By Emily Anderson
Medical school curricula now emphasize evidence-based medicine. We also need to prioritize evidence-based educational strategies. There are some great educational innovations happening at our medical school, but too few publications highlighting these. Conducting research on medical education faces many barriers, not least of all, lack of funding. Publication in any peer-reviewed academic journal usually requires some evaluation data; to get in a top-tier journal, you need solid research methodology, clearly defined outcome measures, and sufficient sample sizes. Medical education journals are notorious for rejecting small pilot studies, which is discouraging. Perhaps even more daunting are the Institutional Review Boards (IRBs). Studies indicate that medical education researchers face challenges in IRB submission and review (1,2). Unfortunately, we often end up implementing new programs – and maybe even doing a solid program evaluation – but never sharing what we’ve learned with colleagues outside our own institution…
My own scholarship focuses primarily on research ethics, and I am in a Department of Medical Education. Thus, I can’t help but think about the ethics of medical research. First and foremost, I believe that generating and disseminating knowledge is a professional obligation of all medical educators. But I must admit, even I am intimidated when preparing an IRB application. The federal research regulations were designed primarily with biomedical research in mind, not medical education research. Typically, an academic medical center’s IRB is set up to review complex drug study protocols that pose significant risk to patient-participants. The methods of medical education research are unfamiliar. Those responsible for reviewing lower risk protocols under exempt and/or expedited procedures may be poised out of habit to see all research as inherently risky. So, we run into the proverbial “square peg/round hole” problem. There have not been the same robust discussions about medical education research in the research ethics literature or within the medical education community as there have been regarding other disciplines that face similar challenges in IRB submission and review, such as quality improvement/quality assurance, oral history, or public health surveillance activities. Consensus regarding shared ethical norms is needed to supplement regulations.
Medical schools collect a lot of data from medical students to assess academic performance, gauge satisfaction, and track well-being. Program evaluation or routine assessment data not only can but should be the basis for faculty scholarship. However, for many medical educators, there continues to be confusion about whether and when the use of student data for research requires IRB review. Figuring out what “counts” as research and what is subject to human research regulations (45 CFR 46, also known as the Common Rule) is no small task for research ethics and regulatory experts, let alone your “average” medical educator (if there is such a thing). Additional challenges include:
- Determining when individual informed consent is required.
- Balancing the need for data from a sufficient and representative number of students with the ethical obligation to minimize pressure on students to participate.
- Identifying and implementing appropriate protections (such as disclosure of the fact of research) even when research activities are exempt from federal regulations and individual consent is not required.
- Negotiating the dual roles of educator and investigator.
In a 2000 special issue of Academic Medicine, medical schools were challenged to develop infrastructure to better support scholarship in medical education (3). At our institution, particularly within the Department of Medical Education, we continue to seek ways to support medical education research. As the local “research ethics person,” I aim to serve as a resource to those new to research or who suffer from IRB anxiety – and as a bridge between medical education researchers and our human research protections program.
Emily E. Anderson, PhD, MPH, is assistant professor in the Ralph P. Leischner, Jr., MD, Department of Medical Education at Loyola University Chicago Stritch School of Medicine. She also directs the research ethics track of the doctoral program in bioethics and health policy.
- Liselotte N Dyrbye, Matthew R Thomas, Klara K Papp, Steven J Durning (2008). Clinician Educators’ Experiences with Institutional Review Boards: Results of a National Survey Academic Medicine 83(6):590-595.
- Liselotte N Dyrbye, Matthew R Thomas, Alex J Mechaber, Anne Eacker, William Harper, Stanford Massie Jr, David V Power, Tait D Shanafelt (2007). Medical Education Research and IRB Review: An Analysis and Comparison of the IRB Review Process at Six Institutions. Academic Medicine 82(7); 654-660.
- Ruth-Marie E Fincher, Deborah E Simpson, Stewart P Mennin, Gary C Rosenfeld, Arthur Rothman, Martha Cole McGrew, Penelope A Hansen, Paul E Mazmanian, Jeffrey M Turnbull (2000). Scholarship in Teaching: An Imperative for the 21st Century. Academic Medicine 75(9):887-894.
One thought on “Medical Education Research and IRB Review”
“We also need to prioritize evidence-based educational strategies.” Thank you Dr. Emily Andersen for your efforts to uphold human research protections/research ethics while supporting scholarly medical education research initiatives…Your IRB practical wisdom is needed, thus hope to see further publications from you and your colleagues for pragmatic guidance in this area.