协和医学杂志2025，Vol.16Issue(6)：1629-1635,7.DOI:10.12290/xhyxzz.2024-1043
罕见病患儿临床试验的知情同意难题及对策研究
Research on the Informed Consent Challenges and Countermeasures in Pediatric Clinical Trials for Rare Diseases
程龙 1潘瑞丽2
作者信息
- 1. 中国医学科学院北京协和医院 转化医学国家重大科技基础设施研究病房,北京 100730
- 2. 中国医学科学院北京协和医院 护理部,北京 100730
- 折叠
摘要
Abstract
Rare diseases have emerged as a critical issue in the field of global public health.Their low prevalence,high complexity,and frequent onset in childhood pose unique ethical challenges to the informed consent process in clinical trials involving pediatric patients.Although clinical trials offer potential therapeutic hope for children with rare diseases,the ethical tension between proxy consent and the child's own assent fur-ther complicates the informed consent procedure.Moreover,the presence of"therapeutic misconception"under-mines the autonomous decision-making capacity of both the child and their proxies,potentially violating the principles of beneficence and non-maleficence.In response to these challenges,this paper proposes several im-provements,including multidimensional assessment and a phased,dynamic informed consent process,with the aim of optimizing informed consent procedures in clinical trials for pediatric rare diseases.These recommenda-tions provide a theoretical foundation for enhancing informed consent practices in this field and may serve as a reference for future research in ethics.关键词
罕见病/儿童临床试验/伦理困境/知情同意/弱势群体保护Key words
rare diseases/pediatric clinical trials/ethical dilemmas/informed consent/protection of vulnerable groups分类
医药卫生引用本文复制引用
程龙,潘瑞丽..罕见病患儿临床试验的知情同意难题及对策研究[J].协和医学杂志,2025,16(6):1629-1635,7.
