《条例》实施背景下对异种器官移植实验动物伦理审查的思考与建议OA

Gene-edited pigs as donors for xenotransplantation have emerged as a potential solution to the global shortage of organ donors.However,this new biomedical technology poses a severe challenge to the traditionally relatively independent review models of medical,human organ transplantation,and experimental animal ethics,revealing a gap in current review standards in relation to xenotransplantation and the incompleteness of risk-assessment dimensions.The latest"Regulations on the Clinical Research and Clinical Transformation Application of Biomedical New Technologies"(hereafter"Regulations")issued by the State Council of China has established a high-standard regulatory framework for clinical research.Its strict requirements for safety and effectiveness also increase the expectations for scientific rigor and ethical completeness in the preceding step of preclinical animal experiment ethics reviews.This review considers the overall transmission impact of the Regulations on the ethical governance of xenotransplantation and discusses how to improve and strengthen the mechanism of preclinical experimental animal ethics review for xenotransplantation,based on existing science and technology regulations systems,and with a clear independent positioning of preclinical review.We focus on analyzing and differentiating the core ethical issues specific to xenotransplantation,such as the welfare and moral status of donor animals and biosafety risks,and accordingly propose specific suggestions such as formulating specialized review guidelines,enhancing review professional capabilities,and strengthening cross-departmental information supervision and coordination based on risk prevention and control.Consolidating independent and crucial preclinical ethics review as a foundational step is expected to support the subsequent clinical research stage regulated by the Regulations,jointly promoting the safe,orderly,and ethical development of xenotransplantation technology,with theoretical and practical significance for improving the ethical governance of leading-edge biotechnologies.