Campus Oversight Organization for DUHS IRB Protocols

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 IRB reviews non-medical human subjects research (HSR) studies.
   
• The DUHS IRB, 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 researcher's proposal includes use of any of the above-described Duke Health resources, it must be submitted to the DUHS IRB for review.

Researchers submitting to the DUHS IRB use 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 conducted by a Clinical Research Unit (CRU; clinical department-based review units in the SOM or SON) or an Oversight Organization (OO; other research units that have oversight for research activities).

This pre-review focuses on scientific integrity, financial accountability, regulatory compliance, and overall quality.

All researchers (PIs and anyone listed as key personnel) are required to complete the Duke Health CITI modules before a protocol can be approved.

The Campus Oversight Organization (COO) for DUHS IRB Protocols may be able to review a study if a) the researcher has their appointment outside of the Schools of Medicine and Nursing, and b) activities associated with the research are confined to use of existing patient information. The COO cannot accept protocols in which Duke Health resources will be used (personnel, physical space, equipment) or when Duke patients or charges in Maestro Care are required. 

This decision tree can aid in determining whether the Campus Oversight Organization is appropriate to your study, or whether you must partner with a researcher within a Clinical Research Unit (CRU). If you have questions about which path to follow, please contact the COO Research Practice Manager, Margaret Pendzich, or Rebecca Brouwer.

The COO can 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.

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

iRIS tip sheets and help

Duke Office of Clinical Research

DUHS IRB

You can contact the Director or Manager of the Campus Oversight Organization for help:

Christopher Freel, Ph.D.
Director
(919) 668-4378
christopher.freel@duke.edu
 

Margaret Pendzich, COO Manager

margaret.pendzich@duke.edu 

Rebecca Brouwer
rebecca.brouwer@duke.edu