SPOTLIGHT

For our spotlight section this month, we have highlighted several important articles that are drawn from our Young Persons and Capacity to Consent sections. . These articles are excellent examples of an emerging literature addressing  assent and decisional capacity in young persons, and implications for responsible research and public health. The final article highlights an important jurisdictional matter involving consent and the legal consequence of refusing HPV vaccination in Indonesia.  We are reaching out to our in-country colleagues in Indonesia to explore this further and will report our findings in a future edition.

Navigating Methodological Challenges and Informed Consent in Pediatric Research: A Scoping Literature Review
C Van Isterdael, Z Claessens, I Huys
Value in Health, December 2024
Abstract
Objectives
In the European health policy space, unmet medical needs are increasingly recognised as essential factors to steer pharmaceutical research and development towards a patient-centred healthcare system. However, the needs of challenging populations, such as paediatric patients, are often overlooked, resulting in substantial unmet needs. This study aims to provide an overview of challenges reported in literature on unmet health related needs in paediatric patients, as well as informed consent forms (ICFs) used in paediatric research.
Methods
This scoping literature review is a case study on paediatric blood cancer patients, following the PRISMA extension for scoping reviews. Two databases were included, PubMed and Embase. Descriptive data as well as qualitative data on methodological challenges and quantitative data on ICF was obtained from the included articles.
Results
In total, 52 articles were included for analysis. Methodological challenges in research on paediatric patients can be categorised by research stage. During recruitment, obtaining a representative sample can be challenging. Moreover, regarding data retrieval, discrepancies may arise between parent and child perspectives and researchers must be aware of parental dominance when interviewing children. Lastly, distinguishing development and disease-related changes can be challenging. ICFs were analysed in relation to the patients’ ages. In studies addressing minors, there was a tendency to involve adolescents rather than younger children. In most cases, parental informed consent (IC) was obtained, complemented with patients’ assent or IC. When studies focused on the needs of younger children, parents typically served as the respondents, either alone or with their child. In the latter case, an equal number of studies obtained IC from parents alone and complemented with the patients’ IC or assent.
Conclusions
This study provides an overview of methodological challenges and ICFs used in studies regarding research on identifying unmet health related needs in paediatric patients.

Decisional Capacity to Consent to Treatment in Children and Adolescents: A Systematic Review
Review Article
Giovanna Parmigiani, Marcello Benevento, Biagio Solarino, Anna Margari, Davide Ferorelli, Luigi Buongiorno, Roberto Catanesi, Felice Carabellese, Antonio Del Casale, Stefano Ferracuti, Gabriele Mandarelli
Psychiatry Research, 25 December 2024
Abstract
Obtaining informed consent in vulnerable populations like children and adolescents, is a relevant issue and raises ethical concerns. Minors are considered unable to consent to treatment, and permission from guardians is required for them. Nevertheless, several studies have been carried out on the competence of pediatric patients, with mixed results. Following PRISMA guidelines, a systematic review was performed to assess children and adolescents’ decisional capacity to consent to treatment. The search strategy identified 2,790 studies, including 10 that survived full-text screening and evaluation. Studies included in the analysis evaluated the decision-making capacity of minors using the MacArthur Competency Assessment Tool – Treatment (MacCAT-T), the Adolescent Psychiatric Patient Competency Questionnaire (CQ-ChP); the Measure of Competency (MOC), the Measure of Competency- Hypothetical (MOC-Hyp). Overall, minors over the age of 13 showed an acceptable decisional capacity. However, further research, preferably on larger groups, is needed to shed more light on this topic.

Improving consent practices in paediatric populations: what can be done?
Letter
Matthew Formstone, Laura Bengree, Robert Wheeler
Archives of Disease in Childhood, 11 January 2025
Excerpt
    The Mental Capacity Act 2005 (MCA) and Gillick judgement,1 taken together, establish clear legal principles to guide consent practices in paediatrics. However, a recent retrospective review of local consent practices highlighted significant shortcomings, primarily concerning clinical documentation.
   Our study reviewed consent practices in oncology and surgery in a UK children’s hospital, analysing clinical notes and consent forms from 63 children. Among under-16s, only three patient records explicitly documented competence, while most children apparently deferred consent to parents, although this conclusion remains speculative since no explanation was recorded. Even among presumedly capacitous 16-year-olds and 17-year-olds, documentation of decision-making processes was very poor. We have no reason to believe our…

Balancing Parental Rights and Public Health: The Challenge of Childhood Vaccination in a Changing Landscape
Commentary
Yang, Y. Tony, Sarah Schaffer
Journal of Public Health Management and Practice, January-February 2025; 31(1) pp 1-4
Abstract
The decline in childhood vaccination rates, exacerbated by the confluence of anti-vaccine sentiment and parental rights advocacy, presents a multifaceted challenge to public health.1 This issue impacts community health and safety, with U.S. measles cases in early 2024 already surpassing 2023 totals.2 Recent surveys show a marked decline in the perceived importance of childhood vaccinations, particularly among Republicans.3 National vaccination coverage for incoming kindergartners dropped from 95% in 2019-2020 to 93% in 2022-2023, with exemption rates increasing in 41 states.4 This trend, coupled with growing support for parental choice to skip vaccines among certain demographic groups,5 underscores the complexity of the current public health landscape. Reflecting this shift, a recent state legislative trend toward requiring explicit parental consent for childhood vaccinations represents a pivotal shift in the public health landscape (Table 1).6 These initiatives, which now often require written informed consent rather than the previously sufficient verbal or implied consent, aim to protect parental rights but can also create barriers that may delay or prevent the administration of vaccines to minors, particularly affecting vulnerable populations. For instance, children from low-income families or those in the foster care system may face significant challenges in obtaining written informed consent from their parents or guardians. This can lead to delays or missed opportunities for vaccination, potentially putting these children at a higher risk of contracting vaccine-preventable diseases and exacerbating existing health disparities.

The Ethical Paradox of Informed Consent in HPV Vaccination: Examining the Legal Boundaries and Ethical Considerations of Parental Consent, Public Health, and Individual Rights
Filia Clementy Daniast Susilo, Bagus Faridian, Alexander Alif Nu’man, Pradina Candraning Tyas, Muhammad Luthfi Firdaus
Asian Journal of Medicine and Health, 17 December 2024
Abstract
Background and Objective
Effective communication is crucial in medical procedures, and informed consent is a key example of this. However, informed consent may face unique circumstances, such as in life support situations or government health programs. The Human Papillomavirus (HPV) vaccination, as part of a government initiative, raises the question of whether informed consent is still required.  The study aims to explore whether informed consent is still necessary for the HPV vaccination and to analyze the legal implications if a citizen refuses to receive the vaccine. Patients have the right to refuse medical actions, making it essential to understand the legal consequences of rejecting the HPV vaccination.
Methods
This study adopts a normative juridical approach with an analytic descriptive specification. Secondary data was gathered from primary, secondary, and tertiary legal sources through literature reviews, document studies, and archival research. The collected data was then analyzed qualitatively and presented in a descriptive format.
Results
The study found that there are exceptions to the requirement for informed consent for vaccinations included in government programs. Specifically, informed consent is not necessary for individuals within the target age group of the government’s HPV vaccination program. In Indonesia, this program targets girls aged 9 to 14. Additionally, there are currently no legal penalties for individuals who refuse the HPV vaccination.
Conclusion
Informed consent is not required for individuals within the targeted age group of the government’s HPV vaccination program in Indonesia. Furthermore, there are no legal penalties for rejecting the vaccination.