Transparency and Accountability of Pediatric Trials: Should Consent Rate Reporting Be Mandatory?
Editorial
Ana Marušić, Ivan Buljan
The Journal of Pediatrics, 1 December 2020; 227 pp 9-10
Excerpt
The study of Lonhart et al in this volume of The Journal sends a warning about reporting consent rates in pediatric trials.1 They analyzed 696 articles from MEDLINE presenting pediatric randomized controlled trials and showed that 60% (n = 418) of them did not report rates of consent for trial participants, or the consent rate was unclear. Among 278 trials that did report the number of consenting subjects, the average consent rate was high (83%), but for 26% of these trials, the average consent rate was less than 70%, which may introduce a bias related to the representativeness of the target population. Overall, the consent rates were greater for trials of vaccination interventions (90%) in comparison with behavioral interventions (79%), and for industry-funded trials (86%) in comparison with government-funded trials (79%). This study raises important questions related to the ethics of pediatric trials and to the quality and validity of evidence from pediatric trials…

Consent Rates Reported in Published Pediatric Randomized Controlled Trials
Julia A. Lonhart, Ashley R. Edwards, Swati Agarwal, Brian P. Lucas, Alan R. Schroeder
The Journal of Pediatrics, 1 December 2020; 227 pp 281-287
Abstract
Objective
To determine the average reported consent rate for published pediatric randomized controlled trials (RCTs) and whether this rate varies by trial characteristics.
Study design
A review of pediatric RCTs published in Medline in 2009, 2010, or 2015 was performed. Secondary analyses of prior trials, trials including adults, trials not requiring consent, or trials with missing or unclear consent data were excluded. Consent rate was defined as the number of patients enrolled divided by number of eligible patients where families were approached. Random effects meta-regression was conducted to determine the weighted average consent rate.
Results
Of 2347 trials identified, 1651 were excluded. An additional 418 of 696 (60%) were excluded because the consent rate was missing or unclear. The average consent rate for 278 included RCTs was 82.6% (95% CI, 80.3%-84.8%) and was higher for vaccination compared with behavioral trials and for industry-funded compared with National Institutes of Health-funded or other government-funded trials. The average consent rate was <70% for 26% of included trials. Of these trials, US trials (28/77 [36.4%]) had a higher probability of a consent rate of <70% than non-US studies (35/64 [21.3%]) and multinational (9/37 [24.3%]) studies. There was slight variation by funding category.
Conclusions
Although the average consent rate for published trials was reasonably high, approximately one-quarter of trials had consent rates of <70%. Consent rates reporting has improved over time, but remains suboptimal. Our findings should assist with the planning of future pediatric RCTs, although consent data from unpublished trials are also needed.

[The informed consent in the mature minor: Understanding and decision-making capacity]
R Boceta, O Martínez-Casares, M Albert
Anales de Pediatria, 29 November 2020
Abstract
Introduction
The informed consent of the minor is a fundamental requirement of paediatric research. There is a lack of harmonisation as regards the age of the mature minor to consent, and there are no systematic tools available to assess competence in decision-making capacity. The objective of this work is to analyse the ethical and legal situation of consent by minors, as well as studies that use an objective assessment tool in the mature minor.
Material and methods
Systematic review of scientific articles in PubMed, Embase and the Grey Literature, published with keywords “informed consent minors”, without date restriction until March 2019. Abstracts and a selection of complete articles were reviewed following a protocol including identification, screening, eligibility, and inclusion.
Results
Of the 260 records identified, 139 were excluded. After categorising the resulting 121 publications, 13 were finally selected following the eligibility criteria, including 7 articles on international ethical and legal regulations and 6 on understanding and decision- making capacity assessment. The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) semi-structured interview was used in 4 studies, including different age ranges (6-21 years) in healthy and sick children.
Conclusions
The semi-structured MacArthur interview adapted to adolescents could be an appropriate tool with robust psychometric measures for assessing competence for the informed consent of minors between 9 and 12 years of age. The regulation of informed consent in paediatric research should consider this evidence.

Editor’s note: This is a Spanish Language Publication.

Moral structuring of children during the process of obtaining informed consent in clinical and research settings
Research Article
Anderson Díaz-Pérez, Elkin Navarro Quiroz, Dilia Esther Aparicio Marenco
BMC Medical Ethics, 25 November 2020; 21(122)
Open Access
Abstract
Background
Informed consent is an important factor in a child’s moral structure from which different types of doctor–patient relationships arise. Children’s autonomy is currently under discussion in terms of their decent treatment, beyond what doctors and researchers perceive. To describe the influential practices that exist among clinicians and researchers toward children with chronic diseases during the process of obtaining informed consent.
Methods
This was a cross-sectional, qualitative study via a subjective and interpretivist approach. The study was performed by conducting semi-structured interviews of 21 clinicians and researchers. Data analysis was performed using the SPSS version 21® and Atlas Ti version 7.0® programs.
Results
The deliberative and paternalistic models were influential practices in the physician–patient relationship. In the deliberative model, the child is expected to have a moral awareness of their care. The paternalistic model determined that submission was a way of structuring the child because he or she is considered to be a subject of extreme care.
Conclusions
The differentiated objectification [educational] process recognizes the internal and external elements of the child. Informed consent proved to be an appropriate means for strengthening moral and structuring the child.

Young women’s autonomy and information needs in the schools-based HPV vaccination programme: a qualitative study
Research Article
Harriet Fisher, Karen Evans, Jo Ferrie, Julie Yates, Marion Roderick & Suzanne Audrey
BMC Public Health, 10 November 2020; 20(1680)
Open Access
Abstract
Background
Until 2019, the English schools-based human papillomavirus (HPV) vaccination programme was offered to young women (but not young men) aged 12 to 13 years to reduce HPV-related morbidity and mortality. The aim of this study is to explore the extent to which young women were able to exercise autonomy within the HPV vaccination programme. We consider the perspectives of young women, parents and professionals and how this was influenced by the content and form of information provided.
Methods
Recruitment was facilitated through a healthcare organisation, schools and community organisations in a local authority in the south-west of England. Researcher observations of HPV vaccination sessions were carried out in three schools. Semi-structured interviews took place with 53 participants (young women, parents of adolescent children, school staff and immunisation nurses) during the 2017/18 and 2018/19 programme years. Interviews were recorded digitally and transcribed verbatim. Thematic analysis was undertaken, assisted by NVivo software.
Results
Young women’s active participation and independence within the HPV vaccination programme was constrained by the setting of vaccination and the primacy of parental consent procedures. The authoritarian school structure influenced the degree to which young women were able to actively participate in decisions about the HPV vaccination programme. Young women exercised some power, either to avoid or receive the vaccine, by intercepting parental consent forms and procedures. Reliance on leaflets to communicate information led to unmet information needs for young women and their families. Communication may be improved by healthcare professional advocacy, accessible formats of information, and delivery of educational sessions.
Conclusions
Strategies to improve communication about the HPV vaccine may increase young people’s autonomy in consent procedures, clarify young people’s rights and responsibilities in relation to their health care services, and result in higher uptake of the HPV vaccination programme.

Be legally wise: When is parental consent required for adolescents’ access to pre-exposure prophylaxis (PrEP)?
Ann Strode, Catherine M. Slack, Zaynab Essack, Jacintha D. Toohey, Linda-Gail Bekker
Southern African Journal of HIV Medicine, 10 November 2020
Open Access
Abstract
Background
South African adolescents (12–17 years) need an array of prevention tools to address their risk of acquiring the life-long, stigmatized condition that is HIV. Prevention tools include pre-exposure prophylaxis (PrEP). However, service providers may not be clear on the instances where self-consent is permissible or when parental consent should be secured.
Aim
To consider the legal norms for minor consent to PrEP using the rules of statutory interpretation.
Setting
Legal and policy framework.
Results
We find that PrEP should be interpreted as a form of ‘medical treatment’; understood broadly so that it falls within the ambit of one of consent norms in the Children’s Act. When PrEP is interpreted as ‘medical treatment’, then self-consent to PrEP is permissible for persons over 12 years, if they have the mental capacity and maturity to understand the benefits, risks, social and other implications of the proposed treatment. Currently, PrEP is only licensed for persons over 35 kg. Reaching the age of 12 years is a necessary but not sufficient criteria for self-consent and service-providers must ensure capacity requirements are met before implementing a self-consent approach. Decisional support and adherence support are critical.
Conclusions
We recommend that service-providers should take steps to ensure that those persons who meet an age requirement for self-consent, also meet the capacity requirement, and that best practices in this regard be shared. We also recommend that policy makers should ensure that PrEP guidelines are updated to reflect the adolescent consent approach articulated above. It is envisaged that these efforts will enable at-risk adolescents to access much needed interventions to reduce their HIV risk.

Consent and refusal of treatment by older children in emergency settings
Perspective
Dominique Moritz, Phillip Ebbs
Emergency Medicine Australasia, 9 November 2020
Abstract
The law recognises that children can exert an increasing level of autonomy and decision‐making about their healthcare as they mature, and that intelligence and maturity levels will vary from one child to the next. Therefore, the parameters for when older children can consent to healthcare can be a complex area for clinicians to navigate. Refusal of treatment provides additional challenges for clinicians because the law is less clear about when older children can be involved in refusing treatment which is in their best interests. This article outlines relevant legislation concerning child consent to treatment across Australian jurisdictions and examines refusal of treatment by children using the 2018 case of Mercy Hospitals Victoria v D1 & Anor.

Caregiver Perspectives on Informed Consent for a Pediatric Learning Healthcare System Model of Care
Research Article
E. Pritchard, T. A. Zabel, L. A. Jacobson, E. Jones, C. Holingue, L. G. Kalb
AJOB Empirical Bioethics, 26 October 2020
Abstract
Background
Data is needed to provide insight into the issue of preference around consent for use of pediatric clinical data for research. This study evaluated caregivers’ preferences concerning use of their child’s clinical information.
Methods
Caregivers of children (n = 101; response rate 81.5% of n = 124) presenting for psychological evaluation at an urban medical center viewed a video regarding how the information contained in their child’s medical record could be used for research.
Results
An anonymous survey following the video indicated that: 1) >90% of caregivers felt comfortable with their child’s information being used; 2) >90% of caregivers felt their child’s privacy would be adequately protected; 3) 98% of caregivers reported themselves to be as or more likely to return to the institution after viewing the video; 4) 60% of caregivers felt no additional consent procedures beyond viewing the video were needed, while 20% preferred an opt-out and 20% preferred a traditional consent procedure. Caregiver demographic variables were largely unrelated to consent preferences.
Discussion
Overall, caregivers reported strong support for use of their child’s clinical data for research purposes.

Issues of consent and assent in pediatric neurosurgery
Review Article
Rajeev D. Sen, Amy Lee, Samuel R. Browd, Richard G. Ellenbogen, Jason S. Hauptman
Child’s Nervous System, 17 October 2020
Abstract
Background
Consent and assent are important concepts to understand in the care of pediatric neurosurgery patients. Recently it has been recommended that although pediatric patients generally do not have the legal capacity to make medical decisions, they be encouraged to be involved in their own care. Given the paucity of information on this topic in the neurosurgery community, the objective is to provide pediatric neurosurgeons with recommendations on how to involve their patients in medical decision-making.
Methods
We review the essential elements and current guidelines of consent and assent for pediatric patients using illustrative neurosurgical case vignettes.
Results
The pediatric population ranges widely in cognitive and psychological development making the process of consent and assent quite complex. The role of the child or adolescent in medical decision-making, issues associated with obtaining assent or dissent, and informed refusal of treatment are considered.
Conclusion
The process of obtaining consent and assent represents a critical yet often overlooked aspect to care of pediatric neurosurgical patients. The pediatric neurosurgeon must be able to distill immensely complex and high-risk procedures into simple, understandable terms. Furthermore, they must recognize when the child’s dissent or refusal to treatment is acceptable. In general, allowing children to be involved in their neurosurgical care is empowering and gives them both identity and agency, which is the vital first step to a successful neurosurgical intervention.

Who Are We Missing? The Impact of Requiring Parental or Guardian Consent on Research With Lesbian, Gay, Bisexual, Trans, Two-Spirit, Queer/Questioning Youth
Adolescent Health Brief
Eli Cwinn, Courtney Cadieux, Claire V. Crooks
Journal of Adolescent Health, 13 October 2020
Open Access
Abstract
Purpose
The purpose was to examine whether a requirement for parental or guardian consent systematically limits which lesbian, gay, bisexual, trans, two-spirit, queer/questioning (LGBT2Q+) youth participate in research.
Methods
A total of 60 LGBT2Q+ youth (aged 14–18 years) completed measures assessing gender and sexual minority identity, depression and anxiety, help-seeking intentions, and social support.
Results
A substantial proportion (37.6%) of youth reported that they would not have participated in the research if parental or guardian consent was required. Those who would not have participated had more negative attitudes about their sexual and gender identity, less family support, lower levels of help-seeking intentions, and higher levels of negative affect.
Conclusions
The results suggest that requiring parental or guardian consent may exclude the most at-risk youth. Policy and practice decisions regarding the health and mental health outcomes of LGBT2Q+ youth might be based on incomplete and unrepresentative data.