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)

This paper examines how people in West Africa are reacting to the Ebola virus disease, an epidemic presently prevalent in the region. Certain lifestyle changes are suggested. Additionally, the heart of the paper focuses on the request by governments to be allowed access to experimental drugs, such as Zmapp and TKM-Ebola, for their infected populations. The author argues that granting such a request would circumvent research ethics procedures, which could potentially constitute significant risk to users of the (...) drugs. The Pfizer Kano meningitis trial of 1996 is cited as an example to buttress how unapproved drugs could prove fatal. (shrink)

Still the Heart of Darkness analyzes Richard Preston's best-selling account of an Ebola virus outbreak in Reston, Virginia in 1989. Through a textual examination of The Hot Zone, this essay demonstrates how Preston grounds his narrative about the threat of rare emerging viruses from the third world in terms of the colonialist discourse about Africa as the white man's grave, most notably Joseph Conrad's Heart of Darkness. By foregrounding previous outbreaks in Africa, Preston simultaneously darkens its landscape and (...) inscribes the Ebola filovirus as an external biological threat to Americans in a post-Cold War world with porous borders. (shrink)

Between 2013 and 2016, West Africa experienced the largest ever outbreak of Ebola Virus Disease. In the absence of registered treatments or vaccines to control this lethal disease, the World Health Organization coordinated and supported research to expedite identification of interventions that could control the outbreak and improve future control efforts. Consequently, the World Health Organization Research Ethics Review Committee was heavily involved in reviews and ethics discussions. It reviewed 24 new and 22 amended protocols for research studies (...) including interventional and observational studies. WHO-ERC provided the reviews within on average 6 working days. The WHO-ERC often could not provide immediate approval of protocols for reasons which were not Ebola Virus Disease specific but related to protocol inconsistencies, missing information and complex informed consents. WHO-ERC considerations on Ebola Virus Disease specific issues are presented. To accelerate study approval in future public health emergencies, we recommend: internally consistent and complete submissions with information documents in language participants are likely to understand, close collaboration between local and international researchers from research inception, generation of template agreements for data and sample sharing and use during the ongoing global consultations on bio-banks, formation of Joint Scientific Advisory and Data Safety Review Committees for all studies linked to a particular intervention or group of interventions, formation of a Joint Ethics Review Committee with representatives of the Ethics Committees of all institutions and countries involved to strengthen reviews through the different perspectives provided without the ‘opportunity costs’ for time to final approval of multiple, independent reviews, direct information exchange between the chairs of advisory, safety review and ethics committees, more Ethics Committee support for investigators than is standard and a global consultation on criteria for inclusion of pregnant women and children in interventional studies for conditions which put them at particularly high risk of mortality or other irreversible adverse outcomes under standard-of-care. (shrink)

Background Between 2013 and 2016, West Africa experienced the largest ever outbreak of Ebola Virus Disease. In the absence of registered treatments or vaccines to control this lethal disease, the World Health Organization coordinated and supported research to expedite identification of interventions that could control the outbreak and improve future control efforts. Consequently, the World Health Organization Research Ethics Review Committee was heavily involved in reviews and ethics discussions. It reviewed 24 new and 22 amended protocols for research (...) studies including interventional and observational studies. WHO-ERC reviews WHO-ERC provided the reviews within on average 6 working days. The WHO-ERC often could not provide immediate approval of protocols for reasons which were not Ebola Virus Disease specific but related to protocol inconsistencies, missing information and complex informed consents. WHO-ERC considerations on Ebola Virus Disease specific issues are presented. Conclusions To accelerate study approval in future public health emergencies, we recommend: internally consistent and complete submissions with information documents in language participants are likely to understand, close collaboration between local and international researchers from research inception, generation of template agreements for data and sample sharing and use during the ongoing global consultations on bio-banks, formation of Joint Scientific Advisory and Data Safety Review Committees for all studies linked to a particular intervention or group of interventions, formation of a Joint Ethics Review Committee with representatives of the Ethics Committees of all institutions and countries involved to strengthen reviews through the different perspectives provided without the ‘opportunity costs’ for time to final approval of multiple, independent reviews, direct information exchange between the chairs of advisory, safety review and ethics committees, more Ethics Committee support for investigators than is standard and a global consultation on criteria for inclusion of pregnant women and children in interventional studies for conditions which put them at particularly high risk of mortality or other irreversible adverse outcomes under standard-of-care. (shrink)

The 2013 Ebola virus outbreak in West Africa, as of writing, is declining in reported human cases and mortalities. The resulting devastation caused highlights how health systems, in particular in West Africa, and in terms of global pandemic planning, are ill prepared to react to zoonotic pathogens. In this paper we propose One Health as a strategy to prevent zoonotic outbreaks as a shared goal: that human and Great Ape vaccine trials could benefit both species. Only recently have (...) two phase 2/3 Ebola human vaccine trials been started in West Africa. This paper argues for a conceptual change in pandemic preparedness. We first discuss the ethics of One Health. Next, we focus on the current Ebola outbreak and defines its victims. Third, we present the notion of a ‘shared benefit’ approach, grounded in One Health, and argue for the vaccination of wild apes in order to protect both apes and humans. We believe that a creation of such inter-species immunity is an exemplar of One Health, and that it is worth pursuing as a coextensive public health approach. (shrink)

The Ebola virus disease epidemic in Western Africa has, in recent months, aroused growing alarm in Western countries. Attention has been drawn to the threat posed to the inhabitants of the region by what has undoubtedly become a major health emergency. As the death toll has mounted, increasingly strident calls for action have been voiced by nongovernmental organizations and international agencies active in the area, such as Médecins Sans Frontières and the World Health Organization and, more recently, even (...) by the U.S. president.Critics of the Western response have claimed that the newfound concern about EVD, which has been present in Africa for nearly 40 years, reflects a longstanding disregard of the needs of people living in the region. They point out that the difficulties in controlling the spread of the disease are in large part due to the lack of effective health infrastructure, which in turn reflects global disparities in wealth and opportunity. Despite the lack of m .. (shrink)

The Ebola epidemic that broke out inWest Africa West AfricaAfrica towards the end of 2013 had been brought under reasonable control by 2015. The epidemic had severely affected three countries. This case study is about a phase I/II clinical trial Phase I/II clinical trial of a candidate Ebola virus vaccine in 2015 in a sub-Saharan AfricanSub-Saharan Africa country which had not registered any cases of the Ebola virus disease. The study was designed as a randomized (...) double-blinded trialRandomized double blinded trial. It was sponsored and funded by one of the biggest Northern multinational pharmaceutical companiesPharmaceutical companies. The protocol received ethics clearance from the relevantNational Ethics Committee national ethics committeeEthics committee. The study was coordinated and managed at the local branch of a big Northern diagnostic laboratoryDiagnostic laboratory and a laboratory of a local regional hospital. The overall study was a multi-countryMulti-country, multi-siteMulti-site trial aimed at recruiting a total of 3,000 research participantsResearch participants across four or five sub-Saharan African countries. For this country, the recruitmentRecruitment sites were two big cities, each aiming to recruit 200 participants: adults at the first site and childrenChildren at the second. The target sampleSample size was almost achieved at the first site but, before the study commenced at the second site, some members of raised the alarm that the governmentGovernment was carelessly risking the health, safetySafety and lives of citizens in the cause of an unproven vaccine that could precipitate a public health disaster. The trial was immediately suspended. A commentary on this case, and on the importance of trustTrust, is provided by Katharine Browne and Doris Schroeder at the end of this chapter. It highlights differences between this case and a phase I Ebola vaccine trial in CanadaCanada in 2014. (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)

The current Ebola virus epidemic in Western Africa appears to be spiraling out of control. The worst-case projections suggested that the unchecked spread could result in almost 1.4 million cases by the end of January 2015 with a case fatality rate of at least 50%. The United States and European nations have begun to respond in earnest with promises of supplies, isolation beds, and trained health care personnel in an effort to contain the epidemic and care for the (...) sick. However, there is neither a vaccine nor specific treatment for Ebola infection, and therapy is ideally centered on supportive care. I have previously argued that the provision of palliative care is obligatory during an overwhelming health catastrophe, notably pandemic influenza. Since affected Ebola patients have best outcomes with technologically advanced intensive care—resources in scarce supply in the area—I suggest that the only acceptable approach to large numbers of very sick, dying, and suffering Ebola patients who overwhelm the reso.. (shrink)

The current Ebola virus epidemic in Western Africa appears to be spiraling out of control. The worst-case projections suggested that the unchecked spread could result in almost 1.4 million cases by the end of January 2015 with a case fatality rate of at least 50%. The United States and European nations have begun to respond in earnest with promises of supplies, isolation beds, and trained health care personnel in an effort to contain the epidemic and care for the (...) sick. However, there is neither a vaccine nor specific treatment for Ebola infection, and therapy is ideally centered on supportive care. I have previously argued that the provision of palliative care is obligatory during an overwhelming health catastrophe, notably pandemic influenza. Since affected Ebola patients have best outcomes with technologically advanced intensive care—resources in scarce supply in the area—I suggest that the only acceptable approach to large numbers of very sick, dying, and suffering Ebola patients who overwhelm the resources available to successfully manage them is effective palliative care. However, this could hasten death in this vulnerable population and hence, while ethically and medically justifiable, is not without social risk. (shrink)

COVID‐19, caused by a novel coronavirus named SARS‐CoV‐2, was identified in December 2019, in Wuhan, China. It was first confirmed in sub‐Saharan Africa in Nigeria on 27 February 2020 and has since spread quickly to all sub‐Saharan African countries, causing more than 111,309 confirmed cases and 2,498 deaths as of 03 June 2020. The lessons learned during the recent Ebola virus disease (EVD) outbreaks in some sub‐Saharan African countries were expected to shape and influence the region’s responses to (...) COVID‐19 pandemic. However, some of the challenges associated with the management of the EVD outbreaks persist and create obstacles for the effective management of the COVID‐19 pandemic. This article describes the commonalities between the EVD epidemics and COVID‐19 pandemic, with a view to draw on lessons learned to effectively tackle the ongoing pandemic. Key successes, failures and lessons learned from previous EVD outbreaks are discussed. Recommendations on how these lessons can be translated to strengthen the COVID‐19 response in sub‐Saharan Africa are provided. (shrink)

The unprecedented outbreak of Ebola virus disease in West Africa has raised several novel ethical issues for global outbreak preparedness. It has also illustrated that familiar ethical issues in infectious disease management endure despite considerable efforts to understand and mitigate such issues in the wake of past outbreaks. To improve future global outbreak preparedness and response, we must examine these shortcomings and reflect upon the current state of ethical preparedness. To this end, we focus our efforts in this (...) article on the examination of one substantial area: ethical guidance in pandemic plans. We argue that, due in part to their focus on considerations arising specifically in relation to pandemics of influenza origin, pandemic plans and their existing ethical guidance are ill-equipped to anticipate and facilitate the navigation of unique ethical challenges that may arise in other infectious disease pandemics. We proceed by outlining three reasons why this is so, and situate our analysis in the context of the EVD outbreak and the threat posed by drug-resistant tuberculosis: different infectious diseases have distinct characteristics that challenge anticipated or existing modes of pandemic prevention, preparedness, response, and recovery, clear, transparent, context-specific ethical reasoning and justification within current influenza pandemic plans are lacking, and current plans neglect the context of how other significant pandemics may manifest. We conclude the article with several options for reflecting upon and ultimately addressing ethical issues that may emerge with different infectious disease pandemics. (shrink)

Herbert, Dilinie The Zika virus has dominated the news media and captured the attention of the international community. Epidemic disease has become the mainstay of public health emergencies in our recent past with Ebola virus in West Africa and now Zika virus in Latin America. An unexpected and troubling feature of this current outbreak is the high incidence of birth defects and neurological health complications. As scientists investigate a possible causal link, health authorities as well as (...) Catholic Church leaders are involved in communicating how women and the wider community should make decisions about their health, reproduction and pregnancy. A morally appropriate, culturally sensitive and socially inclusive approach to managing the immanent risk should be the priority. (shrink)

Herbert, Dilinie The Ebola virus disease outbreak in West Africa is a tragedy of mass proportions. It has afflicted a region with poor public health infrastructure, communities fearful of medical intervention due to past atrocities, and in a situation where the people are protective of themselves and their families. As the death toll continues to rise, experimental treatments are being offered as a solution. The widespread use and management of these treatments is a challenge due to the social (...) and cultural structures that exists in these communities. An approach that is sensitive to these experiences needs to be observed. (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)

The recent Ebola virus disease outbreak in Western African countries has raised questions regarding the feasibility of adopting conventional trial designs such as randomized controlled trials for conducting experimental trials in the midst of a fatal epidemic. In the context of Ebola ça Suffit trial conducted in Guinea for testing the efficacy and effectiveness of rVSV–ZEBOV, a candidate vaccine, I argue that the trial design and the methodologies adopted for the trial have been rightly chosen for their (...) ethical appropriateness and social utilities rather than only epistemic advantages. In this paper, I propose and defend the view that in varying scientific research contexts, it is entirely legitimate that non-epistemic values may be prioritized over epistemic considerations. Two vital methodological choices scientists should make while designing a clinical trial are: the choice of appropriate control group and the choice of appropriate randomization. Given this background, I show that the choice of delayed vaccination arm as the control group over placebo control group and the choice of cluster randomization over individually controlled randomization for conducting Ebola ça Suffit trial are perfect instances of such a scenario where addressing social and ethical issues have been justifiably prioritized over epistemic values so that the research in a specific scientific context could be conducted in a socially relevant manner. (shrink)

The asymmetric distribution of lipids, maintained by flippases/floppases and scramblases, plays a pivotal role in various physiologic processes. Scramblases are proteins that move phospholipids between the leaflets of the lipid bilayer of the cellular membrane in an energy‐independent manner. Recent studies have indicated that viral infection is closely related to cellular lipid distribution. The level and distribution of phosphatidylserine (PtdSer) in cells have been demonstrated to be critical regulators of viral infections. Previous studies have supported that the infection of human (...) immunodeficiency virus (HIV), Zika virus, Ebola virus (EBOV), influenza virus, and dengue fever virus require the externalization of phospholipids mediated by scramblases, which are also involved in the pathogenicity of the pandemic severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2). In this review, we review the relationship of scramblases with viruses and the potential viral effector proteins that might utilize host scramblases. (shrink)

BackgroundThe West African Ebola virus epidemic from 2014 to 2016 is unprecedented in its scale, surpassing all previous and subsequent Ebola outbreaks since 1976. This epidemic provoked a humanitarian emergency that extended to different spheres of life, making visible ethical challenges in addition to medical, economic, and social ones. The present article aims to identify and differentiate the scope of ethical issues associated with the Ebola epidemic.MethodsAn online media analysis was performed on articles published from March (...) 2014 to September 2015 in ten preselected academic journals (scientific press) and two online newspapers (lay press). Two methodological approaches were combined: a systematic literature search and a qualitative content analysis. An additional keyword search was conducted on the PubMed database for the period after the end of the Ebola epidemic (2016-2020) to obtain an overview of research dealing with medical ethics due to the epidemic and to compare these results with the identified ethical challenges.ResultsA total of 389 articles dealing with the subject fields “Ebola epidemic” and “ethics” were researched. For qualitative content analysis, the time span with the highest article density was selected and a total of 64 articles were included (15 scientific articles, 49 popular articles). Five core ethical challenges of the Ebola epidemic emerged: 1. Responsibility and Accountability, 2. Spillover Effects, 3. Research and Development, 4. Health Communication, and 5. Resource Allocation. Articles in academic journals were dominated by the discussion of normative aspects in the area of “research and development”, while newspaper articles focused on aspects of “responsibility and accountability”.ConclusionAn ethical discussion of the Ebola epidemic requires an examination of as many of the ethical dimensions involved as possible. The presented investigation of the two types of media with regard to the Ebola epidemic offers this possibility of a more comprehensive insight into this diversity as a basis for ethical discussions. (shrink)

The recent Ebola outbreak in West Africa began in the spring of 2014 and has since caused the deaths of over 6,000 people. Since there are no approved treatments or prevention modalities specifically targeted at Ebola Virus Disease , debate has focused on whether unproven interventions should be offered to Ebola patients outside of clinical trials. Those engaged in the debate have responded rapidly to a complex and evolving crisis, however, and this debate has not provided (...) much opportunity for in-depth analysis. Additionally, the existing literature on access to unproven therapies has focused on contexts like HIV/AIDS and oncology, which are very different than the Ebola epidemic. In this paper, we examine the ethical issues surrounding access to unproven therapies in the context of the recent Ebola outbreak to yield new insights about this controversial and unsettled issue. We argue first that, in this context, the interests of patients in obtaining access to unproven therapies are not fully aligned.. (shrink)

I read with great bewilderment the unconvincing arguments of Peter F. Omonzejele in his article “Ethical Challenges Posed by the Ebola Virus Epidemic in West Africa” published in the 11 issue of the Journal of Bioethical Inquiry. While the author glaringly mixed up anthropological issues concerning the hygiene of hand-washing and safe burials in an article with a title clearly focused on ethical challenges, he failed to establish how the current Ebola epidemic ravaging some West Africa countries (...) made these human practices ethical challenges. Anecdotal examples cited in the article fit entirely into the realm of anthropological and sociological issues fuelling the spread of Ebola but are not in any way related to ethical challenges. The title was either misleading or the author deliberately discussed anthropological/sociological issues tangentially in an article supposedly written on ethical issues.The author also contradicted himself, having categorized as a compelling need t .. (shrink)

While the global threat of Ebola Virus Disease in 2014 was concentrated in several West African countries, its effects have been felt in many developed countries including the United States. Initial, select patients with EVD, largely among American health care workers volunteering in affected regions, were subsequently transported back to the states for isolation and treatment in high-level medical facilities. This included Emory University Hospital, which sits adjacent to the federal Centers for Disease Control and Prevention in Atlanta, (...) Georgia.The first domestic case of EVD occurred in late September in Dallas, Texas. Additional exposures of two HCWs generated an array of legal issues for state and local public health authorities, hospitals, and providers. Consideration of these issues led to extensive discussion among lawyers, public health practitioners, and other attendees at a late-breaking session on EVD and Legal Preparedness at the 2014 National Public Health Law conference. In this commentary, session presenters from CDC and Emory University share their expert perspectives on legal and policy issues underlying state and local powers to quarantine and isolate persons exposed to or infected with Ebola, as well as facets of hospital preparedness underlying the successful treatment of patients with EVD. (shrink)

This paper examines the case of Ebola, ça Suffit trial which was conducted in Guinea during Ebola Virus Disease (EVD) outbreak in 2015. I demonstrate that various non-epistemic considerations may legitimately influence the criteria for evaluating the efficacy and effectiveness of a candidate vaccine. Such non-epistemic considerations, which are social, ethical, and pragmatic, can be better placed and addressed in scientific research by appealing to non-epistemic values. I consider two significant features any newly developed vaccine should possess; (...) (1) the duration of immunity the vaccine provides; and (2) safety with respect to the side effects of the vaccine. Then, I argue that social and ethical values are relevant and desirable in setting the parameters for evaluating these two features of vaccines. The parameters that are employed for setting up the criteria for assessing the features might have far-reaching implications on the well-being of society in general, and the health conditions of several thousand people in particular. The reason is that these features can play a decisive role during the evaluation of the efficacy and effectiveness of the vaccine. I conclude by showing why it is necessary to reject the concept of epistemic priority, at least when scientists engage in policy-oriented research. (shrink)

Using the case of Ebola Virus Disease as an example, this paper shows why patients at high risk for death have a defensible moral claim to access unregistered medical interventions, without having to enrol in randomized placebo controlled trials.A number of jurisdictions permit and facilitate such access under emergency circumstances. One controversial question is whether patients should only be permitted access to UMI after trials investigating the interventions are fully recruited. It is argued that regulatory regimes should not (...) prioritise trial recruitment over patient access, even if this results in drug research and development delays.We describe how the moral duty to rescue impacts on others' duties to oblige patients seeking emergency access to unregistered medical interventions. The view that eligible patients are owed the provision of access to UMI regardless of their willingness to enrol in a randomised controlled trial is defended. (shrink)

Ebola is a deadly disease with no cure; there is no vaccine developed yet. Many died during the 2014 outbreak in West Africa, and many healthcare professionals went to the virus infected area to treat the patients while placing their lives in danger. Not every medical professional placed in the field is a fully trained specialist, and sometimes one or two under-trained doctors are in charge of the entire clinic with some nurses and operating technicians. When unexpected outbreaks (...) of the virus occur in the places, the doctor(s) would encounter medical and ethical dilemmas. Should they leave or stay? In fact, this dilemma is not confined to the Ebola pandemic but relevant to all similar cases. In this paper, three authors, a medical resident, a clinical bioethicist, and a theoretical bioethicist respond to the dilemma. (shrink)

Background The COVID-19 pandemic forced governments, multilateral public health organisations and research institutions to undertake research quickly to inform their responses to the pandemic. Most COVID-19-related studies required swift approval, creating ethical and practical challenges for regulatory authorities and researchers. In this paper, we examine the landscape of ethics review processes in Africa during public health emergencies (PHEs). Methods We searched four electronic databases (Web of Science, PUBMED, MEDLINE Complete, and CINAHL) to identify articles describing ethics review processes during public (...) health emergencies and/or pandemics. We selected and reviewed those articles that were focused on Africa. We charted the data from the retrieved articles including the authors and year of publication, title, country and disease(s) reference, broad areas of (ethical) consideration, paper type, and approach. Results Of an initial 4536 records retrieved, we screened the titles and abstracts of 1491 articles, and identified 72 articles for full review. Nine articles were selected for inclusion. Of these nine articles, five referenced West African countries including Liberia, Guinea and Sierra Leone, and experiences linked to the Ebola virus disease. Two articles focused on South Africa and Kenya, while the other two articles discussed more general experiences and pitfalls of ethics review during PHEs in Africa more broadly. We found no articles published on ethics review processes in Africa before the 2014 Ebola outbreak, and only a few before the COVID-19 outbreak. Although guidelines on protocol review and approval processes for PHEs were more frequently discussed after the 2014 Ebola outbreak, these did not focus on Africa specifically. Conclusions There is a gap in the literature about ethics review processes and preparedness within Africa during PHEs. This paper underscores the importance of these processes to inform practices that facilitate timely, context-relevant research that adequately recognises and reinforces human dignity within the quest to advance scientific knowledge about diseases. This is important to improve fast responses to PHEs, reduce mortality and morbidity, and enhance the quality of care before, during, and after pandemics. (shrink)

In 2016, following pandemic influenza threats and the 2014–2016 Ebola virus disease outbreaks, the WHO developed a guidance document for managing ethical issues in infectious disease outbreaks. In this article, we analyse some ethical issues that have had a predominant role in decision making in response to the current COVID-19 pandemic but were absent or not addressed in the same ways in the 2016 guidance document. A pandemic results in a health crisis and social and political crises both (...) nationally and globally. The ethical implications of these global effects should be properly identified so that appropriate actions can be taken globally and not just in national isolation. Our analysis, which is a starting point to test the broader relevance of the 2016 WHO document that remains the only available guidance document applicable globally, concludes that the WHO guidance should be updated to provide reasoned and thoughtful comprehensive ethics advice for the sound management of the current and future pandemics. (shrink)

Since the onset of the SARS-CoV-2 pandemic, an array of off-label interventions has been used to treat patients, either provided as compassionate care or tested in clinical trials. There is a challenge in determining the justification for conducting randomised controlled trials over providing compassionate use in an emergency setting. A rapid and more accurate evaluation tool is needed to assess the effect of these treatments. Given the similarity to the Ebola Virus Disease (EVD) pandemic in Africa in 2014, (...) we suggest using a tool designed by the WHO committee in the aftermath of the EVD pandemic: Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI). Considering the uncertainty around SARS-CoV-2, we propose using an improved MEURI including the Plan–Do–Study–Act tool. This combined tool may facilitate dynamic monitoring, analysing, re-evaluating and re-authorising emergency use of unproven treatments and repeat it in cycles. It will enable adjustment and application of outcomes to clinical practice according to changing circumstances and increase the production of valuable data to promote the best standard of care and high-quality research—even during a pandemic. (shrink)

There are competing ethical concerns when it comes to designing any clinical research study. Clinical trials of possible treatments for Ebola virus are no exception. If anything, the competing ethical concerns are exacerbated in trying to find answers to a deadly, rapidly spreading, infectious disease. The primary goal of current research is to identify experimental therapies that can cure Ebola or cure it with reasonable probability in infected individuals. Pursuit of that goal must be methodologically sound, practical (...) and consistent with prevailing norms governing human subjects research. Some maintain that only randomized controlled trials with a placebo or standard-of-care arm can meet these conditions. We maintain that there are alternative trial designs that can do so as well and that sometimes these are preferable to RCTs. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Philosophy of Music Education Review 12.2 (2004) 126-138 [Access article in PDF] Music Education for the Twenty-First Century A Philosophical View of the General Education Core Anthony J. Palmer Boston University We are all one species with one brain and neural system, yet consciousness about our existence is highly contextual. Any culturally transcendent view will still be limited to one's personal experience, analytical capabilities, and cultural shaping. Nevertheless, looking (...) beyond our narrow perspectives is essential if we are to find commonality and compatibility with all humankind.Therefore, I find it incumbent that we, as college/university professors, examine our present culture-national and global-to ascertain current conditions and what positive roles each citizen may be able to play on the larger stage of world affairs. Musician-teachers, who are the products of the curriculum, should not be exempt from the responsibilities of contributing solutions. Rather, they should produce a program that is sensitive to the larger context in which we all reside. To be sure, we have no direct control over global events. We do, however, exercise at least a modicum of control over the kind of person emerging from our courses of study.In light of the foregoing, this paper will examine (1) the present global conditions with which we are confronted, (2) responsibilities of the college/university [End Page 126] faculties toward developing students with greater awareness, (3) examination of the general education that all baccalaureate students must satisfy for the degree, (4) the education within the general education courses with a focus on the music education student, and (5) a proposal on general education. The Present Context Today we are at a juncture where no one can predict the future with any assurance of accuracy. The world in the twenty-first century has taken an unexpected turn toward greater chaos and has the potential to end life as we have known it in previous centuries. Although earlier generations experienced many changes and watershed moments, the conditions were never potentially as cataclysmic as they are today because of the explosive power of our so-called defensive weapons. In addition, fed by technology, the pace of change is extremely rapid and multiplies exponentially. Robert Wright states in this regard, Neither biological evolution nor human history is a smooth, steady process. Both pass through thresholds.... To some people, the current era has the aura of a threshold; it has that unsettling, out-of-control feeling that can portend a major shift. Technological, geopolitical, and economic change seem ominously fast, and the fabric of society seems somehow tenuous.1He goes on to say, World currency markets are rocked by the turbulent force of electronically lubricated financial speculation. Weapons of mass destruction are cultivated by rogue regimes and New Age cults. Nations seem less cohesive than before, afflicted by ethnic or religious or cultural friction. Health officials seriously discuss the prospect of a worldwide plague-the unspeakably gruesome Ebola virus, perhaps, or some microbe we don't yet know about, spread around the world by jet-propelled travelers. Even tropical storms seem to have grown more intense in recent decades, arguably a result of global warming.2The foregoing was written in 2000, well before the devastating events of September 11 and subsequent human-initiated disasters, yet it still rings true. Where are we heading? What is our future with a world torn by terror, the continual development of more destructive weapons, and a seeming lack of desire to ameliorate our differences in a peaceful manner? Add to these the inexorable advance of technology that seems to know no end. It is most likely that the world in 2050-perhaps even as early as 2025-will not be recognized by our present population, assuming that we do survive as a civilized world.Of course, the outlook is not exclusively bleak and the continued development of technology is not all on the debit side of the ledger. Advances made in [End Page 127] medicine portend the re-growing of brain cells, repair... (shrink)

Capps and Lederman, in a paper published in this journal in 2015, argued that, at the time, the dismal circumstances of the Ebola outbreak in West Africa was an opportunity to revisit public health responses to emergent infectious diseases. Using a One Health lens, they argued for an ecological perspective—one that looked to respond to zoonoses as an environmental as well as public health concern. Using Ebola virus disease as an example, they suggested shared immunity as a (...) strategy to vaccinate both humans and great apes. Since then, vaccination as a conservation strategy in this case has been debated and at least one great ape vaccination trial has been proposed: some, however, are less convinced of the ethical arguments to pursue vaccinating wild animals. Using this opportunity, we review Capps and Lederman’s arguments and directly respond to the plausible objections to them. (shrink)

The random]ized clinical trial is widely accepted as the optimal approach to evaluating the safety and efficacy of medical treatments. Resistance to randomized treatment assignment arises regularly, most commonly in situations where the disease is life-threatening and treatments are either unavailable or unsatisfactory. Historical control designs, in which all participants receive the experimental treatment with results compared to a prior cohort, are advocated by some as more ethical in such circumstances; however, such studies are often highly biased in favor of (...) the new treatment and frequently yield misleading results. Alternative controlled designs motivated by the desire to maximize the number of patients with the treatment ultimately determined to be superior have been proposed, but have been challenged on both methodological and ethical grounds. Debates about appropriate and ethical study designs recurred during the recent Ebola Virus Disease epidemic in West Africa. Despite its devastating nature, the EVD epidemic showed the ongoing necessity of conducting randomized trials to obtain convincing evidence of the safety and efficacy of therapeutic interventions. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Philosophy of Music Education Review 12.2 (2004) 126-138 [Access article in PDF] Music Education for the Twenty-First Century A Philosophical View of the General Education Core Anthony J. Palmer Boston University We are all one species with one brain and neural system, yet consciousness about our existence is highly contextual. Any culturally transcendent view will still be limited to one's personal experience, analytical capabilities, and cultural shaping. Nevertheless, looking (...) beyond our narrow perspectives is essential if we are to find commonality and compatibility with all humankind.Therefore, I find it incumbent that we, as college/university professors, examine our present culture-national and global-to ascertain current conditions and what positive roles each citizen may be able to play on the larger stage of world affairs. Musician-teachers, who are the products of the curriculum, should not be exempt from the responsibilities of contributing solutions. Rather, they should produce a program that is sensitive to the larger context in which we all reside. To be sure, we have no direct control over global events. We do, however, exercise at least a modicum of control over the kind of person emerging from our courses of study.In light of the foregoing, this paper will examine (1) the present global conditions with which we are confronted, (2) responsibilities of the college/university [End Page 126] faculties toward developing students with greater awareness, (3) examination of the general education that all baccalaureate students must satisfy for the degree, (4) the education within the general education courses with a focus on the music education student, and (5) a proposal on general education. The Present Context Today we are at a juncture where no one can predict the future with any assurance of accuracy. The world in the twenty-first century has taken an unexpected turn toward greater chaos and has the potential to end life as we have known it in previous centuries. Although earlier generations experienced many changes and watershed moments, the conditions were never potentially as cataclysmic as they are today because of the explosive power of our so-called defensive weapons. In addition, fed by technology, the pace of change is extremely rapid and multiplies exponentially. Robert Wright states in this regard, Neither biological evolution nor human history is a smooth, steady process. Both pass through thresholds.... To some people, the current era has the aura of a threshold; it has that unsettling, out-of-control feeling that can portend a major shift. Technological, geopolitical, and economic change seem ominously fast, and the fabric of society seems somehow tenuous.1He goes on to say, World currency markets are rocked by the turbulent force of electronically lubricated financial speculation. Weapons of mass destruction are cultivated by rogue regimes and New Age cults. Nations seem less cohesive than before, afflicted by ethnic or religious or cultural friction. Health officials seriously discuss the prospect of a worldwide plague-the unspeakably gruesome Ebola virus, perhaps, or some microbe we don't yet know about, spread around the world by jet-propelled travelers. Even tropical storms seem to have grown more intense in recent decades, arguably a result of global warming.2The foregoing was written in 2000, well before the devastating events of September 11 and subsequent human-initiated disasters, yet it still rings true. Where are we heading? What is our future with a world torn by terror, the continual development of more destructive weapons, and a seeming lack of desire to ameliorate our differences in a peaceful manner? Add to these the inexorable advance of technology that seems to know no end. It is most likely that the world in 2050-perhaps even as early as 2025-will not be recognized by our present population, assuming that we do survive as a civilized world.Of course, the outlook is not exclusively bleak and the continued development of technology is not all on the debit side of the ledger. Advances made in [End Page 127] medicine portend the re-growing of brain cells, repair... (shrink)

The coronavirus pandemic has stirred interest in viruses. This has been accompanied by a proliferation of popular works trying to explain how viruses fit into the Christian worldview. In an anthropocentric perspective, viruses are easily regarded as malicious entities. This article, however, shows that a proper understanding of the biology of viruses actually adds another level of complexity to our perception of good and evil. Interestingly, this additional layer of complexity might help us solve some of the most urgent difficulties (...) in the discussion about good and evil, if we recognize the subjective nature of what we call natural evil. We need to be more nuanced not merely in our theological discussion about good and evil, but also in the way we talk about viruses. (shrink)

Human immunodeficiency viruses (HIV) and acquired immunodeficiency syndrome (AIDS), COVID-19 and Ebola have exposed the magnitude of care-related tasks on women. Most often, because of the gendered nature of domestic and reproductive roles, women are expected to assume unpaid care-related, nurturing and domestic work. Despite the valuable duties, women are economically poor and othered. These unpaid care duties are exacerbated by pandemics and ratified even further by religion. For instance, in Nomiya Church (NC), the first African independent church in (...) Kenya, women’s experience narratives and biblical texts such as the story of the Proverbs 31 virtuous woman are used to glorify unpaid charitable work for women. Women’s virtuous personality, hard work and character are upheld in Christian spaces, thus obstructing sound work theologies. This article employed African Women’s theological lens in view of pointing out repressing and transformative tenets in charitable theologies of work for social and gender justice. While applying womanhood hermeneutics in the passage, the article points to valued behavioural postures of hard work in responding to God’s stewardship mandate. An affirmation of fair reward and accumulation of property is embraced as a familial complementary role, especially in pandemic contexts. The article amplifies the accumulation of property as a human right and the mandate of stewardship for all earth communities. Hence, charity work is a stewardship framework that all earth communities must engage in for replenishment and sustenance for all.Contribution: The article challenges literal biblical interpretations that glorify charity work. It advances a stewardship framework in understanding unpaid and charity work that all earth communities must engage in to replenish and sustain all creation. The framework affirms the dignity of all human persons through a transformational understanding of the theology of work as enabled by the African theological hermeneutics. (shrink)

The current COVID-19 pandemic has reactivated ancient metaphors but also initiated a new vocabulary: social distancing, lockdown, self-isolation, and sheltering in place. Terminology is not ethically neutral but reflects prevailing value systems. I will argue that there are two metaphorical vocabularies at work: an authoritarian one and a liberal one. Missing is an ecological vocabulary. It has been known for a long time that emerging infectious diseases are associated with the destruction of functioning ecosystems and biodiversity. Ebola and avian (...) influenza viruses have been significant warnings. Obviously, this pandemic will not be the last one. As the planet is our common home, the major metaphor to explore is sheltering at this home. (shrink)

This article addresses an important, overlooked regulatory challenge during global health emergencies. It provides novel insights into how, and why, best practice can support decision makers in interpreting and implementing key guidance on conducting research during GHEs. The ability to conduct research before, during and after such events is crucial. The recent West-African Ebola outbreaks and the Zika virus have highlighted considerable room for improvement in meeting the imperative to research and rapidly develop effective therapies. A means of (...) effectively capturing these experiences and folding them into future decision-making is lacking; the need for effective practical translational measures remains. The challenge for the research community lies in extracting meaningful action-guiding content from pre-existing guidelines—which draw upon practical examples of guidelines ‘in action’—that assist in determining how to act in a particular situation. Insights are provided into the role of best practice as a means to do so; such examples can provide invaluable support to decision makers in interpreting high-level guidance; overarching guidelines retain their necessary level of generality and flexibility, whilst corresponding best practice examples—which incorporate important lessons learned—illustrate how such guidelines can be interpreted at a practical level. (shrink)

In the midst of the recent Ebola outbreak, scientific developments involving infection challenge experiments on nonhuman primates (NHPs) sparked hope that successful treatments and vaccines may soon become available. Yet these studies pose a stark ethical quandary. On the one hand, they represent an important step in developing novel therapies and vaccines for Ebola and the Marburg virus, with the potential to save thousands of human lives and to protect whole communities from devastation; on the other hand, (...) they intentionally expose sophisticated animals to severe suffering and a high risk of death. Other studies that infect NHPs with a lethal disease in order to test interventions that may prove beneficial for humans pose the same ethical difficulty. Some advocates have argued that all research on primates should be phased out, and ethicists have questioned whether a moral justification of primate research is possible. A 2010 European Union directive banned virtually all research on great apes, and 2013 guidelines from the National Institutes of Health (NIH), based upon recommendations in an influential 2011 Institute of Medicine (IOM) report, eliminated most biomedical research with chimpanzees in the United States. But studies involving other NHPs face no comparable restrictions.Should research on NHPs other than great apes be subject to tighter restrictions than it currently is? In this article, we explore this general question in the context of one particular type of biomedical research: infection challenge studies. We advocate a presumptive prohibition on infection challenge experiments in NHPs, but we also argue that exceptions to this prohibition are permissible, subject to strict substantive and procedural safeguards, when necessary to avert substantial loss of human life or severe morbidity for a substantial number of people. (shrink)

We've outsourced too much of our thinking. How do we get it back? At the height of the 2014 Ebola epidemic, a man who had recently returned from West Africa with a fever and severe abdominal pain entered a hospital in Dallas--and was sent home. Even after healthcare workers learned their patient had come from Liberia, ground zero of the Ebola hot zone, not one of those treating him considered the deadly virus as a possible cause of (...) his condition. Shortly after the man died, one of the nurses who had treated him sought clearance from the Centers for Disease Control to board a commercial flight. She reported a fever of 99.5 degrees, but because the protocol restricted travel at 100.4 degrees or higher, she was cleared. She was later confirmed to be infected with Ebola. A public health disaster akin to the one depicted in the movie Contagion was averted, but only by sheer luck. How could this happen? As Harvard lecturer and global trend watcher Vikram Mansharamani shows in this eye-opening and perspective-shifting book, our complex, data-flooded world has made us ever more reliant on experts, protocols, and technology. We've stopped thinking for ourselves. (Have you ever followed your GPS device to a deserted parking lot?) With stark and compelling examples drawn from business, sports, and everyday life, the author illustrates how in a very real sense we have outsourced too much of our thinking, relinquishing our autonomy. Of course, experts, protocols, and computer-based systems are essential to helping us make informed decisions. What we need is a new approach for integrating these information sources more effectively, harnessing the value they provide without undermining our own autonomy. The author provides principles and techniques for doing just that, empowering readers with a more critical and nuanced approach to making decisions. Think for Yourself is an indispensable guide for those looking to restore self-reliant thinking in a data-driven and technology-dependent yet overwhelmingly uncertain world. (shrink)

DISEASE X is the codename given by the World Health Organisation to a pathogen currently unknown to science that could cause havoc to humankind. Emerging infections are sending us multiple warnings that another Disease X is looming. We've had SARS in 2002, H5N1 bird flu in 2004, H1N1 'swine flu' in 2009, MERS in 2012, Ebola in 2014, Zika in 2015 and now COVID-19. These events are not freak events, but are happening continually, and at an increasing cadence. Written (...) by a long-standing ex-Reuters global health and science correspondent, DISEASE X will use privileged access to the body leading international efforts to control viruses, the Coalition for Epidemic Preparedness Innovations (CEPI), and its CEO, Dr Richard Hatchett. CEPI seed-funded three successful COVID vaccines, including Astra-Zeneca and Moderna. DISEASE X will explore the emergence of the novel coronavirus and the crisis it caused, analysing the responses of global health organisations and experts, including the WHO, national governments such as Britain, China and the USA, COVAX, the global vaccine allocation facility, pharmaceutical companies, and leading research scientists. Weaving in insights from the likes of Bill Gates, Sir Jeremy Farrar, Dr Anthony Fauci and Sir Patrick Vallance, the book will explain how the world's public health scientists are embarking on a 100 Days Mission to snuff out future threats before they become deadly pandemics. This is the inside story written for the public. (shrink)

Should monkeys be used in painful and often deadly infectious disease research that may save many human lives? This is the challenging question that Anne Barnhill, Steven Joffe, and Franklin G. Miller take on in their carefully argued and compelling article “The Ethics of Infection Challenges in Primates.” The authors offer a nuanced and even-handed position that takes philosophical worries about nonhuman primate moral status seriously and still appreciates the very real value of such research for human welfare. Overall, they (...) argue for an extension and revision of the recommendations regarding chimpanzee research offered by the Institute of Medicine in 2011; the practical upshot of their argument would allow for infection challenge research for promising interventions for Ebola and Marburg virus diseases but not for smallpox or the common cold. The IOM recommendations regarding chimpanzee research put in motion an exceptionalist policy for this great ape population. Barnhill and colleagues’ proposal would enlarge the scope of that exceptionalism to embrace NHPs other than great apes. But is such exceptionalism warranted? It is not obvious to me either that the more sophisticated capacities of a species as a whole give it greater ethical protections or that less intellectually or socially sophisticated animals ought to therefore receive less protection when it comes to painful experimental interventions. (shrink)

The multi-purpose of publicizing a scientific consensus includes a communicative strategy by which scientific institutions accommodate the weighty social and economic demands to demonstrate they are collaborating and cooperating with non-scientific sectors of society, relying on a wide range of spokespeople and representatives to carry out the delivery of their consensus in formal, institutionally arranged, professional and impersonal public settings. I investigate the conditions and presuppositions that make it possible for a research consortium to contribute indirectly to public discourse beyond (...) the presentation of empirical data and theoretical speculations routinely associated with knowledge-producing collectives. The baptismal action of researchers in selecting a designative name to announce a new discovery of virus species and species variants does not follow the rigorous regulations that standardize all names of taxonomic categories in other biological sciences as well as higher order taxa in virology. It is argued here that the lack of clarity in the denotation of the term ‘Ebola’ (in epidemiological reports from West Africa throughout 2014–2016) serves the purpose of shifting a receptor’s understanding of a statement from its explicit assertive point to an implicit declarative, commissive, directive or expressive, covertly delivered point. Specialists of nomenclature concerned with quality assurance regard this lapse in standardization as a consequence of human fallibility demanding urgent intervention. Here it is proposed instead that the occlusive effect of a technical descriptive name may serve an important communicative function. (shrink)

This issue’s “Legal Briefing” column covers recent legal developments involving coerced treatment and involuntary confinement for contagious disease. Recent high profile court cases involving measles, tuberculosis, human immunodeficiency virus, and especially Ebola, have thrust this topic back into the bioethics and public spotlights. This has reignited debates over how best to balance individual liberty and public health. For example, the Presidential Commission for the Study of Bioethical Issues has officially requested public comments, held open hearings, and published a (...) 90-page report on “ethical considerations and implications” raised by “U.S. public policies that restrict association or movement (such as quarantine).” Broadly related articles have been published in previous issues of JCE. We categorize recent legal developments on coerced treatment and involuntary confinement into the following six categories: 1. Most Public Health Confinement Is Voluntary 2. Legal Requirements for Involuntary Confinement 3. New State Laws Authorizing Involuntary Confinement 4. Quarantine Must Be as Least Restrictive as Necessary 5. Isolation Is Justified Only as a Last Resort 6. Coerced Treatment after Persistent Noncompliance. (shrink)