The dissertation research for the first time in the domestic civil doctrine proposed the concept of legal regulation of relations, the object of which are biobanks, which aims to improve existing civil and medical legislation to create legal guarantees for personal non-property rights of individuals and their balance with the interests of institutions (managers) of biobanks.
The author's definition of a biobank as an object of legal relations that has a dualistic legal nature is proposed, as it is a combination of biological material that has a materialized nature and is also related with personal data about the person from whom it originates, including information about his health and genetic data.
The legal regime of biological/anatomical materials as an object of civil legal relations is analyzed and the interpretation of the legal relationship between a person and his biological material is argued as "personal legal connection", which gives the person a possibility within the limits specified by law to influence the legal fate of this object of civil rights, which is closely related to personal immaterial rights of individuals.
The need to improve the definition of biological material, which is proposed to be defined as part of a biobank, which may include human tissues, cells, biological fluids and secretions, materials obtained during the application of diagnostic and / or therapeutic measures (except organs), as well as materials embryo-fetal and outer-fetal origin, which are obtained, in the manner prescribed by law, on the basis of a duly informed consent to withdraw and transfer them to the biobank or for other further use.
The concept of understanding the legal regime of an non-implanted embryo in vitro has been improved, as a result of the use of assisted reproductive technologies will be interpreted as a result of the patient's / patients' reproductive rights and them will be entitled to determine the future fate of their embryos, within the limits set by law. The necessity of formation in the legislation of protection guarantees of for living non-implanted embryos for the purpose of implementation in the national legislation of Convention on human rights and biomedicine Art. 18 is substantiated.
Systematization and classification of subjects of the relations concerning creation and use of biobanks, by their division into 2 groups is carried out: the subjects participating in creation of biobank and the subjects participating in use of biobank. The approach to determining the legal status of the institution (manager) of the biobank has been improved, as a result of which two groups of its responsibilities have been identified: organizational (license) and personalized responsibilities.
The legal status of probants as subjects who transfer their biological materials for scientific research, including clinical trials of tissue and cell transplants, and in connection with the lack of legal regulation in this area developed a comprehensive draft law "On research activities involving human and the use of biobanks ".
The expediency of legal regulation is argued and the content of the probant and researcher, as participants in the relations on creation and use of biobanks, mutual rights and obligations.
The definition of personal data has been improved in order to distinguish between impersonal and coded personal data, which will create additional guarantees for the protection of such data and meet the requirements of the new EU Regulation 2016/679.
The position on the content and scope of medical secrecy in the context of the need to expand this concept and include in it also "biobank secrecy" in order to protect personal data that are a part of the biobank.
The interpretation of the legal nature of the informed consent to the withdrawal of biological material for transfer to the biobank for foreign use, as a result of which a person loses personal contact with this biological material as a unilateral transaction.
The general characteristics of the contract of personal storage of biological material are carried out, its assignment by the legal nature to contracts on rendering of services is proved, however storage of biological material for personal or family (non-commercial) use is supposed to be the main service.
The catalog of the basic mutual rights and duties of the executor and the customer under the contract of personal storage of biological materials is formed, and also criteria of proper storage of biological material are formulated.
The approach to determining the grounds for termination of the contract of personal storage of biological materials was improved. The amount of liability in case of negligent or unjustified destruction or other damage, which makes it impossible to use biological material.
