Clinical Trial Decisions in Difficult Circumstances: Parental Consent Under Time Pressure

Jansen-van der Weide, Marijke C, Caldwell, Patrina HY, Young, Bridget ORCID: 0000-0001-6041-9901, de Vries, Martine C, Willems, Dick L, Van't Hoff, William, Woolfall, Kerry ORCID: 0000-0002-5726-5304, van der Lee, Johanna H and Offringa, Martin (2015) Clinical Trial Decisions in Difficult Circumstances: Parental Consent Under Time Pressure PEDIATRICS, 136 (4). E983-E992. ISSN 0031-4005, 1098-4275

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Abstract

Treatments and interventions used to care for children in emergencies should be based on strong evidence. Well-designed clinical trials investigating these interventions for children are therefore indispensable. Parental informed consent is a key ethical requirement for the enrollment of children in such studies. However, if time is limited because of an urgent need for intervention, there are additional ethical challenges to adequately support the informed consent process. The acute situation and associated psychological impact may compromise the ability of parents to give informed consent. Little evidence exists to guide the process of consent seeking for a child's research participation when time is limited. It is also unclear in what circumstances alternatives to prospective informed consent could be applied. This article describes possible options to manage the informed consent process in an appropriate, practical, and, we believe, ethical way when time is limited.

Item Type:	Article
Uncontrolled Keywords:	Humans, Patient Selection, Time Factors, Parental Consent, Child, Emergency Medical Services, Clinical Trials as Topic
Depositing User:	Symplectic Admin
Date Deposited:	19 Jun 2017 08:54
Last Modified:	16 Jun 2026 12:12
DOI:	10.1542/peds.2014-3402
Open Access URL:	http://pediatrics.aappublications.org/content/pedi...
Related Websites:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3008044
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