Obtaining Consent for Research on Risky Behaviours Among Adolescents in Canada: A Scoping Review
Lillian MacNeill, A Luke MacNeill, Shelley Doucet, Alison Luke, Alex Goudreau
Journal Of Empirical Research On Human Research Ethics, 15 May 2024
Open Access
Abstract
This scoping review explores current practices for obtaining consent in research on risky behaviours among adolescents in Canada. The JBI methodology for scoping reviews was used. The database search was conducted in August 2021 and updated in November 2022. Papers published in 2010 or later were included. Extracted data included study characteristics, sample characteristics, and consent procedures. The review included 83 reports covering 57 studies. Nearly 60% of studies relied on adolescent self-consent for participation. Adolescent self-consent was more common than parental/guardian consent for studies using in-person research methods, older adolescent groups, and particularly vulnerable populations. Parental/guardian consent was more common for studies using younger age groups and general population samples. Adolescent self-consent was more common than parental/guardian consent for most risky behaviours covered by this review. These results provide insight into current consent practices in this area and offer guidance to researchers and institutional review boards in Canada.

Racial and Ethnic Disparity in Approach for Pediatric Intensive Care Unit Research Participation
Sarah L. Mayer, Michelle R. Brajcich, Lionola Juste, Jesse Y. Hsu, Nadir Yehya
Original Investigation Pediatrics
JAMA Network Open, 15 May 2024
Key Points
Question
Are sociodemographic factors associated with rates of approach and consent for pediatric intensive care unit (PICU) research?
Findings
This cohort study of 3154 children found disparities in approach and consent according to race and ethnicity, language, religion, and degree of social deprivation. Lower consent rates were partly mediated by lower approach rates, with reduced approach mediating approximately half of the lower rates of consent for Black children.
Meaning
In this study, multiple sociodemographic variables were associated with disparate consent rates for PICU research, and strategies to increase approaches could contribute to equitable enrollment in PICU studies.

Abstract
Importance
While disparities in consent rates for research have been reported in multiple adult and pediatric settings, limited data informing enrollment in pediatric intensive care unit (PICU) research are available. Acute care settings such as the PICU present unique challenges for study enrollment, given the highly stressful and emotional environment for caregivers and the time-sensitive nature of the studies.
Objective
To determine whether race and ethnicity, language, religion, and Social Deprivation Index (SDI) were associated with disparate approach and consent rates in PICU research.
Design, Setting, and Participants
This retrospective cohort study was performed at the Children’s Hospital of Philadelphia PICU between July 1, 2011, and December 31, 2021. Participants included patients eligible for studies requiring prospective consent. Data were analyzed from February 2 to July 26, 2022.
Exposure
Exposures included race and ethnicity (Black, Hispanic, White, and other), language (Arabic, English, Spanish, and other), religion (Christian, Jewish, Muslim, none, and other), and SDI (composite of multiple socioeconomic indicators).
Main Outcomes and Measures
Multivariable regressions separately tested associations between the 4 exposures (race and ethnicity, language, religion, and SDI) and 3 outcomes (rates of approach among eligible patients, consent among eligible patients, and consent among those approached). The degree to which reduced rates of approach mediated the association between lower consent in Black children was also assessed.
Results
Of 3154 children included in the study (median age, 6 [IQR, 1.9-12.5] years; 1691 [53.6%] male), rates of approach and consent were lower for Black and Hispanic families and those of other races, speakers of Arabic and other languages, Muslim families, and those with worse SDI. Among children approached for research, lower consent odds persisted for those of Black race (unadjusted odds ratio [OR], 0.73 [95% CI, 0.55-0.97]; adjusted OR, 0.68 [95% CI, 0.49-0.93]) relative to White race. Mediation analysis revealed that 51.0% (95% CI, 11.8%-90.2%) of the reduced odds of consent for Black individuals was mediated by lower probability of approach.
Conclusions and Relevance
In this cohort study of consent rates for PICU research, multiple sociodemographic factors were associated with lower rates of consent, partly attributable to disparate rates of approach. These findings suggest opportunities for reducing disparities in PICU research participation.

Ethical Frameworks of Informed Consent in the Age of Pediatric Precision Medicine
David Chen
Precision Medicine, 6 May 2024
Abstract
Precision medicine is an emergent medical paradigm that uses information technology to inform the use of targeted therapies and treatments. One of the first steps of precision medicine involves acquiring the patient’s informed consent to protect their rights to autonomous medical decision making. In pediatrics, there exists mixed recommendations and guidelines of consent related practices designed to safeguard pediatric patient interests while protecting their autonomy. Here, we provide a high-level, clinical primer of 1) ethical informed consent frameworks widely used in clinical practice and 2) promising modern adaptations to improve informed consent practices in pediatric precision medicine. Given the rapid scientific advances and adoption of precision medicine, we highlight the dual need to both consider the clinical implementation of consent in pediatric precision medicine workflows as well as build rapport with pediatric patients and their substitute decision-makers working alongside interdisciplinary health teams.

Editor’s note: The modern adaptions mentioned by the authors include having a two-step consent process, providing options for pediatric patients to exercise their right to re-consent for continued use of genomic data at the age of majority, and using broad consent strategies.

The Role of Parental Consent in Counseling for Minors: Requirement or Necessity?
Novianti Novianti, Nandang Budiman, Nadia Aulia Nadhirah
Indonesian Journal of Guidance and Counseling Research, 27 April 2024
Abstract
The purpose of this study is to determine the Role of Parental Consent in Counseling Minors. This research uses the systematic literature review (SLR) method. Based on the results of the synthesis, the urgency of parental consent before the implementation of counseling for minors is as a condition, not a necessity, which means that it must only be fulfilled administratively so that counseling can be carried out but does not have a significant impact on the implementation of counseling. The conclusion of the study reveals that counselors must continue to prioritize the rights and trust of children in conducting counseling, the limits of decisions that can be taken by minors without intervention from parents need to be studied more deeply in further research. The contribution of this research can be used as one of the ethical references for school counselors both theoretically and practically, especially when dealing with minors.

Closing the gaps: consent and preoperative assessment for children and young people
Editorial
Hugo Wellesley, Simon P. Courtman
British Journal of Anaesthesia, 15 April 2024
Summary
The changing ethical and legal landscape in the UK means that anaesthetists should routinely be discussing the risk of death during the consent process. To do this effectively means expanding anaesthetic preassessment services for children and young people, something that has been recognised as a priority, but which still needs investment and an appreciation of its value at the trust level.

Consent and assent in paediatric practice: it’s the conversation that matters
Viewpoint
Hugh T Davies, Jenny Preston
Archives of Disease in Childhood, 4 April 2024
Excerpt
In paediatric medical research, across jurisdictions, parental consent and the assent of their child will usually come from a shared conversation between the researcher and family. This is how a study is introduced, information delivered, uncertainties addressed and understanding confirmed. Evidence indicates the crucial importance of the dialogue1 yet it currently goes unguided, undocumented, and often unchecked as review and research design continue to focus on the Participant Information Sheets (PIS).2 We propose that it’s time to move our focus on to this conversation to help families make their decision and in this viewpoint we suggest how this can be realised working within the constraints that researchers face. We address consent to research, but would contend that this idea has equal applicability in clinical practice…

From vulnerable subjects to research partners: a critical policy analysis of biomedical research ethics guidelines and regulations
Research Article
Maria Cristina Murano
Research Ethics, 29 March 2024
Open Access
Abstract
Over the last three quarters of a century, international guidelines and regulations have undergone significant changes in how children are problematised as participants in biomedical research. While early guidelines enacted children as vulnerable subjects with diminished autonomy and in need of special protection, beginning in the early 2000s, international regulatory frameworks defined the paediatric population as vulnerable due to unaddressed public health needs. More recently, ethical recommendations have promoted the active engagement of minors as research partners. In this paper, I adopt a post-structuralist approach to policy analysis to examine deep-seated assumptions and presuppositions underlying the changes in the problematisation of children as biomedical research participants over time. While biomedical research ethics focuses on the autonomy and vulnerability of minors, ethical guidelines are situated in specific sociocultural contexts, shaped, among other things, by contingent public health needs and changing conceptions of the value of research and science for society. In the process, I demonstrate the challenge of moving away from an approach that in taking adults as the model overshadows the complexity of children’s lived experiences as well as their personal, cultural, and social lives. The lack of acknowledgement of this complexity makes children vulnerable to epistemic injustice, which is particularly crucial to address in public involvement initiatives.

Navigating Theoretical, Methodological, and Ethical Interdependences in Researching Children
Book Chapter
Chikezie E. Uzuegbunam
Children and Young People’s Digital Lifeworlds, 27 March 2024; pp 55–75
Abstract
This chapter discusses the theoretical, methodological, and ethical approaches to conducting research with children in specific, local contexts. It is a journey from negotiating theories and methodological decision-making to data collection, while highlighting the various processes and challenges involved in negotiating access to the actual participants used in both the focus groups and the surveys conducted. There is a conscious and deliberate decision to foreground the entire research on a child-centred approach, from theory, methodology, and ethics to analyses, making all of these components interdependent. Due to contextual differences and the nascent nature of digital media and youth research in Nigeria, conducting research with children and young people in such contexts can present unique ethical and methodological challenges. Such dilemmas dealt with include adult–child power relationships, gendered and group dynamics, problems of language and cognition, techno-shame, shy and assertive participants, the challenges of conducting fieldwork in school settings, and absentee participants.

Reconciling Children’s Best Interests and Right to be Heard
Hege Stein Helland
The International Journal of Children’s Rights, 6 March 2024
Abstract
This article explores the tension between the child’s best interests principle and children’s participation and examines the inherent challenges and different approaches to reconcile the dilemma in law and practice: how can children’s best interests be reconciled with their right to be heard? By exploring different systems’ institutional approaches and empirical ability to implement and honour children’s right to participation in national contexts, this article reviews the literature and suggests a framework for understanding participation through a lens of a global typology of child protection systems. Drawing on the conceptual and empirical reviews and elements from the deliberative ideal for decision-making, the article concludes by drawing up a sketch for a best interest model for meaningful, respectful and successful participation with global applicability. The model aims to enhance children’s citizenship and legitimacy of decision-making in child protection.

[Key considerations in the process of assent in children and adolescents: an integrative review]
Vega Vega P, Miranda Castillo C, Vargas Celis I
Revista Chilena de Pediatria, 1 February 2024; 95(1) pp 91-106
Abstract
The participation of children and adolescents in research requires bioethical measures to safeguard their autonomy and well-being through the application of the informed consent process.
Objective
To critically analyze the factors involved in the process of assent/consent in children and adolescents in research.
Methodology
Integrative review of scientific evidence carried out between April and June 2023, from manuscripts published between 2014 and 2023 in Web of Science, PubMed, CUIDEN, and CINAHL databases, using the descriptors Process Assessment OR Assent AND Informed Consent AND Bioethics AND Minors OR Child OR Children AND adolescent OR teenage AND Pediatrics AND Research. Twenty primary articles were found, and the results were subjected to content analysis.
Result
Three categories were identified: shared consent/assent; child-specific factors for giving assent (age of the child to give assent and autonomy of the child to give assent), and key aspects of the assent process (assent form format; assent form content, and context for applying the assent process).
Conclusions
The assent process is a key tool for legal and ethical compliance with the rights of children and adolescents in clinical trial participation. In addition to favoring participation in informed decision-making together with the parents, it is also an instance where the participant’s competencies, capacity for understanding, and autonomy are valued.

Editor’s note: This is a Spanish language publication.