19. IRB Meeting Minutes: Exactly What 45 CFR 46.115 Requires
After this lesson you can
- State the minute content required by 45 CFR 46.115(a)(2) and 21 CFR 56.115(a)(2)
- Record attendance, quorum, recusals, and votes in the form regulators expect
- Document controverted issues, the basis for requiring changes or disapproval, and risk and category determinations
- Document the specific regulatory findings that must appear in minutes or the record
- Describe agenda preparation, reviewer assignments, and approval letter content as the documentation cycle
Video coming soon
Scheduled for release on October 6, 2026.
IRB Meeting Minutes: What 45 CFR 46.115 Requires, Step by Step covers the one record inspectors use to reconstruct what an IRB decided and why. Only the minutes survive, and this lesson covers the required elements, how to record votes and recusals, and every regulatory finding that must be written down.
5 Key Facts from This Lesson
- Minutes must show attendance, actions taken, votes, the basis for requiring changes or disapproving research, and a written summary of controverted issues and their resolution.
- Votes must be recorded as separate counts for, against, and abstaining, and the word unanimous alone is not enough.
- Controverted issues must be summarized with their resolution even when the final vote is unanimous.
- Members who recuse themselves are recorded as absent for that vote and step out of the room.
- Minutes are IRB records kept at least three years, and the HHS and FDA minute requirements are identical in text.
Exam traps
The distinctions exam questions on this topic are most often built to test. Know them cold.
Vote counts must show for, against, and abstaining as separate numbers; unanimous alone is not enough
Controverted issues must be summarized with their resolution even when the final vote is unanimous
The basis for requiring changes must be recorded, not only the changes themselves
Recused members are recorded as absent for the vote and must physically leave
Minutes are IRB records subject to the three-year retention rule
HHS and FDA minute requirements are identical in text
Practice quiz
- Question 1Under 45 CFR 46.115(a)(2), IRB minutes must include:
- Question 2A member who has a conflicting interest in a protocol under review:
- Question 3Minutes must contain a written summary of the discussion of controverted issues:
- Question 4When an IRB requires changes to secure approval, the minutes must record:
- Question 5Which of the following is NOT required in IRB minutes by 46.115(a)(2)?
Recap
- Five required elements: attendance, actions, votes with for, against, and abstaining, basis for changes or disapproval, controverted issues and resolution
- Attendance with status and alternates; quorum confirmed; recusals recorded with departure and absence from the count
- Basis is always a criterion or requirement not met; controverted issues summarized even when unanimous
- Determinations the minutes carry: risk level, approval period, continuing review decisions, categories, waivers, Subpart findings, device risk, HIPAA
- The documentation cycle from pre-review through the approval letter, which must match the minutes
Coming next
Lesson 20, three protocols from intake to approval letter.
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This course is for educational purposes only and is not legal, regulatory, or compliance advice. Regulations and guidance change, so confirm every requirement against the current eCFR text, OHRP and FDA guidance, and your institution's IRB policies before relying on it. CIP® is a registered certification mark of Public Responsibility in Medicine and Research (PRIM&R). This course is produced independently by Subthesis and is not affiliated with, endorsed by, or reviewed by PRIM&R or the CIP Council. The instructor is not a Certified IRB Professional. Completing this course does not confer CIP certification, satisfy CIP eligibility requirements, or count as CIP recertification continuing education.