Ethical Expertise for Gene Diagnostics and Gene Therapy Clinical Studies

Abstract

Purpose of the study: to develop proposals for improving regulatory documentation on ethical expertise (EE) of gene diagnostics and gene therapy clinical studies.Materials and methods. We used general philosophical research methods, including the formal-logical, historical method, comparative method, systematic approach and axiological method. We analyzed 10 international acts, including acts of «soft law», 4 documents adopted at the level of interstate integration entities, 7 domestic normative legal acts, and a number of various doctrinal sources on the topic under consideration. In addition, we analyzed the regulatory documents for ethical committees (EC) acivities, including those from a historical perspective.Results. We formulated the concept of EE, defined the principles and main areas of EE, including the personalized medicine, and suggested the regulatory principles of EE operating.Conclusion. To improve the regulation of EE, the legal status and requirements for the activities of independent ECs should fit the scope of EE, differentially related to the area of a trial (non-interventional trials, clinical trials with a drug treatment); at the national level, independent ECs conducting EE of drug treatmemnt clinical trials should be institutionalized into a single system; to improve the activities of independent ECs in the field of clinical testing, the development of a special normative regulation is required.