Research ethics and assent in paediatric research — branching viva

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]

Branch 1 — Terminology

Examiner: In paediatric research, distinguish permission, assent and consent, and state the age at which assent is typically sought. [2]

Strong answer: Permission is the informed authorisation the parent or guardian gives for the child to participate; it carries all the elements of informed consent but is given on the child's behalf. Assent is the child's own developmentally appropriate affirmative agreement, sought from about age 7 and adapted to the child. Consent is the legal authorisation a competent older adolescent may give for themselves as a mature minor. A young child does not "consent"; the parent gives permission and the child gives assent. [2]

Examiner: Define minimal risk. [4]

Strong answer: Minimal risk is the probability and magnitude of harm no greater than those ordinarily encountered in daily life or during routine physical or psychological examinations. It is the threshold that gates non-beneficial research in children. [4]

Branch 2 — Non-beneficial physiology study

Examiner: A school-age physiology study adds two venepunctures the child would not otherwise have, offers no direct benefit, and cannot be done in adults. Walk me through the ethics. [1]

Strong answer: This is greater than minimal risk with no prospect of direct benefit, so it falls into the Subpart D tier of a minor increase over minimal risk for vital knowledge. The ethics committee may approve it only if the experience is commensurate with the child's situation, the risk is a minor increase over minimal, and the knowledge is of vital importance to understanding the disorder and cannot be obtained otherwise. Full parental permission and age-appropriate child assent are required, and the child's dissent is generally binding. [1] [4]

Branch 3 — Early-phase oncology and therapeutic misconception

Examiner: A family describes a phase I cancer trial as "the treatment that will cure him". What is the problem and what do you do? [5]

Strong answer: This is therapeutic misconception: the family has mistaken an early dose-finding study, whose primary aim is to find a safe dose for future patients, for individualised curative treatment. The permission is not informed. Re-educate about the purpose, randomisation and realistic likelihood of benefit, preserve reasonable hope, and confirm understanding with teach-back before any enrolment. Document the conversation. [5] [7]

Branch 4 — Emergency resuscitation trial

Examiner: A neuroprotective agent must be given within minutes of return of spontaneous circulation. How is this trial conducted ethically? [6]

Strong answer: Under a deferred-consent pathway approved in advance by the ethics committee, with community consultation and public disclosure before and after the study. The child is enrolled at the moment of crisis; once the family is reachable they are notified and asked about ongoing participation, with the option to withdraw data per protocol. The therapeutic hypothermia after paediatric cardiac arrest trials used this design. Research must never delay emergency care, and deferred consent is a specific overseen exception, not the absence of consent. [6]

Branch 5 — Adolescent mental-health study with payment

Examiner: An adolescent mental-health study offers a payment many times the usual reimbursement to a financially vulnerable family. What is your concern and how is it resolved? [3]

Strong answer: The concern is undue inducement: a payment so large it overrides voluntary judgement. Reasonable reimbursement of time, travel and burden is acceptable and improves equity, but a proportionate, committee-reviewed payment structure is required. In a dependent setting such as an inpatient or justice context, the coercion risk is higher. Assess the young person's capacity for mature-minor consent where relevant, and ensure confidentiality appropriate to the study. [3]

Examiner extras

• Research versus quality improvement: the label does not decide the ethics; if it tests a hypothesis to produce generalisable knowledge on identifiable children, it is research. [1]
• Waiver of assent or permission only if minimal risk and the research cannot practicably be done otherwise. [4]
• Adolescents' own descriptions of research show they value being asked properly and resent token processes. [2]
• Return results to families and register the trial publicly, regardless of outcome. [6]