摘要
伦理委员会在药物临床试验受试者权益保护中扮演的角色至关重要。儿童药物临床试验是当前药物临床研究的热点和难点,其中残疾儿童作为受试者的临床试验更是存在较大的特殊性,其伦理审查也面临一定的挑战和个性化问题。我国对于残疾儿童药物临床试验的伦理审查相关的指导原则和法制存在较大盲区,因此亟需借鉴国际上针对该领域研究的相关成果进一步完善我国药物临床试验的伦理审查体系。本文从国际上残疾儿童临床试验伦理研究概况、残疾儿童生物伦理学研究关注要点等方面综述了残疾儿童药物临床中特殊的伦理问题。同时本文还引用两个国外临床试验案例来进一步阐明涉及残疾儿童的药物研究的伦理审查过程中需要思考和关注的问题,以期为我国残疾儿童药物临床试验伦理审查的研究提供参考和借鉴。
Ethics committee plays a crucial role in protecting the rights and interests of subjects in drug clinical trial. The clinical trial of children＇s drugs is the hot and also the difficuh point in the current drug clinical trial, among which the clinical trial of children with disabilities as subjects is more special. And the ethical review of children with disa- bilities also faces some challenges and individualized problems. The related guiding principles and legal systems of the ethi- cal review about children with disabilities in China are almost lacking. Therefore, it is urgent and necessary to learn from the relevant results of international studies in this field to further improve the Chinese ethical review system of drug clinical trials. From the aspects of general ethical study situation on clinical trial of children with disabilities and the focus point of the research on the bioethics of disabled children, this paper reviews the special ethical issues met in the clinical practice of children with disabilities. Meanwhile, this paper also cites two foreign clinical trial cases to further clarify the problems that need to be considered and paid attention to in the ethical review process of drug research when involving children with disabilities, so as to provide reference for the research on ethical review of drug clinical trials for children with disabilities in China.
作者
杜艾桦
Du Aihua(Department of Scientific Research Management,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China)
出处
《药物流行病学杂志》
CAS
2018年第10期694-698,共5页
Chinese Journal of Pharmacoepidemiology
基金
"重大新药创制"科技重大专项(编号:2017ZX09304022)
关键词
残疾儿童
药物临床试验
伦理审查
知情同意
Children with disabilities
Drug clinical trial
Ethical review
Informed consent
