Hastings Center Report, Volume 51, Issue 5, Page 53-55, September‐October 2021.

Hastings Center Report, Volume 51, Issue 5, Page 30-41, September‐October 2021.

During public health crises including the COVID-19 pandemic, resource scarcity and contagion risks may require health systems to shift—to some degree—from a usual clinical ethic, focused on the well-being of individual patients, to a public health ethic, focused on population health. Many triage policies exist that fall under the legal protections afforded by “crisis standards of care,” but they have key differences. We critically appraise one of the most fundamental differences among policies, namely the use of criteria (...) to categorically exclude certain patients from eligibility for otherwise standard medical services. We examine these categorical exclusion criteria from ethical, legal, disability, and implementation perspectives. Focusing our analysis on the most common type of exclusion criteria, which are disease-specific, we conclude that optimal policies for critical care resource allocation and the use of cardiopulmonary resuscitation (CPR) should not use categorical exclusions. We argue that the avoidance of categorical exclusions is often practically feasible, consistent with public health norms, and mitigates discrimination against persons with disabilities. (shrink)

In this essay, we suggest practical ways to shift the framing of crisis standards of care toward disability justice. We elaborate on the vision statement provided in the 2010 Institute of Medicine (National Academy of Medicine) “Summary of Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations,” which emphasizes fairness; equitable processes; community and provider engagement, education, and communication; and the rule of law. We argue that interpreting these elements through disability (...) justice entails a commitment to both distributive and recognitive justice. The disability rights movement's demand “Nothing about us, without us” requires substantive inclusion of disabled people in decision‐making related to their interests, including in crisis planning before, during, and after a pandemic like Covid‐19. (shrink)

We propose six guideposts that states and hospitals should follow to respect disability rights when designing policies for the allocation of scarce, lifesaving medical treatments. Four relate to criteria for decisions. First, do not use categorical exclusions, especially ones based on disability or diagnosis. Second, do not use perceived quality of life. Third, use hospital survival and near-term prognosis (e.g., death expected within a few years despite treatment) but not long-term life expectancy. Fourth, when patients who use ventilators in their (...) daily lives (e.g., home ventilation) present to acute care hospitals, their personal ventilators should not be reallocated to other patients. Fifth, designate triage officers to assess patients individually on the basis of objective medical evidence, not stereotypes or assumptions. Sixth, include disability rights advocates in policy development and dissemination. (shrink)

Some argue that it is ethically justifiable to unilaterally withdraw life‐sustaining treatment during crisis standards of care without the patient's consent in order to reallocate it to another patient with a better chance of survival. This justification has been supported by two lines of argument: the equivalence thesis and the rule of the double effect. We argue that there are theoretical issues with the first and practical ones with the second, as supported by an experiment aimed at (...) exploring whether the Knobe effect, which affects the folk concept of intention, applies to situations of unilateral withdrawal. Fifty‐two critical care physicians from one university were asked to ascribe intention in two hypothetical scenarios A and B in which outcomes differ—the patient from whom life‐sustaining treatment is withdrawn dies in scenario A but survives in scenario B—but the intention, to save the other patient regardless of the outcome of the other, is the same. The survey was administered via a web‐based survey and all answers were anonymous. A paired proportion test was used to compare responses to both questions. All 52 surveyed individuals responded in scenario A and 30 (57.7%) ascribed intention when outcomes were unfavorable, whereas 50 responded in scenario B and 8 (16%) ascribed intention when outcomes were favorable, a difference that was statistically significant (p < 0.001). There are theoretical and practical issues with the arguments proposed to justify the unilateral withdrawal of life‐sustaining treatment based on the equivalence thesis and the rule of double effect. (shrink)

Extracorporeal membrane oxygenation (ECMO) is a form of life support for cardiac and/or pulmonary failure with unique ethical challenges compared to other forms of life support. Ethical challenges with ECMO exist when conventional standards of care apply, and are exacerbated during periods of absolute ECMO scarcity when “crisis standards of care” are instituted. When conventional standards of care apply, we propose that it is ethically permissible to withhold placing patients on ECMO for reasons (...) of technical futility or when patients have terminal, short-term prognoses that are untreatable by ECMO. Under crisis standards of care, it is ethically permissible to broaden exclusionary criteria to also withhold ECMO from patients who have a low likelihood of recovery, to maximize the overall number of lives saved. Unilateral withdrawal of ECMO against a patient’s preferences is unethical under conventional standards of care, but is ethical under crisis standards of care to increase access to ECMO to others in society. ECMO should only be rationed when true scarcity exists, and allocation protocols should be transparent to the public. When rationing must occur under crisis standards of care, it is imperative that oversight bodies assess for inequities in the allocation of ECMO and make frequent changes to improve any inequities. (shrink)

This article outlines current safe harbors in the law for healthcare practitioners who work in a disaster setting. It reviews available legal protection in crisis situations with respect to the Emergency Medical Treatment and Labor Act (EMTALA), criminal liability, and licensure.

Public health emergencies invariably entail difficult decisions among medical and emergency first responders about how to allocate essential, scarce resources. To the extent that these critical choices can profoundly impact community and individual health outcomes, achieving consistency in how these decisions are executed is valuable. Since the terrorist attacks on September 11, 2001, however, public and private sector allocation plans and decisions have followed uncertain paths. Lacking empirical evidence and national input, various entities and actors have proffered multifarious approaches on (...) how best to allocate scarce resources to protect the public's health. Though beneficial in some jurisdictions, these approaches fail to clarify how the type and amount of care delivered in major emergencies might be curtailed. This is due, in part, to a lack of meaningful guidance on shifting standards of care in major emergencies. (shrink)

Lowering the standard of care in a pandemic is a recipe for inferior care and discrimination. Wealthy white patients will continue to get “standard of care” medicine, while the poor and racial mino...

Hastings Center Report, Volume 51, Issue 5, Page 2-2, September‐October 2021.

The Nuclear Threat Initiative focuses on preventing catastrophes related to weapons of mass destruction, with a wide range of attacks including nuclear, biologic, radiologic, chemical and cyb...

ABSTRACT:It may be too late to avoid the climate crisis, likely to be humanity's most expensive, widespread, and enduring catastrophe. This is a qualitatively different kind of catastrophe, in which increased costs, decreased revenue, and no possibility of bailout force communities to harshly cut budgets, especially in health care. Little is known about making such brutal cuts fair or efficient, nor how to help the public accept them. The crisis presents an opportunity for bioethicists to play a (...) crucial role, but one for which traditional approaches are inherently inadequate. Although often dismissed as heartless, Garrett Hardin's "lifeboat ethics" started a conversation about making ethical choices in global disasters—where all options are painful and unacceptable—and may provide guidance. Bioethics during the climate crisis must focus on communities rather than individuals and help survivors grieve the terrible consequences. Because today's choices will affect many generations, with the burdens falling most heavily on poor communities, we have to construct a radical bioethics to help tomorrow's health care become green, efficient, and fair. (shrink)

Volume 20, Issue 7, July 2020, Page 156-158.

Volume 20, Issue 7, July 2020, Page 167-169.

The Director-General of the WHO has suggested that China’s approach to the COVID-19 crisis could be the standard of care for global epidemics. However, as remarkable as the Chinese strategy might be, it cannot be replicated in other countries and certainly not in Europe. In Europe, there is a distribution of power between the European Union and its member states. In contrast, China’s political power is concentrated in the central government. This enables it to take immediate measures that (...) affect the entire country, such as massive quarantines or closing borders. Moreover, the Chinese legal framework includes restrictions on privacy and other human rights that are unknown in Europe. In addition, China has the technological power to easily impose such restrictions. In most European countries, that would be science fiction. These conditions have enabled China to combat epidemics like no other country can. However, the WHO might have been overoptimistic. The Chinese standard of care for treating COVID-19 also raises problematic issues for human rights, and the real consequences of these actions remain to be seen. (shrink)

The current outbreak of Ebola virus infection in West Africa continues to spread. Several patients have now been treated in the United States and preparations are being made for more. Because of the strict isolation required for their care, questions have been raised about what diagnostic and therapeutic interventions should be available. I discuss the ethical challenges associated with caring for patients in strict isolation and personnel wearing bulky protective gear with reduced dexterity and flexibility, the limitations this may (...) place on available treatments and the permissibility of consequent departures from the standards of care. Restricting access to some interventions such as surgery requiring an operating room, advanced imaging, etc. is reasonable due to concern for protecting other patients, visitors and staff. Cardiopulmonary resuscitation is a special case and the implications for withholding this intervention in situations where it may be desired is discussed, especially with respect to those patients who have suspected, but not proven, infection. These same restrictions are also considered under conditions where there are scarce resources and thus limited numbers of patients may receive care. While it is to be hoped that there is only limited and sporadic infection with Ebola virus in the US, careful thought must be given to the care of these patients under the unusual circumstances demanded by their isolation. I argue that an altered standard of care is reasonable and ethically acceptable under certain conditions. (shrink)

Although telepsychiatry consultations have been tried and tested for several years, at least in relatively limited numbers and settings, the current COVID-19 pandemic has caused an exponential increase in their application. Even as lockdown restrictions were lifted and a return to face-to-face consultations was possible, many practitioners and patients decided to uphold teleconsultations for some or a large part of their interactions. This was mostly driven by the exceptional circumstances of the pandemic, as ongoing safety concerns, the need for PPE (...) use and uncertainty around whether face-to-face meetings could go ahead continued to form barriers to usual care practices. Frittgen and Haltaufderheide aptly hypothesise that extensive changes in online communication behaviour will also impact ethical aspects of the therapeutic relationship.1 After considering how the use of technology may affect the therapeutic relationship in video-based consultations, they provide an ethical analysis of this impact along four dimensions: respect for autonomy, lucidity, fidelity and humanity.1 In this commentary I will have a look at the difference between crisis standards of care and usual care, the need to consider specific patient needs in teleconsultation use, the importance of justice understood as equity and access to technology, and a major challenge ahead. Throughout history, crisis situations have often been major catalysts of technological and other progress. Under challenging …. (shrink)

The pandemic creates unprecedented challenges to society and to health care systems around the world. Like all crises, these provide a unique opportunity to rethink the fundamental limiting assumptions and institutional inertia of our established systems. These inertial assumptions have obscured deeply rooted problems in health care and deflected attempts to address them. As hospitals begin to welcome all patients back, they should resist the temptation to go back to business as usual. Instead, they should retain the more (...) deliberative, explicit, and transparent ways of thinking that have informed the development of crisis standards of care. The key lesson to be learned from those exercises in rational deliberation is that justice must be the ethical foundation of all standards of care. Justice demands that hospitals take a safety‐net approach to providing services that prioritizes the most vulnerable segments of society, continue to expand telemedicine in ways that improve access without exacerbating disparities, invest in community‐based care, and fully staff hospitals and clinics on nights and weekends. (shrink)

During the Covid‐19 pandemic, as resources dwindled, clinicians, health care institutions, and policymakers have expressed concern about potential legal liability for following crisis standards of care (CSC) plans. Although there is no robust empirical research to demonstrate that liability protections actually influence physician behavior, we argue that limited liability protections for health care professionals who follow established CSC plans may instead be justified by reliance on the principle of reciprocity. Expecting physicians to do something they (...) know will harm their patients causes moral distress and suffering that may leave lasting scars. Limited liability shields are both appropriate and proportionate to the risk physicians are being asked to take in such circumstances. Under certain narrow circumstances, it remains unclear that the standard of care is sufficiently flexible to protect physicians from liability. Given this uncertainty, the likelihood that physicians would be sued for such an act, and their desire for such immunity, this limited protection is morally legitimate. (shrink)

The COVID-19 (Coronavirus disease of 2019) pandemic has led to intense conversations about ventilator allocation and reallocation during a crisis standard of care. Multiple voices in the media and multiple state guidelines mention reallocation as a possibility. Drawing upon a range of neuroscientific, phenomenological, ethical, and sociopolitical considerations, the authors argue that taking away someone’s personal ventilator is a direct assault on their bodily and social integrity. They conclude that personal ventilators should not be part of reallocation pools (...) and that triage protocols should be immediately clarified to explicitly state that personal ventilators will be protected in all cases. (shrink)

In "Frailty Triage: Is Rationing Intensive Medical Treatment on the Grounds of Frailty Ethical?," Wilkinson (2021) argues that the use of frailty scores in ICU triage does not necessarily involve discrimination on the basis of disability. In support of this argument, he claims, “it is not the disability per se that the score is measuring – rather it is the underlying physiological and physical vulnerability." While we appreciate the attention Wilkinson explicitly pays to disability in this piece, we find the (...) distinction between disability and underlying vulnerability untenable both theoretically and practically. In this peer commentary, we begin with a brief overview of research in philosophy of disability concerning the meaning of the concept itself. We argue that this research demonstrates that many forms of disability do not involve underlying vulnerabilities, and, furthermore, that Wilkinson equivocates between "disability" understood as a medical category vs. "disability" understood as a feature of lived experience. We reject Wilkinson’s distinction on these grounds and offer further considerations to avoid disability discrimination in emergency and crisis standards of care contexts. (shrink)

When the Covid‐19 pandemic reached the United States in spring 2020, many states and hospitals announced crisis standards of care plans that used age as a categorical exclusion criterion. Such age choosing was quickly flagged as discriminatory, and so some states and hospitals shifted to embedding age as a tiebreaker deeper in their plans. Different rationales were given for using age as a tiebreaker: that younger patients were more likely to survive than older patients, that saving younger (...) patients would save more life years, and that younger patients deserved a chance to live through life's stages. We provide a critical analysis of these three rationales, noting the differences between them, and then questioning the ethical and legal justifications for such age choosing. (shrink)

The COVID-19 pandemic has focused considerable attention on crisis standards of care (CSCs). Most public CSCs at present are effective tools for allocating scarce but not uncommon resources (like ventilators and dialysis machines). However, a different set of challenges arise with regard to extremely scarce resources (ESRs), where the number of patients in need may exceed the availability of the intervention by magnitudes of hundreds or thousands. Using the allocation of extracorporeal membrane oxygenation machines as a case (...) study, this paper argues for a different set of CSCs specifically for ESRs and explores four principles (transparency, uniformity, equity and impact) that should shape such guidelines. (shrink)

Background:Moral distress occurs when constraints prevent healthcare providers from acting in accordance with their core moral values to provide good patient care. The experience of moral distress in nurses might be magnified during the current Covid-19 pandemic.Objective:To explore causes of moral distress in nurses caring for Covid-19 patients and identify strategies to enhance their moral resiliency.Research design:A qualitative study using a qualitative content analysis of focus group discussions and in-depth interviews. We purposively sampled 31 nurses caring for Covid-19 patients (...) in the acute care units within large academic medical systems in Maryland and New York City during April to June 2020.Ethical considerations:We obtained approval from the Institutional Review Board at the University of Maryland, Baltimore.Results:We identified themes and sub-themes representative of major causes of moral distress in nurses caring Covid-19 patients. These included (a) lack of knowledge and uncertainty regarding how to treat a new illness; (b) being overwhelmed by the depth and breadth of the Covid-19 illness; (c) fear of exposure to the virus leading to suboptimal care; (d) adopting a team model of nursing care that caused intra-professional tensions and miscommunications; (e) policies to reduce viral transmission (visitation policy and PPE policy) that prevented nurses to assume their caring role; (f) practicing within crisis standards of care; and (g) dealing with medical resource scarcity. Participants discussed their coping mechanisms and suggested future strategies.Discussion/Conclusion:Our study affirms new causes of moral distress related to the Covid-19 pandemic. Institutions need to develop a supportive ethical climate that can restore nurses’ moral resiliency. Such a climate should include non-hierarchical interdisciplinary spaces where all providers can meet together as moral peers to discuss their experiences. (shrink)

The COVID-19 pandemic that struck New York City in the spring of 2020 was a natural experiment for the clinical ethics services of NewYork-Presbyterian (NYP). Two distinct teams at NYP’s flagship academic medical centers—at NYP/ Columbia University Medical Center (Columbia) and NYP/ Weill Cornell Medical Center (Weill Cornell)—were faced with the same pandemic and operated under the same institutional rules. Each campus used time as an heuristic to analyze our collective response. The Columbia team compares consults during the pandemic with (...) the same period during the year prior. The Weill Cornell service describes the phases of the pandemic to depict its temporal evolution and subsequent ethical challenges. Both sites report that the predominant ethical challenges centered around end-of-life decision making, setting goals of care, and medical futility, all complicated by resource allocation questions and the ambiguity of state law under crisis standards of care. The Columbia campus saw a statistically significant increase in ethics consultations provided to Hispanic patients, perhaps reflective of the disproportionate burden of COVID-19 suffered by this demographic. While Weill Cornell and Columbia saw a surge in clinical ethics consultations, the two services assumed a more expansive role than one normally played in institutional life. Serving as intermediaries between frontline clinicians and senior hospital administrators, consultants provided critical intelligence to hospital leadership about the evolution of the pandemic, disseminated information to clinicians, and attended to the moral distress of colleagues who were asked to provide care under truly extraordinary circumstances. The COVID-19 surge in New York City revealed latent capabilities in ethics consultation that may prove useful to the broader clinical ethics community as it responds to the current pandemic and reconceptualizes its potential for future service. (shrink)

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: prioritise the worst off: restrict access to acute care services and hospital admission for patients at relatively low clinical risk and 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. (shrink)

The problem of standard of care in clinical research concerns the level of treatment that investigators must provide to subjects in clinical trials. Commentators often formulate answers to this problem by appealing to two distinct types of obligations: professional obligations and natural duties. In this article, I investigate whether investigators also possess institutional obligations that are directly relevant to the problem of standard of care, that is, those obligations a person has because she occupies a particular institutional role. (...) I examine two types of institutional contexts: (1) public research agencies – agencies or departments of states that fund or conduct clinical research in the public interest; and (2) private-for-profit corporations. I argue that investigators who are employed or have their research sponsored by the former have a distinctive institutional obligation to conduct their research in a way that is consistent with the state's duty of distributive justice to provide its citizens with access to basic health care, and its duty to aid citizens of lower income countries. By contrast, I argue that investigators who are employed or have their research sponsored by private-for-profit corporations do not possess this obligation nor any other institutional obligation that is directly relevant to the ethics of RCTs. My account of the institutional obligations of investigators aims to contribute to the development of a reasonable, distributive justice-based account of standard of care. (shrink)

Crisis standards of care are a significant change in the standard level of medical care that can be given compared to normal healthcare operations. CSC are implemented when a healthcare facility is overrun due to catastrophic events like earthquakes, or in the case of SARS-CoV-2, a global pandemic. Especially in disasters, resources like hospital beds, pharmaceuticals, and staff become stretched thin, and facilities must adapt their allocation strategies for distributing scarce resources. Inevitably, a question arises: How (...) do we allocate scarce resources justly? During the coronavirus pandemic, bioethicists, healthcare practitioners, and policymakers have asked this question. A recurring worry among them... (shrink)

The problem of standard of care in clinical research concerns the level of treatment that investigators must provide to subjects in clinical trials. Commentators often formulate answers to this problem by appealing to two distinct types of obligations: professional obligations and natural duties. In this article, I investigate whether investigators also possess institutional obligations that are directly relevant to the problem of standard of care, that is, those obligations a person has because she occupies a particular institutional role. (...) I examine two types of institutional contexts: (1) public research agencies – agencies or departments of states that fund or conduct clinical research in the public interest; and (2) private‐for‐profit corporations. I argue that investigators who are employed or have their research sponsored by the former have a distinctive institutional obligation to conduct their research in a way that is consistent with the state's duty of distributive justice to provide its citizens with access to basic health care, and its duty to aid citizens of lower income countries. By contrast, I argue that investigators who are employed or have their research sponsored by private‐for‐profit corporations do not possess this obligation nor any other institutional obligation that is directly relevant to the ethics of RCTs. My account of the institutional obligations of investigators aims to contribute to the development of a reasonable, distributive justice‐based account of standard of care. (shrink)

Historically, the standard of care in medical negligence provided considerable scope for external evaluation of clinical judgment. Under the Bolam test, however, determining the standard was seen by the courts as essentially a matter for the medical profession, to be resolved by expert testimony with minimal court scrutiny. In recent years, courts have become more willing to probe such testimony and challenge the credibility of medical experts, although they would very rarely override clinical judgment. The House of Lords' decision (...) in Bolitho may be construed as inviting courts to reach their own conclusions on the reasonableness of clinical conduct, along standard risk–benefit lines, after having made their own assessment of the expert opinion. Closer scrutiny of such opinion is the more welcome in the light of current concerns about partisanship in expert testimony. (shrink)

The World Medical Association’s revised Declaration of Helsinki endorses the view that all trial participants in every country are entitled to the worldwide best standard of care. In this paper the authors show that this requirement has been rejected by every national and international committee that has examined this issue. They argue that the consensus view now holds that it is ethically permissible, in some circumstances, to provide research participants less than the worldwide best care. Finally, the authors (...) show that there is also consensus regarding the broad conditions under which this is acceptable. (shrink)

The novel coronavirus of 2019 exposed, in an undeniable way, the severity of racial inequities in America’s healthcare system. As the urgency of the pandemic grew, administrators, clinicians, and ethicists became concerned with upholding the ethical principle of “most lives saved” by re-visiting crisis standards of care and triage protocols. Yet a colorblind, race-neutral approach to “most lives saved” is inherently inequitable because it reflects the normality and invisibility of ‘whiteness’ while simultaneously disregarding the burdens of ‘Blackness’. (...) As written, the crisis standards of care adopted by States are racist policies because they contribute to a history that treats Black Americans are inherently less than. This paper will unpack the idealized fairness and equity pursued by CSC, while also considering the use of modified Sequential Organ Failure Assessment as a measure of objective equality in the context of a healthcare system that is built on systemic racism and the potential dangers this can have on Black Americans with COVID-19. (shrink)

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. (shrink)

ABSTRACT The emergence of the coronavirus disease 2019 pandemic has wide-ranging implications for the field of professional psychology. As clinical practice has rapidly adapted to ensure continuity of care, doctoral students have encountered unique opportunities for ethics-related competency development across practicum training settings. This article discusses the relevant American Psychological Association Ethics Code standards and additional ethical considerations facing trainees as they navigate their foundational clinical experiences and develop as professional psychologists in light of a pandemic.

Law wrangles with setting and applying standards for the practice of medicine in many different arenas. One of the most prominent is medical malpractice litigation in which the trial process examines a physician's performance and measures it against the standard of care. The profession's prevailing custom, with some substantial tolerance for “respectable minority” views, has been the gold standard for scrutinizing physician practice and treatment decisions in the malpractice context. Using the profession's custom as the measure against which (...) a physician's performance is judged defers to the expertise of medicine. Deference to the medical profession is attractive as a tool for reining in law. Reliance on customary practice is criticized, however, for driving physicians to the relative safety of the middle of the herd. Creating such a strong incentive for compliance with customary practice can dampen medical innovation and the diffusion of new clinical knowledge. The safety of the herd can also deprive individual patients of the best care in their particular circumstances.Several current trends are strengthening claims that professional practice patterns are an inappropriate tool for distinguishing between high‐quality and substandard care. In particular, advocacy for evidence‐based medicine aggressively asserts that the traditional way of making medical treatment decisions is largely untethered from scientific method or data, rendering professional judgment, even in the aggregate, suspect. (shrink)

It is argued by Lie et al in the current issue of the Journal of Medical Ethics that an international consensus opinion has formed on the issue of standards of care in clinical trials undertaken in developing countries. This opinion, so they argue, rejects the Declaration of Helsinki’s traditional view on this matter. They propose furthermore that the Declaration of Helsinki has lost its moral authority in the controversy in research ethics. Although the latter conclusion is supported by (...) this author, it will be demonstrated in this paper that there is not such a thing as an international consensus opinion, and that the authorities used by Lie et al as evidence in support of their claim should not be relied upon as authorities or final arbiters in this debate. Furthermore, it will be shown that arguments advanced substantively to show that lower standards of care are ethically acceptable in the developing world, conflate scientific with economic reasons, and ultimately fail to bolster the case they are designed to support. (shrink)

ABSTRACT In recent years there has been intense debate regarding the level of medical care provided to ‘standard care’ control groups in clinical trials in developing countries, particularly when the research sponsors come from wealthier countries. The debate revolves around the issue of how to define a standard of medical care in a country in which many people are not receiving the best methods of medical care available in other settings. In this paper, we argue that (...) additional dimensions of the standard of care have been hitherto neglected, namely, the structure and efficiency of the national health system. The health system affects locally available medical care in two important ways: first, the system may be structured to provide different levels of care at different sites with referral mechanisms to direct patients to the appropriate level of care. Second, inefficiencies in this system may influence what care is available in a particular locale. As a result of these two factors locally available care cannot be equated with a national ‘standard’. A reasonable approach is to define the national standard of care as the level of care that ought to be delivered under conditions of appropriate and efficient referral in a national system. This standard is the minimum level of care that ought to be provided to a control group. There may be additional moral arguments for higher levels of care in some circumstances. This health system analysis may be helpful to researchers and ethics committees in designing and reviewing research involving standard care control groups in developing country research. (shrink)

ABSTRACT In recent years there has been intense debate regarding the level of medical care provided to ‘standard care’ control groups in clinical trials in developing countries, particularly when the research sponsors come from wealthier countries. The debate revolves around the issue of how to define a standard of medical care in a country in which many people are not receiving the best methods of medical care available in other settings. In this paper, we argue that (...) additional dimensions of the standard of care have been hitherto neglected, namely, the structure and efficiency of the national health system. The health system affects locally available medical care in two important ways: first, the system may be structured to provide different levels of care at different sites with referral mechanisms to direct patients to the appropriate level of care. Second, inefficiencies in this system may influence what care is available in a particular locale. As a result of these two factors locally available care cannot be equated with a national ‘standard’. A reasonable approach is to define the national standard of care as the level of care that ought to be delivered under conditions of appropriate and efficient referral in a national system. This standard is the minimum level of care that ought to be provided to a control group. There may be additional moral arguments for higher levels of care in some circumstances. This health system analysis may be helpful to researchers and ethics committees in designing and reviewing research involving standard care control groups in developing country research. (shrink)

Shortages of life-saving medical resources caused by COVID-19 have prompted hospitals, healthcare systems, and governmentsto develop crisis standards of care, including 'triage protocols' to potentially ration medical supplies during the public health emergency. At the same time, the pandemic has highlighted and exacerbated racial, ethnic, and socioeconomic health disparities that together constitute a form of structural racism. These disparities pose a critical ethical challenge in developing fair triage systems that will maximize lives saved without perpetuating systemic inequities. (...) Here we review alternatives to 'utilitarian' triage, including first-come first-served, egalitarian, and prioritarian systems of allocating scarce medical resources. We assess the comparative advantages and disadvantages of these allocation schemes. Ultimately, we argue that while triage protocols should not exacerbate disparities, they are not an adequate mechanism for redressing systemic health inequities. Entrenched health disparities must be addressed through broader social change. (shrink)

In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of Molnupiravir, a novel antiviral medicine aimed (...) at reducing the ability of SARS-CoV-2 to multiply in the body, for clinical use by the National Health Service in England and the concomitant testing of Molnupiravir through the large-scale PANORAMIC randomised control trial. By analysing the ways in which the authorisation and clinical use of Molnupiravir complicate standard approaches to clinical equipoise, standard of care, and participant consent in the PANORAMIC randomised control trial we will explain some of ethical implications for clinical trials that aim to study the efficacy and safety of new COVID-19 and other therapeutics when conditional authorisation has already been granted and when such treatments have already been made available to patients by national health providers. (shrink)

This paper introduces the model of Utilitarian Principlism as a framework for crisis healthcare ethics. In modern Western medicine, during non-crisis times, principlism provides the four guiding principles in biomedical ethics—autonomy, nonmaleficence, beneficence, and justice; autonomy typically emerges as the decisive principle. The physician–patient relationship is a deontological construct in which the physician’s primary duty is to the individual patient and the individual patient is paramount. For this reason, we term the non-crisis ethical framework that guides modern (...) medicine Deontological Principlism. During times of crisis, resources become scarce, standards of care become dynamic, and public health ethics move to the forefront. Healthcare providers are forced to work in non-ideal conditions, and interactions with individual patients must be considered in the context of the crisis. The COVID-19 pandemic has forced healthcare to shift to a more utilitarian framework with a greater focus on promoting the health of communities and populations. This paper puts forth the notion of Utilitarian Principlism as a framework for crisis healthcare ethics. We discuss each of the four principles from a utilitarian perspective and use clinical vignettes, based on real cases from the COVID-19 pandemic, for illustrative purposes. We explore how Deontological Principlism and Utilitarian Principlism are two ends of a spectrum, and the implications to healthcare as we emerge from the pandemic. (shrink)

Starting from MacIntyre’s virtue ethics, we investigate several codes of conduct of banks to identify the type of virtues that are needed to realize their mission. Based on this analysis, we define three core virtues: honesty, due care, and accuracy. We compare and contrast these codes of conduct with the actual behavior of banks that led to the credit crisis and find that in some cases banks did not behave according to the moral standards they set themselves. (...) However, although banks and the professionals working in them can be blamed for what they did, one should also acknowledge that the institutional context of the free market economy in which they operated made it difficult to live up to the core values lying at the basis of the codes of conduct. Given the neo-liberal free market system, innovative and risky strategies to enhance profits are considered desirable for the sake of shareholder’s interests. A return to the core virtues in the financial sector will therefore only succeed if a renewed sense of responsibility in the sector is supported by institutional changes that allow banks to put their mission into practice. (shrink)

Standardization has emerged as the dominant principle guiding the organization and provision of healthcare, with standards resultantly shaping how nurses conceptualize and deliver patient care. Standardization has been critiqued as homogenizing diverse patient experiences and diminishing nurses’ skills and critical thinking; however, there has been limited examination of the philosophical implications of standardization for nursing knowledge and practice. In this manuscript, I draw on Foucault's philosophy of order and categorization to inform an analysis of the consequences of healthcare (...) standardization for the profession of nursing. I utilize three exemplars to illustrate the impact of the primacy of standardized thinking and practices on nurses, patients and families: pain assessments using the 0‐10 pain scale; patient triage emergency departments through the Canadian Triage and Acuity Scale; and determination of cause of death within the context of the current opioid crisis. Through each exemplar, I demonstrate that standardization reductively constrains nursing knowledge and the health and healthcare experiences of patients and populations. I argue that the centrality of standardization must be re‐envisioned to embrace the complexity of health and more effectively and meaningfully frame nursing knowledge and practice within healthcare systems. (shrink)

In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of molnupiravir, a novel antiviral medicine aimed (...) at reducing the ability of SARS-CoV-2 to multiply in the body, for clinical use by the National Health Service in England and the concomitant testing of molnupiravir through the large-scale Platform Adaptive trial of Novel antiviRals for eArly treatMent of COVID-19 In the Community randomised control trial. By analysing the ways in which the authorisation and clinical use of molnupiravir complicate standard approaches to clinical equipoise, standard of care and participant consent in the PANORAMIC randomised control trial, we will explain some of ethical implications for clinical trials that aim to study the efficacy and safety of new COVID-19 and other therapeutics when conditional authorisation has already been granted and when such treatments have already been made available to patients by national health providers. (shrink)

While the entire “wish-list” of expected benefits from nanotechnology has received little scrutiny in the U.S. with regard to issues of social justice, ethics specialists and social scientists are beginning to focus on the responsible conduct of actual nano research and development (R&D) in government, commercial, and academic institutions. In view of the current rush to commercialization, the rush by universities to “get aboard,” and the importance of public trust, it is essential to investigate strategies to promote responsible conduct in (...) the nano area. As this paper discusses, public engagement is one strategy; another is the formulation and implementation of standards of care that are the outcome of inclusive, deliberative processes. (shrink)

BackgroundAs a number of commentators have noted, SARS exposed the vulnerabilities of our health care systems and governance structures. Health care professionals (HCPs) and hospital systems that bore the brunt of the SARS outbreak continue to struggle with the aftermath of the crisis. Indeed, HCPs – both in clinical care and in public health – were severely tested by SARS. Unprecedented demands were placed on their skills and expertise, and their personal commitment to their profession was (...) severely tried. Many were exposed to serious risk of morbidity and mortality, as evidenced by the World Health Organization figures showing that approximately 30% of reported cases were among HCPs, some of whom died from the infection. Despite this challenge, professional codes of ethics are silent on the issue of duty to care during communicable disease outbreaks, thus providing no guidance on what is expected of HCPs or how they ought to approach their duty to care in the face of risk.DiscussionIn the aftermath of SARS and with the spectre of a pandemic avian influenza, it is imperative that we (re)consider the obligations of HCPs for patients with severe infectious diseases, particularly diseases that pose risks to those providing care. It is of pressing importance that organizations representing HCPs give clear indication of what standard of care is expected of their members in the event of a pandemic. In this paper, we address the issue of special obligations of HCPs during an infectious disease outbreak. We argue that there is a pressing need to clarify the rights and responsibilities of HCPs in the current context of pandemic flu preparedness, and that these rights and responsibilities ought to be codified in professional codes of ethics. Finally, we present a brief historical accounting of the treatment of the duty to care in professional health care codes of ethics.SummaryAn honest and critical examination of the role of HCPs during communicable disease outbreaks is needed in order to provide guidelines regarding professional rights and responsibilities, as well as ethical duties and obligations. With this paper, we hope to open the social dialogue and advance the public debate on this increasingly urgent issue. (shrink)