Legal Regulation of Compensationt to Healthy Volunteers Participating in Clinical Research

Abstract

Problem setting. The article highlights the existing gaps concerning the legal uncertainty of the status of subjects of clinical research. The issue of the necessity of normative consolidation of methods and types of compensation to subjects of clinical research healthy volunteers in the domestic legislation has been considered. The main approaches to determining compensation and / or reward to healthy volunteers for participating in clinical research, which exist in domestic and foreign practice, have been analysed, and the author’s proposal to include the relevant norm in Ukrainian legislation has been substantiated. Analysis of recent researches and publications. The works of national representatives of the pharmaceutical science V.E. Dobrova, I. A. Zupanets, M.G. Starchenko are devoted to the definition of theoretical and methodological principles and the development of a compensation calculation method for participation in clinical research to healthy volunteers. Among foreign scientists, the publications of Steven Bernstein, Ana Iltis, Lu Ming, Giuseppe Pasqualetti, Martin Wilkinson, Matthew Czarny should be noted. They are dedicated to payments to healthy volunteers during the first phase of clinical research. The analysis of Ukrainian scientific and legal sources suggests that there are no publications on the subject under study in the national legal science. Purposes of research. The purpose of this work is to confront and compare approaches to the definition of compensation and / or rewards to healthy volunteers for participating in clinical research, especially the legal regulation of this issue in various states of the modern world. The attention has been paid to the gaps concerning the legal uncertainty of the status of subjects of clinical research in Ukraine. Proposals on making changes in the current legislation of Ukraine are formulated in order to overcome the gaps in the field of health protection regarding the compensation for participation of healthy volunteers in clinical research. Paper objective. Compensation for participating in clinical research is not a standard and is not fixed at the legislative level in many countries, but in practice, during the 1 st (first) phase of clinical research and bioequivalence studies of medical research, the subjects of research – healthy volunteers, often receive compensation in certain form only for their participation in these studies. Inclusion of provisions regulating the issue of compensation to healthy volunteers to the national health care guidelines, or assigning them to the competence of local ethics commissions at health institutions where a clinical research is conducted, is quite common in foreign countries. Conclusions and prospects for the development. Analysis of the legal regulation of the main approaches to the definition of methods and types of compensation to subjects of clinical research – healthy volunteers, enables concluding that there is a need for further theoretical developments in this field. This problem is actualized due to the lack of clear legislative consolidation of the requirement of compensation to subjects of clinical research healthy volunteers, which generates uncertainty in the actions of the state administrative apparatus and causes errors in the field of clinical research of drugs and the study of bioequivalence.