Version
2.0
Date Updated
Thursday, April 26, 2012
Descripton

Approved by:  Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#:  107
AAHRPP Elements:  II.5.A.


POLICY


  1. 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.
  2. 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
  3. The OPRS staff is responsible for maintaining these documents for the required time consistent with institutional record retention practices.
  4. 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.