浅析临床试验知情同意问题  

Analysis of the Problem of Informed Consent in Clinical Trial

作　　者：伍晓晓 王璐[1] 刘美佑[1] 杨晓娟[1] 彭莉[1] 张颖[1] 贾艳艳[1] 文爱东[1] 

机构地区：[1]第四军医大学西京医院药剂科,陕西西安710032

出　　处：《中国医学伦理学》2018年第1期20-23,共4页Chinese Medical Ethics

基　　金："十一五"重大新药创制计划重大专项(项目编号:2008ZX09312-024);国家"十二五"重大新药创制计划军队特需专项(项目编号:2011ZX09202-013)

摘　　要：目的通过对某三甲医院临床试验知情同意过程的观察,揭露临床试验知情同意过程存在的不规范现象,提出弱势群体参与临床试验应有特殊保护机制。方法结合某三甲医院实际情况,综合分析本中心临床试验知情同意过程中存在的问题,并提出了严格的解决办法,对于弱势群体的知情同意过程也制定了严格的标准。结果通过对弱势群体知情同意过程的严格要求,规范弱势群体参与临床试验的试验过程,同时使弱势群体得到特殊保护。结论知情同意书是保护弱势群体参与临床试验的重要保障。Objective：By observing the process of informed consent in clinical trials of one top three hospital, to disclose the non - standard phenomenon existingin the process of informed consent in clinical trials, and put for- ward that there should be special protection mechanism for vulnerable groups to participate in clinical trials. Meth- ods： Combined with the actual situation of one top three hospital, we comprehensively analyzed the problems exist- ing in the process of informed consent of clinical trials in our center, put forward strict solutions, and also formula- ted strict standards for the informed consent process of vulnerable groups. Results：Through the strict requirements of the informed consent process of vulnerable groups, the test process of vulnerable groups participating in the clini- cal trial was standardized; meanwhile the vulnerable groups were given special protection. Conclusion： Informed consent is an important guarantee that protects vulnerable groups to participate in clinical trials.

关 键 词：临床试验 弱势群体 知情同意书 

分 类 号：R-052[医药卫生]