Ethical Issues in Gene Therapy Research: An American Perspective

Abstract

Publisher Summary This chapter discusses the arguments in favor of gene therapy research, the arguments against gene therapy research, general societal concerns regarding gene therapy, and the American approach to gene therapy research regulation. Gene therapy has generated great interest due to its potential for affecting the human genome. There are two forms of gene therapy currently being researched, somatic-cell gene therapy and germ-cell gene therapy. Supporters of gene therapy focus their endorsement on four primary arguments including scientific freedom, effect and utility, potential for disease eradication, and reproductive freedom. Gene therapy has a strong opposition, based on well-founded arguments and concerns. Four strong criticisms of gene therapy research are its irreversible nature, the potential effects on the gene pool, informed consent (or lack thereof), and risk of harm. Public examination of the issues involved in gene therapy research includes issues of distributive justice, risk of eugenics, the concern of playing God, and the slippery slope argument. The United States pioneered the field of human gene therapy as well as the ethical safeguards surrounding its research through its independent organization called the Recombinant DNA Advisory Committee (RDAC), whose primary purpose is to review human gene transfer study protocols in the United States. In addition, the RDAC organizes safety conferences and publicly maintains databases and adverse event reports, thus enabling investigators to design safer trials. Abstract Gene therapy has been the subject of significant ethical discussion. Gene therapy has spawned great due to its potential for affecting the human genome. There are two forms of gene therapy currently being researched, somatic-cell gene therapy and germ-cell gene therapy. Somatic-cell gene therapy research seeks to alter or manipulate specific organ or tissue cells. Germ-cell gene therapy does not seek to cure a disease currently being suffered, rather it seeks to alter the individual's genome so that a disease-causing mutation will not be inherited by the individual's progeny. In this paper we will discuss the arguments in favor of gene therapy research, the arguments against gene therapy research, general societal concerns regarding gene therapy and the American approach to gene therapy research regulation.