Bioethics of somatic gene therapy: what do we know so far?

To provide a systematic overview of bioethical debate on somatic gene therapy as documented in the scientific literature. We performed a systematic review of reasons, following Strech and Sofaer approach, which is a method to systematically identify and classify arguments (reasons) used in the scientific literature. We identified 217 eligible publications retrieved from PubMed, Lilacs, PhilPapers, and Google Scholar. A meta-synthesis was performed to analyze the data. We extracted 189 arguments. Arguments were grouped into 23 categories. Twelve categories were classified as research-related, including the risk/benefit ratio, priorities and limits, informed consent, review, and monitoring. Eleven were classified as society-related, including population impact, human identity, public perception, human health. Our study provides a database of existing challenges and arguments of somatic gene therapy and may serve as the basis of normative analysis. By presenting collected arguments, we contribute to the discussion about the ethics and social dimensions of somatic gene therapy.