父母对未来同意的看法:来自试点随机试验的经验,该试验在产前期期间招募了极度早产婴儿
Hannah Skelton1,2, Traci-Anne Goyen1, Patricia Viola1
1Neonatal Intensive Care Unit, Westmead Hospital, Sydney, New South Wales, Australia.
Journal of paediatrics and child health
|August 14, 2024
概括
家长们发现,对于极其早产的婴儿,知情同意过程是可以接受的. 延迟同意的方法可能适用于未来的低风险新生儿研究.
科学领域:
- 新生儿研究新生儿研究
- 临床试验 临床试验
- 在知情同意的情况下同意.
背景情况:
- 为临床试验招募极早产婴儿 (孕期<29周) 面临着获得知情同意的独特挑战.
- 父母对同意过程的理解和看法对于伦理研究行为至关重要.
研究的目的:
- 探索父母对知情同意过程的看法,以对极度早产婴儿进行试点随机对照试验.
- 评估家长对在生命的前72小时内进行的低风险干预研究的理解.
主要方法:
- 在"定位早产婴儿用于神经保护"研究中,对同意,拒绝同意或符合条件但未同意的父母进行前性调查.
- 结构化的采访评估了同意方法的可接受性和家长的知识.
- 附加的家长评论的字面转录.
主要成果:
- 大多数家长 (62名受访者) 在同意之前报告对研究有很好的理解.
- 医疗从业者的口头解释被认为是有益的.
- 产后同意在分娩单位的4小时窗口被认为可能太短,建议推迟同意作为替代方案.
结论:
- 对父母来说,同意过程是可以接受的,他们觉得自己得到了充分的信息.
- 对于未来的低风险干预研究,应考虑推迟同意,包括立即招募新生儿.
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