COVID大流行对机构伦理委员会运作的影响:一项比较研究

Yashashri Chandrakant Shetty, Urmila Mukund Thatte, Amitrajit Pal, Janhavi Katkar
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引用次数: 0

摘要

目的和目的:在2019冠状病毒病大流行期间,有必要记录机构伦理委员会(IEC)的运作情况,组织如何适应和应对所带来的挑战,从而形成本次审计背后的基本原理。目的是评估大流行对独立教育教育机构的结构、审查过程、结果和管理的影响,并对其在大流行前阶段的运作进行比较。研究对象和方法:采用回顾性审核方法。在免除伦理审查后,从位于KEM医院的IEC办公室收集数据,并将其分为四个领域:结构、审查过程、结果和管理。数据采用描述性统计进行分析。在5%显著性水平下,采用Mann-Whitney U检验比较两个研究期的项目审批周转时间。采用SPSS软件22对数据进行分析。结果:章程发生了变化,审查了更多与COVID - 19研究有关的协议,会议频率增加了一倍,并修订了《标准操作程序》,以纳入大流行期间面临的变化。在提交查询信和完成研究方面,周转时间显著减少。有更多的协议偏差。由于文书工作和会议在网上举行,财务负担和支出减少。伦理委员会的基础设施和职能必须经历范式转变,以适应新冠肺炎大流行期间出现的各种变化,并克服各种障碍。
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Impact of the COVID pandemic on functioning of the institutional ethics committee: A comparison study
Abstract Purpose and Aim: In COVID 19 pandemic, it was essential to document the functioning of the institutional ethics committee (IEC), how the organization adapted and faced challenges posed, thus forming the rationale behind this particular audit. The objectives were to assess the impact of the pandemic on the structure, review process, outcomes, and administration of IEC and to compare the same during its functioning in the prepandemic stage. Subject and Methods: The study was conducted as a retrospective audit. After exemption from ethics review, the data were collected from the IEC office situated in KEM Hospital and were segregated into four domains: structure, review process, outcomes, and administration. The data were analyzed using descriptive statistics. Mann–Whitney U -test was used to compare the turnover time for approval of projects between the two study periods at 5% level of significance. SPSS software version 22 was used to analyze the data. Results: Constitution changed, more protocols pertaining to COVID 19 studies were reviewed, meetings frequency doubled, and Standard Operating Procedures was amended to incorporate the changes faced during pandemic. Significant decrease in turnover time was noticed with respect to submission to query letter and study completion. There were more protocol deviations. Financial burden and expenditure decreased due to less paperwork and meetings being held online. Conclusion The ethics committee infrastructure and functioning had to undergo a paradigm shift to adapt to the various changes and overcome the various hurdles occurring during the COVID-19 pandemic.
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来源期刊
Perspectives in Clinical Research
Perspectives in Clinical Research Medicine-Medicine (all)
CiteScore
2.90
自引率
0.00%
发文量
41
审稿时长
36 weeks
期刊介绍: This peer review quarterly journal is positioned to build a learning clinical research community in India. This scientific journal will have a broad coverage of topics across clinical research disciplines including clinical research methodology, research ethics, clinical data management, training, data management, biostatistics, regulatory and will include original articles, reviews, news and views, perspectives, and other interesting sections. PICR will offer all clinical research stakeholders in India – academicians, ethics committees, regulators, and industry professionals -a forum for exchange of ideas, information and opinions.
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