The article deals with the methodological problems of ethical regulation of clinical studies: 1) formalism, the inability of researchers to critically analyze the project in terms of safety and well-being of the patient, to implement the principles of bioethics in study; 2) propaedeutic nature of scientific research, the low degree of novelty, theoretical and practical significance for medicine; 3) voluntarism in the selection of the strategy and tactics of the study, the lack of alternative scientific hypotheses.
