The activities of the local ethics committee to improve the quality of biomedical research of young university staff

The article is devoted to the issues of clinical research: their ethical and legal regulation at the present time, the history of ethical expertise in the Russian Federation and at Kazan State Medical University. The role of ethical committees as a structure responsible for quality of scientific research and a guarantor of compliance with the principles of ethics, protection of the rights, safety and well-being of research participants is considered. The article presents the working experience of the local ethics committee of Kazan State Medical University on ethical examination of research projects with human participation and analysis of the most common mistakes in preparation of research documentation made by young scientists of clinical departments. The digital information showing typical errors and inaccuracies in the formation of a package of documents for ethical examination, based on the analysis of 284 initiative papers of PhD candidates from clinical departments: every fifth protocol required revision in accordance with the ethical and legal framework adopted in the Russian Federation, in 1.5% of cases the documentation was submitted for already conducted studies (i.e. ost factum), when no changes to its design are possible anymore. Typical mistakes were the following: inability to form research and control groups, calculate a representative number of participants, write an information sheet for a participant in a clinical trial and a sheet of informed consent, going beyond the specialty, desire to prescribe drugs beyond the scope of registered indications, etc. The ways of increasing both the awareness of young researchers and quality of ethical expertise by specialists of the ethics committee are proposed.