AI Article Synopsis
- The study assesses the Institutional Review Board (IRB) quality and efficiency at a major hospital in Central Southern China during the first three years of its Human Research Protection Program (HRPP), using data from 2015 to 2017.
- A high approval rate of 98% for the 396 submitted protocols was found, with a decrease in average protocol review time from 23 to 15 days, and reviews of 344 serious adverse events (SAEs) and 93 conflicts of interest (COIs) identified.
- While improvements in IRB mechanisms were noted, areas needing attention include enhanced monitoring of COIs, better management of unanticipated risks, clear distinctions between different research types, and improved collaboration with specialized committees.
Article 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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|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8238789 | PMC |
| http://dx.doi.org/10.1177/1556264621995656 | DOI Listing |
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