Policies

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:

Interaction with Compliance Offices by the IRB

Review by the IRB

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.

International Research

Conduct of Research

This policy provides requirements for conducting or participating in international research. Investigators must be aware of and follow the additional requirements that accompany such research, including those of the country in which the research is being conducted, applicable US regulation, and applicable Duke policy.

Investigator Who Is Also a Sponsor

Drugs, Devices, & Biologics

The policy describes additional responsibilities belonging to DUHS Investigators who carry the dual roles of Investigator and Sponsor.  If an Investigator in a proposed research project is also the IND/IDE holder and/or is otherwise subject to FDA regulations related to duties as a sponsor/investigator, then additional institutional requirements and responsibilities to FDA apply.

Investigator/ Study Team Concerns

Conduct of Research

In the course of conducting research with humans, a member of the DUHS research community, such as an investigator, study coordinator, member of the investigator’s key personnel, or a colleague may have concerns or suggestions related to the DUHS human research protection program. These concerns and suggestions are welcomed by the HRPP leaders and staff since they provide a focused opportunity for improvement in the quality of our HRPP.  This policy describes how investigators may bring forth concerns.

IRB Approval Stamp on Consent Forms

Consent

The policy explains the absence of a formal IRB stamp on the consent form.  The iRIS-generated footer on the bottom of each page of the consent form serves as the IRB approval stamp or watermark.

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.

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.

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.