Regulatory issues in human gene therapy.

Protection of human subjects is the ethical and legal responsibility of investigators conducting clinical trials. Public concerns regarding recombinant DNA technology led to additional levels of oversight which are unique to human gene therapy trials. The deaths of a normal volunteer and a gene therapy subject in the late 1990s led to an intensification of oversight with new initiatives that impact gene therapy as well as other clinical investigators. This paper will review the current oversight agencies and identify areas of evolving regulations that pose particular challenges to gene therapy investigators.