关键词: 类器官, 伦理争议, 知情同意, 治理, 负责任创新

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