Institutional leadership needs to stay up-to-date with evolving research trends, as well as upcoming changes to the federal regulatory landscape and implications for research. In this session, speakers will explore three key changes: FDA’s single IRB mandate, NIH Office of Science Policy (OSP) Guidelines, and the Department of Justice's (DOJ) False Claims Act enforcement. These changes will have implications for institutional leadership and their institutions. This dynamic session will provide an opportunity to engage with session speakers and peers, and is preparatory for the "Planning for Ethical and Regulatory Changes in Research Programs" session.
Learning Objectives:
Understand the basic elements of the changes from the FDA’s single IRB mandate, NIH OSP Guidelines, and the DOJ's False Claims Act
Share practical tips and best practices for applying appropriate and necessary changes
Discuss with peers planning and implementation activities occurring at institutions