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.
Recommended Actions
- Develop written procedures for preparing and maintaining IRB meeting minutes
- Create a standard template for minutes that captures all required elements:
- Attendance details
- Actions taken and votes
- Basis for decisions
- Discussion summaries
- Required determinations
- Implement process to document:
- Quorum requirements
- Conflict of interest recusals
- Votes accurately
- Rationale for decisions
- Establish system for:
- Maintaining minutes for required retention period
- Making minutes accessible for regulatory inspections
- Tracking multiple studies across meeting minutes
- Train IRB staff on:
- Requirements for minute documentation
- Level of detail needed
- Use of any templates/forms
- Records retention requirements
- Regularly review minutes to ensure compliance with regulatory requirements
- 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
- Documentation of all actions taken by the IRB (approve, require modifications, disapprove)
- Documentation of votes including number for, against, and abstaining
- Documentation of basis for requiring changes or disapproving research
- Documentation of discussion of controverted issues and their resolution
- Documentation of determinations regarding vulnerable populations (children, prisoners, pregnant women)
- Documentation of emergency research determinations
- Documentation of device risk determinations (SR/NSR)
- Retention of minutes for at least 3 years after study completion
Relevant Guidances
- Continuing Review of Clinical Investigations by Institutional Review Boards (IRBs)
- IRB Responsibilities for Reviewing Investigator Qualifications, Research Sites, and IND/IDE Requirements
- Written Procedures for Institutional Review Boards (IRBs): Administrative Requirements and Operations
- Informed Consent in Clinical Investigations: Requirements, Documentation, 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
- 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
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