本文選題：兒童 + 藥物臨床試驗(yàn)　； 參考：《中國臨床藥理學(xué)雜志》2017年15期

【摘要】：目的為制訂兒童藥物臨床試驗(yàn)中知情同意書的設(shè)計(jì)及簽署要素標(biāo)準(zhǔn)奠定基礎(chǔ)。方法調(diào)查2010-2015年北京兒童醫(yī)院的11項(xiàng)Ⅱ~Ⅲ期藥物臨床試驗(yàn)知情同意書的設(shè)計(jì)及443份知情同意書的簽署情況,分析設(shè)計(jì)要素中試驗(yàn)背景、試驗(yàn)?zāi)康摹⒃囼?yàn)流程、試驗(yàn)相關(guān)信息、簽署信息及簽署要素中簽署早于試驗(yàn)(早于試驗(yàn)篩選期)、簽署版本為倫理委員會(huì)批準(zhǔn)的最新版本、法定監(jiān)護(hù)人簽名、日期、聯(lián)系方式、注明法定監(jiān)護(hù)人與受試者的關(guān)系、研究者簽名、日期及聯(lián)系方式、研究者簽署日期不早于受試者、簽署時(shí)間具體到分鐘以及是否有針對不同人群的不同版本知情同意書、兒童版的是否便于兒童理解(有圖畫、彩色)等要素的出現(xiàn)率。結(jié)果我院知情同意書的設(shè)計(jì)及簽署基本符合《藥物臨床試驗(yàn)質(zhì)量管理規(guī)范》的要求,但仍存在要素缺失和簽署不規(guī)范現(xiàn)象,且國內(nèi)多中心項(xiàng)目較國際多中心項(xiàng)目要素缺失比率高。結(jié)論制訂兒童藥物臨床試驗(yàn)中知情同意書的設(shè)計(jì)及簽署要素標(biāo)準(zhǔn)。加強(qiáng)對研究者倫理審查相關(guān)培訓(xùn),切實(shí)保護(hù)受試者的權(quán)益。
[Abstract]:Objective to lay a foundation for the design and signature criteria of informed consent in children's drug clinical trials. Methods the design of 11 informed consent forms and the signing of 443 informed consent forms were investigated in Beijing Children's Hospital from 2010 to 2015. The background, purpose, procedure and relevant information of the design were analyzed. Signature information and signature elements prior to the test (earlier than the test screening period, signed version is the latest version approved by the ethics committee, legal guardian signature, date, contact information, indicating the relationship between legal guardian and subject, The researcher's signature, date and contact information, the researcher's signature date was no earlier than the subject's, the signature time was specific to minutes, and whether there were different versions of the informed consent form for different groups of people, and whether the children's version was easy for children to understand (there were pictures, The rate of occurrence of elements such as color. Results the design and signing of informed consent in our hospital basically accord with the requirements of quality Management Standard of Drug Clinical trial, but there are still some factors missing and signing nonstandard phenomenon. Moreover, the missing ratio of elements in domestic multi-center project is higher than that in international multi-center project. Conclusion the design and signature criteria of informed consent in children's drug clinical trials are established. Strengthen the relevant training to the ethical review of researchers, and protect the rights and interests of the subjects.
【作者單位】： 首都醫(yī)科大學(xué)附屬北京兒童醫(yī)院藥學(xué)部;
【分類號(hào)】：R95

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本文編號(hào)：1803390