Abstract

To explore clinician educators' perceptions and experiences in obtaining institutional review board (IRB) approval to conduct medical education research (MER). Institutional members of the Clerkship Directors in Internal Medicine (CDIM; n = 110) were surveyed in 2006. The survey included questions about familiarity with and clarity of IRB policies, satisfaction with review of education research protocols, and how MER might be facilitated. Of 83 respondents (response rate 76%), 50 had submitted a MER protocol to an IRB. Nearly all were deemed exempt (74/154) or minimal risk (71/154). No protocols were rejected or not approved. Nearly a fourth of respondents were unfamiliar with specific IRB policies directly applicable to MER. Among those respondents who had some familiarity with the IRB policies specified, 47% to 52% considered the IRB policies clear. Eighteen of 30 (60%) respondents with recent experience in multiinstitutional MER agreed there were notable differences in the expectations of various institutional IRBs; only two reported that multiple IRB reviews resulted in improvements to the protocol. Half (37/73) indicated they would be more likely to conduct MER if they had a better understanding of the IRB's role and requirements in MER. Sixty-six of 73 (90%) agreed they would benefit from a national consensus statement regarding the IRB's role in MER. A high percentage of clinician educators in CDIM are conducting IRB-approved MER. They report several challenges with working with IRBs, and they agree that IRBs and clinician educators would benefit from a national consensus on the IRB's role in MER.

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