The Ethics of Gene Therapy: Balancing the Risks Essay

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The Ethics of Gene Therapy: Balancing the Risks Introduction [Cover: discussion about how risks are balanced during risk assessment, why this is a difficult task -> proposing a set of principles and practical measures that might assist 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 ethics disciplines as a therapeutic application of human genetic engineering. The latter, in particular, has lead to concerns about germline modification and questions about the distinction between therapy and enhancement. The development of the gene therapy field and its progress to the clinic has not been without controversy.…show more content…
Why is risk assessment a difficult task? Risk assessment in clinical research is an intrinsically difficult task, in large part due to the extent of uncertainty involved. Even when preclinical data demonstrates safety and efficacy with statistically significant differences in animal models, a therapeutic intervention may produce unanticipated outcomes in the course of human trials. Extensive data on the use of gamma-retroviral vectors in animal models failed to predict the high frequency of insertional proto-oncogene activation observed in the trials of gene therapy for X-linked severe combined immunodeficiency. When decisions about risk are made on the basis of preclinical data, such as animal studies, it is therefore crucial to acknowledge where the sources of uncertainty lie. Decisions about risk in clinical research involve many parties, including researchers, IECs and subjects. Information about risk, however, is difficult to communicate and is understood and perceived differently by different stakeholders. This may present difficulties during the evaluation of preclinical data, which calls for inherently subjective judgments about acceptable levels of risk. Although reconciling a diversity of opinions regarding risk in gene therapy research represents a challenge, this pluralism may also be construed as a constructive force: open dialogue about risk will lead to more informed decision-making during the

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