Ill. Admin. Code tit. 77 § 1005.140

Current through Register Vol. 48, No. 45, November 8, 2024

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.

Ill. Admin. Code tit. 77, § 1005.140

Added at 38 Ill. Reg. 19251, effective 9/10/2014