摘要
患有罕见疾病的儿童属于弱势群体,在当前中国的医疗保障体系无法提供全面的医疗保障时,他们不仅面临着身体和精神上的折磨,而且儿童参与临床试验的风险也高于成年人。充分保护儿童的安全和权益是伦理审查的关键。对儿童罕见病药物临床试验的现状,包括试验困难、保障制度等方面进行了分析;对临床试验应当遵循的伦理原则,知情同意原则、不伤害原则等进行了说明;并对保障儿童安全和权益的路径进行了探讨,以期提高对药物临床试验伦理审查重要性的认识和关注。
Children with rare disease belong to a vulnerable group.When China's current medical security system cannot provide comprehensive health care,they not only face physical and mental torture,but also have a higher risk of children participating in clinical trials than adults.So,adequate protection of children's safety and rights is the key to ethical review.This paper analyzed the current status of drugs clinical trials for rare disease in children,including trial difficulties and guarantee system;explained the ethical principles that should be followed in clinical trials,such as the principle of informed consent and the principle of no harm;and discussed the path of protecting children's safety and rights,so as to raise awareness and attention of the importance of ethical review of clinical trials.
作者
张慧
刘小红
杨永华
ZHANG Hui;LIU Xiaohong;YANG Yonghua(Department of Pediatrics, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China)
出处
《中国医学伦理学》
2022年第5期494-498,共5页
Chinese Medical Ethics
基金
中国抗癫痫协会-青峰癫痫患者管理基金“应用深度迁移学习视频检测儿童癫痫发作的研究”(CQ-B-2021-10)。
关键词
儿童罕见病
伦理保护
药物临床试验
Rare Diseases in Children
Ethical Protection
Drug Clinical Trials
