Version
1.3
Date Updated
Tuesday, February 2, 2016
Descripton

Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 112
AAHRPP Elements: II.5.B.


POLICY


  1. It is the policy of the UIC that OPRS staff must capture and document decisions at both convened review and in the expedited review process.
  2. For convened review, documentation is accomplished through IRB meeting minutes. 
  3. For convened review, IRB meeting minutes incorporate all of the following documents: information as required by Section II of the Procedure section of this document, the written documentation signature sheet, the attendance sheet, the protocol voting record, and documentation of agenda approval.
  4. For expedited review, documentation is generally in the form of completed review guides, which are maintained with the protocol record.
  5. Assistant Directors/IRB Coordinators are responsible for creating and completing IRB meeting minutes and for ensuring that IRB members properly complete other required documentation, such as materials for expedited review.
  6. As a best practice, meeting minutes should allow a reader who was not present at the IRB meeting to understand how and why the convened IRB arrived at its determinations.  Additionally, the meeting minutes should have sufficient detail to be able to reconstruct the IRBs discussions if necessary at a later time.