涉及儿童的药物临床试验伦理审查要素

Ethical review elements in drug clinical trials involving children

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,但儿童作为弱势群体,严格的伦理审查是保障其权益的重要手段。本文对儿童药物临床试验方案及知情同意的特殊性和伦理审查进行了分析,以期更好地开展儿童药物临床试验的伦理审查工作。

Children participating in clinical trials is an important mean of promoting the healthy development of children medication and drug safety. But children as a vulnerable group,stringent ethical review is an important means to protect their interests. This article analyzed the drug clinical trial program for children and the special nature of informed consent and ethical review,in order to better carry out the ethical review of clinical trials of medicines for children.