Paeds Vivas · adolescent-and-young-adult-medicine
Adolescent consent for research and sensitive services — branching viva
Branching viva on informed consent for research and sensitive services, assent and parental permission, waiver of parental permission, bedside capacity assessment, conditional confidentiality and lawful override.
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Target exams
Stem
The examiner will test whether you can run a consent encounter for both research and sensitive services under pressure, holding the lawful limits of confidentiality. [1] [11]
Branch 1 — Research-consent principles
Examiner: What must be in place to enrol an adolescent ethically in a research study? [2]
Strong answer: Three elements — the young person's assent, parental permission, and research-ethics-committee approval. The committee judges risk, benefit, privacy and whether a waiver is justified. A young person's dissent usually prevails even when parents permit. [2] [3]
Examiner: Distinguish consent, permission and assent. [1]
Strong answer: Consent is the decision of someone with capacity; parental permission authorises care or research for a child who lacks capacity; assent is the child's age-appropriate agreement, sought even when a parent gives permission. [1] [7]
Branch 2 — Waiver of parental permission
Examiner: A researcher wants to run an anonymous survey of adolescent substance use and asks you whether parental permission can be waived. How do you decide? [6]
Strong answer: A research ethics committee — not the clinician — grants the waiver, when the study is minimal risk, the waiver will not adversely affect rights or welfare, it is impracticable without it, and the data are sensitive such that parental notification would distort results or endanger participants. This anonymous substance-use survey fits. You still seek the young person's assent, protect the data, and offer help if risk surfaces. [6] [2]
Examiner: What about an interventional, greater-than-minimal-risk trial? [3]
Strong answer: Parental permission plus assent is the default; capacity for the more complex decision is assessed specifically, and the committee scrutinises risk-benefit closely. [3] [2]
Branch 3 — Sensitive-services consent and capacity
Examiner: A 15-year-old requests contraception and asks that her mother not be told. How do you proceed? [14]
Strong answer: Create time alone, state conditional confidentiality, and assess capacity for this decision — understands, retains, weighs, communicates, with teach-back and a voluntariness check. She may consent under a statute-based minor-consent provision where one applies; plan confidential return of results before acting, and encourage family involvement where safe and she agrees. [14] [1]
Examiner: How is capacity different from age? [7]
Strong answer: Capacity is task-specific and capacity-based, not age-gated, using the Gillick or mature-minor principle. The same young person may consent to contraception yet lack capacity for a complex trial. Re-assess each decision. [1] [7]
Branch 4 — Override inside a research interview
Examiner: During a research interview she discloses an active suicide plan for tonight and begs secrecy. [11]
Strong answer: Override ethically. Secure immediate safety, do not leave her alone, remove means if safe, and escalate to emergency or crisis teams. Tell her what must be shared and why, share the minimum necessary, involve parent or carer and safeguarding as required, and document the reasoning. Follow the study's safety and reporting plan and notify the investigator and ethics committee as the protocol requires. [11] [10]
Examiner: How do you preserve the relationship after the breach? [10]
Strong answer: An ethical override — told in advance, proportionate and explained — can preserve trust. Stay engaged for follow-up so the breach does not become abandonment. [10] [1]
Examiner extras
- Capacity is task-specific; do not stamp "capable" once for all decisions. [7] [5]
- Research doubles the confidentiality stakes — the sensitive answer plus the act of being asked. [5] [8]
- Portal, billing and explanation-of-benefit leaks are modern failure modes; anticipate them. [12] [11]
- Never use family members as interpreters for sensitive or research content. [11] [9]
References
- [1]Katz AL Informed Consent in Decision-Making in Pediatric Practice. Pediatrics, 2016.PMID 27456510
- [2]Santelli JS Guidelines for adolescent health research: a position paper of the society for adolescent medicine. The Journal of adolescent health : official publication of the Society for Adolescent Medicine, 1995.PMID 8924431
- [3]Wendler DS Assent in paediatric research: theoretical and practical considerations. Journal of medical ethics, 2006.PMID 16574878
- [4]Grady C Assent in research: the voices of adolescents. The Journal of adolescent health : official publication of the Society for Adolescent Medicine, 2014.PMID 24630932
- [5]Grady C Adolescent Research Participants' Descriptions of Medical Research. AJOB empirical bioethics, 2016.PMID 27004235
- [6]Bauman LJ Whether to Waive Parental Permission in HIV Prevention Research Among Adolescents: Ethical and Legal Considerations. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics, 2020.PMID 32342775
- [7]Hein IM Informed consent instead of assent is appropriate in children from the age of twelve: Policy implications of new findings on children's competence to consent to clinical research. BMC medical ethics, 2015.PMID 26553304
- [8]Nakalega R Ethical considerations for involving adolescents in biomedical HIV prevention research. BMC medical ethics, 2021.PMID 34556099
- [9]Francis JKR Research Participation of Minor Adolescents in Foster Care. Journal of pediatric and adolescent gynecology, 2021.PMID 33333259
- [10]Ford CA Influence of physician confidentiality assurances on adolescents' willingness to disclose information and seek future health care. A randomized controlled trial. JAMA, 1997.PMID 9307357
- [11]Chung RJ Confidentiality in the Care of Adolescents: Policy Statement. Pediatrics, 2024.PMID 38646690
- [12]English A Adolescent Consent and Confidentiality: Complexities in Context of the 21st Century Cures Act. Pediatrics, 2022.PMID 35531643
- [13]Santelli JS Discussion of Potentially Sensitive Topics With Young People. Pediatrics, 2019.PMID 30651304
- [14]Dickens BM Adolescents and consent to treatment. International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics, 2005.PMID 15847892