This article will explore pediatric consent through the analysis of a clinical case study using the principles of biomedical ethics approach. Application of the principles of autonomy, nonmaleficence, beneficence, and justice will be dissected in order to attempt to establish resolution of the ethical dilemma. The main conflict in this case study deals with whether the wishes of an adolescent for end-of-life care should be followed or should the desire of his parents outweigh this request. In terminal cancer, (...) the hope of early palliative care and dignity in dying serve as priorities in therapy. Application of the moral principles to both sides of the dilemma aided in providing an objective resolution to uphold pediatric consent. (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.

Informed consent, when given by proxy, has limitations: chiefly, it must be made in the interest of the patient. Here we critique the standard approach to parental consent, as present in Canada and the UK. Parents are often asked for consent, but are not given the authority to refuse medically beneficial treatment in many situations. This prompts the question of whether it is possible for someone to consent if they cannot refuse. We present two alternative and (...) philosophically more consistent frameworks for paediatric proxy consent. The first allows meaningful consent (parents may say ‘yes’ or ‘no’ to treatment), provided that parents are medically informed/competent and intend the health and well-being of their child. In the second solution, medical practitioners or the state consent for treatment, with parents only being consulted to help give insight to the child’s circumstances. While we contend that either of these two options is superior to the insincerity of the present paradigm, we suggest that the first solution is preferable. (shrink)

BackgroundObtaining a research participant’s voluntary and informed consent is the bedrock of sound ethics practice. Greater inclusion of children in research has led to questions about how paediatric consent operates in practice to accord with current and emerging legal and socio-ethical issues, norms, and requirements.MethodsEmploying a qualitative thematic content analysis, we examined paediatric consent forms from major academic centres and public organisations across Canada dated from 2008–2011, which were purposively selected to reflect different types of research ethics (...) boards, participants, and studies. The studies included biobanking, longitudinal studies, and gene-environment studies. Our purpose was to explore the following six emerging issues: (1) whether the scope of parental consent allows for a child’s assent, dissent, or future consent; (2) whether the concepts of risk and benefit incorporate the child’s psychological and social perspective; (3) whether a child’s ability to withdraw is respected and to what extent withdrawal is permitted; (4) whether the return of research results includes individual results and/or incidental findings and the processes involved therein; (5) whether privacy and confidentiality concerns adequately address the child’s perspective and whether standard data and/or sample identifiability nomenclature is used; and (6) whether retention of and access to paediatric biological samples and associated medical data are addressed.ResultsThe review suggests gaps and variability in the consent forms with respect to addressing each of the six issues. Many forms did not discuss the possibility of returning research results, be they individual or general/aggregate results. Forms were also divided in terms of the scope of parental consent (specific versus broad), and none discussed a process for resolving disputes that can arise when either the parents or the child wishes to withdraw from the study.ConclusionsThe analysis provides valuable insight and evidence into how consent forms address current ethical issues. While we do not thoroughly explore the contexts and reasons behind consent form gaps and variability, we do advocate and formulate the development of best practices for drafting paediatric health research consent forms. This can greatly ameliorate current gaps and facilitate harmonised and yet contextualised approaches to paediatric health research ethics. (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)

Attempting to balance the needs and interests of minors with the obligation to protect them from their own potentially harmful decisions poses an ethical challenge for the physician. This problem is further exacerbated when the context is not medical treatment but organ donation. That is, medical treatment scenarios generally involve decisions likely to result in objective improvements to the minor's health status. Consent to organ donation, however, raises several vexing problems. First, how should the provider measure both the cognitive (...) ability and competence to consent of the minor to ensure that the minor comprehends the risks and benefits of donation and that no coercion is involved? Second, given that improvement of one's health is an unlikely scenario, is there a way to measure subjective determinations of satisfaction and altruism enjoyed by a minor following organ donation? If so, should the physician regard these values in a manner analogous to physical improvement? Finally, are parents the appropriate decisionmakers for their children when a sibling-to-sibling donation occurs? Is it possible for parents to always act in the best interests of both children in this event? (shrink)

A challenge of performing research in the paediatric emergency and acute care setting is obtaining valid prospective informed consent from parents. The ethical issues are complex, and it is important to consider the perspective of participants, health care workers and researchers on research without prospective informed consent while planning this type of research. We performed a systematic review according to PRISMA guidelines, of empirical evidence relating to the process, experiences and acceptability of alternatives to prospective informed consent, (...) in the paediatric emergency or acute care setting. Major medical databases and grey sources were searched and results were screened and assessed against eligibility criteria by 2 authors, and full text articles of relevant studies obtained. Data were extracted onto data collection forms and imported into data management software for analysis. Thirteen studies were included in the review consisting of nine full text articles and four abstracts. Given the heterogeneity of the methods, results could not be quantitatively combined for meta-analysis, and qualitative results are presented in narrative form, according to themes identified from the data. Major themes include capacity of parents to provide informed consent, feasibility of informed consent, support for alternatives to informed consent, process issues, modified consent process, child death, and community consultation. Our review demonstrated that children, their families, and health care staff recognise the requirement for research without prior consent, and are generally supportive of enrolling children in such research with the provisions of limiting risk, and informing parents as soon as possible. Australian data and perspectives of children are lacking and represent important knowledge gaps. (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)

In 2008 UK legislation was amended to enable the use of deferred consent for paediatric emergency care (EC) trials in recognition of the practical and ethical difficulties of obtaining prospective consent in an emergency situation. However, ambiguity about how to make deferred consent acceptable to parents, children and practitioners remains. In particular, little is known about practitioners’ views and experiences of seeking deferred consent in this setting.

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)

Next SectionObjectives To evaluate the adequacy of paediatric informed consent and its augmentation by a supplemental computer-based module in paediatric endoscopy. Methods The Consent-20 instrument was developed and piloted on 47 subjects. Subsequently, parents of 101 children undergoing first-time, diagnostic upper endoscopy performed under moderate IV sedation were prospectively and consecutively, blinded, randomised and enrolled into two groups that received either standard form-based informed consent or standard form-based informed consent plus a commercial (Emmi Solutions, Inc, Chicago, (...) Il), sixth grade level, interactive learning module (electronic assisted consent). Anonymously and electronically, the subjects' anxiety (State Trait Anxiety Inventory), satisfaction (Modified Group Health Association of America), number of questions asked, and attainment of informed consent were assessed (Consent-20). Statistics were calculated using t test, paired t test, and Mann Whitney tests. Results The ability to achieve informed consent, as measured by the new instrument, was 10% in the control form-based consent group and 33% in the electronic assisted consent group (p<0.0001). Electronically assisting form-based informed consent did not alter secondary outcome measures of subject satisfaction, anxiety or number of questions asked in a paediatric endoscopy unit. Conclusions This study demonstrates the limitations of form-based informed consent methods for paediatric endoscopy. It also shows that even when necessary information was repeated electronically in a comprehensive and standardised video, informed consent as measured by our instrument was incompletely achieved. The supplemental information did, however, significantly improve understanding in a manner that did not negatively impact workflow, subject anxiety or subject satisfaction. Additional study of informed consent is required. Clinical trial registration number ClinicalTrials.gov Identifier NCT00899392. (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)

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)

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)

Research ethics committees (RECs) have a crucial role in protecting children in research. However, studies on REC members’ perspectives on paediatric research are scarce. We conducted a qualitative study to explore Swedish scientific REC members’ perspectives on ethical aspects in applications involving children with severe health conditions. The REC members considered promoting participation, protecting children and regulatory adherence to be central aspects. The results underscored the importance of not neglecting ill children’s rights to adapted information and participation. REC members supported (...) a contextual and holistic approach to vulnerability and risk, which considers the child’s and parents’ psychological wellbeing and the child’s integrity, both short and long term. The ethical complexity of paediatric research requires continuous ethical competence development within RECs. (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)

Pediatric cancer is accompanied by many ethical challenges, particularly those related to respecting the child's opinion and parental responsibility and consent.Questionnaires were collected from 400 participants, from four equal groups: doctors, nurses, parents and medical students, from three cities in Saudi Arabia, about three problematic issues which revolve around the mandatory consent of one or both parents, the extent of a child’s assent, and the acceptable form of consent and assent.Despite the diversity of the participants' cultural (...) backgrounds, most preferred both parents to give consent, followed by either parent without differentiation between parents, which reinforced a trend towards more gender equality. The majority of participants preferred that parental consent forms be detailed enough to obtain the maximum information, while others chose medium‐size consent forms; a large majority preferred that the form seeking to obtain the assent of the child with cancer be short, reflecting their desire not to increase the burden on the child, in addition to the fact that the final decision belongs to the parents rather than the child. Most participants preferred to rely on a child's level of maturity rather than having reached a certain age so that they could give assent, while the rest considered the age of 13‐14 as a suitable age.These findings reflect an increasing ethical awareness regarding parental consent and child assent, and they can be formulated in a recommendation for a more ethical practice in the field of childhood cancer and pediatrics in general. (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)

This discussion paper considers how seldom recognised theories influence clinical ethics committees. A companion paper examined four major theories in social science: positivism, interpretivism, critical theory and functionalism, which can encourage legalistic ethics theories or practical living bioethics, which aims for theory–practice congruence. This paper develops the legalistic or living bioethics themes by relating the four theories to clinical ethics committee members’ reported aims and practices and approaches towards efficiency, power, intimidation, justice, equality and children’s interests and rights. Different approaches (...) to framing ethical questions are also considered. Being aware of the four theories’ influence can help when seeking to understand and possibly change clinical ethics committee routines. The paper is not a research report but is informed by a recent study in two London paediatric cardiac units. Forty-five practitioners and related experts were interviewed, including eight members of ethics committees, about the work of informing, preparing and supporting families during the extended process of consent to children’s elective heart surgery. The mosaic of multidisciplinary teamwork is reported in a series of papers about each profession, including this one on bioethics and law and clinical ethics committees’ influence on clinical practice. The qualitative social research was funded by the British Heart Foundation, in order that more may be known about the perioperative views and needs of all concerned. Questions included how disputes can be avoided, how high ethical standards and respectful cooperation between staff and families can be encouraged, and how minors’ consent or refusal may be respected, with the support of clinical ethics committees. (shrink)

This article provides practical guidance for researchers who wish to enroll and collect data from pediatric research participants through online and mobile platforms, with a focus on the involvement of both children and their parents in the decision to participate.

Drawing on the principle of subsidiarity, this article develops a framework for allocating medical decision-making authority in the absence of capacity to consent and argues that decisional authority in paediatric transgender healthcare should generally lie in the patient. Regardless of patients’ capacity, there is usually nobody better positioned to make medical decisions that go to the heart of a patient’s identity than the patients themselves. Under the principle of subsidiarity, decisional authority should only be held by a higher level (...) decision-maker, such as parents or judges, if lower level decision-makers are incapable of satisfactorily addressing the issue even with support and the higher level decision-maker is better positioned to satisfactorily address the issue than all lower level decision-makers. Because gender uniquely pertains to personal identity and self-realisation, parents and judges are rarely better positioned to make complex medical decisions. Instead of taking away trans youth’s authority over their healthcare decisions, we should focus on supporting their ability to take the best possible decision for themselves. (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)

The paediatric Moral Distress Scale-Revised was previously translated and adapted to Swedish paediatric oncology. Cognitive interviews revealed five not captured situations among the 21 items, resulting in five added items: 22) Lack of time for conversations with patients/families, 23) Parents’ unrealistic expectations, 24) Not to talk about death with a dying child, 25) To perform painful procedures, 26) To decide on treatment/care when uncertain. The aim was to explore experiences of moral distress in the five added situations in the Swedish (...) paediatric MDS-R, among healthcare professionals in paediatric oncology. In this national cross-sectional survey, the Swedish paediatric MDS-R, including five added items, were used. Descriptive statistics, non-parametric analysis of differences between professions and a MDS-R score for each item were calculated. Internal consistency was tested using Cronbach’s alpha and inter-item correlation test. HCPs at all six Swedish paediatric oncology centres participated. The Regional Ethical Review Board had no objections. Consent was assumed when the survey was returned. Nursing assistants reported higher intensity and lower frequency on all added items; registered nurses reported a higher frequency on item 22–25; medical doctors reported higher MDS-R score on item 26. On item 22, intensity was moderate for RNs and MDs and high for NAs, and frequency was high among all. Item 22, had the second highest MDS-R score of all 26 for all professional groups. On item 23, the level of disturbance was low but it occurred often. The 26-item version showed good internal consistency for the overall sample and for all professional groups. However, item 22 and 24 could be viewed as redundant to two of the original 21. In accordance with other studies, the intensity was higher than the frequency, however, the frequency of the added items was higher than of the original items. In line with previous research, item 22 and 23 are important elements of moral distress. RNs experience the situations more often while NAs find them more disturbing. The results indicate that the added items are important in capturing moral distress in paediatric oncology. (shrink)

Background Nurses provide care to meet the complex needs of patients in the increasing workload in the health system and are at risk of compassion fatigue. The concept of compassion fatigue has begun drawing attention in the last decade, as it negatively affects nurses' physical and mental health, job performance and satisfaction, and therefore patient care quality. Objectives This study was to examine compassion fatigue and predictive factors in paediatric surgery nurses. Participants and research context The study was cross-sectional, predictive (...) and quantitative. It was conducted with the 135 paediatric surgery nurses. The data were sent to the email addresses of the members via Google Survey. Research data were collected with the Nurse Information Form, Compassion Fatigue Scale, Life Satisfaction Scale and Multidimensional Perceived Social Support Scale. Ethical considerations After obtaining the approval of the University’s ethics committee, the study was carried out after obtaining participants’ informed written and verbal consent. Results There was a difference between the level of compassion fatigue according to the paediatric surgery unit that worked the longest and the thought of changing their profession. Burn unit nurses and nurses who were considering changing professions have higher compassion fatigue scores. When the predictors of compassion fatigue were examined, the thought of changing the nursing profession and life satisfaction were significant predictors of compassion fatigue. The thought of changing the nursing profession and life satisfaction explained 22% of compassion fatigue. The same variables and the longest working period of the paediatric surgery unit were the estimators of the level of occupational burnout; explaining 29% of occupational burnout. Conclusions Compassion fatigue, life satisfaction and perceived social support of paediatric surgery nurses are moderate. Compassion fatigue is affected by working time, the thought of changing the profession, life satisfaction and perceived social support. (shrink)

Although the therapeutic misconception (TM) has been well described over a period of approximately 20 years, there has been disagreement about its implications for informed consent to research. In this paper we review some of the history and debate over the ethical implications of TM but also bring a new perspective to those debates. Drawing upon our experience of working in the context of translational research for rare childhood diseases such as Duchenne muscular dystrophy, we consider the ethical and (...) legal implications of the TM for parental consent to research. In this situation, it is potentially the parent who is vulnerable to TM. In our analysis we not only consider the context of informed consent for research but also the wider environment in which the value of research is promoted, more broadly through the media but also more specifically through the communication strategies of patient organizations. All dissemination about developments in research for health runs the risk of portraying an overly optimistic view of the promise of biotechnological solutions and has the potential to encourage a ‘collective’ TM. In this paper we consider the challenge that TM presents to parents as well as explore the ethical and legal responsibilities of researchers to ensure an appropriately informed consent: compatible with a hopeful disposition of parents who consent for the their children whilst avoiding a blind and misleading optimism. (shrink)

BackgroundWhile fertility preservation is recommended practice for paediatric oncology patients, it is increasingly being considered for transgender children and young people in paediatric care. This raises ethical issues for clinicians, particularly around consent and shared decision-making in this new area of healthcare.MethodsA systematic review of normative literature was conducted across four databases in June 2020 to capture ethical considerations related to fertility counselling and preservation in paediatric transgender healthcare. The text of included publications was analysed inductively, guided by the (...) Qualitative Analysis Guide of Leuven.ResultsTwenty-four publications were identified for inclusion. Four key ethical considerations emerged from this literature: access to fertility preservation, conscientious objection, decision-making capacity of children and young people, and shared decision-making.ConclusionIn the identified literature, there is consensus that transgender children and young people should not be refused access to fertility preservation services solely due to their gender identity, and that clinicians with conscientious objections to fertility preservation for this group have an obligation to refer on to willing providers. Factors that create ethical complexity in this area of paediatric care include the child’s age, mental health, and parents’ views. (shrink)

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)

In ‘Reification and Assent in Research Involving Those Who Lack Capacity’, Smajdor argues that adults with impaired capacity to grant informed consent (AWIC) are often excluded from participating in biomedical research because they cannot provide informed consent, leading to decreased chances AWIC will benefit from such research. Smajdor uses Honneth’s concept of reification to propose that securing assent (rather than consent) in cases involving AWIC offers patients moral recognition that is not tied to their capacities. Assent provides (...) this recognition by including the patient in a shared moral sphere, highlighting her agency and worth without reducing her to her incapacity or a thing-to-be-managed. Assent also avoids grounding in, or a reliance on, the future development of autonomy (pp.5–6).1 Our recent research on patient and caregiver perspectives of potential paediatric deep brain stimulation (pDBS) for refractory obsessive–compulsive disorder (OCD) and dystonia demonstrates that paediatric neurosurgery patients desire the kind of recognition Smajdor associates with assent, and their caregivers largely agree.2 3 Since (generally) paediatric patients in the USA are unable to grant informed consent, their caregivers must provide it instead. This raises the question of how to properly integrate paediatric patients into the DBS decision-making process. One dimension along which this is evident is that …. (shrink)

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

Non-beneficial paediatric research is vital to improving paediatric healthcare. Nevertheless, it is also ethically controversial. By definition, subjects of such studies are unable to give consent and they are exposed to risks only for the benefit of others, without obtaining any clinical benefits which could compensate those risks. This raises ethical concern that children participating in non-beneficial research are treated instrumentally; that they are reduced to mere instruments for the benefit of science and society. But this would make the (...) research incompatible with the widely endorsed principle of the primacy of the human subject, which stipulates that the interests of the participating individual should prevail over the interests of science and society. This paper deals with this conflict. It analyses solutions to this problem developed in the literature, and shows that they are unsuccessful. Finally, it offers a new idea of how to reconcile the conduct of non-beneficial paediatric research with the PP. The paper argues for a new formula of the PP, and shows that it implies a specific non-comparative definition of the minimal risk threshold. (shrink)

The first principle of the Nuremberg Code requires the informed consent of the subject. Proxy consent was not addressed until the Declaration of Helsinki. U.S. policies regarding consent for the participation of children in research would not be finalized for almost two more decades in subpart D of the federal regulations that govern the participation of subjects in research. In October 2000, the Children's Health Act was passed. Title X required the Secretary of the Department of Health (...) and Human Services to conduct a review of the regulations under subpart D and “to consider any modifications necessary to ensure the adequate and appropriate protection of children participating in research, and report the findings of the Secretary to Congress.” In this article, I provide a brief overview of the current informed consent requirements in pediatric research, which include requirements for parental permission and the child's assent. I then examine the moral bases for these requirements; whether the current policies are consistent with these moral foundations; and if not, how the policies ought to be modified. a. (shrink)

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

The American Journal of Bioethics, Volume 12, Issue 1, Page 37-38, January 2012.

The purpose of this article is to describe the main ethical issues in paediatric nontherapeutic qualitative pain research. It is based on an analysis of the research literature related to ethical issues in research and on experiences from a family interview study focusing on pain assessment and management in children aged 1-6 years. In addition, different views concerning obtaining informed consent from children, as published in the research literature, are compared. Ethical challenges occur during all stages of qualitative research. (...) The risks of emotional distress and possible benefits of the results must be assessed prior to conducting a study. However, risks and harm are difficult to avoid in a study in which the research area, pain, raises emotional distress in both parents and children. The children’s assent and parental permission are both required. It is essential to obtain informed consent from all family members when family research is conducted. Participants’ privacy and confidentiality should be protected during data collection, analysis and publication. Protecting children from harm may be impossible during pain research in which they are required to recall a painful postoperative period. However, after data collection they can be assisted to focus on pleasant activities, for example, by engaging in playful activities with them. Finally, the role of the nurse and the researcher should be carefully assessed, especially in qualitative research, in order to be able to analyse the data and report the findings in an unbiased manner. (shrink)

Objective Some researchers claim that the quality of informed consent of clinical research participants in developing countries is worse than in developed countries. To evaluate this assumption, we reviewed the available data on the quality of consent in both settings. Methods We conducted a comprehensive PubMed search, examined bibliographies and literature reviews, and consulted with international experts on informed consent in order to identify studies published from 1966 to 2010 that used quantitative methods, surveyed participants or parents (...) of paediatric participants in actual trials, assessed comprehension and/or voluntariness, and did not involve testing particular consent interventions. Forty-seven studies met these criteria. We compared data about participant comprehension and voluntariness. The paucity of data and variation in study methodology limit comparison and preclude statistical aggregation of the data. Results and Discussion This review shows that the assertion that informed consent is worse in developing countries than in developed countries is a simplification of a complex picture. Despite the limitations of comparison, the data suggest that: (1) comprehension of study information varies among participants in both developed and developing countries, and comprehension of randomisation and placebo controlled designs is poorer than comprehension of other aspects of trials in both settings; and (2) participants in developing countries appear to be less likely than those in developed countries to say they can refuse participation in or withdraw from a trial, and are more likely to worry about the consequences of refusal or withdrawal. (shrink)

In congenitally or prelingually deaf childrencochlear implantation is open to seriousethical challenge. The ethical dimension ofthis technology is closely related to both asocial standard of quality of life and to theuncertainty of the overall results of cochlearimplantation. Uncertainty with regards theacquisition of oral communicative skills.However, in the western world, available datasuggest that deafness is associated with thelowest educational level and the lowest familyincome. Notwithstanding the existence of aDeaf-World, deafness should be considered as ahandicap. Therefore, society should provide themeans for the (...) fulfilment of a deaf child'sspecific needs.For the time being there is no definitiveanswer with regard the best way to rehabilitatea particular deaf child. Therefore,communitarian values may be acceptable. If thedeaf child parents' decide not to implant,their decision should be respected. Guardiansare entitled to determine which standard ofbest interest to use in a specificcircumstance. They are the proper judges ofwhat (re)habilitation process is best for theirdeaf child. However, most deaf children areborn to two hearing parents. Probably, theywill not be acculturated in the Deaf-World. Itfollows that cochlear implantation is awelcomed (re)habilitation technology.If auditory (re)habilitation will in the futureprovide the necessary communicative skills, inparticular oral language acquisition, customs,values and attitudes of the hearing worldshould be regarded as necessary to accomplish adeaf child's right to an open future. Ifcochlear implantation technology will provideall deaf children with the capacity to developacceptable oral communicative skills –whatever the hearing status of the family andthe cultural environment – then auditory(re)habilitation will be an ethical imperative. (shrink)

This systematic review identifies and critically evaluates instruments that have been developed to measure clinical trial informed consent comprehension in non-cognitively-impaired adults. Literature searches were carried out on Medline (Ovid), PsycInfo, CINHAL, ERIC, ScienceDirect, and Cochrane Library for English language articles published between January 1980 and September 2008. Instruments were excluded if they focused on consent onto paediatric trials, the construct under study was primarily capacity or competency, or the instrument was developed specifically for psychiatric or cognitively-impaired populations. (...) Instruments selected for review were evaluated against the following criteria: (1) method of item generation; (2) type and format of test items; (3) administration and interpretation of test results; and (4) psychometric properties. Three instruments met our defined inclusion criteria: the Deaconess Informed Consent Comprehension Test (DICCT), the Quality of Informed Consent (QuIC) questionnaire and the Brief Informed Consent Protocol (BICEP). Each instrument varied in terms of content measured. Significantly, these are the first standardized instruments developed to assess comprehension in non-cognitively-impaired adults. Yet, each instrument had its own set of limitations such as the lack of generalizability and the absence of details pertaining to how test results should be used to guide clinical decision-making. Standardized clinical trial informed consent comprehension assessments have been developed to identify gaps in research participants' understanding and ensure that respect for patient autonomy is satisfied. (shrink)

Objective To document the legal guardian-related barriers to consent procurement, and their stated reasons for non-participation in a paediatric critical care research study.Study design A multicentre, prospective, cohort study.Participants Legal guardians of children who participated in a multicentre study on adrenal insufficiency in paediatric critical illness. Data were collected on all consent encounters in the main study.Methods Screening data, reasons for consent not being obtained, paediatric risk of mortality scores and age were collected on all 1707 patients (...) eligible for participation in the Adrenal Insufficiency Study.Results The main barriers to approaching legal guardians for consent were lack of availability of the legal guardians and language barriers . Legal guardians of 917 patients were approached with an overall consent rate of 42% . 81% of the 528 legal guardians who declined consent provided an unsolicited reason for refusal. The three most commonly stated reasons were: being overwhelmed , not wanting anything else done to their child and not wanting an additional medication . In addition, 14.2% cited research-related concerns as the reason for their non-participation.Conclusions Barriers to consent procurement in a non-therapeutic paediatric critical care study appear to occur at many levels with lack of availability of legal guardians, and legal guardians feeling overwhelmed, being the most commonly recorded reasons. Further research into the impact of these findings on the validity and generalisability of the results of such studies is necessary prior to the development and study of future consent models. (shrink)

This paper challenges historically preconceived notions surrounding a minor’s ability to make medical decisions, arguing that federal health law should be reformed to allow minors with capacity as young as age 12 to consent to their own Centers for Diseases Control and Prevention (CDC)-approved COVID-19 vaccinations. This proposal aligns with and expands upon current exceptions to limitations on adolescent decision-making. This analysis reviews the historic and current anti-vaccination sentiment, examines legal precedence and rationale, outlines supporting ethical arguments regarding adolescent (...) decision-making, and offers rebuttals to anticipated ethical counterarguments. (shrink)

Ethical concerns have been raised about routine practice in paediatric gender clinics. We discuss informed consent and the risk of iatrogenesis in the prescribing of gonadotropin-releasing hormone...

While most of the mortality associated with severe acute respiratory syndrome coronavirus 2 has been in elderly populations and adults with significant medical comorbidities, there has been death and morbidity in paediatric populations. As vaccine trial data is released to the public, many people look to the future with hope ; with good vaccine uptake there is the opportunity to reduce the spread of infectious pandemics. Initial vaccine trials were completed with adults and were expanded to include paediatric populations delaying (...) paediatric COVID-19 vaccine initiatives. The exclusion of children from initial vaccine trials during a pandemic is not morally justifiable and fosters distrust with the pharmaceutical and medical industries and inevitably postpones vaccinating children when there is a surplus of available vaccines. The delayed vaccination of children under twelve may have significant public health and economic consequences as there may be ongoing viral transmission in the context of reopening strategies. The safety and efficacy of these candidate vaccines in children should be assessed expeditiously so that distribution to vulnerable paediatric populations is not impacted. Vaccine uptake compliance in the general population is important in establishing herd immunity and ensuring that there is thorough scientific evidence to support vaccination for children is important in establishing community trust. (shrink)

The treatment of life-threatening illnesses in childhood is replete with ethical issues and with clinical issues that have ethical implications. The central issues are those involved with a child's participation in the decision-making process and with communication of information about the illness and treatments to children. This article examines the questions of patient autonomy and of parental responsibility and prerogative in the context of pediatric oncology. Included in this examination of the ethical dimensions of pediatric life-threatening illness is (...) a discussion of the many related aspects involved, including medical, cultural, psychosocial, legal, and developmental. A multidimensional approach that considers the ways in which these multiple aspects interact with one another, and which focuses on establishing a strong working alliance between the health care team and the pediatric patient's family, can help to avoid or resolve potential ethical and clinical conflicts. (shrink)

INTRODUCTION[|]The practice of medicine has evolved from old approach, in which all decisions for the patient are taken by physician, to a new approach, which includes patients to the medical decision-making process and endorses informed consent of the patients. In addition to healthcare professionals and patients, parents or legal representatives are stakeholders in the informed consent process of children. The knowledge and attitudes of physicians and medical school students about the informed consent period in children are important (...) for the effectiveness of the medical intervention and the biopsychosocial development of children. In this study, it was aimed to understand involvement of medical students and physicians in the informed consent process of children and their level of knowledge on children's rights and their attitudes in daily clinical practice.[¤]METHODS[|]The study is a descriptive study and n = 150 participants, who were randomly selected from senior medical school students working in medical school campus or university hospital and physicians serving pediatric patients, were included to this study. Questionnaires were applied for the measurement of participants' socio-demographic characteristics, education on pediatric patient rights, and legal provisions. The data were evaluated using SPSS 20.00 software.[¤]RESULTS[|]Of participants, 62% (n = 93) were phase 6 medical students, while 29.33% (n = 44) were resident physicians and the rest were faculty members (8.67%; n = 13). The proportion of physicians, who didn't received training on child rights, was 80.7% (n = 46) and statistically significantly higher than medical students (49.45%; n = 45) (p <0.001). However, participants who were not educated about the children's rights stated with higher ratio (44.83%; n=65), that informed consent should be obtained before medical intervention from individuals under 18 years of age, when they are compared to the the participants who received education (20.69%; n=30) (p = 0,019). The majority of participants (59.5%; n = 88) find the intervention in individuals under the age of 18 years in emergencies without consent of legal representatives ethically and legally appropriate (p <0.001). The participants believe that it is ethically and legally appropriate to conduct an intervention on an individual under the age of 18 years without the legal representative (36. 7%; n=54) (p <0.001).[¤]DISCUSSION AND CONCLUSION[|]This study compared the levels of knowledge and attitudes of participants, who were previously trained in or didn't received any training about children's rights and informed consent of children. However, the quality of the training of the participants on children's rights, was not questioned. This study showed that education on children's rights does not significantly increase the level of legal knowledge on children's rights. Having well-designed a subject focused on this theme in medical deontology and ethics education can increase the knowledge levels and improve the attitudes of medical students. This study sheds light on the issues that need to be focused in the medical faculties and the trainings of physicians and showed lack of information and need for development of attitudes regarding children's rights and informed consent in children.[¤]. (shrink)

BackgroundThis study aimed to determine the elements and the extent of information that child participants and their parents would like to read in an informed assent form /informed consent form of a pediatric drug trial.MethodsA descriptive survey was conducted to determine the perceived importance of each element of the ICF content from child participants and their parents who underwent informed assent/consent of a multi-center pediatric drug trial. The respondents were asked to indicate the level of importance (...) of each item in a questionnaire, by giving a rating scale from 1 to 5.ResultsA total of 22 families, 17 child participants with the diagnosis of hematology or oncology diseases and 27 parents, were enrolled. Among 30 items, risk–benefit aspects were perceived to be of most concerning items from both child participants’ and parents’ viewpoint. None of the items were considered ‘slightly important’ or lower by more than 20% of the respondents.ConclusionsFor pediatric drug trials, risk–benefit information should be made a salient feature of an IAF/icf. This empirical data could help related stakeholders arrange essential information in order of importance and tailor an IAF/icf to better suit child participants’ and parents’ needs, particularly for pediatric drug trials involving children with the diagnosis of hematology or oncology diseases. (shrink)