SOP #04 CSS IRB Meeting Management, Function and Operations

CSS IRB Meeting Management, Function, and Operations

Standard Operating Policy
Policy Number: 04
Effective Date: 10/8/2021
Owner: Vice President of Academic Affairs
Author: CSS IRB

Policy

Except when an expedited review procedure is used, the CSS IRB will review proposed research at convened meetings at which a quorum is present. The IRB will meet monthly or at some other frequency determined by the IRB Chair and the IRB Administrator. These policies and procedures apply to all research submitted to the CSS IRB.

Purpose

The purpose of this standard operating procedure is to describe the management, function and operation of convened meetings of the IRB, including the material provided to IRB members for review, and the information documented in the IRB meeting agenda and minutes.

Definitions

Alternate -  An individual appointed to the IRB who serves in the same capacity as an IRB member for whom the alternate is named, who substitutes for the member at a convened meeting when the member is not available for voting.

Chair, CSS - The Chair functions as the chair of the CSS IRB and provides input for IRB policies and educational training requirements. The Chair works with the IRB Administrator and the Vice President of Academic Affairs.

Vice Chair - If the IRB Chair designates an IRB member to serve as IRB Vice Chair, the IRB Vice Chair will work closely with the IRB Chair. The IRB Vice Chair may be primarily involved in reviewing protocols as needed, adverse events and IRB serious problems, and chair the IRB meeting when necessary. The Vice Chair may also review expedited reviews and changes in protocol and some full board continuing reviews and changes. This individual is selected by the IRB Chair.

IRBNet - The electronic IRB management system.

Full Board Review - Review of proposed research at a convened Full Board IRB meeting at which a majority of the membership of the IRB is in attendance, including at least one member whose primary concerns are in non-scientific areas. For the research to be approved, it must receive the approval of a majority of those members attending the meeting.

Quorum - A quorum is defined as greater than 50% of the voting Members of the IRB, including at least one member whose primary concerns are in scientific areas, and one member whose primary concerns are in non-scientific areas. An IRB alternate may substitute for a member in order to meet quorum requirements at an IRB meeting. A Member present via telephone, video, or other instantaneous electronic connection can be used to establish a quorum. Special consultants cannot be used to establish a quorum.

Procedure

Primary and Secondary Reviewers

Prior to any full board meeting, the IRB Chair or designee will designate a primary and may designate a secondary reviewer for each research protocol undergoing review. At least one primary or secondary reviewer must be present at the IRB meeting for the IRB to act on the protocol. The primary reviewer provides a summary of the protocol, and the initial set of comments. Primary reviewers are responsible for:

  • Having a thorough knowledge of all the details of the proposed research.
  • Performing an in-depth review of the proposed research.
  • Beginning the discussion of the proposed research at the convened meeting, by summarizing the proposed research and leading the IRB through the criteria for approval (See, CSS IRB SOP #12 Criteria for IRB Approval Of Research and Checklist).
  • Making suggestions for changes to the proposed research, where applicable.
  • Completing all applicable IRB reviewer forms.

The secondary reviewer may also provide comments on the review and may lead discussion of the protocol if the primary reviewer is unable to attend the meeting.

The IRB Chair may designate a single reviewer for those studies qualifying for expedited review.

Use of Special Consultants

The IRB Chair may invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may be required to sign a confidentiality agreement before they review a protocol or attend an IRB meeting. They shall not vote.

Meeting Materials Sent Prior to IRB Meetings

The IRB Chair/designee prepares a preliminary agenda for each IRB meeting and submits the draft agenda to the IRB Chair prior to the meeting for review and revision. Once approved by the IRB Chair, the final agenda, monthly reports (e.g., Activities Deemed Exempt/Expedited Review Report), the previous meeting minutes, and documentation required for review will be distributed to all IRB Members no fewer than five (5) business days in advance of the meeting.

A copy of the agenda will be maintained on file with the meeting minutes. Consultants receive the materials specific to the research for which their input is requested.

The IRB Chair finalizes the IRB meeting agenda, which includes:

  1. Reminder for members to disclose, at the beginning of each meeting, any actual or potential conflicts of interest they may have with an agenda item. Members who declare a COI on any matter will recuse themselves from participating in the discussion (except as requested by the IRB Chair) and voting on that matter. The recused member is no longer counted for quorum when the vote is taken. The IRB minutes will reflect such recusals as they occur during meetings and whether quorum is affected by the absence of the recused member;
  1. IRB educational materials;
  2. The report of actions taken using expedited review procedures;
  3. Minutes from the previous convened IRB meeting; and
  4. Submissions scheduled for review.

The agenda and minutes are available via IRBNet.

Questions and comments made by IRB reviewing members will be sent to the IRB Chair. After review the IRB Chair may compile and email the questions to investigators in advance of the meeting to enable them to address issues proactively. A copy of Investigators’ responses to these early comments will be sent electronically to all Members prior to the meeting, time permitting.

Minutes (See also, CSS IRB SOP #17 IRB Meeting Minutes Expedited/Exempt Approval Form) The Federal regulations for the protection of human subjects require that “Minutes of IRB meetings...shall be in sufficient detail to show attendance at the meeting; actions taken by the IRB; the vote on these actions including the number of Members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.” 45 CFR 46.115(a)(2).

Minutes will contain sufficient detail about the following issues/areas:

  1. Meeting attendance, including status of each attendee (member or alternate, affiliated or non-affiliated, consultants and their expertise, etc.), guest and staff present; and, when FDA-regulated research is reviewed involving science beyond the expertise of the members, the IRB may use a consultant to assist in the review (21 CFR 56.107(f); and if meeting attendance is via an alternative mechanism (e.g., teleconference). When an alternate substitutes for a member the minutes will identify the name of the member for whom the alternate is substituting.
  2. A summary of the separate deliberations for each action, including:
    • The approval period for initial and continuing reviews;
    • The action taken by the IRB, including the number of votes for, against, and abstaining;
    • That the regulatory criteria for approval were met for submissions and the IRB approves or approves with modification (IRBNet will include documentation of the details for each required element for approval);
    • The basis for requiring changes in or disapproving research; and
    • The discussion of controverted issues (See, CSS IRB SOP #28 Controverted Issues) (if any) and their resolution. If there are no controverted issues associated with a submission, the minutes will not reference controverted issues.
  3. Any protocol-specific information required for specific categories of research, including:
    • Required Consent Documentation (See, CSS IRB SOP #16 Informed Consent w/Checklist and Templates);
    • Research involving Children (See, CSS IRB SOP #33 Research Involving Children and Investigator/Reviewer Checklist);
    • Research involving Pregnant women, human fetuses or neonates (See, CSS IRB SOP #35​​​​​​​ Research Involving Pregnant Women. and Reviewer Checklist);
    • Research involving Prisoners (See, CSS IRB SOP #34 Research Involving Prisoners );
    • For research involving other potentially vulnerable subjects due to their (a) impaired decision-making capacity or mental health, (b) status as wards of the state, (c) social or economic conditions or (d) other factors, the additional safeguards and protections deemed appropriate by the convened committee (if any) as described in CSS IRB SOP #23 Vulnerable Subjects / Populations;
    • For research involving investigational medical devices (See, CSS IRB SOP #40 Research Studies Involving Investigational Medical Devices), the IRB’s Significant or Non-Significant risk determination, unless the FDA has already made a risk determination for the device study.
    • For research involving the investigation of an approved drug(s) or biologic(s), the IRB’s​​​​​​​ determination as to whether the research meets the criteria for exemption from the requirement for an IND in accordance with 21 CFR 312.2.
  1. For expedited review actions (See, CSS IRB SOP #11 Expedited Review Procedure / Checklist), including the review of issues requiring prompt reporting (e.g., unanticipated problems involving risks to subjects or others (See, CSS IRB SOP #24 reporting an Unanticipated Problem Involving Risks to Subjects or Others / Adverse Event and Report Form), serious or continuing noncompliance, suspension or termination of IRB approval (See, CSS IRB SOP #30​​​​​​​ Non-Compliance with Human Subjects Research Policies / Guide and Report Form)), reported to the convened committee, an indication that the IRB members had an opportunity to ask questions or raise concerns, and a summary of questions or concerns, if any, raised by the IRB members.
  2. Any discussion related to issues that require prompt reporting to the IRB (e.g., an unanticipated problem involving risk to human subjects or others), which were reviewed or decisions made outside the convened meeting.
  3. Any discussion related to the educational information shared with the IRB.

During the convened IRB meeting, the IRB will review the IRB Meeting Minutes, approved by the Chair from the previous meeting, that were distributed to members prior to the IRB meeting.

  • Comments and corrections provided by the member will be incorporated into the minutes, when applicable.

Participation from Remote Locations

Members unable to attend an IRB meeting in person may participate via telephone conference or video conference. They may vote and be counted toward the quorum. Members participating by a remote mechanism will receive and have access to IRB submission materials and will be able to participate in the discussion as if they were physically present. The meeting minutes will indicate which members attended via an alternate mechanism (e.g. telephone or video conferencing).

Voting

For each application, IRB Members will vote upon the merits of the application in conjunction with the issues raised and discussed during the meeting, and the criteria for approval established by 45 CFR​​​​​​​ 46.111 (See, CSS IRB SOP #12 Criteria for Approval of IRB Research) , §46.116, and §46.117, and when appropriate Subparts B, C, and/or D. IRB Members also will determine level of risk, the frequency of review for each protocol; and, if appropriate to the protocol, monitoring of the investigative site, and whether third party assessment and follow-up will be needed.

A majority of Members must vote in favor of an action for that action to be accepted by the IRB. Only regular Members, and designated alternate Members, acting in place of regular Members, may vote. The vote, including any abstentions, will be recorded in the minutes

Conflict of Interest

Members with a COI will recuse themselves from the review of applications with which they have a COI, except to answer specific questions posed by the IRB. Members with a COI will recuse themselves from the discussion and voting, and such will be noted in the minutes.

Full Board Meeting

The IRB Administrator or a designated member of the IRB Committee will take minutes in IRBNet. The IRB Chair (or designee) presides over the meeting, using the agenda as a guide. The IRB Chair is responsible for procedural conduct, the review of the protocols, and providing leadership throughout the IRB meeting. The IRB Chair is responsible for ensuring the appropriateness of all IRB decisions and actions.

Investigators of protocols under discussion may be invited to attend the meeting for the purpose of providing further clarification or answering any questions the IRB may pose. However, investigators must not be present during deliberations and voting on any protocol.

References

45 CFR 46.107, 46.108, 46.109, 46.111, 46.115

21 CFR 56.108, 56.109, 56.111, 56.113

Purdue University - https://www.irb.purdue.edu/docs/new/sops-web.pdf

Allina Health - https://www.allinahealth.org/-/media/allina-health/files/for-medical-professionals/research/allina-research-administration-home/hrpp-irb-sop-manual.pdf

 

 

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