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Evaluation

2025 PRIM&R Annual Conference

Foundations of Research Ethics and Oversight

IRB Operations and Management

Navigating Ethical Challenges

Regulatory Frameworks and Compliance

A01 - PLENARY: Navigating the IRB's Role Beyond Regulatory Compliance

Friday, November 7, 2025
10:30 AM - 11:45 AM ET
Human Subject Research - HSR Thought Leader Series Call for Session Proposal - CSP Live Streamed Session Live Session Recorded
IRBs are legally mandated to ensure human subjects research meets regulatory requirements, but their role often extends beyond mere compliance. When IRBs address ethical concerns not explicitly covered by regulations or adopt standards that exceed the legal minimum, they may face criticism for “mission creep” or for unnecessarily hindering research. How can IRBs strike the right balance between facilitating research and safeguarding ethical integrity? Is there room to promote the highest ethical standards rather than settling for the minimum? This session will explore the interplay between regulatory compliance and ethical excellence, clarify the boundary between mission creep and appropriate participant protection, and offer practical examples and strategies to navigate these challenges.

Learning Objectives:

  • Explain the differences between legal compliance, pursuing higher ethical standards, and the concept of mission creep
  • Identify ethical issues that IRBs may need to address beyond regulatory requirements and reflect on the IRB’s fundamental role as an ethics review committee
  • Describe community-driven IRB strategies for bridging regulatory gaps and promoting ethical research