Practical aspects of the organization of ethical review of clinical trials in the context of the COVID-19 pandemic

Abstract

The COVID-19 pandemic has greatly affected all spheres of life, including biomedical research. The ethical regulation of clinical trials has a long history in international and domestic practice. An efficient infrastructure of international and national legislation has been created. At the same time, there are features of the organization of ethical review of clinical trials that arise under the restrictions associated with COVID-19. Healthcare of all countries is faced with the need to develop new approaches caused by the speed of the spread of the disease, its severe consequences for the life and health of people, the excessive burden on the medical worker, not only physical, but also psychological, including those associated with ethical problems. The purpose of this research was to study and analyze the experience of ethical review of clinical trials in the context of the COVID-19 epidemic, its regulatory framework in international and domestic practice. For high-quality and lawful conduct of clinical trials in Russia in the context of the COVID-19 epidemic, appropriate conditions were created, namely, a vertical base: the central ethical committee of the Ministry of Health of the Russian Federation local ethical committees based in clinical institutions and research centers. They are provided with sufficient and high-quality legal support in the form of laws of the Russian Federation, country standards and by-laws. The work of local ethics committees is built in accordance with strict ethical international and domestic standards. Standard operating procedures implemented in local ethics committees provide for all the nuances of situations, including those implemented using modern telecommunication technologies and other end-to-end information technologies. Even if many restrictions are imposed, biomedical research must continue, and accordingly, it must be carried out under the strict control and monitoring of research ethics committees. The article presents an overview of legal sources, an analysis of the main approaches in domestic and foreign literature, taking into account historical retrospective.