人体试验中知情同意权的伦理意蕴探析

Analysis of Ethical Connotation of "Informed Consent" Authority in the Human Body Experiment

在人体临床试验中,受试者作为整个试验过程中最重要的组成部分,其权益极易受到侵害,而受试者对本身权益是否受到侵犯却相当陌生。如何对待受试者,如何才能够真正保护他们的利益不受损害,成为我们亟需关心的首要问题。知情同意是人体生物医学研究的主要伦理要求之一,是人体试验和临床实践的行动指南。实施知情同意旨在有效地保护人体试验中受试者的合法权利不受侵犯,作者从生命伦理学的角度出发,追溯了知情同意的缘起及其发展过程,对知情同意所引发的道德问题进行了分析和探讨,并对知情同意权的实现作了初步构想。

As the most important composition in the entire testing, the testee＇s rights and interests is easily violated. But the testees are always not aware if their rights and interests is to receive the infringements. How to treat them, how to protect them from being injured truly come to be the first consideration that we should care. Informed consent as one of main ethics requests in human body biomedical research, is the guide for action in human body experiment and the clinical practice. The goal of Implementation of informed consent is to protect the testee＇s rights and interests from being violated. This article traces the origin and developing process of informed consent, and analyzes and discusses moral questions which informed consent causes, give some preliminary conception to the realization of informed consent.