Decullier Evelyne, Lhéritier Véronique, Chapuis François
French National Conference of Research Ethics Committees, Lyon, France.
BMC Med Ethics. 2005 Oct 17;6:E9. doi: 10.1186/1472-6939-6-9.
Clinical trials throughout the world must be evaluated by research ethics committees. No one has yet attempted to clearly quantify at the national level the activity of ethics committees and describe the characteristics of the protocols submitted. The objectives of this study were to describe 1) the workload and the activity of Research Ethics Committees in France, and 2) the characteristics of protocols approved on a nation-wide basis.
Retrospective cohort of 976 protocols approved by a representative sample of 25/48 of French Research Ethics Committees in 1994. Protocols characteristics (design, study size, investigator), number of revisions requested by the ethics committee before approval, time to approval and number of amendments after approval were collected for each protocol by trained research assistant using the committee's files and archives.
Thirty-one percent of protocols were approved with no modifications requested in 16 days (95% CI: 14-17). The number of revisions requested by the committee, and amendments submitted by the investigator was on average respectively 39 (95% CI: 25-53) and 37 (95% CI: 27-46), per committee and per year. When revisions were requested, the main reasons were related to information to the patient (28%) and consent modalities (18%). Drugs were the object of research in 68% of the protocols examined. The majority of the research was national (80%) with a predominance of single-centre studies. Workload per protocol has been estimated at twelve and half hours on average for administrative support and at eleven and half hours for expertise.
The estimated workload justifies specific and independent administrative and financial support for Research Ethics Committees.
世界各地的临床试验必须由研究伦理委员会进行评估。尚未有人尝试在国家层面清晰量化伦理委员会的工作量，并描述所提交方案的特征。本研究的目的是描述：1）法国研究伦理委员会的工作量和活动；2）在全国范围内获批方案的特征。
对1994年法国48个研究伦理委员会中25个具有代表性的样本所批准的976个方案进行回顾性队列研究。由经过培训的研究助理利用委员会的文件和档案，收集每个方案的特征（设计、研究规模、研究者）、伦理委员会在批准前要求的修订次数、批准所需时间以及批准后的修订次数。
31%的方案在16天内获批且无需修改（95%置信区间：14 - 17）。每个委员会每年要求的修订次数以及研究者提交的修订次数平均分别为39次（95%置信区间：25 - 53）和37次（95%置信区间：27 - 46）。当要求进行修订时，主要原因与向患者提供信息（28%）和同意方式（18%）有关。在所审查的方案中，68%以药物为研究对象。大多数研究是全国性的（80%），且以单中心研究为主。每个方案的工作量估计平均行政支持为12.5小时，专业评估为11.5小时。
估计的工作量证明应为研究伦理委员会提供专门且独立的行政和财政支持。
