涉及儿童的医学研究伦理审查中特殊保护的探讨
Discussion of the special protection in ethical review of medical research involving children
李争 1黄纪毅 1段君凯1
作者信息
- 1. 江西省儿童医院科教科,南昌 330008
- 折叠
摘要
目的 探讨涉及儿童的医学研究伦理审查工作中的"特殊"审查要点及伦理对策,为该群体医学研究的伦理审查提供参考.方法 结合儿童群体自身的身心特点,对照一般临床研究伦理审查要点,探讨涉及儿童的医学研究的伦理审查工作中需重点关注环节及实施的"特殊保护"对策.结果 伦理委员会需充分认识到儿童身心发育的特殊性,在风险—受益评估阶段,需充分理解儿童群体中最小风险的定义,针对不同状况下的风险受益比制定伦理对策及特殊风险的规避措施;在知情同意环节,需遵守基本原则,尊重"反对"的声音,为研究设计多个知情同意书版本及脆弱儿童群体的知情同意对策.结论 针对儿童开展的医学研究的伦理审查应有更严谨、科学的伦理审查程序,既可保护未成年人的权益,也可进一步规范儿科领域的临床研究,促进儿童医疗事业健康发展.
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 defi-nition 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 devel-oping 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.
关键词
儿童/医学研究/伦理审查/特殊保护Key words
Children/Medical research/Ethical reviews/Special protection引用本文复制引用
出版年
2024
NETL
NSTL
万方数据