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Process for Clinical Investigations Involving Children Requiring Additional Safeguards

This guidance outlines FDA's process for handling clinical investigations involving children that require additional safeguards and have been referred for review under 21 CFR 50.54. It describes the procedures for IRBs, sponsors, and clinical investigators when a clinical investigation involving children does not meet the standard requirements and needs special consideration.

  1. Consult with sponsor about possible protocol modifications before referring to FDA under 50.54
  2. Submit complete referral package to FDA’s Office of Pediatric Therapeutics including:
    • IRB findings and explanation
    • Research protocol
    • IND/IDE number if applicable
    • Informed consent documents
    • Supporting documentation
  3. Ensure all documents are in “IRB-approvable” condition except for 50.54 issues
  4. For multi-site studies, notify all sites of the referral
  5. Prepare for participation in:
    • Public comment period
    • Pediatric Ethics Subcommittee meeting
    • Pediatric Advisory Committee meeting
  6. Plan for approximately 6-month review timeline
  7. If joint FDA-HHS jurisdiction applies, prepare for coordinated review process

Key Considerations

Clinical testing

  • Clinical investigations cannot proceed until Commissioner approval after IRB referral
  • Multi-site clinical investigations may continue at other sites during review process
  • IRB must document that investigation presents reasonable opportunity to further understanding/prevention/alleviation of serious problems affecting children’s health/welfare

Safety

  • Must ensure protection of rights, safety and welfare of children
  • Must be conducted according to sound ethical principles
  • Adequate provisions required for obtaining child assent and parental permission

Other considerations

  • 21 CFR Part 50 Subpart D: Additional Safeguards for Children in Clinical Investigations
  • 45 CFR Part 46 Subpart D: Additional Protections for Children Involved as Subjects in Research

Original guidance

  • Process for Clinical Investigations Involving Children Requiring Additional Safeguards
  • HTML / PDF
  • Issue date: 2006-12-01
  • Last changed date: 2024-08-09
  • Status: FINAL
  • Official FDA topics: Medical Devices, Pediatric Product Development, Good Clinical Practice (GCP), Drugs, Biologics
  • ReguVirta summary file ID: 5cba51f1b4e6d89b0c50defce87d1d4c
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