POLICY STATEMENT

The UAB Institutional Official exercises overall supervision of the UAB Human Research Protection Program and is responsible for its implementation. Policies related to establishment of the Human Research Protection Program (including Institutional Review Boards) the jurisdiction, and scope of authority, and designation of institutional authorities, roles and responsibilities for the Program will have the approval of UAB’s President.

Under the UAB Policy on the Protection of Human Subjects in Research, the Institutional Official as appointed by the Provost, exercises overall supervision the UAB Human Research Protection Program, and has authority to approve policies and procedures for the Human Research Protection Program. The Institutional Official will periodically, but no less than annually, arrange meetings with select representatives of various units of the Human Research Protection Program at UAB, including the IRB, OIRB, and the Office of Counsel, to review existing policies and procedures, address the need for new or revised policies and/or procedures, and discuss new developments and information relevant to the Human Research Protection Program. The Institutional Official is solely authorized to approve policies and procedures for the Human Research Protection Program. The Institutional Official may delegate his/her authority to develop policies and procedures for the IRB and/or the OIRB to the IRB Chair and the OIRB Director, or other appropriate individuals. All approvals, revisions of policies and procedures, and delegations of authority must be in writing, dated, and signed to be effective. All policies will be reviewed and updated, if necessary, every 5 years.

The OIRB will maintain all policies and procedures of the UAB Human Research Protection Program as well as a copy of applicable federal, state, and local laws and regulations affecting human subject research and make them accessible to the UAB research community at the OIRB and via electronic means. (See also: PRO110 Procedure for Policy Development and Communication for the Human Research Protection Program.)