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Academic Medicine:
doi: 10.1097/ACM.0b013e3181f04765
Letters to the Editor

Time to Clarify Guidelines for Researchers and IRBs in Medical Education Research

Fiebach, Nicholas H. MD

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Professor of clinical medicine and vice chair for graduate and continuing medical education, Department of Medicine, Columbia University College of Physicians and Surgeons, New York, New York; nhf2101@columbia.edu.

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To the Editor:

I applaud the requirement announced by the editor of Academic Medicine that reports of studies submitted to the journal must include details of ethical approval for the research or, if the author does not have access to a formal approval process, information about the treatment of the study's human participants.1

In addition to the editor's five reasons for this requirement, I would add another one: that students or residents or even faculty recruited for educational research studies are potentially vulnerable to coercion to participate, loss of privacy, or adverse actions.

It is not always easy to balance this potential vulnerability of students, residents, and faculty against existing regulations and researchers' goals in recruiting subjects. Medical education research may be exempt from institutional review board (IRB) approval, under the provisions of Subpart A, Section 46.101 of the Federal Code of Regulations regarding “research conducted in established or commonly accepted educational settings, involving normal educational practices.”2 However, there appears to be considerable variation in the way this provision is interpreted and implemented by different IRBs, as previously reported in Academic Medicine.3–5

I hope the journal will publish more discussion about the ethics of medical education research. It's time to clarify the guidelines for researchers and IRBs.

Nicholas H. Fiebach, MD

Professor of clinical medicine and vice chair for graduate and continuing medical education, Department of Medicine, Columbia University College of Physicians and Surgeons, New York, New York; nhf2101@columbia.edu.

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References

1 Kanter S. Ethical approval for studies involving human participants: Academic Medicine's new policy. Acad Med. 2009;84:149–150.

2 U.S. Department of Health and Human Services. Code of Federal Regulations. Title 45: Public Welfare. Part 46: Protection of human subjects. Subpart A, Section 46.111: Criteria for IRB approval of research. Available at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Accessed May 31, 2010.

3 Dyrbye LN, Thomas MR, Mechaber AJ, et al. Medical education research and IRB review: An analysis and comparison of the IRB review process at six institutions. Acad Med. 2007;82:654–660.

4 Carline JD, O'Sullivan PS, Gruppen LD, Richardson-Nassif K. Crafting successful relationships with the IRB. Acad Med. 2007;82(10 suppl):S57–S60.

5 Dyrbye LN, Thomas MR, Papp KK, Durning SJ. Clinician educators' experiences with institutional review boards: Results of a national survey. Acad Med. 2008;83:590–295.

© 2010 Association of American Medical Colleges

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