关于在出生时使用放弃知情同意的审判的父母观点
Anup Katheria1, Georg Schmolzer2, Brenda Law2
1Sharp Mary Birch Hospital for Women & Newborns.
Research square
|November 14, 2023
概括
大多数家长认为,在新生儿试验中,放弃同意是可以接受的,并允许未来的参与. 这种方法支持伦理研究,同时尊重父母对孩子健康的看法.
科学领域:
- 新生儿研究伦理学
- 儿科临床试验的临床试验
- 经知情同意的程序 信息同意的程序
背景情况:
- 豁免同意有时用于对非活力婴儿的新生儿研究.
- 父母的观点对于评估伦理研究实践至关重要.
- 了解父母对同意方法的接受对于试验招募和保留至关重要.
研究的目的:
- 在新生儿临床试验中评估父母对豁免同意程序的接受度.
- 评估家长对未来参与类似研究的舒适度.
- 收集关于向家长提供的信息清晰度的反.
主要方法:
- 匿名调查对非有活力的婴儿的生物学父母进行了调查.
- 婴儿在分娩室被随机分配,用于使用放弃同意的特定干预.
- 分析了121项已完成调查的数据.
主要成果:
- 92%的家长认为放弃同意的过程是可以接受的.
- 96%的家长会允许未来的孩子参与.
- 超过90%的人报告清楚地理解随机化后的信息.
- 只有4%的人对这项研究对孩子健康的影响持负面看法.
结论:
- 大多数家长接受了研究设计,包括在新生儿期放弃同意.
- 大多数家长认为这项研究对孩子健康的影响是积极的.
- 建议进行进一步的研究,以探索各种各样的家长参与和儿科同意方法.
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