Flexibility and Innovation in IRB Processes Track
2019 AER Conference
Alexander M. Capron, LLB, MA (Hon).
University Professor; Scott H. Bice Chair in Healthcare Law, Policy and Ethics, Gould School of Law; Professor of Medicine and Law, Keck School of Medicine; Co-Director, Pacific Center for Health Policy and Ethics, University of Southern California
Scott H. Bice Chair in Healthcare Law, Policy and Ethics, Gould School of Law; Professor of Medicine and Law, Keck School of Medicine; , University of Southern California
A frequent regulatory issue is whether a practice conducted by a physician or an institution, when consistently practiced in that institution, but novel and not yet adopted by the community, counts as medical innovation or research. For example: when a physician or group of physicians want to collect data on their consistently provided, but unique/novel practice (i.e., this practice "would be provided anyway" to their patients), is this standard of care, medical innovation, or research? If it is research, how should it be reviewed? This issue is important as it comes up frequently in IRB review, although it may be addressed differently by IRBs. This session will present the issue, discuss potential ways of addressing it, and attempt to problem solve the best treatment of these common situations. This session will make heavy use of active learning techniques, such as small group work, case studies, hands-on activities, and interactive discussion, and presumes sufficient experience and understanding to actively contribute to the discussion of and solution to these problems. This session will not review basic concepts. During this session, speakers and attendees will: