Practical approaches for supporting informed consent in neonatal clinical trials.

Susan H Wootton,Matthew Rysavy,Peter Davis,Marta Thio, Mar Romero-Lopez,Lindsay F Holzapfel, Tamara Thrasher, Jaleesa D Wade,Louise Owen

Acta paediatrica (Oslo, Norway : 1992)(2024)

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摘要
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.
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