A Material Transfer Agreement (MTA) is a contract that governs the transfer of tangible research materials and associated data between two institutions for the purposes of protecting the interests and ownership rights of the researchers and their institutions. A Data Transfer Agreement (DTA) is a contract used to transfer human subject data between institutions or organizations for use in research. With transfer agreements, the term "data" can sometimes also refer to biospecimens/tissue samples, or other collected materials.
When any type of data or biospecimens owned by the University of Utah are to be shared with anyone external to the institution, a legal agreement is needed to transfer custody and ownership of the data/specimens. An agreement is needed regardless of the identifiability of the data/specimens. Researchers, physicians, faculty members, and all University affiliates are not permitted to share University of Utah data without consulting the appropriate department representatives as described below.
The most common types of agreements are Data Transfer Agreements (DTAs) or Material Transfer Agreements (MTAs). Sometimes the contract is referred to as a Data Use Agreement (DUA), though a DUA is actually a different kind of agreement with a Limited Data Set.
An agreement is needed regardless of whether the data is research data, clinical data, or other University-owned data. The type of data helps the University decide which agreement is used and who needs to sign off on the agreement. Signatories may include but are not limited to: UU principal investigator, https://technologylicensing.utah.edu/ representative, Office of Sponsored Projects (OSP) representative, Vice President for Research, IRB Director, department chair, Associate Vice President for Research Integrity, and representatives from the other institution.
Transfer agreements are usually initiated by the institution who is sharing their data.
Getting Started
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Contact your project/grant officer at OSP. OSP will determine if an agreement is required, sometimes data sharing is covered in the sponsored research agreement or grant application. They will also determine who needs to sign off on the agreement.
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Contact the PIVOT office. PIVOT will determine if an agreement is required and what type of agreement is required. They will also determine who needs to sign off on the agreement.
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Contact the Technology Licensing Office. The Technology LIcensing Office will determine if an agreement is required and what type of agreement is required. They will also determine who needs to sign off on the agreement.
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If an investigator has hired an external company to conduct a specific research procedure on behalf of the investigator, and the company is returning all data/samples and not maintaining any data/samples for their own use after the procedures, this type of data sharing is generally covered by a Business Associates Agreement (BAA). This is an agreement that is used when UU hires an entity to conduct its business. Contact the Office of General Counsel to learn more about this process.
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When the IRB makes an “Exempt” determination for research, this is related to the type of regulatory oversight that is required. Exempt research is human subject research and if a Data or Material Transfer Agreement are used, the IRB must sign off before any data collected as part of an Exempt research project can be shared outside the institution. You should follow the process listed elsewhere on this page that applies to your situation.
How is the IRB Involved in This Process?
If the data being shared was collected as part of a human subject research project, the IRB must sign off on the Transfer Agreement to ensure the sharing is consistent with the approved IRB application, the consent form (if applicable), and any applicable research regulations. The Technology Licensing Office or OSP will circulate the agreement to the IRB for sign off.
Sometimes the data being shared is not part of an ongoing study at University of Utah. But, if the data was collected as part of a closed or archived human subject research project, the IRB will still need to review for consistency and sign off on the agreement. Additionally, there are times where the IRB is signing off on the agreement as a way of confirming an IRB application is not needed for this data sharing.
Tips:
- The IRB must review the Transfer Agreement, even if the data being shared is de-identified. The IRB is looking to ensure the consent form is consistent with what and how you want to share the data.
- Save time in the DTA/MTA review process by ensuring the data sharing plan in the agreement (including Exhibit A) is consistent with the ERICA application! The IRB will compare your data sharing plan outlined on the HIPAA and the Covered Entity page of your ERICA application with the agreement. If the agreement is not consistent, you will be asked to either update the agreement or submit an Amendment to the ERICA application.
How Do I Contact the Technology Licensing Office?
