Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 107
AAHRPP Elements: II.5.A.
- The institution, study sponsors, and federal regulatory agencies such as the OHRP or the FDA may audit the IRB meeting records. Therefore, the files must be maintained in a consistent manner.
- Meeting records for individual IRB meetings at UIC consist of documentation of agenda approval, the agenda, the signature sheet, the attendance roster, the minutes for the same meeting, the protocol voting records, and any attachments to the minutes, such as educational offerings
- The OPRS staff is responsible for maintaining these documents for the required time consistent with institutional record retention practices.
- Specific file space has been designated for storage of IRB meeting records for each UIC IRB. The maintenance of the meeting files is the ultimate responsibility of the Assistant Director assigned to each Board. The Assistant Director may delegate specific duties related to the creation and storage of the meeting records to one or more of the coordinators or other OPRS support staff.
- Each UIC IRB has designated space for the storage and maintenance of the meeting records.
- Files are prepared by each AD, or designee. Folders are labeled with the meeting dates. Each label indicates the Board #, the meeting date (month fully spelled out, date, year), and states “Meeting Minutes.”
- Agenda, Educational Material, and Other Handouts
- Once a meeting agenda is created, approved, and finalized, documentation of agenda approval and a copy of the agenda are placed in the appropriate file folder.
- Educational materials and other handouts that are distributed with the agenda should be placed in the file at the same time as the agenda.
- Educational materials and other handouts that are distributed at the meeting should be placed in the file immediately after the meeting.
- Immediately after the meeting, the attendance roster should be completed electronically based on the signature sheet. The roster should then be printed and placed along with the signature sheet in the appropriate file folder. These documents will later be incorporated into the finalized meeting minutes.
- The completed protocol voting records should be clipped together and placed in the file immediately after the meeting.
- Once the meeting minutes have been prepared and approved by the Chair (or by Vice Chair, if the Chair did not preside over a meeting), the approval of the meeting minutes is documented via the Chair’s signature (or Vice Chair’s signature, if the Chair did not preside over a meeting). The original signed document is then filed in the appropriate file folder.
- IRB 2 and 4 require that the draft meeting minutes are reviewed via Convened review for discussion and vote prior to obtaining the Chair’s signature (or Vice Chair’s signature, if the Chair did not preside over a meeting).
- The meeting record should be organized in the following manner:
- The meeting minutes will be placed in the front of the file. The signature sheet and attendance roster will be incorporated into the document, in the appropriate order as indicated in the meeting minutes.
- If multiple versions of the minutes are present due to revisions, then the most recent version should be placed in front. A note to file explaining the reason for the revised version should be included.
- The protocol voting records are placed directly behind the minutes. These records should be clipped together.
- All educational materials, handouts, or other attachments to the agenda are placed directly behind the protocol voting records.
- The agenda is placed directly behind the educational materials, handouts, or other attachments.
- If multiple versions of the agenda are present due to revisions, then the most recent version should be in front of older agendas. Multiple versions should be clipped together.
- The documentation of agenda approval is placed directly behind the agenda.
- In the case of an audit, an auditor would need to receive the entire file as all contents are considered to be a component of the meeting minutes. If the auditor is provided with the original file rather than a copy of the entire file, the auditor will be informed that no documents may be altered or removed from the file; however, copies of requested documents will be provided.
- Signature Sheet, Attendance Roster, and Protocol Voting Records
- Record Order
21 CFR 56.115 (a) (2) and (b)
38 CFR 16.115 (a) (2) and (b)
45 CFR 46.115 (a) (2) and (b)
VHA Handbook 1200.05 (Paragraph 28)
Version (#, date)
Replaces (#, date)
Summary of changes
Elaborates on the contents of the meeting record; Clarifies the procedures for the signature sheet, attendance roster, and protocol voting records; Clarifies the order of the meeting record and the availability of the contents of the record to auditors; and Inclusion of the VHA Handbook 1200.05 as a reference.