[生物医学研究知情同意书:编辑指南]
[Informed consent form for biomedical research: a tutorial for redaction].
作者信息
Hénin Yvette, de Boischevalier Bénédicte, Reboul-Salze Françoise, Cracowski Jean-Luc, Dualé Christian
机构信息
Inserm CIC BT505, Paris, France.
出版信息
Therapie. 2010 Mar-Apr;65(2):71-94. doi: 10.2515/therapie/2010006. Epub 2010 May 19.
Since the full implementation in France of the European Directive 2001/20/EC about biomedical research, a written information form must be given to any participant in research, who must give in return his/her written consent. The written and consent form must be validated by a referent ethics committees prior to the research, but guidelines for the redaction of such document are missing. Thus, the investigators who are often in charge of the redaction could be helped by a tutorial that may consider the legal aspects, the rights of the participant and the quality of information. For this, a group from the French network of the clinical investigation centres--directed by the Inserm--worked on a tutorial which is presented here. This tutorial has been built stepwise, with review of the literature, enquiry within the French clinical investigation centres, primary redaction, internal validation, and final validation by external experts versed in the field of ethics for biomedical research.
自欧洲关于生物医学研究的2001/20/EC指令在法国全面实施以来,必须向任何参与研究的人员提供书面信息表,而该人员必须相应地给出他/她的书面同意。书面同意表必须在研究之前由相关伦理委员会进行验证,但目前缺少编写此类文件的指南。因此,通常负责编写工作的研究人员可能会受益于一个教程,该教程可以考虑法律方面、参与者的权利以及信息质量。为此,由法国国家健康与医学研究院(Inserm)指导的法国临床研究中心网络的一个小组编写了一个教程,在此予以介绍。本教程是逐步构建的,包括文献综述、在法国临床研究中心进行的调查、初稿编写、内部验证以及由生物医学研究伦理领域的外部专家进行的最终验证。