在一个欠发达国家的知情同意期间的理解
Daniel W Fitzgerald1, Cécile Marotte, Rose Irene Verdier
1Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes, Port au Prince, Haiti.
Lancet (London, England)
|November 5, 2002
概括
确保发展中国家的知情同意至关重要. 通过与辅导员的多次会议提供信息,与单个医生会议相比,参与者对同意表格的理解显著提高.
科学领域:
- 全球健康 全球健康
- 临床研究伦理学
- 在知情同意的情况下同意.
背景情况:
- 在欠发达国家,确保参与者理解同意表格的实际指导方针是有限的.
- 知情同意是临床研究的关键伦理组成部分,特别是在弱势群体中.
研究的目的:
- 评估改善研究参与者对资源有限环境中的同意表格理解的方法.
- 评估不同信息传递方法对理解率的有效性.
主要方法:
- 一项关于海地HIV-1传播的研究要求参与者通过关于同意表格内容的口头考试 (80%的通过分数).
- 最初的组 (n=15) 在一次医生会议中获得信息;随后的组 (n=30) 在三次辅导员会议中获得信息.
主要成果:
- 只有20% (3/15) 的参与者在一次医生会议后通过了理解测试.
- 当辅导员在三次会议上提供信息时,获得了80% (24/30) 的明显更高的合格率.
结论:
- 信息传递的方法在不发达国家对研究参与者的理解有重大影响.
- 实施正式的理解评估和利用多次会议辅导应该是这些环境中知情同意的标准做法.
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