Expert consensus on ethical review of clinical research of ophthalmic cell gene therapy in China

Title: Expert consensus on ethical review of clinical research of ophthalmic cell gene therapy in China
Edition: Original
Classification: Experts consensus
Field: Others
Countries and regions: China
Guidelines users:
Evidence classification method: not available
Development unit: Fundus Disease Group of Chinese Medical Association Ophthalmology Branch Fundus Disease Committee of Chinese Medical Doctor Association Ophthalmology Branch
Registration time: 2022-06-18
Registration number: IPGRP-2022CN347
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.