中外药物临床试验知情同意书要素缺陷分析
发布时间：2018-07-15 14:58
【摘要】：调查湘雅三医院伦理委员会受理的122份中国和72份国外知情同意书各要素的出现率,总结缺陷要素。国内知情同意书在研究分组、试验方案、随访过程、其他情况申明、受益与风险告知、保护受试者隐私及数据机密性和联系方式共7方面缺失明显高于国外,中外均易忽视以下6个要素的说明,即入选/排除标准、盲态审查、药物储存条件、用药依从性、法定代表人说明和信息/样本使用期限,且中国各缺失要素出现率均低于国外。由此分析缺陷要素并提出对策,以进一步规范知情同意书管理,使受试者全面理解告知信息,充分保障受试者的权益。
[Abstract]:This paper investigates the occurrence rate of 122 informed consent forms in China and 72 foreign informed consent forms accepted by the Ethics Committee of Xiangya third Hospital, and summarizes the defect factors. The lack of informed consent in China was significantly higher than that in foreign countries in seven aspects: research subgroup, trial scheme, follow-up process, other statements, benefits and risk notification, protection of subjects' privacy and data confidentiality, and contact information. It is easy to ignore the explanation of the following six factors: selection / exclusion criteria, blind examination, drug storage conditions, drug compliance, legal representative's description and information / sample duration, Moreover, the occurrence rate of missing elements in China is lower than that in foreign countries. In order to further standardize the management of informed consent form, make the subjects fully understand the information of information and fully protect the rights and interests of the subjects.
【作者单位】： 中南大学湘雅三医院临床药理中心;
【基金】：国家“重大新药创制”科技重大专项“重大疾病新药临床评价研究综合技术平台建设”,项目编号:2012ZX09303014001 国家自然科学基金项目“肾功能损害合并高血压患者优化降压方案的研究”,项目编号:81273594 “十二五”国家科技支撑计划课题“老年人群治疗风险及策略的临床转化医学技术研究”,项目编号:2012BAI37B05
【分类号】：R95
本文编号：2124461
[Abstract]:This paper investigates the occurrence rate of 122 informed consent forms in China and 72 foreign informed consent forms accepted by the Ethics Committee of Xiangya third Hospital, and summarizes the defect factors. The lack of informed consent in China was significantly higher than that in foreign countries in seven aspects: research subgroup, trial scheme, follow-up process, other statements, benefits and risk notification, protection of subjects' privacy and data confidentiality, and contact information. It is easy to ignore the explanation of the following six factors: selection / exclusion criteria, blind examination, drug storage conditions, drug compliance, legal representative's description and information / sample duration, Moreover, the occurrence rate of missing elements in China is lower than that in foreign countries. In order to further standardize the management of informed consent form, make the subjects fully understand the information of information and fully protect the rights and interests of the subjects.
【作者单位】： 中南大学湘雅三医院临床药理中心;
【基金】：国家“重大新药创制”科技重大专项“重大疾病新药临床评价研究综合技术平台建设”,项目编号:2012ZX09303014001 国家自然科学基金项目“肾功能损害合并高血压患者优化降压方案的研究”,项目编号:81273594 “十二五”国家科技支撑计划课题“老年人群治疗风险及策略的临床转化医学技术研究”,项目编号:2012BAI37B05
【分类号】：R95
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