IRB Meetings

POLICY

A fully convened meeting of the CPHS must review human subjects research that does not qualify for exempt or expedited review.  Actions at the meeting may be taken only when a quorum is present. A quorum is considered over one-half of the 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 - The IRB staff will prepare the meeting agenda and distribute to IRB members prior to each meeting. The agenda and meeting materials are maintained in iRIS. All IRB members have access to meeting materials in iRIS to allow them to perform a substantive review.

Meeting Process: When quorum is met, the IRB chair shall call the meeting to order. While a non-affiliated member is not essential for quorum to be met, the IRB staff will make an effort to ensure that non-affiliated members attend at least 9 of the 12 meetings held each year for each panel. 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 subcommittee chair will make a motion to approve, approve pending, defer or disapprove the submission and the motion is seconded. The IRB chair shall then open the item for discussion by the Committee. Following discussion, 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 are may stay to answer any questions, but must sign off during the deliberations and voting. IRB staff will invite the conflicted member back to the meeting when the voting is over.

Principal Investigator: The Principal Investigator 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 CPHS for review and approval. The PI and/or any member of the study team however, shall not participate in the deliberation, decision-making and voting.

Minutes: The IRB staff will prepare the meeting minutes. The minutes will include the following general information:

1. Date and time the meeting begins and ends.
2. Members present at the meeting.
3. Guests, staff, and ex-officio members that are present.
4. Any announcements made by those present.
5. Any old business discussed.
6. Any informational/educational documents provided to the CPHS 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:

1. Summary of discussions of controverted issues and their resolution, even when the resolution of the issue is to accept the protocol as submitted.
2. Action taken.
3. The basis for requiring modifications to the research as presented including, but not limited to, application, informed consent document, advertisements, etc.
4. The basis for disapproving research.
5. 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 CPHS makes specific determinations, these findings shall be fully documented in the minutes and shall include protocol-specific information justifying each determination. Examples of specific determinations include the following:

1. Alteration or waiver of informed consent
2. Waiver of documentation of informed consent
3. Research involving children as participants
4. Research involving prisoners
5. 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 using the following format:

Total:    NN :  For-NN, Against -N, Abstain-N, Recused– N (Name of person who recused and reason if COI)

Dissemination and Approval: The draft minutes shall be distributed to IRB panel members and the VP HRPP for review and comment.  Following review and comment, the IRB staff will forward the finalized minutes to the IRB chair for approval and signature. IRB staff will file the signed minutes in the IRB office.

APPLICABLE REGULATIONS

1. 45 CFR 46 Protection of Human Subjects
2. 21 CFR 50 Protection of Human Subjects
3. 21 CFR 56 Institutional Review Board

REFERENCES TO OTHER POLICIES

1. 101-B04 Conflict of Interest CPHS Members and Consultants.

ATTACHMENTS

1. Agenda template
2. Minutes template

If you find errors in this document, contact cphs@uth.tmc.edu

CPHS HELPLINE   713-500-7943
iRIS HELPLINE    713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)

IRB OFFICE HOURS Thursdays from 1 to 4pm, via the Teams Room at this link

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