研究者伦理意识对药物临床试验中受试者保护作用的探讨

Discussion about the subject protective effect of researchers ' ethical awareness in drug clinical trials

通过分析当前我国受试者保护法规和制度方面的不足,强调在此背景下研究者作为临床试验执行者与受试者直接接触者,在保护受试者、协助受试者权益维护中的重要作用。探讨采取以伦理培训提高研究者伦理意识、完善法规制度、建立研究者与伦理委员的良好沟通等方式,促进临床试验中的受试者权益保护。

Through analyzing the deficiency of subjects protection in our country ＇s current laws,regulations and systems,the article emphasized that researchers,as practitioners,who had direct contact with the subjects in clinical trials,they played significant roles in protection and safeguard of rights and interests of subjects. In addition,the paper discussed the ways to enhance the protection of rights and interests of the subjects in clinical trials,such as enhancing the ethical awareness of researchers by ethics training, perfecting laws and regulations,strengthening the communication between researchers and ethics committee,etc.