JMIR Publications

ABSTRACT

FAIR-by-design is the prospective implementation of the FAIR (Findable, Accessible, Interoperable, Reusable) principles throughout the research lifecycle to maximise the return on investment in research. We present our experience implementing FAIR-by-design within ECRAID-Base, a consortium led by the Ecraid Foundation that hosts a pan-European network of perpetual observational studies (POS) designed to enable rapid research responses to infectious diseases with epidemic and pandemic potential, including antimicrobial resistance. We describe how we applied the FAIR principles prospectively across participant-level data collection, metadata cataloguing, informed consent, data and sample governance, data repository selection, and research output management. We describe key challenges experienced in standardising participant-level data, including connecting intervention and observational studies through data standards, non-conformant implementation of data standards, discoverability of non-standard variables, and conformance validation. Through our work in ECRAID-Base, we demonstrate how FAIR-by-design can extend beyond data capture to encompass machine-readable consent, transparent data and sample governance, federated data reuse, software, and other research outputs. We present nine actionable policy recommendations to help biomedical research networks, funders, and research infrastructures develop a FAIR-by-design strategy in the context of pandemic preparedness, where reusing participant-level data has important consequences for the quality and speed of research, clinical practice, and public health response. We discuss how FAIR-by-design aligns ECRAID-Base with European Open Science policy, the European Health Data Space, and the GloPID-R principles for data sharing in public health emergencies, showing how prospective FAIR implementation is central to pandemic-ready research ecosystems.