Federal Regulation of Gene Therapy: Who Will Save our Germline?

Abstract

This paper will attempt to address some of these more complex issues involving human gene therapy and the encompassing regulations. The first section will deal with the science of gene therapy and will briefly touch upon the scientific hurdles that remain for scientists in this field, as this is important to understanding many of the ethical issues. This section will be divided into a basic genetic overview, a description of somatic gene therapy, and a summary of germline gene therapy. The second section will address the ethics debate that surrounds gene therapy today. Somatic gene therapy, genetic enhancements, and germline alterations are all included in this discussion. The next section will explain the current regulatory scheme that monitors human gene therapy currently in the United States. This includes an overview of the FDA and the NIH and their delegated responsibilities regarding gene therapy. Finally, the forth section of the paper will set forth a proposal in order to tackle the aforementioned scientific, ethical and legal problems.