中国医学伦理学2026，Vol.39Issue(5)：609-615,7.DOI:10.12026/j.issn.1001-8565.2026.05.08
研究者发起的国际合作研究的伦理管理存在问题以及对策探讨
Existing issues and countermeasure exploration of the ethical management in the investigator-initiated international collaborative research
摘要
Abstract
With the increasing number of investigator-initiated international multicenter research,clinical innovation and cross-border collaboration have significantly advanced.However,international collaborative projects encounter challenges such as inconsistent ethical review standards,complexities in informed consent,variations in data privacy protection,and insufficient disclosure of conflicts of interest,affecting both research standardization and the protection of participants'rights and interests.Therefore,optimizing ethical management systems and improving the efficiency of ethical reviews have become critical issues that urgently necessitate addressing.This paper systematically analyzed current issues in the ethical management system,including inconsistent review standards,inadequate disclosure of conflicts of interest,insufficient communication and coordination,and others.It also proposed solutions such as optimizing multi-center ethical review mechanisms,standardizing informed consent,improving data privacy management agreements,establishing transparent disclosure mechanisms of conflicts of interest,and building cross-center communication platforms.These strategies aimed to enhance the standardization,transparency,and efficiency of ethical management in international collaborative research,providing a feasible ethical management framework for Chinese ethics committees and researchers conducting and reviewing international collaborative research projects in the future,thus promoting the sustainable development of global medical scientific research cooperation.关键词
研究者发起的临床研究/国际合作/数据隐私保护/伦理管理Key words
investigator-initiated trial/international collaboration/data privacy protection/ethical management分类
医药卫生引用本文复制引用
周梅珊,邬凤娟..研究者发起的国际合作研究的伦理管理存在问题以及对策探讨[J].中国医学伦理学,2026,39(5):609-615,7.基金项目
2024年佛山市自筹经费类科技创新项目"科研伦理管理现状分析与对策研究"(2420001004181) （2420001004181）
