A Data Use Agreement (DUA) is a contract that establishes terms and conditions governing the transfer of research-related individual patient-level data between UTHealth and another institution or company. A DUA between a providing entity and a receiving entity should be fully executed before any data elements are sent or received. If you are uncertain whether a DUA is needed, you may reference the DUA Decision Tree.

DUA In (Receiving Data):	DUA Out (Providing Data):
A DUA-In must be completed when a UTHealth PI has requested data from another entity. Typically, the providing entity will provide its own DUA template for UTHealth’s review and execution.	A DUA-Out must be completed when a UTHealth PI desires to send data to a researcher at another entity. In these instances, a UTHealth DUA template will be sent to the receiving entity for review and execution.
All DUAs should be forwarded to the [email protected] for review.

PROCESS

If a UTHealth PI has requested data to be transferred to him/her from another entity or if another entity has requested data to be transferred from the UTHealth PI, the PI/department will submit a DUA request in UTSTART using the instructions below. If human subject data is being sent or received, please be sure to include the IRB protocol number in the UTSTART submission. SPA will negotiate the legal terms and conditions of the DUA with the other entity and notify the PI/department when the DUA is complete.

How to submit a DUA request in UTSTART:

1. Login to START Login
2. Navigate to the Agreements Module
3. Select the “Data Use/Business Assoc.” agreement type (Click here to see)
4. Fill out the intake form under the “Transfer e-Form” tab and press “Submit” once complete. If you received an agreement draft from the other entity, you may upload that in the Transfer e-Form or under the separate “Attachments” tab (Click here to see)

            *Please note that pressing submit is essential for SPA to receive the request*

If you have any additional questions about DUAs or the submission process, please reach out to [email protected].

DEPARTMENT TASKS/RESPONSIBILITIES

1. Submit a DUA request in UTSTART using the instructions above.
2. If the other entity is not listed in UTSTART, submit a Sponsor/Subcontractor Request Form to [email protected].
3. PI will need to provide SPA with an active IRB protocol if (i) UTHealth PI is sending clinical data to another entity (including de-identified data), or (ii) UTHealth PI is receiving clinical data with personal identifiers. Please note that zip codes and dates of service are also considered personal identifiers. If you are unsure if the data includes personal identifiers, you may consult the Human Data Classification Tool. Please note that the IRB protocol must be approved before the DUA can be signed.
4. If there is not already an active IRB protocol as stated above, submit a new IRB protocol or update an existing IRB protocol through iRIS to cover the new transfer/receipt of data

SPA TASKS/RESPONSIBILITIES

1. Draft and/or negotiate legal terms of the agreement with the other entity on behalf of the PI and UTHealth.
2. Route the final version agreement for internal signature by UTHealth’s authorized official.
3. Send the final draft of the DUA to the other entity for final execution
4. Send the PI a copy of the fully executed agreement and retain a copy for institutional record.