Continuing Review of Clinical Investigations by Institutional Review Boards (IRBs)
This guidance is intended to assist IRBs in carrying out their continuing review responsibility under FDA regulations by providing recommendations regarding the criteria, process, and frequency of continuing review to ensure protection of human subjects enrolled in clinical investigations. It also aims to help clinical investigators and sponsors understand their responsibilities related to continuing review.
Recommended Actions
- Establish written procedures for conducting continuing review that include:
- Process for determining review frequency
- Required documentation and materials
- Methods for tracking approval periods
- Procedures for expedited review when applicable
- Implement a system to:
- Track study approval periods
- Notify investigators of upcoming continuing review deadlines
- Document all continuing review activities
- Report suspensions/terminations to FDA
- For each continuing review:
- Verify all required materials are received
- Assess any new risk information
- Review study progress and enrollment
- Evaluate informed consent updates
- Document determinations in minutes
- For multi-site studies:
- Obtain study-wide information
- Review data monitoring committee reports
- Consider using cooperative review agreements
- Coordinate with other reviewing IRBs
- Maintain clear communication with:
- Investigators regarding requirements and deadlines
- Sponsors regarding significant findings or concerns
- FDA for reportable events
- Study subjects when necessary for safety
Key Considerations
Clinical testing
- IRB must conduct continuing review at intervals appropriate to degree of risk, but not less than once per year
- For multi-site studies, IRBs should obtain study-wide information and data monitoring committee reports
- IRB should review trial progress including enrollment rates and subject withdrawals
- IRB should assess whether risks to subjects remain minimized and reasonable
Safety
- IRB must determine that criteria for approval under 21 CFR 56.111 continue to be satisfied
- IRB should review any new safety information since last review
- IRB must promptly report suspensions or terminations of approval to FDA
- IRB should consider need to inform subjects about suspensions/terminations
Other considerations
- IRB must follow written procedures for conducting continuing review
- IRB must document continuing review activities in meeting minutes
- IRB approval lapses require stopping all research activities except where necessary for subject safety
- IRB should maintain fixed anniversary dates for continuing review when possible
- Expedited review may be used in certain circumstances as defined in the regulations
Relevant Guidances
- 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
- IRB Registration Requirements and Procedures
- Categories of Research Eligible for Expedited IRB Review
Related references and norms
- 21 CFR 56: Institutional Review Boards
- 21 CFR 50: Protection of Human Subjects
- 21 CFR 312: Investigational New Drug Application
- 21 CFR 812: Investigational Device Exemptions
Original guidance
- Continuing Review of Clinical Investigations by Institutional Review Boards (IRBs)
- HTML / PDF
- Issue date: 2012-02-27
- Last changed date: 2020-04-24
- Status: FINAL
- Official FDA topics: Medical Devices, Good Clinical Practice (GCP), Drugs, Biologics, Administrative / Procedural
- ReguVirta summary file ID: abb37d1ec06d1792276078253a6e3dbd
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