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Paeds SAQsadolescent-and-young-adult-medicine

Paeds SAQs · adolescent-and-young-adult-medicine

Adolescent consent for research and sensitive services — formative SAQs

Two formative short-answer questions on adolescent consent for research enrolment and for sensitive clinical services, including assent and parental permission, waiver of parental permission, capacity assessment and conditional confidentiality.

20 marks30 min
On this page & tools

Target exams

RACP General PaediatricsRACP DWEMRCPCH TheoryMRCPCH ClinicalABP General Pediatrics

Target exams

RACP General PaediatricsRACP DWEMRCPCH TheoryMRCPCH ClinicalABP General Pediatrics
Prompt
Adolescent consent for research and sensitive services

SAQ 1 — Ethical research enrolment and waiver of parental permission (10 marks)

A 14-year-old is invited to take part in an anonymous school-based survey of sexual behaviour and substance use. The researchers propose to obtain the young person's assent but to waive parental permission. [2] [6]

Questions

  1. State the three elements usually required for ethical adolescent research enrolment. (2 marks) [2]
  2. Outline the criteria under which a research ethics committee may waive parental permission, and explain why this study may meet them. (5 marks) [6] [2]
  3. Describe how you would present the study to the young person and confirm understanding, including the right to withdraw. (3 marks) [3] [4]

Model answer

Three elements (2). Ethical adolescent research enrolment usually requires the young person's assent, parental (or guardian) permission, and research-ethics-committee approval. Each protects a different interest — developing autonomy, the family's protective role, and the participant against a study that offers no guaranteed personal benefit. [2] [3]

Waiver criteria (5). A research ethics committee may waive parental permission when the study is minimal risk; the waiver will not adversely affect the young person's rights or welfare; the research could not practicably be carried out without it; and the data are sensitive such that parental notification would distort the results or endanger the participant. This anonymous survey of sexual behaviour and substance use is minimal risk and exactly the case where requiring parental permission would drive away the adolescents most at risk and distort the data, so a waiver is defensible — granted by the committee, not the clinician. [6] [2]

Presenting the study (3). Explain in plain, age-appropriate language the purpose, what participation involves, the risks and discomforts, the alternatives (including not taking part), that it is voluntary, and that the young person can withdraw at any time without penalty or any effect on care. Confirm understanding with teach-back, assure confidentiality of the data with its lawful limits, and document the assent. [3] [4]

SAQ 2 — Sensitive-services consent, capacity and conditional confidentiality (10 marks)

A 15-year-old attends requesting contraception and sexually transmitted infection testing, and asks that her mother not be told. During the private interview she discloses an active suicide plan for tonight and begs you to keep it secret. [14] [11]

Questions

  1. Outline how you assess her decision-making capacity for the contraception decision, and the basis on which she may consent to STI testing. (4 marks) [14] [1]
  2. Give your conditional confidentiality script, including the lawful limits. (2 marks) [11] [10]
  3. Describe your immediate actions after the suicide-plan disclosure, including how you break confidentiality ethically. (4 marks) [11] [1]

Model answer

Capacity and STI consent (4). Capacity is task-specific: assess whether she understands the contraception choice (what it is, efficacy, risks, alternatives, doing nothing), retains it, weighs it in her own situation, and communicates a stable, voluntary choice, using teach-back. Check voluntariness and coercion. For STI testing she may consent in her own right under a statute-based minor-consent provision where one applies; capacity still governs any service the statute does not cover. Document the reasoning. [14] [1]

Confidentiality script (2). "What we talk about privately stays private, unless I become worried you are not safe, that someone else is being hurt, or the law says I must act. If that happens, I will tell you what I need to do and we will plan it together as much as possible." Limits: serious harm to self or others, abuse or assault, and other legal mandates. [11] [10]

Immediate actions after disclosure (4). Secure immediate safety — do not leave her alone, remove means if safe, and escalate to emergency department or crisis teams per the local pathway. Break confidentiality ethically: tell her what you must share and why, share the minimum necessary with the people who need it, involve parent or carer and safeguarding services as required, and document who was informed and why. Treat under best interests while capacity is reassessed, and stay engaged so the breach does not become abandonment. [11] [1]

References

  1. [1]Katz AL Informed Consent in Decision-Making in Pediatric Practice. Pediatrics, 2016.PMID 27456510
  2. [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. [3]Wendler DS Assent in paediatric research: theoretical and practical considerations. Journal of medical ethics, 2006.PMID 16574878
  4. [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. [5]Grady C Adolescent Research Participants' Descriptions of Medical Research. AJOB empirical bioethics, 2016.PMID 27004235
  6. [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. [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. [8]Nakalega R Ethical considerations for involving adolescents in biomedical HIV prevention research. BMC medical ethics, 2021.PMID 34556099
  9. [9]Francis JKR Research Participation of Minor Adolescents in Foster Care. Journal of pediatric and adolescent gynecology, 2021.PMID 33333259
  10. [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. [11]Chung RJ Confidentiality in the Care of Adolescents: Policy Statement. Pediatrics, 2024.PMID 38646690
  12. [12]English A Adolescent Consent and Confidentiality: Complexities in Context of the 21st Century Cures Act. Pediatrics, 2022.PMID 35531643
  13. [13]Santelli JS Discussion of Potentially Sensitive Topics With Young People. Pediatrics, 2019.PMID 30651304
  14. [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