Ethical review of preclinical research

Abstract

The main goal of medicine has been and remains the desire to preserve the health of the population, increase human life expectancy and its quality. For those purposes, it is necessary to constantly improve treatment measures, create and introduce into medical practice new methods of therapy, innovative medicines, guided by strict rules of evidence of their high effectiveness and safety, study the mechanisms of physiological processes of a living organism in normal conditions and in pathology, the possibilities of correction and prevention of disease processes, and this means the need to conduct research, including those involving animals. The modern ethical and legal framework for research involving animals contains a requirement for mandatory examination of a research project by an ethical committee, monitoring its implementation, and analysis of the results. An ethics committee is a structure implemented into the research process to help researchers navigate the complex network of guidelines, rules and best practices, as well as the existing legal framework for conducting scientific research that guarantees quality results of work that do not violate these principles and restrictions. The local ethics committee is responsible for ensuring that research conducted in the territory under its supervision complies with modern ethical standards. This article presents the experience of the local ethics committee of the Kazan State Medical University in the ethical review of research projects involving animals, and substantiates the list and content of the requirements for documents submitted by the researcher for ethical review. The shortcomings identified in the preclinical research protocols submitted for examination were separately analyzed, and references were provided to the ethical and legal framework existing in the Russian Federation.