Pediatric Ethics Research Articles

Ethics and Brain Death in Pediatrics: Recent Controversy and Practical Suggestions.

Who decides when a child is dead? The story of Jahi McMath has brought this question into focus for pediatric intensivists, ethicists, and the American public. In this article, we address this question by arguing that medical professionals do not have an obligation to acquiesce when families insist upon postmortem therapies. To do so may harm the dignity of the child by subjecting him or her to procedures that objectify the body, damage the child's reputation, and violate his or her privacy. Applying this answer to the real world of pediatric intensive care, we suggest practices meant to preserve the dignity of the child while accepting that the family is struggling to understand the tragedy. Muddled communication or an unyielding attitude will fail to help the family understand and cope with the death of their young loved one. Clear and honest communication-in conjunction with an empathetic disposition-can improve pre- and postmortem care for both patient and family.

Ethical Conduct of Research in Children: Pediatricians and Their IRB (Part 2 of 2).

In part 1 of this series, we discussed the historical, ethical, and legal background that provides justification for the current system of protection of subjects of human experimentation. We also discussed briefly the implementation of those principles in institutional review board (IRB) operations. In part 2, we focus on legislation dealing with pediatric research, the rules and ethics of assent, and then turn our attention to minimal-risk studies. To that end, we discuss the minimal-risk threshold and the process of balancing benefit and risk in IRB decisions for pediatric studies. We define the notion of consent waiver as well as the procedures for expedited review, management of adverse events, and amendments to approved protocol. Finally, we mention some miscellaneous issues, including central and commercial IRB, reliance agreements, biobanks, and sample shipping regulations.

Pediatric Ethics and Communication Excellence (PEACE) Rounds: Decreasing Moral Distress and Patient Length of Stay in the PICU.

This paper describes a practice innovation: the addition of formal weekly discussions of patients with prolonged PICU stay to reduce healthcare providers' moral distress and decrease length of stay for patients with life-threatening illnesses. We evaluated the innovation using a pre/post intervention design measuring provider moral distress and comparing patient outcomes using retrospective historical controls. Physicians and nurses on staff in our pediatric intensive care unit in a quaternary care children's hospital participated in the evaluation. There were 60 patients in the interventional group and 66 patients in the historical control group. We evaluated the impact of weekly meetings (PEACE rounds) to establish goals of care for patients with longer than 10 days length of stay in the ICU for a year. Moral distress was measured intermittently and reported moral distress thermometer (MDT) scores fluctuated. "Clinical situations" represented the most frequent contributing factor to moral distress. Post intervention, overall moral distress scores, measured on the moral distress scale revised (MDS-R), were lower for respondents in all categories (non-significant), and on three specific items (significant). Patient outcomes before and after PEACE intervention showed a statistically significant decrease in PRISM indexed LOS (4.94 control vs 3.37 PEACE, p = 0.015), a statistically significant increase in both code status changes DNR (11% control, 28% PEACE, p = 0.013), and in-hospital death (9% control, 25% PEACE, p = 0.015), with no change in patient 30 or 365 day mortality. The addition of a clinical ethicist and senior intensivist to weekly inter-professional team meetings facilitated difficult conversations regarding realistic goals of care. The study demonstrated that the PEACE intervention had a positive impact on some factors that contribute to moral distress and can shorten PICU length of stay for some patients.

What kinds of cases do paediatricians refer to clinical ethics? Insights from 184 case referrals at an Australian paediatric hospital

Clinical ethics has been developing in paediatric healthcare for several decades. However, information about how paediatricians use clinical ethics case consultation services is extremely limited. In this project, we analysed...

Efficacy of ketamine in refractory convulsive status epilepticus in children: a protocol for a sequential design, multicentre, randomised, controlled, open-label, non-profit trial (KETASER01)

IntroductionStatus epilepticus (SE) is a life-threatening neurological emergency. SE lasting longer than 120 min and not responding to first-line and second-line antiepileptic drugs is defined as ‘refractory’ (RCSE) and requires...

Informed consent for paediatric clinical trials in Europe

ObjectivePaediatric clinical trials are often conducted as multinational trials. Informed consent or assent is part of the ethics committee approval for clinical trials. The consent requirements vary between countries due...

Promoting an ethic of engagement in pediatric palliative care research.

BackgroundThis paper defends the ethical and empirical significance of direct engagement with terminally ill children and adolescents in PPC research on health-related quality of life. Clinical trials and other forms of health research have resulted in tremendous progress for improving clinical outcomes among children and adolescents diagnosed with a life-threatening illness. Less attention has been paid, however, to engaging this patient population directly in studies aimed at optimizing health-related quality of life in PPC. Though not restricted to care at the end of life, PPC—and by extension PPC research—is in part dependent on recognizing the social complexities of death and dying and where health-related quality of life is a fundamental element. To explore these complexities in depth requires partnership with terminally ill children and adolescents, and acknowledgement of their active social and moral agency in research.DiscussionPrinciples of pediatric research ethics, theoretical tenets of the “new sociology of the child(hood),” and human rights codified in the United Nations Convention on the Rights of the Child (UNCRC) underpin the position that a more engagement-centered approach is needed in PPC research. The ethics, sociologies and human rights of engagement will each be discussed as they relate to research with terminally ill children and adolescents in PPC. Qualitative method(ologies) presented in this paper, such as deliberative stakeholder consultations and phenomenology of practice can serve as meaningful vehicles for achieving i) participation among terminally ill children and adolescents; ii) evidence-bases for PPC best practices; and iii) fulfillment of research ethics principles.ConclusionPPC research based on direct engagement with PPC patients better reflects their unique expertise and social epistemologies of terminal illness. Such an approach to research would strengthen both the ethical and methodological soundness of HRQoL inquiry in PPC.

Professionally Responsible Disclosure of Genomic Sequencing Results in Pediatric Practice.

Genomic sequencing is being rapidly introduced into pediatric clinical practice. The results of sequencing are distinctive for their complexity and subsequent challenges of interpretation for generalist and specialist pediatricians, parents, and patients. Pediatricians therefore need to prepare for the professionally responsible disclosure of sequencing results to parents and patients and guidance of parents and patients in the interpretation and use of these results, including managing uncertain data. This article provides an ethical framework to guide and evaluate the professionally responsible disclosure of the results of genomic sequencing in pediatric practice. The ethical framework comprises 3 core concepts of pediatric ethics: the best interests of the child standard, parental surrogate decision-making, and pediatric assent. When recommending sequencing, pediatricians should explain the nature of the proposed test, its scope and complexity, the categories of results, and the concept of a secondary or incidental finding. Pediatricians should obtain the informed permission of parents and the assent of mature adolescents about the scope of sequencing to be performed and the return of results.

144 Effect of treatment with ivacaftor on exhaled nitric oxide

Objectives Nitric oxide (NO) is reduced in cystic fibrosis (CF) airways and NO deficiency may contribute to CF lung disease. Previous studies have shown that antibiotic treatment for CF pulmonary exacerbations resulted in an increase in airway NO formation. Ivacaftor is the first CFTR-targeting drug that was approved for the treatment of people with CF and certain CFTR gating mutations. Methods We studied the effect of ivacaftor treatment on airway NO in people with CF in an observational trial. The study was approved by the pediatric and adult study site Institutional Research Ethics Boards. Results So far, a total of 12 (8 pediatric and 4 adult) patients with CF were recruited. All carried at least one copy of the Gly551Asp-CFTR mutation. Mean age at enrolment was 20 (range 6–50) years. Pulmonary function (spirometry) and fraction of exhaled NO (FENO 50 ) were measured before and 4 weeks after initiation of ivacaftor treatment. Both mean (±SD) forced vital capacity (93.4±11.6 vs 100.9±9.1% of predicted, p=0.004) and forced expiratory volume in one second (FEV1) (71.6±16.0 vs 83.3±16.2% of predicted, p=0.002) improved with treatment. FENO increased in all but one of the study participants (p Conclusion Four weeks of treatment with ivacaftor resulted in a significant increase in pulmonary function and airway NO formation. These data suggest that CFTR-targeting therapies may result in reconstitution of impaired airway NO formation in patients with CF.

Ethics consultation volume at U.S. children's hospitals: A cross-sectional survey

abstractBackground: There is growing interest in credentialing hospital ethicists. Consult volume is being incorporated into credentialing criteria, although few data supporting this approach are available. The objectives of this study were to (1) measure the consult volume at U.S. children's hospitals, (2) identify the factors associated with consult volume, and (3) determine the relevant views of pediatric ethics consultants. Methods: The study population was U.S. children's hospitals with at least 100 beds that have a dedicated pediatric ethics consultation service (n = 56). The study was a cross-sectional, Internet-based survey of the best informants at these hospitals. Results: The response rate was 79% (44/56). The median number of consults conducted per year was 8 (range 1–57). Factors associated with consult volume adjusted for hospital beds were salary support of the consultation service (p = 0.002); the frequency of didactic ethics lectures (p = 0.001); the frequency of ethics consultants informally visiting the hospital wards (p = 0.007), the number of educational services provided (p = 0.003); the frequency of ethics rounds (p = 0.02); and the use of a call schedule (p = 0.003). Seventy-nine percent believed that quality of ethics consultation is related to the number of consults performed, and 68% supported minimum standards for consult volume in a credentialing policy. Overall, 64% expressed support for credentialing of hospital ethicists. Conclusions: Educational and outreach efforts by hospital ethics committees, as well as salary support for hospital ethicists, are associated with increased pediatric ethics consultation volume at U.S. children's hospitals.

An introduction to behavioural decision‐making theories for paediatricians

Behavioural decision-making theories provide insights into how people make choices under conditions of uncertainty. However, few have been studied in paediatrics. This study introduces these theories, reviews current research and makes recommendations for their application within the context of shared decision-making. As parents are expected to share decision-making in paediatrics, it is critical that the fields of behavioural economics, communication and decision sciences merge with paediatric clinical ethics to optimise decision-making.

Not just little adults: a review of 102 paediatric ethics consultations.

The American Academy of Pediatrics statement on institutional ethics committees highlights the importance of paediatric ethics consultation. However, little has been published on actual experience with ethics consultation in paediatrics. The objective of this study was to review and describe topics covered by a large retrospective sample of clinical ethics consultations in paediatric medicine. We reviewed ethics consultations involving patients of <18years of age from January 2005 to July 2013 at one institution. Descriptive statistics of the patient population, the reason for the ethics consultation and the consultant's perceived contribution to the case were generated. Subgroups of patients were compared based on demographic and clinical characteristics using Wilcoxon's rank sum tests, chi-square tests and logistic regression models. Most of the 102 eligible consultations originated from intensive care units and were requested by attending physicians. The most frequent topic leading to consultation was end-of-life issues. Both younger age and male sex were associated with consults for end-of-life issues (p<0.001 and p=0.010). This analysis provides important information describing the type of consults requested in paediatric medicine, which is necessary given the movement towards professionalising clinical ethics consultation. Further empirical research is needed on ethics consultation in paediatrics.

Experience of an Ethics Committee of a pediatric reference hospital

Since 1960, there has been a growing interest in the complexity of the ethical problems posed by medical practice. Ever since then, many ethical theories have attempted to support bioethics, setting the necessary grounds for decision making process. The aim of this article is to briefly present the history and working of a pediatric hospital's Assistance Ethics Committee, as well as its evolution from the very beginning. Throughout the Committee's career, progressive changes were made in the way of working. During its first years, the fulfillment of certain formalities was demanded when presenting patients, but this was modified overtime towards a less rigid and more reflexive and pluralistic presentation. Regarding our Ethics Committee, deliberation is the main and most valuable tool in the search for the best option when dealing with harsh and problematic cases that are presented.

Children's Hospital ICU Nurse and Physician Rankings of Important Considerations in Pediatric End-of-Life Decision Making

Background: Families and clinicians must often weigh competing priorities when making medical decisions for a pediatric patient at the end of life. Few empirical data exist regarding the importance that clinicians place on varying priorities and whether clinical practice conforms to decision-making standards discussed in the literature. Methods: We administered a discrete choice experiment to understand the relative importance of nine pediatric end-of-life decision-making priorities using responses from 364 nurses and physicians from three intensive care units (ICUs) (pediatric ICU, pediatric cardiothoracic ICU, neonatal ICU) in a large children's hospital, with a 54% response rate. We used latent class analysis to characterize subgroups of health professionals based on their patterns of importance for the nine attributes and examined differences in class membership using multinomial logistic regression. Results: Eighty-two percent of respondents were nurses, consistent with the proportion of nurse and physician staff in the units. Latent class analysis separated our sample of health professionals into five distinct classes. All five groups rated the child's comfort and the best interests as most important but differed regarding how they valued other considerations: Group 1 rated highly consideration of the entire family and medical judgment; Group 2, the entire family's interests, parents’ preferences, and religious beliefs; Group 3, maintaining harmony between parents and medical team; Group 4, responsible use of medical resources; and Group 5, medical evidence and prolonging the child's life. Those with more years of experience were less likely to fall in Group 5 (medical evidence/life-prolonging). Profession was not associated with group membership. Conclusions: Nurses and physicians who care for dying children prioritize foremost the child's best interests and comfort but then possess varying secondary priorities about what is most important when making medical decisions. Pediatric palliative care and ethics consultative services should be aware of and prepared to address these differing concerns.

Pediatric Research Ethics: Islamic Perspectives

Background: Children’s participation is crucial in research on childhood diseases and cases associated with childhood health. Despite the existence of many publications that address ethical issues related to the participation of children in clinical research around the world, very little has been written about these ethical issues from an Islamic perspective. Methods: In this study, we analyzed medical research on children from three Islamic resources: plural fatwas by juristic institutions, the opinions of Islamic medical organizations and individual writings. Results: Seven plural fatwas from three juristic councils could be found. Only four of them raise ethical concerns about research on children. Two documents from medical organizations were identified. Conclusion: Three different positions could be concluded from these fatwas: a total prohibition, prohibition unless and permission. Prevention any harm is a major concern in all fatwas. Guardian's consent is necessary, but more details are needed. The guidelines of Islamic Organization of Medical Sciences IOMS reflect the best available Islamic perspective about research on children.

Knowledge of Pediatric Ethics: Results of a Survey of Pediatric Ethics Consultants

Background: Ethics consultants (ECs) are increasingly expected to possess core knowledge and skills. Few data address whether ECs actually possess recommended core knowledge. We aimed to measure pediatric ECs’ understanding of ethical principles, identify knowledge gaps, and explore associations between experience/training and knowledge in pediatric ethics consultations. Methods: We identified the 2 ECs most knowledgeable in pediatric ethics from each of 45 freestanding children's hospitals and an equal number of general teaching hospitals in the United States. This yielded a sample of 159 eligible pediatric ECs. Pediatric ECs were sent a survey measuring ethics training, characteristics of the ethics consultation service, and EC knowledge, as assessed by a previously validated scale entitled the Test of Residents’ Ethics Knowledge for Pediatrics (TREK-P). Of 102 completed surveys received, 99 were used in the analysis. Results: Seventy-three percent of ECs had completed ≥1 formal training modality, most commonly bioethics mini-courses, master's degrees, or certificate programs (20–30% each). Respondents infrequently received salary support (32%) or had a budget (28%) to support ethics work. The median TREK-P score was 19 (interquartile range [IQR] 17–21). Forty percent of subjects scored ≥20, surpassing the threshold of adequate performance proposed in previous work. Median scores were significantly higher among ECs with formal training in ethics but did not differ significantly by other variables. In secondary analyses, high scores (≥20) were significantly more common among ECs receiving salary support (55% vs. 33%, p = 0.04) and who had formal ethics training (47% vs. 22%, p = 0.02). Items pertaining to privacy, genetic testing, and assent, were answered incorrectly by >33% of ECs. Conclusions: High scores on a validated ethics knowledge scale were more common among ECs with salary support or formal ethics training. The study highlights knowledge gaps that warrant consideration as EC becomes a professionalized endeavor.

Fifty years of paediatric ethics.

In 1965, when the first issue of Journal of Paediatrics and Child Health appeared, medical ethics was just becoming established as a discipline. The sub-speciality of paediatric ethics did not make an appearance until the late 1980s, with the first key texts appearing in the 1990s. Professional concern to practice ethically in paediatrics obviously goes much further back than that, even if not named as such. In clinical areas of paediatrics, the story of the last 50 years is essentially a story of progress - better understanding of disease, better diagnosis, more effective treatment, better outcomes. In paediatric ethics, the story of the last 50 years is a bit more complicated. In ethics, the idea of progress, rather than just change, is not so straightforward and is sometimes hotly contested. There has certainly been change, including some quite radical shifts in attitudes and practices, but on some issues, the ethical debate now looks remarkably similar to that of 40-50 years ago. This is the story of some things that have changed in paediatric ethics, some things that have stayed the same and the key ethical ideas lying beneath the surface.

Germline mutations in children with cancer - leopoldina meeting report, september 26, 2014, jesuit monastery merzhausen

Under the umbrella of the Leopoldina, National Academy of Science Germany, a one-day workshop took place with experts from Pediatric Oncology, Human Genetics, Jurisprudence and Science Ethics. Professor Dr. Matthias Brandis, former head of the Clinic of Pediatrics and Adolescent Medicine, Albert-Ludwigs-University Freiburg, encouraged the authors to organize this workshop near Freiburg and provided professional and logistic support. Professor Dr. Matthias Brandis serves as the chairmen of our pediatric-gynecological section within the Leopoldina.

PO-0948 Evolving Ethics Support To A Children’s Hospital

Background and aims Increasing interventions for children with complex problems are leading to moral dilemmas for both professionals and families. We reviewed support to a children’s hospital from a bespoke Clinical Ethics Committee (CEC): 20 voluntary members, 1 part-time administrator. (Funded GOSH Children’s Charity) Membership: ethics/law, lay/parents, nurses, paediatricians, anaesthetists, surgeons, social care, psychologists, patient advocacy and managers. Aim Describe activity and case review change from full CEC Methods Retrospective CEC database and minutes review March 2013–14 and same 2009–10. Results Cases: 2013–14: 14 cases - 1 full CEC and 13 RR, 3 included external hospitals - 1 via videoconference. Parents attended 12. Themes: withdrawal life-sustaining therapy: 3; limitation life-sustaining therapy e.g. ECMO: 5; innovative therapies: 4; capacity/consent: 1, complex dilemma 1. 2009–10: 7 cases - 5 cases CEC, 2 RR. Parents 2. Themes: LLST 3, innovative 2, WLST 2. 3 meetings general ethical aspects of therapy – enzyme replacement provision, arteriolysis/thrombolysis for limb salvage and mitochondrial ethical pathway. Education: 1PhD, 2 BSc and 8 SSC medical students - leading to 8 presented abstracts and 2 publications. Lecture series for hospital/other staff. Paediatric Ethics Meeting ‘Making Tomorrows People’; 2 CEC education ‘away days.’ (Judiciary and academic philosophers). Media: Participation national (BBC) TV and radio ethics programmes and print media. Conclusions Ethics support to a variety of specialist teams and families is increasing. Support now provided for other hospitals with local reviews or videoconference support. Increasingly prevalent urgent ethics issues have lead to RR being preferred.

Actual aspects of medical ethics in training of the pediatrician

Nowadays the problems of medical ethics are gaining the special significance as a result of changes in social and economic relations, healthcare modernization due to appearance of new effective methods for instrumental and laboratory examinations, treatment approaches, development of market relations in medicine. The aim of the presented paper is to cover the actual aspects of medical ethics in pediatrics. The paper reviews the ethical aspects of the work of a in detail. Differentiated approach in choosing pediatrician interns, which is based not only on academic progress, but also on professional and moral qualities of the medical university alumni and continuity in their upbringing starting form the first years of the medical school until the end of post-graduate education, seems rationale. It is during the student years when the cognitive and moral values of a forthcoming specialist are formed, which may be a criterion of a suitability of working with children. The roles of the competition, including the modular approach to knowledge evaluation, professional competencies and rating system are stressed. Considering the modern requirements to a young professional, the accent is made on the role of the leading tutor in a forthcoming specialist formation. The requirements to a higher education teacher and the importance of the moral atmosphere in hospitals and faculties for forming the ethical features of a forthcoming pediatrician and improving his/her professional level according to the medical progress are outlined. Thus, teaching pediatrics has a lot of particularities, including teaching the basics of medical ethics, having an extremely important role in professional education of pediatricians for proper forming of the young professional according to contemporary life requirements.