Data ownership refers to both the possession of and responsibility for information. Data owners have the ability to access, create, modify, package, derive benefit from, sell, or remove data, as well as the right to assign these access privileges to others. Data in a registry traditionally has been owned by the registry sponsor. If there is more than one sponsor of the registry, ownership of the data should be clearly defined and legally documented. However, increasingly patient registries, especially those sponsored by rare and genetic disease patient groups and umbrella organizations, are providing more ownership rights to individual participants, including allowing participants to decide on a case by case basis who can view or access their data.
If a registry contains health information from a hospital or clinician’s office or research data from a university or industry, data ownership may be more complicated and should be negotiated and defined clearly prior to including this type of data in a patient registry.
HHS Reponsible Conduct in Data Management: Data Ownership
HHS Office of Research Integrity: Data Ownership
Principles of Registry Ethics, Data Ownership, and Privacy from “Registries for Evaluating Patient Outcomes: A User’s Guide” [Internet, 4th edition]
Rare Diseases Registry Program (RaDaR): Learn About Data Ownership