700-23-Full Board Review

Title:	Full Board Review
Owner:	IRB
Last Update/Revised:	5/1/2024

Policy: For proposed research requiring a full board review, a quorum of the IRB will convene virtually (via Zoom or a similar platform). Due to the infrequency of the need for full board reviews, the IRB will meet as needed. A submitted proposal that is complete and that requires a convened meeting will be scheduled within one month of submission.

Procedures:

Meeting Preparation
1. The IRB is an ad hoc committee. When a full board meeting needs to be convened, the IRB Chair or designee will poll the members to find the earliest possible date for a quorum.
2. The IRB Chair or designee will draft the IRB agenda and place all documents that will be reviewed in a shared Google Drive and assign reviewer (or reviewers, as appropriate).
Assigning Reviewers
1. A primary reviewer is assigned to relevant agenda items (e.g., new study, continuing review, amendment, etc.). A secondary reviewer is assigned if the study targets a vulnerable population.
2. The IRB Chair or designee confirms the reviewer(s) agree to the assignment and sends the appropriate IRB Reviewer checklist(s) and all documentation at least 2 weeks prior to the meeting date.
3. Primary reviewers perform an in-depth review (using the appropriate IRB Reviewer Checklist) of all documentation and materials submitted and are prepared to lead the discussion at the meeting. Completed checklists become part of the electronic record of the submission.
4. Secondary reviewers, if assigned, are expected to review all submitted documents in advance of the meeting (using the appropriate IRB Reviewer Checklist) and are responsible for reviewing the consent process outlined in detail by the protocol and adding to the discussion as necessary. Completed checklists become part of the electronic record of the submission.
Agenda Distribution
1. The IRB Chair or designee will send the finalized agenda and provide the link to all documents related to agenda items to all committee members planning to attend at least 1 week prior to the meeting (on occasion, an urgent agenda item may be added less than 1 week prior to the meeting).
  1. All members are expected to be familiar with the agenda and items for the meeting they will attend.
  2. Agenda items may include but are not limited to initial and continuing reviews, amendments, potential serious or continuing noncompliance, potential unanticipated problems involving risks to subjects or others, draft policies, and changes to IRB procedures.
Virtual Meeting Requirements
1. Contacting members individually via telephone is not acceptable as a method to conduct a meeting. However, using conferencing technology tools to poll members present in a virtual meeting is acceptable.
2. Meetings may be convened via audio or video conferencing. To allow for appropriate discussion, all members must be connected simultaneously for a meeting to take place. All members must be able to hear one another to allow for discussion.
  1. A quorum must be present for the meeting to be convened.
    - A quorum is defined as more than half of the regular voting members. A quorum consists of regular members or their alternate and includes at least one member whose primary concerns are in scientific areas and one whose primary concerns are in nonscientific areas.
    - An alternate member may attend in the place of an absent regular member in order to meet the quorum requirements as defined in this policy.
    - Ad hoc consultant reviewer(s) may not be used to establish a quorum.
3. The IRB Chair is responsible for monitoring the meeting for attendance. If a quorum is lost during the course of a meeting, the IRB Chair will not allow any further action or votes to be taken until a quorum is restored, which may require rescheduling the meeting (if this occurs the items requiring a vote will be tabled, see below).
Meeting Attendance
1. Attendance is recorded by the IRB Chair or designee in the meeting minutes.
2. Guests may attend upon approval of the IRB Chair.
3. All attendees must have a signed confidentiality agreement on file with the IRB (stored in the IRB Google Drive).
Discussion of Agenda Items
1. The IRB Chair or designee will lead the meeting.
2. Primary reviewers present their findings for the agenda items they have reviewed, providing an assessment of the merits and safety of the protocol, reviewing the consent process (in the absence of a secondary review) and recommending specific actions to the IRB. They lead the discussion of the study at the convened meeting.
3. Each assigned reviewer summarizes the IRB Reviewer Checklist they completed, presenting their findings and how they determined whether the study meets the minimum criteria for approval.
4. Comments are not limited to the assigned reviewer(s). All members of the IRB panel have access to the submitted documents and may provide comments regarding any proposed research. At their discretion, any board member can request any of (but are not limited to) the following: ad hoc consultant review, any additional necessary information beyond what has been provided by the investigator, and third-party verification of information submitted by the investigator.
Actions
1. For initial studies, amendments, and continuing reviews, the IRB may approve as written, conditionally approve, require modifications, defer to another meeting with requests for information and/or required modifications, disapprove, or table submissions. For studies requiring modifications, deferrals, and disapprovals, the action must be stated along with the basis for the action. The actions are described below:
  1. Approved. If the IRB approves an application as submitted, approval commences on that day.
  2. Conditionally Approved. In the case that a study requires approval at another location, but that organization requires conditional approval from USU prior to review, this category may be used. When conditional approval is granted, the only remaining requirement for approval by USU’s IRB is that the collaborating organization approves the study. The study may not be conducted until formal approval from the USU IRB is granted, following the approval at the collaborating institution.
  3. Modifications Required. The IRB may stipulate minor modifications to a protocol or accompanying document(s) or request additional information. Modifications must stipulate specific revisions. The investigator (and chair, if the investigator is a doctoral student) will be informed in writing via email of the required changes or requested information and must provide the IRB with the changes or information. The IRB Chair or designee has the authority to review the requested revisions or information via expedited review unless the IRB specifies that the material or information must be reviewed by a convened IRB, the primary reviewer or another individual delegated by the IRB to review the response. Any response from the Investigator that is pertinent and relevant to judgments required by a convened IRB will be returned to a convened IRB for review and approval.
  4. Tabled. If the convened IRB requests substantive clarifications or modifications regarding the protocol or informed consent documents that are directly relevant to the determinations required by the IRB, the study is tabled pending subsequent review by the convened IRB of responsive material. If a designated expedited reviewer believes a study should be tabled, the reviewer documents the recommendation in the reviewer checklist and contacts the IRB Chair. The IRB Chair moves the item to the agenda for discussion by the convened board. If a quorum is not obtained or is lost during a convened meeting, the research will be tabled.
  5. Disapproved. If the proposal fails to meet one or more criteria used by the IRB for approval of research, the IRB may disapprove the application. A study proposal may only be disapproved by a majority vote at a convened meeting of the IRB. Criteria for disapproval may include but is not limited to the following:
    - The study violates any laws or regulations of the United States or USU policy.
    - Risks to subjects outweigh the benefits to them or society.
    - Unnecessary risks are created.
    - Selection of subjects is inequitable.
    - Procedures for obtaining and documenting informed consent are inadequate.
    - Payment or other offered inducements are likely to influence subjects’ judgment.
    - The study is poorly or improperly designed such that meaningful conclusions cannot be derived.
2. Approval date determination
  1. If approved at a convened meeting, the study approval date is the date of the meeting.
  2. If modifications are required, the study approval date is the date that the modifications are deemed satisfactory by the expedited reviewer.
3. Length of approval – studies will be approved for one year (see 700-27: Length of Approval Period).
4. Members must vote on actions regarding suspension or termination of a study, on whether noncompliance is serious or continuing, and on whether an event is an unanticipated problem involving risks to subjects or others (see 700-31: Unanticipated Problems Involving Risks to Participants or Others; 700-33: Non-Compliance and Research Misconduct; and 700-34: Administrative, Hold, Suspension, and Termination of Research).
5. Suspensions and terminations must follow USU policy, and any decision of such that was made outside of a meeting (e.g., by the Provost) should be reported to the convened IRB, discussed, and summarized in the minutes along with any subsequent action of the IRB (see 700-34: Administrative, Hold, Suspension, and Termination of Research).
Procedures for Voting
1. A majority of members must vote in favor of an action for that category of action to be accepted by the IRB. Majority is defined as more than half of the total number of IRB members attending the meeting at which the vote takes place. Only regular and alternate members acting in place of absent regular members may vote.
2. Members not present at the convened meeting may not vote on an issue discussed during that meeting. Voting by proxy is not permitted.
3. Ad hoc consultants do not vote.
4. The IRB Chair or designee is responsible for counting and documenting all votes.
Procedures for Managing Conflicts of Interest
1. Each meeting agenda includes a statement reminding IRB members to declare any potential conflict(s) of interest they may have with research that is reviewed and reminds attendees of the Confidentiality Agreement (see 700-5: Duties of IRB Members and 700-9: Conflict of Interest).
2. The IRB Chair begins each meeting with a statement requesting IRB members to declare any potential conflict(s) of interest they may have with items on the agenda. A verbal declaration of any such conflict is recorded by the IRB Chair (or designee) in the minutes of the meeting.
  1. Ad hoc consultant reviewers are required to disclose to the IRB any real or potential conflicts of interest involving the review of any specific research protocol. If a conflict of interest is disclosed, the IRB will not permit the requested ad hoc consultant to review the research project, forming the basis for the conflict (see 700-8: Ad Hoc Consultant Reviewers).
  2. IRB members, alternates, or others with conflicting interests may not participate in any portion of the review of research activities except to provide information requested by the IRB and must excuse themselves from the meeting during the IRB’s deliberative discussion and vote on the affected research.
  3. IRB members, ad hoc consultants, and other attendees may excuse themselves from the discussion and vote for any reason if they feel it is necessary to avoid any appearance of a conflicting interest.
Recording Minutes
1. Minutes document discussions, decisions, and findings made during convened IRB meetings. The IRB Chair or designee prepares minutes and records the items listed below.
  1. Meeting attendance (including when an alternate member replaces a regular member, ad hoc consultants, and guests).
  2. The presentation and discussion of each agenda item (new studies, continuing review, review of amendments, etc.). Each item will be discussed and voted on individually, including a description for the basis of requiring changes in or disapproving the research.
  3. Summary of the discussion of controversial issues and resolution.
  4. Recommendations documented in the IRB Reviewer Checklist(s) submitted prior to the meeting may deviate from board decisions after a discussion at a convened meeting. If recommendations in the IRB Reviewed Checklist are inconsistent with the conclusions resulting from the board discussion, the minutes will document the final decisions and determinations.
  5. Voting results include numbers for, opposed, and abstaining. This will include only voting members present at the meeting when the vote is called. The names of the members absent from the vote will be documented. Members who recused themselves for a conflicting interest will be recorded in the minutes.
  6. Determination of the level of risk (minimal, greater than minimal).
  7. For initial and continuing review, the approval period.
  8. If applicable, determinations required by regulation and protocol specific findings justifying those determinations for: waiver or alteration of informed consent and/or authorization; waiver of documentation of consent; research involving vulnerable populations; etc.
  9. If applicable, the rationale for conducting the continuing review on research that otherwise would not require continuing review.
  10. If applicable, the rationale for an expedited reviewer’s determination that research appearing on the expedited review list is more than minimal risk.
Distribution and Approval of Minutes
1. The IRB Chair (or designee) prepares the meeting minutes.
2. Meeting minutes are shared with all members within 1 week of the meeting via a shared Google document located on the IRB Google Drive. Members will have an opportunity to request revisions.
3. A vote for the approval of the minutes is solicited electronically.
4. Finalized minutes are made available via a shared Google document located on the IRB Google Drive.
For Procedures for Notifying Investigators of IRB Actions, see 700-26: Documentation and Notification of IRB Discussions, Decisions, Actions, and Findings.

Purpose: The purpose of this policy is to describe how convened meetings are administered.

Scope: This policy applies only to convened meetings.

Documents and Forms:

IRB Meeting Agenda Template (available on IRB Google Drive)

IRB Meeting Minutes Template (available on IRB Google Drive)

IRB Reviewer Checklist (available on IRB Google Drive)