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Review
. 2024 May;113(5):923-930.
doi: 10.1111/apa.17165. Epub 2024 Feb 22.

Practical approaches for supporting informed consent in neonatal clinical trials

Susan H Wootton  1   2   3 , Matthew Rysavy  2   3   4 , Peter Davis  5   6   7 , Marta Thio  5   6   7   8 , Mar Romero-Lopez  2   3   4 , Lindsay F Holzapfel  3   4 , Tamara Thrasher  3   9 , Jaleesa D Wade  4 , Louise S Owen  5   6   7
Affiliations
Review

Practical approaches for supporting informed consent in neonatal clinical trials

Susan H Wootton et al. Acta Paediatr. 2024 May.

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.

Keywords: checklists; clinical trials; ethics; informed consent; neonatology.

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Conflict of interest statement

CONFLICT OF INTEREST STATEMENT

None.

References

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