The Ethical Evaluation of Gene Therapy in the United States, 1969-1990

Th e first three h u m a n gene transfer/therapy clinical protocols are n o w underway after having been subjected to an extensive review process by the Recombinant D N A Advisory Committee ( R A C ) and its H u m a n G e n e Therapy Subcommittee. T h e "Points to Consider" document developed by the R A C established the framework for evaluating genetic intervention protocols. This review process is taking place in a broader social context. Public attitude surveys in this country have indicated a general lack of knowledge in the area of genetic engineering but an acceptance of somatic-cell gene therapy as treatment for disease. Internationally, numerous policy statements on h u m a n genetic intervention have been published, all of which support the moral legitimacy of somatic-cell gene therapy for the cure of disease. T h e debate over the ethical issues related to somatic-cell gene therapy has evolved over a ten-year-period. T h e time has n o w c o m e to begin a formal public process for the ethical assessment of germ-line genetic intervention.