This document describes what information the UW-Madison IRBs include in IRB meeting minutes and other documentation outlining regulatory findings.
Minutes of an IRB meeting must include documentation of the following.
Attendance at the meetings, including:
When an alternate member replaces a primary member during an IRB meeting.
The names of members who participate through videoconference or teleconference.
That quorum was achieved and maintained.
For initial, continuing, changes of protocol, and reportable event reviews, as applicable:
Actions taken by the IRB and the votes on those actions with the number of members voting for, against, and abstaining.
The names of IRB members who leave the meeting during a vote due to a conflict of interest.
The basis for requiring changes in or disapproval of research.
A summary of any controverted issues and their resolution.
The approval period.
If the approval period is less than a year, the reason for the shortened review period.
The Common Rule and other applicable criteria for IRB approval of research have been met.
For federally funded research involving pregnant women, human fetuses and neonates, prisoners, and children, regulatory findings under the applicable subparts of the Common Rule.
Minutes of an IRB meeting or the study file must include documentation of the following regulatory requirements.
Any additional safeguards to protect vulnerable populations as well as documentation as to why the population and/or individuals are considered vulnerable.
Adequacy of safeguards to protect the rights and welfare of participants who are likely to be susceptible to coercion or undue influences.
The presence of all required elements of consent, a waiver or alteration of informed consent, and/or waiver of consent documentation.
Determinations required by applicable regulations and institutional policy for full or partial waiver or alteration of a signed HIPAA Authorization for the research use of protected health information.
Any applicable federal or state regulatory criteria (including Departments of Defense, Department of Education, and Food and Drug Administration) in addition to the Common Rule for IRB approval of research have been met.
The rationale for conducting continuing review of research that otherwise would not require continuing review as described in 45 CFR 46.109(f)(1).
The rationale for an expedited reviewer’s determination under 45 CFR 46.110(b)(1)(i) that research appearing on the expedited review list described in 45 CFR 46.110(a) is more than minimal risk.
Minutes of a convened IRB meeting should include documentation of the following institutional requirements:
If an external consultant with particular expertise was required, this should be noted along with the expertise of the reviewer and his/her comments cited.
Draft minutes are generally written and available for review within 3 weeks of the meeting date.
Once adopted, substantive changes to meeting minutes can only be made by the convened IRB.
Non-substantive changes, e.g. correcting typos and redacting direct and indirect identifiers of a research participant, can be made by the IRB Chair, IRB Director, or designee.
When changes are made, the reason(s) for the change(s) should be documented along with the changes.
Institutional Official, Associate Vice Chancellor for Research Policy and Compliance
Post Approval Monitor -- Travis Doran, firstname.lastname@example.org, (608) 890-4399