国际人用药品技术要求协调理事会（ICH）发布的ICH E6（R3）给包括中国在内的全球药物临床试验注入了新活力。该原则于2026年3月31日起正式适用于我国新开展的临床研究，其明确提出的风险相称原则，为药物临床研究的伦理审查提供了从“合规导向”转向“风险导向”的方法论框架。儿童中药临床研究不仅以儿童弱势人群作为研究对象，更叠加了中药制剂的复杂性和中医药理论的特殊性，使相关伦理审查面临诸多挑战。首先阐释风险相称原则的内涵与法规依据，进而分析儿童中药临床研究的伦理风险和特点，重点从科学性审查、风险获益评估、知情同意设计与实施、儿童参与者招募、利益冲突管理、跟踪审查等维度，系统探讨基于该原则下的儿童中药临床研究伦理审查策略与方法，为构建以儿童、中药为特色的伦理审查技术体系提供借鉴与参考。

The ICH E6 (R3) issued by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use has injected new vitality into global drug clinical trials, including those in China. This principle will officially apply to new clinical studies in China as of March 31, 2026. It clearly stipulates the principle of risk equivalence, providing a methodological framework for ethical review of drug clinical research to shift from a “compliance-oriented” approach to a “risk-oriented” one. The clinical research of traditional Chinese medicine for children not only takes children as the research subjects, but also incorporates the complexity of traditional Chinese medicine preparations and the particularity of traditional Chinese medicine theory, presenting many challenges for the relevant ethical review. This article first explains the connotation and regulatory basis of the principle of risk equivalence, then analyzes the ethical risks and characteristics of clinical research of traditional Chinese medicine for children, and focuses on systematically exploring the ethical review strategies and methods for clinical research of traditional Chinese medicine for children based on this principle from dimensions such as scientific review, risk-benefit assessment, informed consent design and implementation, recruitment of children participants, conflict of interest management, and follow-up review, in order to provide reference and guidance for building an ethical review technical system featuring children and TCM.

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2024年天津中医药大学第二附属医院“育才计划”项目（YC-RW202405）