儿科人群真实世界研究伦理审查要点探析

Analysis on Ethical Review of Real-world Research in Pediatric Population

目的分析和探索儿科人群真实世界研究的伦理审查要点,为儿科人群真实世界研究的伦理审查提供参考。方法依据真实世界研究与儿科临床试验的特点,对照一般临床研究伦理审查原则及重点,分析和探讨儿科人群真实世界研究的审查要点。结果伦理委员会应当特别关注知情同意、隐私保护、风险受益评估、费用与补偿的审查,同时还应考虑到研究设计、数据治理、研究的利益冲突、研究注册与发表等方面,对儿科人群真实世界研究进行科学合理的伦理审查。结论儿科人群临床试验应当要有更严格、科学的伦理审查,既可保护未成年人这一弱势群体的利益,也可规范儿科人群真实世界研究,促进儿科临床研究健康发展,从而更好保护儿童,促进儿童健康。

Objective:To analyze and explore the key points of the ethical review of real-world research in pediatric population,and to provide reference for ethical review of real-world research in pediatric population.Methods:According to the characteristics of real-world research and pediatric clinical trials,the review points of real-world research in pediatric population were analyzed and discussed in comparison with the principles and focus of ethical review in general clinical research.Results:The ethics committee should pay particular attention to the review of informed consent,privacy protection,risk benefit assessment,cost and compensation,and should also take into account the research design,data governance,research conflicts of interest,research registration and publication,etc.,and conduct scientific and reasonable ethical review of real-world research in pediatric population.Conclusion:Clinical trials in pediatric population should have stricter and scientific ethical review,which can not only protect the interests of vulnerable groups of minors,but also standardize real-world research in pediatric population and promote the healthy development of pediatric clinical research,so as to better protect children and promote their health.