Committee For the Protection of Human Subjects

IRB Meetings

POLICY

A fully convened meeting of the CPHS must review human subjects research that does not qualify for exempt or expedited review.  CPHS has 4 IRB Panels. Each IRB Panel meets monthly.

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 ORSC Staff will prepare the meeting agenda and distribute to CPHS members prior to each meeting. The agenda and meeting materials are maintained in iRIS. All CPHS members have access to meeting materials in iRIS to allow them to perform a substantive review.

Meeting Process: When quorum is met, the Chairperson shall call the meeting to order. The Chairperson shall announce that members who are involved in research listed on the agenda may not be present during discussions or voting, except to provide information about that research. The Chairperson shall ask that any conflict of interest(s) be declared. The Chairperson will also remind members that all discussions during the meeting are confidential.

Prior to the discussion of each item on the agenda, any CPHS members who have a COI must excuse themselves from the room, unless the CPHS requests the member be present for any relevant questions. The member with the COI must leave the room during voting. The meeting minutes shall specifically document the names of members who left the room due to a conflict of interest.

For each item on the agenda, the subcommittee Chairperson, or designee, shall present a summary of the research submission with emphasis on the ethical issues and identified concerns. The subcommittee Chairperson will make a motion to approve, approve pending, defer or disapprove the submission and the motion is seconded. The IRB Chairperson shall then open the item for discussion by the Committee. Following discussion, the IRB Chairperson calls for a vote for all in favor of the motion, all opposed and any abstentions. The ORSC Staff records the vote.

After all the items on the agenda are discussed, the Chairman shall open the meeting for any other discussion(s). The meeting shall be adjourned by the Chairperson.

Teleconferencing: Whenever possible, CPHS meetings shall take place with all participating CPHS members physically present. Circumstances sometimes warrant conducting meetings via a telephone conference call.   A member who is unable to be present at the convened meeting may participate by videoconference or a conference telephone call. Member(s) participating through teleconferencing may vote and will be counted as part of the quorum.

Executive Sessions: At the discretion of the Executive Chairperson or IRB Panel Chairperson, an executive session may be called for discussion of sensitive and/or confidential issues.  In this event, only voting members shall be allowed to stay in the room.  At the discretion of the Chairperson, non-voting members, the panel coordinator and other staff members, and additional persons may also be invited to attend. The discussion and outcome of the Executive Session are recorded in the minutes.

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 ORSC 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.       Any alternate members present that are voting and for whom they are voting.

4.       Guests, staff, and ex-officio members that are present.

5.       Any announcements made by those present.

6.       Any old business discussed.

7.       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: The ORSC Staff shall include summary of the voting results for each protocol item discussed. The minutes shall 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 shall be documented. Votes shall be recorded in the minutes using the following format:

Total:     16,

Vote:     For-13,

Opposed-0,

Abstained-1

Not Present for Vote – 2 (Name of person with COI)

Dissemination and Approval: Copies of the draft minutes shall be distributed to all CPHS members and the Vice President for the Human Research Protection Program for review and comment.  Following review and comment, the ORSC Staff will forward the finalized minutes to the IRB Chairperson for approval and signature. ORSC Staff will file the signed minutes in the ORSC office.

APPLICABLE REGULATIONS

1.       45 CFR 46

2.       21 CFR 56

3.       21 CFR 50

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 clinicaltrials@uth.tmc.edu

 

Document Number:

101-B03

Document Name:

CPHS Meetings

Approved by:

ORSC Director

Effective:

1 Aug 2008

Revision History:

1 Aug 2011


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

How can we improve this site?


Committee for the Protection of Human Subjects
6410 Fannin, Suite 1100
Houston, Texas 77030

Phone 713.500.7943
Fax     713.500.7951
Email cphs@uth.tmc.edu 

IRIS Support 713.500.7960

CLINICAL TRIALS RESOURCE CENTER 

OFFICE OF RESEARCH 

ENVIRONMENTAL HEALTH & SAFETY 

CORE LABORATORIES

SPONSORED PROJECTS

TECHNOLOGY MANAGEMENT


aahrpp logo