title: Perspective: medical education research and the institutional review board: reexamining the process.
abstract: Medical school and residency training curricula across the country have undergone extensive revisions and, much like clinical quality improvement (QI) initiatives, require assessments of new programs. Because sharing knowledge is a hallmark of academic medicine, program evaluation may come under the purview of the institutional review board (IRB); however, the distinction between QI and research is often unclear. And yet a medical education (ME) inquiry can be designed according to either paradigm. The purpose of this article is to bring IRBs and ME researchers closer to a shared understanding of key concepts underlying human participation in research and QI activities, and to consensus on the application of these concepts. The current QI discourse provides a useful framework for making this distinction; the authors identify key theoretical principles and practical considerations derived from this work that are relevant to ME and training, such as the application of the regulatory definition of human subject research to ME inquiries. For ME inquiries defined as human subject research, and therefore subject to IRB review, this article explores the application of the human research regulations to ME research. It concludes with practical suggestions for institutions, IRBs, and ME researchers, which range from formal procedures for making the QI versus research distinction, to instruction in study design and development and the human subject regulatory implications. The intent is to promote a discussion that will result in greater consensus and a more consistent application of the regulatory framework.
authors: Harvard Medical School, Division of Translational Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA. ajohanss@bidmc.harvard.edu
authors: Anna C
authors: AC
authors: Johansson
authors: Steven J
authors: SJ
authors: Durning
authors: Larry D
authors: LD
authors: Gruppen
authors: Marianne E
authors: ME
authors: Olson
authors: Richard M
authors: RM
authors: Schwartzstein
authors: Patricia A
authors: PA
authors: Higgins