What does good governance of federated biomedical data reuse look like? A scoping review protocol.

Background Federated reuse of participant-level biomedical data enables public health institutions, healthcare providers, and researchers to analyse data without moving it from its source, providing access to a more diverse data ecosystem. Data governance determines whether this reuse is trustworthy, addressing the legal, ethical, and technical questions raised when decentralised analysis balances privacy with utility. Effective governance is central to protecting participant rights, ensuring benefit sharing, and supporting equity while enabling collaboration across data sources. This scoping review will identify and synthesise recommendations for data governance in the federated reuse of biomedical data, focusing on how approaches address participant rights, benefit-sharing, inclusivity, and legal and ethical compliance, and how they vary across reuse mechanisms. Methods We will apply the Arksey and O’Malley framework to map current recommendations and best practices and to identify gaps. A search strategy developed in line with the PRESS guidelines was piloted and tailored for Ovid (MEDLINE), EMBASE, and Web of Science, and covers the period from January 2000 to the search date, without language or geographic limits. Title and abstract screening will be conducted by one reviewer with ASReview as the second reviewer; full-text screening by two independent reviewers; and data extraction by one reviewer, verified by a second. Stakeholder consultation will refine the charting framework and the interpretation of findings. Results As part of the review protocol, this article reports no results. The completed review will map governance models, chart how each addresses participant rights and benefit-sharing, and compare approaches across data types, technical architectures, geographies, and legal contexts. Conclusions The review will provide the first structured synthesis of data governance for federated reuse of biomedical data, informing efforts to build transparent, equitable, and scalable frameworks. Ethical approval is not required; the protocol was registered with Open Research Europe before searching, and results will be published open access.