Protection of Personal Non-Property Rights of Individuals, Biological Materials and Personal Data of Whose Are Subject to Research as a Part of Biobanks in Ukraine: Comparison with the EU Recommendation CM/Rec(2016)6

Abstract

The European integration process in Ukraine requires the harmonization of legislation regulating the lawful and safe use of human biological material and data as parts of biobanks, in accordance with European standards. The legislation currently in force in Ukraine only partially regulates these relations and is characterized by fragmentation and absence of a special law that would establish a general framework for the permissibility of scientific and clinical research involving human subjects, and using research biobanks and future scientific use of biological materials and data obtained initially with non-research purpose. This study concludes that there is a need to adopt a special law “On the legal regulation of research activities involving human subjects and using biobanks”, the task of which will be: to establish permissible limits of such research; to promote the quality, competence and transparency of clinical research in humans, and its aim will be the protection of human dignity, privacy and health in the process of carrying out research in humans. A general concept has been formulated for legal regulation of legal guarantees of probants non-property rights, balancing them with interests of science and freedom of scientific research activities. The probants legal status has been determined, which is bound up to the legal status of a researcher (a biobank manager or its users) and is disclosed through the right of a probant to self-determination. The ways to protect personal data of a probant have been identified, in the form of pseudonymization and anonymization.