在COVID-19大流行期间进行临床研究的知情同意和试验优先级. 利益相关者的经验和观点
Stefanie Weigold1, Susanne Gabriele Schorr1, Alice Faust1
1QUEST Center for Responsible Research, Berlin Institute of Health (BIH) at Charité - Universitätsmedizin Berlin, Berlin, Germany.
PloS one
|April 30, 2024
概括
这项研究探讨了疫情期间知情同意和临床试验优先级的挑战和策略. 在不确定的研究环境中,有效的优先级是克服同意问题的关键.
科学领域:
- 临床研究 临床研究
- 流行病的准备 流行病的准备
- 生物伦理学生物伦理学
背景情况:
- 在流行病期间,对知情同意和研究优先级的实际挑战的理解有限.
- 需要确定危机环境中临床研究的有效应对策略.
研究的目的:
- 识别知情同意的挑战和潜在的应对策略.
- 确定临床研究优先级的挑战和潜在应对策略.
- 在COVID-19大流行背景下探索这些问题.
主要方法:
- 在COVID-19大流行期间,与德国临床研究利益相关者进行半结构面试.
- 面试成绩单的主题文本分析,直到主题和.
- 涉及的调查人员,监督机构,资助者和研究支持单位.
主要成果:
- 确定了知情同意的三个主要主题:挑战,影响和战略.
- 确定了研究优先级的两个主要主题:感知效益和策略.
- 对于所有已识别的主题,提供了详细的子主题和支持性引用.
结论:
- 针对知情同意和研究优先级的响应策略具有重叠的元素.
- 高质量的研究优先级程序可以减轻知情同意方面的挑战.
- 严格的科学,医学和伦理理由对于在不确定性中进行试验选择至关重要.
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