POLICY
Research that does not qualify for exemption or review by expedited procedure must be reviewed by a convened IRB. Actions at the IRB meeting may be taken only when a quorum present. A quorum is considered over one-half of voting members. The quorum must include at least one member whose primary concerns are in nonscientific areas. Should the meeting lose quorum, it shall be closed for further votes until the quorum is re-established.
PROCEDURE
Meeting Agenda - IRB staff will prepare the meeting agenda and distribute to IRB members prior to each meeting. The meeting agenda and meeting materials are maintained in iRIS, the IRB electronic system. All IRB members have access to meeting materials in iRIS to allow them to perform a substantive review.
Meeting Process: When quorum for the IRB panel is met, the IRB chair shall call the meeting to order. When the agenda includes research involving vulnerable populations, IRB staff will ensure that at least one or more members who are knowledgeable about or experienced in working with such participants are present. The IRB chair will remind members that all discussions during the meeting are confidential. The IRB chair will also remind members that anyone who is involved in research listed on the agenda may not be present during discussions or voting, except to provide information about that research. The meeting minutes shall specifically document the names of members who left the room due to a conflicting interest.
For each item on the agenda, the subcommittee chair, or designee, shall present a summary of the research submission. The IRB chair shall then open the item for discussion by the Committee. After discussion, the subcommittee chair will make a motion to approve, approve pending, defer, or disapprove the submission and the motion is seconded. Following the subcommittee chair’s motion, the IRB chair calls for a vote for all in favor of the motion, all opposed and any abstentions. The IRB staff records the vote.
After all the items on the agenda are discussed, the IRB chair shall open the meeting for any other discussion(s). The meeting shall be adjourned by the IRB chair.
Virtual Meetings: Convened IRB meetings via teleconferencing or virtual meeting platforms are conducted just like in person meetings. When IRB members have a conflicting interest, they may stay to answer any questions, but must leave the meeting during the deliberations and voting. IRB staff will invite the conflicted member back to the meeting when the voting for the conflicted item is over.
Principal Investigator: The Principal Investigator (PI) and/or any member of the study team may be invited to attend the meeting to provide information on any aspect of a research project submitted to the IRB for review and approval. The PI and/or any member of the study team, however, shall not participate in the deliberation, decision-making, or voting.
Minutes: The IRB staff will prepare the meeting minutes. The minutes will include the following general information:
- Date and time the meeting begins and ends.
- Members present at the meeting.
- Guests, staff, and ex-officio members that are present.
- Any announcements made by those present.
- Any old business discussed.
- Any informational/educational documents provided to the IRB members.
For each protocol undergoing initial review, continuing review, and review of change requests, protocol deviation, data and safety monitoring reports, and other miscellaneous items on the agenda, the minutes shall include the following details:
- Summary of discussions of controverted issues and their resolution, even when the resolution of the issue is to accept the protocol as submitted.
- Action taken.
- The basis for requiring modifications to the research as presented including, but not limited to, application, informed consent document, advertisements, etc.
- The basis for disapproving research.
- For initial and continuing reviews, the decision for the period of approval.
When reviewing emergency research requesting exception from informed consent requirements, the minutes shall specifically record the licensed physician member’s affirmative vote and document that the research meets FDA criteria for approval of exception from informed consent requirements for emergency research.
When the convened IRB makes specific determinations, these findings shall be fully documented in the minutes.:
- Alteration or waiver of informed consent
- Waiver of documentation of informed consent
- Research involving children as participants
- Research involving prisoners
- Documentation of the rationale for significant risk / non-significant risk determinations for research involving devices
Voting: IRB staff will include summary of the voting results for each protocol item discussed. The minutes will document votes on each action taken including the number of members voting for, against, and abstaining. The names of those members not present for vote due to conflict of interest will be documented.
Votes shall be recorded in the minutes as: Votes For, Against, Abstain and Recused (with name of person and reason if recusal is for conflict of interest
Dissemination and Approval: IRB minutes will be shared with members via the iRIS system. The Institutional Official has access to the minutes in the iRIS system.
REFERENCES
- 45 CFR 46 Protection of Human Subjects
- 21 CFR 50 Protection of Human Subjects
- 21 CFR 56 Institutional Review Board
- IRB Policy - IRB Membership
- IRB Policy - Conflict of Interest IRB Members and Consultants.
If you find errors in this document, contact [email protected]
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Document Number: |
101-B03 |
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Document Name: |
IRB Meetings and Minutes |
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Reviewed by: |
Associate Vice President, Research Compliance |
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Effective: |
1 Aug 2008 |
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Revision History: |
1 Aug 2011, 1 Jun 2016, 21 Jan 2019, 1 Jun 2021, 1 Jun 2026 |
Please contact the IRB office for answers to questions, express concerns, and convey suggestions regarding human subjects protections.
IRB Office House: Thursdays, 1–4pm via Teams Room
Email: [email protected]
IRB Helpline: 713-500-7943 (please leave a message and we will get back to you as soon as possible)
iRIS Helpline: 713-500-7960
IRB Review Feedback: IRB Survey
Houston, Texas 77030
Phone: 713-500-7943
Email: [email protected]
Committee for the Protection of Human Subjects
IRIS Support: 713-500-7960
