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2022 PRIM&R Annual Conference

Populations Requiring Additional Protections

Advancing Equity and Justice in Research

A05 - A Case Study Exploring the Ethical Considerations for Pediatric Clinical Trials

Monday, December 12, 2022
11:45 AM – 12:45 PM ET
Location: Livestreamed
Livestreaming Session Icon CIP Accredited Human Subjects Research Deep Dive Series
FDA’s regulations for human subjects protections for children, the Additional Safeguards for Children in Clinical Investigations (21 CFR 50, subpart D), must be considered when children are enrolled in a clinical trial. This session will provide an overview of FDA’s current policy related to the interpretation and application of Subpart D in pediatric clinical trials, a case example, and a panel discussion.

Learning Objectives:

  • Describe FDA’s policy related to key concepts related to the enrollment of children in clinical trials in 21 CFR 50, Subpart D, including “prospect of direct benefit,” the meanings of “minimal risk” and “minor increase over minimal risk,” and “component analysis”
  • Evaluate a clinical trial protocol to determine if a trial may be allowed to proceed under 21 CFR 50.51, 50.52, or 50.53