BACKGROUND Organoid technology is emerging rapidly as a valuable tool for precision medicine, particularly in the field of Cystic Fibrosis (CF). However, biobank storage and use of patient-derived organoids raises specific ethical and practical challenges that demand sound governance. We examined the perspectives of professionals affiliated with CF or organoids on the ethical aspects of organoid biobanking for CF precision medicine. By conducting this study parallel to the process of innovation and development of organoid biobanking, its findings are valuable for the design of responsible governance frameworks. METHODS To identify relevant themes and attitudes we conducted 21 semi-structured qualitative interviews with professionals in the field of organoid technology, biobanking, or CF research and care. RESULTS We identified three key challenges, as well as the suggestions of professionals on how to address them: (1) The challenges associated with commercial involvement, trust, and ownership, (2) Navigating the blurring boundary between research and clinical care, (3) Appropriate approaches to the informed consent procedure. CONCLUSION Sound governance of organoid biobanks aimed at precision medicine requires coming to terms with the fact that its stakeholders no longer belong to separate domains. Responsible governance should be aimed at finding a sound, context-sensitive balance between integration of ongoing co-operation and mutual consideration of interests, and maintaining a feasible and sustainable research climate.

中文翻译：

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用于囊性纤维化个性化治疗的类器官：关于类器官生物样本库伦理和治理的专业观点

背景类器官技术正在迅速成为一种有价值的精准医学工具，特别是在囊性纤维化（CF）领域。然而，生物样本库的存储和使用源自患者的类器官提出了特定的伦理和实践挑战，需要健全的治理。我们研究了与 CF 或类器官相关的专业人士对 CF 精准医学的类器官生物样本库伦理方面的看法。通过与类器官生物样本库的创新和发展过程并行进行这项研究，其研究结果对于设计负责任的治理框架很有价值。方法 为了确定相关主题和态度，我们对类器官技术、生物样本库或 CF 研究和护理领域的专业人士进行了 21 次半结构化的定性访谈。结果 我们确定了三个关键挑战，以及专业人士关于如何解决这些问题的建议：(1) 与商业参与、信任和所有权相关的挑战，(2) 探索研究和临床护理之间模糊的界限，(3) 知情同意的适当方法程序。结论 以精准医学为目标的类器官生物库的健全治理需要接受这样一个事实，即其利益相关者不再属于不同的领域。负责任的治理应旨在在持续合作的整合与利益的相互考虑之间找到合理的、因地制宜的平衡，并保持可行和可持续的研究环境。(2) 探索研究和临床护理之间模糊的界限，(3) 知情同意程序的适当方法。结论 以精准医学为目标的类器官生物库的健全治理需要接受这样一个事实，即其利益相关者不再属于不同的领域。负责任的治理应旨在在持续合作的整合与利益的相互考虑之间找到合理的、因地制宜的平衡，并保持可行和可持续的研究环境。(2) 探索研究和临床护理之间模糊的界限，(3) 知情同意程序的适当方法。结论 以精准医学为目标的类器官生物库的健全治理需要接受这样一个事实，即其利益相关者不再属于不同的领域。负责任的治理应旨在在持续合作的整合与利益的相互考虑之间找到合理的、因地制宜的平衡，并保持可行和可持续的研究环境。