HRPP Manual Section 5-5

Meetings

The Biomedical and Health Institutional Review Board (BIRB) typically meets twice a month, while the Social Science / Behavioral / Education Institutional Review Board (SIRB) typically meets once a month; each IRB may schedule other meetings on an emergency basis as needed. Meetings may include meeting remotely through web or teleconferencing. Meeting dates are posted on the Human Research Protection Program (HRPP) website (hrpp.msu.edu). When necessary, web conferencing or teleconferencing is utilized for some or all members. 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 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.

If complete full review initial applications, full review continuing renewed approvals (continuing review) and non-minor modifications are received with all appropriate supporting documents they will be placed on an upcoming meeting agenda upon consultation with the IRB chair. However, studies that have substantial IRB reviewer comments which have not been sufficiently addressed by the investigator prior to the meeting may not be considered complete and may be removed from the agenda upon consultation with the IRB chair or deferred (may also be referred to as tabled) by the IRB.

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 web or teleconference is usually sufficient; if in-person presence at the meeting is requested, the IRB administrator will notify the research team prior to the meeting date.

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 with assistance from the IRB administrator and/or the HRPP manager. 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. Quorum is confirmed during the voting process. 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 the IRB may not vote on proposed research unless and until a quorum is restored. The IRB administrator and/or the HRPP manager will assist the IRB 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. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, 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 (e.g., new full review studies, full review continuing review, non-minor modifications, IRB submissions that otherwise qualify for exempt or expedited review that require review by the convened IRB, IRB submissions that require input from the convened IRB, 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 meeting workspace available through the MSU IRB online system also includes a report of all studies that were approved via an expedited process in the last 45 days. The materials are accessible via the MSU IRB online system. If the meeting is conducted in person, laptop computers are made available to IRB members.

Materials made available include:

  • Draft of minutes from the previous convened IRB meeting (available on the previous meeting’s workspace)

  • Preliminary agenda

  • Studies requiring full review (e.g., initial full review applications, full review continuing review, non-minor modifications, IRB submissions that otherwise qualify for exempt or expedited review that require review by the convened IRB, IRB submissions that require input from the convened IRB)

  • Any documentation associated with discussion items

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

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 the web:

  • Agenda

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

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

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

  • Information items

  • Discussion items

Web 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. 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. Expedited studies approved in the last 45 days will be available through a report on the meeting workspace 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 continuing review, non-minor modifications, 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, deferring, 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 “Committee Review Procedure” 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, deferred, 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. The total vote count is announced after each voting action.  If a member(s) is attending the meeting through web or teleconference, the member(s)’s vote will be clarified as needed. The IRB administrator and/or the HRPP manager will assist the IRB chair in clarifying vote counts when needed.

Federal regulations (e.g., 45 CFR 46.107(e)(Pre-2018 Requirements), 45 CFR 46.107(d)(2018 Requirements), 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 (or the web or teleconference if meeting remotely) during discussion and voting of such studies, except to provide information at the IRB’s request. 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.

Guests

Individuals who are not IRB members may attend convened IRB meetings when there is a legitimate business need for attendance. This includes, but is not limited to, the IRB office manager, IRB administrator(s) supporting the meeting and taking minutes, consultants, and members of the research team for studies under review. Individuals may be asked to attend a portion of the meeting (e.g., members of the research team, consultant) or the whole meeting. Individuals who are not part of the HRPP who are present for IRB member deliberation may be asked to sign a visitor agreement. Individuals who are not IRB members may not vote. If a researcher would like an individual from outside their research team to accompany them, they should submit the request in writing at least seven calendar days before the convened meeting and any relevant ethics rules will be followed.  

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. It is the expectation that no IRB member or guest would audio or video record the meeting.

Meeting Minutes

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

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

    • Each IRB member’s first and last name and representative capacity (a copy of the current IRB roster may be included with the minutes to indicate representative capacity)

    • When an alternate member replaces a primary member; if both members are present, documentation must clearly indicate which member voted

    • If consultant(s) are present, the first and last name of consultant(s), a brief description of the consultant’s expertise, and documentation that the consultant did not vote

    • If other individual(s) are present, the first and last names of the non-members and guests (e.g., HRPP staff, researcher(s), study coordinator(s)

    • Whether individual(s) participated remotely through web or teleconference

  • Actions taken by the IRB, with sufficient information to identify the research activities being reviewed and voted on by the IRB, including initial review of a protocol, modifications, and continuing renewed approval

  • 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, when required

  • Basis for requiring changes in or disapproving research

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

  • 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, informed consent exception for screening, recruiting, or determining eligibility, 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 made available to IRB members to review prior to the subsequent meeting on the previous meeting workspace.

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. Revision 7 approved by Senior VP for Research and Innovation on 1-18-2019. Revision 8 approved by Assistant VP Regulatory Affairs on 11-29-2021.

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