中外藥物臨床試驗知情同意書要素缺陷分析
發(fā)布時間：2018-07-15 14:58
【摘要】：調(diào)查湘雅三醫(yī)院倫理委員會受理的122份中國和72份國外知情同意書各要素的出現(xiàn)率,總結(jié)缺陷要素。國內(nèi)知情同意書在研究分組、試驗方案、隨訪過程、其他情況申明、受益與風險告知、保護受試者隱私及數(shù)據(jù)機密性和聯(lián)系方式共7方面缺失明顯高于國外,中外均易忽視以下6個要素的說明,即入選/排除標準、盲態(tài)審查、藥物儲存條件、用藥依從性、法定代表人說明和信息/樣本使用期限,且中國各缺失要素出現(xiàn)率均低于國外。由此分析缺陷要素并提出對策,以進一步規(guī)范知情同意書管理,使受試者全面理解告知信息,充分保障受試者的權(quán)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.
【作者單位】： 中南大學湘雅三醫(yī)院臨床藥理中心;
【基金】：國家“重大新藥創(chuàng)制”科技重大專項“重大疾病新藥臨床評價研究綜合技術(shù)平臺建設(shè)”,項目編號:2012ZX09303014001 國家自然科學基金項目“腎功能損害合并高血壓患者優(yōu)化降壓方案的研究”,項目編號:81273594 “十二五”國家科技支撐計劃課題“老年人群治療風險及策略的臨床轉(zhuǎn)化醫(yī)學技術(shù)研究”,項目編號:2012BAI37B05
【分類號】：R95
本文編號：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.
【作者單位】： 中南大學湘雅三醫(yī)院臨床藥理中心;
【基金】：國家“重大新藥創(chuàng)制”科技重大專項“重大疾病新藥臨床評價研究綜合技術(shù)平臺建設(shè)”,項目編號:2012ZX09303014001 國家自然科學基金項目“腎功能損害合并高血壓患者優(yōu)化降壓方案的研究”,項目編號:81273594 “十二五”國家科技支撐計劃課題“老年人群治療風險及策略的臨床轉(zhuǎn)化醫(yī)學技術(shù)研究”,項目編號:2012BAI37B05
【分類號】：R95
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