title: Clinical Trial Decisions in Difficult Circumstances: Parental Consent Under Time Pressure.
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.
authors.affiliation: Pediatric Clinical Research Office, Emma Children's Hospital, Academic Medical Center, Amsterdam, Netherlands; Jansen.mc@amc.uva.nl.
authors.forename: Marijke C
authors.initials: MC
authors.lastname: Jansen-van der Weide
authors.affiliation: Discipline of Paediatrics and Child Health, University of Sydney, Sydney, Australia;
authors.forename: Patrina H Y
authors.initials: PH
authors.lastname: Caldwell
authors.affiliation: Institute of Psychology, Health and Society, University of Liverpool, Liverpool, United Kingdom;
authors.forename: Bridget
authors.initials: B
authors.lastname: Young
authors.affiliation: Departments of Pediatrics, Medical Ethics and Law, Leiden University Medical Center, Leiden, Netherlands;
authors.forename: Martine C
authors.initials: MC
authors.lastname: de Vries
authors.affiliation: Section of Medical Ethics, Department of General Practice, Academic Medical Center/University of Amsterdam, Amsterdam, Netherlands;
authors.forename: Dick L
authors.initials: DL
authors.lastname: Willems
authors.affiliation: Clinical Research Facility, Great Ormond Street Hospital, London, United Kingdom; and.
authors.forename: William
authors.initials: W
authors.lastname: Van't Hoff
authors.affiliation: Institute of Psychology, Health and Society, University of Liverpool, Liverpool, United Kingdom;
authors.forename: Kerry
authors.initials: K
authors.lastname: Woolfall
authors.affiliation: Pediatric Clinical Research Office, Emma Children's Hospital, Academic Medical Center, Amsterdam, Netherlands;
authors.forename: Johanna H
authors.initials: JH
authors.lastname: van der Lee
authors.affiliation: Child Health Evaluative Sciences, SickKids Research Institute, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Martin
authors.initials: M
authors.lastname: Offringa
mesh_terms: D002648:Child; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000379:methods; D004632:Emergency Medical Services / Q000941:ethics*; D006801:Humans; D033282:Parental Consent / Q000941:ethics*; D018579:Patient Selection / Q000941:ethics*; D013997:Time Factors