32. Responsibilities: IRB Chairs and Vice Chairs
IRB Chairs and Vice Chair are authorized to sign all documents relevant to the review and approval of human subject research projects (e.g., waivers of HIPAA authorization) and documents submitted for post-approval monitoring (e.g., safety reports that are not unanticipated problems; acknowledgement of and notifications from external IRBs), except IRB Institutional Agreements, which are signed by the Institutional Official or designee).
IRB Chairs and Vice Chairs may designate signatory authority to qualified IRB members, the IRB Director, and IRB staff who are voting members of the IRB as appropriate. In all cases individuals sign their own name. NOTE: Electronic signatures procured via IRBNet require access through secure login procedures and are therefore considered valid by the RIO and the IRB.
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.