When do medical students become human subjects of research? The case of program evaluation.

Intense national dialogue exists around federal requirements protecting the rights of human subjects in clinical research. There is much less discussion surrounding protections for human subjects in such areas as evaluation research when the subjects are also students. Differential interpretation of 45 CFR 46 (the standing regulation on research involving human subjects) by institutional review boards (IRBs) leaves many confused about whether research using student data requires IRB review. At the heart of the uncertainty are "dual purpose activities," for example, when student data from program evaluation or routine assessments subsequently become the basis for faculty scholarship that is disseminated as "generalizable knowledge" to the community of medical educators. The authors identify two factors that should be considered as institutions develop applications and interpretations of 45 CFR 46. First, medical educators should enter into dialogues with their IRBs to become more familiar with these regulations and their application in evaluation or assessment studies. Second, for reasons of professionalism, faculty should seek opportunities to model in their role as researchers those ethical behaviors that are central to an honest relationship between physician and patient. In the educational context this means faculty disclosure of how student data may be used by faculty in their own scholarship and determination of when student consent is needed. The authors also describe how one medical school addressed this thorny challenge with assistance from the university IRB and offer suggestions to improve institutional procedures.