It is UAB policy that the OIRB will maintain documentation of all IRB activities in accordance with federal regulations, state and local law, UAB policy and contractual sponsored research obligations. IRB records will be treated as confidential documents in accordance with UAB policy (see SUP411 UAB INFORMATION DISCLOSURE AND CONFIDENTIALITY POLICY; PRO126 Procedure for Maintenance of IRB Records) and be accessible for inspection and copying at reasonable times and in a reasonable manner by authorized representatives of OHRP and FDA as prescribed in federal regulations.
IRB records include copies of the following:
IRB records for a protocol will be organized to permit reconstruction of a complete history of all IRB actions related to review and approval of the protocol (see PRO115 Procedure for Organization of Protocol Records). IRB records will clearly reflect what the IRB actually approved. IRB records for initial and continuing reviews by an expedited procedure will include the specific permissible category, description of the review, and action taken, and any findings required by federal regulations. For exemption determinations or non-human use designations, the IRB records will include citation of the specific category justifying the exemption or the basis for the non-human use designation. The IRB records will document protocol-specific findings required by applicable regulations and UAB policy. IRB records for each protocol’s initial and continuing review will include the frequency of the next continuing review (not to exceed 1 year) and contain a copy of the final approved informed consent document. IRB records will be maintained indefinitely.
Richard B. Marchase, PhDVice President for Research and Economic DevelopmentFerdinand Urthaler, MDIRB Chair
Sheila Deters Moore, CIPOIRB Director