儿科癌症试验中受试者权益保护问题研究

Research on the Protection of the Rights and Interests of Subjects in Pediatric Cancer Trials

鉴于儿童无法或很难表达同意,儿科相关研究必须符合比成人研究更严格的伦理和监管标准。借鉴国际法规对儿童受试者权益保护的规定,分析中国儿科癌症试验中受试者权益保护存在的问题:缺乏关于未成年受试者保护的具体法律法规,儿童受试者知情同意不全面,儿科癌症试验中风险与受益监管不到位。从完善未成年受试者保护立法、完善儿童受试者知情同意相关规定以及加强监管儿科癌症试验风险与受益等三个方面提出了建议。

Given that children are unable or difficult to provide consent,pediatric research must meet more stringent standards of ethical and regulatory than adult research.This paper mainly drawn lessons from the American and the international law to the child subject rights and interests protection stipulation,analyzed the Chinese pediatric cancer trial subject rights and interests protection question:lack of specific laws and regulations on the protection of juvenile subjects,and the age division of children’s informed consent and the right to self-determination,and the inadequate supervision of risks and benefits in pediatric cancer trials.Suggestions were made from three aspects:perfecting the legislation for the protection of juvenile subjects,improving the relevant regulations on the informed consent of child subjects,and strengthening the supervision of the risks and benefits of pediatric cancer trials.