A cultural-historical exploration of relational ethics in research involving children
Review Article
Gloria Quinones, Niina Rutanen, Yaiza Lucas Revilla
Learning, Culture and Social Interaction, October 2023; 42
Abstract
Participatory studies involving children are a growing topic of debate concerning research on early childhood education and care (ECEC). Developments in ethnographic methods and the use of video recordings to collect data have raised new challenges for researchers who study children regarding such issues as formal procedures for informed consent and obtaining children’s assent to research encounters. A growing number of studies have explored children’s and researchers’ relationships, as well as the ethical aspects of research encounters. We contribute to this discussion by adopting a cultural-historical (wholeness) approach to research that involves children, partnering as researchers with a child participant. By using a cultural-historical approach, we analyzed a critical incident that involved a child’s assent and dissent process through dynamic motive orientations. We focused on the importance of considering dynamic motive orientation as researchers navigate new ethical challenges. Our findings reveal that adopting a wholeness approach requires researchers to serve as activity partners, reflecting on and recalibrating their own motives and centering child participants in the research process.

Perspectives on informed assent and bodily integrity in prospective deep brain stimulation for youth with refractory obsessive-compulsive disorder
Research Article
Jared N Smith, Natalie Dorfman, Meghan Hurley, Ilona Cenolli, Kristin Kostick-Quenet, Gabriel Lazaro-Munoz, Eric A Storch, Jennifer Blumenthal-Barby
Clinical Ethics, 16 September 2023
Abstract
Background
Deep brain stimulation is approved for treating refractory obsessive-compulsive disorder in adults under the US Food and Drug Administration Humanitarian Device Exemption, and studies have shown its efficacy in reducing symptom severity and improving quality of life. While similar deep brain stimulation treatment is available for pediatric patients with dystonia, it is not yet available for pediatric patients with obsessive-compulsive disorder, although soon could be. The prospect of growing indications for pediatric deep brain stimulation raises several ethical concerns relating to bodily integrity, the ability to offer informed assent, and the role pediatric patients play in the decision-making process.
Objective
The aim of this study is to solicit and assess the views of stakeholders (children, parents, clinicians) on pediatric assent, autonomy, and bodily integrity in the context of potential pediatric deep brain stimulation for obsessive-compulsive disorder.
Methods
Semi-structured interviews were conducted with pediatric obsessive-compulsive disorder patients (n = 21), caregivers of pediatric obsessive-compulsive disorder patients aged 14–18 (n = 19), and clinicians with experience treating refractory obsessive-compulsive disorder (n = 25). Interviews were transcribed and coded in MAXQDA 2018 and 2020 software and processed for thematic content analysis to isolate and compare specific themes.
Results
A majority of respondents (74%, 48/65) across all three stakeholder groups voiced that the decision-making process should be collaborative and involve everyone (clinicians: 84% or 21/25, caregivers 71% or 15/21, and patients 63% or 12/19). We identified a split between respondents’ views on who should have the final say in the event of disagreement (38% or 25/65 favored the patient versus 35% or 23/65 favoring caregivers). A split between respondents also emerged concerning the maturity relevant for deep brain stimulation decision-making, with 45% (29/65) favoring developmental maturity (age/physiological development) and 45% (29/65) favoring decisional maturity (capacity to understand and weigh information). A majority of clinicians indicated that they would not move forward with deep brain stimulation without securing patient assent (80% or 20/25), with some stating the only exception is if patient quality of life was very poor and/or they lacked insight. Both caregivers and patients expressed a significant respect for the patient’s right to bodily integrity, with 67% of caregivers (14/21) and 68% of patients (13/19) justifying patient involvement in decision-making specifically with reference to infringements of bodily integrity.
Conclusion
Our findings demonstrate that despite broad agreement across stakeholders that the decision-making process for pediatric deep brain stimulation for obsessive-compulsive disorder should be collaborative and somehow involve pediatric patients, there is disagreement about what this process entails and what factors determine patient involvement in the process. However, there is agreement that children have a right to bodily and brain integrity, which should only be infringed upon in rare circumstances.

Parental experiences of the informed consent process in randomized clinical trials—A Nordic study
Research Article
Nina Mogensen, Ulrika Kreicbergs, Birgitte Klug Albertsen, Päivi Lähteenmäki, Mats Heyman, Arja Harila
Pediatric Blood & Cancer, 7 September 2023
Open Access
Abstract
Background
Randomized clinical trials (RCTs) are an essential part of improving acute lymphoblastic leukemia (ALL) treatment. This population-based questionnaire study investigated parents’ experiences of the informed consent process in the RCTs within the Nordic NOPHO (Nordic Society of Paediatric Haematology and Oncology) ALL2008 trial.
Procedure
Parents in Sweden, Denmark, and Finland whose child was alive and in first remission after end of therapy and who were asked to participate in any RCT in the ALL2008 protocol, were asked to complete 15 questions/items regarding their experience of the RCT consent process.
Results
A total of 483 parents of 279 children met the inclusion criteria and answered the study questionnaire. Most (91%) agreed/strongly agreed to having received sufficient information to make a well-informed decision, felt confidence in the study design (86%), and thought that the process was satisfactory (86%). Those who did not consent reported a generally more negative experience of the process. More than a third of all parents and over half of parents who had refused participation felt that it was burdensome to decide. Most parents (66%) in general, and one-third of those with children 8 years or older, reported that their child was not involved in the process.

Parental perspectives about information and deferred versus two-stage consent in studies of neonatal asphyxia
Original Research
Christian A. Maiwald, Charlotte Rovers, Annie Janvier, Heidrun Sturm, Martina Michaelis, Georg Marckmann, Hans-Joerg Ehni, Christian F Poets, Mario Rüdiger, Axel R Franz
ADC Fetal & Neonatal, 30 August 2023
Abstract
Objective
The ALBINO Trial (NCT03162653) investigates effects of very early postnatal allopurinol on neurocognitive outcome following perinatal asphyxia where prenatal informed consent (IC) is impossible. Ethically and legally, waiver of consent and/or deferred consent (DC) is acceptable in such an emergency. Short oral/two-step consent (SOC, brief information and oral consent followed by IC) has recently been investigated.
Methods
Mixed-methods analysis of parental opinions on DC versus SOC in the context of neonatal asphyxia in a survey at two German centres. Prospective parents (ProP), parents of healthy newborns (PNeo) and parents of asphyxiated infants (PAx) born between 2006 and 2016 were invited.
Results
108 of 422 parents participated (ProP:43; PNeo:35; PAx:30). Most parents trusted physicians, wanted preinterventional information and agreed that in emergencies interventions should begin immediately. Intergroup and intragroup variability existed for questions about DC and SOC. In the ALBINO Trial situation, 55% preferred SOC, and 26% reported DC without information might adversely affect their trust. Only 3% reported to potentially take legal action after DC. PAx were significantly more likely to support DC. PAx more frequently expressed positive emotions and appreciation for neonatal research. In open-ended questions, parents gave many constructive recommendations.
Conclusion
In this survey, parents expressed diverse opinions on consent, but the majority preferred SOC over DC. Parents who had experienced emergency admission of their asphyxiated neonates were more trusting. Obtaining parental perspectives is essential when designing studies, while being cognisant that these groups of parents may not represent the opinion of all parents.