冠状病毒 (COVID) 流行病对机构道德委员会运作的影响:一项比较研究
Yashashri Chandrakant Shetty1, Urmila Mukund Thatte2, Amitrajit Pal1
1Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India.
Perspectives in clinical research
|January 29, 2024
概括
随着COVID-19的流行,机构伦理委员会 (IEC) 的运作发生了重大变化,包括更快的审查时间和修订的程序. 这次审计评估了大流行病的情况.
科学领域:
- 医学伦理 医学伦理
- 公共卫生 公共卫生
- 医疗保健服务研究 医疗服务研究
背景情况:
- 随着COVID-19的流行,机构伦理委员会 (IEC) 面临了前所未有的挑战.
- 在全球卫生危机期间,调整IEC的运作对于持续的伦理研究监督至关重要.
- 对于未来的准备工作来说,这些适应的记录是必不可少的.
研究的目的:
- 在COVID-19大流行期间审核机构伦理委员会 (IEC) 的运作.
- 评估疫情对IEC结构的影响,审查流程,结果和管理.
- 为了比较IEC在流行病期间的表现与流行病前阶段的表现.
主要方法:
- 对KEM医院的IEC数据进行了追溯审计.
- 数据被收集并分为结构,审查过程,结果和管理领域.
- 描述性统计数据和曼·惠特尼U测试被用于分析,比较大流行前和大流行期间.
主要成果:
- 国际电竞委员会结构发生了变化,对COVID-19协议的审查增加,会议频率增加了一倍.
- 修改了标准操作程序,导致提交查询和研究完成时间大幅减少.
- 观察到协议偏差的增加,以及由于在线会议和更少的文书工作而减少的财务负担.
结论:
- IEC的基础设施和运作经历了范式的转变,以适应与流行病相关的变化和挑战.
- 委员会成功地克服了障碍,表现出了性和适应能力.
- 这些发现强调了在公共卫生紧急情况下需要灵活和响应性的伦理审查流程.
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