The research analyzes the process of formation of the ethics committee as a new institution in the system of regulation of genetic research. The external factors of this process are the increasing digitalization of medical and research practices, as well as the special situation that is developing in the field of genomic research and the use of genetic technologies, where issues of philosophy, jurisprudence and administration have generated many fundamentally new, and sometimes unexpected contexts. The author shows the similarity and (...) difference of approaches to the inclusion of the ethics committee in the national regulatory systems of different countries and determines the prospects for further integration of the new institution into normative and administrative-regulatory and law enforcement practices. The research applies all the main methods of system analysis and structural and functional analysis, as well as the comparative legal method. At the stage of generalization of empirical material, the author turns to the means and methods of philosophical phenomenology and phenomenological sociology. The study revealed that the ethics committee may have different institutional and regulatory functions in a variety of management and legal systems. Being hybrid in nature, the ethics committee performs various functions, and in various state legal systems and traditions it can combine elements of legislative, executive and judicial power. At times, the ethics committee may go beyond the scope of both a purely administrative and exclusively legal regulator. All this indicates that the integration of this institution into the legal system and into a variety of social practices is far from being completed. (shrink)