The Ethics of Gene Therapy: Balancing the RisksIntroduction[Cover: Discussion of how risks are balanced during risk assessment, because this is a difficult task -> propose a set of principles and practical measures that could help both researchers and patients, to enable more informed decisions about risk] Ethics and gene therapy Since its inception, gene therapy has captured the attention of the public and ethical disciplines as an application therapeutics of human genetic engineering. The latter, in particular, has led to concerns about germline modification and questions about the distinction between therapy and enhancement. The development of the field of gene therapy and its progress toward the clinic has not occurred without controversy. Although initially seen as a promising approach for treating disease genetics, the field has faced disappointment for failing to realize its potential. With the removal of many of the barriers that limited the progress of gene therapy and the increase in reports of clinical success, it is now generally recognized that previous expectations may have been premature. High-profile adverse events that attracted disproportionate media attention prevented a major challenge for gene therapy. in the field, with the death of Jesse Gelsinger in a gene therapy trial for ornithine transcarbamylase deficiency undermining public confidence in clinical research in the United States. There is a danger that the gene therapy field may have become too risk-averse in response to these adverse events, and that this could manifest itself in fewer trials that take longer to get started. In the context of a research environment that increasingly turns to developing countries for the timely conduct of clinical trials, it is imperative...... half of paper ...... the matopoietic compartment using integrative vectors particularly needs to understand genotoxicity risks in relation to the risks of conventional bone marrow transplantation. A QPL could direct them to ask questions about the risks, benefits, and survival rates after transplantation at local centers; the prognosis of patients in different hematopoietic gene therapy studies; the number and status of patients who developed leukemia in SCID-X1 gene therapy trials; and whether there are differences between the proposed vector and the vector used in the SCID-X1 study and any safety developments. This type of guidance can help patients understand both what is known and unknown about specific gene therapy applications. Conclusion [Could invite GT societies to develop their own standards/guidelines and publish them on websites for the use of their members?]