中外藥物臨床試驗(yàn)知情同意書要素缺陷分析
發(fā)布時(shí)間：2018-07-15 14:58
【摘要】：調(diào)查湘雅三醫(yī)院倫理委員會(huì)受理的122份中國(guó)和72份國(guó)外知情同意書各要素的出現(xiàn)率,總結(jié)缺陷要素。國(guó)內(nèi)知情同意書在研究分組、試驗(yàn)方案、隨訪過(guò)程、其他情況申明、受益與風(fēng)險(xiǎn)告知、保護(hù)受試者隱私及數(shù)據(jù)機(jī)密性和聯(lián)系方式共7方面缺失明顯高于國(guó)外,中外均易忽視以下6個(gè)要素的說(shuō)明,即入選/排除標(biāo)準(zhǔn)、盲態(tài)審查、藥物儲(chǔ)存條件、用藥依從性、法定代表人說(shuō)明和信息/樣本使用期限,且中國(guó)各缺失要素出現(xiàn)率均低于國(guó)外。由此分析缺陷要素并提出對(duì)策,以進(jìn)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(xué)湘雅三醫(yī)院臨床藥理中心;
【基金】：國(guó)家“重大新藥創(chuàng)制”科技重大專項(xiàng)“重大疾病新藥臨床評(píng)價(jià)研究綜合技術(shù)平臺(tái)建設(shè)”,項(xiàng)目編號(hào):2012ZX09303014001 國(guó)家自然科學(xué)基金項(xiàng)目“腎功能損害合并高血壓患者優(yōu)化降壓方案的研究”,項(xiàng)目編號(hào):81273594 “十二五”國(guó)家科技支撐計(jì)劃課題“老年人群治療風(fēng)險(xiǎn)及策略的臨床轉(zhuǎn)化醫(yī)學(xué)技術(shù)研究”,項(xiàng)目編號(hào):2012BAI37B05
【分類號(hào)】：R95
本文編號(hào)：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(xué)湘雅三醫(yī)院臨床藥理中心;
【基金】：國(guó)家“重大新藥創(chuàng)制”科技重大專項(xiàng)“重大疾病新藥臨床評(píng)價(jià)研究綜合技術(shù)平臺(tái)建設(shè)”,項(xiàng)目編號(hào):2012ZX09303014001 國(guó)家自然科學(xué)基金項(xiàng)目“腎功能損害合并高血壓患者優(yōu)化降壓方案的研究”,項(xiàng)目編號(hào):81273594 “十二五”國(guó)家科技支撐計(jì)劃課題“老年人群治療風(fēng)險(xiǎn)及策略的臨床轉(zhuǎn)化醫(yī)學(xué)技術(shù)研究”,項(xiàng)目編號(hào):2012BAI37B05
【分類號(hào)】：R95
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