Data Use Agreements

 

Staff Proposals Forms Training Policies

 

 

Procedures and Information

 

Definition/Purpose

 

A Data Use Agreement (DUA) is a contractual document between a “Data Users” (usually the UMBC investigator requesting access to information) and the "Data Set Source" (the organization or institution providing the data) describing the provisions associated with the transfer of confidential, protected , or restricted-use data. Examples include records from governmental agencies or corporations, student records information, existing human research subjects data, and limited data sets.

 

DUAs address important issues such as limitations on use of the data, liability for harm arising from the use of the data, publication, and privacy rights that are associated with transfers of confidential or protected data. The DUA also assures that Data Users are using the data in accordance with applicable law (e.g. HIPAAFERPA) and prevents the inappropriate use of protected or confidential data that could cause harm to the investigator, the University, or individuals whose data is part of the data set.

 

In general, a Data Use Agreement includes:

  • What data will be released or shared
  • Who has ownership of the data
  • What, if any, identifiers will be included
  • The purposes for which the data may be used
  • With whom, if anyone, the data may be shared
  • Data security and safeguards
  • To whom violations of the agreement should be reported
  • The term of the agreement
  • The disposition of the data at the end of the agreement
  • Any indemnification or insurance requirements

Review of Data Use Agreements

 

It is important for researchers to read the terms of a DUA before forwarding it to the UMBC Office of Sponsored Programs (OSP) for review. It is the researcher’s responsibility to understand and follow the terms of the DUA and to only use data for purposes specified. OSP assumes that a researcher who transmits a DUA to OSP has read and agrees to conform to those terms, whether or not the researcher’s signature is required on the DUA itself. When a researcher signs such an agreement, they could be subjected to legal and financial risks. A researcher should not sign a DUA prior to OSP approval of the DUA.

OSP serves as the campus signatory for research-based Data Use Agreements. DUAs must be routed through OSP for final sign-off and approval. OSP is authorized to enter into contractual agreements, including DUAs, on behalf of UMBC to ensure compliance with appropriate policies and regulations. Researchers are not authorized to negotiate or sign these agreements and cannot sign DUAs on behalf of UMBC. DUAs should not be signed by University faculty or staff members in the absence of institutional approval from OSP.

 

Data Use Agreements and Human Subjects Research

 

DUAs are commonly used when a researcher wishes to access archives or restricted data sets that may contain identifiable information about individuals for the purpose of conducting research.  The IRB must be contacted if the use of the archived protected health data falls under the definition of “research”. 

If a DUA is a part of the project submitted to the IRB, a draft version must be included in the protocol application. The IRB may provide conditional approval of a protocol if it is needed in order to get a DUA signed, but final IRB-approval will not be granted until a copy of the signed DUA is received from the Office of Sponsored Programs and submitted to the IRB.

 

For more information, human subject restricted source examples and the IRB's process of review, please click here or contact the ORPC at 5-2737 or compliance@umbc.edu.

  • Procedure

    Sometimes, a transfer of data from one entity to another is addressed in the context of a larger agreement between the parties, such as a subaward agreement or a contracted services agreement.  Data transfer as part of such a collaborative research project is often addressed in the study protocol or in the funding agreement terms and conditions.  In those cases, a separate DUA is generally not necessary.  However, for a data transfer that takes place in the absence of a funding agreement (grant, contract, subaward, contracted services agreement, etc) between the provider and the recipient, you should first review and fill out the DUA Submission Form (under development) that appears on this website.

    The DUA Submission Form has two columns:  The left side should be used when a UMBC investigator is receiving data; the right side should be used when a UMBC investigator is providing data to another party.  If there is a mutual exchange of data, please complete both sides of the DUA Submission Form.  The completed, signed form should be emailed to ospa@umbc.edu along with any applicable compliance documentation.

    If the UMBC investigator is receiving data and the providing party has sent a form of agreement, make sure to include the agreement when sending your submission materials to the OSP.  If you have received the agreement electronically, sending it to the OSP via email will greatly help expedite the review process. 

    If the UMBC investigator is providing data, OSP staff members will offer the recipient the appropriate DUA according to the information provided on the Data Use Submission Form.  Since data transfers take place in many different circumstances, there is not a single template agreement UMBC uses for outgoing transfers of data.

Information

 

Return to OSP Procedues

 

August 23, 2013

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Didn’t find what you needed? Contact the OSP staff at 410-455-3140, ospa@umbc.edu