Improvised Exemptions: A Soloist’s Perspective

Joe Konstan, PhD, Distinguished McKnight Professor and Distinguished University Teaching Professor of Computer Science and Engineering at the University of Minnesota, gave a plenary speech at an OHRP sponsored RCF in Cincinnati, Ohio. The co-hosts of the RCF, Cincinnati Children's Hospital Medical Center, Schulman IRB, University of Cincinnati, University of Kentucky Office of Research Integrity, Cincinnati Veterans Affairs Medical Center, the UK Center for Clinical and Translational Science, and the Center for Clinical & Translational Science & Training, posted this recording of Dr. Konstan's presentation for public education purposes.

In this talk, Dr. Konstan discusses the distinctive challenges that exempt studies present for IRBs. Some areas of research need rapid review, and standard IRB policies are often silent when faced with changes in an exempt study and deciding when they rise to the level of review. Looking at exempt research from the PI perspective, he uses examples to draw lessons on how PIs and IRBs might better collaborate on ensuring compliance and safety in exempt research.