The minutes of the IRB meetings will specify the members of the committee who were present at the meeting; members who were absent, but provided written comments, and members who were absent. IRB Office staff (i.e., not serving as members of the committee), consultants to the committee, and guests will be listed separately.
Protocol Specific Information
Each research submission reviewed by the IRB will be listed separately by IRB number, principal investigator name, and protocol title. For each research submission, the minutes address:
- the action (i.e., full approval, approval subject to modifications, reconsideration, disapproval) taken by the committee and the corresponding numerical vote;
- Documentation of the numerical vote will address the number of IRB members voting for or against the action taken by the committee; the number of IRB members abstaining from the vote; and any IRB members listed as being present at the committee meeting, but who were absent during the discussion of the research submission and subsequent vote. The vote will be reflected as the number for the action, the number against the action and abstentions (e.g., 13 members for the action; 0 members against the action; 1 abstention).
- the risk level of the research as determined by the committee;
- the IRB approval interval designated by the committee;
- pertinent comments and concerns of the primary IRB reviewers and pertinent comments and concerns expressed during open discussion of the research submission, to include significant new findings to be communicated to research subjects and a summary of controverted issues and their resolution (when the IRB reached consensus).
- In order to ensure that human subject protection issues are fully addressed at the IRB meeting, many times housekeeping problems (i.e., grammatical and typographical errors) are not presented for committee discussion. However, in preparing the meeting minutes, which are used directly to generate IRB response letters to the involved investigators, these housekeeping problems are included; especially as they relate to the consent form and ensuring its understanding by potential research subjects.
Additional Documentation Requirements
- Reconsideration or Disapproval of Protocols
For research submissions voted for reconsideration or disapproval, the following information should be recorded in the minutes:
- a summary of the primary reason(s) for such determination by the full-board IRB;
- where applicable (i.e., wherein there was a vote for reconsideration or disapproval in the face of majority vote for approval), a summary of the unresolved controverted issues.
- Regulatory Forms
The research review coordinator will ensure that all criteria outlined on the regulatory forms are included in the meeting minutes.
Approval and Utilization of Minutes
Minutes of the IRB committee meeting will be reviewed and accepted by the IRB Vice Chair overseeing the meeting and/or, if present at the meeting, by the IRB Chair or another IRB Vice Chair. Following their acceptance by an IRB Vice Chair or IRB Chair, the minutes of the IRB committee meeting will be directly used to generate written notifications of IRB decisions regarding the approval status of the research submission for dissemination to the listed principal investigator.
The minutes of the IRB committee meeting will be included with the materials prepared for review at the next convened meeting of the IRB committee, and will be voted for approval at the convened meeting. The minutes will be modified as necessary to obtain approval of the IRB committee. If modifications to the minutes affect the approval status of a research study, the Principal Investigator will be notified.
The Institutional Official has access to all approved IRB minutes through the OSIRIS system, including a listing of research studies granted final approval by the IRB.