Current policies related to the Duke Health IRB and Human Research Protection Program (HRPP) are located here. View the complete list of policies.The policies are below, and you can search for policies in the following categories:
IRB-1400 Promptly Reportable Information
This policy establishes the requirements for the prompt identification, reporting and review of unanticipated problems involving risks to subjects or others (UPIRTSO), allegations of noncompliance, serious or continuing noncompliance, and other reportable information.
IRB-1450 IRB Review and Reporting of Promptly Reportable Information
This policy establishes the requirements and responsibilities for the DUHS IRB’s review and reporting obligations of unanticipated problems involving risks to subjects or others (UPIRTSO), allegations of noncompliance, serious or continuing noncompliance, and other reportable information.
Key Personnel
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. This policy also provides the definition of "Key Personnel" on a research study. Furthermore, this policy provides guidance on who should be added as outside key personnel.
Legal Counsel Opinion
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.
Legally Authorized Representative (LAR)
The policy defines a Legally Authorized Representative (LAR) and describes Investigator and IRB considerations for using the LAR in research.
Local Physician Participation
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.
Mandatory State Reporting Requirements
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.
Membership, Voting and Quorum for the 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.
Minutes of the IRB Meetings
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).
Modifications Processing Procedure
This document outlines the DUHS IRB procedure for preparing and processing the modifications (“mods”) necessary before a protocol can receive IRB approval.