Practical approaches for supporting informed consent in neonatal clinical trials

Practical approaches for supporting informed consent in neonatal clinical trials
Mini Review
Susan H. Wootton, Matthew Rysavy, Peter Davis, Marta Thio, Mar Romero-Lopez, Lindsay F. Holzapfel, Tamara Thrasher, Jaleesa D. Wade, Louise Owen
Acta Paediatrica, 22 February 2024
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.

Editor’s note: Acta Paediatrica is a peer-reviewed monthly journal published on behalf of the Foundation Acta Paediatrica based at the Karolinska Institute in Sweden.