A copy of the minutes of each IRB meeting (signed by the Chairperson or his designated representative) must be retained for at least three (3) years following the termination of research reviewed at the meeting. Approval to destroy old records must be obtained from the RFMH.
The minutes must include:
The facility name, date, time and place of the meeting;
names of attendees: members, researchers, consultants, others (if applicable).
Note: a quorum consists of a majority of the members and must include a non-scientific member:
Review of Applications: - record each study separately
study title, principal investigator
summary of issues discussed and their resolution, dissenting reports and opinions;
actions taken by the IRB (Note: approval of changes may only be delegated to the chair or other member if the changes are specifically described by the IRB. If judgement is required to determine whether the changes satisfy the IRB concerns the change must be brought back to another meeting.
the basis for requiring changes in or disapproving research
who has been approved to assess capacity
who has been approved to obtain consent
approval period - based on level of risk. Record when the next continuing review is due and base the decision, among other things, on the level of risk of the study.
determination that the conditions for granting a waiver of some or all of the elements of informed consent or for waiving documentation of consent have been met - cite to the specific section of 45 CFR 46 (when appropriate)
determination that the conditions for inclusion of special populations, e.g. prisoners, have been met. Cite to the specific regulatory requirements.
decisions made about the monitoring of each study
name any member who may have a conflict of interest, document that they left the room for the final discussion and vote
vote: the number voting for, against and abstaining. The vote cannot be 'unanimous'. Vote format: Total=15; Vote: For - 14, Opposed - 0, Abstained - 1 (name).
Reports to the IRB:
Expedited reviews conducted since the last full board meeting - unless written notification has previously been sent to all IRB members
Monitoring reports - describe, or reference and attach, monitoring reports to the IRB by QM or others carrying out monitoring for the IRB
Adverse Event Reports
Describe training conducted at the meeting and document training that has occurred since the last meeting.
Describe policy and other issues discussed at the meeting.
Set date, time and place
Meeting Concluded: (time)
The minutes should be recorded in sufficient detail to allow an outside reviewer, e.g.. an FDA auditor, to gain a clear understanding of the issues that were raised and their resolution.