A goal to assure the effectiveness of the review process shall be to schedule IRB meetings at least once every other week. The HSRO shall ensure that meetings are scheduled in advance and that an agenda and all pertinent documents are made available to members (and alternates if appropriate) with sufficient time prior to meetings. Individual meetings may be cancelled by the Associate Vice Provost for Human Subject Research or his/her designee following consultation with the IRB Chair due to:
1) Insufficient applications or other matters requiring convened board review
2) University holiday
3) Inability to secure a quorum for attendance
4) Other reasons (such as inclement weather) that make a scheduled meeting unnecessary or otherwise inappropriate
Except when an exempt or expedited review procedure is used, the IRB shall review initial or continuing studies at convened meeting at which a quorum is present. A quorum for a convened IRB meeting is 50% of the voting primary membership (including alternate members who may replace voting members) plus one. A quorum must be maintained for each vote to occur. If a quorum is not maintained, the meeting shall end or be suspended and the study shall be tabled.
Additional quorum policies are:
1) The IRB chair and vice chair count toward the quorum
2) At least one member whose primary concerns are in nonscientific areas must be present to complete a quorum
3) If research involving an FDA-regulated article is involved, a licensed physician must be included in the quorum
4) Members absenting themselves due to conflicts of interest may not be counted toward quorum requirements
Although the physical presence of IRB members at meetings is encouraged, a member or alternate member (if appropriate) may be considered present if participating through teleconferencing or videoconferencing. In this case, the member or alternate member must have received all pertinent material prior to the meeting and must be able to participate activity and equally in all discussions and votes. Minutes of such meetings shall clearly document that these two conditions have been satisfied in addition to the usual regulatory requirements.