What is a Data Use Agreement (DUA)?
A Data Use Agreement (DUA) is used when transferring protected health information (PHI), including coded de-identified data, limited data sets (LDS), and personally identifiable human data from one party to another. A DUA defines the rights, responsibilities, and obligations of both the providing and receiving parties regarding issues such as permitted use, ownership, publications, intellectual property, and liability.
When is a DUA Used?
The University of Florida is a member of the Federal Demonstration Partnership. The FDP is a program convened by the Government-University-Industry Research Roundtable of the National Academies. Its purpose is to reduce the administrative burdens associated with research grants and contracts. The FDP has provided guidance on when and how to use a DUA:
Who Negotiates DUAs for UF?
The UF Office of Clinical Research (OCR) Contracting team negotiates all UF DUAs.
What DUA Templates are Used at UF?
- Data Use Agreement
- Attachment 2 – DUA Limited Data Set
- Attachment 2 – DUA Personally Identifiable Human Data
- Attachment 2 – DUA De-identified Data
How are DUA Requests Processed?
- The OCR Contracting team processes all UF DUAs.
- All DUAs must be entered into UFIRST.
- If a DUA is funded (i.e. UF is receiving money for the data), the DUA will need to be entered into the OCR Human Subjects Research Intake Form and will then be entered into UFIRST by the OCR Contracting team.
- If a DUA is unfunded, the DUA should be entered directly into UFIRST.
How do I Submit a DUA to OCR?
| FUNDED DUAs | Un-FUNDED DUAs |
|---|---|
| Submit via Human Subjects Research Intake Form | Enter into UFIRST |
DUA Special Handling
Some DUAs require special handling; examples are listed below.
Centers for Medicare and Medicaid Services (CMS)
- CMS Overview of DUAs – includes General Guidelines for Submission of DUAs
- Extensions & Closures of CMS DUAs
NCBI dbGaP DataBase of Genotypes and Phenotypes
- NCBI dbGAP DUA requests are submitted here: NCBI dbGAP DUAs.
- The Signing Official (SO) must always be Jason Cline.
- IT Director must always be Erik Deumens.
Requests Requiring the Chief Information Officer’s (CIO) Signature
- Elias G. Eldayrie is the Chief Information Officer for the University of Florida.
- Departments must submit a request via the UF Risk Management System to enable UF Information Security to review and implement the security plan for the DUA.
Questions?
- Email: OCR-Contracting@ahc.ufl.edu
- Team Lead: Sherrie Bowen (352) 273-7817
- Individual team members: See Our Staff