 2019 PMID: 30866723 DOI: 10.1177/1556264619831895
Source DB: PubMed Journal: J Empir Res Hum Res Ethics ISSN: 1556-2646 Impact factor: 1.742