关键词: checklists clinical trials ethics informed consent neonatology

Mesh : Infant, Newborn Humans Informed Consent Checklist Critical Illness

来  源:   DOI:10.1111/apa.17165   PDF(Pubmed)

Abstract:
The survival and health of preterm and critically ill infants have markedly improved over the past 50  years, supported by well-conducted neonatal research. However, newborn research is difficult to undertake for many reasons, and obtaining informed consent for research in this population presents several unique ethical and logistical challenges. In this article, we explore methods to facilitate the consent process, including the role of checklists to support meaningful informed consent for neonatal clinical trials. CONCLUSION: The authors provide practical guidance on the design and implementation of an effective consent checklist tailored for use in neonatal clinical research.
摘要:
在过去50年中,早产儿和危重病儿的生存和健康状况有了显著改善,在进行良好的新生儿研究的支持下。然而,新生儿研究难以进行,原因有很多,在这一人群中获得知情同意进行研究提出了一些独特的伦理和后勤挑战。在这篇文章中,我们探索促进同意过程的方法,包括检查表的作用,以支持有意义的知情同意新生儿临床试验。结论:作者为设计和实施为新生儿临床研究量身定制的有效同意清单提供了实践指导。
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