A05 - The Ethical Conduct of Cell and Gene Therapy Research: Novel Challenges for Industry and the IRB

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Cell and gene therapy presents complex challenges in trial design and implementation to ensure equitable recruitment, effective informed consent, and participant safety. The scientific and clinical novelty of each intervention, cost of treatment development, the irreversibility of the therapeutic intervention, and the required commitment by industry to long-term engagement with participants each create new standards for ethical conduct and its oversight that are distinct from other interventional trials. Fulfilling the goals of equitable and diverse enrollment introduces additional responsibilities. In this session, experts from industry and bioethics will describe the novel ethical demands of gene therapy trials in adults and in children and discuss model approaches.