The purpose of this policy is to describe the processes by which new IRB members are identified, nominated, trained, and added as members to the IRB and all members are evaluated.

This document outlines the DUHS IRB procedure for preparing and processing the modifications (“mods”) necessary before a protocol can receive IRB approval.

This policy serves as guidance for the preparation, recording and finalization of minutes for convened meetings of the Duke University Health System Institutional Review Board (DUHS IRB).

This policy describes characteristics of the DUHS IRB membership, and processes for voting.  Also, the policy provides a definition for quorum in convened IRB meetings.

The Duke University Health System Institutional Review Board (DUHS IRB) may, as needed, request an opinion or clarification from the Office of University Counsel for issues pertaining to research involving human subjects.  This policy discusses the process for doing so.

This document describes the process by which the Duke University Health System (DUHS) Institutional Review Board (IRB) confirms the qualifications for employees of DUHS to conduct research involving human subjects.  Also, this policy provides the definition of "Key Personnel" on a research study.

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.

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.

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

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.