32. Roles and Responsibilities: IRB Chairs and Vice Chairs
In addition to the roles/responsibilities of IRB members, IRB Chairs and Vice Chairs are expected to direct the proceedings and discussions of IRB meetings to ensure review and approvals are in accordance with regulatory requirements, the ethical principles of the Belmont Report, state laws and University policy. To achieve this end, Chairs and Vice Chairs ensure
- ample time is allowed for discussion for each study;
- regulatory determinations are made as required;
- voting takes place for each study;
- members who have a conflict of interest leave the room during deliberation and voting; and
- studies are approved only if the regulatory criteria for approval have been met.
For protocols and reportable events, IRB Chairs and Vice Chairs may
- seek outside consultation when needed;
- review post-approval reports to evaluate study risks and benefits were effected and to determine if review by the full committee is warranted;
- review initial allegations of serious and/or continuing noncompliance to determine whether to refer the incident for full committee deliberation;
- review and approve IRB correspondence to be issued to investigators (as needed); and
- review investigator responses to correspondence (as needed).
With respect to their relationships with other members, IRB Chairs and Vice Chairs
- Formally evaluate the IRB members on their committee at least once a year.
- Provide guidance to IRB members during the review process at the meetings and outside of meetings when appropriate.
- Discuss with the Director Committee member performance and needs for additional members.
IRB Chairs and Vice Chairs work with the RIO Director and staff
- review correspondence as requested;
- provide consultation and guidance to the staff as needed; and
- inform the director of occasions for praise and concerns related to staff performance.