Covid-19 大流行病对肯尼亚医学研究所研究组合和审批周转时间的影响

Enock Kipchirchir Kebenei, Daisy Cheruiyot, Gideon Cornel Msee, James Nguya, T. Kiplagat, Elizabeth A Bukusi
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摘要

背景:Covid-19 大流行给全球许多领域(包括科研)带来了前所未有的影响。我们评估了 Covid-19 大流行对肯尼亚医学研究所 (KEMRI) 的研究组合以及提交给科学与伦理审查股 (SERU) 的研究方案审批周转时间的影响。方法:我们对 2019 年 10 月 1 日至 2020 年 3 月 31 日(期间 1)提交的研究方案与 2020 年 4 月 1 日至 9 月 30 日(期间 2)提交的研究方案进行了比较。我们使用文件审查工具从这两个时期审查和批准的 198 份研究方案中提取数据。结果:在审查的两个时期中,涉及传染病和寄生虫病的研究方案所占比例最大(89/198,45.4%),横断面研究设计所占比例最大(75/198,38%)。在大流行之前,审查与 KEMRI 相关的方案所需的时间中位数为 87 天,而审查与 KEMRI 无关的方案所需的时间中位数为 121 天。在大流行期间,由于 KEMRI SERU 简化了流程,KEMRI 和非 KEMRI 方案的审批周转时间分别降至 66 天和 92 天。结论研究项目组合受大流行病的影响很小。在大流行期间,采用电子邮件提交以及比平时更快的处理和审查规程缩短了审批周转时间。
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The impact of Covid-19 pandemic on the research portfolio and approval turnaround time at the Kenya Medical Research Institute
Background: The Covid-19 pandemic led to unprecedented impact on many sectors globally including research. We assessed the impact of the Covid-19 pandemic on the research portfolio, and on the approval turnaround time for research protocols submitted to the Scientific and Ethics Review Unit (SERU), at the Kenya Medical Research Institute (KEMRI). Methods: We compared research protocols submitted between October 01, 2019 and March 31, 2020 (Period 1), to those submitted between April 1 and September 30, 2020 (Period 2). A document review tool was used to extract data from the 198 research protocols reviewed and approved over the two periods. Results: In the two periods under review, the single largest percentage of protocols (89/198, 45.4%) involved infectious and parasitic diseases, and the single largest percentage of study designs was cross-sectional (75/198, 38%). Before the pandemic, the median time taken to review KEMRI-linked protocols was 87 days and for non-KEMRI linked protocols it was 121 days. During the pandemic, approval turnaround time dropped for both KEMRI and non-KEMRI protocols to 66 days and 92 days, respectively, due to the streamlined processes at the KEMRI SERU. Conclusion: The research portfolio was minimally affected by the pandemic. The adoption of email submission, and faster-than-usual processing and review protocols during the pandemic reduced the approval turnaround time.
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