Policies

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.

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

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 document provides the procedures for IRB continuing review of a research study as well as possible IRB actions upon review.

When a protocol is approved during initial or continuing review, either with no modifications or with minor modifications to secure approval, the decision includes the period for which IRB approval is to be granted. This approval period must be for one year or less, if the study is subject to FDA regulation, or if the study involves more than minimal risk; and the approval period must be appropriate to the degree of risk (45 CFR 46.109, 21 CFR 56.108 and 21 CFR 56.109).  This policy explains this process.

This policy defines expanded access for an investigational medical product for an individual patient, including for emergency use.

It is the policy of the Duke University Health System IRB (DUHS IRB) that qualified human subject research be reviewed using the expedited procedure in accordance with federal regulations. An expedited procedure refers to review of research involving human subjects by the IRB Chair, Vice Chair or qualified IRB member designee in accordance with 45 CFR 46.110 and 21 CFR 56.110. This policy defines this expedited process.

The policy describes how the DUHS IRB relies upon and works cooperatively with the Office of Audit, Risk and Compliance (OARC) to investigate complaints, allegations of non-compliance, and allegations of misconduct in human subject research.