Institutional Official Discussion: Emerging Oversight Challenges and Necessary Process Enhancements

The role of the Institutional Official is complex and has broad responsibility for compliance with the federal regulations for the protection of human subjects, through ensuring the institution has a robust integrated infrastructure with sufficient resources. In this dynamic session, speakers will put a broad set of issues on the table for discussion, including: cultivating an integrated HRPP with your other compliance programs (e.g., COI, COC, Export Control, Sponsored Programs, etc.); single IRB facilitation; supporting a virtual IRB and workforce; promoting external evaluations (peer review) of your program; supporting internal quality assurance; assessing the value and risk of investigator initiated studies; leadership cultivation within the office and on the IRB; promoting diversity, equity, and inclusion within the office and on the IRB; and exploring recent noncompliance/issues of HRPP programs. This session is intended to be dynamic and rapid paced, in order to cover topics that Institutional Officials are currently faced with or should be anticipating.