As set forth in 45 CFR 46.107(f) and 21 CFR 56.107(f), the IRB may, at its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB.  This document describes the process for use of a consultant by the DUHS IRB.

This policy is meant to serve as guidance for the conduct of convened meetings of the Duke University Health System (DUHS) Institutional Review Board.

This policy describes when case reports must be submitted to the IRB for review.  If you plan to present or publish a single case report, or a case series of multiple case reports, please read this policy.

This document describes how the DUHS IRB assesses the adequacy of a study's data and safety monitoring plan.  Also, this policy provides considerations for when a Data Safety Monitoring Board (DSMB) may be required for a study.

This document defines the different types of amendments and procedures for IRB review and approval.  The policy also discusses when participants must be notified or reconsented, the Investigator's responsibilities, and the IRB's responsibilities.