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Evaluation

2025 PRIM&R Annual Conference

Foundations of Research Ethics and Oversight

Regulatory Frameworks and Compliance

B03 - Navigating Ethical and Regulatory Complexities in Research with Children

Friday, November 7, 2025
1:45 PM - 3:00 PM ET
Human Subject Research - HSR Learning Lab Series Call for Session Proposal - CSP Live Streamed Session Live Session Recorded
Research involving children presents distinct ethical and regulatory challenges that require careful interpretation of both Subpart D of the HHS regulations (45 CFR 46) and the foundational principles that guide their application. This session examines how IRBs can thoughtfully apply ethical principles and regulatory requirements to more complex scenarios involving child participants. Through discussion of real-world examples, attendees will consider how to assess risk, navigate assent and parental permission, and leverage regulatory flexibilities in the review of pediatric research protocols.

Learning Objectives:

  • Analyze how the definition of “children” under Subpart D influences the ethical and regulatory requirements for assent and parental consent in varying research contexts
  • Distinguish between the regulatory categories for minimal risk and greater-than-minimal risk pediatric research, and assess how to apply these categories in protocol review
  • Evaluate the ethical obligations and permissible regulatory flexibilities that IRBs and institutions can use to safeguard child participants while supporting ethically sound research