FAIR but Restricted: Stewardship of Genomic and Sensitive Data in Clinical Research

The widespread adoption of genetic testing, driven by technological advancements and reduced costs, offers tremendous potential for advancing personalized healthcare. However, because genomic data acts as a permanent, unique biometric identifier with an inherently familial nature, its sharing raises severe privacy concerns. Key risks include the re-identification of individuals or blood relatives from anonymized data, unauthorized inference of disease predispositions, and potential data misuse by third parties, e. g. health insurance companies. Consequently, under Article 9 of the GDPR, genetic data is classified as a "special category," strictly prohibiting processing by default unless explicit, separate consent is obtained. For institutional Data Stewards, these strict legal and ethical boundaries present a challenge in aligning GDPR compliance with the principles of data shareability and reusability. To bridge this gap, we will present a stewardship framework that implements a "Restricted Access" model. While genomic datasets undergo anonymization or pseudonymization and access remains tightly controlled, non-sensitive, structured metadata is published openly. This approach satisfies the "Findable" aspect of FAIR data, demonstrating that genomic research can achieve full compliance with the highest standards of privacy while remaining structurally valuable to the scientific community. Supported by MH CZ - DRO („Institute of Hematology and Blood Transfusion – IHBT, 00023736“).