In their article, Luchtenberg and colleagues give voice to the opinions of young people on participation in clinical trials (Luchtenberg et al. 2015). Over time, it has become indisputable that chi...

Transgender and gender expansive (TGE) youth often seek a variety of gender-affirming healthcare services, including pubertal suppression and hormone therapy requiring that TGE youth and their parents participate in informed consent and decision making. While youth must demonstrate the ability to understand and appreciate treatment options, risks, benefits, and alternatives as well as make and express a treatment choice, standardized approaches to assess the capacity of TGE youth to consent or assent in clinical practice are not routinely used. This scoping (...) review identified the currently available data regarding adolescent capacity to consent to gender-affirming medical treatments. Articles relevant to assessing adolescent capacity for clinical decision-making were identified using OVID Medline, Web of Science, and PubMed. Articles were reviewed and thematically analyzed. Eight relevant articles were identified using three tools for measuring adolescent clinical decision-making capacity: Measure of Understanding, Measure of Competence, and MacArthur Competence Assessment Tool (MacCAT). These studies explored hypothetical treatment decisions, mental health treatment decisions, HIV treatment decisions, genetic testing decisions, and gender-affirming medical decisions. Only one study specifically examines the capacity of TGE youth to consent to medical treatments. Age was correlated with capacity in most, but not all studies. Other studies found cognitive measures (IQ, literacy, numeracy) may impact important aspects of capacity (understanding and reasoning). For clinicians caring for TGE youth, tools such as the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) may prove useful, in conjunction with consideration of youth developmental abilities and utilization of shared decision-making practices. A standardized, collaborative approach to assessing TGE youth capacity would benefit TGE youth and their parents, and allow clinicians to more easily resolve ethical concerns. (shrink)

Decision-making capacity in children and adolescents in healthcare requires thorough assessment: the minor's maturity, understanding of the decision, risk of the situation and contextual factors needs to be explored. The intention was to design and validate a test—the Maturtest—to assess the maturity of minors in decision-making processes in healthcare. A reasoning test on moral conflicts for adolescents was designed to infer the degree of maturity of minors applied to decision-making regarding their own health. The test was completed by a sample (...) of 441 adolescents aged from twelve to sixteen, with a corresponding analysis of their psychometric skills to measure feasibility, viability, reliability, validity, and sensitivity to change. Psychometric test results showed viability, reliability, validity, and sensitivity to change. High correlation between the test score and the reference method were notable. A high stability was obtained with an intraclass correlation coefficient. The average response time of the test was twenty-three minutes. This test measures the moral maturity of adolescents. It is presented as an objective, useful, valid, reliable tool, easy to fill out, edit and apply in a healthcare context. It helps to assess the maturity of minors faced with a decision. (shrink)

ObjectivesIn 2015, the Province of Quebec, Canada passed a law that allowed voluntary active euthanasia. Palliative care stakeholders in Canada have been largely opposed to euthanasia, yet there is little research about their views. The research question guiding this study was the following: How do palliative care physicians in Quebec position themselves regarding the practice of VAE in the context of the new provincial legislation?MethodsWe used interpretive description, an inductive methodology to answer research questions about clinical practice. A total of (...) 18 palliative care physicians participated in semistructured interviews at two university-affiliated hospitals in Quebec.ResultsParticipants positioned themselves in opposition to euthanasia. Their justifications were framed within their professional commitment to not hasten death, which sat in tension with the value of patients’ autonomy to choose how to die. Participants described VAE as unacceptable if it impeded opportunities to evaluate and alleviate suffering. Further, they contested government rhetoric that positioned VAE as a way to improve end-of-life care. Participants felt that VAE would diminish the potential of palliative care to relieve suffering. Dilemmas were apparent in their narratives, about reconciling respect for patient autonomy with broader palliative care values, and the value of accompanying and not abandoning patients who make requests for VAE while being committed to neither prolonging nor hastening death.ConclusionsThis study provides insight into nuanced positions of experienced palliative care physicians in Quebec and confirms expected tensions between an important stakeholder and the practice of VAE as guided by the new legislation. (shrink)

Inclusion of children in medical decision making, to the extent of their ability and interest in doing so, should be the default position, ensuring that children are routinely given a voice. However, optimizing the involvement of children in their health care decisions remains challenging for clinicians. Missing from the literature is a stepwise approach to assessing when and how a child should be included in medical decision making. We propose a systematic approach for doing so, and we apply this approach (...) in a discussion of two challenging clinical cases. The approach is informed by a literature review, and is anchored by case studies of teenagers' refusal of clinical care, regulatory requirements for research assent, and the accepted approach to involving cognitively impaired adults in medical decisions. (shrink)

Paediatric research in low-income countries is essential to tackle high childhood mortality. As with all research, consent is an essential part of ethical practice for paediatric studies. Ethics guidelines recommend that parents or another proxy provide legal consent for children to participate, but that children should be involved in the decision through providing assent. However, there remain uncertainties about how to judge when children are ready to give assent and about appropriate assent processes. Malawi does not yet have detailed guidelines (...) on assent. Understanding perspectives among children and their parents can assist in developing contextually-appropriate assent guidance. Qualitative research was conducted with children and parents in three settings in Southern Malawi, to take account of any variations between socioeconomic and cultural contexts. In each setting, interviews were conducted with parents and their children who had participated in paediatric research to understand their experiences of assent and views on appropriate assent practice. Focus groups were also conducted with children and parents, to understand broader social perspectives. We found widespread support for involving children in decisions on research participation. Participants identified a range of factors that affect children’s capacity to give assent, including intellectual capacity, emotional development, life experience and cultural norms. Age was often mentioned as a consideration, but deemed an unreliable sole indicator of capacity to assent. In relation to appropriate assent processes, participants emphasised considerations such as supporting effective understanding and minimizing harms. Views on how to achieve these aims varied; for example, there were different ideas about the appropriate order in which to approach children and parents, and about whose decision to respect in the event of disagreement. Parents and children agreed about the value of involving children in decisions on research, and about the need to promote children’s decision-making capacity while respecting parents’ interests in children’s welfare. Developing practical guidance that meets these principles is challenging, particularly given the need for flexible approaches that suit different study types, children’s capacities and family environments. Further discussion within the Malawi research and ethics community will help develop contextually-appropriate guidelines. (shrink)

Key legislations in many countries emphasize the importance of involving children in decisions regarding their own health at a level commensurate with their age and capacities. Research is engaged in developing tools to assess capacity in children in order to facilitate their responsible involvement. These instruments, however, are usually based on the cognitive criteria for capacity assessment as defined by Appelbaum and Grisso and thus ill adapted to address the life-situation of children. The aim of this paper is to revisit (...) and critically reflect upon the current definitions of decision-making capacity. For this purpose, we propose to see capacity through the lens of essential contestability as it warns us against any reification of what it means to have capacity. Currently, capacity is often perceived of as a mental or cognitive ability which somehow resides within the person, obscuring the fact that capacity is not just an objective property which can be assessed, but always operates within a dominant cultural framework that “creates” that same capacity and defines the threshold between capable and incapable in a specific situation. Defining capacity as an essentially contested concept means using it in a questioning mode and giving space to alternative interpretations that might inform and advance the debate surrounding decision-making. (shrink)

The COVID-19 pandemic during 2020–2022 raised ethical questions concerning the balance between individual autonomy and the protection of the population, vulnerable individuals and the healthcare system. Pediatric COVID-19 vaccination differs from, for example, measles vaccination in that children were not as severely affected. The main question concerning pediatric vaccination has been whether the autonomy of parents outweighs the protection of the population. When children are seen as mature enough to be granted autonomy, questions arise about whether they have the right (...) to decline vaccination and who should make the decision when parents disagree with each other and/or the child. In this paper, I argue that children should be encouraged to not only take responsibility for themselves, but for others. The discussion of pediatric vaccination in cases where this kind of risk–benefit ratio exists extends beyond the 2020–2022 pandemic. The pandemic entailed a question that is crucial for the future of public health as a global problem, that is, to what extent children should be seen as responsible decision-makers who are capable of contributing to its management and potential solution. I conclude that society should encourage children to cultivate such responsibility, conceived as a virtue, in the context of public health. (shrink)

The outcome of very preterm infants is marked by the development of complications that can have an impact on the quality of life of the children and their families. The concept of quality of life and its evaluation in the long term raise semantic and ethical problems for French physicians in perinatal care. Our reflection aims to gain a better understanding of the representations surrounding quality of life in neonatal medicine.

Background Few studies have been conducted to assess the quality of orientation practices for ethics advisory committees that conduct ethics consultation. This survey study focused on several Harvard teaching hospitals, exploring orientation quality and committee members’ self-evaluation in the American Society of Bioethics and Humanities ethics consultation competencies. Methods We conducted a survey study that involved 116 members and 16 chairs of ethics advisory committees, respectively. Predictor variables included professional demographics, duration on committees and level of training. Outcome variables included (...) familiarity with and preparedness in the ASBH competencies and satisfaction with orientations. We hypothesised that responses would be associated with both the aforementioned predictors and whether or not participants had encountered the ASBH competencies in training. Results A majority of respondents found their orientation curricula to be helpful, although a significant portion of respondents did not receive any orientation or were unsatisfied with their orientation. Familiarity with ASBH competencies was a statistically significant predictor of respondents’ self-evaluation in particular categories. Standard educational materials were reported as offered during orientation, such as readings and case studies ; different medium resources were less evidenced such as videos on ethics consultation. Conclusions Institutions should re-evaluate orientation practices for ethics committee members that perform ethics consultation. Integrating ASBH competencies and useful methods into a resourceful pedagogy will help improve both member satisfaction with orientation and preparation in consultation. (shrink)

There is a claim that clinical ethics support services (CESS) improve healthcare quality within healthcare organisations. However, there is lack of strong evidence supporting this claim. Rather, the current focus is on the quality of CESS themselves or on individual learning outcomes. In response, this article proposes a theoretical framework leading to empirical hypotheses that describe the relationship between a specific type of CESS, moral case deliberation and the quality of care at the organisational level. We combine insights from the (...) literature on CESS, organisational learning and quality improvement and argue that moral case deliberation causes healthcare professionals to acquire practical wisdom. At the organisational level, where improving quality is a continuous and collective endeavour, this practical wisdom can be aggregated into morisprudence, which is an ongoing formulation of moral judgements across cases encountered within the organisation. Focusing on the development of morisprudence enables refined scrutinisation of CESS-related quality claims. (shrink)

The Médecins Sans Frontières ethics review board has been solicited in an unprecedented way to provide advice and review research protocols in an ‘emergency’ mode during the recent Ebola epidemic. Twenty-seven Ebola-related study protocols were reviewed between March 2014 and August 2015, ranging from epidemiological research, to behavioural research, infectivity studies and clinical trials with investigational products at early development stages. This article examines the MSF ERB’s experience addressing issues related to both the process of review and substantive ethical issues (...) in this context. These topics include lack of policies regarding blood sample collection and use, and engaging communities regarding their storage and future use; exclusion of pregnant women from clinical and vaccine trials; and the difficulty of implementing timely and high-quality qualitative/anthropological research to consider potential upfront harms. Having noticed different standards across ethics committees, we propose that when multiple ethics reviews of clinical and vaccine trials are carried out during a public health emergency they should be accompanied by transparent communication between the ECs involved. The MSF ERB experience should trigger a broader discussion on the ‘optimal’ ethics review in an emergency outbreak and what enduring structural changes are needed to improve the ethics review process. (shrink)

Participation in healthcare decision-making is considered to be an important right of minors, and is highlighted in both international legislation and public policies. However, despite the legal recognition of children’s rights to participation, and also the benefits that children experience by their involvement, there is evidence that legislation is not always translated into healthcare practice. There are a number of factors that may impact on the ability of the child to be involved in decisions regarding their medical care. Some of (...) these factors relate to the child, including their capacity to be actively involved in these decisions. Others relate to the family situation, sociocultural context, or the underlying beliefs and practices of the healthcare provider involved. In spite of these challenges to including children in decisions regarding their clinical care, we argue that it is an important factor in their treatment. The extent to which children should participate in this process should be determined on a case-by-case basis, taking all of the potential barriers into account. (shrink)

BackgroundFor many decades, the debate on children’s competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that children’s competence to consent to clinical research could be accurately assessed by the modified MacArthur Competence Assessment Tool for Clinical Research. Age limits for children to be deemed competent to decide on research participation have been studied: generally children of 11.2 (...) years and above were decision-making competent, while children of 9.6 years and younger were not. Age was pointed out to be the key determining factor in children’s competence. In this article we reflect on policy implications of these findings, considering legal, ethical, developmental and clinical perspectives.DiscussionAlthough assessment of children’s competence has a normative character, ethics, law and clinical practice can benefit from research data. The findings may help to do justice to the capacities children possess and challenges they may face when deciding about treatment and research options. We discuss advantages and drawbacks of standardized competence assessment in children on a case-by-case basis compared to application of a fixed age limit, and conclude that a selective implementation of case-by-case competence assessment in specific populations is preferable. We recommend the implementation of age limits based on empirical evidence. Furthermore, we elaborate on a suitable model for informed consent involving children and parents that would do justice to developmental aspects of children and the specific characteristics of the parent-child dyad.SummaryPrevious research outcomes showed that children’s medical decision-making capacities could be operationalized into a standardized assessment instrument. Recommendations for policies include a dual consent procedure, including both child as well as parents, for children from the age of 12 until they reach majority. For children between 10 and 12 years of age, and in case of children older than 12 years in special research populations of mentally compromised patients, we suggest a case-by-case assessment of children’s competence to consent. Since such a dual consent procedure is fundamentally different from a procedure of parental permission and child assent, and would imply a considerable shift regarding some current legislations, practical implications are elaborated. (shrink)