We read with interest the letter to the editor from Dr. van den Broek and colleagues describing the impressive effort by the Netherlands Association for Medical Education to centralize and streamline the process of review of health professions education (HPE) research in the Netherlands. This effort reflects, on a national scale, the same goals that guided the development of our HPE-specific institutional review board (IRB) template.1
The transition to electronic templates for IRB submissions at many academic health centers in the United States has already had a great impact on the efficiency of submissions and reviews for IRBs and therefore has reduced barriers for investigators. The template described in our article has already evolved into a fully redesigned, Web-based IRB interface at our institution.
We must admit, however, that we were troubled by a particular assertion made by the letter’s authors. We strongly disagree with the contention that the risks to learners or educators are less severe than the risks to subjects in other research fields. While the authors correctly state that most HPE research indeed falls in exempt review (as determined in the United States by the exemption criteria described in the common rule),2 there are certainly cases where independent review and consideration of risks to learners is important and should not be minimized: (1) in cases where investigators are receiving significant outside funding for research; (2) in cases where coercion may be particularly important, such as studies which alter the relationship between student and supervising faculty/clinician; or (3) in cases where students may feel that educational research may have negatively impacted their education.3
The centralized Research Ethics Committee for HPE research described by Dr. van den Broek and colleagues is very innovative and intriguing, and perhaps an excellent model to be replicated in the United States. We have previously contended that the variability in how individual IRBs review education research (and whether they deem it worthy of review at all) makes review of HPE research projects that reach across institutions especially problematic for investigators. We thank the authors for introducing us to this excellent model for HPE research review.
Stephen DeMeo, DO, MEd
Attending neonatologist, WakeMed Health & Hospitals, Raleigh, North Carolina, and adjunct professor of pediatrics, Duke University Medical Center, Durham, North Carolina; email@example.com.
Mitchell T. Heflin, MD, MHS
Associate professor of medicine, Division of Geriatrics, and Geriatric Medicine Fellowship program training director, Duke University Medical Center, Durham, North Carolina.
Alisa Nagler, JD, EdD
Assistant director, Accreditation, Validation and Credentialing, American College of Surgeons, Chicago, Illinois, and adjunct associate professor of the practice of medical education, Duke University School of Medicine, Durham, North Carolina.
1. DeMeo SD, Nagler A, Heflin MT. Development of a health professions education research-specific institutional review board template. Acad Med. 2016;91:229232.
2. Department of Health and Human Services. 45 CFR 46.101(b)(1–6). Revised January 15, 2009. http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/#46.101
. Accessed September 14, 2016.
3. Tomkowiak JM, Gunderson AJ. To IRB or not to IRB? Acad Med. 2004;79:628632.