[Gene therapy: ethical aspects and problems of genetic safety]

Gene therapy (GT) is based on the introduction of various genetic constructions in the human organism. Rapid development of GT technologies and the increasing tendency to apply them in therapy for certain human diseases has created a number of ethical problems. These first and foremost concern direct intervention in the genome of germline cells, which may change the genome of further generations. According to current views, such manipulations are ethically unacceptable. Introduction of genetic constructs in somatic cells with therapeutic purposes (somatic GT) is considered permittable in principle but requires certain procedures to ensure the genetic safety (causing no damage) of both the patient and other people. The latter hazard is associated with a possibility of uncontrolled spreading of viral (especially retroviral) constructions used in many GT protocols. These and other ethical and genetic safety problems of modern GT are discussed.