Section 1005.140  Documentation of Institutional Review Board Activities
 

a)         Documentation of IRB activities will be prepared and maintained and will include the following:

1)         Copies of all research proposals reviewed, scientific evaluations that may accompany the proposals, approved sample consent documents, progress reports submitted by researchers, and reports of injuries to participants;

2)         Minutes of IRB meetings, which will be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions, including the number of members voting for, against and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controversial issues and their resolution;

3)         Records of continuing review activities;

4)         Copies of all correspondence between the IRB and investigators;

5)         A list of IRB members; and

6)         Statements of significant new findings provided to IRB members.

b)         A log of approved human research projects will be made public on the Department's website unless otherwise exempt from disclosure under the Freedom of Information Act.

(Source:  Added at 38 Ill. Reg. 19251, effective September 10, 2014)