国内外企业发起临床试验知情同意书的问题对照分析及提示  

Comparison and analysis of issues existing in informed consent forms of clinical trials sponsored by foreign and domestic enterprises

作　　者：白彩珍[1] 樊啸[1] 任佩娟[2] 李娜[1] 

机构地区：[1]首都医科大学附属北京天坛医院院长办公室,北京100050 [2]首都医科大学附属北京天坛医院科研处,北京100050

出　　处：《中国新药杂志》2015年第15期1750-1753,共4页Chinese Journal of New Drugs

基　　金：北京市科委"脑卒中诊疗技术规范研究"(D101107049310006)

摘　　要：目的:分析比较国外企业与国内企业发起的临床试验知情同意书中存在的问题。方法:回顾性统计并分析我院2011-2014年对不同背景申办者发起的药物和医疗器械临床试验项目的知情同意书给出的伦理审查建议。结果:国外企业发起的试验语言表述偏重于翻译语言,繁杂冗长;国内企业发起的试验内容太过简洁,专业术语多,条理不清楚,含有诱导性语言。试验费用承担者告知部分国外企业主要是对费用承担做出条件限制;而国内企业主要是对试验相关损伤的费用承担者的告知模糊或缺失。结论:两组存在问题有差别;需要优先选择法律背景委员审查国外企业发起的试验项目;提升研究者对知情同意书内容的重视。Objective： To compare and analyze the issues existing in the informed consent forms（ ICFs） of clinical trials sponsored by foreign and domestic enterprises. Methods： The defects in the ICFs of clinical trials sponsored by different background enterprises picked out by our hospital＇s ethical committee（ EC） from 2011 to2014 were retrospectively collected and analyzd. Results： The ICFs of foreign enterprises were mostly translated from foreign languages,resulting in long and complicated sentences; while the ICFs of Chinese enterprises did not provide enough information about the trials to the subjects,used too much technical terms,and exaggerated the benefits of the trials. In the section of trial-related compensation,the foreign enterprises mainly set limitations for compensation,while the Chinese ones only provided ambiguous information about who need to pay for trial-related hurt or even neglected this part. Conclusion： There is difference between foreign and domestic enterprises in the ICF defects. EC members with legal background should be selected for reviewing the projects sponsored by foreign enterprises; investigators need to pay more attention to the content of ICF.

关 键 词：临床试验 伦理审查 知情同意书 申办者 对照 分析 

分 类 号：R969[医药卫生—药理学]