Subject: IRB Review of Human Subjects Research - Full Committee

Procedure:

1. Investigator Responsibilities.
   1. The Investigator shall submit to the IRB all human subjects research for review.
   2. The Investigator shall submit to the IRB any proposed changes to the research for review and approval prior to implementation.
   3. The Investigator shall comply with all IRB Policies and Procedures.
   4. The Investigator shall conduct the research activities in an ethical manner that includes appropriate participant protections.
2. IRB Committee Responsibilities.
   1. IRB Committee Members shall notify the Specialist of any conflicts of interest that they may have with respect to items scheduled for IRB review. Members must reply in the specified timeframe, generally within 24 hours of receiving the items.
   2. IRB Committee Members with conflicts or potential conflicts should be disclosed and documented at the committee meeting. No member having a conflict will serve as a primary or secondary reviewer.
   3. IRB Committee Members serving as primary reviewers shall complete their reviewer summary using the reviewer's checklist and uploading it directly in IRBe a minimum of two business days prior to the scheduled meeting.
   4. IRB Committee Members with disclosed conflicts of interest will receive all meeting materials but will recuse themselves from the meeting discussion and voting on the items for which they disclosed a conflict.
   5. The IRB Chair will preside over each IRB meeting. If the Chair is absent, the IRB Vice Chair will serve as the acting Chair. In the event that neither the Chair nor the Vice Chair will be available to preside over a specific meeting, the Medical Director will designate a Chair of another Committee to serve as the acting Chair for that meeting. In the event that the Committee Chair or Vice Chair is absent and/or conflicted during the call for the vote he/she may designate another committee member to preside over the meeting.
   6. The IRB will review research at a convened meeting at which the majority of IRB Committee Members are present including at least one member whose primary concerns are in a non-scientific area as set forth in IRB Policy VI. A^[1].
   7. The IRB will review and determine if the research meets all the criteria for the approval of research and the interval for continuing review as set forth in IRB Policies III.F^[2] and III.I^[3].
   8. The IRB, with the majority of members present, will render determinations as set forth in IRB Policy III. B^[4].
   9. If the Committee is unable to review a protocol due to time constraints or quorum issues during the convened meeting, the protocol will be tabled and rescheduled for review at the beginning of the next regularly scheduled IRB meeting.
3. IRB Administrative Staff Responsibilities.
   1. The IRB Operations Office is responsible for managing the logistics of each IRB meeting.
   2. The IRB Operations Office shall ensure that each meeting is attended, at a minimum, by the Specialist and an Assistant. An IRB Coordinator, Compliance Coordinator, or Director of Operations may also attend IRB meetings to provide regulatory guidance, respond to queries related to the operations, etc.
   3. IRB Operations Office will make appropriate arrangements to electronically record the entire Committee meeting for use in finalizing of minutes following the meeting. The recordings are deleted after the meeting minutes are generated and approved by the Committee.
   4. IRB Operations Staff will inform each committee the roster for their committee.
4. IRB Specialist Responsibilities.
   1. Upon receipt, the Specialist will review the submission within two working days and will assign it to the next available agenda.
   2. The Specialist will review all documents for completeness using the Intake Checklist and communicate with the Investigator until all documents are received and complete. The Intake Checklist will be uploaded into IRBe.
   3. Once the Specialist confirms that all documents are received and complete, the protocol is scheduled for review. The Specialist will assign the protocol to the Primary (Scientific) and Secondary Reviewer and schedule it to a meeting. The reviewers are informed via email of the meeting date when the convened IRB will review the protocol. The completed application will include:
      1. Protocol documents
      2. Informed consent documents,
      3. Any relevant materials, such as, Investigator's Brochure, contact materials, etc.
   4. The Specialist will schedule the studies for review in the order that they are received and determined to be complete. They will be assigned for review on a meeting agenda in this first come, first served order. The Specialist may deviate from this rule if there are special circumstances related to a particular protocol but must consult with the Director of Operations and/or IRB Chair prior to such deviation.
   5. The Specialist will distribute the agenda to all members via IRBe.
   6. Following the members' disclosures of conflicts of interest and/or potential conflicts of interest with items scheduled for review, the IRB Specialist will generate the meeting agenda with the following standard items/section:
      1. Call to Order/Welcome;
      2. Review of Minutes from a previous meeting (meeting date will be listed); including Expedited Meeting Minutes and Approvals;
      3. Hot Topic (Education)
      4. General Business for example: Reminders and announcements for members, etc.
      5. Review of any UPIRTSOs
      6. Review of Continuing Review Reports
      7. Review of Modifications to Research
      8. Review of New Protocols
      9. Adjournment.
   7. The Specialist will use scheduling guidelines for setting agenda. The Specialist will also take into account the location of the Investigator when assigning the review times.
      1. As the Committee may wish to speak with a Principal Investigator during a review, the Committee will be conscious of the time zone differences.
      2. The Committee may wish to contact a Principal Investigator during an initial review and the Specialist will make the arrangements for this interaction.
         1. The Specialist will contact the Principal Investigator via email and inform them of the assigned review time for the initial review if necessary.
         2. The Principal Investigator will be asked to provide the appropriate contact number where they can be reached at the designated review time.
   8. When possible, reviews will be scheduled in such a manner that if a member has a conflict with more than one review, he/she will be recused from the discussion and voting for one time period rather than several times throughout the meeting.
   9. The Specialist will list the following information on the agenda for each item:
      1. Type of review;
      2. Primary reviewer;
      3. Recused members;
      4. Protocol title;
      5. IRB assigned number.
   10. The Specialist will check the time allotted on the preset IRB Committee Meeting Dates for the year and will schedule agenda items accordingly.
   11. The Specialist will check the attendance record for each meeting to determine review responsibilities.
   12. The Specialist will include the agenda in the pre-meeting packet of materials and distribute them through IRBe to all members approximately 5 days prior to a scheduled meeting.
   13. The Specialist will assign reviewers from among the committee members on a rotating basis to ensure that responsibilities are evenly distributed. Reviewer assignments are also based on the expertise of the committee members.
   14. The Specialist will finalize the meeting agenda and provide the committee members with the agenda and pre-meeting packets through the IRBe approximately 5 days prior to the scheduled meeting.
   15. The Specialist will follow-up with the primary reviewers as needed to ensure timely submission of the review.
   16. The Specialist will ensure the reviewers checklist/comments are incorporated into the agenda of the meeting to be viewable by the other committee members.
   17. The Specialist will document at the meeting each committee member who is participating and will assure that a quorum is present before official IRB business is conducted.
   18. The Specialist will ensure that quorum is maintained throughout the meeting. A quorum exists when a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas^[5].
   19. The Specialist will ensure that members recused from the discussion and vote on a protocol are not counted in the total number of Committee Members present at the meeting for any given discussion. In order for the discussion and vote on a given protocol to be valid, quorum must be maintained after members have been recused. The Specialist will document that the recused member has left the room during the discussion and vote.
   20. The Specialist will record minutes of the meeting including a record of those in attendance, for every vote to assure quorum throughout the meeting.
   21. The Specialist will finalize and seek approval for all minutes (including Letters to the PI) at the committee meeting. However, in the event when one or more minute items cannot be finalized and approved at the meeting, the Specialist will complete these within 1 working day of the meeting and send them on to the Chair for review and approval.
   22. If there is a necessity to revise an approved minute, the Specialist will complete and send a "Request for Amending Meeting Minutes" form to the irbservicecenter@mayo.edu for approval. Amendments to any approved minutes (including Letter to the PI) may only be executed when approval is granted through this method.

^[1] IRB Policy VI.A

^[2] IRB Policy III.F

^[3] IRB Policy III.I

^[4] IRB Policy III.B

^[5] 45 CFR 46.108(b)