The IRB Chair, IRB-designee of the chair or an HSRO Administrator assigned to that IRB may designate IRB members as the Primary or Secondary Reviewers for a study to be reviewed by the IRB. Both the primary and secondary reviewers should have sufficient expertise to adequately fulfill these roles. If an IRB member believes that he/she cannot be a reviewer for a particular study for any reason, including but not limited to a lack of expertise or to a conflict of interest, the IRB Chair or the HSRO Administrator should be immediately notified.
Both the Primary and Secondary Reviewers should carefully review all aspects of the submission, including the protocol, consent form, and other accompanying materials. If the Primary Reviewer is unable to present a summary and recommendations for a submission due to absence, the Secondary Reviewer will be expected to do so. If the IRB finds that its membership lacks sufficient expertise to appropriately review a specific study, it may seek additional expertise outside of the membership of the IRB. Individuals invited to assist in reviews of issues that require expertise beyond or in addition to that available on the IRB may participate in discussions but may not vote with the IRB.
Assignments to primary and secondary reviewers notwithstanding, all IRB members shall be provided with the required materials to ensure thorough initial and continuing review of each research matter. The entire IRB file shall be available to all IRB members prior to and during the convened meeting, and all IRB members shall be afforded full opportunity to discuss each research matter during the convened meeting.