Return of the IRB Jedi: Exploring Regulations, Guidance, and Institutional Policies

The Revised Common Rule reigns. There is unrest in the research galaxy. Implemented in January 2019, the research community must navigate between pre-2018 and 2018 regulatory requirements. Previously approved studies are in flux. The exempt category realm has expanded. Single IRB controls collaborative studies and informed consent requires key information. With new frontiers, IRBs are challenged to examine their practices and extend their expertise across two sets of regulations. This session will examine the importance of understanding where regulations end, where guidance begins (i.e., OHRP, SACHRP, etc.), the acknowledgement of institutional policies, and the challenges of this intersection. It will demonstrate application of the regulations and practical strategies for "it depends" scenarios. These strategies can serve as a foundation to adopt approaches taking in your institution's size, staff resources, and/or research community's portfolio.