Paeds Vivas · professional-practice-and-evidence
Research ethics and assent in paediatric research — branching viva
Branching structured oral on paediatric research ethics: permission versus assent versus consent, the risk-benefit categories of Subpart D, therapeutic misconception, deferred consent in emergency research, payment and biobank ethics across common and high-stakes scenarios.
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Target exams
RACP General PaediatricsRACP DCEMRCPCH ClinicalRCPSC Pediatrics
Prompt
You are the paediatric registrar asked to advise on research encounters across the service: a non-beneficial physiology study in school-age children, a phase I oncology trial, a resuscitation trial needing deferred consent, and an adolescent mental-health study with payment. The examiner will probe the terminology, the risk-benefit categories, therapeutic misconception, and the limits of permission and assent.
Stem
You are advising on research encounters across an acute and chronic paediatric service. The examiner will challenge the terminology, the risk-benefit categories, and the limits of permission and assent. [1] [2]
References7ShowHide
- [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]Wiener L, Viola A, Wilfond BS, et al. Contrasting views of risk perception and influence of financial compensation between adolescent research participants and their parents J Empir Res Hum Res Ethics, 2015.PMID 25742666
- [4]Kopelman LM Using the minimal risk threshold for all no-benefit pediatric studies Am J Bioeth, 2014.PMID 25127267
- [5]Unguru Y Ethical Challenges in Early-Phase Pediatric Research for Life-Limiting Illness Semin Pediatr Neurol, 2015.PMID 26358428
- [6]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
- [7]Marron JM, Cronin AM, DuBois SG, et al. Duality of purpose: Participant and parent understanding of the purpose of genomic tumor profiling research among children and young adults with solid tumors JCO Precis Oncol, 2019.PMID 31240271