MSU HRPP Manual Section 5-5

5-5, Meetings

The Biomedical and Health Institutional Review Board (BIRB) typically meets twice a month, while the Community Research Institutional Review Board (CRIRB) and the Social Science / Behavioral / Education Institutional Review Board (SIRB) each meet once a month; each IRB may schedule other meetings on an emergency basis as needed. Meetings may include teleconferencing. Meeting dates are posted on the Human Research Protection Program (HRPP) website (hrpp.msu.edu): BIRB and SIRB meetings are held on campus. When necessary, videoconferencing or teleconferencing is utilized for some members. CRIRB meetings are held contemporaneously using the web and/or teleconferencing. When technology is used and it is not possible to view the presence of an individual, an IRB member or administrator will check-in with the individual(s) throughout the meeting to assure that the attendee is still present and quorum is maintained. All requirements, as outlined in this policy, must be followed. If no business is necessary on any particular month, that month’s regularly scheduled meeting may be cancelled.

Chair and Vice Chair Meeting Roles & Responsibilities
The Institutional Review Board (IRB) chair shall chair and vote at the appropriate IRB meetings. A vice chair shall perform the chair duties when the chair is unavailable. See HRPP Manual 5-1 “IRB Chairs” for a complete list of chair duties.

Deadline
The deadline for distribution of agenda materials to all IRB members is typically at least ten days before the meeting date. In special circumstances and in consultation with the IRB chair, a research study may be added in the week preceding the meeting. If a study is added, the IRB staff will provide the materials to all IRB members to review the information.

Investigator submission deadlines for full review initial applications, full review renewals, and non-minor revisions will be posted to the HRPP website. If complete full review initial applications, full review renewals and non-minor revisions are received with all appropriate supporting documents by the submission deadline they will be placed on the meeting agenda for discussion. However, studies that have substantial IRB reviewer comments which have not been sufficiently addressed by the investigator prior to the meeting may be tabled by the IRB. Applications with all supporting material received after the posted deadline date will be included in the next agenda with limited exceptions. 

For full review initial applications, at least one member of the research team must typically be available to answer questions from the IRB at the time of the meeting. Availability through teleconference is usually sufficient; if presence at the meeting is requested, the IRB administrator will notify the research team.

Quorum
A quorum is needed and must be maintained for a meeting to proceed. A quorum is constituted when a majority of IRB members are present including at least one non-scientific member. The IRB administrator determines anticipated attendance the week preceding the meeting. The IRB chair will confirm quorum prior to the start of the meeting.  If quorum is not met, actions or votes may not be taken.  Throughout the meeting the IRB chair checks and confirms quorum. The attendance, arrival, and departure of members are noted by the IRB administrator and in the minutes to assure that no action is taken unless a quorum is present. During the meeting, if attendance falls below quorum or quorum is lost because there is no longer at least one non-scientist member present, the IRB chair will announce that quorum has been lost and no further actions can be taken unless and until a quorum is restored. The IRB administrator will assist the chair in monitoring quorum.

The IRB chair will assure appropriate representative capacities are provided for as part of the review. If research involves prisoners, the IRB chair will assure that the prisoner representative is present. Research involving prisoners that requires full review can only be reviewed if the prisoner representative is present at the convened IRB meeting. See HRPP Manual Section 6-8-B, “Prisoners,” for requirements. If the research involves investigational drugs or devices, at least one physician member must be available. If the IRB reviews research that involves categories of subjects vulnerable to coercion or undue influence, one or more individuals who are knowledgeable about or experienced in working with such subjects must be present. If there is not at least one person on the IRB with appropriate scientific or scholarly expertise to conduct an in-depth review of the study, the IRB will defer to another meeting, another IRB, or obtain consultation. See HRPP Manual 5-4 “Additional Expertise” for policies and procedures on obtaining additional expertise.

The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, cultural backgrounds, and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. See HRPP Manual 5-3 “IRB Membership” for IRB composition requirements. MSU considers the presence of non-affiliated representation and representation that represents the general perspective of participants at convened IRB meetings an important element of the IRB's diversity. Attendance at convened meetings of all members will be documented on an ongoing, yearly basis through a standard form. The IRB chair will evaluate attendance of members, including non-affiliated members and members that represent the general perspective of participants. If there are frequent absences, the IRB chair will discuss with the IRB member(s) attendance and expectations for regular presence at convened meetings.

Information Provided to IRB Members
A preliminary agenda detailing items to be discussed at the meeting (including, new full review studies, full review renewals, non-minor revisions, noncompliance, unanticipated problems involving risks to subjects or others, information items, and discussion items), and pre-meeting materials are available to all IRB members, including members who use web or teleconferencing and alternates anticipated to attend the meeting, typically a minimum of ten days prior to the scheduled meeting. The agenda also includes all studies that were approved via an expedited and exempt review process since the last convened IRB meeting. The materials are accessible via the MSU IRB online system.

Materials made available include:

  • Draft of minutes from the previous convened IRB meeting

  • Preliminary agenda

  • Studies requiring full review received by the submission deadline (initial full review applications, full review renewals, non-minor revisions)

  • Any documentation associated with discussion items

  • Items for notification (i.e., expedited, exempt)

 See HRPP Manual 8-3 “Full Board Review Procedure” for specific materials provided for review.

 At the meeting, the following materials are available to each IRB member via a laptop computer:

  • Agenda

  • Initial full review applications: lead review summary, initial application, consent form(s), recruitment material, reviewer(s) comment(s), investigator response(s)

  • Full review renewals: renewal review sheet, renewal application, consent form(s), study progress report (if applicable), reviewer(s) comment(s), investigator response(s)

  • Non-minor revisions: revision review sheet, revision application, revised and/or modified material(s), reviewer(s) comment(s), investigator response(s)

  • Information items

  • Discussion items

Links to items such as the HRPP Manual and the regulations for the protection of human subjects are also available to IRB members during the meeting via a laptop computer. The paper files of all studies under review by the convened IRB are available for review upon request.

Actions Taken and Communication of Such Actions
Exempt and expedited applications typically do not require review by the convened board and are reviewed outside of convened meetings on a continuous basis. These studies will be listed on the meeting agenda and may be discussed at the request of any member present or by request of an IRB member prior to the meeting. No vote or action is usually required for these items by the convened IRB unless it is determined that a decision requires a full committee vote.

Applications undergoing full review must be discussed and voted on by IRB members at a convened IRB meeting. The lead reviewer, IRB chair, or other designated member will summarize the review and questions raised during the primary review. Members at the convened IRB meeting may ask questions or provide discussion about each particular study. Other actions requiring a vote at IRB meetings include full review renewals, non-minor revisions, and discussion items (e.g., noncompliance, unanticipated problems).

Approval will be granted when a majority of members present vote for approval.  A majority of members present may also vote for conditional approval, tabling, or disapproval of research studies.

There is no limit on the number of full review studies which can be reviewed at each meeting. There are also no limits to the number of items (e.g. applications, noncompliance, unanticipated problems, other items) placed on the agenda. Discussion and review of each study under consideration by the convened IRB must be substantive and meaningful. However, if quorum is lost during the meeting, the meeting will stop immediately and no further action will be taken until quorum is restored. See HRPP Manual 8-3 “Full Review” for a description of the above mentioned actions and how they are communicated to investigators.

See HRPP Manual 9-1 “Unanticipated Problems Involving Risks to Subjects or Others,” HRPP Manual 9-2 “Noncompliance,” 9-3 “Termination or Suspension of Research,” and 4-8 “Reporting Policy” for policies and procedures on these actions, including materials reviewed by the IRB and communication of actions.

Criteria for Approval
See HRPP Manual 6-1 “Criteria for Institutional Review Board Approval of Research” for a complete list of criteria for IRB approval of research.

Voting
Individuals listed on the roster are voting members. If both the primary and alternate members attend a convened meeting, only one of them may vote at a given time. After each study is discussed, the IRB chair or vice chair will call for a vote to determine if the study is approved, conditionally approved, tabled, or disapproved. Members are asked to vote “for,” “against,” or to “abstain” regarding the study. The majority vote determines the outcome. The IRB minutes shall reflect the outcome of each vote.  If a member is attending the meeting through web or teleconference, the IRB chair will clarify the member’s vote.

Federal regulations (e.g., 45 CFR 46.107(e), 21 CFR 56.107(e)) prohibit a member of the IRB from participating in the initial or continuing review of any study in which the member has a conflicting interest, except to provide information at the IRB’s request. IRB members may not vote on studies if they have a conflict of interest and must leave the room during discussion and voting of such studies. See HRPP Manual 10-1 “Conflict of Interest” for policies and procedures on IRB member conflict of interest. The IRB chair will remind IRB members of this requirement at the beginning of each meeting.

Confidentiality
MSU IRBs are confidential review bodies. University members, community members, consultants, and guests hold the contents of meetings in confidence to the maximum extent allowed by law and may not use any information gleaned from meetings for any non-IRB purpose or for their own gain.

Meeting Minutes
The minutes of the IRB meeting shall document, at a minimum:

  • Attendance (including when an alternate member replaces a primary member)

  • Actions taken by the IRB

  • Separate deliberation for each action taken and the vote on each research study (including the number of members voting for, against, and abstaining)

  • Approval period for initial and continuing review

  • Basis for requiring changes in or disapproving research

  • Written summary of the discussion and resolution of controverted issues regarding research studies

  • Justification of any deletion or substantive modification of information concerning risks or alternative procedures contained in the DHHS-approved sample consent document

  • Determinations required by the regulations and study specific information justifying each determination (e.g., research involving pregnant women, fetuses or neonates, children, prisoners, waiver of consent, alteration of consent, or waiver of documentation of consent, research involving participants with diminished capacity to consent)

  • Rationale for significant risk / non-significant risk device determinations, when appropriate

  • Arrival and departure of members during the convened IRB meeting

  • Departure of members because of a conflict of interest, specifically documenting the name of the IRB member who left the meeting because of a conflict of interest along with the fact the conflict of interest is the reason for leaving

The minutes may also contain additional information that reflects the length of meeting, decisions on studies made outside the IRB meeting, actions on other items of business, and a listing of information items as well as any educational presentations provided for discussion.

If a consultant was solicited to review a study pursuant to HRPP Manual 5-4 “Additional Expertise” and attends the meeting and speaks, the information will be recorded in the minutes. However, the consultant cannot vote if they are not a member of the IRB and will not be present for the vote. See HRPP Manual 5-4 “Additional Expertise.”

A standard form will be used to document the discussion and actions and will be incorporated into the minutes. The minutes will be distributed to IRB members to review prior to the subsequent meeting.

The minutes are made available to the Institutional Official or his/her designee. The minutes are maintained in accordance with HRPP Manual 4-7 “Recordkeeping.”

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 4-21-2005. Revision 1 approved by VP Research & Graduate Studies on 11-2-2005. Revision 2 approved by VP Research & Graduate Studies on 4-5-2006. Revision 3 approved by VP Research & Graduate Studies on 3-9-2008. Revision 4 approved by VP of Research & Graduate Studies on 7-21-2011. Revision 5 approved by VP Research & Graduate Studies on 12-11-2015. Revision 6 approved by Assistant VP Regulatory Affairs on 6-30-2016.

Related HRPP Manual Sections

Approved PDF Version

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