Analysis on Ethical Review of Real-world Research in Pediatric Population
10.12026/j.issn.1001-8565.2023.01.05
- VernacularTitle:儿科人群真实世界研究伦理审查要点探析
- Author:
Linyan QI
1
;
Xin SHEN
2
;
Qibo FU
1
;
Chunmei LI
1
;
Shaoqing NI
1
Author Information
1. Clinical Trial Institution Office,the Children’s Hospital, Zhejiang University School of Medicine/National Clinical Research Center for Child Health, Hangzhou 310052, China
2. College of Pharmacy, Hangzhou Medical College, Hangzhou 310053, China
- Publication Type:Journal Article
- Keywords:
Pediatrics;
Children;
Real-world Research;
Ethical Review;
Informed Consent
- From:
Chinese Medical Ethics
2023;36(1):27-32
- CountryChina
- Language:Chinese
-
Abstract:
【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.
