Health Care Clinicians and Product Promotion by Industry.

Medical pharmaceutical and device manufacturers are essential in making products that benefit patients, and collaboration between health care providers and industry is necessary in the design, testing, and manufacture of these medical products. However, health care providers must recognize that their duties and the interests of industry may, at times, diverge. Relationships with industry, even seemingly minor ones, have the potential to shape the decisions made on behalf of patients. The marketing divisions of pharmaceutical and medical device firms view health care providers as a target of their efforts, and some of the interactions that occur between industry and health care providers have the potential to alter decision making in ways that may not necessarily benefit patients. Health care providers have an ethical duty to recognize situations and marketing strategies that are designed to influence their choice of diagnostic and therapeutic options for their patients. Health care providers should be aware of the techniques used to attempt to alter their behavior and guard against them.

Health Care Clinicians and Product Promotion by Industry.

Medical pharmaceutical and device manufacturers are essential in making products that benefit patients, and collaboration between health care clinicians and the industry is necessary for the design and manufacture of these medical products. However, health care clinicians must recognize that their duties and the interests of the industry may at times diverge. Relationships with the industry, even seemingly minor ones, have the potential to shape the decisions made on behalf of patients. The marketing divisions of pharmaceutical and medical device firms view health care clinicians as targets of their efforts, and some of the interactions that occur between the industry and health care clinicians have the potential to alter decision making in ways that may not necessarily benefit patients. Health care clinicians have an ethical duty to recognize situations and marketing strategies that are designed to influence their choice of diagnostic and therapeutic options for their patients. At a minimum, health care clinicians should be aware of the techniques used to attempt to alter their behavior and guard against them.

Perspectives of Triage Team Members Participating in Statewide Triage Simulations for Scarce Resource Allocation During the COVID-19 Pandemic in Washington State.

Importance: The COVID-19 pandemic prompted health care institutions worldwide to develop plans for allocation of scarce resources in crisis capacity settings. These plans frequently rely on rapid deployment of institutional triage teams that would be responsible for prioritizing patients to receive scarce resources; however, little is known about how these teams function or how to support team members participating in this unique task. Objective: To identify themes illuminating triage team members' perspectives and experiences pertaining to the triage process. Design, Setting, and Participants: This qualitative study was conducted using inductive thematic analysis of observations of Washington state triage team simulations and semistructured interviews with participants during the COVID-19 pandemic from December 2020 to February 2021. Participants included clinician and ethicist triage team members. Data were analyzed from December 2020 through November 2021. Main Outcomes and Measures: Emergent themes describing the triage process and experience of triage team members. Results: Among 41 triage team members (mean [SD] age, 50.3 [11.4] years; 21 [51.2%] women) who participated in 12 simulations and 21 follow-up interviews, there were 5 Asian individuals (12.2%) and 35 White individuals (85.4%); most participants worked in urban hospital settings (32 individuals [78.0%]). Three interrelated themes emerged from qualitative analysis: (1) understanding the broader approach to resource allocation: participants strove to understand operational and ethical foundations of the triage process, which was necessary to appreciate their team's specific role; (2) contending with uncertainty: team members could find it difficult or feel irresponsible making consequential decisions based on limited clinical and contextual patient information, and they grappled with ethically ambiguous features of individual cases and of the triage process as a whole; and (3) transforming mindset: participants struggled to disentangle narrow determinations about patients' likelihood of survival to discharge from implicit biases and other ethically relevant factors, such as quality of life. They cited the team's open deliberative process, as well as practice and personal experience with triage as important in helping to reshape their usual cognitive approach to align with this unique task. Conclusions and Relevance: This study found that there were challenges in adapting clinical intuition and training to a distinctive role in the process of scarce resource allocation. These findings suggest that clinical experience, education in ethical and operational foundations of triage, and experiential training, such as triage simulations, may help prepare clinicians for this difficult role.

A world away and here at home: a prioritisation framework for US international patient programmes.

Programmes serving international patients are increasingly common throughout the USA. These programmes aim to expand access to resources and clinical expertise not readily available in the requesting patients' home country. However, they exist within the US healthcare system where domestic healthcare needs are unmet for many children. Focusing our analysis on US children's hospitals that have a societal mandate to provide medical care to a defined geographic population while simultaneously offering highly specialised healthcare services for the general population, we assume that, given their mandate, priority will be given to patients within their catchment area over other patients. We argue that beyond prioritising patients within their region and addressing inequities within US healthcare, US institutions should also provide care to children from countries where access to vital medical services is unavailable or deficient. In the paper, we raise and attempt to answer the following: (1) Do paediatric healthcare institutions have a duty to care for all children in need irrespective of their place of residence, including international patients? (2) If there is such a duty, how should this general duty be balanced against the special duty to serve children within a defined geographical area to which an institution is committed, when resources are strained? (3) Finally, how are institutional obligations manifest in paradigm cases involving international patients? We start with cases, evaluating clinical and contextual features as they inform the strength of ethical claim and priority for access. We then proceed to develop a general prioritisation framework based on them.

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.

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.

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.

The Ethics of Creating a Resource Allocation Strategy During the COVID-19 Pandemic.

The coronavirus disease 2019 pandemic has affected nearly every aspect of medicine and raises numerous moral dilemmas for clinicians. Foremost of these quandaries is how to delineate and implement crisis standards of care and, specifically, how to consider how health care resources should be distributed in times of shortage. We review basic principles of disaster planning and resource stewardship with ethical relevance for this and future public health crises, explore the role of illness severity scoring systems and their limitations and potential contribution to health disparities, and consider the role for exceptionally resource-intensive interventions. We also review the philosophical and practical underpinnings of crisis standards of care and describe historical approaches to scarce resource allocation to offer analysis and guidance for pediatric clinicians. Particular attention is given to the impact on children of this endeavor. Although few children have required hospitalization for symptomatic infection, children nonetheless have the potential to be profoundly affected by the strain on the health care system imposed by the pandemic and should be considered prospectively in resource allocation frameworks.

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.

Fairness, severe intellectual disability, and the special case of transplantation.

Children with severe intellectual disability have historically been excluded from solid organ transplantation. The purpose of this article was to review the arguments for excluding this population, including claims of poorer recipient and graft survival, a lower QoL as pediatric recipients become adults, and poorer outcomes for other, more deserving pediatric transplant candidates, and make the case that these arguments are no longer persuasive. We will argue that pediatric transplant centers for reasons of social justice, value of relationships, power differential, and fairness should generally not consider intellectual ability or disability as a criterion when making decisions regarding organ transplant eligibility.

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.

Achieving an Optimal Childhood Vaccine Policy.

Policies to remove parents' ability to opt-out from school immunization requirements on the basis of religious or personal beliefs (ie, nonmedical exemptions) may be a useful strategy to increase immunization rates and prevent outbreaks of vaccine-preventable disease. However, there is uncertainty about the effectiveness of this strategy and the range of possible outcomes. We advocate for a more deliberative process through which a broad range of outcomes is scrutinized and the balance of values underlying the policy decision to eliminate nonmedical exemptions is clearly articulated. We identify 3 outcomes that require particular consideration before policies to eliminate nonmedical exemptions are implemented widely and outline a process for making the values underlying such policies more explicit.

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.

Physician Dismissal of Families Who Refuse Vaccination: An Ethical Assessment.

Thousands of U.S. parents choose to refuse or delay the administration of selected vaccines to their children each year, and some choose not to vaccinate their children at all. While most physicians continue to provide care to these families over time, using each visit as an opportunity to educate and encourage vaccination, an increasing number of physicians are choosing to dismiss these families from their practice unless they agree to vaccinate their children. This paper will examine this emerging trend along with the reasons given by those who advocate such an approach. I will argue that the strategy of refusing to allow families into a clinic unless they agree to vaccinate their children is misguided, and the arguments for doing so fail to stand up to close scrutiny. Such a strategy does not benefit the child or the health of the community, and may have a negative impact on both. Furthermore, some of the arguments in support of dismissal policies ignore the importance of professional obligation and appear to favor self-interest over the interest of the patient.

An official American Thoracic Society policy statement: managing conscientious objections in intensive care medicine.

RATIONALE: Intensive care unit (ICU) clinicians sometimes have a conscientious objection (CO) to providing or disclosing information about a legal, professionally accepted, and otherwise available medical service. There is little guidance about how to manage COs in ICUs. OBJECTIVES: To provide clinicians, hospital administrators, and policymakers with recommendations for managing COs in the critical care setting. METHODS: This policy statement was developed by a multidisciplinary expert committee using an iterative process with a diverse working group representing adult medicine, pediatrics, nursing, patient advocacy, bioethics, philosophy, and law. MAIN RESULTS: The policy recommendations are based on the dual goals of protecting patients' access to medical services and protecting the moral integrity of clinicians. Conceptually, accommodating COs should be considered a "shield" to protect individual clinicians' moral integrity rather than as a "sword" to impose clinicians' judgments on patients. The committee recommends that: (1) COs in ICUs be managed through institutional mechanisms, (2) institutions accommodate COs, provided doing so will not impede a patient's or surrogate's timely access to medical services or information or create excessive hardships for other clinicians or the institution, (3) a clinician's CO to providing potentially inappropriate or futile medical services should not be considered sufficient justification to forgo the treatment against the objections of the patient or surrogate, and (4) institutions promote open moral dialogue and foster a culture that respects diverse values in the critical care setting. CONCLUSIONS: This American Thoracic Society statement provides guidance for clinicians, hospital administrators, and policymakers to address clinicians' COs in the critical care setting.