8. IRB Membership, Quorum, and Authority: 45 CFR 46.107 to 46.113
After this lesson you can
- State the membership requirements of 45 CFR 46.107 and 21 CFR 56.107
- Define quorum and the conditions under which a convened IRB may act
- Describe the roles of chair, alternates, consultants, and the Institutional Official
- State the IRB's authority to approve, require modifications, disapprove, suspend, and terminate, and the limits on institutional override
- Explain IRB registration under 45 CFR 46 Subpart E and 21 CFR 56.106
Video coming soon
Scheduled for release on September 22, 2026.
IRB Membership, Quorum, and Authority: 45 CFR 46.107 to 113 covers who sits on an IRB, when it can vote, what it can decide, and where institutional power ends. Composition errors undermine approvals, and they appear regularly in OHRP determination letters and FDA inspections.
5 Key Facts from This Lesson
- An IRB must have at least five members, including at least one scientist, one nonscientist, and one member not otherwise affiliated with the institution.
- Quorum is a majority of members and must include at least one nonscientist, but the unaffiliated member does not have to be present.
- Approval requires a majority of the members present at a meeting with quorum, not a majority of the full membership.
- Consultants never vote, and alternates vote only in place of an absent primary member.
- An institution may disapprove research its IRB approved, but it can never approve research the IRB disapproved.
Exam traps
The distinctions exam questions on this topic are most often built to test. Know them cold.
Five members is a floor, not a typical size; the exam asks the minimum
Quorum needs a nonscientist present; it does not require the unaffiliated member to be present
Approval is by a majority of members present at a quorate meeting, not a majority of the full membership
Consultants never vote; alternates vote only in place of an absent primary member
The institution can overrule an approval but can never overrule a disapproval
IRB registration renews every three years; the FWA renews every five
Practice quiz
- Question 1The minimum number of IRB members required by 45 CFR 46.107 is:
- Question 2For a convened IRB meeting to have quorum, which member must be present?
- Question 3An institutional official may:
- Question 4A consultant invited to an IRB meeting for special expertise:
- Question 5IRB registration with OHRP must be renewed every:
Recap
- Membership: at least five, varying backgrounds, a scientist, a nonscientist, an unaffiliated member, no single profession, conflicted members recuse, consultants do not vote
- Quorum: a majority including a nonscientist; approval by a majority present; recalculated at every vote
- Roles: chair presides and conducts expedited review; alternates substitute; the Institutional Official signs the FWA and may disapprove but not approve
- Authority: approve, require modifications, disapprove; continuing review; suspend and terminate with a report to the agency
- Registration: three-year renewal, ninety-day updates, same system for HHS and FDA
Coming next
Lesson 9, the eight exemption categories.
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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.