Standard No.:	DB31/T 899-2025
English Name:	Specification for ethical review of life sciences and medical research involving human participants
Chinese Name:	涉及人的生命科学与医学研究伦理审查规范
Chinese Classification:	C05    Medical science
Professional Classification:	DB    Provincial Standard
Source Content Issued by:	Shanghai Municipal Administration for Market Regulation
Issued on:	2025-12-23
Implemented on:	2026-4-1
Status:	to be valid
Superseding:	DB31/T 899-2015 Standards and operational guidance for ethical review of biomedical research involved human participants
Target Language:	English
File Format:	PDF

本文件规定了本市医疗卫生机构（以下简称“机构”）开展涉及人的生命科学与医学研究伦理审查的基本要求、审查流程、审查要点、文档管理和评估与改进。
本文件适用于本市机构内的伦理审查委员会开展涉及人的生命科学与医学研究的伦理审查，区域伦理审查委员会可参照执行。