Debating opt-in/opt-out on genetic/genomic data sharing for scientific research in the EHDS Regulation: an invitation to look behind the tree that hides the forest
Résumé
Background/Objectives: The European Health Data Space Regulation (EHDSR) under discussion within the European institutions is the occasion to debate once again on the major issues surrounding the options for individuals to (dis)agree to the secondary use of genetic/genomic data. As genetic/genomic data are being particularly sensitive personal data, opt-in consent/opt-out is questioned as the best way to ensure control by individuals over their secondary use for research within the European Research Area. Prolonging the efforts made for equilibrating research needs with data subject’s control along GDPR negotiations which established opt-out as a standard and opt-in as a discretionary choice for Member States, the EHDSR offers an opportunity for the research community and policy-makers to decide about harmonised rules for facilitating genetic/genomic data sharing for secondary uses in research. Methods: This communication will analyse the main positions of actors such as EU institutions, Scientific Societies, European Patients’ Organisations to compare their principal arguments to favour either opt-in or opt-out positions. Results: We will highlight the rationale and advantages of opt-out approach to support secondary use of health data for research that has been defended by many genetic research stakeholders for several years and backed by national laws and discuss the challenges posed by opt-out. Conclusion: Ultimately, we will formulate suggestions for optimal conditions allowing opt-out to be used as a mechanism ensuring efficient involvement of individuals in a trustworthy multi-level data sharing governance system serving research.
