Risks, benefits and ethical, legal, and societal considerations for translation of prenatal gene therapy to human application.

The still experimental nature of prenatal gene therapy carries a certain degree of risk, both for the pregnant mother as well as for the fetus. Some of the risks are procedural hazards already known from more conventional fetal medicine interventions. Others are more specific to gene therapy such as the potential for interference with normal fetal development, the possibility of inadvertent germ line gene transfer, and the danger of oncogenesis. This chapter reviews the potential risks in relation to the expected benefits of prenatal gene therapy. It discusses the scientific, ethical, legal, and social implications of this novel preventive approach to genetic disease and outlines preconditions to be met in preparation for a potential future clinical application.