This resource was developed to enable data sharing among separate academic institutions. The question of data ownership is a common governance challenge in that institutions, such as medical centers and/or universities, often do not have general policies that allow data sharing among other institutions, even for the purpose of conducting a research study. The data access agreement that was developed enables the data to be used by the participating institutions for the purpose of the conduct of the research study. The process of having this agreement reviewed and signed by institutional officials was time-consuming and difficult, but it enabled the data from a comparative effectiveness trial to be shared and for this trial to be conducted in an effective and efficient manner.
Legal and regulatory concerns, Data sharing approaches and considerations
Type of Governance Resource
Healthcare Setting(s) in which Data were Collected
Electronic Health/Medical Records (EHR or EMR), Diagnostic data, Data Collected for Independent, Research Studies (e.g. clinical trial, longitudinal outcomes study)
Generalizability to Other Settings
This resource could potentially be used for any type of data to be shared among various types of institutions, academic or otherwise.
Partners: institutional attorneys specializing in technology licensing/patents, members of the institution’s contracts office, and the institution’s conflicts-of-interest program official.
Geographic scope type
Kushida, Clete; Nichols, Deborah; Walsh, James; Griffin, Kara; and Hyde, Pamela, "Comparative Outcomes Management with Electronic Data Technologies (COMET) Data Access Agreement" (2013). Governance Toolkit. Paper 1.
Acknowledgement of Funders