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中国应如何为医学研究设定伦理准则?

How should China set ethical guardrails for medical research?

机构信息

Department of Medical Ethics and Law, School of Health Humanities, Peking University, Beijing, China.

Law School, Sichuan University, Chengdu, Sichuan, China.

出版信息

J Med Ethics. 2024 Oct 22;50(11):744-748. doi: 10.1136/jme-2023-109621.

Abstract

'Ethics first' reform in China significantly changes the governance framework for the research of emerging technologies. The misapplication of human genome editing technology reflects the urgent need to reform the governance framework. Strengthening ethics governance in medical research has become a consensus in China, where legal and ethical reforms are proceeding in parallel. The protection of human dignity, the prevention of biosafety risks, as well as the regulation of technological crimes are at the core of the legal system, which has been embodied in numerous fundamental legislations following the CRISPR-babies incident. Establishing a national ethics committee to coordinate ethics governance, and reinforcing ethics review and external oversight are significant steps in ethical reform. Essentially, ethics governance requires implementing the basic concept of 'ethics first', focusing on forward-looking and preventive governance rather than delayed intervention, while maintaining openness and collaboration.

摘要

中国的“伦理先行”改革,显著改变了新兴技术研究的治理框架。人类基因组编辑技术的不当应用反映出改革治理框架的迫切需要。加强医学研究的伦理治理已成为中国的共识,法律和伦理改革并行推进。保护人类尊严、防范生物安全风险以及规范技术犯罪,是这一法律体系的核心,这在“CRISPR 婴儿”事件后出台的众多基本立法中都有所体现。建立国家伦理委员会协调伦理治理,加强伦理审查和外部监督,是伦理改革的重要步骤。从本质上讲,伦理治理需要践行“伦理先行”的基本理念,注重前瞻性和预防性治理,而非滞后干预,同时保持开放性和协作性。

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