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Process for Research Involving Children that Requires FDA and OHRP Review under 21 CFR 50.54 and 45 CFR 46.407 (DRAFT)

This guidance outlines the process for reviewing research involving children as subjects that cannot be approved by an Institutional Review Board (IRB) under standard provisions and requires referral to FDA under 21 CFR 50.54 and/or OHRP under 45 CFR 46.407. It details the procedures for IRBs, institutions, investigators, and sponsors to submit referrals and explains how FDA and OHRP conduct their reviews, including the use of expert panels and public comment periods.

This is a draft guidance. Not for implementation.

  1. Determine if research requires referral to FDA and/or OHRP based on inability to approve under standard provisions
  2. Submit complete referral package including:
    • IRB’s explanation why research doesn’t meet standard requirements
    • Research protocol and informed consent documents
    • Supporting documentation (IRB minutes, correspondence, etc.)
  3. Work with FDA/OHRP on redaction of confidential information for public posting
  4. Attend expert panel meeting to present and answer questions about the research
  5. Implement any required changes based on final determination from Commissioner/ASH
  6. For multi-site studies:
    • Notify sponsor/HHS division of referral
    • Inform other study site IRBs
    • Follow clinical hold requirements if applicable
  7. Maintain documentation of all communications and determinations throughout the process

Key Considerations

Clinical testing

  • Research must present a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting children’s health or welfare
  • Research must be conducted according to sound ethical principles
  • For FDA-regulated studies, clinical holds may be applied to all sites in multi-site studies

Human Factors

  • Adequate provisions must be made for obtaining assent from children and permission from parents/guardians

Safety

  • Research must be conducted in accordance with sound ethical principles
  • Adequate protections must be in place for child subjects

Other considerations

  • 21 CFR 50: Protection of Human Subjects
  • 45 CFR 46: Protection of Human Subjects
  • 21 CFR 312: Investigational New Drug Application
  • 21 CFR 812: Investigational Device Exemptions

Original guidance

  • Process for Research Involving Children that Requires FDA and OHRP Review under 21 CFR 50.54 and 45 CFR 46.407
  • HTML / PDF
  • Issue date: 2023-03-30
  • Last changed date: 2024-04-11
  • Status: DRAFT
  • Official FDA topics: Medical Devices, Pediatric Product Development, Drugs, Biologics
  • ReguVirta summary file ID: e5e2e5c7325c65b1826db10ecaef05d6
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