To the Editor:
Recently, DeMeo and colleagues1 stressed the need for a specific ethics template to evaluate health professions education (HPE) research by institutional review boards (IRBs), as IRBs should acknowledge the unique characteristics of such research. While we fully agree that IRBs generally are not well equipped to evaluate education studies and that a targeted approach to HPE research is valuable, we suggest a more radical approach. In 2010, the Netherlands Association for Medical Education established a national Research Ethics Committee (REC), specifically for HPE research, that not only has adequate expertise but is also well suited to serve multi-institutional studies.2
DeMeo and colleagues rightly state that an HPE-specific REC should evaluate research projects with the same rigor that applies to biomedical research.1 However, there are relevant differences. Students are usually less dependent on teachers than patients are on doctors. Harm and disadvantage may differ as the risks involved in HPE research are arguably often less severe than those associated with medical research, and often even absent. Also, we think students (and teachers, who may be research subjects too) generally will have a good understanding of the subject studied and can therefore weigh arguments and considerations. This obviously requires adequate provision of information. We therefore believe a risk-adaptive model for the review of HPE research is warranted. We believe a full review of risk–benefit ratios is necessary only in cases when there is the possibility of harm or risk for participants. In other cases, a limited review by one or two board members in which we focus mostly on evaluating the informed consent forms is sufficient.
Another issue is speed. Education research often needs a quick review because otherwise the education is over before it is studied. For our REC, we developed a Web-based submission procedure with a self-administered questionnaire whose purpose is to determine the appropriate level of review for submitted protocols. Researchers submitting requests for review are instructed to answer all questions truthfully. Thanks in part to this questionnaire, in 2015 the mean time to evaluate projects was 14 working days.
The number of applications to our HPE-specific REC has risen over the past few years, and currently we receive about 90 applications annually. We believe this model may be of interest for others reviewing HPE research.
W.E. Sjoukje van den Broek, MD
Secretary, Netherlands Association for Medical Education Ethical Review Board, and PhD candidate in medical education, University Medical Center Utrecht, Utrecht, The Netherlands; [email protected].
Fedde Scheele, MD, PhD
Chairman, Netherlands Association for Medical Education, and full professor of health systems innovation and education, VU University Medical Center, Amsterdam, The Netherlands.
Olle ten Cate, PhD
Cofounder, Netherlands Association for Medical Education Ethical Review Board, and full professor of medical education, University Medical Center Utrecht, Utrecht, The Netherlands.
Johannes J.M. van Delden, MD PhD
Chairman, Netherlands Association for Medical Education Ethical Review Board, and full professor of medical ethics, Julius Center for Health Sciences and Primary Care of Utrecht University, Utrecht, The Netherlands.
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. Eikelboom JI, ten Cate OT, Jaarsma D, Raat JA, Schuwirth L, van Delden JJ. A framework for the ethics review of education research. Med Educ. 2012;46:731733.