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.
What You Need to Know? 👇
What are the key steps when transferring clinical investigation oversight from one IRB to another?
The FDA recommends eight key steps: identifying studies for transfer, ensuring record availability and retention, establishing an effective transfer date, conducting appropriate review by the receiving IRB, confirming continuing review dates, determining consent form revisions, notifying key parties, and updating IRB registration information.
How long must IRB records be retained after transferring oversight to another IRB?
IRB records must be retained for at least three years after completion of the research and remain accessible for FDA inspection. Both original and receiving IRBs can arrange suitable record retention agreements, but records must always be available to FDA at reasonable times.
Does the receiving IRB need to conduct a new review before accepting transferred studies?
While not required by regulation, receiving IRBs often perform some type of review as due diligence. Initial review is strongly recommended for higher-risk studies or when transfers occur due to original IRB noncompliance. The receiving IRB has flexibility to choose initial review, continuing review, or no review until the next scheduled date.
What happens if IRB approval expires during the transfer process?
FDA regulations provide no grace period beyond IRB approval expiration dates. If the receiving IRB’s review doesn’t occur before the original approval expires, all research activities involving human subjects must stop, and new subject enrollment cannot occur. FDA expects approval lapses to be rare occurrences.
Must informed consent forms be updated when transferring IRB oversight?
Yes, consent forms must be revised when IRB transfer results in changes to contact information for subject rights or research-related injuries. For enrolled subjects, this can be accomplished through a letter providing new contact information. New subjects must receive updated consent forms with current contact details.
How should sponsors notify FDA about IRB oversight transfers?
Sponsors must update the associated IND or IDE with the receiving IRB’s name, contact information, and effective transfer date. For drug/biologic studies, this is done through IND amendments. For device studies, notification occurs through IDE annual reports or other appropriate submissions to FDA.
What You Need to Do 👇
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): Content and Organization
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