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.

Independent adolescent consent to mental health care: An ethical perspective
Cassandra B. Rowan
Ethics & Behavior, 19 July 2023
Abstract
Despite a growing need for mental health services for adolescents, treatment access among adolescents remains poor. Psychologists practicing in the United States are subject to highly variable legal standards for consent and confidentiality of minor clients, which can further suppress treatment accessibility. States permit independent consent for minors according to a wide range of criteria, but whether these criteria are empirically derived remains unknown. Inconsistencies between the law and ethical obligations for psychologists can expose minor clients to harm and force psychologists to make disclosures that violate patients’ rights and ethical standards. These harms may be particularly severe for clients from vulnerable populations such as sexuality and gender diverse youth (SGDY). To prevent ethical dilemmas, psychologists and professional organizations should work toward an empirical understanding of the adolescent capacity to consent to mental health care and use that understanding to promote uniform consent and confidentiality standards.

Philosophy of Childhood and Its Implications for the Age of Consent
Pratap Sharan
Journal of Indian Association for Child and Adolescent Mental Health, 17 July 2022
Open Access
Abstract
The philosophy of childhood which deals with issues related to conception about childhood, children’s rights, and moral status, etc., is important for clarifying attitudes towards the children in care provision and ethical and legal conundrums related to child and adolescent mental health. This is highlighted through the implications of philosophy of childhood on the age of consent, in particular, in reference to medical and sexual consent.

Ethical Aspects of Involving Adolescents in HIV research: A Systematic Review of the Empiric Literature
Katherine R. MacDonald, Leslie A. Enane, Megan S. McHenry, Neilkant L. Davis, Elizabeth C. Whipple, Mary A. Ott
The Journal of Pediatrics, 1 July 2023
Abstract
Introduction
To evaluate the ethics of involving adolescents in HIV research, we conducted a systematic review of the empiric literature.
Methods
Electronic databases Ovid Medline, Embase, and CINAHL were systematically searched using controlled vocabulary terms related to ethics, HIV, specified age groups, and empiric research studies. We reviewed titles and abstracts, including studies that collected qualitative or quantitative data, evaluated ethical issues in HIV research, and included adolescents. Studies were appraised for quality, data were extracted, and studies were analyzed using narrative synthesis.
Results
We included 41 studies: 24 qualitative; 11 quantitative; 6 mixed methods; 22 from high-income countries (HIC), 18 from low-middle income countries (LMIC), and 1 from both HIC and LMIC. Adolescent, parent, and community perspectives assert benefits of involving minors in HIV research. Participants in LMIC expressed mixed views regarding parental consent requirements and confidentiality given adolescents’ both increasing autonomy and continued need for adult support. In studies in HIC, sexual or gender minority youth would not participate in research if parental consent were required or if there were confidentiality concerns. There was variation in comprehension of research concepts, but adolescents generally demonstrated good comprehension of informed consent. Informed consent processes can be improved to increase comprehension and study accessibility. Vulnerable participants face complex social barriers which should be considered in study design.
Conclusion
Data support inclusion of adolescents in HIV research. Empiric research can inform consent processes and procedural safeguards to ensure appropriate access.

Consent, assent and randomised evaluations
Discussion
Michael Sanders, Jack Summers, Vanessa Hirneis, Susannah Hume, Gabrielle McGannon
Policy Press, 9 June 2023
Abstract
Background
Randomised trials have been on the rise in social policy over the last decade and a half, particularly in areas working with young people and vulnerable adults. Informed consent is an important principle for ethics committees governing research conducted by universities.
Aims and objectives
We consider the arguments for and against opt-in consent by parents, and opt-out assent, when it comes to trials taking place, particularly in schools.
Methods
We review what is known about this from a methodological standpoint.
Findings
We find that extant evidence suggests that requiring opt-in consent, rather than assent, to participation, risks reducing the ethical standards of trials by minimising participation; and by potentially risking disclosure of sensitive information about a child’s life to their parents. Moreover, there are important equity considerations, with more vulnerable groups likely to be excluded from research findings under an opt-in framework.
Discussion and conclusion
We conclude that the ethical argument for assent rather than consent is compelling under some circumstances, and should be considered on a case-by-case basis. Precautions must always be taken to safeguard participants.

Editor’s note: Policy Press is a product of Bristol University.

Lowering the age of consent: Legal, ethical, and clinical implications of adolescent-directed therapy
Special Feature
Kathleen McNamara
Family Court Review, 8 June 2023
Abstract
This article discusses a recently enacted Colorado law that aims to reduce the youth suicide rate by lowering the age of consent for psychotherapy from age 15 to age 12. The author discusses the challenges therapists face when young adolescents seek therapy without parental consent in cases involving interparental conflict. Suggestions for managing adolescent-directed therapy are offered.

Consent in minors: the differential treatment of acceptance and refusal. Part 1 Autonomy and children’s rights
Tim Hawkins, Martin Curtice, Tom Adams
BJPsych Advances, 5 June 2023
Summary
This is the first of two articles reviewing consent in those under the age of 18 (also referred to as ‘minors’ in UK law). This can be a complex issue in clinical practice because the law endows competent/capacitated minors with the absolute right to accept treatment, but a limited right to refuse. This first article summarises recent cases of refusal of treatment in minors. It uses them to ask two central questions: how do we, as clinicians, think about autonomous self-determination in minors and to what extent does the rights agenda support minors’ autonomous self-determination? Autonomy as one of the principles of biomedical ethics is explored. How the minors’ rights agenda supports the development of autonomy is considered. The amount of weight given in the domestic courts to the rights of minors with reference to the Human Rights Act 1998 and the United Nations Convention on the Rights of the Child is described. These considerations demonstrate the way that the courts are giving the views of the minor greater weight in decision-making in keeping with age and maturity. This article introduces the second article, which comprehensively reviews decision-making in minors, explores competence and capacity in minors and examines the differential treatment of acceptance and refusal.

Editor’s note: BJPsych Advances distils current, peer-reviewed, clinical knowledge dealing with physical and biological aspects of treatment, psychological and sociological interventions, management issues and treatments specific to the different psychiatric subspecialties.

Consent in minors: the differential treatment of acceptance and refusal. Part 2 Minors’ decision-making and the reach of their capacity
Tim Hawkins, Martin Curtice
BJPsych Advances, 5 June 2023
Summary
This is the second of a pair of articles reviewing the topic of consent in minors. Both articles have a particular emphasis, drawing on theory and case law, on the differential treatment of acceptance and refusal in minors. This article considers the concept of capacity in young people (aged 16 and over) and competence in children (under the age of 16) by reviewing underpinning statute and case law with particular reference to England and Wales. This provides a platform for consideration of the reach of capacity in minors with regard to acceptance and refusal of treatment. In doing so the article explores the key, but still elusive, ingredient of maturity, which has significance to the process. Fictitious vignettes allow consideration of the application of the concepts of maturity and autonomy in clinical practice. The article also considers the potential for the UK’s Parliament to make changes to current statute regarding consent in minors.