To IRB or Not to IRB?

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Abstract

Improving medical practice begins with the improvement of medical education. In this process, most academic medical faculty assume the dual roles of both teacher and researcher, often without intending to or realizing that they are. With the increased tightening of regulation and supervision of biomedical research in the United States, academic medical institutions and their individual faculty face the daunting regulatory compliance problems that are traditionally associated with clinical and bench research projects.

In 2000, as part of a new geriatrics curriculum initiative, one medical school (not the authors’ present institution) developed a mentor program that was designed to positively influence students’ attitudes about aging. Despite the attempts of faculty to design the curriculum and evaluation process to conform to human subjects regulations, formal allegations of research misconduct were brought against the faculty who were in charge of the curriculum. Even though research that shows that 70% of alleged research misconduct charges result in exoneration, an accusation of misconduct can have serious consequences for faculty including suspension of their project, undergoing an intensive investigation, and potentially making it impossible for the faculty member or institution to apply for future federally supported research funds. The authors wrote this article to serve as a wake-up call for medical educators to become intimately familiar with their own institution's institutional review board process and be proactive in educating themselves and their peers regarding research in medical education.

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