In the Scalable Partnering Network (SPAN) for CER and Surveillance, Prevention, and Management of Diabetes Mellitus (SUPREME-DM) studies, investigators determined that dates of clinical service were needed for scientific analyses. The combination of dates and information from medical records constituted protected health information (PHI) and, thus, defined the data set as limited. According to HIPAA, a data use agreement (DUA) was required: “A data use agreement entered into by both the covered entity and the researcher, pursuant to which the covered entity may disclose a limited data set to the researcher for research, public health, or health care operations” [45 CFR 164.514(e)], Department of Health and Human Services. This case study focuses on data sharing in the SUPREME-DM project.

The HMORN created a DUA template in 2009. Elements of the agreement that are study specific are usually limited to the data set description and the permitted uses and disclosures by the data recipient. Historically, DUAs are executed between two sites: a data provider and data recipient. Since CER requires data sharing across multiple sites, executing data agreements is repetitive, time-consuming, and fails to add value or increased institutional or patient protections to the research enterprise. SUPREME-DM’s study staff collaborated with the human subjects protections team to propose a modification to the existing DUA template. They created a single reciprocal agreement that addressed data elements, uses and disclosures and the data flow among the sites involved. In this case, “reciprocal” meant that all sites agreed to the use and disclosure of limited data sets by all other participating sites. The lead site would be considered the “initial data provider” and, thus, would initiate and draft this modified agreement. This modified agreement allowed for consensus among the sites on the specific data elements that all sites would share and included a diagram illustrating the reciprocal nature of the agreement allowing any of the participating institutions to receive a limited data set for analysis.

Publication Date


Type of Governance Resource

Sample Agreement/Contract

Other Data Type


Generalizability to Other Settings

The SUPREME-DM DUA and data flow can serve as a model for other CER studies attempting to share data and analysis among multiple sites.

Network Description

By allowing all sites to share and receive analytic data sets, this increased value for the funder by: increasing the amount and accelerating the pace of the research conducted; strengthening the Network by scientifically engaging researchers; and enabling needed analyses to occur where there was the greatest expertise and interest.

Geographic scope type


Acknowledgement of Funders

This project was supported by grant number R01HS019859 from the Agency for Healthcare Research and Quality. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Agency for Healthcare Research and Quality.

Additional Information

This reciprocal Data Use Agreement was how the SUPREME-DM Network facilitated sharing limited data sets for CER among the sites.

Creative Commons License

Creative Commons Attribution-Noncommercial-No Derivative Works 3.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 3.0 License.