对涉及人的生物医学研究之知情同意书问题分析  

The Analysis of Deficiencies and Shortcomings in Informed Consent of Biomedical Research Involving Human Subjects

作　　者：任佩娟[1] 王猛[1] 宋茂民[1] 白彩珍[1] REN Pei-juan WANG Meng SONG Mao-min et al.(Institutional Review Board, Beijing Tian Tan Hospital, Capital Medical University, Beijing 100050, China)

机构地区：[1]首都医科大学附属北京天坛医院医学伦理委员会,北京100050

出　　处：《医学与哲学（A）》2017年第3期34-37,共4页Medicine & Philosophy:Humanistic & Social Medicine Edition

基　　金：2012年"重大新药创制"国家科技重大专项(2012ZX09303005)

摘　　要：回顾性收集北京天坛医院医学伦理委员会2011年~2015年审查的涉及人的生物医学研究(药物、器械、科研)项目,对191份知情同意书给出的伦理审查意见与建议进行统计分析。结果显示,三类研究没有明显差异。在语言表述方面,药物临床试验存在的问题较多;在告知信息方面,三类研究都存在较多问题;在试验费用承担者告知方面,药物和器械试验研究问题较多。虽然要求知情同意书需按模板撰写,以保证要素的完整性,但还是有一些欠缺与不足,提示还需对申办者及研究者进行相关的培训,以提高对受试者保护的意识。The data of ethical review recommendations on informed consent of biomedical researches involving human subjects （including scientific research project, drugs and medical devices clinical trials） given by the institutional review board （IRB） of Beijing Tian Tan Hospital from year 2011 to year 2015 were collected. 191 pieces of review recommendations of consent forms were investigated. The results showed that there was no significant difference in the problems of informed consent among three types of researches. In the aspect of language, there were more problems in drug clinical trials. In the aspect of information informing, there were problems in all three types of researches. In the aspect of informing test cost payer, drugs and medical devices clinical trials had more problems. Although the template of consent form was used to ensure the integrity of the information elements, there were still some deficiencies and shortcomings, which suggested that sponsors and researchers need to be trained, so as to improve the awareness of the protection of subjects.

关 键 词：知情同意书 伦理审查意见 科研项目 器械临床试验 药物临床试验 

分 类 号：R-052[医药卫生]