南非COVID-19疫苗试验参与者的感知,经验和动机:一种定性研究
Thandeka Nkosi1,2, Chanelle Mulopo3, Bey-Marrié Schmidt3,4
1School of Public Health, University of the Western Cape, Bellville, Cape Town, South Africa. Thandeka.Nkosi@hiv-research.org.za.
Research integrity and peer review
|July 28, 2024
概括
临床试验的知情同意过程需要持续的参与,而不仅仅是初步讨论. 了解COVID-19疫苗试验中的参与者经验可以改善伦理研究实践.
科学领域:
- 临床研究伦理学
- 公共卫生 公共卫生
- 疫苗学 疫苗学 疫苗学
背景情况:
- 伦理临床试验需要一个强大的知情同意程序.
- 参与者必须了解自己的权利和责任.
- 这项研究调查了南非COVID-19疫苗试验中的参与者经验.
研究的目的:
- 探索参与者对知情同意过程的看法.
- 了解COVID-19疫苗试验期间参与者的经验.
- 确定激励参与临床试验的因素.
主要方法:
- 描述性的定性研究设计.描述性的定性研究设计.
- 在一项COVID-19疫苗试验中,有25名成年参与者 (18-64岁).
- 焦点小组讨论和半结构面试在南非德班进行.
- 数据解释的专题分析方法.
主要成果:
- 经历试验事件增强了参与者关于知情同意的讨论.
- 重复解释改善了对知情同意的理解.
- 记忆或理解的差距导致了参与者生成的解释.
- 参与的动机包括报销,医疗保健,家庭保护和社会自由.
结论:
- 知情同意过程应该是持续的,而不是单一的事件.
- 了解参与者的观点可以加强同意文件和流程.
- 以参与者为中心的方法提高了伦理的临床试验行为.
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