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.
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October 2015
Special Article|
October 01 2015
Clinical Trial Decisions in Difficult Circumstances: Parental Consent Under Time Pressure
Marijke C. Jansen-van der Weide, PhD;
aPediatric Clinical Research Office, Emma Children’s Hospital, Academic Medical Center, Amsterdam, Netherlands;
Address correspondence to M.C. Jansen-van der Weide, PhD, Pediatric Clinical Research Office, Academic Medical Center, H8-236, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands. E-mail: Jansen.mc@amc.uva.nl
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Patrina H.Y. Caldwell, MD;
Patrina H.Y. Caldwell, MD
bDiscipline of Paediatrics and Child Health, University of Sydney, Sydney, Australia;
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Bridget Young, PhD;
Bridget Young, PhD
cInstitute of Psychology, Health and Society, University of Liverpool, Liverpool, United Kingdom;
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Martine C. de Vries, MD;
Martine C. de Vries, MD
dDepartments of Pediatrics, Medical Ethics and Law, Leiden University Medical Center, Leiden, Netherlands;
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Dick L. Willems, MD;
Dick L. Willems, MD
eSection of Medical Ethics, Department of General Practice, Academic Medical Center/University of Amsterdam, Amsterdam, Netherlands;
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William Van’t Hoff, MD;
William Van’t Hoff, MD
fClinical Research Facility, Great Ormond Street Hospital, London, United Kingdom; and
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Kerry Woolfall, PhD;
Kerry Woolfall, PhD
cInstitute of Psychology, Health and Society, University of Liverpool, Liverpool, United Kingdom;
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Johanna H. van der Lee, MD;
Johanna H. van der Lee, MD
aPediatric Clinical Research Office, Emma Children’s Hospital, Academic Medical Center, Amsterdam, Netherlands;
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Martin Offringa, MD
Martin Offringa, MD
gChild Health Evaluative Sciences, SickKids Research Institute, University of Toronto, Toronto, Ontario, Canada
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Address correspondence to M.C. Jansen-van der Weide, PhD, Pediatric Clinical Research Office, Academic Medical Center, H8-236, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands. E-mail: Jansen.mc@amc.uva.nl
FINANCIAL DISCLOSURE: Dr Van’t Hoff has received travel grants from Orphan Europe to attend scientific and educational meetings but has not received any personal financial support. The other authors have indicated they have no financial relationships relevant to this article to disclose.
Pediatrics (2015) 136 (4): e983–e992.
Article history
Accepted:
July 08 2015
Citation
Marijke C. Jansen-van der Weide, Patrina H.Y. Caldwell, Bridget Young, Martine C. de Vries, Dick L. Willems, William Van’t Hoff, Kerry Woolfall, Johanna H. van der Lee, Martin Offringa; Clinical Trial Decisions in Difficult Circumstances: Parental Consent Under Time Pressure. Pediatrics October 2015; 136 (4): e983–e992. 10.1542/peds.2014-3402
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