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Policies

Key Personnel Qualifications

Review by the IRB

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.

Click Here for the Key Personnel Qualifications Policy

Legal Counsel Opinion

Review by the IRB

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.

Click Here for the Legal Counsel Opinion Policy

Legally Authorized Representative (LAR)

Consent

The policy defines a Legally Authorized Representative (LAR) and describes Investigator and IRB considerations for using the LAR in research.

Click Here for LAR Policy

Local Physician Participation

Conduct of Research

This policy outlines what the IRB requires when a research participant's local physician will be asked to conduct limited, specific, study-directed activities at a site external to Duke.  Such activities, limited in scope and approved by the DUHS IRB, might include the planned periodic administration of a study drug, or conducting study-directed follow up evaluations.

Click Here for the Local Physician Participation Policy

Mandatory State Reporting Requirements

State Law Considerations

The policy describes mandatory State of North Carolina reporting requirements.  A physician or other health professional must report certain conditions/circumstances/diseases to State and local agencies whether they are found in the course of non-research clinical care or as part of a research protocol. This policy relates to research-related findings that present themselves during the conduct of a protocol and must be reported outside of the institution.

Click Here for Policy on Mandatory State Reporting Requirements

Minutes of the IRB Meetings

Review by the IRB

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).

Click Here for Minutes of IRB Meetings Policy

Modifications Processing Procedure

Review by the IRB

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

Click Here for the Modifications Policy

Multiple Site Research

Conduct of Research

This policy describes what the IRB requires when: 1) a DUHS Investigator conducts research external to Duke, 2) a DUHS Investigator is Principal Investigator of a multi-site research project, 3) a DUHS Investigator oversees an operations or coordinating center for multi-site research, 4) a DUHS Investigator oversees a statistical center for multi-site research.  The policy also discusses IRB reliance agreements.

Click Here for Multiple Site (Multi-Site) Research Policy

Non-compliance

Compliance

The policy defines non-compliance (serious or continuing) and gives examples.  The policy describes how the IRB handles allegations of non-compliance, the process for review, and actions available to the convened IRB.

Click Here for Non-Compliance Policy

Non-English-Speaking Subjects

Consent

The policy describes requirements related to the informed consent process in research involving non-English-speaking subjects. The policy discusses translation requirements, and use of the long form consent and short form consent for non-English-speaking subjects.

Click Here for Non-English-Speaking Subjects Policy

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