77 Ill. Adm. Code 1005.140
Documentation of Institutional Review Board Activities
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.