Subject: Institutional Review Board Committee Review Responsibilities

Procedure:

1. IRB Committee Member Responsibilities.
   1. Each IRB Committee Member will evaluate each research project in a timely manner prior to each meeting to ensure that they meet the criteria for IRB approval as set forth in IRB Policy III.F ^[1].
   2. Each IRB Committee Member will attempt to resolve all the questions or concerns prior to the meeting, which may necessitate contacting the Investigator for clarification of issues.
   3. Each IRB Committee Member will consider outside reviews of the research (e.g. NIH review, Department / Division review), but the IRB shall have final authority to make a determination as set forth in IRB Policy III.B^[2].
   4. Each IRB Committee Member will seek the expertise of consultants or ad hoc reviewers if the IRB Committee Member lacks the scientific expertise to make these determinations without such consultation.
   5. Each IRB Committee Member will identify personal conflicts of interest as set forth in Mayo Clinic Policy and recuse him/herself from the discussion and vote if a conflict of interest is identified. If during the discussion, input from the recused IRB Committee Member would provide benefit to the review process; the IRB Committee Member may return for questions then recuse him/herself from further discussion and the vote.
   6. Each IRB Committee Member will maintain confidentiality of Committee discussions and all meeting material, and comply with Mayo Clinic Policy on Confidentiality^[3].
   7. Each IRB Committee Member will attend regularly scheduled Committee meetings either in person or via teleconference (MCA and MCJ).
   8. Each IRB Committee Member will serve as primary reviewers for scheduled reviews when assigned, and submit a written review of the assigned protocol using the appropriate reviewer form. All reviews should be posted on IRBe at least two business days prior to the scheduled meeting.
   9. Each IRB Committee Member will actively participate in discussions at IRB meetings
   10. Each IRB Committee Member will vote to approve, disapprove, defer, or table protocol reviews based on the regulatory requirements and abstain if a conflict of interest exists.
   11. Each IRB Committee Member will keep abreast of regulations and policies pertaining to human research.
   12. Each IRB Committee Member will inform the IRB Specialist a minimum of fourteen days in advance of the meeting, barring emergencies, if he/she cannot attend a particular meeting.
   13. An IRB Committee Member who is serving as a primary reviewer for a protocol but is not able to attend the meeting due to an emergency, will provide the written review summary to the Chair prior to the meeting.
2. Consultant or Ad Hoc Reviewer Responsibilities.
   1. The consultant or ad hoc reviewer will evaluate the research proposal for scientific merit and other issues as requested by the IRB.
   2. The consultant or ad hoc reviewer will not agree to review research in which a conflict of interest may exist.
   3. The consultant or ad hoc reviewer may provide a written report to the IRB and may be requested to attend the committee meeting for questions and clarification of issues.
   4. The ad hoc reviewer will maintain confidentiality of the research study information.
3. IRB Chair Responsibilities.

   It is the responsibility of the Chair to:

   1. Possess knowledge of the ethical, legal and regulatory issues applicable to the conduct of IRB meetings, studies, and consent documents reviewed by the IRB;
   2. Review all studies presented to the full Committee and communicate with other reviewers as needed so that important IRB issues may be resolved or identified prior to the convened meeting;
   3. Direct the proceedings and discussion of convened IRB meetings by keeping the dialogue focused on important IRB issues and ensuring that the meeting process is both efficient and effective;
   4. As appropriate, participate in the development of IRB meeting agendas, policies, and procedures;
   5. Adhere to and administer Committee decisions;
   6. Determine if studies that are reviewed at Full Board meeting meet federally defined criteria for subsequent expedited review;
   7. Respond to all questions from the IRB Specialist in a timely manner;
   8. Review and approve IRB minutes in a timely fashion or delegate the authority to the Vice Chair or Medical Director to do so;
   9. As appropriate, participate in the resolution of controversial, substantive or procedural matters;
   10. Represent the IRB in discussing IRB decisions with the Investigators and/or the Executive Committee;
   11. In the event that the Chair is unable or unwilling to perform these duties, the Medical Director will appoint a replacement to serve as the IRB Chair;
   12. The IRB Chair is also expected to participate in IRB-related educational activities, such as attending educational meeting or taking online training via electronic modules, at least once a year in addition to the IRB Education Days.
4. IRB Vice Chair Responsibilities.
   1. The Vice Chair will assume all responsibilities and obligations of the Chair whenever the Chair is unavailable.
   2. If the Chair is unable or unwilling to perform his/her duties, the Vice Chair will assume all responsibilities of the Chair until the Medical Director appoints a replacement IRB Chair.
5. IRB Administration Responsibilities
   1. The IRB Medical Director will remove any member who is unwilling or unable to fulfill his/her responsibilities.
   2. The IRB Medical Director will request the resignation of any member who participates in less than 50 percent of the scheduled meetings per year.

^[1] IRB Policy III.F

^[2] IRB Policy III.B

^[3] Mayo Clinic Policy on Confidentiality