| 标题： | 中国眼科细胞基因治疗临床研究伦理审查专家共识 |
| title： | Expert consensus on ethical review of clinical research of ophthalmic cell gene therapy in China |
| 版本： | 原创版 |
| version： | Original |
| 分类： | 专家共识 |
| classification： | Experts consensus |
| 领域： | 其他 |
| field： | Others |
| 国家和地区： | 中国 |
| Country and region： | China |
| 指南使用者： | |
| Guide users： | |
| 证据分级方法： | 不适用 |
| Evidence grading method： | not available |
| 制定单位： | 中华医学会眼科学分会眼底病学组， 中国医师协会眼科医师分会眼底病专业委员会 |
| Formulating unit： | Fundus Disease Group of Chinese Medical Association Ophthalmology Branch Fundus Disease Committee of Chinese Medical Doctor Association Ophthalmology Branch |
| 注册时间： | 2022-06-18 |
| Registration time： | |
| 注册编号： | IPGRP-2022CN347 |
| Registration number： | |
| 指南制订的目的： | 眼睛是公认开展基因、细胞治疗的最佳靶器官，已成为近年眼科临床研究的热点领域，但目前关于眼科细胞基因治疗临床研究的伦理审查尚未形成系统的规范化指导意见。因此，为了规范眼科细胞基因临床研究的伦理审查，中华医学会眼科学分会眼底病学组和中国医师协会眼科医师分会眼底病专业委员会组织国内相关专家，经过反复讨论，提出我国眼科细胞基因治疗临床研究伦理审查规范化意见，以供临床参考应用，规范医疗机构开展眼科细胞基因治疗临床研究的伦理审查实践，切实保护好患者利益 |
| Purpose of the guideline： | The eye is considered as the best targeted organ for gene and cell therapies, which have become hot fields of ophthalmic clinical trials in recent years. However, the formal guidelines of ethical review on ophthalmic cell or gene therapy clinical researches have not reached. In order to standardize the ethical reviews on these trials, after several rounds of discussion, the experts from Fundus Disease Group of Chinese Medical Association Ophthalmology Branch and Fundus Disease Committee of Chinese Medical Doctor Association Ophthalmology Branch proposed the formal ethical review guidelines. The proposed guideline plays a positive role in standardizing future gene and cell therapies clinical trials. |
