Executive Summary Patient registries are important tools for advancing research, improving healthcare quality, and supporting health policy. Registries contain vast amounts of data that could be used for new purposes when linked with other sources or shared with researchers. This toolkit was developed to summarize current best practices and provide information to assist registries interested in sharing data. The contents of this toolkit were developed based on review of the literature, existing registry practices, interviews with registries, and input from key stakeholders involved in the sharing of registry data. While some information in this toolkit may be relevant in other countries, this toolkit focuses on best practices for sharing data within the United States. Considerations related to data sharing differ across registries depending on the type of registry, registry purpose, funding source(s), and other factors; as such, this toolkit describes general best practices and considerations rather than providing specific recommendations. Finally, data sharing raises complex legal, regulatory, operational, and technical questions, and none of the information contained herein should be substituted for legal advice. The toolkit is organized into three sections: “Preparing to Share Data,” “Governance,” and “Procedures for Reviewing and Responding to Data Requests.” The section on “Preparing to Share Data” discusses the role of appropriate legal rights to further share the data and the need to follow all applicable ethical regulations. Registries should also prepare for data sharing activities by ensuring data are maintained appropriately and developing policies and procedures for governance and data sharing. The “Governance” section describes the role of governance in data sharing and outlines key governance tasks, including defining and staffing relevant oversight bodies; developing a data request process; reviewing data requests; and overseeing access to data by the requesting party. Governance structures vary based on the scope of data shared and registry resources. Lastly, the section on “Procedures for Reviewing and Responding to Data Requests” discusses the operational steps involved in sharing data. Policies and procedures for sharing data may depend on what types of data are available for sharing and with whom the data can be shared. Many registries develop a data request form for external researchers interested in using registry data. When reviewing requests, registries may consider whether the request aligns with the registry’s mission/purpose, the feasibility and merit of the proposed research, the qualifications of the requestor, and the necessary ethical and regulatory approvals, as well as administrative factors such as costs and timelines. Registries may require researchers to sign a data use agreement or other such contract to clearly define the terms and conditions of data use before providing access to the data in a secure manner. The toolkit concludes with a list of resources and appendices with supporting materials that registries may find helpful.
Examining Data Repository Guidelines for Qualitative Data Sharing
