Key concepts in clinical epidemiology: FAIRification of biomedical research data

The Findable, Accessible, Interoperable, and Reusable guiding principles promote Findability, Accessibility, Interoperability, and Reuse of data to enhance data management and stewardship. In biomedicine, particular ethical, legal, and technical barriers complicate research data sharing. To help researchers overcome these challenges, we propose a framework of FAIRification from three dimensions – scientific, technical, and legal/ethical. We advocate for prospective FAIRification of study data, starting with a strong emphasis on planning for data-sharing from the beginning. Reflective questions throughout the process guide researchers to reflect on their situation. Researchers should assess resources and feasibility, secure technical and legal support, consider stakeholder needs, and devise an appropriate data sharing process. Given the sensitivity of biomedical data, confidentiality and security require careful attention. The data sharing strategy should be finalized before the study starts and documented in relevant study materials. Technical preparation for data sharing follows planning. Data should be well-documented with a data dictionary and metadata to facilitate reuse and provided in an accessible format. The data can be hosted on a repository to promote sharing and reuse. While a secure repository provides the technical foundation for data protection, effective administration is required to enforce data use agreements and licensing. We also discuss the importance of subsequent management upon data upload. Continued support for researchers and data maintenance are essential for effective reuse. Examples and resources to facilitate FAIRification are included to help researchers navigate challenges and ensure biomedical data are FAIR and reusable.