POLICY STATEMENTIt 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: - All research proposals reviewed;
- Departmental approvals (PORFs) and any other scientific or special approvals;
- DHHS-approved sample informed consent documents;
- Progress reports submitted by investigators;
- Reports of injuries to participants;
- Minutes of IRB meetings;
- Records of continuing review activities;
- All correspondence or written communication between the IRB and the investigators;
- A list of IRB members;
- Procedures for the IRB;
- Statements of significant new findings provided to participants;
- Other materials generated or received by the IRB and OIRB related to review of research proposals;
- Communications from participants.
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. Unless otherwise required by an applicable regulation, UAB policy, or other governing standard, any record that is associated with an IRB or privacy board determination will be stored and retained for 7 years following completion and termination of the study. Records associated with an administrative determination only, will be will be stored and retained for 7 years after the administrative determination. |
