从理论到治理：中国医学伦理学的学科建构与伦理治理法治化^*

From Theory to Governance: The Disciplinary Construction of Chinese Medical Ethics and the Legalization of Ethical Governance

摘要

本文聚焦党的十八大以来，中国特色社会主义新时代背景下我国医学伦理领域的法治化转型，通过历时性梳理与规范性分析方法，系统呈现其从分散自律向集成治理演进的内在逻辑与实践路径。学科层面，历经“理论奠基与域外引介-实践转向与建制探索-制度反思与体系优化-法治引领与全域覆盖”四阶段发展；法律层面，构建起以法律法规为核心，专项审查办法为支撑的精细化规范体系；治理层面，实现从被动应对到主动塑造，审查范围走向全领域覆盖，流程管控与责任追究均纳入法治化轨道。未来，需进一步平衡制度刚性与实践弹性，为健康中国建设贡献伦理智慧，为全球科技伦理治理提供中国方案。

Abstract

This article focuses on the legal transformation of medical ethics in China during the new era of socialism with Chinese characteristics, since the 18th National Congress of the Communist Party of China. By employing diachronic review and normative analysis, it systematically presents the internal logic and practical pathways of the field’s evolution from fragmented self-regulation to integrated governance. Academically, the discipline has advanced through four stages: theoretical foundation and foreign introduction, practical shift and institutional exploration, critical reflection and systemic optimization, and legal-led, full-coverage advancement. Legally, a refined regulatory system has been established, centered on national laws and supported by specialized review regulations. In governance, a transition from passive response to proactive shaping has been achieved, with ethical review expanding across all domains of life science research, and procedural management and accountability fully incorporated into the rule of law. Looking ahead, it is essential to balance institutional rigidity with practical flexibility, contribute ethical wisdom to the Healthy China initiative, and offer a Chinese solution to global science and technology ethics governance.

关键词

医学伦理学 / 伦理治理 / 伦理审查 / 科技伦理 / 法治化

Key words

Medical ethics / Ethical governance / Ethical review / Science and technology ethics / Legalization

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