Medical education research and IRB review: An analysis and comparison of the IRB review process at six institutions

Liselotte (Lotte) Dyrbye, Matthew R. Thomas, Alex J. Mechaber, Anne Eacker, William Harper, F. Stanford Massie, David V. Power, Tait D. Shanafelt

Research output: Contribution to journalArticle

39 Citations (Scopus)

Abstract

PURPOSE: To compare how different institutional review boards (IRBs) process and evaluate the same multiinstitutional educational research proposal of medical students' quality of life. METHOD: Prospective collection in 2005 of key variables regarding the IRB submission and review process of the same educational research proposal involving medical students, which was submitted to six IRBs, each associated with a different medical school. RESULTS: Four IRBs determined the protocol was appropriate for expedited review, and the remaining two required full review. Substantial variation existed in the time to review the protocol by an IRB administrator/IRB member (range 1-101 days) and by the IRB committee (range 6-115 days). One IRB committee approved the study as written. The remaining five IRB committees had a median of 13 requests for additional information/changes to the protocol. Sixty-eight percent of requests (36 of 53) pertained to the informed consent letter; one third (12 of 36) of these requests were unique modifications requested by one IRB but not the others. Although five IRB committees approved the survey after a median of 47 days (range 6-73), one committee had not responded six months after submission (164 days), preventing that school from participating. CONCLUSIONS: 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.

Original languageEnglish (US)
Pages (from-to)654-660
Number of pages7
JournalAcademic Medicine
Volume82
Issue number7
DOIs
StatePublished - Jul 2007

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Research Ethics Committees
Medical Education
Biomedical Research
educational research
medical student
education
Advisory Committees
reform
school
quality of life
Medical Students
Research Design
evidence
Administrative Personnel
Informed Consent
Medical Schools

ASJC Scopus subject areas

  • Nursing(all)
  • Public Health, Environmental and Occupational Health
  • Education

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Medical education research and IRB review : An analysis and comparison of the IRB review process at six institutions. / Dyrbye, Liselotte (Lotte); Thomas, Matthew R.; Mechaber, Alex J.; Eacker, Anne; Harper, William; Massie, F. Stanford; Power, David V.; Shanafelt, Tait D.

In: Academic Medicine, Vol. 82, No. 7, 07.2007, p. 654-660.

Research output: Contribution to journalArticle

Dyrbye, LL, Thomas, MR, Mechaber, AJ, Eacker, A, Harper, W, Massie, FS, Power, DV & Shanafelt, TD 2007, 'Medical education research and IRB review: An analysis and comparison of the IRB review process at six institutions', Academic Medicine, vol. 82, no. 7, pp. 654-660. https://doi.org/10.1097/ACM.0b013e318065be1e
Dyrbye, Liselotte (Lotte) ; Thomas, Matthew R. ; Mechaber, Alex J. ; Eacker, Anne ; Harper, William ; Massie, F. Stanford ; Power, David V. ; Shanafelt, Tait D. / Medical education research and IRB review : An analysis and comparison of the IRB review process at six institutions. In: Academic Medicine. 2007 ; Vol. 82, No. 7. pp. 654-660.
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