Paeds Cases · professional-practice-and-evidence
Research ethics and assent OSCE — paediatric trial enrolment and emergency deferred consent
Observed communication encounter testing permission versus assent terminology, risk-benefit categorisation, screening for therapeutic misconception, and management of a child's dissent and a deferred-consent emergency scenario.
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Target exams
RACP General PaediatricsRACP DCEMRCPCH ClinicalRCPSC Pediatrics
Prompt
Station A is a parent of an 8-year-old being invited into a non-beneficial physiology study, where the child has expressed reluctance. Station B is a registrar briefing a parent after their child was enrolled in a cardiac-arrest resuscitation trial under deferred consent.
Station objectives
- Use the correct terminology — parental permission, child assent, and consent — and seek assent at the right developmental level. [2]
- Categorise a study by its risk-benefit tier and explain what the ethics committee must find to approve it. [1] [3]
- Screen for therapeutic misconception before enrolment and correct it without extinguishing reasonable hope. [4]
- Explain a deferred-consent pathway to a family whose child was enrolled in an emergency trial, and offer the option to withdraw data. [5]
References5ShowHide
- [1]Shah S, Whittle A, Wilfond B, Gensler G, Wendler D How do institutional review boards apply the federal risk and benefit standards for pediatric research? JAMA, 2004.PMID 14747505
- [2]Wendler DS Assent in paediatric research: theoretical and practical considerations J Med Ethics, 2006.PMID 16574878
- [3]Kopelman LM Using the minimal risk threshold for all no-benefit pediatric studies Am J Bioeth, 2014.PMID 25127267
- [4]Unguru Y Ethical Challenges in Early-Phase Pediatric Research for Life-Limiting Illness Semin Pediatr Neurol, 2015.PMID 26358428
- [5]Moler FW, Silverstein FS, Holubkov R, et al Rationale, timeline, study design, and protocol overview of the therapeutic hypothermia after pediatric cardiac arrest trials Pediatr Crit Care Med, 2013.PMID 23842585