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2023 PRIM&R Annual Conference

QA/QI and Postapproval Monitoring

B10 - [IN-PERSON ONLY] Protocol Deviations, Protocol Violations, Protocol Variances, Protocol Exceptions, and Noncompliance: What Really Needs to be Reported to an IRB

Monday, December 4, 2023
2:15 PM – 3:15 PM ET
Location: Room 150 AB
Human Subjects Research Learning Lab Series
This session is being held in-person only at PRIMR23. It will not be recorded for on-demand access or for the PRIMR23/SBER23 Virtual Meeting.

The Common Rule and sections 21 CFR 50 and 56 of the FDA regulations only refer to serious and continuing noncompliance, but do not define any of the terms while the phrase protocol deviations only occur in FDA device regulations. Even though protocol deviations, exceptions, and violations are common parlance amongst research teams, auditors and monitors, and IRBs and HRPPs, the regulations are unclear regarding what events should be reported to an IRB, which has led to significant variation in IRB reporting requirements. Using didactic and case study approaches, participants in this session will explore the following objectives. 

Learning Objectives:

  • Discuss the regulatory basis of event reporting
  • Explore variation in IRB requirements for event reporting, the consequences of this variation (including for single IRB arrangements), and opportunities for harmonization
  • Discover which events should be reported to IRBs to promote the protection of human subjects