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Exception from Informed Consent Requirements for Emergency Research

This guidance assists Institutional Review Boards (IRBs), clinical investigators and sponsors in conducting emergency research under an exception from informed consent requirements (21 CFR 50.24). It applies to investigations involving human subjects who have a life-threatening medical condition that necessitates urgent intervention, cannot provide informed consent due to their condition, and where available treatments are unproven or unsatisfactory.

  1. Establish and document therapeutic window based on scientific evidence
  2. Develop comprehensive plan for:
    • Community consultation activities
    • Public disclosure before and after study
    • Contacting legally authorized representatives
    • Informing subjects/representatives about participation
  3. Submit separate IND/IDE application clearly identifying exception from informed consent
  4. Establish independent data monitoring committee for study oversight
  5. Create procedures for:
    • Documenting attempts to contact representatives
    • Allowing discontinuation of participation
    • Maintaining required records
    • Reporting study results
  6. Obtain IRB review and approval of:
    • Study protocol
    • Informed consent procedures/documents
    • Community consultation plans
    • Public disclosure plans
  7. Monitor and document:
    • Community consultation activities
    • Public disclosure activities
    • Contact attempts with representatives
    • Study conduct and safety
  8. Report results through:
    • Public disclosure
    • Clinical trial registration
    • FDA submissions
    • Scientific publications

Key Considerations

Clinical testing

  • Must demonstrate prospect of direct benefit to subjects
  • Must be conducted under separate IND/IDE
  • Phase 1 studies generally not appropriate under this exception
  • Non-inferiority trials may be acceptable if they meet regulation requirements
  • Must establish independent data monitoring committee for oversight

Non-clinical testing

  • Must have appropriate animal and preclinical data supporting potential benefit
  • Must demonstrate reasonable risk-benefit ratio based on available evidence

Human Factors

  • Must document why obtaining informed consent is not feasible
  • Must attempt to contact legally authorized representative within therapeutic window
  • Must provide opportunity for family members to object to participation
  • Must inform subjects/representatives at earliest feasible opportunity about participation

Safety

  • Must establish therapeutic window based on scientific evidence
  • Must have procedures to protect subject rights and welfare
  • Must have procedures for informing subjects/representatives about participation
  • Must allow discontinuation of participation without penalty

Other considerations

  • ICH E6: Good Clinical Practice
  • ICH E10: Choice of Control Group and Related Issues in Clinical Trials

Original guidance

  • Exception from Informed Consent Requirements for Emergency Research
  • HTML / PDF
  • Issue date: 2013-04-01
  • Last changed date: 2020-04-21
  • Status: FINAL
  • Official FDA topics: Medical Devices, Drugs, Good Clinical Practice (GCP), Biologics
  • ReguVirta summary file ID: bcd88b49a74bc51eb93141b332fba930
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