《条例》实施背景下异种器官移植实验动物伦理审查的思考与建议
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1.空军军医大学实验动物中心;2.西安交通大学第一附属医院重症医学科

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] 国家重点研发计划(2024YFC3406800);陕西省创新能力支撑计划项目(2024CX-GXPT-36)。


Research on the Ethical Review System for Laboratory Animals in Xenotransplantation from the Perspective of Regulations
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1.Laboratory Animal Center,Air Force Medical University,Xi’an;2.Department of Critical Care Medicine,The First Affiliated Hospital of Xi’an Jiaotong University,Xi’an

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    摘要:

    基因编辑猪作为异种器官移植的供体已成为解决全球性器官短缺的潜在途径。然而这一生物医学新技术,对医学伦理、人类器官移植伦理与实验动物伦理等传统伦理的审查模式构成了严峻挑战,暴露出现行审查标准不统一、权责不明等系统性不足。国务院最新颁布的《生物医学新技术临床研究和临床转化应用管理条例》(简称《条例》)对异种移植的伦理提出了指导性意见。本文旨在通过系统解析《条例》所确立的全过程管理、审查主体资质法定化及备案评估机制,探讨如何构建一个专门适用于异种器官移植的整合型伦理审查制度。重点辨析了异种移植特有的知情同意复杂性、生物安全公共风险、动物道德地位跃升等核心伦理议题,并据此提出构建整合型审查制度的具体措施。期望以《条例》为统领,推动医学伦理、人类器官移植伦理与实验动物伦理的深度融合与制度衔接;明确《条例》是确保异种器官移植技术安全、有序、合乎伦理发展的关键,对引领前沿生物技术伦理治理具有重要理论与实践意义。

    Abstract:

    Gene-edited pig xenotransplantation, as a potential solution to the global organ shortage crisis, has achieved a series of breakthroughs from animal experiments to clinical exploration. This groundbreaking technology that transcends species boundaries poses a serious challenge to the traditional ethical review model, which is based on separate systems of human ethics, organ transplantation ethics, and animal ethics. It reveals the systemic deficiencies such as inconsistent review standards, unclear rights and responsibilities, and incomplete scope in the current system. This article aims to base its discussion on the latest regulations issued by the State Council, namely the "Regulations on Clinical Research and Clinical Transformation Application of Biomedical New Technologies", and explore how to establish an integrated ethical review system specifically applicable to xenogeneic organ transplantation. Through a systematic analysis of the entire process management, the legalization of review subject qualifications, and the filing and assessment mechanisms stipulated in the "Regulations", it demonstrates that these measures provide a crucial institutional opportunity to bridge the gaps in the existing ethical review system. This article deeply identifies the core ethical issues specific to xenogeneic transplantation, such as the complexity of informed consent, public risks in biological safety, and the rising moral status of animals. Based on this, it proposes specific measures for the construction of an integrated review system. It is believed that with the "Regulations" as the guideline, promoting the deep integration and institutional connection of medical ethics, organ transplantation ethics, and experimental animal ethics is the key to ensuring the safe, orderly, and ethical development of xenogeneic organ transplantation technology. It also has significant theoretical and practical significance for leading the ethical governance of frontier biotechnology.

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  • 收稿日期:2025-11-21
  • 最后修改日期:2026-01-13
  • 录用日期:2026-05-07
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