Members: $225
Nonmembers: $330
Not all HRPP programs have equal resources or the same compliance needs, yet every HRPP—regardless of size—must ensure adherence to the Common Rule (45 CFR 46), FDA human subjects regulations (21 CFR Parts 50 and 56), and the ethical principles that guide research oversight. Programs must structure their processes so they fulfill required regulatory functions such as review, continuing oversight, reporting, and documentation, while maintaining flexibility to adapt to institutional constraints and changing operational environments.
In this session, speakers will discuss how their HRPPs interpret and implement key regulatory requirements within different resource models. They will highlight approaches to meeting mandated compliance activities—such as IRB review responsibilities, informed consent requirements, continuing review (when applicable), unanticipated problem reporting, and quality assurance—while managing program size, staff capacity, and institutional priorities. The discussion will include examples of how HRPPs monitor regulatory adherence, maintain documentation that meets Common Rule and FDA expectations, and adjust compliance strategies in real time without compromising protections for participants