Relationship between public concerns and regulation oversight of human gene transfer therapy

The concept of "gene therapy" has gone from hypothesis to reality, with the National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC) and Federal Food and Drug administration (FDA) each having sanctioned study of the fate of tumor infiltrating lymphocytes (TIL cells). Already some five commercial enterprises have been organized to pursue similar type studies. The application of human gene transfer therapy to treat human diseases, which these events signify, raises ethical, medical and legal issues.