The Network of Services for COVID-19 Vaccination in Persons With Mental Disorders: The Italian Social Health System, Its Organization, and Bioethical Issues.

The adoption of restrictive measures aimed at curtailing the spread of SARS-CoV2 has had a harmful impact on socio-affective relationships, while limiting the scope of interventions and activities to promote social inclusion, with considerable negative repercussions for patients with mental disorders. Vaccination has been and will continue to be a valid tool to overcome the barriers of social isolation and to protect the health of this category of patients. In this paper we present an overview of the Italian network of social and healthcare services for COVID-19 vaccination among patients with mental disorders. Some aspects of medical ethics are discussed in order to share good practices for improving the health of this vulnerable group of people. We then consider the measures implemented by the health system in Italy to deal with the phenomenon of vaccine hesitancy before addressing the issue of autonomy and restricted access to vaccination points. Finally, we illustrate some of the perspectives already adopted by the Italian system, which may be useful to the global scientific community.

[The ″medical fallacy″: John Henry Newman's unspoken response to bioethical issues of our time]. / La ″falacia médica″: una tácita respuesta de John Henry Newman a cuestiones bioéticas de nuestro tiempo.

The aim of this article is to explore John Henry Newman's reflections on the meaning of the medical profession in a lecture to medical students in Dublin. Specifically, it will show how Newman's exposition of what we have called the ″medical fallacy″ allows us to consider him as an authoritative interlocutor in the debate on the naturalistic fallacy and the indefinition of the good, led by David Hume and Georg Edward Moore. Thus, in times of COVID-19, euthanasia and emotivism, delving into the thought of the English author can contribute to illuminating the bioethical problems of our time.

Bio-Ethics and One Health: A Case Study Approach to Building Reflexive Governance.

Surveillance programs supporting the management of One Health issues such as antibiotic resistance are complex systems in themselves. Designing ethical surveillance systems is thus a complex task (retroactive and iterative), yet one that is also complicated to implement and evaluate (e.g., sharing, collaboration, and governance). The governance of health surveillance requires attention to ethical concerns about data and knowledge (e.g., performance, trust, accountability, and transparency) and empowerment ethics, also referred to as a form of responsible self-governance. Ethics in reflexive governance operates as a systematic critical-thinking procedure that aims to define its value: What are the "right" criteria to justify how to govern "good" actions for a "better" future? The objective is to lay the foundations for a methodological framework in empirical bioethics, the rudiments of which have been applied to a case study to building reflexive governance in One Health. This ongoing critical thinking process involves "mapping, framing, and shaping" the dynamics of interests and perspectives that could jeopardize a "better" future. This paper proposes to hybridize methods to combine insights from collective deliberation and expert evaluation through a reflexive governance functioning as a community-based action-ethics methodology. The intention is to empower individuals and associations in a dialogue with society, which operation is carried out using a case study approach on data sharing systems. We based our reasoning on a feasibility study conducted in Québec, Canada (2018-2021), envisioning an antibiotic use surveillance program in animal health for 2023. Using the adaptive cycle and governance techniques and perspectives, we synthesize an alternative governance model rooted in the value of empowerment. The framework, depicted as a new "research and design (R&D)" practice, is linking operation and innovation by bridging the gap between Reflexive, Evaluative, and Deliberative reasonings and by intellectualizing the management of democratizing critical thinking locally (collective ethics) by recognizing its context (social ethics). Drawing on the literature in One Health and sustainable development studies, this article describes how a communitarian and pragmatic approach can broaden the vision of feasibility studies to ease collaboration through public-private-academic partnerships. The result is a process that "reassembles" the One Health paradigm under the perspective of global bioethics to create bridges between the person and the ecosystem through pragmatic ethics.

Putting ethics and clinical decision making before politics: requiring COVID-19 immunization for Solid Organ Transplantation (SOT) Candidates and their Support Team.

We recommend that vaccination for COVID-19 should be a requirement for waitlist activation for solid organ transplant (SOT). We also recommend that such vaccination be required of the primary member of the in-home support team. We argue that these requirements are consistent with current standard practices that draw on a well-established ethical framework. As a result, these recommendations should be easily received and are only controversial owing to the inflamed and politicized state of public discourse.

Dying individuals and suffering populations: applying a population-level bioethics lens to palliative care in humanitarian contexts: before, during and after the COVID-19 pandemic.

BACKGROUND: Humanitarian crises and emergencies, events often marked by high mortality, have until recently excluded palliative care-a specialty focusing on supporting people with serious or terminal illness or those nearing death. In the COVID-19 pandemic, palliative care has received unprecedented levels of societal attention. Unfortunately, this has not been enough to prevent patients dying alone, relatives not being able to say goodbye and palliative care being used instead of intensive care due to resource limitations. Yet global guidance was available. In 2018, the WHO released a guide on 'Integrating palliative care and symptom relief into the response to humanitarian emergencies and crises'-the first guidance on the topic by an international body. AIMS: This paper argues that while a landmark document, the WHO guide took a narrowly clinical bioethics perspective and missed crucial moral dilemmas. We argue for adding a population-level bioethics lens, which draws forth complex moral dilemmas arising from the fact that groups having differential innate and acquired resources in the context of social and historical determinants of health. We discuss dilemmas concerning: limitations of material and human resources; patient prioritisation; euthanasia; and legacy inequalities, discrimination and power imbalances. IMPLICATIONS: In parts of the world where opportunity for preparation still exists, and as countries emerge from COVID-19, planners must consider care for the dying. Immediate steps to support better resolutions to ethical dilemmas of the provision of palliative care in humanitarian and emergency contexts will require honest debate; concerted research effort; and international, national and local ethical guidance.

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.

The neuroethics of disorders of consciousness: a brief history of evolving ideas.

Neuroethical questions raised by recent advances in the diagnosis and treatment of disorders of consciousness are rapidly expanding, increasingly relevant and yet underexplored. The aim of this thematic review is to provide a clinically applicable framework for understanding the current taxonomy of disorders of consciousness and to propose an approach to identifying and critically evaluating actionable neuroethical issues that are frequently encountered in research and clinical care for this vulnerable population. Increased awareness of these issues and clarity about opportunities for optimizing ethically responsible care in this domain are especially timely given recent surges in critically ill patients with prolonged disorders of consciousness associated with coronavirus disease 2019 around the world. We begin with an overview of the field of neuroethics: what it is, its history and evolution in the context of biomedical ethics at large. We then explore nomenclature used in disorders of consciousness, covering categories proposed by the American Academy of Neurology, the American Congress of Rehabilitation Medicine and the National Institute on Disability, Independent Living and Rehabilitation Research, including definitions of terms such as coma, the vegetative state, unresponsive wakefulness syndrome, minimally conscious state, covert consciousness and the confusional state. We discuss why these definitions matter, and why there has been such evolution in this nosology over the years, from Jennett and Plum in 1972 to the Multi-Society Task Force in 1994, the Aspen Working Group in 2002 and the 2018 American and 2020 European Disorders of Consciousness guidelines. We then move to a discussion of clinical aspects of disorders of consciousness, the natural history of recovery and ethical issues that arise within the context of caring for people with disorders of consciousness. We conclude with a discussion of key challenges associated with assessing residual consciousness in disorders of consciousness, potential solutions and future directions, including integration of crucial disability rights perspectives.

Emerging viral threats and the simultaneity of the non-simultaneous: zooming out in times of Corona.

This paper addresses global bioethical challenges entailed in emerging viral diseases, focussing on their socio-cultural dimension and seeing them as symptomatic of the current era of globalisation. Emerging viral threats exemplify the extent to which humans evolved into a global species, with a pervasive and irreversible impact on the planetary ecosystem. To effectively address these disruptive threats, an attitude of preparedness seems called for, not only on the viroscientific, but also on bioethical, regulatory and governance levels. This paper analyses the global bioethical challenges of emerging viral threats from a dialectical materialist (Marxist) perspective, focussing on three collisions: (1) the collision of expanding networks of globalisation with local husbandry practices; (2) the collision of global networks of mobility with disrupted ecosystems; and (3) the collision of viroscience as a globalised research field with existing regulatory frameworks. These collisions emerge in a force field defined by the simultaneity of the non-simultaneous. Evidence-based health policies invoke discontent as they reflect the normative logic of a globalised knowledge regime. The development of a global bioethics or macro-ethics requires us to envision these collisions not primarily as issues of benefits and risks, but first and foremost as normative tensions closely entangled with broader socio-economic and socio-cultural developments.

Clinical and bioethical implications of health care interruption during the COVID-19 pandemic: A cross-sectional study in outpatients with rheumatic diseases.

BACKGROUND: To determine the impact of health care interruption (HCI), on clinical status of the patients reincorporated to an outpatient clinic for rheumatic diseases (OCDIR), from a tertiary care level center who was temporally switched to a dedicated COVID-19 hospital, and to provide a bioethical analysis. METHODS: From March to June 2020, the OCDIR was closed; since June, it is limited to evaluate 25% of the ongoing outpatients. This cross-sectional study surveyed 670 consecutive rheumatic outpatients between June 24th and October 31th, concomitant to the assessment of the rheumatic disease clinical status by the attendant rheumatologist, according to disease activity level, clinical deterioration and adequate/inadequate control. Multiple logistic regression analysis identified factors associated to HCI and to clinical deterioration. RESULTS: Patients were middle-aged females (86.7%), with median disease duration of 10 years, comorbidity (38.5%) and 138 patients (20.6%) had discontinued treatment. Primary diagnoses were SLE and RA, in 285 (42.5%) and 223 (33.3%) patients, respectively. There were 344 patients (51.3%) with HCI. Non-RA diagnosis (OR: 2.21, 95%CI: 1.5-3.13), comorbidity (OR: 1.7, 95%CI: 1.22-2.37), patient's need for rheumatic care during HCI (OR: 3.2, 95%CI: 2.06-4.97) and adequate control of the rheumatic disease (OR: 0.64, 95%CI: 0.45-0.9) were independently associated to HCI. There were 160 patients (23.8%) with clinical deterioration and associated factors were disease duration, substantial disease activity previous HCI, patients need for rheumatic care and treatment discontinuation. CONCLUSIONS: HCI during COVID-19 pandemic impacted course of rheumatic diseases and need to be considered in the bioethical analysis of virus containment measures.

Moral Distress and Moral Injury in Nephrology During the COVID-19 Pandemic.

Across the world, challenges for clinicians providing health care during the coronavirus disease 2019 (COVID-19) pandemic are highly prevalent and have been widely reported. Perspectives of provider groups have conveyed wide-ranging experiences of adversity, distress, and resilience. In understanding and responding to the emotional and psychological implications of the pandemic for renal clinicians, it is vital to recognize that many experiences also have been ethically challenging. The COVID-19 pandemic has prompted rapid and extensive transformation of health care systems and widely impacted care provision, heightening the risk of barriers to fulfillment of ethical duties. Given this, it is likely that some clinicians also have experienced moral distress, which can occur if an individual is unable to act in accordance with their moral judgment owing to external barriers. This review presents a global perspective of potential experiences of moral distress in kidney care during the COVID-19 pandemic. Using nephrology cases, we discuss why moral distress may be experienced by health professionals when withholding or withdrawing potentially beneficial treatments owing to resource constraints, when providing care that is inconsistent with local prepandemic best practice standards, and when managing dual professional and personal roles with conflicting responsibilities. We argue that in addition to responsive and appropriate health system supports, resources, and education, it is imperative for health care providers to recognize and prevent moral distress to foster the psychological well-being and moral resilience of clinicians during extended periods of crisis within health systems.

What Has Covid-19 Exposed in Bioethics? Four Myths.

The Covid-19 pandemic has exposed four myths in bioethics. First, the flood of bioethics publications on how to allocate scarce resources in crisis conditions has assumed authorities would declare the onset of crisis standards of care, yet few have done so. This leaves guidelines in limbo and patients unprotected. Second, the pandemic's realities have exploded traditional boundaries between clinical, research, and public health ethics, requiring bioethics to face the interdigitation of learning, doing, and allocating. Third, without empirical research, the success or failure of ethics guidelines remains unknown, demonstrating that crafting ethics guidance is only the start. And fourth, the pandemic's glaring health inequities require new commitment to learn from communities facing extraordinary challenges. Without that new learning, bioethics methods cannot succeed. The pandemic is a wake-up call, and bioethics must rise to the challenge.

Effective Contact Tracing for COVID-19 Using Mobile Phones: An Ethical Analysis of the Mandatory Use of the Aarogya Setu Application in India.

Several digital contact tracing smartphone applications have been developed worldwide in the effort to combat COVID-19 that warn users of potential exposure to infectious patients and generate big data that helps in early identification of hotspots, complementing the manual tracing operations. In most democracies, concerns over a breach in data privacy have resulted in severe opposition toward their mandatory adoption. This paper examines India as a noticeable exception, where the compulsory installation of such a government-backed application, the "Aarogya Setu" has been deemed mandatory in certain situations. We argue that the mandatory app requirement constitutes a legitimate public health intervention during a public health emergency.