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Data use agreements (DUA) are commonplace in clinical research. As a rule, a DUA may be required by UTSW whenever data will be shared with outside entities.
Data from clinical research in general should not be shared with outside entities without an evaluation by the UT Southwestern Human Research Protection Program (HRPP) of the need for a DUA. The HRPP will determine if a DUA is needed when the study (or modification to the study) is submitted online to the Institutional Review Board (eIRB) for review.
DUAs are neither created nor signed by the investigators but rather signed by the UTSW official with appropriate delegated signature authority. The researcher, however, should review and understand the terms of a DUA as they need to conform to those terms.
We are working on creating a simplified, transparent, and efficient DUA process. In the meantime, we will abide by these general guidelines:
A standard DUA is required when:
- Data transfer takes place between the provider and the recipient in the absence of a signed HIPAA authorization or HIPAA waiver that describes the data sharing, or
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Data is being shared with a commercial entity and has intellectual property (IP) potential.
A custom DUA may be required when any of the following are true:
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Biospecimens are also shared (this requires Material Transfer Agreement language).
- The recipient of the data will not accept the terms of the standard DUA.
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Research is more complicated (e.g., multisite consortium).
A business associate agreement (BAA) is required when:
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Protected health information that is individually identifiable will be shared/transferred to a vendor who will provide a service for UTSW.
A DUA is not required:
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When a study is funded by an outside entity such as a private-for-profit, private not-for-profit, or foundation, and the transfer of data from one entity to another is addressed in the context of a larger agreement between the parties, such as a sub-award agreement or a clinical trial agreement.
- If the patient signs a HIPAA authorization or the IRB/HRPP waives the requirement for a HIPAA authorization.
Note: The DUA processes outlined above is specific to UTSW analyses and may not apply to data acquired through the Parkland Health & Hospital System, Children's Health, Scottish Rite for Children, and Texas Health Resources.
For more information, contact Rhonda Oilepo, M.S., CIP, CHRC, CHPC, Assistant Vice President, Human Research Administration.
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