ETHICAL BALANCE ON CONDUCTING SPONSORED RESEARCH IN UNEQUAL SOCIAL, ЕСОNOMIС AND REGULATORY CONDITIONS

Abstract

The modern concept of international clinical trials (CT) has reached strict regulation in terms of norms and ethics and is convincingly reflected in a series of current legislative acts, at the global, regional and national levels [2,3,7,8,10-13,23,32]. Of particular interest in this area are situations of dual loyalty related to moral, financial and legal gradation of research in countries with different levels in economic development and priorities for owning the investigational drug’s patent. Based on this, the new picture of the modern Russia geopolitical map on participation in international research requires adapting and revisiting the series of semantic characteristics. First of all, this concerns a fundamental change in Russia’s status that developed from a region for conducting research on foreign drugs to be further registered, to the position as the sponsor of research on domestic drugs in third countries, usually with limited economic and infrastructural resources. This metamorphosis is not only significant in terms of the qualitative redistribution of roles, but, in connection with the high rates of popularization and real increase in the volume of such research, for example, in Africa, it dictates a need to rethink the entire system of administrative and ethical approaches to their implementation. In this article, a targeted attention is first paid to the factor of special responsibility for the adoption and regulatory consolidation in the Russia the special ethical code for sponsor’s research in the context of their implementation in regions with limited resources. This task is coupled to introducing domestic experience as well as deep legal and information baggage accumulated by international practice into the protocol for the development of sponsor research in the Russia. The specificity is also of special importance because this work consists of the direct authorial involvement in the process for establishing and forming partnership ethical code based on the principles of justice, respect, care and honesty in research with unequal resources.