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]

Paediatrics Fellowship Pro

You have read the opening of this case. The complete unit — every section and its primary-source references — is part of the Paediatrics Fellowship fellowship atlas.

References5Show ledger

[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

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]

Paediatrics Fellowship Pro

You have read the opening of this case. The complete unit — every section and its primary-source references — is part of the Paediatrics Fellowship fellowship atlas.

References5Show ledger

[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

Research ethics and assent OSCE — paediatric trial enrolment and emergency deferred consent

Station objectives

Research ethics and assent OSCE — paediatric trial enrolment and emergency deferred consent

Station objectives