Structuring the Review of Human Genetics Protocols - Part III : Gene Therapy Studies

In this article, the authors propose a framework to assist the review of gene therapy protocols. The authors provide a general description of three gene therapy techniques: gene marking, gene supplementation and gene therapy. They then set out a checklist identifying issues for IRB review. Finally, they discuss in greater detail four points of controversy raised by this kind of research: the appropriate forum for review; the risks associated with gene therapy studies, including risks to both subjects and society; interventions that may affect the germ line intentionally or unintentionally; and advantages and disadvantages of germ-line therapy. Because a number of the issues discussed in their previous papers are relevant to gene therapy, the authors suggest that all three papers be read together