N14 - Sponsored Session from Advarra: Demystifying the Reporting of Unanticipated Problems and Serious/Continuing Noncompliance to Federal Agencies for IRB Professionals
Saturday, November 8, 2025
12:30 PM - 1:30 PM ET
Location: Room 343-344
Feel free to bring your lunch to this session!
Navigating the complexities of reportable events can be one of the more challenging aspects of Institutional Review Board (IRB) oversight responsibilities. This session is designed to empower IRB professionals with clarity and confidence in identifying, assessing, and reporting unanticipated events and serious and continuing noncompliance to the Office of Human Research Protections (OHRP) and Food and Drug Administration (FDA).
Learning Objectives:
Identify relevant OHRP and FDA regulations and guidance for unanticipated problems and serious/continuing noncompliance
Apply decision-making strategies to assess the severity, scope, and impact of these potential reportable events, ensuring consistent and defensible determinations
Outline reporting pathways to the IRB, appropriate institutional officials, and regulatory agencies
Strengthen institutional readiness for handling reportable events and identifying areas for improvement
.jpg "Jan L. Hewett, BSN, JD (she/her/hers) photo")