Self-Regulation of genetic studies in Russia: search for the optimal model

The article is devoted to the general analysis of self-regulatory practices of genetic research in Russia (conducted by public research institutions and commercial companies). Selfregulation is a special type of regulation, performed by organizations providing genetic research and their associations as well as by relevant professional and scientific community; it is regulated by local acts, agreements, memoranda, professional standards, codes of ethics, etc. and is aimed at establishing relationships in the field of organization, provision and use of results of genetic studies. Basically, selfregulation is especially critical in various aspects of organization and conducting genetic research in the worldwide perspective. The analysis provided by this article allows concluding that self-regulation practice in Russia is applied in several public research institutions, but rather fragmentarily. Moreover, the development of such form of regulation goes slowly. At the same time non-public genomic institutions are trying to evade any significant self-regulation of their activities; they do not provide for any expanded rules or standards of their practices (or they just confine themselves to references and general provisions which are not in line with the specifics of the mentioned activities). On the other hand, it is important to keep in mind that the current Russian legislation is full of gaps in terms of regulating genetic research process. Analysis of several websites of Russian private companies providing genetic profiling services revealed that those organizations almost never place complex information guides on their information portals; they neither provide the standards for performing genetic research in an intelligible form. The websites do not contain any information on possible risks or threats to health connected with application of medical procedures, while the issue of disclosure the gathered genomic information to third parties (e.g., enforcement agencies) is often ignored. More than that, there are hardly any published standards for conducting genomic research or documents on protecting patients’ rights, etc. Thus, we are forced to acknowledge that the institute of self-regulation in the field of genetic studies is not developed well enough in Russia. The current fragmented nature of legal regulation and selfregulation concerning genetic research may contribute to violation of rights and legitimate interests of patients in terms of confidentiality and safeguarding genetic information, gathered in the process of research. The state therefore should within the established goals of intensive genetic technological development provide all the necessary conditions (including of legal character). However, it is still not clear how the issues of legal regulation of status of genetic research participants, protection of genetic data, incentives for providing genetic research, etc. should be handled. We assume that one of the possible ways of tackling the aforementioned challenges is developing relevant complex legal regulation (including departmental acts) and/or investing the frontline public research institutions with special functions (i.e., within a special council, commission, or association). Such powers will contribute to regulating certain aspects of administering and conducting genetic research and using its results in the framework of legal regulation, which should be mandatory, including for non-public organizations, offering genetic services in the territory of the Russian Federation.