Lensink Michael A, Boers Sarah N, Jongsma Karin R, Carter Sarah E, van der Ent Cornelis K, Bredenoord Annelien L
Julius Center for Health Sciences and Primary Care, Department of Medical Humanities, University Medical Center Utrecht, Internal Post Str. 6.131, P.O. Box 85500, 3508 GA Utrecht, The Netherlands.
Department of Pediatric Pulmonology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Internal Post KH.01.419.0, P.O. Box 85090, 3508 AB Utrecht, The Netherlands.
J Cyst Fibros. 2021 May;20(3):443-451. doi: 10.1016/j.jcf.2020.11.015. Epub 2020 Dec 7.
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.
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.
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.
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.
类器官技术正在迅速崛起，成为精准医学的一项重要工具，尤其是在囊性纤维化（CF）领域。然而，生物样本库对患者来源类器官的储存和使用引发了特定的伦理和实际挑战，需要完善的管理。我们研究了与CF或类器官相关的专业人员对用于CF精准医学的类器官生物样本库伦理方面的看法。通过在类器官生物样本库的创新和发展过程中同步开展这项研究，其结果对于设计负责任的管理框架具有重要价值。
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研究与护理领域的专业人员进行了21次半结构化定性访谈。
我们确定了三个关键挑战，以及专业人员关于如何应对这些挑战的建议：（1）与商业参与、信任和所有权相关的挑战；（2）应对研究与临床护理之间模糊界限的问题；（3）知情同意程序的适当方法。
针对精准医学的类器官生物样本库的完善管理需要认识到其利益相关者不再属于不同领域这一事实。负责任的管理应旨在在持续合作的整合与利益的相互考量之间找到合理的、因地制宜的平衡，并维持可行且可持续的研究环境。
