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

Station objectives

1. Use the correct terminology — parental permission, child assent, and consent — and seek assent at the right developmental level. [2]
2. Categorise a study by its risk-benefit tier and explain what the ethics committee must find to approve it. [1] [3]
3. Screen for therapeutic misconception before enrolment and correct it without extinguishing reasonable hope. [4]
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]

Candidate brief

You are the paediatric registrar in a mixed acute and research-active service. You have 12 minutes for Station A and 12 minutes for Station B. Examiners score correct terminology, structured reasoning, and the candidate's respect for the child's voice over encyclopaedic recall. [2] [1]

Station A — Non-beneficial physiology study with a reluctant child

Setup: Parent and 8-year-old. A non-beneficial physiology study requiring two extra venepunctures has ethics approval and offers no direct benefit. The parent has given permission; the child has said "I don't want to". [3]

Expected actions:

• Confirm the terminology with the parent: they have given permission, and the child is being asked for assent, not "consent". [2]
• Categorise the study as greater than minimal risk with no prospect of direct benefit (a minor increase over minimal risk for vital knowledge), and explain that approval rests on the knowledge being vital. [1] [3]
• Explore the child's reluctance in a setting free of coercion; explain that their dissent to non-beneficial research is generally binding and will be respected and recorded. [2]
• Document the child's view in their own words, the parent's permission, and the outcome, and offer the family time and a follow-up if they wish to reconsider. [2] [3]

Station B — Deferred consent after cardiac arrest

Setup: Parent of a school-age child who was enrolled, while in cardiac arrest, in an ethics-approved resuscitation trial under deferred consent. The child is now stable. [5]

Expected actions:

• Explain in plain language why the child was enrolled without prior permission: the treatment window was minutes long, the pathway was approved in advance by the ethics committee, and community consultation had occurred. [5]
• Offer the family the choice about ongoing participation and the option to withdraw the data already collected per protocol; do not imply the child is trapped in the study. [5]
• Describe how the child will be brought into assent for any further involvement now that they are stable, and how adverse events are reported. [5]
• Commit to returning the study results to the family in plain language, regardless of outcome. [5]

Marking anchors

Clear pass: correct permission/assent/consent terminology, accurate risk-benefit categorisation, explicit handling of the child's dissent, a clear and honest deferred-consent explanation with the withdrawal option, and respect for the child's voice throughout. [1] [5] Borderline: correct facts but the child's view is not actively elicited, or the deferred-consent safeguards (committee approval, community consultation) are only partially named. [2] [3] Fail: uses "consent" for a young child, overrides a dissent to non-beneficial research, presents deferred consent as "no consent needed", or fails to offer withdrawal of data. [2] [5]

Debrief pearls

• The words matter: parents give permission, children give assent, competent adolescents may give consent. [2]
• A child's dissent to non-beneficial research is generally binding — record it. [2] [3]
• Deferred consent is a specific, committee-approved, community-consulted exception for true emergencies — never a default. [5]
• Screen for therapeutic misconception by asking the family what they expect the study will do for the child. [4]