试论药物临床研究中未成年人受试者权益保护

Protection of minor subjects in drug clinical trial

本文通过分析我国药物临床研究中未成年人受试者权益保障的现状;介绍未成年人受试者权益保护的域外法规定,提出了健全我国药物临床试验的法律体系,引入风险评估机制,强化未成年人受试者的知情同意,加强伦理委员会的伦理审查的建议,旨在为药物临床研究中未成年人受试者权益保护提供参考。

To provide references for protection of minor subjects, we analyzed the current situation of the protection of minor subjects in drug clinical trials in China. Besides, we introduced related foreign legislation. We should improve the legal system of drug clinical trials, introduce risk assessment mechanism, strengthen the informed consent of minor subjects, and strengthen the ethical review of ethics committee to strengthen the protection of minor subjects in drug clinical trials in China.