Pediatric Decision-Making: ethical aspects specific to neonates.

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.

How We Found Consensus on Pediatric Decision-Making and Why It Matters.

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.

Limits on Parental Discretion in Medical Decision-Making: pediatric intervention principles converge.

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.

Pediatric Decision-Making for Children in State Custody.

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.

Determining the state of guidance on pediatric biobanking for researchers, HRECS, and families: Regulatory mapping of international guidance.

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.

Developing rights-based standards for children having tests, treatments, examinations and interventions: using a collaborative, multi-phased, multi-method and multi-stakeholder approach to build consensus.

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.

Off-Label Prescription of COVID-19 Vaccines in Children: Clinical, Ethical, and Legal Issues.

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.

Ethical and Social Values for Paediatric Health Technology Assessment and Drug Policy.

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.

Ethical and Professional Considerations in Integrated Behavioral Health.

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.

New ethical challenges in the management of rare pediatric diseases with innovative therapies.

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.

Relational, Emotional, and Pragmatic Attributes of Ethics Consultations at a Children's Hospital.

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.

SARS-CoV-2 vaccine testing and trials in the pediatric population: biologic, ethical, research, and implementation challenges.

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.