Medical Education Research and IRB Review: An Analysis and Comparison of the IRB Review Process at Six Institutions

Abstract

The findings suggest variability in the timeliness and consistency of IRB review of medical education research across institutions that may hinder multi-institutional research and slow evidence-based medical education reform. The findings demonstrate the difficulties of having medical education research reviewed by IRBs, which are typically designed to review clinical trials, and suggest that the review process for medical education research needs reform.

Clinician Educators??? Experiences with Institutional Review Boards: Results of a National Survey

“…Recent publications suggest that some clinician educators have experienced unnecessary frustration during the IRB review process. [7][8][9] These publications highlight difficulties with the process of IRB review (tediousness of required paperwork, multiple paper copies, prolonged delays, etc.) for medical education research.…”

Student participation in health professions education research: in pursuit of the Aristotelian mean

“…The TCPS and Belmont report both emphasize that research studies reviewed by the REB should minimize risk and maximize potential benefit. However, some argue that principles laid out in the reports are more suited towards clinical trials and are less applicable to education research and to health professions students as research participants (Dyrbye et al 2007;Pugsley and Dornan 2007). In HPER, nearly all studies meet the ''minimal risk'' definition as set out by 45 CFR 46 (Evans 2002).…”

“…While students might very well benefit from innovative teaching methods, it could be equally reasonable to see how some innovations could result in student harm by exposing students to unevaluated, inappropriate, or ineffective teaching modalities (Eva 2007). However, some have argued that the onerous demands of REBs deter education researchers in the health professions and create significant barriers to conducting intended studies (Dyrbye et al 2007). …”

Education Research and Human Subject Protection: Crossing the IRB Quagmire

“…4 Education researchers report frustration with the required paperwork, multiple copies, prolonged delays, and other ''hurdles'' of the IRB oversight process. 3,12,13 Also, education researchers may have less assistance than biomedical researchers for creating ''The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. '' and tracking IRB submission paperwork.…”

“…A 2005 study examined the results of the same education proposal, which included an anonymous survey and focus groups of medical students, submitted to 6 medical school IRBs. 12 Four of the IRBs judged the study appropriate for expedited review, whereas 2 performed a full review. For the reviews by a single member, the time to decision ranged from 1-101 days.…”