Legal and ethical expertise of genetic research: issues of regulation and institutionalization

Abstract

Although legal regulation of genetic research has been steadily improved, it is still lagging behind promotion of genetic research, especially in the field of development and use of its achievement-based technologies. A distinct feature of this legal area is currently a higher dependence on ethics. This resulted in establishment of a special institution, an ethics committee, that unites the possibilities of ethical and legal expertise giving birth to numerous organizational and substantive issues. Some of them are reflected in discussions about the relationship between moral reflection and legislative processes, epidemiological status of bioethics, etc. For instance, in Russian literature there is a thesis that organization and conduction of ethical expertise is regulated much better than those of legal one and can be implemented within the current legal and regulatory framework. Meanwhile, a need for legal expertise in genomic research and genetic technologies is not inferior but even superior. This is confirmed by deficient legal support of many important decisions taken by the authorities and actions accomplished by research groups. The article reviews opinions of Russian and foreign scientists who provide different assessment of the role of ethics committees and their possible falling within law or ethics. The role and place of ethics committees in the system of rule-making harmonization and law enforcement are specified.