Written Procedures for Institutional Review Boards (IRBs): Content and Organization

Recommended Actions

1. Develop comprehensive written procedures covering all required regulatory elements
2. Ensure procedures include sufficient operational details beyond just restating regulations
3. Structure procedures to reflect institution’s specific organizational setup and research types
4. Include position titles rather than names to avoid frequent updates
5. Implement regular review and update process for written procedures
6. Make procedures accessible to relevant stakeholders (investigators, sponsors)
7. Establish training program on written procedures for IRB members and staff
8. Create documentation system for tracking compliance with written procedures
9. Develop contingency plans for IRB oversight transfer if needed
10. Establish process for verifying procedures are followed consistently

Key Considerations

Human Factors

• Written procedures for reviewing studies involving vulnerable populations
• Procedures for assessing additional safeguards for subjects likely to be vulnerable to coercion
• Process for reviewing informed consent forms and consent process

Safety

• Procedures for reviewing and reporting unanticipated problems involving risks to subjects
• Process for suspending or terminating approval of research associated with unexpected serious harm
• Procedures for emergency use of test articles
• Process for ensuring prompt reporting of changes needed to eliminate immediate hazards

Other considerations

• Procedures for initial and continuing review of research
• Process for determining review frequency and verification requirements
• Procedures for reporting proposed changes and obtaining IRB approval
• Requirements for IRB membership and operations
• Record keeping and documentation requirements
• Procedures for cooperative IRB review arrangements
• Process for handling subject complaints and concerns

Relevant Guidances

• Continuing Review of Clinical Investigations by Institutional Review Boards (IRBs)
• IRB Responsibilities for Reviewing Investigator Qualifications, Research Sites, and IND/IDE Requirements
• Minutes of Institutional Review Board (IRB) Meetings - Content and Documentation Requirements
• Informed Consent in Clinical Investigations: Requirements, Documentation, and Procedures
• Transfer of Clinical Investigation Oversight Between Institutional Review Boards
• IRB Registration Requirements and Procedures

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Original guidance

• Written Procedures for Institutional Review Boards (IRBs): Content and Organization
• HTML / PDF
• Issue date: 2025-02-05
• Last changed date: 2025-02-05
• Status: FINAL
• Official FDA topics: Biologics, Medical Devices, Drugs, Good Clinical Practice (GCP), Investigation & Enforcement
• ReguVirta summary file ID: e92052a1a825739b57074d4700714c3b