随机临床试验的伦理问题研究  

Ethical Research on Issues of Randomized Clinical Trial

作　　者：王晓敏[1] 

机构地区：[1]中南大学公共管理学院,湖南长沙410083

出　　处：《中国医学伦理学》2012年第4期405-407,共3页Chinese Medical Ethics

基　　金：国家社科基金重大项目"现代医疗技术中的生命伦理及其法律问题研究"(11&ZD177);湖南省博士生科研创新项目"随机临床试验的伦理问题研究"(CX2010B097)

摘　　要：随机临床试验所遵循的严格的科学方法与受试者人体机理的特殊性之间存在一定矛盾,可能会对受试者的生命健康权、隐私权、知情同意权、自主权产生伦理伤害。随机临床试验的均势原则无法真正避免这些伤害或风险的发生,特别是发达国家与发展中国家科技与福利的不对等性,有可能加剧这种对受试者伤害的风险可能性。如何在保证科学性的同时遵循伦理道德规范、保证受试者的权益,是我国当前迅猛发展的医药市场和国家药监等相关部门需要慎重思考的。There is certain contradiction exists between the strict scientific methods and the particularity of hu- man subjects in randomized clinical trials, might have some ethical damage on the right of subjects＇life and heahb, privacy, right of informed consent, and the right of autonomy. The balance principle of randomized clinical trial cant really avoid these damage or risk, furthermore, inequality of the welfare of the science between developed countries and the developing countries could raise the risk of injury to subjects. How to ensure the scientificalness as well as the medical ethics, and ensure the rights and interests of the subjects, should be carefully considered by the related departments under the background of current rapid development of the medical market in China.

关 键 词：随机临床试验 伦理问题 科研伦理 生命健康权 知情同意 隐私权 

分 类 号：R-052[医药卫生]