Procedure
Administrative Staff:
- Maintains a current listing of IRB membership and posts list on IRB web site (see PRO101 Procedure for IRB Member Roster and Quorum).
- Maintains documents on IRB members qualifications and acknowledgements of confidentiality and conflicting interests by IRB members and consultants (see PRO104 Procedure for Qualifications and Composition of IRBs and OIRB Staff; POL009 policy and PRO109 procedure on IRB member and consultant conflicting interest).
- Maintains protocol records (see PRO115 Procedure for Organization of Protocol Files).
- Maintains electronic records of Exemption Requests and Emergency Use Notifications.
- Maintains minutes of convened IRB meetings, including agendas, information regarding member attendance, discussion held, determinations and actions, record of votes, and any additional or supplemental materials considered for the IRB’s review (see PRO146 Procedure for Documentation of Convened IRB Meetings).
- Maintains protocol records on Not Human Subjects Research designation applications.
Management Staff: - Arranges access to electronic records for inspection and copying at reasonable times and in a reasonable manner in response to requests by authorized representatives of OHRP, and the FDA, as prescribed by federal regulations and in accordance with applicable UAB policy (e.g., SUP411 UAB INFORMATION DISCLOSURE AND CONFIDENTIALITY POLICY).
- Grants access to IRB records by other individuals in accordance with UAB policy (see SUP411);
- Monitors hard copy and electronic records for destruction after the records retention period has expired according to POL026 UAB Policy on the Maintenance of IRB Records.
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