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.

An ethical analysis of obesity as a contraindication to pediatric liver transplant candidacy.

Childhood obesity is becoming more prevalent in the United States (US) and worldwide, including among children in need of a liver transplant. Unlike with heart and kidney failure, end-stage liver disease (ESLD) is unique in that no widely available medical technology can re-create the life-sustaining function of a failing liver. Therefore, delaying a life-saving liver transplant for weight loss, for example, is much harder, if not impossible for many pediatric patients, especially those with acute liver failure. For adults in the United States, guidelines consider obesity a contraindication to liver transplant. Although formal guidelines are lacking in children, many pediatric transplant centers also consider obesity a contraindication to a pediatric liver transplant. Variations in practice among pediatric institutions may result in biased and ad hoc decisions that worsen healthcare inequities. In this article, we define and report the prevalence of childhood obesity among children with ESLD, review existing guidelines for liver transplant in adults with obesity, examine pediatric liver transplant outcomes, and discuss the ethical considerations of using obesity as a contraindication to pediatric liver transplant informed by the principles of utility, justice, and respect for persons.

An ethical analysis of obesity as a contraindication of pediatric kidney transplant candidacy.

The inclusion of body mass index (BMI) as a criterion for determining kidney transplant candidacy in children raises clinical and ethical challenges. Childhood obesity is on the rise and common among children with kidney failure. In addition, obesity is reported as an independent risk factor for the development of CKD and kidney failure. Resultantly, more children with obesity are anticipated to need kidney transplants. Most transplant centers around the world use high BMI as a relative or absolute contraindication for kidney transplant. However, use of obesity as a relative or absolute contraindication for pediatric kidney transplant is controversial. Empirical data demonstrating poorer outcomes following kidney transplant in obese pediatric patients are limited. In addition, pediatric obesity is distributed inequitably among groups. Unlike adults, most children lack independent agency to choose their food sources and exercise opportunities; they are dependent on their families for these choices. In this paper, we define childhood obesity and review (1) the association and impact of obesity on kidney disease and kidney transplant, (2) existing adult guidelines and rationale for using high BMI as a criterion for kidney transplant, (3) the prevalence of childhood obesity among children with kidney failure, and (4) the existing literature on obesity and pediatric kidney transplant outcomes. We then discuss ethical considerations related to the use of obesity as a criterion for kidney transplant.

Caregiver COVID-19 vaccination for solid organ transplant candidates.

An increasing proportion of transplant centers have implemented a mandate for vaccination against COVID-19 for solid organ transplant candidates. There has been comparatively little exploration of the ethical considerations of mandating vaccination of a candidate's primary caregiver, despite a high risk of transmission given the close nature of contact between the candidate and caregiver. We examine how a caregiver mandate can improve overall utility in organ allocation, particularly in circumstances where vaccine effectiveness at preventing transmission and serious disease is low among recipients but high in caregivers. Our analysis reveals how sensitive such mandates must be to the evolving circumstances of disease severity, transmissibility, and vaccine effectiveness: as the facts change, the degree of benefit gained and therefore the degree of infringement on access to transplant and caregiver choice that is tolerated will likewise change.

Staffing crisis capacity: a different approach to healthcare resource allocation for a different type of scarce resource.

Severe staffing shortages have emerged as a prominent threat to maintaining usual standards of care during the COVID-2019 pandemic. In dire settings of crisis capacity, healthcare systems assume the ethical duty to maximise aggregate population-level benefit of existing resources. To this end, existing plans for rationing mechanical ventilators and intensive care unit beds in crisis capacity focus on selecting individual patients who are most likely to survive and prioritising these patients to receive scarce resources. However, staffing capacity is conceptually different from availability of these types of discrete resources, and the existing strategy of identifying and prioritising patients with the best prognosis cannot be readily adapted to fit this real-world scenario. We propose that two alternative approaches to staffing resource allocation offer a better conceptual fit: (1) prioritise the worst off: restrict access to acute care services and hospital admission for patients at relatively low clinical risk and (2) prioritise staff interventions with high near-term value: universally restrict selected interventions and treatments that require substantial staff time and/or energy but offer minimal near-term patient benefit. These strategies-while potentially resulting in care that deviates from usual standards-support the goal of maximising the aggregate benefit of scarce resources in crisis capacity settings triggered by staffing shortages. This ethical framework offers a foundation to support institutional leaders in developing operationalisable crisis capacity policies that promote fairness and support healthcare workers.

Rhetoric, Persuasion, Compulsion, and the Stubborn Problem of Vaccine Hesitancy.

Despite the impact of vaccination on the control and prevention of many infectious diseases, vaccine opposition and hesitancy remain significant barriers to fully protecting individuals and communities against serious disease. The primary response to the problem of vaccine hesitancy includes persuasion and some degree of compulsion, usually in the form of vaccine mandates. Persuasion, if it can be successfully leveraged to provide sufficient control of disease spread, is the ethically preferred approach. Yet persuasion has proven less than adequate, leading to increasing calls for vaccination mandates and the elimination of nonmedical exemptions to those mandates. Four scholars have recently examined the underlying causes of vaccine hesitancy in the interest of improving rhetoric surrounding vaccination. This article reviews those books and offers suggestions for optimizing the strategy of persuasion in the interest of reducing the need for compulsion.

The limits of refusal: An ethical review of solid organ transplantation and vaccine hesitancy.

Patients pursuing solid organ transplantation are encouraged to receive many vaccines on an accelerated timeline. Vaccination prior to transplantation offers the best chance of developing immunity and may expand the pool of donor organs that candidates can accept without needing posttransplant therapy. Furthermore, transplant recipients are at greater risk for acquiring vaccine-preventable illnesses or succumbing to severe sequelae of such illnesses. However, a rising rate of vaccine refusal has challenged transplant centers to address the phenomenon of vaccine hesitancy. Transplant centers may need to consider adopting a policy of denial of solid organ transplantation on the basis of vaccine refusal for non-medical reasons (i.e., philosophical or religious objections or personal beliefs that vaccines are unnecessary or unsafe). Arguments supporting such a policy are motivated by utility, stewardship, and beneficence. Arguments opposing such a policy emphasize justice and respect for persons, and seek to avoid worsening inequities or medical coercion. This paper examines these arguments and situates them within the special cases of pediatric transplantation, emergent transplantation, and living donation. Ultimately, a uniform national policy addressing vaccine refusal among transplant candidates is needed to resolve this ethical dilemma and establish a consistent, fair, and standard approach to vaccine refusal in transplantation.

Vaccine ethics: an ethical framework for global distribution of COVID-19 vaccines.

This paper addresses the just distribution of vaccines against the SARS-CoV-2 virus and sets forth an ethical framework that prioritises frontline and essential workers, people at high risk of severe disease or death, and people at high risk of infection. Section I makes the case that vaccine distribution should occur at a global level in order to accelerate development and fair, efficient vaccine allocation. Section II puts forth ethical values to guide vaccine distribution including helping people with the greatest need, reducing health disparity, saving the most lives and promoting narrow social utility. It also responds to objections which claim that earlier years have more value than later years. Section III puts forth a practical ethical framework to aid decision-makers and compares it with alternatives.

Ventilator Triage Policies During the COVID-19 Pandemic at U.S. Hospitals Associated With Members of the Association of Bioethics Program Directors.

BACKGROUND: The coronavirus disease 2019 pandemic has or threatens to overwhelm health care systems. Many institutions are developing ventilator triage policies. OBJECTIVE: To characterize the development of ventilator triage policies and compare policy content. DESIGN: Survey and mixed-methods content analysis. SETTING: North American hospitals associated with members of the Association of Bioethics Program Directors. PARTICIPANTS: Program directors. MEASUREMENTS: Characteristics of institutions and policies, including triage criteria and triage committee membership. RESULTS: Sixty-seven program directors responded (response rate, 91.8%); 36 (53.7%) hospitals did not yet have a policy, and 7 (10.4%) hospitals' policies could not be shared. The 29 institutions providing policies were relatively evenly distributed among the 4 U.S. geographic regions (range, 5 to 9 policies per region). Among the 26 unique policies analyzed, 3 (11.3%) were produced by state health departments. The most frequently cited triage criteria were benefit (25 policies [96.2%]), need (14 [53.8%]), age (13 [50.0%]), conservation of resources (10 [38.5%]), and lottery (9 [34.6%]). Twenty-one (80.8%) policies use scoring systems, and 20 of these (95.2%) use a version of the Sequential Organ Failure Assessment score. Among the policies that specify the triage team's composition (23 [88.5%]), all require or recommend a physician member, 20 (87.0%) a nurse, 16 (69.6%) an ethicist, 8 (34.8%) a chaplain, and 8 (34.8%) a respiratory therapist. Thirteen (50.0% of all policies) require or recommend that those making triage decisions not be involved in direct patient care, but only 2 (7.7%) require that their decisions be blinded to ethically irrelevant considerations. LIMITATION: The results may not be generalizable to institutions without academic bioethics programs. CONCLUSION: Over one half of respondents did not have ventilator triage policies. Policies have substantial heterogeneity, and many omit guidance on fair implementation. PRIMARY FUNDING SOURCE: None.

Competencies and Milestones for Bioethics Trainees: Beyond ASBH's Healthcare Ethics Certification and Core Competencies.

Clinical ethics training programs are responsible for preparing their trainees to be competent ethics consultants worthy of the trust of patients, families, surrogates, and healthcare professionals. While the American Society for Bioethics and Humanities (ASBH) offers a certification examination for healthcare ethics consultants, no tools exist for the formal evaluation of ethics trainees to assess their progress toward competency. Medical specialties accredited by the Accreditation Council for Graduate Medical Education (ACGME) use milestones to report trainees' progress along a continuum of professional development as a means of "operationalizing and implementing" medical competencies. Utilizing the Core Competencies for Healthcare Ethics Consultation and the ACGME and American Board of Pediatrics' (ABP) Pediatric Milestones Project, we developed milestones for 17 subcompetencies in clinical ethics consultation and academic bioethics. As the field of clinical ethics becomes more standardized, such tools will be needed to promote the development of robust training programs and to certify that their graduates are competent practitioners.

Pandemics and Beyond: Considerations When Personal Risk and Professional Obligations Converge.

With each novel infectious disease outbreak, there is scholarly attention to healthcare providers' obligation to assume personal risk while they care for infected patients. While most agree that healthcare providers have a duty to assume some degree of risk, the extent of this obligation remains uncertain. Furthermore, these analyses rarely examine healthcare institutions' obligations during these outbreaks. As a result, there is little practical guidance for healthcare institutions that are forced to weigh whether or when to exclude healthcare providers from providing care or allow them to opt out from providing care to protect themselves. This article uses the COVID-19 pandemic to examine the concept of risk and the professional duties of both healthcare providers and healthcare institutions, and proposes a framework that can be used to make concrete institutional policy choices. This framework should be a useful tool for any hospital, clinic, or health agency that must make these choices during the current pandemic and beyond.

Do Clinical Ethics Fellowships Prepare Trainees for their First Jobs? A National Survey of Former Clinical Ethics Fellows.

Clinical ethics consultants provide a range of services in hospital settings and in teaching environments. Training to achieve the skills needed to meet the expectations of employers comes in various forms, ranging from on-the-job training to formal fellowship training programs. We surveyed graduates of clinical ethics fellowships to evaluate their self-reported preparedness for their first job after fellowship training. The results indicated several areas of need, including greater exposure to program-building skills, quality improvement skills, and approaches to working with members of higher administration. These data will be of use to educators as well as to fellows who advocate for elements of training in preparation for their first position.

Decision Making on Behalf of Children: Understanding the Role of the Harm Principle.

Thirty years ago, Buchanan and Brock distinguished between guidance principles and interference principles in the setting of surrogate decision making on behalf of children and incompetent adult patients. They suggested that the best interest standard could serve as a guidance principle, but was insufficient as an interference principle. In this issue of The Journal of Clinical Ethics, Ross argues that the best interest standard can serve as neither a guidance or interference principle for decision making on behalf of children, but that her model of constrained parental autonomy can serve as both. I will argue that Buchanan and Brock were correct that a single model or standard cannot serve as both a guidance and interference principle in pediatrics and that the best interest standard is a sufficient guidance principle. The harm principle fulfills the conditions necessary for an interference principle, at least insofar as deciding when state intervention to interfere with parental decision making is justified.

Ethical Guidance for Selecting Clinical Trials to Receive Limited Space in an Immunotherapy Production Facility.

Our aims are to (1) set forth a multiprinciple system for selecting among clinical trials competing for limited space in an immunotherapy production facility that supplies products under investigation by scientific investigators; (2) defend this system by appealing to justice principles; and (3) illustrate our proposal by showing how it might be implemented. Our overarching aim is to assist manufacturers of immunotherapeutic products and other potentially breakthrough experimental therapies with the ethical task of prioritizing requests from scientific investigators when production capacity is limited.

From protection to entitlement: selecting research subjects for early phase clinical trials involving breakthrough therapies.

Our goals are to (1) set forth and defend a multiprinciple system for selecting individuals who meet trial eligibility criteria to participate in early phase clinical trials testing chimeric antigen receptor (CAR T-cell) for acute lymphoblastic leukaemia when demand for participation exceeds spaces available in a trial; (2) show the relevance of these selection criteria to other breakthrough experimental therapies; (3) argue that distinct distributive justice criteria apply to breakthrough experimental therapies, standard research and healthcare and (4) argue that as evidence of benefit increases, the emphasis of justice in research shifts from protecting subjects from harm to ensuring fair access to benefits.

Decision-Making for Children with Disabilities: Parental Discretion and Moral Ambiguity.

We argue that medical decisions on behalf of children should be made with the welfare of the child as the primary interest, that parents should generally be allowed to determine which options optimize the interests of their child, and that those decisions should be formally challenged only when the parental decision places the child at substantial risk of a serious harm as compared to the option favored by the health-care provider. In situations where moral ambiguity exists and no possible solution could unequivocally be declared the right or good one, a parental decision favoring one or the other of the reasonable options should be supported. Parents should be provided with adequate time to consider information provided and weigh the various options presented. If parents find themselves unable to make a decision, we suggest several strategies for shared decision-making. Finally, we recommend setting time points for reassessment of the situation following each therapeutic change to allow reevaluation of whether the chosen path should be altered.

A quality of life quandary: a framework for navigating parental refusal of treatment for co-morbidities in infants with underlying medical conditions.

Parental refusal of a recommended treatment is not an uncommon scenario in the neonatal intensive care unit. These refusals may be based upon the parents' perceptions of their child's projected quality of life. The inherent subjectivity of quality of life assessments, however, can exacerbate disagreement between parents and healthcare providers. We present a case of parental refusal of surgical intervention for necrotizing enterocolitis in an infant with Bartter syndrome and develop an ethical framework in which to consider the appropriateness of parental refusal based upon an infant's projected quality of life.

Personal belief exemptions from school vaccination requirements.

Despite the impact vaccination has had on the control and prevention of many infectious diseases, some parents choose not to vaccinate their children. Although there is no federal law requiring vaccination of children in the United States, all states require evidence of vaccination against at least some diseases as a condition of school entry. Which vaccines are required; how many doses are required; whether entry requirements apply to child care, kindergarten, or middle school; and whether exemptions from vaccine requirements will be allowed all differ by state. All but two states allow some kind of personal belief exemption from school vaccination requirements. This article reviews the history of school vaccination requirements and exemptions, the legal status of state vaccination laws and exemptions, the impact of school vaccination requirements and personal belief exemptions on vaccination rates and disease incidence, and strategies for maintaining adequate vaccination rates in states that allow personal belief exemptions.