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Transfer of Clinical Investigation Oversight Between Institutional Review Boards

This guidance discusses the regulatory responsibilities of institutional review boards (IRBs), clinical investigators, and sponsors when oversight of a previously approved, ongoing clinical investigation under FDA's jurisdiction is transferred from one IRB to another IRB. It provides recommendations on procedures and processes required/recommended when such oversight is transferred.

  1. Document transfer plan in written agreement between original and receiving IRBs
  2. Identify studies being transferred and establish effective transfer date
  3. Ensure availability and retention of pertinent records:
    • Research protocols
    • Consent forms
    • Meeting minutes
    • Correspondence
    • Reports
  4. Determine if receiving IRB will conduct initial/continuing review before accepting responsibility
  5. Update informed consent documents with new contact information
  6. Notify all key parties involved in transfer
  7. Update IRB registration information if needed
  8. Update IND/IDE with new IRB information
  9. Establish clear process for handling adverse events and safety reporting during transition
  10. Maintain continuous IRB oversight with no lapses in approval or human subject protection

Key Considerations

Clinical testing

  • Continuous IRB oversight with no lapse in approval or protection of human subjects must be maintained during transfer
  • If oversight cannot be obtained by closure date, approval is considered suspended/terminated with no further subject enrollment
  • Receiving IRB must review study before approving substantive changes to research or informed consent

Labelling

  • Informed consent document must be updated with new contact information for subjects’ rights and research-related injuries
  • For enrolled subjects, updates can be provided via letter
  • For new subjects, consent forms must be revised with new contact information

Safety

  • IRBs must ensure protection of human subjects during transfer
  • Receiving IRB has authority to suspend/terminate approval if study not conducted according to requirements
  • Must promptly report any suspension/termination to investigator, officials and FDA

Other considerations

  • 21 CFR 50: Protection of Human Subjects
  • 21 CFR 56: Institutional Review Boards
  • 21 CFR 312: Investigational New Drug Application
  • 21 CFR 812: Investigational Device Exemptions

Original guidance

  • Transfer of Clinical Investigation Oversight Between Institutional Review Boards
  • HTML / PDF
  • Issue date: 2014-05-23
  • Last changed date: 2020-05-07
  • Status: FINAL
  • Official FDA topics: Medical Devices, Drugs, Good Clinical Practice (GCP), Biologics
  • ReguVirta summary file ID: 4a4e2abe381514c831c05d9c7ab351b5
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