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Evaluation Live Stream

2025 SBER Conference

Social, Behavioral, and Educational Research

Foundations of Research Ethics and Oversight

Regulatory Frameworks and Compliance

IRB Operations and Management

B02 - When SBER Meets FDA: A Survival Guide to Support SBE IRBs and Researchers

Thursday, November 6, 2025
11:30 AM - 12:30 PM ET
Location: Room 339-342
Human Subject Research - HSR Learning Lab Series Call for Session Proposal - CSP CIP Accredited Live Session Recorded Live Streamed Session
FDA regulations can be overwhelming, especially for the SBER community, which often doesn’t encounter—or realize the need for—FDA oversight. However, as innovation and interdisciplinary research grow, SBER studies increasingly include FDA-regulated components. This session will explore how SBER IRBs can support researchers in navigating FDA complexities, covering varied interpretations of FDA-regulated activities, their intersection with SBE research, and best practices for managing reviews and communication.

Learning Objectives:

  • Identify common challenges faced by SBE researchers conducting FDA-regulated studies
  • Understand how to interpret and apply FDA regulations across different SBE research contexts
  • Outline FDA requirements for IRB review and ongoing oversight of FDA-regulated research