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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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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 challenging 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.ConclusionThe 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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Key words
checklists,clinical trials,ethics,informed consent,neonatology
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