论临床试验结束后的医学伦理问题  

Ethical Issues after the Clinical Trial

作　　者：卜今[1] 

机构地区：[1]南京医科大学学报编辑部,江苏南京210029

出　　处：《中国医学伦理学》2013年第4期514-516,共3页Chinese Medical Ethics

摘　　要：随着大量临床试验的开展,试验后续反应以及试验后责任成为人们所关注的另一个伦理矛盾。目前国内尚缺试验后续反应以及试验后责任问题的管理规范,该问题暂时也不是卫生行政管理及研究机构的关注重点。但随着生物技术及医学的发展,国内外合作交流的快速增加以及生命伦理学学科的不断完善,试验后续反应以及试验后责任问题不可避免的将成为临床试验伦理审查中必须考虑的问题。从试验后续反应以及试验后责任产生的原因、现状以及实施的困难等方面探讨这一伦理问题,旨在引起卫生行政管理部门及机构伦理委员会等的高度关注,找到适合我国国情的妥善解决方案。With the development of a large number of clinical trials, the follow - up tests and the following responsibility become another ethical conflict. At present, there are no management standards in domestic for the follow - up reaction and the liability management after trial, the problem is currently not for the focus of health administrative and research institutions. With the development of biotechnology and medicine, the cooperation and between health administration agencies and research institutions, domestic and international organizations rapidly increased. The subsequent reaction of trial and posttrial obligation inevitably become a problem that must be considered in the ethical review of clinical trials. The author explored the ethical issues on the test subsequent reaction of trial and and post - trial obligation for the current situation as well as the difficulties of implementation, to initi- ate, causing a high degree of concern in the health administrative departments and institutions ethics committee, and to find the conditions for the proper solution.

关 键 词：临床试验 试验后责任 试验后续反应 伦理问题 

分 类 号：R-052[医药卫生]