Gene editing in cancer research: technical, ethical and legal aspects

The adaptive immune system of clustered regularly interspaced short palindromic repeats (CRISPR) is currently revolutionizing basic medical research. The simplicity, precision and versatility of the CRISPR technology not only enables genes to be switched on or off but also enables correction of erroneous mutations. This results in the hope for the use of CRISPR-mediated gene therapy in oncology to correct cancer-driving mutations with the goal of preventing malignant cell growth or inducing tumor shrinkage. From a purely technical viewpoint this scenario appears feasible; however, ethical and legal frameworks need to be discussed and established beforehand. Ethical and legal questions in relation to gene editing in humans have been discussed for many years; however, these same questions need to be addressed with a new urgency due to the ever-increasing speed with which the CRISPR technology is developing. Therefore, a comprehensive ethical assessment, including questions related to the scientific ethics and culture as well as potential long-term social consequences accompanying the development and possible application of the CRISPR technology is needed. From a legal perspective, somatic gene therapy is covered by the general regulations of drug development, while gene therapy in germline cells is not permitted in Germany; however, in light of the anticipated worldwide developments in gene editing this ban appears to be neither reasonable nor sustainable. This article elucidates the technical, ethical and legal aspects of gene editing in cancer research and treatment and discusses the resulting questions: what is feasible, what should be done and what is permitted in relation to CRISPR?