Children’s ages of consent to non-urgent heart surgery: The views of two paediatric cardiology teams
Original Article
Priscilla Alderson, Hannah Bellsham-Revell, Liz King, Trisha Vigneswaran, Jo Wray
Children & Society, 4 March 2023
Open Access
Abstract
Paediatric cardiology practitioners and related experts report unusually young ages when they begin to inform children about their non-urgent heart surgery and begin to respect children’s consent or refusal. Research methods included observations in two paediatric cardiology units, audio-recorded interviews with 45 experts, and qualitative data analysis. Significantly younger ages were cited than are usually recommended in the clinical and legal literature. Interviewed practitioners took seriously children’s consent to or refusal of a heart transplant from around 6 years, and a child’s firm refusal of induction of anaesthesia from around 4 years, when surgery might be postponed.

Adolescent Self-Consent for COVID-19 Vaccination: Views of Healthcare Workers and Their Adolescent Children on Vaccination Autonomy
Original Article
Jeanne R. Delgado, Lisa N. Mansfield, Katia Bruxvoort, Mayra Macias, Joseph Grotts, Bruno Lewin, David Bronstein, Corrine Munoz-Plaza, Peter Szilagyi, John Chang, Kristen Choi
Journal of Adolescent Health, 10 February 2023
Abstract
Purpose
This study explored the perceptions of healthcare worker parents (physicians, nurses, and staff) and their adolescents (aged 12–17 years) on adolescent self-consent to COVID-19 vaccination by applying the concept of positive deviance of those already vaccinated against COVID-19.
Methods
We used a qualitative descriptive design to conduct individual, semi-structured interviews with COVID-19–vaccinated healthcare workers in Southern California and their vaccinated adolescent children. Separate interviews were conducted with parents and adolescents from November to December 2021 using digital phone conferencing software. All interviews were recorded and transcribed. Thematic and constant comparative analysis techniques were used to identify relevant themes and subthemes.
Results
Twenty one healthcare workers (9 nurses, one nurse practitioner, one technologist, and 10 physicians) and their adolescents (N = 17) participated. Three overarching themes were identified to describe participants’ perspectives about adolescent self-consent for COVID-19 vaccination: (1) Family values and practices around adolescent vaccination; (2) Differences in parent and adolescent support for vaccine self-consent laws; and (3) Parent and adolescent uncertainty on readiness for vaccine self-consent laws. Adolescents largely supported self-consent while parents supported the policy if they would be able to have a discussion with their adolescent prior to the decision.
Discussion
Parents and adolescents supported adolescent self-consent for COVID-19 vaccination, with the reservation that adolescents should discuss the decision alongside their parents to exercise their medical autonomy with supportive guidance. Greater adolescent involvement in making decisions and providing self-consent for healthcare, including vaccines, could prepare adolescents to have a greater sense of autonomy over their health and contribute to population health measures.

Children and bioethics: clarifying consent and assent in medical and research settings
Invited Review
Merle Spriggs
British Medical Bulletin, 8 December 2022
Open Access
Abstract
Introduction
The concept of consent in the pediatric setting is complex and confusing. Clinicians and researchers want to know whose consent they should obtain, when a child can provide independent consent and how that is determined. The aim of this article is to establish what produces the justification to proceed with medical or research interventions involving children and the role of consent in that. I clarify concepts such as consent, assent, capacity and competence.
Source of data
Literature review.
Areas of agreement
Engaging with children and involving them in decisions about matters that affect them is a good thing. Areas of controversy: The role of competence or capacity and the question of when a child can provide sole consent.
Growing points
Flawed assumptions around competence/capacity.
Areas for developing research
An account of children’s well-being that accommodates children’s interests during the transition to adulthood.

Establishing a global regulatory floor for children’s decisions about participation in clinical research
Special Article
Steven Joffe, Albert J. Allen, Jonathan M. Davis, Elisa Koppelman, Susan Z. Kornetsky, Grace Marie V. Ku, Victoria A. Miller, Jennifer Preston, Lesha D. Shah, Barbara E. Bierer
Pediatric Research, 28 January 2023
Abstract
Background
Enrolling children in clinical trials typically requires parental or guardian permission and, when appropriate, child assent. Aligning requirements across jurisdictions would facilitate multisite pediatric trials. Guidance from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is the best candidate for a global standard but would benefit from additional specification.
Methods
Ethical analysis of ICH guidance for permission and assent for pediatric trials, with recommendations for clarification.
Results
ICH guidance regarding permission and assent would be enhanced by additional detail in the following areas: (1) what information should be provided to parents, guardians, and children considering a trial, and how that information should be provided; (2) the definition of “assent,” the criteria for when assent should be required, and the need to include children in discussions even when assent is not mandated; (3) criteria for requiring children’s signatures indicating agreement; (4) greater specificity regarding children’s right to decline or withdraw; and (5) clarification of when children’s wish to decline or withdraw from participation may be overridden and of what the overriding process should entail.
Conclusion
ICH guidance provides a global standard for decision-making regarding children’s participation in trials. Several clarifications would facilitate the conduct of multinational pediatric research.

Incentives in Pediatric Research in Developing Countries: When Are They Too Much?
Erwin Jiayuan Khoo, Devan M. Duenas, Benjamin S. Wilfond, Luke Gelinas, Armand H. Matheny Antommaria
Pediatrics, 20 January 2023
Abstract
When incentives are offered to parents and their children to partake in research, there are concerns that parents may be unduly influenced by the incentives, and the children may be exploited. We present a case from a low- and middle-income country and consider the ethical issues that arise when the children are asked to participate in a multinational, double-blind, randomized, placebo-controlled trial of the effects of a nutritional supplement on growth. The first commenter, from Malaysia, notes that their residents might not share Americans’ expectations regarding children’s role in the consent process from a cultural perspective, which may alter the analysis of the concerns. The authors of the second commentary emphasize the use of incentives that benefit the child participant rather than their parent or are provided directly to the child participant to address the concerns. The third commentator discusses the importance of minimizing the study’s risks and balancing the benefits and the risks, which attenuates the concerns.

Who decides? Consent for healthcare decisions of minors in the United States
Nichole M Stettner, Ella N Lavelle, Patrick Cafferty
Current Opinion in Pediatrics, 18 January 2023
Abstract
Purpose of review
The purpose of this review is to examine when parents and legal guardians have the authority to make medical decisions on behalf of the minors in their care, when the decisions of healthcare professionals may supersede those of parents and guardians, and under what conditions minors can make healthcare decisions for themselves.
Recent findings
The coronavirus disease 2019 (COVID-19) pandemic has reignited discussion of who should make healthcare decisions for minors. Though serious adverse reactions to COVID-19 vaccines are rare, hesitancy toward pediatric COVID-19 vaccination is prevalent among parents in the United States. This has contributed to large numbers of minors who are not up-to-date or not fully vaccinated against severe acute respiratory syndrome coronavirus 2 infection. Surveys reveal a majority of minors in the United States are willing to receive a COVID-19 vaccine. A number of scholars have recommended allowing adolescents the ability to consent to COVID-19 vaccination without parental approval.
Summary
Allowing adolescents with a minimum age of 15 to consent to vaccination without parental or guardian approval will more quickly enable adolescents to receive new vaccines as they become available, such as the COVID-19 bivalent vaccine.

Views of Adolescents and Young Adults with Cancer and Their Oncologists Toward Patients’ Participation in Genomic Research
Amanda M. Gutierrez, Jill O. Robinson, Robin Raesz-Martinez, Isabel Canfield, Mary A. Majumder, Sarah Scollon, Lauren R. Desrosiers, Rebecca L. Hsu, Wendy Allen-Rhoades, D. Williams Parsons, Sharon E. Plon, Amy L. McGuire, Janet Malek
Journal of Adolescent and Young Adult Oncology, 2 January 2023
Abstract
Purpose
With increased use of genomic testing in cancer research and clinical care, it is important to understand the perspectives and decision-making preferences of adolescents and young adults (AYAs) with cancer and their treating oncologists.
Methods
We conducted an interview substudy of the BASIC3 Study, which enrolled newly diagnosed cancer patients <18 years of age with assent. Of 32 young adults (YAs) with cancer who reached the age of majority (AOM; 18 years) while on study, 12 were successfully approached and all consented to study continuation at AOM. Of those, seven completed an interview. Patients’ oncologists, who enrolled and participated in return of clinical genomic results, were also interviewed (n = 12). Interviews were transcribed, deidentified, and analyzed using thematic analysis.
Results
YAs cited the possibility of helping others and advancing science as major reasons for their assent to initial study enrollment and their willingness to consent at AOM. YAs thought obtaining informed consent from research participants for study continuation at AOM was a good idea in case they changed their minds or wanted to make their own decisions, and to keep them aware of study activities. There was diversity in what YAs understood and learned from genomic testing: some recalled specific findings, while some remembered minimal information about their results. Oncologists varied in their assessment of adolescents’ engagement with the study and understanding of their results.
Conclusion
Given the different ways AYAs engage with genomic information, careful assessment of AYAs’ diverse communication and decision-making preferences is needed to tailor interactions accordingly.