中国中南部一家顶尖医院的人类研究保护计划下机构审查委员会审查的质量与效率提升：头三年的描述性分析
Developing Quality and Efficiency of Institutional Review Board Review Under a Human Research Protection Program at a Leading Hospital in Central Southern China: A Descriptive Analysis of the First Three Years.
作者信息
Wang Xiaomin, Hahne Jessica, Li Lun, Khoshnood Kaveh, Yang Guoping, Yuan Hong, Liu Xing
机构信息
Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, P.R. China.
Clinical Research Center, The Third Xiangya Hospital, Central South University, Changsha, Hunan, P.R. China.
出版信息
J Empir Res Hum Res Ethics. 2021 Jul;16(3):280-289. doi: 10.1177/1556264621995656. Epub 2021 Mar 17.
Abstract
This study analyzes the Institutional Review Board (IRB) quality and efficiency at a leading hospital in Central Southern China, under the first three years of a Human Research Protection Program (HRPP). We conducted a descriptive, retrospective analysis from 2015 through 2017. We extracted characteristics from the protocol archive in duplicate. Of 396 protocols submitted, 98% were approved. Mean protocol review time decreased from 23 to 15 calendar days, 344 serious adverse events SAEs were reviewed, and 93 conflicts of interest (COIs) were disclosed. IRB quality and efficiency mechanisms improved. Remaining needs include increased monitoring of COIs and unanticipated problem involving risks to subjects or others, distinctions between research types, and cooperation with specialized committees.
摘要
本研究分析了中国中南部一家顶尖医院在人类研究保护计划（HRPP）实施的前三年中，机构审查委员会（IRB）的质量和效率。我们在2015年至2017年期间进行了描述性回顾性分析。我们从方案档案中提取特征并进行了双份提取。在提交的396份方案中，98%获得批准。方案平均审查时间从23个日历日降至15个日历日，审查了344起严重不良事件（SAE），并披露了93起利益冲突（COI）。IRB的质量和效率机制得到了改善。仍需改进的方面包括加强对利益冲突以及涉及受试者或他人风险的意外问题的监测、区分研究类型以及与专业委员会的合作。
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