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 discussi on surrounding protections for human subjects in such areas as evaluation r esearch when the subjects are also students. Differential interpretation of 45 CFR 46 (the standing regulation on research involving human subjects) b y institutional review boards (IRBs) leaves many confused about whether res earch using student data requires IRB review. At the heart of the uncertain ty are "dual purpose activities," for example, when Student data from progr am evaluation or routine assessments subsequently become tl-Le basis for fa culty 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 educa tors should enter into dialogues with their IRBs to become more familiar wi th these regulations and their application in evaluation or assessment stud ies. Second, for reasons of professionalism, faculty should seek opportunit ies to model in their role as researchers those ethical behaviors that are central to an honest relationship between physician and patient. In the edu cational context this means faculty disclosure of how student data may be u sed by faculty in their own scholarship and determination of when student c onsent is needed. The authors also describe how one medical school addressed this thorny chal lenge with assistance from the university IRB and offer suggestions to impr ove institutional procedures.