在韩国COVID-19大流行期间,政府对研究伦理的倡议
1Department of the History of Medicine and Medical Humanities, Seoul National University College of Medicine, Seoul, Korea.
Journal of Korean medical science
|April 2, 2024
概括
韩国 韩国 韩国 韩国
科学领域:
- 公共卫生政策 公共卫生政策
- 临床研究伦理学
- 流行病的准备 流行病的准备
背景情况:
- 在流行病期间对临床研究伦理的政府政策变化存在有限的文献.
- 之前的研究重点是韩国对大流行病的反应或制度道德,而不是积极的政府政策.
- 本文涉及COVID-19大流行期间快速医疗产品开发的伦理挑战.
研究的目的:
- 在韩国COVID-19大流行期间,检查积极的政策变化和政府对研究伦理问题的反应.
- 分析韩国政府在紧急医疗产品开发和供应中确保研究伦理的战略.
主要方法:
- 在COVID-19大流行期间使用与研究伦理和诚信相关的关键词搜索政府文件.
- 仅包括来自政府或公共机构的文件,选择24份用于分析.
- 将文件分为两个阶段:紧急响应 (2020年1月至2021年2月) 和长期准备 (2021年3月至2023年2月).
主要成果:
- 实施措施,使COVID相关研究的伦理审查时间缩短到不到一周.
- 建议联合机构审查委员会 (IRB),加快审查,并指定监管机构.
- 允许临时非面对面的知情同意和临床试验程序,包括在线伦理培训.
结论:
- 韩国对伦理原则的承诺防止了医疗系统的崩,并确保了伦理的流行病研究.
- 在2015年中东呼吸综合征流行病之前的经验为迅速的道德举措奠定了基础.
- 政府的举措成功地平衡了流行病研究伦理与流行病应对需求.
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