Sunnybrook Health Sciences Centre, Toronto and University of Toronto Ross E. G. Upshur * Sunnybrook Health Sciences Centre, Joint Centre for Bioethics University of Toronto, Toronto * Corresponding author: Ross E. G. Upshur, Primary Care Research Unit, Sunnybrook Health Sciences Centre, 2075 Bayview Avenue, #E-349, Toronto, Ontario, Canada M4N 3M5. Tel.: 416-480-4753; Fax: 416-480-4536; Email: ross.upshur{at}sunnybrook.ca ' + u + '@' + d + ' '//--> Abstract Are restrictive measures and duties to care ethically (...) reasonably acceptable to faith-based organizations? This study describes the perceptions of individually interviewed spiritual leaders of the disease control measures used during the recent SARS outbreak in Toronto. Four central themes were identified: the relationship between religious obligation and civic responsibilities; the role of faith-based organizations in supporting public health restrictive measures; the reciprocal obligations of public health and religious communities during restrictions; and justifiable limits to duties to care. We conclude that, within certain constraints, spiritual leaders find restrictive measures ethically reasonable and that spiritual leaders can play an important role during pandemic and epidemic control planning. Public health officials should therefore include them in the early and ongoing deliberations of the criteria and logistics for implementation during public health emergencies. CiteULike Connotea Del.icio.us What's this? (shrink)

The evolving Ebola epidemic in West Africa is unprecedented in its size and scope, requiring the rapid mobilization of resources. It is too early to determine all of the ethical challenges associated with the outbreak, but these should be monitored closely. Two issues that can be discussed are the decision to implement and evaluate unregistered agents to determine therapeutic or prophylactic safety and efficacy and the justification behind this decision. In this paper, I argue that it is not compassionate use (...) that justifies this decision and suggest three lines of reasoning to support the decision. (shrink)

As a result of increased interest in global health, more and more medical students and trainees from the.

Clinical research is now a global enterprise. However, research ethics capacity has lagged behind the growth and expansion of clinical research in low and middle income countries. To address this mismatch, the Fogarty International Center of the National Institutes of Health has created a program to fund education in research ethics. This series of articles describes the experiences of graduates from 5 nations of the University of Toronto’s Joint Centre for Bioethics International Masters of Health Science Program. The program has (...) graduated 32 students to return to their institutions to build research ethics capacity. (shrink)

The most powerful lesson learned from the 2013-2016 outbreak of Ebola in West Africa was that we do not learn our lessons. A common sentiment at the time was that Ebola served as a “wake-up call”—an alarm which signalled that an outbreak of that magnitude should never have occurred and that we are ill-prepared globally to prevent and respond to them when they do. Pledges were made that we must learn from the outbreak before we were faced with another. Nearly (...) five years later the world is in the grips of a pandemic of the severe acute respiratory syndrome coronavirus 2 that causes coronavirus disease 2019. It is therefore of no surprise that we are now yet again hearing that the COVID-19 pandemic serves as the “wake-up call” we need and that there are many lessons to be learned to better prepare us for future outbreaks. Will anything be different this time around? We argue that nothing will fundamentally change unless we truly understand and appreciate the nature of the lessons we should learn from these outbreaks. Our past failures must be understood as moral failures that offer moral lessons. Unless we appreciate that we have a defect in our collective moral attitude toward remediating the conditions that precipitate the emergence of outbreaks, we will never truly learn. (shrink)

The exercise of identifying lessons in the aftermath of a major public health emergency is of immense importance for the improvement of global public health emergency preparedness and response. Despite the persistence of the Ebola Virus Disease outbreak in West Africa, it seems that the Ebola ‘lessons learned’ exercise is now in full swing. On our assessment, a significant shortcoming plagues recent articulations of lessons learned, particularly among those emerging from organizational reflections. In this article we argue that, despite not (...) being recognized as such, the vast majority of lessons proffered in this literature should be understood as ethical lessons stemming from moral failures, and that any improvements in future global public health emergency preparedness and response are in large part dependent on acknowledging this fact and adjusting priorities, policies and practices accordingly such that they align with values that better ensure these moral failures are not repeated and that new moral failures do not arise. We cannot continue to fiddle at the margins without critically reflecting on our repeated moral failings and committing ourselves to a set of values that engenders an approach to global public health emergencies that embodies a sense of solidarity and global justice. (shrink)

Naturalistic theories of disease appeal to concepts of biological function, and use the notion of dysfunction as the basis of their definitions. Debates in the philosophy of biology demonstrate how attributing functions in organisms and establishing the function-dysfunction distinction is by no means straightforward. This problematization of functional ascription has undermined naturalistic theories and led some authors to abandon the concept of dysfunction, favoring instead definitions based in normative criteria or phenomenological approaches. Although this work has enhanced our understanding of (...) disease and illness, we need not necessarily abandon naturalistic concepts of function and dysfunction in the disease debate. This article attempts to move towards a new naturalistic theory of disease that overcomes the limitations of previous definitions and offers advantages in the clinical setting. Our approach involves a re-evaluation of concepts of biological function employed by naturalistic theories. Drawing on recent insights from the philosophy of biology, we develop a contextual and evaluative account of function that is better suited to clinical medicine and remains consistent with contemporary naturalism. We also show how an updated naturalistic view shares important affinities with normativist and phenomenological positions, suggesting a possibility for consilience in the disease debate. (shrink)

Naturalistic theories of disease appeal to concepts of biological function, and use the notion of dysfunction as the basis of their definitions. Debates in the philosophy of biology demonstrate how attributing functions in organisms and establishing the function-dysfunction distinction is by no means straightforward. This problematization of functional ascription has undermined naturalistic theories and led some authors to abandon the concept of dysfunction, favoring instead definitions based in normative criteria or phenomenological approaches. Although this work has enhanced our understanding of (...) disease and illness, we need not necessarily abandon naturalistic concepts of function and dysfunction in the disease debate. This article attempts to move towards a new naturalistic theory of disease that overcomes the limitations of previous definitions and offers advantages in the clinical setting. Our approach involves a reevaluation of concepts of biological function employed by naturalistic theories. Drawing on recent insights from the philosophy of biology, we develop a contextual and evaluative account of function that is better suited to clinical medicine and remains consistent with contemporary naturalism. We also show how an updated naturalistic view shares important affinities with normativist and phenomenological positions, suggesting a possibility for consilience in the disease debate. (shrink)

Background Tuberculosis is a major cause of morbidity and mortality globally. Recent scholarly attention to public health ethics provides an opportunity to analyze several ethical issues raised by the global tuberculosis pandemic. Discussion Recently articulated frameworks for public health ethics emphasize the importance of effectiveness in the justification of public health action. This paper critically reviews the relationship between these frameworks and the published evidence of effectiveness of tuberculosis interventions, with a specific focus on the controversies engendered by the endorsement (...) of programs of service delivery that emphasize direct observation of therapy. The role of global economic inequities in perpetuating the tuberculosis pandemic is also discussed. Summary Tuberculosis is a complex but well understood disease that raises important ethical challenges for emerging frameworks in public health ethics. The exact role of effectiveness as a criterion for judging the ethics of interventions needs greater discussion and analysis. Emerging frameworks are silent about the economic conditions contributing to the global burden of illness associated with tuberculosis and this requires remediation. (shrink)

Editors' introduction to 3rd thematic issue on philosophy of medicine.

This paper explores the notion of reciprocity in the context of active pulmonary and laryngeal tuberculosis treatment and related control policies and practices. We seek to do three things: First, we sketch the background to contemporary global TB care and suggest that poverty is a key feature when considering the treatment of TB patients. We use two examples from TB care to explore the role of reciprocity: isolation and the use of novel TB drugs. Second, we explore alternative means of (...) justifying the use of reciprocity through appeal to different moral and political theoretical traditions. We suggest that each theory can be used to provide reasons to take reciprocity seriously as an independent moral concept, despite any other differences. Third, we explore general meanings and uses of the concept of reciprocity, with the primary intention of demonstrating that it cannot be simply reduced to other more frequently invoked moral concepts such as beneficence or justice. We argue that reciprocity can function as a mid-level principle in public health, and generally, captures a core social obligation arising once an individual or group is burdened as a result of acting for the benefit of others. We conclude that while more needs to be explored in relation to the theoretical justification and application of reciprocity, sufficient arguments can be made for it to be taken more seriously as a key principle within public health ethics and bioethics more generally. (shrink)

ObjectiveTo identify the ethical challenges associated with the development and implementation of new tuberculosis drugs and diagnostics.MethodsTwenty-three semi-structured qualitative interviews conducted between December 2015 and September 2016 with programme administrators, healthcare workers, advocates, policymakers, and funders based in the Americas, Europe, and Africa. Interviews were analysed using thematic analysis.ResultsDivergent interests and responsibilities, coupled with power imbalances, are a primary source of ethical challenges; the uncertain risk profiles of new drugs present an additional one. Although this challenge can be partially mitigated (...) through stringent pharmacovigilance, respondents highlighted that high-burden countries tend to lack the resources to facilitate safe implementation. Increased advocacy and community engagement are considered an ethical imperative for future TB development and implementation.ConclusionsThis project helps identify some of the ethical challenges of new TB technologies. It demonstrates that investigating ethical challenges through qualitative research is one way to apprehend the difficulty of implementing new TB technologies. Addressing this difficulty will require that those in positions of power reconsider their interests in relation to disempowered communities.Policy implicationsEfforts to build consensus regarding what values should underpin the global governance of TB research, prevention, and care are essential to facilitate the ethical implementation of new TB technologies. (shrink)

What kind of knowledge is medical knowledge? Can medicine be explained scientifically? Is disease a scientific concept, or do explanations of disease depend on values? What is ‘evidence-based’ medicine? Are advances in neuroscience bringing us closer to a scientific understanding of the mind? The nature of medicine raises fundamental questions about explanation, causation, knowledge and ontology – questions that are central to philosophy as well as medicine. In this book Paul R. Thompson and Ross E. G. Upshur introduce (...) the fundamental issues in philosophy of medicine for those coming to the subject for the first time. They introduce and explain the following key topics: Understanding the physician-patient relationship: the phenomenology of the medical encounter. Models and theories in biology and medicine: what role do theories play in medicine? Are they similar to scientific theories? Randomised controlled trials: can scientific experiments be replicated in clinical medicine? What are the philosophical criticisms levelled at RCTs? The concept of evidence in medical research: what do we mean by ‘Evidence-based medicine?’ Should all medicine be based on evidence? Causation in medicine What do advances in neuroscience reveal about the relationship between mind and body? Defining health and disease: are explanations of disease objective or do they depend on values? Evolutionary medicine: what is the role of evolutionary biology in understanding medicine? Is it relevant? Extensive use of empirical examples and case studies is made throughout the book. These include debates about smoking and cancer, the use of placebos in randomised controlled trials and controversies about research into the causes of HIV and autism. This is an indispendable introduction to those teaching philosophy of medicine and philosophy of science. (shrink)

Objective: Ethical guidelines are designed to ensure benefits, protection and respect of participants in clinical research. Clinical trials must now be registered on open-access databases and provide details on ethical considerations. This systematic survey aimed to determine the extent to which recently registered clinical trials report the use of standard of care and post-trial obligations in trial registries, and whether trial characteristics vary according to setting. Methods: We selected global randomized trials registered on http://www.clinicaltrials.gov and http://www.controlled-trials.com. We searched for intervention (...) trials of HIV/AIDS, malaria, and tuberculosis from 9 October 2004, the date of the most recent version of the Helsinki Declaration, to 10 April 2007. Results: We collected data from 312 trials. Fifty-eight percent (58%, 95% CI = 53 to 64) of trial protocols report informed consent. Fifty-eight percent (58%, 95% CI = 53 to 64) of trials report active controls. Almost no trials (1%, 95% CI = 0.5 to 3) mention post-trial provisions. Most trials measure surrogate outcomes. Twenty percent (20%, 95% CI = 16 to 25) of trials measure patient-important outcomes, such as death; and the odds that these outcomes are in a low income country are five times greater than for a developed country (odds ratio (OR) 5.03, 95% CI = 2.70 to 9.35, p = < 0.001). Pharmaceutical companies are involved in 28% (CI = 23 to 33) of trials and measure surrogate outcomes more often than nonpharmaceutical companies (OR 2.45, 95% CI = 1.18 to 5.09, p = 0.31). Conclusion: We found a large discrepancy in the quality of reporting and approaches used in trials in developing settings compared to wealthier settings. (shrink)

In this paper, we explore the role of reciprocity in the employment of restrictive measures in contexts of contagion. Reciprocity should be understood as a substantive value that governs the use, level and extent of restrictive measures. We also argue that independent of the role reciprocity plays in the legitimisation the use of restrictive measures, reciprocity can also motivate support and compliance with legitimate restrictive measures. The importance of reciprocity has implications for how restrictive measures should be undertaken when preparing (...) and evaluating public health responses to contagion. (shrink)

North America is in the grips of an epidemic of opioid-related poisonings. Overdose education and naloxone distribution programmes emerged as an option for structurally vulnerable populations who could not or would not access mainstream emergency medical services in the event of an overdose. These task shifting programmes utilize lay persons to deliver opioid resuscitation in the context of longstanding stigmatization and marginalization from mainstream healthcare services. OEND programmes exist at the intersection of harm reduction and emergency services. One goal of (...) OEND programmes is to help redress the health-related inequities common among people who use drugs, which include minimizing the gap between people who use drugs and the formal healthcare system. However, if this goal is not achieved these inequities may be entrenched. In this article, we consider the ethical promises and perils associated with OEND as task shifting. We argue that public health practitioners must consider the ethical aspects of task shifting programmes that may inadvertently harm already structurally vulnerable populations. We believe that even if OEND programmes reduce opioid-related deaths, we nevertheless question if, by virtue of its existence, OEND programmes might also unintentionally disenfranchise structurally vulnerable populations from comprehensive healthcare services, including mainstream emergency care. (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)

Are restrictive measures and duties to care ethically reasonably acceptable to faith-based organizations? This study describes the perceptions of individually interviewed spiritual leaders of the disease control measures used during the recent SARS outbreak in Toronto. Four central themes were identified: the relationship between religious obligation and civic responsibilities; the role of faith-based organizations in supporting public health restrictive measures; the reciprocal obligations of public health and religious communities during restrictions; and justifiable limits to duties to care. We conclude that, (...) within certain constraints, spiritual leaders find restrictive measures ethically reasonable and that spiritual leaders can play an important role during pandemic and epidemic control planning. Public health officials should therefore include them in the early and ongoing deliberations of the criteria and logistics for implementation during public health emergencies. (shrink)

Evidence-based medicine has beendefined as the conscientious and judicious useof current best evidence in making clinicaldecisions. This paper will attempt to explicatethe terms ``conscientious'''' and ``judicious''''within the evidence-based medicine definition.It will be argued that ``conscientious'''' and``judicious'''' represent virtue terms derived fromvirtue ethics and virtue epistemology. Theidentification of explicit virtue components inthe definition and therefore conception ofevidence-based medicine presents an importantstarting point in the connection between virtuetheories and medicine itself. In addition, aunification of virtue theories andevidence-based medicine will illustrate theneed for (...) future research in order to combinethe fields of virtue-based approaches andclinical practice. (shrink)

This essay explores the role of informal logicand its application in the context of currentdebates regarding evidence-based medicine. This aim is achieved through a discussion ofthe goals and objectives of evidence-basedmedicine and a review of the criticisms raisedagainst evidence-based medicine. Thecontributions to informal logic by StephenToulmin and Douglas Walton are explicated andtheir relevance for evidence-based medicine isdiscussed in relation to a common clinicalscenario: hypertension management. This essayconcludes with a discussion on the relationshipbetween clinical reasoning, rationality, andevidence. It is argued that (...) informal logic hasthe virtue of bringing explicitness to the roleof evidence in clinical reasoning, and bringssensitivity to understanding the role ofdialogical context in the need for evidence inclinical decision making. (shrink)

The generation of evidence is integral to the work of public health and health service providers. Traditionally, ethics has been addressed differently in research projects, compared with other forms of evidence generation, such as quality improvement, program evaluation, and surveillance, with review of non-research activities falling outside the purview of the research ethics board. However, the boundaries between research and these other evaluative activities are not distinct. Efforts to delineate a boundary – whether on grounds of primary purpose, temporality, underlying (...) legal authority, departure from usual practice, or direct benefits to participants – have been unsatisfactory. (shrink)

This paper explores the relationship between concepts of probability and hermeneutics. It seeks to examine the relationship between subjective (Bayesian) views of probability and hermeneutic descriptions of understanding. It is argued that Gadamer'saccount of the prejudicial nature of understanding, derived from Heidegger'sanalysis of foreunderstanding, offers a provocative model of clinical reasoning. The implications of this model for evidence-based medicine are discussed in conclusion.

As health care embraces the tenets of evidence-based medicine it is important to ask questions about how evidence is produced and interpreted. This essay explores normative dimensions of evidence production, particularly around issues of setting the tolerable level of uncertainty of results. Four specific aspects are explored: what health care providers know about statistics, why alpha levels have been set at 0.05, the role of randomization in the generation of sufficient grounds of belief, and the role of observational studies. The (...) essay concludes with recommendations to acknowledge the value permeation of outcome measures and suggests that attention to reasoning and argument analysis can augment traditional evidence-based approaches in providing a robust critical approach to medical knowledge. (shrink)

Medical technologies and assistive devices such as ventilators and power wheelchairs are designed to sustain life and/or improve functionality but they can also contribute to stigmatization and social exclusion. In this paper, drawing from a study of ten men with Duchenne muscular dystrophy, we explore the complex social processes that mediate the lives of persons who are dependent on multiple medical and assistive technologies. In doing so we consider the embodied and emplaced nature of disability and how life is lived (...) through bodies coupled with technologies and experienced as 'techno-body-subjects in situ'. Normative implications for theory and research, including bioethics research, are discussed. (shrink)

Medical technologies and assistive devices such as ventilators and power wheelchairs are designed to sustain life and/or improve functionality but they can also contribute to stigmatization and social exclusion. In this paper, drawing from a study of ten men with Duchenne muscular dystrophy, we explore the complex social processes that mediate the lives of persons who are dependent on multiple medical and assistive technologies. In doing so we consider the embodied and emplaced nature of disability and how life is lived (...) through bodies coupled with technologies and experienced as ‘techno-body-subjects in situ’. Normative implications for theory and research, including bioethics research, are discussed. (shrink)