人源类器官的应用前景、伦理风险与治理建议

Application prospect and ethical risk of human organoids research

人源类器官能够突破传统疾病研究模型的瓶颈,可结合基因编辑、器官芯片等新兴技术,为转化医学提供全新平台,在构建疾病模型、筛选药物、器官移植、基因治疗和精准医疗方面具有广阔应用前景。然而,人源类器官在大幅缩短整个生物医学研究创新周期的同时,也模糊了主体与客体、公共与私人、研究与治疗等传统边界,将引发诸多伦理风险。结合人源类器官的研究进展和应用前景,分析了类器官道德地位、知情同意、商业化和利益共享等主要伦理问题,并探索了多维治理策略。

The use of human organoids is a breakthrough with respect to the animal models in biomedical research and is a new alternative platform for the translational medicine by combining the emerging technologies such as the gene editing and the organ chip.Human organoids have broad application prospects in establishing disease models,screening drugs,organ transplantation,gene therapy and precision medicine.However,while the whole innovation cycle of the biomedical research is greatly shortened,the use of human organoids also blurs the traditional boundaries between subject and object,public and private,research and treatment,which will cause many ethical and legal challenges.This paper reviews the research progress and the application prospect of human organoids,including a systematic discussion of the main ethical issues such as the moral status of organoids,the informed consent,the commercialization and the benefit sharing.It is concluded that a multi-dimensional governance strategy is needed to guide a healthy and sustainable development of studies of organoids.