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.
Xiaomin Wang, Jessica Hahne, Lun Li, Kaveh Khoshnood, Guoping Yang, Hong Yuan, Xing Liu
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引用次数: 5
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.
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