630. IRB Meetings
Updated Oct. 4, 2019
The University IRB meets at noon on the second and fourth Thursdays of each month although meeting dates are adjusted as necessary to accommodate holidays. The IRB meeting schedule, including submission deadlines, is available on the RI website. The 12-month schedule is updated in May of each year.
The Research Integrity (RI) Director, in consultation with staff, may cancel an IRB meeting due to lack of quorum or submissions, or to limit the number of submissions scheduled for a given meeting to ensure each action item on the agenda receives due consideration.
The current meeting schedule adequately controls the volume of action items allowing sufficient time for discussion of action items and acceptable and reasonable turn-around time for new projects, investigator revisions, and continuing and amendment reviews requiring Full Committee Review.
Agendas provide a format for meetings by listing the items to be discussed/reviewed during the meeting (i.e., action items); prompt the Chair to inquire about conflicts of interest and confirm the DHHS criteria for IRB approval are met; notify IRB members of projects/packages approved by exempt and expedited review (i.e., notification items); identify old and new business including new/revised policies, researcher forms, and review worksheets; and specify topics for continuing education.
Complete projects/packages requiring Full Committee Review and submitted by the deadline are scheduled as action items for the next available agenda. Incomplete submissions are NOT assigned to an agenda regardless of the submission date.
Review of any submission requiring Full Committee Review may be postponed pending IRB member expertise. Generally, to conduct a meeting for 60-90 minutes, the agenda should have no more than 3 new studies, 3 continuing review (renewal) or amendments. If necessary to accommodate more than these action items, the meeting may be extended as long as a quorum of the IRB members agree to attend the full duration of the extended meeting. This agreement would be negotiated prior to the scheduled meeting in case alternate members are required to attend.
Action items include old business; approval of minutes; closures requiring assessment by the convened IRB; projects/packages for continuing, amendment, or new project review; reportable events (i.e., potential noncompliance or Unanticipated Problem); and new business.
For action items, agendas provide project/package number and title, PI and sponsor names, submission and review type, and the primary and (when applicable) secondary reviewer. For amendment reviews, agendas provide a summary of the changes being requested.
Meeting agendas notify IRB members of the effective dates for projects/packages approved with conditions at convened meetings; of continuing reviews, amendments, and new projects approved via Expedited Review; and of new projects approved by Exempt Review.
For notification items, agendas provide project/package number and title, PI and sponsor names, submission, and review type and category (i.e., expedited 1-7, DHHS exempt 1-5, or Flex-exempt), action (i.e., IRB decision), project status, effective and expiration dates, and reviewer names.
Member/Consultant Notification and Access to Review Materials
No later than one week prior to the meeting, IRB members are notified the agenda is ready for review; and are given access in IRBNet to the new project, continuing review, and amendment packages scheduled for review at the meeting. IRBNet notifies members assigned as Primary or Secondary Reviewers. Primary and Secondary reviews (as well as any IRB member) has access to the IRBNet package. This package includes the application form, Cover Sheet part 1, Informed Consent form and other study documents that may include Investigator Brochure, recruitment documents, manufacturer information on drug/device, etc. The Primary Reviewer should be familiar with all package documents but be prepared to discuss the application, Investigator Brochure, information specific to the drug/device, documentation regarding the data monitors, risk level, inclusion and exclusion criteria and standard of care for the procedure. Secondary reviewers should be familiar with all package documents and focus on the informed consent document, recruiting materials and study handouts for the participant. All IRB members should review the package documents and focus on the application and informed consent documents.
After confirming their willingness to consult on a submission, RI staff notify consultants of the date, time, and location of the scheduled meeting and provide them with copies of the materials relevant to the consult/review.
See the online HRPP Policy Manual for
- submission requirements for Full Committee Review for New Projects; Continuing Review; and Project Amendments); for review materials and worksheets (i.e., the list of materials required by review type); and
- procedures for Full Committee New Project Reviews, Continuing Reviews, and Amendment Reviews.
Discussion, Motions, and Voting
Following presentation of the project/package by the Primary Reviewer (and consultant when present), the Primary Reviewer or another IRB member makes a motion that includes recommendations for
- the IRB Action,
- each approved research protocol meets the required criteria for approval
- the length of the approval period for new projects and continuing reviews (unless the project is deferred, not approved, or tabled without action),
- requested minor/directed changes or substantive revisions, and
- who may approve the requested revisions (i.e., designated IRB member by Expedited Review for conditional approval or convened IRB by Full Committee Review for deferrals).
The Chair recognizes the motion and asks for additional comments from those in attendance, ensuring adequate time is allotted for a comprehensive and meaningful discussion and satisfactory resolution of controverted issues.
When the discussion is over, the motion is restated or revised as warranted by the discussion, and the Chair calls for a vote. Members vote for or against the recommendations in the motion, or abstain from voting.
IRB Meeting Quorum Requirements
RI staff use the OHRP roster to assess attendance for quorum requirements, and document attendance in the IRB minutes. The OHRP roster lists IRB members, Alternative Members and the primary members they may replace, and affiliated and nonaffiliated members; and indicates the scientific status of each member.
An IRB is considered convened when a quorum of the membership is present. A quorum requires the presence of
- a majority* of voting members; and
- at least one voting member with non-scientific status.
* Majority is achieved when half the members (or designated alternatives) plus one are in attendance either in person or via conference call or videoconferencing.
Additional quorum requirements apply as follows:
- review of research involving prisoners requires the presence of the Prisoner Representative and
- review of VA research requires the presence of at least one VA Representative.
Chairs are voting members of the IRB and are counted towards quorum. The RI Director and assigned senior staff are Primary or Alternative members. Alternative members may attend meetings as non-voting members. Alternative members are counted towards quorum (and allowed to vote) only when replacing a Primary member who is absent or who is not voting.
Quorum is confirmed by the RI staff member who is overseeing the administration of the meeting and is acknowledged by the Chair.
If members join or leave the convened IRB, quorum is reconfirmed and the vote tallies are adjusted accordingly. Voting members who absent themselves from the discussion and voting due to a Conflict of Interests are not counted toward quorum for the vote of the project/package for which the conflict exists.
If quorum is lost during a meeting, the RI staff member notifies the Chair and voting is halted. The loss of quorum is noted in the meeting minutes. The remaining members may address agenda items that do not require a quorum such as providing comments on projects or approving studies which would otherwise qualify for expedited review, until such time as quorum is restored and full discussion or action can be taken. If quorum is not regained, the review of action items requiring a quorum is tabled until the next scheduled meeting.
Other Considerations for Quorum at IRB Meetings
Tele/video-Conferencing: The University IRB uses teleconferencing or videoconferencing for members that live in other cities. RI staff ensure that IRB members who participate via tele/videoconferencing receive all pertinent materials prior to the meeting (e.g., via access in IRBNet), and are able to actively and equally participate in the discussion of action items. When these two conditions are met, tele/videoconferencing members who are Primary members (or Alternatives substituting for an assigned Primary member) vote and count towards quorum. The minutes document the two conditions were satisfied.
Community Representative: The University IRB considers the unaffiliated members (i.e., community representatives) as representing the general perspective of participants. Ideally, at least one community representative is present at each convened meeting. However, this is a preference; not a requirement for quorum. The unaffiliated members’ attendance is documented in the IRB minutes.
When a submission involves categories of subjects vulnerable to coercion or undue influence, the RI Director or staff coordinating the meeting ensures one or more individuals who are knowledgeable about or experienced in working with such subjects are present at the meeting. This is not a requirement for quorum but contributes to the IRB’s responsibility to protect human participants.
If members do not attend the meeting either in person or via tele/video-conferencing, but transmit their opinions by mail, telephone, facsimile or e-mail, the information may be considered by the attending IRB members but recommendations/determinations from absent members are not counted as votes and absent members are not counted towards quorum.
Once a motion has been confirmed, the Chair calls for members to vote for or against the motion, or to abstain from voting. Votes are taken by voice vote. The RI staff member notes
- the number of votes for and against, and the number of abstentions for Primary members and Alternative members substituting for absent or nonvoting Primary members; and
- the name and reason for voting members who left the meeting due to conflict of interests.
NOTE: If a primary member and her/his alternative are both in attendance, only one of them votes and is counted towards quorum.
When a majority of voting members vote for a motion, the motion is carried.