美国临床试验中受试者权利保护制度的借鉴意义

The Referential Significance of Subjects' Rights Protection System of American Clinical Trials

本文介绍了美国临床试验中受试者权利的保护制度,并结合分析我国临床试验中受试者权利保护的现状,认为应借鉴美国的相关制度,完善我国相关的立法、行政监管和伦理委员制度。

This paper introduces subjects rights protection system of clinical trials,analyzes the present situa?tion of the clinical trial subjects rights protection,and argues we should draw lessons from the related system in America,perfect relevant legislation,administrative regulation and ethics committee systems in China.