The Ethics of Gene Therapy: Balancing the RisksIntroduction[Cover: discussion of how risks are balanced in risk assessment, why this is is a difficult task -> propose a set of principles and practical measures that could help both researchers and patients, in order to enable more informed decisions about risks.]Ethics and gene therapySince its inception, gene therapy has attracted the attention of the public and ethics disciplines as a therapeutic application of human genetic engineering. This last point, in particular, has raised concerns about germline editing and questions about the distinction between therapy and enhancement. The development of the gene therapy field and its progress toward the clinic has not been without controversy. Although initially seen as a promising approach to treating disease genetics, the field has met with disappointment as it has failed to realize its potential. With many of the obstacles that limited progress in gene therapy removed and reports of clinical successes increasing, it is now generally recognized that initial expectations may have been premature. High-profile adverse events leading to disproportionate media attention helped avert greater difficulty for the field, with the death of Jesse Gelsinger in a gene therapy trial for ornithine transcarbamylase deficiency undermining public confidence in the clinical research in the United States. There is a risk that the gene therapy field has become too risk averse in response to these adverse events, which could result in fewer trials and longer start-ups. In the context of a research environment that is increasingly looking to developing countries for the rapid conduct of clinical trials, it is imperative...... middle of paper ...... matopoetic compartment using integrative vectors particularly need to understand risks of genotoxicity compared to the risks of conventional bone marrow transplantation. A QPL might ask 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 trials; the number and status of patients who developed leukemia in SCID-X1 gene therapy trials; and whether there are any differences between the proposed vector and the vector used in the SCID-X1 trial and any possible safety developments. This type of guidance can help patients understand both what is known and unknown about specific applications of gene therapy. Conclusion [Could invite GT societies to develop their own standards/guidelines and publish them on websites for use by their members.?]