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.
What You Need to Know? 👇
What are the five mandatory elements that must be documented in IRB meeting minutes?
IRB minutes must document: (1) attendance at meetings, (2) actions taken by the IRB, (3) vote counts including members voting for, against, and abstaining, (4) basis for requiring changes or disapproving research, and (5) written summary of controverted issues and their resolution.
How should IRBs document quorum requirements in meeting minutes?
Minutes must show that a majority of IRB members were present, including at least one nonscientist member. The attendance section should list full names and representative capacity of each member present, clearly indicating which members participated via telephone or video conferencing.
What constitutes “controverted issues” that must be summarized in IRB minutes?
Controverted issues are matters causing controversy, dispute, or disagreement among IRB members during review. These include debates about research aspects, differing opinions, or concerns that generate discussion. Minutes must summarize both the discussion and how issues were resolved.
Are IRBs required to document all regulatory determinations in the meeting minutes?
While IRBs must document the five mandatory elements in minutes, other regulatory findings and determinations can be documented elsewhere in IRB records (e.g., reviewer forms, checklists, databases) to avoid redundancy, provided they include relevant summary information.
How long must IRB meeting minutes be retained and who can access them?
IRB minutes must be retained for at least 3 years after completion of the research reviewed. They must be accessible for inspection and copying by authorized OHRP and FDA representatives at reasonable times and in a reasonable manner.
Can IRB members vote on research proposals outside of convened meetings?
No, IRB members cannot vote on proposed research outside convened meetings (e.g., via email). Absent members cannot send substitutes to vote. Opinions from absent members may be considered but cannot be counted as votes or toward quorum.
What You Need to Do 👇
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 đź”—
- 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): Content and Organization
- Informed Consent in Clinical Investigations: Requirements, Documentation, and Procedures
Related references and norms đź“‚
- 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 ID: d1f44289048211acc7dccdc1125b7d06