The Campus Oversight Organization for DUHS IRB Protocols supports Campus faculty submitting protocols to the Duke University Health System Institutional Review Board. This webpage explains how a Campus department-based Faculty member can choose which IRB to use, how the DUHS IRB review process works, and who to contact for help with this process.
Investigators who wish to conduct studies with human subjects must obtain approval from an Institutional Review Board (IRB) before commencing their research. At Duke, there are two distinct IRBs:
- The Campus Human Subjects Protections Program (the Campus IRB), which reviews non-medical human subjects research (HSR) studies.
- The DUHS IRB, which reviews HSR studies that utilize Duke Health patients or patient data, Duke Health resources, or services that generate a Maestro Care charge.
Duke faculty members with primary appointments in the Schools of Medicine (SOM) or Nursing (SON) must submit to the DUHS IRB. Campus researchers may submit proposals to either IRB; however, if a Campus proposal includes use of any of the above-described Duke Health resources, it must be submitted to the DUHS IRB for review.
Campus protocols that utilize Duke Health patients or resources are submitted to the DUHS IRB using the iRIS system. Once submitted, the study is pre-reviewed to ensure a complete and streamlined package for final IRB review. This initial review is typically conducted by the Clinical Research Units (CRUs)— clinical department-based review units in the SOM—and focuses on scientific integrity, financial accountability, regulatory compliance, and overall quality. However, depending on the nature of the proposed work, a CRU may not be the appropriate operational home for all Campus-based studies.
This decision tree can aid in determining whether a CRU or the Campus Oversight Organization is appropriate to your study.
In place of a CRU review, the Campus Oversight Organization for DUHS IRB Protocols may be able to review a study if existing patient information or Duke Health resources will be used (personnel, physical space, equipment) but Duke patients or charges in Maestro Care are not required.
This organization can also help during the study planning and protocol development phases to ensure efficient review. We also provide consultations for study and participant documentation practices to assure compliance with Duke and federal standards.
If you have questions about which path to follow, please contact Rebecca Brouwer or Margaret Pendzich.
When submitting a protocol to the DUHS IRB through iRIS, the researcher must select an organization for this first review. In iRIS, this information is located in section 600. For general assistance with iRIS and submitting a new study application, visit the iRIS support page.
Campus faculty can obtain study planning and protocol development assistance for CRU-based studies from Dr. Sunita Patil or Margaret Pendzich. The myRESEARCHnavigators team also provides many study planning resources for faculty who are new to Duke and/or are new to clinical research, or would like some extra guidance. More information on the services available to Campus researchers can be found on the DOCR site.
The following pages provide information relevant for Campus faculty submitting to the DUHS IRB:
Required & Suggested Research Training for DUHS IRB Studies
Information on the Notice of Privacy Practices
Duke Office of Clinical Research
You can contact the Director or Manager of the Campus Oversight Organization for help:
Christopher Freel, Ph.D.