It is the responsibility of the HSRO to ensure that official IRB meeting minutes, recording the reviews, deliberations and votes of the IRB are written and subsequently provided to the IRB for approval. If applicable, these minutes should be in sufficient detail to demonstrate that the review of studies, modifications, unexpected events and continuing reviews were done in accordance with federal, state and local laws and regulations and with university policies and that the safety and welfare of human subjects are protected.
It is also the responsibility of the HSRO to make any corrections to the minutes as defined by the IRB. IRB votes to approve, disapprove, defer or table studies or other matters shall be recorded. If an IRB member elects to abstain from a vote, the minutes shall record the abstention. Minutes shall not reflect how an individual member has voted on any particular motion but shall reflect only the outcomes of voting actions.
Required information to be documented within meeting minutes relative to IRB reviews and decision is defined in federal regulations [45 CFR 46.115(a)(2) and 21 CFR 56.115(a)(2)]. This information shall include but is not limited to:
1. Attendance at the start of the meeting, the mode of attendance if other than in person (i.e. video conference, teleconference, etc.) and any changes in attendance or the mode of attendance that occur during the meeting
2. Documentation that all members received all pertinent materials prior to the meeting and were able to actively and equally participate in discussions
3. The presence of a quorum throughout the meeting including the presence of at least one member whose primary concern is in a non-scientific area, the presence of at least one member not affiliated with the university and the presence (if applicable) of consultants with the appropriate expertise to provide guidance/recommendations to the IRB upon request of the IRB
4. The review and approval of previous meeting minutes
5. That any IRB member with a real or potential conflict of interest relative to a study under consideration was not present during the deliberations or voting on the proposal (and that the quorum was maintained)
6. The determination of the level of risk in each reviewed study
7. The determination of the risk level of an investigational device (if applicable) and the rationale for this determination
8. The determination of whether or not the subject population will receive any direct benefit or if there is benefit to society as a whole
9. The deliberations (if applicable) on the justification for waiving any or all of the required elements of informed consent
10. The determination that informed consent documents were reviewed in accordance with applicable regulations and contains all of the required elements
11. Actions taken by the IRB
12. The vote on actions taken by the IRB including the number of members voting for, against and abstaining
13. The basis for requiring changes in or disapproving studies and documentation of resolution of these issues if/when resolution occurs
14. The length of time of an approval
15. A written summary of the discussion with emphasis upon the identification and deliberation related to controverted issues and the resolution of such issues
16. The deliberations relevant to the inclusion and safeguarding of vulnerable populations if entered as study subjects
17. Documentation of the required findings when approving a consent procedure that does not include or that alters some or all of the required elements of informed consent or when waiving the requirement to obtain an informed consent or when waiving the requirement to obtain documentation of informed consent
18. Any educational/training information provided to the IRB during the convened meeting
In addition to the review of pending studies, meeting minutes shall include (when applicable) a summary and other relevant information regarding expedited approvals, modifications, terminations, emergency/single patient use, placebos, symptom provocation, adverse events and unanticipated problems, and any other business appropriate for IRB meetings.
Minutes shall be included on the agenda of a subsequent IRB meeting and be available for approval by the IRB. Once approved, the minutes shall not be altered. The minutes of the IRB meetings shall be maintained in the HSRO office for a minimum of three (3) years following closure of each study discussed at the meeting covered by the minutes.
Upon request, any IRB member shall have access to the complete IRB study file and relevant IRB minutes prior to or during the convened IRB meeting.