利用放射性同位素示踪技术进行新药临床试验存在着相应伦理问题,如对受试者和工作人员放射性损害的风险,和对环境造成污染的可能. 本文介绍了本伦理委员会对一项放射性同位素标记药物临床试验进行伦理审查的过程及其伦理考量,供同行进行讨论与参考,以促进完善针对该类技术临床试验的伦理审查.“,”The use of radioisotope tracer technique in human new drug trials has some ethical issues , such as the risk of radiation damage to the subject and to the staff , the concern of environmental contamination by the radiolabeled drugs.This article describes the process of the ethical review of a radiolabelled drug clinical trial and our ethical considerations , for the purpose of peer discussion and reference to promote the improve-ment of ethical review of clinical trials for such technology .