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Minutes of Institutional Review Board (IRB) Meetings - Content and Documentation Requirements

This guidance provides recommendations for institutions and IRBs on preparing and maintaining minutes of IRB meetings in compliance with HHS and FDA regulations. It details the required content and level of detail needed in IRB meeting minutes to document attendance, actions taken, votes, basis for decisions, and discussion of controverted issues.

  1. Develop written procedures for preparing and maintaining IRB meeting minutes
  2. Create a standard template for minutes that captures all required elements:
    • Attendance details
    • Actions taken and votes
    • Basis for decisions
    • Discussion summaries
    • Required determinations
  3. Implement process to document:
    • Quorum requirements
    • Conflict of interest recusals
    • Votes accurately
    • Rationale for decisions
  4. Establish system for:
    • Maintaining minutes for required retention period
    • Making minutes accessible for regulatory inspections
    • Tracking multiple studies across meeting minutes
  5. Train IRB staff on:
    • Requirements for minute documentation
    • Level of detail needed
    • Use of any templates/forms
    • Records retention requirements
  6. Regularly review minutes to ensure compliance with regulatory requirements
  7. Consider recording meetings as optional tool to assist in preparing written minutes

Key Considerations

Human Factors

  • Documentation of attendance at meetings including members, alternates, consultants and guests
  • Documentation of quorum requirements being met
  • Documentation of any members participating via telephone/video conferencing
  • Documentation of recusals due to conflicts of interest

Safety

  • Documentation of any unanticipated problems involving risks to subjects
  • Documentation of serious or continuing noncompliance
  • Documentation of suspensions or terminations of IRB approval

Other considerations

  • 45 CFR 46: Protection of Human Subjects
  • 21 CFR 50: Protection of Human Subjects
  • 21 CFR 56: Institutional Review Boards

Original guidance

  • Minutes of Institutional Review Board (IRB) Meetings - Content and Documentation Requirements
  • HTML / PDF
  • Issue date: 2017-09-25
  • Last changed date: 2024-11-14
  • Status: FINAL
  • Official FDA topics: Medical Devices, Good Clinical Practice (GCP), Pediatric Product Development, Investigation & Enforcement, Drugs, Biologics
  • ReguVirta summary file ID: d1f44289048211acc7dccdc1125b7d06
This post is licensed under CC BY 4.0 by the author.