Consent forms: the participation of children in research
Research
Flavia Andrade Nunes Fialho, Ieda Maria Ávila Vargas Dias, Marisa Palacios de Almeida Rego
Revista Bioética, April – June 2022; 30(2)
Abstract
The Resolution 466/2012 of the National Council of Health establishes the term of assent as compulsory for research carried out with children. However, the resolution presents the definition of assent without specifying the terms necessary for the document. This gap makes current and pertinent the approach of this topic by this study, which aims to discuss the participation of children in research. The results present a theoretical framework from which we can reflect on the ethics of Research with children, considering their vulnerability, which can lead to irreparable situations. We conclude that the theme must remain in the academic and professional debates since, on top of being a dynamic reality, this population segment has many specificities.

Editor’s note: This abstract refers to the National Council of Health in Brazil.

Parental informed consent comprehension in childhood cancer clinical trials: Associations with social determinants of health
Paula Aristizabal, Shilpa Nataraj, Bianca Perdomo, Elena Martinez, Jesse Nodora, Courtney D Thornburg
Journal of Clinical Oncology, 1 June 2022 [2022 ASCO Annual Meeting]
Abstract
Background
Adequate informed consent (IC) comprehension is an ethical right prior to participation in clinical trials. Research investigating IC comprehension and associations with social determinants of health (SDoH) is lacking. We assessed whether SDoH and related contextual factors were associated with parental IC comprehension in therapeutic childhood cancer clinical trials.
Methods
We prospectively enrolled parents of children with newly-diagnosed cancer. Univariable and multivariable regression were used to assess whether objective IC comprehension and related domains (Purpose/Procedures/Randomization, Risks/Benefits, Alternatives, and Voluntariness) were associated with SDoH (ethnicity, marital status, language, education attainment, employment, insurance, socio-economic status, health literacy [HL]) and contextual factors (cancer type, voluntariness, satisfaction with IC).
Results
Of 223 parents included, 112 (50%) were Hispanic and 38% of Hispanics were monolingual Spanish-speaking. In adjusted multivariable analyses, limited HL was significantly associated with lower overall IC comprehension (β = -7.22; 95% CI, -10.9 to -3.59; P < 0.001) and lower comprehension of Purpose/Procedures/Randomization (β = -7.53; 95% CI, -11.3 to -3.73; P < 0.001), Risks/Benefits (β = -8.14; 95% CI, -15.5 to -0.772; P = 0.031), and Alternatives (β = -17.0; 95% CI, -30.5 to -3.57; P = 0.013). Preferred Spanish language of written/verbal medical information was significantly associated with lower comprehension of Purpose/Procedures/Randomization (β = -8.50; 95% CI, -15.1 to -1.89; P = 0.012) and Voluntariness (β = -20.1; 95% CI, -34.9 to -5.33; P = 0.008). Lower satisfaction with informed consent (β = 0.988; 95% CI, 0.460 to 1.52; P < 0.001) and single marital status (β = -4.42; 95% CI, -7.81 to -1.02; P = 0.011) were significantly associated with lower IC comprehension.
Conclusions
Among parents of children with newly diagnosed cancer who provided consent for their child’s participation in a therapeutic clinical trial, limited HL was consistently associated with lower IC comprehension in all domains analyzed, except for Voluntariness. Spanish language preference for medical information was associated with lower comprehension of two domains; and lower satisfaction was associated with lower overall IC comprehension. These findings suggests that parents with limited HL, limited English-proficiency, and lower satisfaction may not fully comprehend the IC and thereby not truly make informed decisions. Our findings highlight the potential role of language-concordant interventions tailored to the participant’s HL level in order to ultimately improve IC comprehension and contribute to a reduction of disparities in clinical trial participation and promote equitable translation of discoveries and treatments to underserved groups.

Should Children Be Enrolled in Clinical Research in Conflict Zones?
Case and Commentary
Dónal O’Mathúna, Nawaraj Upadhaya
AMA Journal of Ethics, June 2022
Abstract
This commentary examines 4 ethical issues in a case of clinicians considering conducting research on children in conflict zones: (1) whether any time or resources should be taken away from treating acute injuries in order to conduct research; (2) obtaining consent for children to participate in research, which is particularly challenging given that children can be separated from parents or guardians; (3) whether the research is feasible at the moment, since starting research that stands little chance of being completed is ethically questionable; and (4) maintaining neutrality, impartiality, and humanity. Research that puts participants and researchers at risk of additional harm must be considered carefully. Here, we propose that both research and clinical care might occur simultaneously when researchers engage humbly with involved communities as the research is being designed, conducted, and reported in order to understand and resolve ethical issues involved.

Relational ethics, informed consent, and informed assent in participatory research with children with complex communication needs
Invited Review
Leni Van Goidsenhoven, Elisabeth De Schauwer
Developmental Medicine & Child Neurology, 28 April 2022
Open Access
Abstract
There is a need for qualitative participatory research involving children with intellectual disability and complex communication needs (CCNs), but procedural ethics cannot always adequately respond to the associated realities. To tackle this challenge, procedural ethics can be expanded with relational ethics to engage with consent and assent practices in participatory research projects. By drawing on several key incidents of participatory research with children with CCNs, we explore the complex moral spaces and times of ambivalent and iterative (dis)engagements within research processes. We reconceptualize the consent/assent terrain as a relationally constituted process, more aligned with the overall epistemological frameworks of participatory research and ensuring (disabled) children’s ongoing and meaningful involvement in research.

Cultural considerations for informed consent in paediatric research in low/middle-income countries: a scoping review
Original Article
Marcela Colom, Peter Rohloff
BMJ Paediatrics Open, 5 December 2018; 2
Open Access
Abstract
Introduction
Conducting research with children in low/middle-income countries (LMIC) requires consideration of socioeconomic inequalities and cultural and linguistic differences. Our objective was to survey the literature on informed consent in paediatric LMIC research, assessing for practical guidance for culturally and linguistically appropriate procedures.
Methods
We conducted a scoping review on informed consent in paediatric LMIC research searching the PubMed, Web of Science and PsycINFO databases. Eligible articles were published in English, from any date range, of any study design or format.
Results
The search identified 2027 references, of which 50 were included in the analysis following full-text review. Reviewed guidelines emphasised individual, informed and voluntary consent from parents and caregivers. Reviewed articles provided detailed practical guidance on adapting these guiding principles to LMIC settings, including considerations for community engagement, verbal or other alternative consent procedures for low-literacy settings or less commonly spoken languages and guarding against therapeutic misconception by caregivers. There was uncertainty, however, on how to best protect individual autonomy, especially when influenced by gender dynamics, leadership hierarchies or the social status of researchers themselves. There was, furthermore, limited research discussing the special case of research involving adolescents or of procedures for documenting assent by participating children.
Conclusions
A scoping review of paediatric research in LMICs revealed substantial guidance on several features of culturally appropriate informed consent. However, additional research and guidance is needed, especially in the areas of gender imbalances, research with adolescents and children’s own assent to participate in research.

Health-related confidentiality and consent among minors: Data on adult perspectives from Belgium and The Netherlands
David De Coninck, Koen Matthijs. Peter de Winter, Jaan Toelen
Data in Brief, June 2022; 42
Open access
Abstract
The data presented in this article provide one of the first large-scale insights on adult preferences for confidentiality and consent with regards to medical decision-making for minors. We collected data on these preferences through 12 hypothetical scenario’s that were presented, for which each participant had to indicate if they would (not) follow the minor’s preferences. Data regarding family communication, relationship quality, and sociodemographic characteristics were also collected. The data were collected through an online survey in September and October 2020, which yielded responses from 1000 Belgian and 1000 Dutch participants between 35 and 55 years of age. We selected this age range because it increased the chances that they had a child near the age of the fictional minor in the hypothetical cases. These data can be of interest for family researchers and/or health workers who want to explore adults’ perceptions regarding confidentiality and consent among minors.

Getting parental consent when treating children
Feature
Rupert Hoppenbrouwers
BDJ Team, 20 May 2022; 9 pp 20–21
Excerpt
When treating young children, it may be necessary to get the authority of someone with parental responsibility. With complex family relationships however, it might not be clear to dental professionals who has parental responsibility, and this can create a dilemma. Here we explain the principles and procedures around parental responsibility when treating younger children…

Editor’s note: BDJ Team is a product of the British Dental Association.

Living bioethics, theories and children’s consent to heart surgery
Research Article
Priscilla Alderson, Deborah Bowman, Joe Brierley, Nathalie Dedieu, Martin J Elliott, Jonathan Montgomery, Hugo Wellesley
Clinical Ethics, 7 April 2022
Abstract
Background
This analysis is about practical living bioethics and how law, ethics and sociology understand and respect children’s consent to, or refusal of, elective heart surgery. Analysis of underlying theories and influences will contrast legalistic bioethics with living bioethics. In-depth philosophical analysis compares social science traditions of positivism, interpretivism, critical theory and functionalism and applies them to bioethics and childhood, to examine how living bioethics may be encouraged or discouraged. Illustrative examples are drawn from research interviews and observations in two London paediatric cardiac units. This paper is one of a series on how the multidisciplinary cardiac team members all contribute to the complex mosaic of care when preparing and supporting families’ informed consent to surgery.
Results
The living bioethics of justice, care and respect for children and their consent depends on theories and practices, contexts and relationships. These can all be undermined by unseen influences: the history of adult-centric ethics; developmental psychology theories; legal and financial pressures that require consent to be defined as an adult contract; management systems and daily routines in healthcare that can intimidate families and staff; social inequalities. Mainstream theories in the clinical ethics literature markedly differ from the living bioethics in clinical practices.
Conclusion
We aim to contribute to raising standards of respectful paediatric bioethics and to showing the relevance of virtue and feminist ethics, childhood studies and children’s rights.

Reconsidering Informed Consent for Trans-Identified Children, Adolescents, and Young Adults
Stephen B Levine, E Abbruzzese, Julia M Mason
Journal of Sex and Marital Therapy, 17 March 2022
Abstract
In less than a decade, the western world has witnessed an unprecedented rise in the numbers of children and adolescents seeking gender transition. Despite the precedent of years of gender-affirmative care, the social, medical and surgical interventions are still based on very low-quality evidence. The many risks of these interventions, including medicalizing a temporary adolescent identity, have come into a clearer focus through an awareness of detransitioners. The risks of gender-affirmative care are ethically managed through a properly conducted informed consent process. Its elements deliberate sharing of the hoped for benefits, known risks and long-term outcomes, and alternative treatments must be delivered in a manner that promotes comprehension. The process is limited by: erroneous professional assumptions; poor quality of the initial evaluations; and inaccurate and incomplete information shared with patients and their parents. We discuss data on suicide and present the limitations of the Dutch studies that have been the basis for interventions. Beliefs about gender-affirmative care need to be separated from the established facts. A proper informed consent processes can both prepare parents and patients for the difficult choices that they must make and can ease professionals’ ethical tensions. Even when properly accomplished, however, some clinical circumstances exist that remain quite uncertain.

Children’s informed signified and voluntary consent to heart surgery: Professionals’ practical perspectives
Empirical Paper
Priscilla Alderson, Hannah Bellsham-Revell, Joe Brierley, Nathalie Dedieu, Joanna Heath, Mae Johnson, Samantha Johnson, Alexia Katsatis, Romana Kazmi, Liz King, Rosa Mendizabal, Katy Sutcliffe, Judith Trowell
Nursing Ethics, 25 February 2022
Open Access
Abstract
Background
The law and literature about children’s consent generally assume that patients aged under-18 cannot consent until around 12 years, and cannot refuse recommended surgery. Children deemed pre-competent do not have automatic rights to information or to protection from unwanted interventions. However, the observed practitioners tend to inform young children, respect their consent or refusal, and help them to “want” to have the surgery. Refusal of heart transplantation by 6-year-olds is accepted.
Research question
What are possible reasons to explain the differences between theories and practices about the ages when children begin to be informed about elective heart surgery, and when their consent or refusal begins to be respected?
Research design, participants and context
Research methods included reviews of related healthcare, law and ethics literature; observations and conversations with staff and families in two London hospitals; audio-recorded semi-structured interviews with a purposive sample of 45 healthcare professionals and related experts; interviews and a survey with parents and children aged 6- to 15-years having elective surgery (not reported in this paper); meetings with an interdisciplinary advisory group; thematic analysis of qualitative data and co-authorship of papers with participants.
Ethical considerations
Approval was granted by four research ethics committees/authorities. All interviewees gave their informed written consent.
Findings
Interviewees explained their views and experiences about children’s ages of competence to understand and consent or refuse, analysed by their differing emphases on informed, signified or voluntary consent.
Discussion
Differing views about children’s competence to understand and consent are associated with emphases on consent as an intellectual, practical and/or emotional process.
Conclusion
“Greater respect for children’s practical signified, emotional voluntary and intellectual informed consent can increase respectful understanding of children’s consent. Nurses play a vital part in children’s practitioner-patient relationships and physical care and therefore in all three elements of consent.”