Collection of human biological samples and personal data: a legal study for a trustworthy biobank governance

Research biobanks are collections of human biological samples and personal data on a long-term basis for future scientific research purposes and, therefore, fundamental infrastructure for the conduction of scientific research and the advancement of society, especially in the medical field. However, the matter is not specifically regulated, either at the supranational or the national level, and therefore the applicable provisions should be found in the sectorial regulations that govern biobanking activities. Among the various controversial issues that arise in this field, that of the models for the collection of human biological samples and the personal data to be stored in the biobank is particularly controversial. The aim of this study is, therefore, to provide a comprehensive analysis of these models from a regulatory perspective, at both the supranational and national level. After having provided general definitions of the main concepts used in biobanking and an overview of the hard and soft law instruments applicable to the field, the study is devoted to describing the available lawful methods for collecting biological samples and personal data first as a primary and then as a secondary use. In order to choose the appropriate method, the biobank should evaluate its impact on the participant’s right to data protection in its actual conceptualisation, and strike a balance between the latter and the interest of society in the advancement of scientific research. Moreover, the study proposes a subsidiary test to conduct to this end, i.e. a trust test to evaluate the impact of the choice on participant’s trust in biobanking. Finally, an overview of the issue of anonymity in the context of biobanking is provided, usually referred to as the technical measure to solve data protection issues, but which is rendered increasingly more challenging to achieve by technological advancements.