摘要
在人体生物医学研究日益发达的今天,受试者权益保护问题逐渐浮出水面。目前我国对受试者的保护主要依赖于知情同意书和伦理委员会,关于受试者权益保护的规范性文件存在层级低、不系统和不完整等问题。建立专门的受试者保护法,完善受试者权益保护相关制度迫在眉睫。研究认为,制定专门的人体生物医学研究受试者权益保护法律,完善伦理委员会制度,推行强制保险以及救济金制度,建立严格的责任体系、开展积极的社会教育是受试者权益保护的基本对策。
As an increasing development of human biomedical research, the protection of the participant ＇s interest starts to appear. The current protection towards the participant in China mainly relies on the informed consent and the ethics committee. The standard document on the protection of the participant＇ s interest is low level, not systemic and incomplete. It is imminent to establish special law to protect the participant and to improve relevant systems. Studies suggest that a basic countermeasure to protect the participant include establishing special law, improving ethics committee, practicing compulsory insurance and relief payment system and setting strict liability system.
出处
《医学与哲学（A）》
北大核心
2014年第2期55-57,共3页
Medicine & Philosophy:Humanistic & Social Medicine Edition
基金
2011年江苏省社会科学基金项目"医学研究中受试者权益保护法律问题研究"
项目编号:11FXD016
关键词
人体生物医学研究
受试者
医院伦理委员会
强制保险制度
救济金制度
human biomedical research, participant, hospital ethics committee, compulsory insurance system, emergency relief system
