Written Procedures for Institutional Review Boards (IRBs): Administrative Requirements and Operations
This guidance, jointly prepared by OHRP and FDA, assists institutions and IRBs in developing and maintaining written procedures for IRB operations. It provides a comprehensive checklist to ensure written procedures cover all regulatory requirements while allowing flexibility in format and content based on institutional needs.
Recommended Actions
- Develop comprehensive written procedures covering all checklist items relevant to your institution’s IRB operations
- Ensure procedures include sufficient operational detail beyond just restating regulations
- Use position titles rather than names in procedures to avoid frequent updates
- Implement regular review and update process for written procedures
- Make procedures accessible to investigators and other stakeholders
- Establish training program on procedures for IRB members and staff
- Create documentation templates aligned with procedural requirements
- Implement quality control process to verify procedures are being followed
- Establish process for maintaining and archiving IRB records per requirements
- Create contingency plans for IRB oversight continuity
Key Considerations
Clinical testing
- Review of emergency use of test articles
- Review of expanded access/treatment use requests
- Review of Humanitarian Use Device (HUD) requests
Human Factors
- Review of subject populations vulnerable to coercion
- Process for handling subject complaints and concerns
- Protection of subject rights and welfare
Labelling
- Review of informed consent forms and process
- Translation requirements for non-English speaking subjects
- Documentation of consent requirements
Safety
- Review of unanticipated problems involving risks to subjects
- Process for suspending or terminating research approval
- Verification of no material changes affecting safety
Other considerations
- IRB membership and operations requirements
- Record keeping and documentation requirements
- Reporting requirements to institutional officials and regulatory agencies
- Cooperative review arrangements
- Training requirements for IRB members and staff
- Conflict of interest management
- Quality assurance processes
Relevant Guidances
- Minutes of Institutional Review Board (IRB) Meetings - Content and Documentation Requirements
- 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
- Transfer of Clinical Investigation Oversight Between Institutional Review Boards
- IRB Registration Requirements and Procedures
Related references and norms
- 45 CFR 46: Protection of Human Subjects
- 21 CFR 50: Protection of Human Subjects
- 21 CFR 56: Institutional Review Boards
Original guidance
- Written Procedures for Institutional Review Boards (IRBs): Administrative Requirements and Operations
- HTML / PDF
- Issue date: 2018-05-17
- Last changed date: 2024-11-14
- Status: FINAL
- Official FDA topics: Medical Devices, Good Clinical Practice (GCP), Investigation & Enforcement, Drugs, Biologics
- ReguVirta summary file ID: e92052a1a825739b57074d4700714c3b
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