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2023 PRIM&R Annual Conference

FDA Regulated Research

Informed Consent

C04 - [IN-PERSON/RECORDED] Exception From Informed Consent (EFIC): Overview and Common Pitfalls

Monday, December 4, 2023
3:45 PM – 4:45 PM ET
Location: Room 145 AB
Live Session Recorded Human Subjects Research Deep Dive Series
This session will be offered in-person and recorded for on-demand access by in-person PRIMR23 attendees registered for this day, and PRIMR23/SBER23 Virtual Meeting registrants.

EFIC requirements for emergency research at 21 CFR 50.24 provide a narrow exception to obtaining informed consent. Protocols for clinical trials conducted under EFIC have a high regulatory and ethical threshold for acceptability and also require robust community engagement, transparent public disclosure, rigorous review prior to being allowed to proceed, and thoughtful oversight.

Learning Objectives:

  • Describe the regulatory requirements under 21 CFR 50.24
  • Identify common EFIC related deficiencies identified in submissions to FDA
  • Review the commonalities of the regulations between 21 CFR 50.24 and 21 CFR 50, subpart D “Additional Safeguard for Children in Clinical Investigations”  
  • Discuss the unique issues, ethical considerations, and requirements in clinical trials conducted under EFIC