| 摘要: |
| 目的:调查中国大陆部分多中心临床试验伦理审查模式的现状,分析原因,并结合国际趋势给出改进建议。方法:对来自辽宁、江苏、四川、上海和广东等省市共21家综合性或专科医院参加伦理审查执行能力培训班的代表进行匿名问卷调查；另外选择20家临床试验机构或伦理委员会进行电话调查,并填写调查表。回收所有调查表,判断其有效性后,对调研结果进行统计分析。结果:65.1%的受访者表示不采用中心伦理审查方式,主要原因是不能评估中心伦理审查的质量、出于对受试者保护责任的考虑、与中心伦理委员会沟通不畅、难以满足知情同意书本地化的要求。34.9%受访者表示接受中心伦理审查,主要原因是可以缩短审查周期、避免影响研究进度和中心伦理审查质量令人满意。结论:中心伦理审查方式没有得到广泛认可,有待于完善制度、提高审查质量、加强伦理委员会间交流与合作。 |
| 关键词: 多中心研究 临床试验 临床伦理学委员会 问卷调查 |
| DOI：10.3724/SP.J.1008.2009.01182 |
| 投稿时间：2008-11-11修订日期：2009-07-07 |
| 基金项目:第二军医大学长海医院2008年度科研创新基金. |
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| Inspection of ethical issues in multicenter clinical trails in China: a survey of current status |
| HUANG Jin1,LIU Hou-jia2,HU Jin-hong1* |
| (1.Department of Pharmacy,Changhai Hospital,Second Military Medical University,Shanghai 200433,China;2.Department of Scientific Administration,Changhai Hospital,Second Military Medical University,Shanghai 200433) |
| Abstract: |
| Objective:To investigate the inspection mode of ethical issues for multicenter clinical trails in China,and to make analysis and give suggestions while taking into consideration of the international conventions. Methods: Representatives from 21 general hospitals and specialized hospitals from Liaoning province,Jiangsu province,Sichuan province,Guangdong province and Shanghai participated in a training course on promotion of ethical review capability; they were surveyed by anonymous questionnaire. Another 20 clinical trial agencies and ethical committees were interviewed by telephone. The questionnaires were collected and valid questionnaires were subjected to statistical analysis.Results: We found that 65.1% of the interviewees never used a central institutional review board (IRB); the main reasons included that they could not assess the quality of central IRB,they wanted to protect the subjects,they had a poor communication with the IRB,and they could not obtain a satisfactorily-localized informed consent forms. There were 34.9% of the interviewees used a central IRB,because they wanted to shorten the inspection time,avoid influence to the research progress,and to have satisfactory quality of IRB. Conclusion: Central IRB is not widely accepted. The related system needs to be further completed so as to improve the outcome of the inspection. The communication and cooperation between the central and local IRBs should be strengthened. |
| Key words: multicenter study clinical trail clinical ethics committees questionnaires |
