Bioethics Blogs

Medical Education Research and IRB Review

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.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.