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.
Recommended Actions
- Document transfer plan in written agreement between original and receiving IRBs
- Identify studies being transferred and establish effective transfer date
- Ensure availability and retention of pertinent records:
- Research protocols
- Consent forms
- Meeting minutes
- Correspondence
- Reports
- Determine if receiving IRB will conduct initial/continuing review before accepting responsibility
- Update informed consent documents with new contact information
- Notify all key parties involved in transfer
- Update IRB registration information if needed
- Update IND/IDE with new IRB information
- Establish clear process for handling adverse events and safety reporting during transition
- 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
- Clear documentation of transfer plan between original and receiving IRBs
- Records must be retained for at least 3 years after study completion and be accessible for FDA inspection
- IRB registration must be updated within 30 days if changes occur in types of FDA-regulated research reviewed
- Key parties must be notified of transfer (investigator, sponsor, institutional members, etc.)
- IND/IDE must be updated with new IRB information
Relevant Guidances
- Continuing Review of Clinical Investigations by Institutional Review Boards (IRBs)
- IRB Responsibilities for Reviewing Investigator Qualifications, Research Sites, and IND/IDE Requirements
- Informed Consent in Clinical Investigations: Requirements, Documentation, and Procedures
- Minutes of Institutional Review Board (IRB) Meetings - Content and Documentation Requirements
- Written Procedures for Institutional Review Boards (IRBs): Administrative Requirements and Operations
Related references and norms
- 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
This post is licensed under CC BY 4.0 by the author.