异种器官移植的多维审视与风险治理

Multidimensional examination and risk governance of xenotransplantation

  • 摘要: 得益于基因修饰技术的应用、新型免疫抑制药的研发以及选择将猪作为器官主要供体的转向,异种器官移植开启了新一轮的“破冰之旅”。在应对器官供需失衡、延长器官衰竭患者生命、提升人类身体机能方面,异种器官移植展现出了较强的正向价值。但异种器官移植还会引发诸如健康受损和病毒传播等安全性隐忧、知情同意原则被虚置、个体的同一性和独立性被损害及受试机会和能力分配的公平性追问等一系列伦理风险问题。为此,应当通过架构事前概括同意和事中具体同意相结合的机制以及完善动态化、留痕化的同意流程,以保障患者的自主性;通过打造“瀑布式”监管制度和前沿技术聚合机制,以提升异种器官移植的安全性;根据异种器官移植探索不同阶段以及不同目标指向制定相应的分配和治理规则,以提升异种器官移植的公平性;通过类型化的方式确定哪些人群在当前医疗水平条件下可以进行异种器官移植,以实现伤害的最小化。

     

    Abstract: Thanks to the application of gene modification technology, the development of new immunosuppressive and the shift towards using pigs as the main organ donors, xenotransplantation has embarked on a new round of "ice-breaking journey". Xenotransplantation demonstrates strong positive value in addressing the imbalance between organ supply and demand, extending the lives of patients with organ failure and enhancing human physical functions. However, xenotransplantation also raises a series of ethical risks, such as safety concerns over health damage and virus transmission, the hollowing out of the principle of informed consent, the impairment of individual identity and independence, and the distribution fairness of access and capability for trials. To address these issues, a mechanism combining prior general consent and specific consent during the process should be established, along with a dynamic and traceable consent procedure to safeguard patient autonomy. A "waterfall-style" regulatory system and a mechanism for aggregating cutting-edge technologies should be created to enhance the safety of xenotransplantation. Distribution and governance rules should be formulated according to different stages and goals of xenotransplantation exploration to improve fairness. A typological approach should be used to determine which groups of people can undergo xenotransplantation under current medical conditions to achieve the minimization of harm.

     

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