Do patients and research subjects have a right to receive their genomic raw data? An ethical and legal analysis

摘要: As Next Generation Sequencing technologies are increasingly implemented in biomedical research and (translational) care, the number of study participants patients who ask for release their genomic raw data is set to increase. This raises question whether have a legal moral right receive and, if so, how this should be into practice. In first step we clarify some central concepts such as “raw data”; second sketch international framework. The third provides an extensive ethical analysis which comprehends two parts: evaluation there prima facie one’s data, contextualization discussion light potentially conflicting interests rights subject herself parties; last fourth emphasize main practical consequences analyses propose recommendations data. several legislations like new European General Data Protection Regulation, do principle However, procedural implementation it involves genetic counselling at discretion Member States. Even more questions remain with respect context. suggests that subjects addresses aspects also relevance costs its impact on academic freedom. Taking account specific nature implications contexts health concerns themselves involved researchers, physicians, institutions relatives arise. Instead using them argue favor restrictions subjects’ addressed through provision information other measures. To end, relevant recommendations.