Controlled development of technologies for introducing heritable changes in the human genome (primarily CRISPR/Cas9 technologies) requires adequate legal proactive regulation in the area.
A comparison is used as the main method of the research, in the variant of a small-N case-study of several countries (USA, China, Great Britain), which allow editing the human germline at the level of fundamental research. The author returns back to Russia from an exciting trip to abroad and formulates rational and realistic conclusions for the domestic legal order. The legal approach is complemented by knowledge from the field of molecular biology to the extent necessary to explain the proposed solutions.
Based on the results of the study, the following dimensions of legal regulation of genetic editing at the level of fundamental research in Russia are formulated: the choice of the intended purpose of the technology (editing for medical purposes, with specific nosological forms for the use of technology); introduction of a transparently organized licensing procedure for conducting research (including the definition of a body authorized to issue a permit, the establishment of procedures for scientific groups and the imposition of sanctions in case of violation of these procedures); expanding the practice of interdisciplinary ethics commissions (and addressing the issue of training personnel for work in commissions); long-term monitoring of research results; creation of a legal framework with a predominance of professional positions; attention to the rules of editing the human genome in foreign countries.