Data Sharing Experience, Guidance, and Resources From the Rare Diseases Clinical Research Network (RDCRN)

Abstract

The Rare Diseases Clinical Research Network (RDCRN) comprises research consortia and other partners focused on the study of rare diseases. Its goals include sharing de-identified data with the scientific community and other stakeholders to advance rare disease research. The RDCRN Data Use & Data Sharing Committee and RDCRN Data Management and Coordinating Center reviewed data sharing practices across established consortia and published literature to develop guidance documents. The Committee produced “RDCRN Suggestions for Establishing Data Sharing and Data Management Guidance for Individual Consortia”, which lays out the common elements of successful data sharing, and “Principles of Data Sharing Checklist,” which outlines the components of informed consent language, contractual language, and consortium policies that govern data sharing and use. Key principles of the guidance are: (1) informed consent language should allow data sharing while protecting participants' rights, (2) the research database should track participant's choices on how their data can be used and shared to ensure appropriate data use limitations are followed, (3) the research protocol and consortium agreements should include language stipulating that data will be shared with the consortium Administrative Core (Admin Core) for the purpose of further sharing according to NIH policies, and (4) consortia policies and agreements should emphasize the role of the Admin Core as the primary steward of the collective data and recognize its authority to further share consortium data. The RDCRN experience and learnings contribute to the advancement of Clinical and Translational Science and may help other research networks in designing data sharing policies.