Genomic sequencing (GS) is increasingly used in paediatric medicine to aid in screening, research and treatment. Some health systems are trialling GS as a first-line test in newborn screening programmes. Questions about what to do with genomic data after it has been generated are becoming more pertinent. While other research has outlined the ethical reasons for storing deidentified genomic data to be used in research, the ethical case for storing data for future clinical use has not been explicated. In (...) this paper, we examine the ethical case for storing genomic data with the intention of using it as a lifetime health resource. In this model, genomic data would be stored with the intention of reanalysis at certain points through one’s life. We argue this could benefit individuals and create an important public resource. However, several ethical challenges must first be met to achieve these benefits. We explore issues related to privacy, consent, justice and equality. We conclude by arguing that health systems should be moving towards futures that allow for the sequential interrogation of genomic data throughout the lifespan. (shrink)

Gilles de la Tourette syndrome (TS) is a childhood neuropsychiatric disorder characterised by the presence of motor and vocal tics. Patients with malignant TS experience severe disease sequelae; risking morbidity and mortality due to tics, self-harm, psychiatric comorbidities and suicide. By definition, those cases termed ‘malignant’ are refractory to all conventional psychiatric and pharmacological regimens. In these instances, deep brain stimulation (DBS) may be efficacious. Current 2015 guidelines recommend a 6-month period absent of suicidal ideation before DBS is offered to (...) patients with TS. We therefore wondered whether it may be ethically justifiable to offer DBS to a minor with malignant TS. We begin with a discussion of non-maleficence and beneficence. New evidence suggests that suicide risk in young patients with TS has been underestimated. In turn, DBS may represent an invaluable opportunity for children with malignant TS to secure future safety, independence and fulfilment. Postponing treatment is associated with additional risks. Ultimately, we assert this unique risk-benefit calculus justifies offering DBS to paediatric patients with malignant TS. A multidisciplinary team of clinicians must determine whether DBS is in the best interest of their individual patients. We conclude with a suggestion for future TS-DBS guidelines regarding suicidal ideation. The importance of informed consent and assent is underscored. (shrink)

When a minor research participant reaches the age of majority or the level of maturity necessary to be granted legal decision-making capacity, reconsent can be required for ongoing participation in research or use of health information and banked biological materials. Despite potential logistical concerns with implementation and ethical questions about the trade-offs between maximising respect for participant agency and facilitating research that may generate benefits, reconsent is the approach most consistent with both law and research ethics.Canadian common law consent requirements (...) are expansive and likely compel reconsent on obtaining capacity. Common law doctrine recognises that children are entitled to decision-making authority that reflects their evolving intelligence and understanding. Health consent legislation varies by province but generally either compels reconsent on obtaining capacity or delegates the ability to determine reconsent to research ethics boards. These boards largely rely on the Canada’s national ethics policy, the Tri-Council Policy Statement, which states that, with few exceptions, reconsent for continued participation is required when minors gain capacity that would allow them to consent to the research in which they participate. A strict interpretation of this policy could require researchers to perform frequent capacity assessments, potentially presenting feasibility concerns. In addition, Canadian policy and law are generally consistent with the core principles of key international ethical standards from the United Nations and elsewhere.In sum, reconsent of paediatric participants upon obtaining capacity should be explicit and informed in Canada, and should not be presumed from continued participation alone. (shrink)

Clinical trials of xenotransplantation (XTx) may begin early in the next decade, with kidneys from genetically modified pigs transplanted into adult humans. If successful, transplanting pig hearts into children with advanced heart failure may be the next step. Typically, clinical trials have a specified end date, and participants are aware of the amount of time they will be in the study. This is not so with XTx. The current ethical consensus is that XTx recipients must consent to lifelong monitoring. While (...) this presents challenges to the right to withdraw in the adult population, additional and unanswered questions also linger in the paediatric population. In paediatric XTx, parents or guardians consent not only to the initial treatment of the child but also to lifelong monitoring, thus making a decision whose consequences will remain present as the child develops the capacity for assent, and finally the capacity for informed consent or refusal. This article presents and evaluates unanswered paediatric ethical questions in regard to the right to withdraw from XTx follow-up in the paediatric population. (shrink)

This study explored paediatric nurses’ decision-making regarding resuscitation in patients with unequivocal signs of death and no Do Not Resuscitate (DNR) order. A cross-sectional survey was conducted between October 2023 and April 2024 across the paediatric wards of four Australian hospitals. Participants were asked to respond to two hypothetical clinical scenarios involving a three-year-old boy and a twelve-year-old girl, both clearly deceased—neither of whom had documented DNR orders. Participants indicated their intended resuscitation plan and reasoning for each scenario. (...) Data were analysed descriptively. All respondents (n = 26) (100 per cent) indicated that they would initiate resuscitation for the younger child, while 84.6 per cent (n = 22) would do so for the twelve-year-old. The absence of a DNR order and perceived duty of care were key reasons for their decisions. Findings reveal ethical, legal, and clinical challenges inherent to paediatric resuscitation decisions. This highlights the need for clearer policies, education, and support to guide determination of when resuscitation is appropriate. (shrink)

Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe, efficacious treatment. In South Africa and other low and middle-income countries, research is needed to optimise care and ensure rational, equitable allocation of scare paediatric critical care resources.

PurposeAdolescents develop their decision-making ability as they transition from childhood to adulthood. Participation in their medical care should be encouraged through obtaining assent, as recommended by the American Academy of Pediatrics (AAP). In this research, we aim to define the current knowledge of AAP recommendations and surgeon practices regarding assent for elective reconstructive procedures.MethodsAn anonymous electronic survey was distributed to North American paediatric surgeons and fellows through the American Pediatric Surgical Association (n=1353).ResultsIn total, 220 surgeons and trainees responded (16.3%). (...) Fifty per cent of the surgeons who are familiar with the concept of assent had received formal training; 12% of the respondents had not heard of assent before the survey. Forty-seven per cent were aware of the 2016 AAP policy statement regarding assent in paediatric patients. Eighty-nine per cent always include adolescents as part of the consent discussion. Seventy-seven per cent solicit an expression of willingness to accept the proposed care from the patient. The majority (74%) of the surgeons perceived patient cooperation/understanding as the biggest barrier to obtaining assent. Over half of the respondents would consider proceeding with elective surgery despite the adolescent patient’s refusal. Reasons cited for proceeding with elective surgery include surgeons’ perception of medical necessity, perceptions of disease urgency, and lack of patient maturity.ConclusionPaediatric surgeons largely acknowledge the importance of assent, but variably practice the principles of obtaining assent from adolescent patients undergoing elective reconstructive procedures. Fewer surgeons are explicitly aware of formal policy statements or received formal training. Additional surgeon education and institutional policies are warranted to maximise inclusion of adolescents in their medical care. (shrink)

Background: Paediatric nurses often face complex situations requiring decisions that sometimes clash with their own values and beliefs, or with the needs of the children they care for and their families. Paediatric nurses often use new technology that changes the way they provide care, but also reduces their direct interaction with the child. This may generate ethical issues, which nurses should be able to address in the full respect of the child. Research question and objectives: The purpose of (...) this review is to describe the main ethical dimensions of paediatric nursing. Our research question was, ‘What are the most common ethical dimensions and competences related to paediatric nursing?’ Research design: A rapid evidence assessment. Method: According to the principles of the rapid evidence assessment, we searched the PubMed, SCOPUS and CINAHL databases for papers published between January 2001 and March 2015. These papers were then independently read by two researchers and analysed according to the inclusion criteria. Ethical considerations: Since this was a rapid evidence assessment, no approval from the ethics committee was required. Findings: Ten papers met our inclusion criteria. Ethical issues in paediatric nursing were grouped into three areas: (a) ethical issues in paediatric care, (b) social responsibility and (c) decision-making process. Conclusion: Few studies investigate the ethical dimensions and aspects of paediatric nursing, and they are mainly qualitative studies conducted in critical care settings based on nurses’ perceptions and experiences. Paediatric nurses require specific educational interventions to help them resolve ethical issues, contribute to the decision-making process and fulfil their role as advocates of a vulnerable population (i.e. sick children and their families). Further research is needed to investigate how paediatric nurses can improve the involvement of children and their families in decision-making processes related to their care plan. (shrink)

Malaysia had its first four patients with COVID-19 on 25 January 2020. In the same week, the World Health Organization declared it as a public health emergency of international concern. The pandemic has since challenged the ethics and practice of medicine. There is palpable tension from the conflict of interest between public health initiatives and individual’s rights. Ensuring equitable care and distribution of health resources for patients with and without COVID-19 is a recurring ethical challenge for clinicians. Palliative care aims (...) to mitigate suffering caused by a life-limiting illness, and this crisis has led to the awareness and urgency to ensure it reaches all who needs it. We share here the palliative care perspectives and ethical challenges during the COVID-19 pandemic in Malaysia. (shrink)

Background: It is stated that the communication and disease experiences of paediatric patients, especially paediatric oncology patients, with healthcare professionals are completely different from those of adults. Objective: The aim of this study was to determine the definitions of a good physician and good nurse provided by elementary school-age oncology patients. Research design: In this qualitative research, data were collected through semi-structured individual interviews. The data were evaluated thorough thematic analysis. Participants and research context: Eighteen children hospitalised due (...) to cancer in paediatric oncology and haematology clinics of a university hospital in Turkey. Ethical considerations: Permission to conduct the study was obtained from the Institution’s Ethics Committee. The objectives of this study were explained to the participants and families, and written consent was obtained from them. Also, participants were assured that necessary measures would be taken to protect their anonymity and confidentiality. Findings: The definitions of children were based on five main themes: interpersonal relationships, virtues, professional responsibility, security and individual characteristics. Conclusion: Children conveyed important messages to health professionals. They emphasised that a good physician and good nurse should communicate well, not only with themselves but also with their family. In addition, children were sensitive about health professionals who played with them and actively participated in the treatment by informing them about the disease. Meeting the expectations of children can be possible by improving the communication skills of physicians and nurses and by adding games and activities to the treatment and care plan. (shrink)

In paediatric oncology, research and treatments are often closely combined, which may compromise voluntary informed consent of parents. We identified two key scenarios in which voluntary informed consent for paediatric oncology studies is potentially compromised due to the intertwinement of research and care. The first scenario is inclusion by the treating paediatric oncologist, the second scenario concerns treatments confined to the research context. In this article we examine whether voluntary informed consent of parents for research is compromised (...) in these two scenarios, and if so whether this is also morally problematic. For this, we employ the account of voluntary consent from Nelson and colleagues, who assert that voluntary consent requires substantial freedom from controlling influences. We argue that, in the absence of persuasion or manipulation, inclusion by the treating physician does not compromise voluntariness. However, it may function as a risk factor for controlling influence as it narrows the scope within which parents make decisions. Furthermore, physician appeal to reciprocity is not controlling as it constitutes persuasion. In addition, framing information is a form of informational manipulation and constitutes a controlling influence. In the second scenario, treatments confined to the research context qualify as controlling if the available options are restricted through manipulation of options. Although none of the influences is morally problematic in itself, a combination of influences may create morally problematic instances of involuntary informed consent. Therefore, safeguards should be implemented to establish an optimal environment for parents to provide voluntary informed consent in an integrated research-care context. (shrink)

Potential conflicts between the roles of physicians and researchers have been described at the theoretical level in the bioethics literature (Czoli, et al., 2011). Physicians and researchers are generally in mutually distinct roles, responsible for patients and participants respectively. With increasing emphasis on integration of research into clinical settings, however, the role divide is sometimes unclear. Consequently, physician–researchers must consider and negotiate salient ethical differences between clinical– and research–based obligations (Miller et al, 1998). This paper explores the subjective experiences and (...) perspectives of 30 physician–researchers working in three Canadian paediatric settings. Drawing on qualitative interviews, it identifies ethical challenges and strategies used by physician–researchers in managing dual roles. It considers whether competing obligations could have both positive and adverse consequences for both physician–researchers and patients. Finally, we discuss how empirical work, which explores the perspectives of those engaged in research and clinical practice, can lead the way to understanding and promoting best practice. (shrink)

Background Nurses caring for hospitalised children can be told not to disclose information to the patient. Such non-disclosure directives in adult care pose recognised ethical problems, as they impinge on a patient’s autonomy and right to their own information, and have been discussed widely in the literature, from a physician’s perspective. Despite the ethical implications, there is less discussion of the ethics of withholding information from children. Nurses are well positioned to advocate for the rights of a child while considering (...) their best interests; hence, nurses’ thinking about the ethics of non-disclosure directives is valuable. Aim The aim of this study was to explore the experiences and attitudes of nurses with truth-telling to seriously ill children, specifically how nurses frame and think about the ethical challenges when given a directive not to tell the truth to a child. Design An interpretive phenomenological approach was employed for this research, with data collected by semi-structured interviews. Participant Population Twenty-six nurses in Australia who had cared for children hospitalised with a serious illness in the previous 5 years. Ethical Considerations Ethics approval was granted by the University of Melbourne’s Human Research Ethics Committee (37283A). Informed consent was acquired from all participants. Findings Four themes encompass the views nurse-participants expressed about the ethics of a non-disclosure directive: (i) Lying is wrong, (ii) Children should know, (iii) It’s hard for us when the child doesn’t know, but (iv) It’s not our place to tell. Nurse-participants described how a non-disclosure directive affected how they cared for their patients. Conclusions Nurse-participants believed they should be honest and articulated ethical reasons why children should be told the truth about their medical condition, but did not feel they were able to initiate this. It is recommended that nurses are supported in these ethically challenging situations and included in decision-making about how to respond when parents direct that information be withheld from their child. (shrink)

The facilitation of tight regulatory frameworks necessary to ensure that new drugs are safe and effective have yet to be effectively applied within the paediatric population. Utilization of unlicensed and off-label drugs in children results in a variety of problems ranging from inefficacy, adverse reactions and in some cases death. This ethically questionable behaviour has led the European government to legally force pharmaceutical companies to propose paediatric applications and carry out clinical studies at early stages of drug development. (...) The new European Paediatric Regulation implemented in 2007 opens a new era of paediatric drug development and will offer the opportunity to vastly improve children's health. However, this brighter outlook for the paediatric community might encourage potentially unethical behaviour in a pharmaceutical industry that finds itself in economically unstable times. The article records the gradual evolution of the US Paediatric Exclusivity Plan and the underlying principle of the newly introduced European Paediatric Regulation. It discusses some of the potential drawbacks and detrimental consequences of implementing the new European regulation, and the prospects of avoiding these by critically evaluating the difficulties experienced by the US. (shrink)

This book provides the reader with a theoretical and practical understanding of two health care delivery models: the patient/child centred care and family-centred care. Both are fundamental to caring for children in healthcare organizations. The authors address their application in a variety of paediatric healthcare contexts, as well as the ethical and legal issues they raise. Each model is increasingly pursued as a vehicle for guiding the delivery of health care in the best interests of children. Such models of (...) health care delivery shape health care policies, programs, facility design, resource allocation decisions and day-to-day interactions among patients, families, physicians and other health care professionals. To maximize the health and ethical benefits these models offer, there must be shared understanding of what the models entail, as well as the ethical and legal synergies and tensions they can create. This book is a valuable resource for paediatricians, nurses, trainees, graduate students, practitioners of ethics and health policy. (shrink)

Paediatric Intensive Care Units (PICU) are complex interdisciplinary environments where challenging, high stakes decisions are frequently encountered. We assert that appropriate decisions are more likely to be made if the decision-making process is comprehensive, reasoned, and grounded in thoughtful deliberation. Strategies to overcome barriers to high quality decision-making including, cognitive and implicit bias, group think, inadequate information gathering, and poor quality deliberation should be incorporated. Several general frameworks for decision-making exist, but specific guidance is scarce. In this paper, we (...) provide specific guidance on collaborative complex decision-making for PICUs. The proposed approach is on principles of procedural justice and pragmatic hermeneutics. The process encompasses set-up/planning, information gathering, question formulation, analysis (perspectives, values, and principles), action plan development, decision documentation, and a review and appeal mechanism. The process can be adapted to suit other clinical contexts. Research evaluating the process, exploring how best to develop education for clinicians, and how to build a culture that values high quality deliberation, is worthwhile. (shrink)

Obtaining informed consent in paediatrics is an essential yet ethically complex aspect of clinical practice. Children have varying levels of autonomy and understanding based on their age and developmental maturity, with parents traditionally playing a central role in decision-making. However, there is increasing recognition of children’s evolving capacities and their right to be involved in care decisions, raising questions about facilitating meaningful consent, or at least assent, in complex medical situations. Large language models (LLMs) may offer a partial solution to (...) these challenges. These generative artificial intelligence (AI) systems can provide interactive, age-appropriate explanations of medical procedures, risks and outcomes tailored to each child’s comprehension level. LLMs could be designed to adapt their responses to young patients’ cognitive and emotional needs while supporting parents with clear, accessible medical information. This paper examines the ethical implications of using LLMs in paediatric consent, focusing on balancing autonomy promotion with protecting children’s best interests. We explore how LLMs could be used to empower children to express preferences, mediate family disputes and facilitate informed consent. However, important concerns arise: Can LLMs adequately support developing autonomy? Might they exert undue influence or worsen conflicts between family members and healthcare providers? We conclude that while LLMs could enhance paediatric consent processes with appropriate safeguards and careful integration into clinical practice, their implementation must be approached cautiously. These systems should complement rather than replace the essential human elements of empathy, judgement and trust in paediatric consent. (shrink)

OBJECTIVES: To investigate the need for hospital clinical ethics committees by studying the frequency with which ethical dilemmas arose, the perceived adequacy of the process of their resolution, and the teaching and training of staff in medical ethics. DESIGN: Interviews with individuals and three multidisciplinary teams; questionnaire to randomly selected individuals. SETTING: Two major London children's hospitals. RESULTS: Ethical dilemmas arose frequently but were resolved in a relatively unstructured fashion. Ethical concerns included: the validity of consent for investigations and treatment; (...) lack of children's involvement in consent; initiation of heroic or futile treatments; resource allocation. Staff expressed the need for a forum which would provide consultation on ethical issues, develop guidelines for good ethical practice, undertake teaching and training, and provide ethical reflection outside the acute clinical setting. CONCLUSION: Multidisciplinary, accountable and audited clinical ethics committees with predominantly advisory, practice development and educational roles could provide a valuable contribution to UK clinical practice and perhaps in other countries that have not developed hospital clinical ethics committees. (shrink)

The present article aims to scrutinize publishing ethics in the fields of paediatrics and paediatric nursing. Full-text readings of all original research articles in paediatrics from a high-income economy, i.e. Sweden, and from all low-income economies in Sub-Saharan Africa, were reviewed as they were indexed and stored in Web of Science for the search period from 1 January 2007 to 7 October 2009. The application of quantitative and qualitative content analysis revealed a marked discrepancy in publishing frequencies between the (...) two contrasting economies. Authors from 16 low-income economies in Sub-Saharan Africa, with at least one article stored, were obviously closely linked to co-authorships and foreign funding sources, predominantly from Europe and the USA. Statements concerning conflicts of interest were frequently missing (both regions), even when multiple financial sources, including companies, were involved. It is necessary to be aware of possible systematic bias when using electronic databases to search for certain topics and regions. Further research regarding publishing ethics in paediatrics and paediatric nursing is emphasized. (shrink)

In this paper, we first briefly describe neuroimaging technology, our reasons for studying magnetic resonance imaging (MRI) technology, and then provide a discussion of what we have identified as priority issues for paediatric MRI research. We examine the issues of respectful involvement of children in the consent process as well as privacy and confidentiality for this group of MRI research participants. In addition, we explore the implications of unexpected findings for paediatric MRI research participants. Finally, we explore the (...) ethical issues concerning advances in functional MRI. This paper aims to provide a clear description of priority paediatric MRI research ethics issues to make some preliminary recommendations regarding next steps. (shrink)

BackgroundIn paediatric oncology, healthcare professionals face moral challenges. Clinical ethics support services, such as moral case deliberation (MCD), aim to assist them in dealing with these challenges. Yet, healthcare professionals can have different expectations and goals related to clinical ethics support services.MethodsIn this study, the perceptions held by healthcare professionals (nursing assistants, registered nurses, physicians, and others) regarding the importance of possible outcomes of MCDs, prior to implementation of MCDs, were investigated. A multisite, cross-sectional, quantitative study was performed at (...) all six Paediatric Oncology Centres in Sweden. Healthcare professionals answered the Euro-MCD instrument with 26 potential MCD outcomes using a scale from Not important (1) to Very important (4). Descriptive and comparative statistical analyses were carried out.ResultsAll outcomes were rated high, i.e., between 3.12 and 3.78. More open communication, developing skills to analyse ethically difficult situations, better mutual understanding, and deciding on concrete actions were rated as most important. Understanding of ethical theories and critical examination of policies were rated less important. Most often nursing assistants rated higher and physicians lower than the other professions did. Women and participants without previous experience of MCDs perceived outcomes as more important. There were differences between centres as one centre had significantly higher, and one centre had significantly lower ratings compared to the others.ConclusionIt is clear that healthcare professionals want MCDs to improve teamwork and skills in order to analyse and manage ethically difficult situations. When comparing to previous research about important MCD outcomes, there were similarities in what healthcare professionals consider to be important when handling moral challenges regardless of country and potential differences in healthcare settings and systems, such as paediatric vs. adult care. (shrink)

Background: Providing oncological care to children is demanding and ethical issues concerning what is best for the child can contribute to moral distress. Objectives: To explore healthcare professionals’ experiences of situations that generate moral distress in Swedish paediatric oncology. Research design: In this national study, data collection was conducted using the Swedish Moral Distress Scale-Revised. The data analysis included descriptive statistics and non-parametric analysis of differences between groups. Participants and research context: Healthcare professionals at all paediatric oncology centres (...) in Sweden were invited to participate. A total of 278 healthcare professionals participated. The response rate was 89%. Ethical considerations: In its advisory statement, the Regional Ethical Review Board decided that the study was of such a nature that the legislation concerning ethical reviews was not applicable. All participants received written information about the aim of the study and confidentiality. Participants demonstrated their consent by returning the survey. Findings: The two situations with the highest moral distress scores concerned lack of competence and continuity of personnel. All professional groups reported high levels of disturbance. Nurses rated significantly higher frequencies and higher total Moral Distress Scale scores compared to medical doctors and nursing assistants. Discussion: Lack of competence and continuity, as the two most morally distressing situations, confirms the findings of studies from other countries, where inadequate staffing was reported as being among the top five morally distressing situations. The levels of total Moral Distress Scale scores were more similar to those reported in intensive care units than in other paediatric care settings. Conclusion: The two most morally distressing situations, lack of competence and continuity, are both organisational in nature. Thus, clinical ethics support services need to be combined with organisational improvements in order to reduce moral distress, thereby maintaining job satisfaction, preventing a high turnover of staff and ensuring the quality of care. (shrink)

The transplantation of non-human organs into humans, or xenotransplantation (XTx), has recently garnered new attention and is being developed to help address the problem of organ scarcity in transplantation. Ethical issues surrounding XTx have been studied since initial interest arose decades ago and have experienced renewed discussion in the literature. However, the distinct and relevant differences when applied to children has largely been overlooked with few groups attending to the concerns that XTx in children raises. In this paper, we explore (...) ethical challenges to be expected in paediatric XTx, in particular exploring organ sizing concerns, infectious risks, psychological burdens, and issues of moral hazard. We review these domains with the aim of highlighting the implications of pursuing paediatric XTx and the cross-disciplinary approach needed to solve these issues. Children require a unique analysis from a bioethical perspective to best prepare for the issues XTx presents. (shrink)

Objective We sought to understand ethics and education needs of emergency nurses and physicians in paediatric and adult emergency departments in order to build ethics capacity and provide a foundation for the development of an ethics education programme. Methods This was a prospective cross-sectional survey of all staff nurses and physicians in three tertiary care EDs. The survey tool, called Clinical Ethics Needs Assessment Survey, was pilot tested on a similar target audience for question content and clarity. Results Of (...) the 123 participants surveyed, 72% and 84% of nurses and physicians fully/somewhat agreed with an overall positive ethical climate, respectively. 69% of participants reported encountering daily or weekly ethical challenges. Participants expressed the greatest need for additional support to address moral distress, conflict management with patients or families and resource issues. Of the 23 reported occurrences of moral distress, 61% were associated with paediatric mental health cases. When asked how the ethics consultation service could be used in the ED, providing education to teams was the most desired method. Conclusions Nurses report a greater need for ethics education and resources compared with their physician colleagues. Ethical challenges in paediatric EDs are more prevalent than adult EDs and nurses voice specific moral distress that are different than adult EDs. These results highlight the need for a suitable educational strategy, which can be developed in collaboration with the leadership of each ED and team of hospital ethicists. (shrink)

Cystic fibrosis (CF) is a life-limiting genetic disease frequently associated with pancreatic insufficiency (PI), traditionally considered irreversible. CF transmembrane conductance regulator modulators such as elexacaftor/tezacaftor/ivacaftor (ETI; Trikafta) have transformed CF care yet remain FDA-approved only for children aged 2 years and older. We present the case of a 9-month-old female with CF and PI whose mother, highly health-literate and resourceful, pursued early ETI exposure through breastmilk transfer and later direct off-label dosing, despite medical guidance and regulatory restrictions. Remarkably, the child (...) achieved pancreatic sufficiency, discontinued pancreatic enzyme replacement therapy and showed no evidence of hepatic or ophthalmologic toxicity. This case raises significant ethical questions: What constitutes an appropriate physician’s response when parents pursue unapproved but plausibly effective therapies? Should monitoring and harm reduction be seen as ethically permissible, or should stronger discouragement—including refusal of guidance or child protective intervention—be considered? Using an adapted risk–benefit framework derived from complementary and complementary medicine ethics, we argue that the medical team’s approach—recommending standard of care while monitoring for safety and efficacy—was ethically justifiable harm reduction in light of the mother’s persistence, the plausible biological rationale and early positive outcomes. We further explore how this assessment may shift when FDA-approved alternatives become available and compare this case to analogous dilemmas such as paediatric stem cell tourism. Ultimately, we suggest that calibrated physician responses, scaled to the degree of risk and potential benefit, best serve the child’s interests in ethically ambiguous contexts of parental pursuit of unproven but potentially beneficial treatments. (shrink)

BackgroundObtaining consent has become a standard way of respecting the patient’s rights and autonomy in clinical research. Ethical guidelines recommend that the child’s parent/s or authorised legal guardian provides informed consent for their child’s participation. However, obtaining informed consent in paediatric research is challenging. Parents become vulnerable because of stress related to their child’s illness. Understanding the views held by guardians and researchers about the consent process in Malawi, where there are limitations in health care access and research literacy (...) will assist in developing appropriate consent guidelines.MethodsWe conducted 20 in-depth interviews with guardians of children and research staff who had participated in paediatric clinical trial and observational studies in acute and non-acute settings in the Southern Region of Malawi. Interviews were audio-recorded, transcribed verbatim, and thematically analysed. Interviews were compared across studies and settings to identify differences and similarities in participants’ views about informed consent processes. Data analysis was facilitated by NVIVO 11 software.ResultsAll participants across study types and settings reported that they associated participating in research with therapeutic benefits. Substantial differences were noted in the decision-making process across study settings. Guardians from acute studies felt that the role of their spouses was neglected during consenting, while staff reported that they had problems obtaining consent from guardians when their partners were not present. Across all study types and settings, research staff reported that they emphasised the benefits more than the risks of the study to participants, due to pressure to recruit. Participants from non-acute settings were more likely to recall information shared during the consent process than participants in the acute setting.ConclusionThe health care context, culture and research process influenced participants’ understanding of study information across study types and settings. We advise research managers or principal investigators to define minimum requirements that would not compromise the consent process and conduct study specific training for staff. The use of one size fits all consent process may not be ideal. More guidance is needed on how these differences can be incorporated during the consent process to improve understanding and delivery of consent.Trial registration Not applicable. (shrink)

In order to involve children in the decision-making process about participation in medical research it is widely recommended that the child’s assent be sought in addition to parental consent. However, the concept of assent is fraught with difficulties, resulting in confusion among researchers and ethics committees alike.

Ethical climate (EC) has been broadly described as how well institutions respond to ethical issues. Developing a tool to study and evaluate EC that aims to achieve sustained improvements requires a contemporary framework with identified relevant drivers. An extensive literature review was performed, reviewing existing EC definitions, tools and areas where EC has been studied; ethical challenges and relevance of EC in contemporary paediatric intensive care (PIC); and relevant ethical theories. We surmised that existing EC definitions and tools designed (...) to measure it fail to capture nuances of the PIC environment, and sought to address existing gaps by developing an EC framework for PIC founded on ethical theory. In this article, we propose a Paediatric Intensive Care Ethical Climate (PICEC) conceptual framework and four measurable domains to be captured by an assessment tool. We define PICEC as the collective felt experience of interdisciplinary team members arising from those factors that enable or constrain their ability to navigate ethical aspects of their work. PICEC both results from and is influenced by how well ethical issues are understood, identified, explored, reflected on, responded to and addressed in the workplace. PICEC encompasses four, core inter-related domains representing drivers of EC including: (1) organisational culture and leadership; (2) interdisciplinary team relationships and dynamics; (3) integrated child and family-centred care; and (4) ethics literacy. Future directions involve developing a PICEC measurement tool, with implications for benchmarking as well as guidance for, and evaluation of, targeted interventions to foster a healthy EC. (shrink)

Interactive technology assessment is a novel approach to evaluating (health) technology, which philosophically draws from the works of Rawls and Habermas. That is, it seeks to organise a practical setting for discursive ethics in order to find a legitimate basis for policy to be pursued when the technology under scrutiny features a moral controversy. Interactive technology assessment involves a cycle of interviews with all stakeholders, who are explicitly asked to respond (anonymously) to the concerns and issues raised by other participants. (...) This cycle is completed repeatedly, so that a process of vicarious learning develops. This process aims at identifying issues agreed and disagreed upon, on the basis of which widely endorsed policy recommendations can be formulated. This chapter involves an interactive technology assessment of paediatric cochlear implantation. The rationale, the design, and the results are explained, as well as the main ethical aspects of the procedure. (shrink)

Background: Ethical climate and moral distress have been shown to affect nurses’ ethical behaviour. Despite the many ethical issues in paediatric oncology nursing, research is still lacking in the field. Research aim: To investigate paediatric oncology nurses’ perceptions of ethical climate and moral distress. Research design: In this cross-sectional study, data were collected using Finnish translations of the Swedish Hospital Ethical Climate Survey–Shortened and the Swedish Moral Distress Scale–Revised. Data analysis includes descriptive statistics and non-parametric analyses. Respondents and (...) research context: Ninety-three nurses, working at paediatric oncology centres in Finland, completed the survey. Ethical considerations: According to Finnish legislation, no ethical review was needed for this type of questionnaire study. Formal research approvals were obtained from all five hospitals. Return of the questionnaire was interpreted as consent to participate. Results: Ethical climate was perceived as positive. Although morally distressing situations were assessed as highly disturbing, in general they occurred quite rarely. The situations that did appear often reflected performing procedures on school-aged children who resist such treatment, inadequate staffing and lack of time. Perceptions of ethical climate and frequencies of morally distressing situations were inversely correlated. Discussion: Although the results echo the recurrent testimonies of busy work shifts, nurses could most often practise nursing the way they perceived as right. One possible explanation could be the competent and supportive co-workers, as peer support has been described as helpful in mitigating moral distress. Conclusion: Nurturing good collegial relationships and developing manageable workloads could reduce moral distress among nurses. (shrink)

This systematic review aims to raise awareness of the concept of parental hope, which is distinct from the idea of agency – acting on behalf of someone else. Parental hope is an important factor in end-of-life care, particularly in light of recent advances in perinatology, neonatology, and paediatric palliative care (PPC). Parenting involves autonomous agency – acting and thinking on one's own behalf – as well as making decisions for one's children. Consequently, parental permission, authority and decision-making are integral (...) aspects of parental attitudes towards their children in PPC. To our knowledge, this is the first systematic review to focus specifically on the ethical implications of parental hope in PPC. A qualitative systematic review utilising Charmaz’s initial and focused coding of constructing grounded theory. A systematic search was conducted across two databases: Web of Science and Embase. The research period was from 01/01/2014 to 20/02/2025. Two reviewers independently screened articles against the eligibility criteria and appraised them using CASP critical appraisal tools. Sixty studies met the inclusion criteria and were analysed using initial and focused coding, with the results presented in diagrams. The results were reported in the PRISMA protocol. Key findings included identifying parental hope in PPC as a valuable area of future ethical research, given the various dilemmas involved and the potential advantages for parents of developing their caregiving skills for their children. The results of the four themes (‘False and realistic versus unrealistic parental hope’, ‘Evolution of parental hope as a child’s illness progresses’ with 17 sub-themes, ‘Parental hope and decision-making in PPC’, and ‘Social and structural determinants of parental hope’) were presented in four conceptual diagrams. The results reveal the preference of parents for honest encouragement over false hope. Furthermore, parents can use hope as a cognitive heuristic to influence their decision-making process. Parents also expect clinicians to understand their situation and help them manage their hopes while respecting parental authority. Ethical concerns include equitable access to support programmes and online groups that aid parental caregiving. We believe that the moral beliefs expressed by parents in our review could inform values and standards for parents as caregivers in PPC. (shrink)

This study is part of a comprehensive investigation of ethical thinking among male and female physicians and nurses. Nine women physicians with different levels of expertise, working in various wards in paediatric clinics at two of the university hospitals in Norway, narrated 37 stories about their experience of being in ethically difficult care situations. All of the interviewees’ narrations were concerned with problems relating to both action ethics and relation ethics. The main focus was on problems in a relation (...) ethics perspective. The most common themes in an action ethics perspective were overtreatment and withholding treatment. The more experienced physicians reasoned differently from the group of less experienced physicians and they coped with pressure in different ways. The less experienced physicians disclosed their professional experience yet seemed uncertain, while putting on an air of certainty, but the more experienced physicians disclosed both their professional and personal experience of caregiving and they seemed to allow themselves to feel uncertain in their certainty. Both groups emphasized a need for deep discussion between colleagues about their being in ethically difficult care situations. (shrink)

Background The use of long-term life-sustaining technology for children improves survival rates in paediatric intensive care units (PICUs), but it may also increase long-term morbidity. One example of this is children who are dependent on invasive long-term ventilation. Clinicians caring for these children navigate an increasing array of ethical complexities. This study looks at the meaning clinicians give to the bioethical considerations associated with the availability of increasingly sophisticated technology. Methods A hermeneutic phenomenological exploration of the experiences of clinicians (...) in deciding whether to initiate invasive long-term ventilation in children took place, via unstructured interviews. Data were analysed to gain insight into the lived experiences of clinicians. Participants were from PICUs, or closely allied to the care of children in PICUs, in four countries. Results Three themes developed from the data that portray the experiences of the clinicians: forming and managing relationships with parents and other clinicians considering, or using, life sustaining technology; the responsibility for moral and professional integrity in the use of technology; and keeping up with technological developments, and the resulting ethical and moral considerations. Discussion There are many benefits of the availability of long-term life-sustaining technology for a child, however, clinicians must also consider increasingly complex ethical dilemmas. Bioethical norms are adapting to aid clinicians, but challenges remain. Conclusion During a time of technological solutionism, more needs to be understood about the influences on the initiation of invasive long-term ventilation for a child. Further research to better understand how clinicians, and bioethics services, support care delivery may positively impact this arena of health care. (shrink)

Clinical ethical issues in paediatric practice are relatively common due to the nature of the doctor-parent-patient relationship, as these patients run the spectrum from newborns, infants, children and adolescents. The Clinical Ethics Consultation Service (CECS) was established at Hospital Al-Sultan Abdullah (HASA) in 2020. It has played a crucial role in addressing the ethical issues and dilemmas faced by healthcare professionals in their clinical practice. This study aimed to identify common ethical issues encountered in paediatric practice at HASA (...) to provide recommendations on improving clinical ethics support. A qualitative approach employing key informant interviews (KIIs) was utilised. Five HASA paediatricians were interviewed. The results were divided into three sections. Section one focused on common ethical issues encountered by paediatricians. The issues were related to clinical decision-making, refusal of treatment by parents, end-of-life issues and resource allocation. Section two focused on the paediatrician’s understanding and experience of clinical ethics which yielded mixed responses. Section three looked at input regarding the development of paediatric clinical ethics support. Recommendations include promoting the CECS and its services through awareness and educational programmes at HASA. It also recommends enhancing case consultations through participation during grand rounds, providing ethics education and training, as well as guidelines and policy development in paediatric practice at HASA. This study provided meaningful insights into common ethical issues faced by paediatricians at HASA and recommendations on how clinical ethics can support their practice. It also adds to the limited literature on clinical ethics in Malaysia. (shrink)

In an article published in the Archives of Disease in Childhood, paediatric intensivist Paul Baines criticises the conceptual and ethical basis for an assent requirement in paediatric research.1 Existing international research guidelines stipulate that children who cannot competently consent to research should ‘assent’ to their participation. However, Baines finds existing descriptions of assent both inadequate and contradictory. The guidelines also fail to provide a clear rationale ….

A summary of the existing literature related to moral distress (MD) and the paediatric intensive care unit (PICU) reveals a high-tech, high-pressure environment in which effective teamwork can be compromised by MD arising from different situations related to: consent for treatment, futile care, end-of-life decision making, formal decision-making structures, training and experience by discipline, individual values and attitudes, and power and authority issues. Attempts to resolve MD in PICUs have included the use of administrative tools such as shift worksheets, (...) the implementation of continuing education, and encouragement to report. The literature does not yet show these approaches to be effective in the resolution of MD. The need to acknowledge MD among PICU teams is discussed and an argument made that, to facilitate understanding among team members, practice stories need to be shared. (shrink)

Since the 19th century, innocence has been a hallmark of childhood. The innocence of children is seen as both a sanctity worth defending and a feature that excuses the unavoidable mistakes of adolescence. While beneficial in many settings, notions of childhood innocence are often entangled with values judgements. Inherent in innocence is the notion that that which we are innocent of is undesirable. Further, attributing innocence to some implies the tolerability of blame for others. This has unique implications in a (...) medical setting. This essay explores the implications of espousing the innocence of paediatric patients. Ultimately, because attribution of innocence is both prone to bias and rooted in the same framework as blame, it degrades patient-centred care and compromises the patient–provider relationship. I argue that avoiding such characterisations may allow providers to more effectively promote paediatric health. (shrink)

Background: How well ethical concerns are handled in healthcare is influenced by the ethical climate of the workplace, which in this study is described as workplace factors that contribute to healthcare professionals’ ability to identify and deal with ethical issues in order to provide the patient with ethically good care. Objectives: The overall aim of the study was to describe perceptions of the paediatric hospital ethical climate among healthcare professionals who treat/care for children with cancer. Research design: Data were (...) collected using the Hospital Ethical Climate Survey developed by Olsson as a separate section in a questionnaire. Descriptive statistics were used to analyse perceptions of the ethical climate. Participants and research context: Physicians, nurses and nurse-aides (n = 89) from three paediatric units participated in this study: haematology/oncology, chronic diseases and neurology. Ethical considerations: The study was approved by the regional ethical review board. Findings: Different perceptions of the ethical climate were rated as positive or negative/neutral. Nurses’ ratings were less positive than physicians on all items. One-third of the participants perceived that they were able to practice ethically good care as they believed it should be practised. Discussion: Differences in professional roles, involving more or less power and influence, might explain why physicians and nurses rated items differently. A positive perception of the possibility to practice ethically good care seems to be related to inter-professional trust and listening to guardians/parents. A negative/neutral perception of the possibility to practice ethically good care appears to be influenced by experiences of ethical conflicts as well as a lack of ethical support, for example, time for reflection and discussion. Conclusion: The two-thirds of participants who had a negative/neutral perception of the possibility to practice ethically good care are at risk of developing moral stress. Clinical ethics support needs to be implemented in care where important values are at stake. (shrink)

Background: Nurses providing 24-h care for the primary caregiver role have a number of significant roles to play in potential problems or conflicts associated with patient privacy and confidentiality. Research objectives: The objective of the study is to determine the prevailing attitudes towards gossip and the patient privacy practices of nurses working in paediatric units. Research design: A descriptive and cross-sectional design was used. A Descriptive Characteristics Form, a Gossip and Rumour Attitude Scale and a Patient Privacy Scale were (...) used to collect data. Participants and research context: A total of 112 paediatric nurses working in Turkey were included in the study. The response rate was 79.43%. Ethical considerations: Permission to conduct the study was obtained from the university’s ethics committee. The participants were informed of the aim of the study, and voluntary participation, anonymous response and confidentiality were explained to them. Findings: It was observed that nurses who had a higher education level, who were educated about patient privacy and who had read the patient rights regulations were more concerned about patient privacy. Negative correlations were found between the attitudes towards gossiping and the average scores on the patient confidentiality scale. Nurses who negatively defined gossip were more concerned about patient confidentiality. Discussion: Privacy is important for securing and protecting the personal, physical and psychological things that are important and special for patients. It is argued that obstacles to maintaining the privacy of hospitalized children and adolescents are a tolerant attitude towards gossiping, a lack of education about patient privacy and insufficient information about patient’s rights regulations and the Convention on the Rights of the Child. Conclusion: A nurse’s knowledge about the provision of patient confidentiality affects their privacy practices. For this reason, regular training sessions are recommended in hospitals. (shrink)

Microethics is about the ethics of everyday clinical practice. The subtle nuances in communication between doctor and patient (the doctor’s choice of words, tone, body language, gestures, etc.) can influence the exercise of the patient’s autonomy. The four models of the doctor- patient/physician-patient relationship (paternalistic, informative, interpretive, deliberative) weigh respect for autonomy and beneficence in varying proportions. Each model may be appropriate in certain circumstances. This article considers these models from the perspective of microethics and the unique dimensions created by (...) the doctor-child-parent relationship. In particular, the article considers the nuances to the autonomy principle created by the child’s developing maturity and the parent’s role as a co-fiduciary of the child’s interests. Ultimately, the deliberative model seems most appropriate to the paediatric setting, since it accommodates the child’s developing maturity in making healthcare-related decisions. This model infuses care into the doctor’s communication with the child and parent. (shrink)

The goal is to present how shared decision-making in paediatric oncology occurs from the viewpoints of parents and physicians. Eight Swiss Pediatric Oncology Group centres participated in this prospective study. The sample comprised a parent and physician of the minor patient. Surveys were statistically analysed by comparing physicians’ and parents’ perspectives and by evaluating factors associated with children’s actual involvement. Perspectives of ninety-one parents and twenty physicians were obtained for 151 children. Results indicate that for six aspects of information (...) provision examined, parents’ and physicians’ perceptions differed. Moreover, parents felt that the children were more competent to understand diagnosis and prognosis, assessed the disease of the children as worse, and reported higher satisfaction with decision-making on the part of the children. A patient’s age and gender predicted involvement. Older children and girls were more likely to be involved. In the decision-making process, parents held a less active role than they actually wanted. Physicians should take measures to ensure that provided information is understood correctly. Furthermore, they should work towards creating awareness for systematic differences between parents and physicians with respect to the perception of the child, the disease, and shared decision-making. (shrink)

The topic of consent in paediatrics is made more difficult, and at the same time more interesting, by the complexity of the issues involved and the consequent diversity of viewpoints. In a teaching session for senior medical students on consent in paediatrics it proved necessary to reinstate previous learning from a range of disciplines. Philosophical medical ethics, developmental psychology, communication skills and the appropriate legal definitions all contributed to a proper understanding of the cases presented. The two most important additional (...) components appeared to be a) a basic knowledge of cognitive development and how to apply it, and b) an awareness of the need to balance an individual child's rights or best interests, with those of the family unit, as well as the wider society. (shrink)

Many children in the USA are prescribed psychotropic drugs that have not been fully investigated in paediatric clinical trials. The common practice of prescribing psychotropic drugs off-label poses unknown and potentially serious short- and long-term consequences for these children. This paper briefly reviews the factors associated with the lack of paediatric clinical trials. We advocate a shift toward increasing paediatric trials with psychotropic drugs through a combination of adequate safety controls, additional reimbursement/compensation, a more organised and large-scale (...) effort to collate results and outcomes across researchers and studies and additional public education about the importance of this research. In addition, we encourage the re-examination of the ethical standards for children's participation in phase 1 clinical trials as well as argue for longitudinal developmental studies on children who are prescribed off-label psychotropic drugs. (shrink)