The IRB Chair assigns one primary reviewer and at least one secondary reviewer for each new protocol, who receive the complete study documentation for review.
The primary reviewer is assigned consistent with protocol content and reviewer expertise.
Secondary reviewer(s) may be assigned using additional factors such as their ability to provide a valuable perspective on salient non-scientific aspects of the research.
The reviewers, who are assigned based on their expertise, lead the discussion of that protocol. Other IRB members review summary information only, but have access to complete study documentation upon request.
If external reviewers are also assigned, they must be subject to the same conflict of interest policies as IRB members.
Except when an expedited review procedure is used, a quorum of the IRB, duly convened through written notice, shall be a majority of voting members with varying backgrounds to promote complete and adequate review of research activities, including at least one member whose primary concerns are in nonscientific areas.
In order for the research to be approved, it shall receive the approval of a majority of those voting members present at the meeting. IRB meetings conducted virtually are permitted pursuant to OHRP guidelines.
Principal Investigators, including those who are also IRB members, may offer information and answer questions about their protocols at a convened meeting, but may not be present during voting (even if this means being unable to continue the meeting because of quorum requirements).