基于小组的在线知情同意对话 (eConsent) 在低风险疫苗接种临床试验参与者的评估
Ngoc H Tan1, Melvin Lafeber1,2, Roos S G Sablerolles1
1Department of Hospital Pharmacy, Erasmus Medical Center, Rotterdam, the Netherlands.
Trials
|August 6, 2024
概括
集体电子知情同意 (eConsent) 在临床研究中提供了效率和社区意识. 然而,隐私问题和群体动态可能会限制其使用,这表明未来研究的混合方法.
科学领域:
- 临床研究 临床研究
- 公共卫生 公共卫生
- 疫苗学 疫苗学 疫苗学
背景情况:
- 在欧洲,电子知情同意 (eConsent) 的采用正在增加,由大流行加速.
- 临床研究经常面临参与者招募和推广缓慢的挑战.
- 集团eConsent在SWITCH-ON研究中试点使用,以解决招聘障碍.
研究的目的:
- 探索参与者对群体eConsent的体验.
- 评估未来临床研究群体eConsent的可行性.
主要方法:
- 在SWITCH-ON研究中,招募了434名医疗保健工作者进行两价COVID-19增剂疫苗接种分析.
- 通过问卷收集参与者的经验,分析了360个答案.
- 使用描述性和主题分析分析了定量和定性数据.
主要成果:
- 参与者发现团队eConsent是有效的,培养团结的感觉,并允许共享问询.
- 限制包括隐私的减少,在小组中提出问题的困难以及潜在的同行压力.
- 46%的人认为群组eConsent适合招募具有某些条件的参与者,而24%的人指出局限性.
结论:
- 在一项低风险疫苗接种研究中,群体eConsent得到了积极的接待.
- 建议采用混合模式,将一般信息的网络研讨会和同意的个人会议结合起来.
- 这种方法旨在利用集团eConsent的好处,同时减轻隐私和参与障碍.
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