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:
Corrective Actions for COI
This policy describes corrective actions (conflict of interest management plans for Duke faculty and staff) required by the DUSOM Conflict of Interest (COI) Committee or by the Duke Office of Scientific Integrity-Conflict of Interest (DOSI-COI). The policy discusses how the DUHS IRB and DOSI-COI work together to see that corrective actions are implemented as required, in the setting of research involving human subjects.
De-Identification of Protected Health Information
This policy discusses methods for de-identifying protected health information (PHI) as per the HIPAA Privacy Rule.
Decision Making Capacity in Adults
The policy establishes guidelines for when and how to assess for decision making capacity in adults participating in a research study.
Department of Defense (DoD) Research
Special considerations apply to research involving human subjects supported by a DoD component through a contract, grant, cooperative agreement, or other arrangement. This policy describes additional requirements for research funded by a DoD component.
Department of Education Research
Special considerations apply to all research involving human subjects supported or conducted by the U.S. Department of Education. These considerations are in addition to those found in 45 CFR 46 Subparts A-D.
Engagement and Recruitment of Patients to a Research Protocol
This policy describes broader recruitment methods allowable for research protocols, and the IRB’s role in reviewing and considering the appropriateness of the recruitment methods in regard to the target population and the research objectives.
Expanded Access Including Emergency Use
This policy defines expanded access for an investigational medical product for an individual patient, including for emergency use.
Expedited Review
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.
Expiration of IRB Approval and Closing Reports
This policy defines an active research study and outlines the notification procedures for IRB expiration. The policy also discusses lapses in IRB approval.
External IRBs
Duke University Health System (DUHS) may rely on an external IRB, meaning the IRB of another institution or organization, or an independent (commercial) IRB, for review and approval of human research if such reliance benefits DUHS, its investigators, and/or its research participants.