IRB Guidance: Data Release Agreements
This page addresses requirements when receiving research data or other information covered by a contract, MOU, data sharing and/or data use agreement.
Many research projects include a contract or other legal agreement as part of the proposed application. These agreements, while presented with a number of different acronyms and titles - Data Use Agreements (DUA), Memorandums of Understanding (MOU), Business Associate Agreement (BAA) - they all fall under the umbrella of Data Release Agreements. For the purposes of this document, Data Release Agreement is used. However, please note that the same or similar provisions are applicable to all of the agreements (and others) mentioned above. A Data Release Agreement is a contractual document used for the transfer of non-public or restricted use data. Examples include records from governmental agencies or corporations, student records information, existing human research subjects data, and limited data sets.
Importance of Data Release Agreements
- Disclosure of data is for research purposes;
- Individual authorization for disclosure to this recipient is not/has not been obtained (i.e. through use of a subject-signed informed consent authorization);
- When no other form of contract concerning the data transfer exists between the provider and the recipient (i.e. sub-award agreement or a contracted services agreement).
- Records from governmental agencies or corporations;
- Student record information;
- Existing, identifiable human subject data;
- A limited or restricted use data set.
- When data is publicly available in public domain;
- When data is exchanged that is not subject to a legal or other restriction on its use;
- If a research subject signs a consent authorization form that authorizes data sharing with the recipient;
- When another agreement, such as such as a sub-award agreement or a contracted services agreement is in place;
- 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 (i.e. grant, contract, sub-award, contracted services agreement, etc.). In these cases, a separate Data Release Agreement is generally not necessary.
- It is important for researchers to read the terms of a Data Release Agreement before forwarding it to a signatory for review and approval. It is the researcher’s responsibility to understand and follow the terms of the agreement and to only use data for purposes specified. Campus signatories assume that a researcher who transmits a Data Release Agreement has read and agrees to conform to those terms, whether or not the researcher’s signature is required (in addition to campus signatory) on the agreement itself.