摘要
儿童参加临床试验是促进儿童用药健康发展和用药安全的重要手段,但邀请儿童参加临床试验面临的风险高于成人。为了保护儿童的利益,使其免受伤害,作为保护受试者权益重要措施的知情同意和知情同意书,在遵循一般医学伦理学原则基础上,还应考虑儿童心理、思维发育尚未完全的特点,本着保护儿童这一弱势群体合法权益、尊重儿童意愿的精神进行设计与操作。
Clinical trial for children plays an important role to evaluate the efficacy and safety of medication for children. However, the risk to recruit children weighs more than to invite adults in clinical trial In order to protect their rights and keep them away from harms, the informed consent procedure and written informed consent form, based on the general principle of medical ethics, would be fundamental to the clinical trial. What＇s more, to conduct the clinical trials in children, the protocol design and trials implementation should always take into account that children, as the disadvantaged group, are physically and psychologically underdeveloped, and thus their interests will be above everything.
出处
《药物评价研究》
CAS
2014年第2期163-165,共3页
Drug Evaluation Research
基金
国家科技重大专项十二五"重大新药创制"课题"儿科中药新药临床评价研究技术平台规范化建设"(2011ZX09302-006-03)
关键词
儿童用药
药物临床试验
知情同意
知情同意书
medication for children
clinincal trail of drug
informed consent
informed consent form
