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Updated: Jul 2, 2025

Electrophysiological Measurements and Analysis of Nociception in Human Infants
Published on: December 20, 2011
Practical approaches for supporting informed consent in neonatal clinical trials
Susan H Wootton1,2,3, Matthew Rysavy2,3,4, Peter Davis5,6,7
1Division of Infectious Diseases, Department of Pediatrics, McGovern Medical School at UTHealth Houston, Houston, Texas, USA.
Informed consent for neonatal research is challenging. This study offers practical guidance on using checklists to improve the informed consent process for clinical trials involving critically ill newborns.
Area of Science:
- Neonatal research
- Clinical trials
- Bioethics
Background:
- Neonatal survival and health have improved due to research.
- Conducting research with newborns presents unique ethical and logistical challenges.
- Obtaining informed consent is a significant hurdle in neonatal research.
Purpose of the Study:
- To explore methods for facilitating the informed consent process in neonatal research.
- To highlight the role of checklists in supporting meaningful informed consent.
- To provide practical guidance for neonatal clinical trials.
Main Methods:
- Exploration of methods to facilitate informed consent.
- Focus on the utility of checklists.
- Guidance on design and implementation of consent checklists.
Main Results:
- Checklists can support meaningful informed consent in neonatal clinical trials.
- Practical guidance is provided for creating effective consent tools.
- The study addresses ethical and logistical challenges in neonatal research consent.
Conclusions:
- Effective consent checklists are crucial for ethical neonatal clinical research.
- The authors offer practical strategies for implementing consent checklists.
- Improving the consent process enhances the feasibility of neonatal research.
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