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Many transplant programs worldwide are likely to impose vaccine mandates for pediatric solid organ transplant candidates; some already do. Three potential benefits that advocates invoke to justify mandates are improved patient outcomes, efficient organ allocation, and contributions to community protection. We show that none of these benefits can justify mandates. The medical benefits of mandates are unlikely to outweigh the risks of denying life-saving care, mandates threaten trust and equity in organ allocation, and the impact on community protection is likely negligible, while the burden on unvaccinated children would be disproportionate. We also reject the claim that clinician burdens in dealing with vaccine refusers are good reasons for mandates, and point out, to the contrary, that the potential political backlash to mandates is a good reason for restraint. Rather, we argue that vaccine mandates for pediatric transplant candidates should be a last resort; they should only be considered after all evidence-based noncoercive measures have been exhausted, and after mandates for transplant professionals and staff are in place. Since there is little evidence that all such measures have been attempted, it is premature to consider vaccine mandates., (© 2025 Wiley Periodicals LLC.)

Background: This study explores the ethical and moral challenges faced by paediatric oncologists when they are informed of patient genomic results, particularly during molecular tumour boards (MTBs), highlighting the interplay between their clinic, research and expert roles., Methods: This was an explanatory sequential mixed-methods study using a survey distributed to paediatric oncologists in Quebec followed by optional semi-structured interviews. Oncologists' attitudes and comfort levels with six hypothetical germline DNA results identified in a patient from a clinical vignette were assessed using Likert scales. Hypothetical genetic results represented ethical challenges of extended paediatric genomic sequencing. Interviews were conducted with a subgroup of participants to gain insight and context on key survey results., Results: Eighty per cent (n=28) of oncologists in Quebec completed the survey; five participated in the interviews. Comfort levels of oncologists were influenced by the type of genetic result (expected, secondary, incidental finding), whether or not the oncologist was the patient's treating physician, and whether the information disclosed to the patient aligned with the information that they had received. Awareness of a genetic result was sufficient to trigger a feeling of responsibility and liability for that result., Conclusion: Oncologists who take part in genomic sequencing initiatives and who attend MTBs have privileged access to genomic results, above what may be accessible to patients. This imbalance in knowledge contributes to moral discomfort experienced by oncologists who feel responsible for genomic information they are aware of. We propose recommendations applicable to consent processes, policies and pipelines for sharing genomic results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2025. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Decision-making capacity in pediatric health care is crucial for upholding ethical practices and protecting patient autonomy. It involves a patient's ability to understand the benefits, risks, and alternatives of a proposed treatment or intervention, demonstrate understanding, appreciate the consequences, reason clearly, and communicate their wishes. Informed consent and assent are essential concepts in pediatric decision-making, ensuring that patients, including children, clearly understand their treatment options, and voluntarily agree to them. The involvement of children in medical decisions should be proportional to their developmental stage, with adolescents having more autonomy in health care decisions., Competing Interests: Disclosure The authors have nothing to disclose., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Context: Children are a uniquely vulnerable patient population with restricted abilities for self-advocacy and autonomy, risking infringement upon their dignity. Yet the concept of dignity in pediatrics remains underexplored relative to the adult literature and other outcome measures., Objectives: To characterize how dignity is defined, evaluated, and/or measured in pediatrics., Methods: We conducted a systematic review following PRISMA guidelines across the following databases: MEDLINE, Embase, Cumulative Index of Nursing and Allied Health, PsycINFO, Global Health, Social Science Premium Collection, and Dissertation and Theses. We included publications from database inception through April 2023, in English, involving children aged 0-18 years, and prioritizing dignity as a central theme with a focus on defining, evaluating, or measuring dignity. Study descriptions and pertinent characteristics were extracted and synthesized using a predefined form., Results: Forty-four articles met inclusion criteria; fewer than half comprised original research (20/44, 45%). Most studies (38/44, 86%) included description of the meaning of dignity, with emergence of salient themes around respect, communication, agency/autonomy, and privacy. Less than half (19/44, 43%) included a measurement or evaluation of dignity; approximately one-third described dignity therapy. More than one-third of publications focused on dignity at end of life (17/44, 39%) and included discussions of palliative medicine and hospice (15/44, 34%)., Conclusion: Relatively few published studies describe dignity in pediatrics. Opportunities exist to broaden scholarship on this topic in partnership with patients, families, and clinicians, with the goal of assessing and strengthening dignity-centered care across the illness course and at the end of life., (Copyright © 2024 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Pediatric advocacy is an effort to champion the well-being of children and adolescents, ensuring access to quality health care and addressing socioeconomic issues linked to adverse health. This article explores pediatricians' responsibilities in advocating for their patients within the health care system and in broader societal contexts. Models of physician advocacy and the concept of advocacy as a fundamental professionalism responsibility, grounded in ethical principles and societal obligations, are introduced. As providers for patients who lack the capacity to advocate for themselves, the unique role of the pediatrician is examined. The improving landscape of advocacy education in undergraduate and graduate medical training programs is presented, and the concept that engaging in advocacy can help physicians battle burnout is raised. Barriers to advocacy for pediatricians are addressed. Pediatricians should leverage their expertise and influence to advance the health and rights of patients and their families. [ Pediatr Ann . 2024;53(12):e452-e457.] .

Medical decisions about pediatric gastroenterology pathologies often involve collaboration between the medical team and the family. On occasions, conflict may arise between the individuals involved in decision making (team-family conflict) causing delays in managing a child's health condition. Little is known on the strategies that can be implemented to address such conflicts. Using the systematic review model by McCullough et al., an electronic literature search was conducted using PUBMED databases and SCOPUS. Studies published between 2001 and 2022 were analyzed to identify high-risk families, the barriers and facilitators involved in the team-family conflict and the circumstances in which healthcare professionals can be ethically justified to override parents' medical decisions and to trigger the state intervention. The present review provides recommendations on the more suitable ways to manage team-family conflict and gives a practical approach using a case vignette., (© 2024 European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.)

Background: Little is known about the extent to which pediatric palliative care (PPC) clinicians are engaged in ethics consults or how they perceive interactions with ethics consultants. Objective: Describe the extent to which PPC team members serve in pediatric health care ethics (PHCE) consultancy roles and to describe their experiences interacting with pediatric ethic consultant services. Design: Online survey distributed to members of the American Academy of Pediatrics and American Academy of Hospice and Palliative Care pediatric and ethics section and special interest groups in the United States. Results: Eighty-six responses were obtained (response rate 45%) from PPC teams in 70 different children's hospitals located in 34 states. Almost all (97%) reported a functional ethics consult service such that PPC is not expected to meet the ethics need of the institution. A person involved on the PPC team also performed ethics consults in half (49%) of the settings, predominantly the PPC physician. Most respondents who perceive PPC teams engage in ethics-relevant work as part of their everyday PPC work. Formal ethics training was lacking among PPC members involved in ethics consults with few ethics degrees (15%), certifications (6%), or fellowships (2%). Discord (67%), conflict (49%), limitations to treatment (48%), and distress (41%) were cited as the most frequent reasons for which PPC teams consult ethics. PPC respondents identified role clarity, coordinated engagement, timely presence, and open communication as strong PHCE consultant practices. Conclusions: PPC team members performing ethics consults may benefit from additional ethics education and training. Further research is warranted to delineate scope of ethics consultancy relevant to PPC and role clarity.

Background: This study assesses how pediatric assent is conceptualized and justified within the therapeutic context. Pediatric ethicists generally agree that children should participate in medical care decisions in developmentally appropriate ways. Much attention has been paid to pediatric assent for research participation, but ambiguities persist in how assent is conceptualized and operationalized in the therapeutic context where countervailing considerations such as the child's best interest and parental permission must also be weighed., Methods: Searches were conducted in 11 databases including PubMed, Embase, Cochrane Library, and Web of Science. Articles published between 2010 and 2020 were screened in COVIDENCE for meeting each of four criteria: (1) focusing on pediatric assent, (2) focusing on clinical care, (3) including normative claims, and (4) containing substantive statements about the meaning of pediatric assent. Full texts were abstracted for (1) operational definitions of assent, (2) discussion of the temporal nature of assent, (3) description of the concept of "understanding," and (4) ethical justifications for soliciting assent. These excerpts were coded and code patterns formed themes presented in the results., Results: The final analytic data set contained 29 articles. Analysis yielded three key themes. First, valid assent varies by treatment, population (e.g., younger versus older), and geographic/cultural context. Second, assent represents two distinct longitudinal processes: One involves eliciting preferences over a disease course or care episode; the other focuses on children's developmental maturation. Third, ethical justifications for assent draw variously on instrumental and intrinsic reasons, but often remain ambiguous., Conclusions: There is widespread agreement that assent is morally valuable, but there remain substantial ambiguities or disagreements about its meaning, process, and ethical justification.

Pediatric diseases possess unique characteristics, requiring pediatricians to have strong critical thinking skills and sound ethical decision-making abilities. This study aims to investigate and analyze the critical thinking dispositions of pediatric medical students and their impact on ethical decision-making levels, and to propose suggestions for improving teaching methods. A cross-sectional study design was adopted, using the Chinese version of the California Critical Thinking Disposition Inventory (CCTDI-CV) and an ethical decision-making questionnaire. An online survey was conducted among 240 pediatric medical students at Chongqing Medical University, collecting participants' basic demographic information. The study described the CCTDI-CV scores and ethical decision-making questionnaire scores (mean ± standard deviation), with distribution and trend analyses performed using t tests and H-tests. Pearson correlation analysis was used to examine the relationship between the 2, and regression analysis was conducted to explore factors influencing ethical decision-making abilities. A total of 229 students (95.4%) completed the survey. The overall average score of critical thinking disposition among pediatric medical students was 287.96 ± 39.09, with 139 students (60.70%) demonstrating positive or highly positive critical thinking dispositions. Ethical decision-making abilities were excellent in 85 students (37.12%). There was a significant positive correlation between critical thinking abilities and ethical decision-making abilities (R = 0.774, P < .001), particularly with analysis abilities, systematic abilities, and cognitive maturity showing higher correlations with total ethical decision-making scores. CCTDI-CV scores had a significant positive impact on ethical decision-making levels (P < .001), with factors such as family background and high school performance also significantly influencing ethical decision-making abilities (P < .001). Chinese pediatric medical students generally exhibit strong critical thinking and ethical decision-making abilities. Critical thinking plays a crucial role in medical ethical decision-making, with family background and high school performance being important influencing factors. Educators should focus more on developing multidimensional critical thinking skills to enhance students' ethical decision-making abilities, thereby improving overall healthcare service quality. The study results also provide new perspectives for international pediatric medical educators., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2024 the Author(s). Published by Wolters Kluwer Health, Inc.)

Competing Interests: Great Ormond Street Hospital and University College London, Institute of Child Health receive support as a National Institute for Health and Care Research (NIHR) Biomedical Research Center. Prof. Peters’ institution received funding from the U.K. NIHR Health Technology Assessment Program. The views expressed are those of the authors and not necessarily those of the National Health Service, the NIHR, or the U.K. Department of Health. Ms. Plant has disclosed that she does not have any potential conflicts of interest.

This letter responds to the Other Voices commentaries "Troubling Trends in Health Misinformation Related to Gender-Affirming Care," by Stef M. Shuster and Meredithe McNamara; "Values and Evidence in Gender-Affirming Care," by Os Keyes and Elizabeth Dietz; "Breaking Binaries: The Critical Need for Feminist Bioethics in Pediatric Gender-Affirming Care," by Lisa Campo-Engelstein, Grayson Jackson, and Jacob Moses; and "Minors Lack the Autonomy to Consent to Gender-Affirming Care: Best Interests Must Be Primary," by John C. Bester, in the May-June 2024 issue of the Hastings Center Report., (© 2024 The Hastings Center.)

AbstractThe field of surgery has relied on innovation and creativity to improve patient care and propel the field forward. Historically, regulatory oversight of innovative approaches to surgery has been largely inconsistent, rendering surgeons relatively unrestricted creative latitude in the operating room; whether this has proven to be more beneficial or harmful is subject to debate. While innovation plays a crucial role in the advancement of surgical techniques, the potential drawbacks of unregulated innovation must be seriously considered, especially when treating vulnerable populations such as infants and children. This article provides an overview of the ethical aspects surrounding innovation in pediatric surgery, including discussion of relevant considerations, controversies, and pitfalls. The following includes a review of the current and past literature surrounding the topic. The purpose of this review is to heighten awareness of the ethical challenges that surgeons face when considering novel operative techniques on pediatric patients.

Children commonly refuse induction of anesthesia. Anesthesia providers must then decide whether to honor the child's dissent or to proceed over objection. In some circumstances, a forced induction involves restraining the child, incurring both practical and ethical harms to the patient-provider encounter. This educational review explores the practical dilemma encountered when a child dissents to induction of anesthesia. In the course of exploring this dilemma, dissent and associated terms are defined and compared, and the prominent ethical underpinnings regarding pediatric decision-making are described to clarify dissent as an ethical and practical concept. Important legal and professional standards are summarized, and practice trends are discussed to depict the current state of practice, including novel approaches to honoring pediatric dissent for elective surgeries. This information is then used to invite providers to consider where they ethically situate themselves within a legally and professionally defined space of acceptable practice. Finally, these considerations are synthesized to discuss important nuances regarding pediatric refusal, and some key questions are presented for clinicians to ponder as they consider their practice of choosing whether to honor pediatric dissent at induction., (© 2024 John Wiley & Sons Ltd.)

The Academy of Medicine of Malaysia College of Paediatrics acknowledges the role of children in research and this position statement explores the ethical considerations in obtaining assent from minors in the Malaysian context. It highlights the importance in respecting children's agency and navigating cultural complexities. The College proposes flexibility in the minimum age for assent of at least nine years old, while emphasising the need for a tailored assent procedure. Addressing language and cultural diversities and expanding local empirical research on a formal assent process are some building blocks in developing a standardised nationwide process in obtaining assent from children.

Pediatric procedure-related pain management is often incompletely understood, inadequately addressed, and critical in influencing a child's lifelong relationship with the larger health care community. We highlight the evolution of ethics and expectations around optimizing periprocedural pain management as a fundamental human right. We investigate the state-of-the-art of topical anesthetics, reviewing their mechanisms of action and providing comparisons of their relative safety and efficacy data to help guide clinical selection. In total, this two-part review offers a combination of conventional approaches and innovative techniques that should be used multimodally-in series and in parallel-to help optimize pain management and provide alternatives to sedation medication and general anesthesia., (© 2024 Wiley Periodicals LLC.)

Ready access to the internet and online sources of information about child health and disease has allowed people more 'distant' from a child, family and paediatric clinician to inform and influence clinical decisions. It has also allowed parents to share aspects of their child's health and illness to garner support or funding for treatment. As a consequence, paediatric clinicians must consider and incorporate the crowd of opinions and voices into their clinical and ethical reasoning.We identify two key ethical principles and related ethics concepts foundational to this task. We then propose a series of exploratory ethics questions to assist paediatric clinicians to engage ethically with the multiple voices in the clinical encounter while keeping the child's needs as a central focus. Using two clinical hypothetical case examples, we illustrate how our proposed ethics questions can assist paediatric clinicians to navigate the crowd in the room and bring moral reasoning to bear.We highlight a need for specific practical interactional skills training to assist clinicians to ethically respond to the crowd in the room, including to identify and weigh up the harms and benefits of endorsing or going against proposed treatments for a child, and how to discuss social media and online sources of information with parents., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

This commentary responds to Moti Gorin's article "What Is the Aim of Pediatric 'Gender-Affirming' Care?" We argue that Gorin's case against pediatric gender-affirming care rests upon numerous false conceptual binaries: female/male, public/private, objective/subjective, and medically necessary/elective. Drawing on feminist bioethics, we show how such dichotomous thinking is both inaccurate and marginalizing of gender minorities., (© 2024 The Hastings Center.)

Biobanking-the storage of human biological samples, including tissue, blood, urine, and genetic data-raises many ethical, legal, and social issues, including confidentiality and privacy. Pediatric biobanking is more complicated, with difficulties arising because children lack capacity to consent and acquire this capacity upon maturity when the research is still ongoing. Yet given the limited availability of pediatric samples, the translational nature of biobanking presents a unique opportunity to share samples and produce clinically necessary information about pediatric development and diseases. Guidance on navigating these legal and ethical difficulties is needed for those involved in pediatric biobanking-including researchers, participants, and families, and those involved in biobank governance. This paper seeks to map the current regulatory framework governing pediatric biobanking to determine what guidance is currently offered. Regulatory mapping of current international and national guidelines on pediatric biobanking addressing the ethical, legal, and social nuances of pediatric biobanking was undertaken. This paper finds that international guidelines around biobanking are mostly for adults, and even when pediatric-specific, documents are non-binding, inconsistent, or only limited guidance is offered on a range of important issues specific to pediatric biobanks.   Conclusion: This paper shows a need for consistent, comprehensive, and clear regulation on pediatric biobanking so that research can more quickly, efficiently, and ethically be translated to useful information and treatment in pediatric care. What is Known: • Pediatric biobanking presents new opportunities to conduct valuable translational research to benefit pediatric populations. However, the storage of pediatric biological samples raises many ethical, legal and social issues-in part because child participants may be considered to lack capacity to consent but can acquire this capacity upon maturity when the research is still ongoing. Pediatric biobanks must grapple with issues of consent, confidentiality and privacy, and long-term participation regarding child participants. What is New: • Regulatory guidance on these ethical, legal, and social issues is needed for researchers, participants, and families and those involved in biobank governance. This paper identifies nationally specific and international guidance on biobanking and summarizes the guidance provided in relation to these pediatric specific issues. It finds that most guidance is non-binding and inconsistent between guidance documents and may offer only limited guidance to stakeholders. A need for consistent, comprehensive, and clear regulation on pediatric biobanking is needed at an international level to enable research., (© 2024. The Author(s).)

Pediatricians have a fiduciary responsibility to advocate for the best interests of their patients. They accomplish this through the therapeutic alliance with the patient and their parent. In everyday clinical medicine, the pediatrician may be faced with challenging situations. When a case raises concerns, the pediatrician needs to determine if the issues relate to ethical obligations and whether they are in conflict. To resolve the concerns, a systematic process for gathering, organizing, and analyzing the facts of a case is needed to discern morally permissible options. This article presents a framework for performing an ethics case analysis., (Copyright © 2023 Elsevier Inc. All rights reserved.)

In summer 2022, six points of consensus emerged from a symposium addressing the question, "In the context of U.S. pediatric care, what moral precepts ought to guide parents and clinicians in medical decision making for children?" (Salter et al. 2023). The authors of this statement wrote, however, that the points of consensus may require modification or may not apply in their entirety to children in state custody. This article addresses the consensus recommendations in the context of the thousands of children removed annually from the custody of their parents. While the consensus statements developed at the symposium provide a good starting point for decision-making in the context of these children, some alterations and nuance must be applied to attend to the specific needs of this population. The article works through what special considerations and changes ought to be made to expand the reach of the original points of consensus without neglecting the particular conditions of children in state custody, as well as their parents and caregivers.

Recently published consensus recommendations on pediatric decision-making by Salter and colleagues (2023) did not address neonatal decision-making, due to the unique complexities of neonatal care. This essay explores three areas that impact neonatal decision-making: legal and policy considerations, rapid technological advancement, and the unique emotional burdens faced by parents and clinicians during the medical care of neonates. The authors evaluate the six consensus recommendations related to these considerations and conclude that the consensus recommendations apply to neonates.

This article describes the process engaged by 17 expert scholars in the development of a set of six consensus recommendations about the normative foundations of pediatric decision-making. The process began with a robust pre-reading assignment, followed by three days of in-person symposium discussions that resulted in a publication in Pediatrics entitled "Pediatric Decision-Making: Consensus Recommendations" (Salter et al. 2023). This article next compares the six recommendations to existing statements about pediatric decision-making (specifically those developed by the American Academy of Pediatrics), highlighting similarities and differences. Finally, the article discusses the value of finding consensus in the field of pediatric bioethics.

Background: Physicians are frequently faced with ethical dilemmas that require answers based in moral reasoning, which develops and evolves during their lives and their medical education. According to Kohlberg, there are three levels of moral reasoning development: pre-conventional (in which decisions are guided by oneself convenience), conventional (focused on obeying society's rules), and post-conventional (decisions are based in universal ethical principles). The aim of this study was to describe the level of moral reasoning among new pediatric resident physicians in a tertiary hospital., Method: This cross-sectional descriptive study was conducted from 2020 to 2023. The Defining Issues Test was used to assess the level of moral reasoning among 195 new pediatric resident physicians in a tertiary hospital., Results: Most resident physicians considered the fourth stage affirmations to be the most important. The median P-index (PI) was 40, and 49% of participants were on the post-conventional level of moral reasoning. The year with the lowest number of new resident physicians on the post-conventional level was 2021., Conclusion: The moral reasoning level among pediatric resident physicians was higher than the average found in general population. This suggests that the education received during the medical formation may influence the individuals' moral development., (Copyright: © 2024 Permanyer.)

Pediatric intervention principles help clinicians and health-care institutions determine appropriate responses when parents' medical decisions place children at risk. Several intervention principles have been proposed and defended in the pediatric ethics literature. These principles may appear to provide conflicting guidance, but much of that conflict is superficial. First, seemingly different pediatric intervention principles sometimes converge on the same guidance. Second, these principles often aim to solve different problems in pediatrics or to operate in different background conditions. The potential for convergence between intervention principles-or at least an absence of conflict between them-matters for both the theory and practice of pediatric ethics. This article builds on the recent work of a diverse group of pediatric ethicists tasked with identifying consensus guidelines for pediatric decision-making.

Children continue to experience harm when undergoing clinical procedures despite increased evidence of the need to improve the provision of child-centred care. The international ISupport collaboration aimed to develop standards to outline and explain good procedural practice and the rights of children within the context of a clinical procedure. The rights-based standards for children undergoing tests, treatments, investigations, examinations and interventions were developed using an iterative, multi-phased, multi-method and multi-stakeholder consensus building approach. This consensus approach used a range of online and face to face methods across three phases to ensure ongoing engagement with multiple stakeholders. The views and perspectives of 203 children and young people, 78 parents and 418 multi-disciplinary professionals gathered over a two year period (2020-2022) informed the development of international rights-based standards for the care of children having tests, treatments, examinations and interventions. The standards are the first to reach international multi-stakeholder consensus on definitions of supportive and restraining holds.    Conclusion: This is the first study of its kind which outlines international rights-based procedural care standards from multi-stakeholder perspectives. The standards offer health professionals and educators clear evidence-based tools to support discussions and practice changes to challenge prevailing assumptions about holding or restraining children and instead encourage a focus on the interests and rights of the child. What is Known: • Children continue to experience short and long-term harm when undergoing clinical procedures despite increased evidence of the need to improve the provision of child-centred care. • Professionals report uncertainty and tensions in applying evidence-based practice to children's procedural care. What is New: • This is the first study of its kind which has developed international rights-based procedural care standards from multi-stakeholder perspectives. • The standards are the first to reach international multi-stakeholder consensus on definitions of supportive and restraining holds., (© 2023. The Author(s).)

Background: Public policy approaches to funding paediatric medicines in advanced health systems remain understudied. In particular, the ethical and social values dimensions of health technology assessment (HTA) and drug coverage decisions for children have received almost no attention in research or policy., Methods: To elicit and understand the social values that influence decision-making for public funding of paediatric drugs, we undertook a series of in-depth, semi-structured interviews with a stratified purposive sample (n = 22) of stakeholders involved with or affected by drug funding decisions for children at the provincial (Ontario) and national levels in Canada. Constructivist grounded theory methodology guided data collection and thematic analysis., Results: Our study provides empirical evidence about the unique ethical and social values dimensions of HTA for children, and describes a novel social values typology for paediatric drug policy decision-making. Three principal categories of values emerged from stakeholder reflections on HTA and drug policy-making for children: procedural values, structural values, and sociocultural values. Key findings include the importance of attention to the procedural legitimacy of HTA for children, with emphasis on the inclusion of child health voices in processes of technology appraisal and policy uptake; a role for HTA institutions to consider the equity impacts of technologies, both in setting review priorities and in assessing the value of technologies for public coverage; and the potential benefits of a distinct national framework to guide drug policy for children., Conclusion: Current approaches to HTA are not well designed for the realities of child health and illness, nor the societal priorities regarding children that our study identified. This research generates new knowledge to inform decision-making on paediatric drugs by HTA institutions and government payers in Canada and other publicly-funded health systems, through insights into the relevant social values for child drug funding decisions from varied stakeholder groups., (© 2022 The Author(s); Published by Kerman University of Medical Sciences. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.)

The US Food and Drug Administration (FDA) approval of the biologics license application for the Pfizer-BioNTech coronavirus disease 2019 vaccine (Comirnaty) on August 23, 2021, opened the door to the off-label vaccination of children younger than the age range currently covered by either the biologics license application (16 years old and older) or the emergency use authorization (12 to 15 years old). Although prescribing medications at doses, for conditions, or in populations other than those approved by the FDA is generally legal and is common in pediatrics, the FDA, the Centers for Disease Control and Prevention, and the American Academy of Pediatrics have recommended against off-label prescription of the coronavirus disease 2019 vaccine. Several commentaries consider a case in which parents ask their child's pediatrician to prescribe the vaccine for their 11-year-old with special health care needs before approval or authorization in her age group. The first commentary considers the potential benefits and risks to the patient, as well as to the family, the provider, and society, emphasizing the unknown risks in younger patients and the need for adequate informed consent. The second commentary describes an algorithm and principles for evaluating off-label prescribing and argues that the current benefits of prescribing Comirnaty off label to children <12 do not outweigh the risks. The third commentary addresses ethical and legal issues, ultimately calling on federal agencies to remove legal barriers to making the vaccine available to children in age groups that currently lack authorization., Competing Interests: FINANCIAL DISCLOSURES: The authors have indicated they have no financial disclosures relevant to this article to disclose., (Copyright © 2022 by the American Academy of Pediatrics.)

As the nation implements SARS-CoV-2 vaccination in adults at an unprecedented scale, it is now essential to focus on the prospect of SARS-CoV-2 vaccinations in pediatric populations. To date, no children younger than 12 years have been enrolled in clinical trials. Key challenges and knowledge gaps that must be addressed include (1) rationale for vaccines in children, (2) possible effects of immune maturation during childhood, (3) ethical concerns, (4) unique needs of children with developmental disorders and chronic conditions, (5) health inequities, and (6) vaccine hesitancy. Because COVID-19 is minimally symptomatic in the vast majority of children, a higher acceptable risk threshold is required when evaluating pediatric clinical trials. Profound differences in innate and adaptive immunity during childhood and adolescence are known to affect vaccine responsiveness for a variety of childhood diseases. COVID-19 and the accompanying social disruption, such as the school shutdowns, has been disproportionately damaging to minority and low-income children. In this commentary, we briefly address each of these key issues, specify research gaps, and suggest a broader learning health system approach to accelerate testing and clinical trial development for an ethical and effective strategy to implement a pediatric SARS-CoV-2 vaccine as rapidly and safely as possible. IMPACT: As the US begins an unprecedented implementation of SARS-CoV-2 vaccination, substantial knowledge gaps have yet to be addressed regarding vaccinations in the pediatric population. Maturational changes in the immune system during childhood have influenced the effectiveness of pediatric vaccines for other diseases and conditions, and could affect SARS-CoV-2 vaccine responsiveness in children. Given that COVID-19 disease is far milder in the majority of children than in adults, the risk-benefit of a pediatric SARS-CoV-2 vaccine must be carefully weighed. The needs of children with developmental disabilities and with chronic disease must be addressed. Minority and low-income children have been disproportionately adversely affected by the COVID-19 pandemic; care must be taken to address issues of health equity regarding pediatric SARS-CoV-2 vaccine trials and allocation. Research and strategies to address general vaccine hesitancy in communities must be addressed in the context of pediatric SARS-CoV-2 vaccines., (© 2021. The Author(s), under exclusive licence to the International Pediatric Research Foundation, Inc.)

Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht.

Integrated behavioral health models of care offer many benefits for patient experience and outcomes. However, multidisciplinary teams are comprised of professionals who each may have different professional norms and ethical obligations, which may at times be in conflict. This article offers a framework for negotiating potential conflicts between professional norms and expectations across disciplines involved in integrated behavioral health teams., Competing Interests: Disclosure No financial or relationship conflicts of interest relevant to this publication., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Introduction: Rare diseases, despite their low individual prevalence, affect a large number of children. Their management has considerably improved recently due to new treatments, modifying the diseases evolution without being totally curative. Since this raises many ethical dilemmas, we present a study about respecting the principles of medical ethics in the management of rare diseases in pediatrics., Material and Methods: We carried out a qualitative study in a French pediatric neurology department. In our study, we included health caregivers and parents of children being monitored for rare diseases and benefiting from innovative therapies. We conducted semi-structured interviews and, after transcription, we performed computerized and manual analysis., Results: A total of 26 participants were included. Six main themes were addressed: rare diseases, science and medical research, general disease management, specific innovative treatments, neonatal screening, and cost of these treatments. Discussions centered on the children. Particular importance was given to the notions of information and the physician/family relationship. A major place is given to the treatment objectives and the improvement of quality of life. We also noted a sense of satisfaction with the current overall management of these diseases., Conclusion: Our study suggests that our current practice, including the use of innovative therapies, respects the four main ethical principles, from the points of view of both caregivers and parents., (Copyright © 2021 French Society of Pediatrics. Published by Elsevier Masson SAS. All rights reserved.)

Background: Pediatric ethics consultations are important but understudied, with little known about consultations' contextual attributes, which may influence how ethically problematic situations are perceived and addressed., Methods: We analyzed data regarding 245 pediatric clinical ethics consultations performed between 2013 and 2018 at a large children's hospital. Prespecified data elements included 17 core problematic issues that initiate consultations, 9 ethical considerations identified by the consultation service, and 7 relational, emotional, and pragmatic contextual attributes of the consultation. The main process measure was the cumulative consultation process, ranging from one-on-one discussions with the requestor, to meeting with the clinical team, separate meetings with the patient or family and the clinical team, or combined meeting with the patient or family and the clinical team., Results: The most-prevalent core problematic issues were intensity or limitation of treatment (38.8%) and treatment adherence and refusal (31%). Common pertinent ethical considerations were best interest (79.2%), benefits versus harms of treatment (51%), and autonomy and decision-making (46.5%). A total of 39.2% of consults culminated with a meeting with the clinical team, 9.4% with separate meetings, and 8.2% with a meeting with all parties. Common contextual attributes were discord (43.3%), acknowledged dilemma (33.5%), and articulate disagreement (29.8%). In exploratory analyses, specific contextual attributes were associated with the core problematic issue that initiated the consultation and with how the consultative process culminated., Conclusions: Pediatric ethics consultations have contextual attributes that in exploratory analyses are associated with specific types of problems and, to a lesser degree, with the cumulative ethics consultation process., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2021 by the American Academy of Pediatrics.)

Objective: Breaking bad news about life-threatening and possibly terminal conditions is a crucial part of paediatric care for children in this situation. Little is known about how the parents of children with life-threatening conditions experience communication of bad news. The objective of this study is to analyse parents' experiences (barriers and facilitators) of communication of bad news., Design: A qualitative study consisting of a constant comparative analysis of in-depth interviews conducted with parents., Setting: The Netherlands., Participants: Sixty-four parents-bereaved and non-bereaved-of 44 children (aged 1-12 years, 61% deceased) with a life-threatening condition., Interventions: None., Results: Based on parents' experiences, the following 10 barriers to the communication of bad news were identified: (1) a lack of (timely) communication, (2) physicians' failure to ask parents for input, (3) parents feel unprepared during and after the conversation, (4) a lack of clarity about future treatment, (5) physicians' failure to voice uncertainties, (6) physicians' failure to schedule follow-up conversations, (7) presence of too many or unknown healthcare professionals, (8) parental concerns in breaking bad news to children, (9) managing indications of bad news in non-conversational contexts, and (10) parents' misunderstanding of medical terminology., Conclusions: This study shows healthcare professionals how parents experience barriers in bad news conversations. This mainly concerns practical aspects of communication. The results provide practical pointers on how the communication of bad news can be improved to better suit the needs of parents. From the parents' perspective, the timing of conversations in which they were informed that their child might not survive was far too late. Sometimes, no such conversations ever took place., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

The pediatrician has a privileged relationship with a child with infantile spinal muscular atrophy (SMA). At all times, he/she must be the child's mentor, promoting a comprehensive approach and support in order to ensure the best possible solution for the patient's autonomy. In all circumstances, an ethical stance is essential. After a reminder on the notions of ethics of care, we will address various ethical questions encountered through three critical situations during the care of a child with infantile spinal muscular atrophy: the announcement of the diagnosis, the transmission of information on innovative therapies, and palliative care and end-of-life support. © 2020 French Society of Pediatrics. Published by Elsevier Masson SAS. All rights reserved., (Copyright © 2020 French Society of Pediatrics. Published by Elsevier Masson SAS. All rights reserved.)

The goal of perinatal medicine is to provide professionally responsible clinical management of the conditions and diagnoses of pregnant, fetal, and neonatal patients. The New York Declaration of the International Academy of Perinatal Medicine, "Women and children First - or Last?" was directed toward the ethical challenges of perinatal medicine in middle-income and low-income countries. The global COVID-19 pandemic presents common ethical challenges in all countries, independent of their national wealth. In this paper the World Association of Perinatal Medicine provides ethics-based guidance for professionally responsible advocacy for women and children first during the COVID-19 pandemic. We first present an ethical framework that explains ethical reasoning, clinically relevant ethical principles and professional virtues, and decision making with pregnant patients and parents. We then apply this ethical framework to evidence-based treatment and its improvement, planned home birth, ring-fencing obstetric services, attendance of spouse or partner at birth, and the responsible management of organizational resources. Perinatal physicians should focus on the mission of perinatal medicine to put women and children first and frame-shifting when necessary to put the lives and health of the population of patients served by a hospital first.

Background: Progress in precision medicine relies on the access to, use of, and exchange of genomic and associated clinical data, including from children. The ethical, legal, and social issues (ELSI) of such data access, use, and exchange may be accentuated in the pediatric context due in part to the highly sensitive nature of genomic data, children's consent-related vulnerabilities, and uncertain risks of reidentification. Systematic analyses of the ELSI and scientific reasons for why and how genomic data may be shared responsibly are, however, limited. Methods: We conducted a modified systematic review of reasons according to Sofaer and Strech to examine the ELSI and scientific reasons for "responsible" sharing of children's genomic and associated clinical data. Empirical articles, commentaries, and data-sharing policies indexed in Medline, Scopus, Web of Science, and BIOSIS were included in the analysis if they discussed ELSI and were published between 2003 and 2017 in English. Results: One hundred and fifty-one records met our inclusion criteria. We identified 11 unique reasons and 8 subreasons for why children's genomic data should or should not be shared. Enhancing the prospect of direct and indirect benefits and maximizing the utility of children's data were top reasons why data should be shared. Inadequate data privacy protection was the leading reason why it should not. We furthermore identified 8 reasons and 30 subreasons that support conditional data sharing, in which recontact for the continued use of children's data once they reach the age of majority was the most frequently endorsed condition. Conclusions: The complete list of ELSI reasons and responsible conditions provides an evidentiary basis upon which institutions can develop data-sharing policies. Institutions should encourage the sharing of children's data to advance genomic research, while heeding special reconsent and data protection mechanisms that may help mitigate uncertain longitudinal risks for children and families.

The primary objective was to review pediatric ethics consultations (PECs) at a large academic health center over a nine year period, assessing demographics, ethical issues, and consultant intervention. The secondary objective was to describe the evolution of PECs at our institution. This was a retrospective review of Consultation Summary Sheets compiled for PECs at our Academic Health Center between January 2008 and April 2017. There were 165 PECs reviewed during the study period. Most consult requests came from the inpatient setting, with the Pediatric and Neonatal Intensive Care Units being the highest utilizers. Consultation utilization increased over the study period. The most common patient age was less than one year. Physicians were most likely to request consultation. Patient Best Interest, Withholding/Withdrawing of Life Sustaining Therapy, and Provider Moral Distress were ethical issues most commonly identified by the consultants. Making recommendations was the most common consultant intervention. The ethics consultation process evolved over time from informal provider discussions, to a hospital infant care review committee, to a pediatric only consultation service, to a combined adult/pediatric consultation service, with variable levels of salary support for consultants. Ethics consultation requests are growing at our institution. Similarities in identified ethical issues exist between our findings and existing literature, however meaningful comparisons remains elusive secondary to variability in approaches to investigation and reporting. A combined paid/volunteer/trainee ethics consultation service model appears sustainable and real time ethics consultation is feasible using this approach.