Research on human brain organoids is progressing at speed. Therefore, an ethical and legal framework needs to be put in place to ensure their responsible use, while not constraining innovation.

对人脑类器官的研究正在飞速发展。因此，需要建立一个道德和法律框架，以确保它们的负责任使用，同时不限制创新。

Human brain organoids are being explored as in vitro models of brain development and function to investigate the biology, physiology and pathology of the human brain. Their power lies in their ability to model human-specific processes, an inherent advantage over animal models, and the possibility to generate patient-specific brain models, opening-up the way to personalized medicine1.

正在探索人脑类器官作为大脑发育和功能的体外模型，以研究人脑的生物学，生理学和病理学。他们的力量在于他们能够模拟人类特定的过程，这是动物模型的固有优势，以及生成患者特定大脑模型的可能性，为个性化药物开辟了道路1。

However, these key advantages are also at the core of an ethical debate that has evolved as organoid models have started making their way into preclinical testing and commercialized diagnostic and therapeutic applications, in part fuelled by the US Food and Drug Administration (FDA) Modernization Act 2.0.This ethical debate centres around the source of the cells used to grow human brain organoids, which essentially translates to questions of ownership and commercialization, their (sometimes unforeseen and undisclosed) use in research, and their transplantation into animals and potentially humans2.In this issue, Baum et al.

然而，这些关键优势也是一场伦理辩论的核心，随着类器官模型开始进入临床前测试和商业化诊断和治疗应用，这场辩论已经演变，部分是由美国食品和药物管理局（FDA）现代化法案2.0推动的。这场伦理辩论的中心是用于培养人脑类器官的细胞的来源，这基本上转化为所有权和商业化的问题，它们（有时不可预见和未披露）在研究中的用途，以及它们移植到动物和潜在的人类中。在本期中，Baum等人。

outline the ethical landscape of human brain organoids, including considerations of sample procurement, informed consent, commercialization, regulatory policy, scarcity, prioritization and uncertainty of their use. They also touch upon the question of whether organoids may, in principle, be capable of developing consciousness and cognitive experiences, which would entitle them to some form of moral status and similar protections to those given to human and animal research participants3.

概述人脑类器官的道德景观，包括样品采购，知情同意，商业化，监管政策，稀缺性，优先级和使用不确定性的考虑因素。他们还谈到了原则上类器官是否能够发展意识和认知经验的问题，这将使他们有权获得某种形式的道德地位，并获得与人类和动物研究参与者类似的保护3。

However, guidelines published by the International Society for Stem Cell Research (ISSCR) focus on the current state of organoids as being devoid of human consciousness, but without much speculation for the future. Indeed, today’s human brain organoids may be far from having such capabilit.

然而，国际干细胞研究学会（ISSCR）发布的指南侧重于缺乏人类意识的类器官的现状，但对未来没有太多猜测。事实上，今天的人脑类器官可能远没有这样的能力。

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？J、 生物技术。Inq公司。https://doi.org/10.1007/s11673-024-10349-9（2024年）。Cyranoski，D.自然https://doi.org/10.1038/d41586-019-01580-1（2019年）。Mallapaty，S。Nature 603213-214（2022）。下载参考文献Rights and Permissions打印和许可本文引用本文伦理学需要跟上人脑类器官研究的步伐。。

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