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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.

  1. Develop comprehensive written procedures covering all checklist items relevant to your institution’s IRB operations
  2. Ensure procedures include sufficient operational detail beyond just restating regulations
  3. Use position titles rather than names in procedures to avoid frequent updates
  4. Implement regular review and update process for written procedures
  5. Make procedures accessible to investigators and other stakeholders
  6. Establish training program on procedures for IRB members and staff
  7. Create documentation templates aligned with procedural requirements
  8. Implement quality control process to verify procedures are being followed
  9. Establish process for maintaining and archiving IRB records per requirements
  10. 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

  • 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
This post is licensed under CC BY 4.0 by the author.