LEGAL REGULATION OF THE CONCEPT AND PRINCIPLES OF RESEARCH AS A PURPOSE OF CREATION AND USE OF RESEARCH BIOBANKS

Abstract

Problem setting. Research biobanks are created and used to develop medical science and to develop new drugs or treatment methods. Absence of complex special legal regulation of research activity with human participation in general, and research of human biological materials and personal data related to health of a person in particular, which are part of research biobanks, creates favorable conditions for violation of personal non-property rights of investigated persons.

Analysis of recent researches and publications. O. Kashintseva, R. Maidanyk, S. Mykhaylyuk, S. Pustovit, R. Stefanchuk, I. Senyuta and others studied the issues of bioethical and legal principles of research in the field of medical research and the definition of the concept and types of such activity.

Target of research is to identify the fundamental principles that should underpin such a particular type of research as research of the human biological material and related information, and to define the concept of such activity and the scope of a future special law governing this relationship, to offer a unified approach to understanding the concepts and types of medical research.

Articles main body. In this article, based on an analysis of doctrinal sources, applicable law and Swiss law that can serve as an example for Ukraine, the basic principles on which human research should be based are defined, the types of such activities are formulated and their definitions formulated to unify terminology. The scope of a comprehensive special law is defined, the task of which is to regulate all types of human research activities, including studies of human biological materials and related to health personal data.

Conclusions and prospects for the development. The basic principles of human research are: the predominance of human interests over the interests of science and society; scientific validity of the research; non-discrimination; free expression of will; the right to information; prohibition of commercialization; scientific requirements (freedom of scientific activity, scientific quality, qualification of responsible persons). These principles, on the one hand, create the conditions for the security of human research and create the space for researchers to implement their scientific projects for the benefit of mankind.

The following types of research are identified, which should be included in the sphere of regulation of a special law: investigation of diseases - investigation of the causes, methods of prevention, diagnosis, treatment and epidemiology of physical and mental disorders of human health; studies of the structure and functioning of the human body - basic research, in particular on anatomy, physiology, genetics of the human body, as well as studies not related to diseases and having the object of intervention and effects on the human body; research with expected direct benefit - a research project whose expected results should improve the health of the person involved; clinical research (trial) - a research project, the subject of research in which is a person (investigated), during which there is an intervention in the field of health of the investigated person in order to study the impact of the subject of research on the health, structure or functioning of the human organism.

The scope of the special law should extend to the study of human diseases, as well as to the study of the structure and functioning of the human body conducted: directly with the participation of persons (on living persons) - clinical trials; on the body of deceased persons (post-mortem studies); on embryos and fetuses; using biological materials; using personal data related to a person’s health. Instead, excluded from the scope of this law should be research of the anonymous (impersonal) biological materials and received anonymized or anonymized personal data related to a person’s health, since their anonymous (impersonal) nature excludes the violation of the investigated person’s non-property rights.