Abstract:

Organoid technology, which leverages the cultivation of three-dimensional (3D) miniature organ models from stem cells in vitro to simulate the structure and function of human organs, has emerged as a cornerstone in biomedical fields such as disease modeling and drug screening. Despite its significant contributions, the rapid advancement of this frontier technology also raises profound ethical challenges, necessitating a robust framework for its normalization and legalization. This paper firstly provides a comprehensive analysis of the development of organoid technology, elucidating its distinctive characteristics and substantial value in biomedical applications. Currently, the technology is advancing towards the construction of more complex organ systems, achieving higher fidelity, and integrating more intricately with other cutting-edge technologies. This evolution enhances the capability of organoids to mimic human physiology accurately, thereby improving the predictive accuracy of medical research and pharmaceutical developments. The paper examines the primary ethical challenges raised by organoid technology, including the informed consent of donors, privacy protection, and equitable access to this technology. These issues are pivotal in maintaining public trust and compliance with ethical norms. Additionally, it explores the ethical implications of modeling sensitive organs such as the brain and embryos, raising questions about the moral status of such models and potential psychological impacts on society. It also reviews how various countries and international organizations respond to these ethical controversies. Major developed countries and international bodies have adopted a variety of governance measures, primarily in the form of ethical guidelines or standards, which provide a flexible yet sometimes insufficient framework for addressing rapidly evolving technologies. In contrast, China lacks specific legislative policies regarding organoid technology, indicating a need for tailored governance strategies that align with both international standards and local ethical considerations. In order to bridge these gaps, this paper attempts to construct a “moral assessment scale” framework. This tool is designed to quantify ethical considerations and guide decision-making in organoid research and application. The paper advocates for strengthened interdisciplinary cooperation and the improvement of the informed consent process, essential for ethical compliance. Moreover, establishing an international unified ethical code could facilitate global cooperation and harmonize standards across borders. Supporting ethical research and fostering public discussions are also crucial for the responsible development of organoid technologies. By thoroughly examining the ethical challenges and proposing actionable solutions, this paper aims to foster a balance between scientific innovation and ethical responsibility. This balanced approach will not only advance the field but also ensure that it develops in a manner respecting human dignity and societal values, ultimately better serving human health and well-being.

Key words: organoids, ethical controversies, informed consent, governance, responsible innovation

摘要：

类器官技术，通过利用干细胞在体外培养构建的三维（3D）微型器官模型，模拟人体器官的结构及功能，已在疾病建模、药物筛选等生物医药领域得到广泛应用。然而，该前沿领域的快速发展亦引发一系列伦理问题，这些问题的解决对于促进领域的规范化与合法化发展至关重要。本文首先解析类器官技术的发展历程，并探讨其特征与应用价值。当前，类器官技术正逐步向构建更复杂的器官系统、实现更高仿真度及与其他技术的深度融合方向发展。考虑到人源类器官的特殊性、复杂性及敏感性，重点深入探讨了伴随技术进展而出现的伦理挑战，包括捐赠者的知情同意、隐私保护、技术的可及性，以及在模拟敏感器官（如大脑和胚胎）时所涉及的道德地位问题。国际组织与主要发达国家已在类器官研究的伦理治理方面采取了多项措施，通过发布伦理指南或标准，从多个维度应对类器官领域的伦理问题。相比之下，我国在这一领域尚未出台相关的立法政策。最后，本文提出了从评估量表的设计原则、评估标准的制定、量化方法、实施与监管、持续评估与反馈等要素构建“道德评估量表”框架，并建议加强跨学科合作，完善知情同意流程，以及建立国际统一的伦理准则。此外，支持伦理研究和公共讨论也是确保类器官技术负责任发展的关键措施。通过深入探讨类器官技术带来的伦理挑战及其应对之策，旨在促进科技创新与伦理关切之间的平衡，推动类器官领域的负责任创新，以更好地服务于人类健康和福祉。

关键词: 类器官, 伦理争议, 知情同意, 治理, 负责任创新