Discussion of the special protection in ethical review of medical research involving children
10.3760/cma.j.cn113565-20231128-00128
- VernacularTitle:涉及儿童的医学研究伦理审查中特殊保护的探讨
- Author:
Zheng LI
1
;
Jiyi HUANG
;
Junkai DUAN
Author Information
1. 江西省儿童医院科教科，南昌 330008
- Keywords:
Children;
Medical research;
Ethical reviews;
Special protection
- From:
Chinese Journal of Medical Science Research Management
2024;37(4):241-245
- CountryChina
- Language:Chinese
-
Abstract:
Objective:This study aimed to explore the ″special″ review points and ethical strategies in the ethical review of medical research involving children, providing references for the medical research on this group.Methods:Combining the physical and mental characteristics of children, and comparing clinical research ethics review points, this study discussed the key aspects to be concerned about in the ethical review of medical research involving children, and proposed " special protection" strategies to be implemented.Results:Ethics committees should fully recognize the uniqueness of child development. The definition of minimal risk in the child population needs to be fully understood at the risk-benefit assessment stage, to develop ethical responses to the risk-benefit ratios in different situations, and to avoid special risks. Informed consent procedures should adhere to basic principles while respecting dissenting voices by designing multiple versions of informed consent for research, and developing informed consent countermeasures for vulnerable children groups.Conclusions:Medical research involving children should follow more rigorous and scientific procedures to protect rights, standardize clinical research in pediatric healthcare, and promote the healthy development of pediatric health endeavors.
