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Evaluation

2025 PRIM&R Annual Conference

Foundations of Research Ethics and Oversight

IRB Operations and Management

Regulatory Frameworks and Compliance

E02 - Research Plot Twists: Addressing and Expecting the Unexpected

Saturday, November 8, 2025
1:45 PM - 3:00 PM ET
Human Subject Research - HSR Learning Lab Series Call for Session Proposal - CSP CIP Accredited Live Session Recorded Live Streamed Session
At first glance, the IRB’s most significant effort often seems to come during the initial review of a project—and ideally, everything proceeds smoothly from there. But research is dynamic, and unexpected challenges can arise. When they do, IRB review can become complex and demanding. This session will use discussion and case studies to provide practical guidance on handling protocol deviations, potential unanticipated problems, serious or continuing noncompliance, and other unforeseen issues that may emerge during a study.

Learning Objectives:

  • Understand the regulatory definitions and responsibilities related to protocol deviations, unanticipated problems, serious noncompliance, and continuing noncompliance
  • Discuss strategies for distinguishing between event types and ensuring clear communication among researchers, the IRB, and regulatory authorities
  • Examine methods to ensure balanced, timely reviews without allowing a single topic to monopolize discussion
  • Apply concepts to real-world examples of deviations, noncompliance, and unanticipated problems