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Exception from Informed Consent Requirements for Emergency Research

This guidance addresses the requirements and procedures for conducting emergency research under 21 CFR 50.24, which provides an exception from informed consent requirements for research involving subjects who are in life-threatening situations where available treatments are unproven or unsatisfactory. The guidance is intended for IRBs, clinical investigators, and sponsors conducting such research under FDA regulations.

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By ReguVirta
3 min read

What You Need to Know? 👇

What are the key requirements for conducting emergency research under 21 CFR 50.24?

Emergency research requires subjects in life-threatening situations where available treatments are unproven/unsatisfactory, obtaining consent isn’t feasible due to medical condition, intervention must be administered before consent can be obtained, and the research holds prospect of direct benefit to subjects.

Can emergency research studies be conducted in pediatric populations?

Yes, pediatric studies may be conducted under 21 CFR 50.24. The IRB must additionally find that the study meets requirements of 21 CFR 50, Subpart D. Community consultation should include parents of children with the condition under study and children themselves when appropriate.

What is the difference between community consultation and public disclosure in emergency research?

Community consultation involves two-way discussions with community representatives before IRB approval, allowing meaningful input into decision-making. Public disclosure is one-way information dissemination to communities about study plans before initiation and results after completion, ensuring broader community awareness.

Are placebo-controlled trials allowed under the emergency research exception?

Yes, placebo-controlled trials may be conducted when appropriate. Typically, standard care is given to all subjects, with randomization to test treatment or placebo. Sponsors should provide sound rationale for any design excluding standard treatment aspects and consult with FDA.

What role does the Data Monitoring Committee play in emergency research studies?

An independent Data Monitoring Committee (DMC) must be established before study initiation to exercise oversight of the clinical investigation. The sponsor may either establish a new independent DMC or secure services of an already established DMC to meet regulatory requirements.

How long do investigators have to contact legally authorized representatives or family members?

Investigators must attempt contact within the therapeutic window - the time period based on scientific evidence during which the investigational product must be administered to have potential clinical effect. Contact attempts shouldn’t exhaust the entire window before administering the test article.

What You Need to Do 👇

  1. Develop detailed protocol documenting life-threatening condition and inadequacy of available treatments
  2. Establish independent data monitoring committee for study oversight
  3. Create comprehensive plans for:
    • Community consultation activities
    • Public disclosure before and after study
    • Contacting LARs/family members
    • Informing subjects/LARs/family of participation
    • Documentation of all required elements
  4. Submit separate IND/IDE application clearly identifying exception from informed consent
  5. Obtain IRB approval documenting all required findings under 50.24
  6. Obtain FDA authorization before study initiation
  7. Implement procedures to:
    • Contact LARs within therapeutic window
    • Document all contact attempts
    • Inform subjects/LARs/family of participation
    • Allow discontinuation of participation
    • Maintain required records
  8. Conduct and document community consultation and public disclosure activities
  9. Establish oversight mechanisms including data monitoring committee
  10. Create process for ongoing IRB review and continuing documentation of requirements

Key Considerations

Clinical testing

  • Must involve subjects in life-threatening situations requiring urgent intervention
  • Available treatments must be unproven or unsatisfactory
  • Research must hold prospect of direct benefit to subjects
  • Must have appropriate animal/preclinical data supporting potential benefit
  • Must establish therapeutic window based on scientific evidence

Human Factors

  • Must attempt to contact legally authorized representative (LAR) within therapeutic window
  • If no LAR available, must attempt to contact family member for opportunity to object
  • Must inform subject/LAR/family of participation at earliest feasible opportunity
  • Must allow discontinuation of participation at any time

Safety

  • Must have independent data monitoring committee oversight
  • Risks must be reasonable relative to condition, standard therapy, and potential benefits
  • Must document efforts to contact LAR/family
  • Must maintain records for at least 3 years

Other considerations

  • Must conduct community consultation before study initiation
  • Must provide public disclosure before and after study
  • Must submit protocol under separate IND/IDE
  • Must obtain prior FDA authorization
  • Must document IRB findings and determinations

Relevant Guidances 🔗

Original guidance

  • Exception from Informed Consent Requirements for Emergency Research
  • HTML / PDF
  • Issue date: 2013-04-01
  • Last changed date: 2025-02-03
  • Status: FINAL
  • Official FDA topics: Medical Devices, Good Clinical Practice (GCP), Biologics, Drugs
  • ReguVirta ID: bcd88b49a74bc51eb93141b332fba930
FDA guidance, Final
Medical Devices Good Clinical Practice (GCP) Biologics Drugs
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