Interactions between microbes and human hosts can lead to a wide variety of possible outcomes including benefits to the host, asymptomatic infection, disease (which can be more or less severe), and/or death. Whether or not they themselves eventually develop disease, asymptomatic carriers can often transmit disease-causing pathogens to others. This phenomenon has a range of ethical implications for clinical medicine, public health, and infectious disease research. The implications of asymptomatic infection are especially significant in situations where, and/or to the extent (...) that, the microbe in question is transmissible, potentially harmful, and/or untreatable. This article reviews the history and concept of asymptomatic infection, and relevant ethical issues associated with this phenomenon. It illustrates the role and ethical significance of asymptomatic infection in outbreaks, epidemics, and pandemics–including recent crises involving drug resistance, Zika, and Covid19. Serving as the Introduction to this Special Issue of Monash Bioethics Review, it also provides brief summaries of the other articles comprising this collection. (shrink)

The ethics of conducting research in epidemic situations have yet to account fully for differences in the proportion and acuteness of epidemics, among other factors. While epidemics most often arise from infectious diseases, not all infectious diseases are of epidemic proportions, and not all epidemics occur acutely. These and other variations constrain the generalization of ethical decision-making and impose ethical demands on the individual researcher in a way not previously highlighted. This paper discusses a number of such (...) constraints and impositions. It applies the ethical principles enunciated by Emmanuel et al.1 to the controversial Pfizer study in Nigeria in order to highlight the particular ethical concerns of acute epidemic research, and suggest ways of meeting such challenges. The paper recommends that research during epidemics should be partly evaluated on its own merits in order to determine its ethical appropriateness to the specific situation. Snap decisions to conduct research during acute epidemics should be resisted. Community engagement, public notification and good information management are needed to promote the ethics of conducting research during acute epidemics. Individual consent is most at risk of being compromised, and every effort should be made to ensure that it is maintained and valid. Use of data safety management boards should be routine. Acute epidemics also present opportunities to enhance the social value of research and maximize its benefits to communities. Ethical research is possible in acute epidemics, if the potential challenges are thought of ahead of time and appropriate precautions taken. (shrink)

The ethics of conducting research in epidemic situations have yet to account fully for differences in the proportion and acuteness of epidemics, among other factors. While epidemics most often arise from infectious diseases, not all infectious diseases are of epidemic proportions, and not all epidemics occur acutely. These and other variations constrain the generalization of ethical decision‐making and impose ethical demands on the individual researcher in a way not previously highlighted. This paper discusses a number of such (...) constraints and impositions. It applies the ethical principles enunciated by Emmanuel et al.1 to the controversial Pfizer study in Nigeria in order to highlight the particular ethical concerns of acute epidemic research, and suggest ways of meeting such challenges.The paper recommends that research during epidemics should be partly evaluated on its own merits in order to determine its ethical appropriateness to the specific situation. Snap decisions to conduct research during acute epidemics should be resisted. Community engagement, public notification and good information management are needed to promote the ethics of conducting research during acute epidemics. Individual consent is most at risk of being compromised, and every effort should be made to ensure that it is maintained and valid. Use of data safety management boards should be routine. Acute epidemics also present opportunities to enhance the social value of research and maximize its benefits to communities.Ethical research is possible in acute epidemics, if the potential challenges are thought of ahead of time and appropriate precautions taken. (shrink)

The current Ebola epidemic has presented challenges both medical and ethical. Although we have known epidemics of untreatable diseases in the past, this particular one may be unique in the intensity and rapidity of its spread, as well as ethical challenges that it has created, exacerbated by its geographic location. We will look at the infectious agent and the epidemic it is causing, in order to understand the ethical problems that have arisen.

Vaccines are a powerful measure to protect the health of individuals and to combat outbreaks such as the COVID-19 pandemic. An ethical dilemma arises when one effective vaccine has been successfully developed against an epidemic disease and researchers seek to test the efficacy of another vaccine for the same pathogen in clinical trials involving human subjects. On the one hand, there are compelling reasons why it would be unethical to trial a novel vaccine when an effective product exists already. (...) First, it is a firm principle of medical ethics that an effective treatment or vaccine should not be withheld from patients if their life may depend on it. Second, since epidemic outbreaks often emerge in settings with less-resourced health systems, there is a pronounced risk that any trial withholding an effective vaccine would disproportionately affect the vulnerable populations that historically have been exploited for biomedical research. Third, clinical trials for novel vaccines may be at odds with efforts to control active outbreaks. On the other hand, it may be justified to conduct a trial for a candidate vaccine if it is expected to have certain advantages compared with the existing product. This essay discusses key factors for comparing vaccines against epidemic pathogens, including immunological, logistical and economic considerations. Alongside a case study of the development of vaccines for Ebola, the essay seeks to establish a general framework that should be expanded and populated by immunologists, epidemiologists, economists and bioethicists, and ultimately could be applied to the case of COVID-19 vaccines. (shrink)

Institute for Biomedical Ethics, Geneva University Medical School * Corresponding author: Médecins Sans Frontières (OCG), rue de Lausanne 78, CH-1211 Geneva 21, Switzerland. Tel.: +41 (0)22 849 89 29; Fax: +41 (0)22 849 84 88; Email: philippe_calain{at}hotmail.com ' + u + '@' + d + ' '//--> Abstract Outbreaks of filovirus (Ebola and Marburg) hemorrhagic fevers in Africa are typically the theater of rescue activities involving international experts and agencies tasked with reinforcing national authorities in clinical management, biological diagnosis, (...) sanitation, public health surveillance and coordination. These outbreaks can be seen as a paradigm for ethical issues posed by epidemic emergencies, through the convergence of such themes as: isolation and quarantine, privacy and confidentiality and the interpretation of ethical norms across different ethnocultural settings. With an emphasis on the boundaries between public health investigations and research, this article reviews specific challenges, past practices and current normative documents relevant to the application of ethical standards in the course of outbreaks of filovirus hemorrhagic fevers. Aside from commonly identified issues of informed consent and institutional review processes, we argue for more clarity over the specification of which communities are expected to share benefits, and we advocate for the use of collective definitions of duty to care and standard of care. We propose new elaborations around existing normative instruments, and we suggest some pathways toward more comprehensive approaches to the ethics of research in outbreak situations. CiteULike Connotea Del.icio.us What's this? (shrink)

This open access casebook addresses complex and important ethical challenges arising when health-related research in conducted in the context of epidemics and pandemics. This book provides contextually-rich real-world case studies illustrating research ethics issues encountered by researchers, ethics reviewers and regulators around the globe during the COVID-19 pandemic. The accompanying commentaries outline relevant conceptual approaches and ethical considerations. These promote understanding and reflection on relevant ethical issues, ethical approaches and competing considerations in a manner supporting thoughtful evaluation of (...) their implications for practice. As such the casebook is relevant to academic and professional audiences with an interest in global health, research ethics, and outbreaks and epidemics. (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)

Much of the fear and uncertainty around Zika epidemics stem from potential association between Zika virus complications on infected pregnant women and risk of their babies being born with microcephaly and other neurological abnormalities. However, much remains unknown about its mode of transmission, diagnosis and long-term pathogenesis. Worries of these unknowns necessitate the need for effective and efficient psychosocial programs and medical-legal strategies to alleviate and mitigate ZIKV related burdens. In this light, local and global efforts in maintaining fundamental health (...) principles of moral, medical and legal decision-making policies, and interventions to preserve and promote individual and collectiveHuman Rights, autonomy, protection of the most vulnerable, equity, dignity, integrity and beneficence that should not be confused and relegated by compassionate humanitarian assistance and support. This paper explores the potential medical and ethical-legal implications of ZIKV epidemics emergency response packages and strategies alongside optimizing reproductive and mental health policies, programs and best practice measures. Further long-term cross-borders operational research is required in elucidating Zika-related population-based epidemiology, ethical-medical and societal implications in guiding evidence-based local and global ZIKV maternal-child health complications related approaches and interventions. Core programs and interventions including future Zika safe and effective vaccines for global Zika immunization program in most vulnerable and affected countries and worldwide should be prioritized. (shrink)

Much of the fear and uncertainty around Zika epidemics stem from potential association between Zika virus complications on infected pregnant women and risk of their babies being born with microcephaly and other neurological abnormalities. However, much remains unknown about its mode of transmission, diagnosis and long-term pathogenesis. Worries of these unknowns necessitate the need for effective and efficient psychosocial programs and medical-legal strategies to alleviate and mitigate ZIKV related burdens. In this light, local and global efforts in maintaining fundamental health (...) principles of moral, medical and legal decision-making policies, and interventions to preserve and promote individual and collectiveHuman Rights, autonomy, protection of the most vulnerable, equity, dignity, integrity and beneficence that should not be confused and relegated by compassionate humanitarian assistance and support. This paper explores the potential medical and ethical-legal implications of ZIKV epidemics emergency response packages and strategies alongside optimizing reproductive and mental health policies, programs and best practice measures. Further long-term cross-borders operational research is required in elucidating Zika-related population-based epidemiology, ethical-medical and societal implications in guiding evidence-based local and global ZIKV maternal-child health complications related approaches and interventions. Core programs and interventions including future Zika safe and effective vaccines for global Zika immunization program in most vulnerable and affected countries and worldwide should be prioritized. (shrink)

Zika virus was recognised in 2016 as an important vector-borne cause of congenital malformations and Guillain-Barré syndrome, during a major epidemic in Latin America, centred in Northeastern Brazil. The WHO and Pan American Health Organisation, with partner agencies, initiated a coordinated global response including public health intervention and urgent scientific research, as well as ethical analysis as a vital element of policy design. In this paper, we summarise the major ethical issues raised during the Zika epidemic, highlighting the (...) PAHO ethics guidance and the role of ethics in emergency responses, before turning to ethical issues that are yet to be resolved. Zika raises traditional bioethical issues related to reproduction, prenatal diagnosis of serious malformations and unjust disparities in health outcomes. But the epidemic has also highlighted important issues of growing interest in public health ethics, such as the international spread of infectious disease; the central importance of reproductive healthcare in preventing maternal and neonatal morbidity and mortality; diagnostic and reporting biases; vector control and the links between vectors, climate change, and disparities in the global burden of disease. Finally, there are controversies regarding Zika vaccine research and eventual deployment. Zika virus was a neglected disease for over 50 years before the outbreak in Brazil. As it continues to spread, public health agencies should promote gender equity and disease control efforts in Latin America, while preparing for the possibility of a global epidemic. (shrink)

Outbreaks of epidemics like Ebola trigger difficult ethical challenges for civilian and military health care personnel. This book offers theoretical reflections combined with reports from recent military and NGO missions in the field. The authors of this volume focus on military medical ethics adding a distinct voice to the topic of epidemics and infectious diseases. While military health care personnel are always crucially involved during disaster relief operations and large-scale public health emergencies, most of the current literature treats ethical (...) issues during epidemics from a more general perspective without taking into account the specifics of the military context. The contributions in this volume provide first-hand insights into some of the ethical issues encountered by military health care personnel in missions during the Ebola outbreak in 2014/2015. This practical perspective is complimented by academic analyses and theoretical reflections on ethical issues associated with epidemics. (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)

Various forms of research are essential in emergency, disaster and disease outbreak situations, but challenges exist including the long length of time it takes to get research proposals approved. Consequently, it would be very advantageous to have an acceptable model for efficient coordination and communication between and among research ethics committees/IRBs and ministries of health, and templates for expediting ethical review of research proposals in emergency and epidemic situations to be used across the Caribbean and in other low (...) and middle income countries. This project involved a literature search and the interviewing of ministry of health officials, public health practitioners, and research ethics committee/IRB members in Jamaica and St. Lucia, to obtain suggestions for the best model for efficient coordination and communication between research ethics committees, and developed a template for expediting review of research protocols in epidemic and emergency conditions. (shrink)

The recent review by Monrad1 presents several issues about secondary vaccine trials. It lays out the case in which a vaccine has been tested through phases I–III and is being deployed. Subsequently, consideration is being given to conducting ‘trials for another vaccine for the pathogen’. Monrad states: ‘In summary, we may say that researchers have strong prima facie reasons not to conduct a secondary vaccine trial.’ Monrad discusses several factors meriting careful consideration about the need for developing and testing more (...) than one vaccine: relative efficacy, length of immunity, adverse reactions, ease of storage and administration, economic and logistical factors. What is not addressed are the ethical duties that exist when there are competing phase III vaccine candidates for COVID-19. We have serious concerns about potential ethical inadequacies about these ongoing trials and …. (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)

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)

In this essay I follow one argument strand from Linda Singer's Erotic Welfare. How can we have a forward-looking and affirmative ideal of sexual freedom when the AIDS panic has altered the sexual landscape and instigated new justifications for oppressive sexual disciplines? How can we be sexual subjects when processes of commodification and disciplinary practices have constrained sexual expression while proliferating sexual fetishes? These are some of the questions this book formulates, without answering.

COVID-19 is a very complex pandemic. It has affected individuals, different countries and regions of the world equally in some senses and differently in other senses. While sub-Saharan Africa has weathered a range of outbreaks of emerging and re-emerging infectious diseases, the manner in which the COVID-19 pandemic has evolved necessitates some observations, remarks and conclusions from our own situated observation point. Compared to previous epidemics/pandemics, many African countries have displayed a sense of solidarity in the face of COVID-19 that (...) convincingly demonstrates that an Ubuntu ethic is viable and globalizable. The African continent seems, at last, to have realized that ethics dumping must be avoided and has made strides in defining its COVID-19 research agenda and strengthening its epidemic response for both public health and health research. More needs to be done in terms of public engagement, funding and technical support for research on potential therapies/candidate vaccines that are a product of scientific studies on the continent. (shrink)

The author introduces two key issues of the Ebola epidemic very clearly. However, the author could elaborate further on the objections to using experimental drugs. The author does a very good job of enumerating the reasons for using these drugs. In terms of reasons against using the drugs, the author only writes that there are regulations in place that are usually followed. Several supporting facts are given to suggest different regulations should be put in place for a crisis like (...) Ebola. Ebola is a deadly disease with no cure. At present, all we have are these experimental drugs. Ordinarily, such drugs would not be given without extensive testing. However, in this case, there is no time for that to be done. People who contract Ebola have no other alternatives, so an unapproved experimental treatment is better than nothing at all. It is important to weigh the risks and benefits. Some may argue that the risks of using an experimental drug may be too great and that we should wait to administer any experimental drug until it has been proven safe. We do not know what the long-term side effects may be. While that argument may be appropriate for other situations, in the case of Ebola epidemic, I do not think it applies. As I have said, and as the author has said, there is no cure or other treatment available for Ebola. People who contract it will likely die of the disease and these experimental treatments are their only option. In this case, the benefits outweigh the risks. As the author mentions, access to these drugs is very problematic. However, they do not elaborate enough on both sides of the issue. There are reasons supporting and reasons against giving health care workers experimental treatments first and I think including them would have added to the depth of the argument presented here. (shrink)

In this humane and graceful book, philosopher Timothy Murphy offers insight into our attempts--popular and academic, American and non-American, scientific and ...

Volume 20, Issue 7, July 2020, Page W7-W11.

The COVID-19 pandemic has generated an imbalance between the clinical needs of the population and the effective availability of advanced life support (ALS) resources. Triage protocols have thus become necessary. Triage decisions in situations of scarce resources were not extraordinary in the pre-COVID-19 era; these protocols abounded in the context of organ transplantation. However, this prior experience was not considered during the COVID-19 outbreak in Spain. Lacking national guidance or public coordination, each hospital has been forced to put forth independent (...) and autonomous triage protocols, most of which were, nonetheless, based on common ethical principles and clinical criteria. However, controversial, non-clinical criteria have also been defended by Spanish scientific societies and public institutions, including setting an age cut-off value for unilaterally withholding ALS, using ‘social utility’ criteria, prioritising healthcare professionals or using ‘first come, first served’ policies. This paper describes the most common triage criteria used in the Spanish context during the COVID-19 epidemic. We will highlight our missed opportunities by comparing these criteria to those used in organ transplantation protocols. The problems posed by subjective, non-clinical criteria will also be discussed. We hope that this critical review might be of use to countries at earlier stages of the epidemic while we learn from our mistakes. (shrink)

Global health emergencies such as the COVID-19 pandemic are contexts in which it is critical to draw upon learning from prior research and to conduct novel research to inform real-time decision-making and pandemic responses. While research is vitally important, however, emergencies are radically non-ideal contexts for its conduct, due to exceptional uncertainty, urgency, disruption, health needs, and strain on existing health systems, amongst other challenges. This generates novel ethical challenges and a broader conception of research ethics is necessary to (...) effectively address the complexity of pandemic research contexts. Going beyond traditional approaches to research ethics centring on the design of specific studies, this broader conception requires consideration of fundamental questions relating to the exercise of power and influence throughout research pathways, and a broader attention to both salient ethical issues, and the ethical responsibilities of stakeholders. These include important questions about responsibilities to gather evidence and generate knowledge systematically during emergencies, to implement policy responses in ways that are amenable to evaluation, and even potential moral obligations to participate in research. In situations of heightened uncertainty, additional questions arise about what constitutes sufficient evidence to justify the development and implementation of policy responses, and the responsibilities of scientific and social science researchers involved in policy-making processes. The four cases in this chapter prompt reflection on evolving and at times competing values and responsibilities of policy-makers, regulators, health authorities and researchers during the design and conduct of research, and proposed early implementation of research findings. These cases highlight issues arising when conducting research of national importance in a pandemic, where researchers are required to liaise with authorities responsible for pandemic responses and address complex ethical issues, including protecting the interests of participants and publics when tensions arise between prioritising the completion of research and accelerating the rollout of novel health interventions. This chapter invites reflection on the practical ethical implications of commitments to undertake research during emergencies, including the nature and scope of the relevant responsibilities of a range of stakeholders. (shrink)

Public health decisions made by the state involve considerable disagreements on the course of actions, uncertainties, and compromises that arise from moral tensions between the demands of civil liberties and the goals of public health. With such complex decisions, it can be extremely difficult to arrive at and justify the best option. In this article, we propose an ethical decision-making framework based on the philosophy of Ubuntu and argue that in sub-Saharan African settings, this approach provides attractive alternative conventions of (...) moral decision-making and a useful language for understanding moral reasoning and ethics. Through its emphasis on humanity, compassion, and social responsibility, Ubuntu (“I am because we are”) has the potential to facilitate solutions to and avert conflicts between individual rights and public health. The use of Ubuntu shifts the moral reasoning and ethics of decision-making from a field of philosophy shaped by the global north, to the everyday values, decision-making, and consequent practices of people in much of Africa. Using examples of Ebola, pandemic influenza, and tuberculosis, we illustrate how Ubuntu can be applied to tackle conflicting ethical problems in public health and medicine. (shrink)

Obesity is increasingly becoming a problem for Western societies, to the extent that politicians, scientists, patient organisations and the media now refer to it as ‘the obesity epidemic’. Concerns about the damaging effect of increasing body weight on public health has led to a strong growth in the amount of scientific work on the condition, with the medical professions leading the way. This article discusses that, first of all, scientific evidence for obesity-associated mortality is at best ambiguous, and proposes (...) that at least some of contemporary medical preoccupation with obesity has a moral origin in that it seeks to correct unwanted or immoral behaviour. It then continues to reflect on the effect of the conceptual transformation of healthy children into patients, and concludes with some reflections on the ethical implications of the obesity disease for the wellbeing of children. (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)

Over 60% of all epidemics have a zoonotic origin, that is, they result from the transmission of infectious diseases from animals to humans. The spill-over of diseases often happens because humans exploit and use animals. In this article, I outline the four most common interfaces that favour the emergence and spread of zoonotic infectious diseases: wildlife hunting, small-scale farming, industrialised farming practices and live animal markets. I analyse which practices serve human food security – and thus have a non-trivial purpose (...) – and which predominantly have an economic purpose or serve as a symbol of wealth. I conclude that many practices that increase the risk for zoonotic infectious disease outbreaks actually do not contribute to the survival and food security of humans. I make two arguments in turn. First, I argue that in cases where the consumption and use of animal products does not contribute to the food security of a population, then this population has a duty to abstain from them, since they impose a grave and avoidable risk to themselves as well as to innocent third-parties. However, some communities must sometimes rely on practices that increase the risk of emergence and transmission of zoonotic infectious diseases, because they have no healthy alternatives. That is, the food security of the local population depends on the consumption and use of risky animal products. The second argument I advance is that, in such scenarios, the international community has a duty to provide the communities concerned with alternative food options, as well as economic and educational opportunities and technologies, in order to reduce the spill-over risk of infectious diseases. Given that abstention from such practices contributes signifcantly to the public good and benefits the international community, the latter has a corresponding duty to provide local communities which abandon such practices with alternatives. (shrink)

In his stimulating target article, 1 Philippe Calain discusses how the traditional ethical framework for clinical research was challenged during the 2013–2016 Ebola epidemic in West Africa. One of his key claims is that conventional research ethics did not have the resources to address the ‘profound tension’ 1, between individual and public interests in clinical research during this epidemic. I agree with this claim, but would like to provide a modified argument in its support. As Calain points (...) out, although a tension between individual and public interests in clinical research always exists, this tension was heightened during the Ebola epidemic. Ebola had an average fatality rate of 40%–60% in this outbreak and reached up to 90% in some locations. Appropriate personal protective equipment was not always available; the level of benefit from supportive care was contested; and there were no targeted treatments and vaccines for the... (shrink)

In this paper, we claim that we can only seek to eradicate the stigma associated with the contemporary opioid overdose epidemic when we understand how opioid stigma and the epidemic have co-evolved. Rather than conceptualizing stigma as a parallel social process alongside the epidemiologically and physiologically defined harms of the epidemic, we argue that the stigmatized history of opioids and their use defines the epidemic. We conclude by offering recommendations for disrupting the burden of opioid stigma.

Obesity is increasingly becoming a problem for Western societies, to the extent that politicians, scientists, patient organisations and the media now refer to it as ‘the obesity epidemic’. Concerns about the damaging effect of increasing body weight on public health has led to a strong growth in the amount of scientific work on the condition, with the medical professions leading the way. This article discusses that, first of all, scientific evidence for obesity-associated mortality is at best ambiguous, and proposes that (...) at least some of contemporary medical preoccupation with obesity has a moral origin in that it seeks to correct unwanted or immoral behaviour. It then continues to reflect on the effect of the conceptual transformation of healthy children into patients, and concludes with some reflections on the ethical implications of the obesity disease for the wellbeing of children. (shrink)

In 2009, in a provocative article in the Lancet , Granich et al . proposed a radical public health intervention to address the vast human toll exacted by the HIV epidemic in regions with generalized epidemics where millions are infected. The proposal, based on modeling, suggested that universal screening for HIV and immediate treatment for all found to be infected, regardless of immune status, could ultimately reverse an epidemiological course that has appeared resistant to efforts at prevention.

The incidence and moral implications of cheating depend on how it is defined and measured. Research that defines and operationalizes cheating as an inventory of acts, that is, “cheating in any form,” has often fueled concern that cheating is reaching “epidemic proportions.” Such inventory measures appear, however, to conflate moral and administrative conceptions of the problem. Inasmuch as the immorality of behavior is a function of moral judgment, academic misconduct is immoral only when it is intentional, and the greatest (...) moral weight should be ascribed to violations that students judge to be the most “serious.”. (shrink)

RESUMO O tema do artigo é a proliferação de más condutas na ciência que vem ocorrendo nas últimas décadas, designada ao longo do texto pelo termo "a epidemia". As más condutas são violações de normas éticas da ciência, sendo os tipos mais importantes as várias modalidades de fraude, e de falsidades autorais. O artigo divide-se em seis seções. Na primeira, apresenta-se o tema e alguns esclarecimentos terminológicos. Na segunda, são expostas as evidências que corroboram a existência da epidemia. A terceira (...) versa sobre a reação à epidemia, caracterizando sua dinâmica, marcada pelo conflito entre duas posições: a moralizadora, que aplica o tratamento moralizador no combate à epidemia; e a negacionista, que tende a negar a existência da epidemia e que resiste às medidas moralizadoras. A quarta seção versa sobre as causas da epidemia, introduz uma distinção entre produtivismo e producionismo e propõe uma análise das formas como o produtivismo fomenta as más condutas. A quinta consiste em uma crítica ao tratamento moralizador, fundamentada em suas inadequações, principalmente sua ineficácia. Na conclusão, procura-se dar uma ideia de qual seria uma alternativa satisfatória ao tratamento moralizador. ABSTRACT The article deals with the proliferation of violations of ethical norms of science, that started to develop a few decades ago. It will be referred to as "the epidemic". The most important types of these violations are varieties of fraud, and such forms of author misconduct as plagiarism, self-plagiarism, etc. The article is divided into six sections. In the first, the topic is introduced and some terminology clarified. In the second, evidence is presented which corroborates the existence of the epidemic. The third deals with the reaction to the epidemic, by characterizing its dynamics in terms of being dominated by conflict between two positions: the moralizing one - which promotes the application of the moralizing treatment to combat the epidemic; and the negationist one - which tends to deny the existence of the epidemic, and resists the moralizing measures. The fourth explores the causes of the epidemic. A distinction is introduced between productivism and productionism, and an analysis is proposed of the ways productivism fosters violations of ethical norms of science. The fifth consists of a critique of the moralizing treatment, based on its inadequacies, mainly its inefficacy. The conclusion points to an alternative to the moralizing treatment. (shrink)

In this essay I follow one argument strand from Linda Singer's Erotic Welfare. How can we have a forward-looking and affirmative ideal of sexual freedom when the AIDS panic has altered the sexual landscape and instigated new justifications for oppressive sexual disciplines? How can we be sexual subjects when processes of commodification and disciplinary practices have constrained sexual expression while proliferating sexual fetishes? These are some of the questions this book formulates, without answering.

This article examines bioethics in Tanzania, particularly in relation to the HIV/AIDS epidemic for the following reasons: First, not only is HIV/AIDS the most alarming health problem in most parts of Africa, but the complexity of issues involved in medical and research ethics clearly illustrates the various levels of problems that bioethics—more precisely, both professional medical ethics and research ethics—faces in a poor, developing country. The article defends uniformity in the general, international bioethical guidelines but calls (...) for wider discussion in their applicability in different economic and social conditions by claiming that in the present debates the issues of distributive justice, culture, and individual professional judgment have been tangled together in a manner that tends to justify double standards in practice. To avoid this confusion there is a need to find a more coherent approach to bioethics that brings together the normative requirements set by international guidelines, national policy planning, social ethics, and professional medical ethics. a. (shrink)

BackgroundRapid data sharing can maximize the utility of data. In epidemics and pandemics like Zika, Ebola, and COVID-19, the case for such practices seems especially urgent and warranted. Yet rapidly sharing data widely has previously generated significant concerns related to equity. The continued lack of understanding and guidance on equitable data sharing raises the following questions: Should data sharing in epidemics and pandemics primarily advance utility, or should it advance equity as well? If so, what norms comprise equitable data sharing (...) in epidemics and pandemics? Do these norms address the equity-related concerns raised by researchers, data providers, and other stakeholders? What tensions must be balanced between equity and other values?MethodsTo explore these questions, we undertook a systematic scoping review of the literature on data sharing in epidemics and pandemics and thematically analyzed identified literature for its discussion of ethical values, norms, concerns, and tensions, with a particular emphasis on equity. We wanted to both understand how equity in data sharing is being conceptualized and draw out other important values and norms for data sharing in epidemics and pandemics.ResultsWe found that values of utility, equity, solidarity, and reciprocity were described, and we report their associated norms, including researcher recognition; rapid, real-time sharing; capacity development; and fair benefits to data generators, data providers, and source countries. The value of utility and its associated norms were discussed substantially more than others. Tensions between utility norms and equity norms were raised.ConclusionsThis study found support for equity being advanced by data sharing in epidemics and pandemics. However, norms for equitable data sharing in epidemics and pandemics require further development, particularly in relation to power sharing and participatory approaches prioritizing inclusion. Addressing structural inequities in the wider global health landscape is also needed to achieve equitable data sharing in epidemics and pandemics. (shrink)

The obesity epidemic among children and adolescents in the United States continues to worsen. The most recent analysis of data from the National Health and Nutrition Examination Survey showed that the prevalence of overweight among children and adolescents – defined as a Body Mass Index at or above the 95th percentile on gender-specific BMI-for-age growth charts developed by the Centers for Disease Control and Prevention – increased significantly between 1999-2000 and 2003-2004. Over this period, the prevalence of overweight among (...) children and adolescents aged 2-19 increased 23% – from 13.9% to 17.1%. In 2003-2004, 18.8% of children aged 6-11 and 17.4% of adolescents aged 12-19 were overweight. Roughly comparable proportions of each age group were considered to be at risk of becoming overweight. (shrink)

Background The opioid epidemic has enabled rapid and unsurpassed use of big data on people with opioid use disorder to design initiatives to battle the public health crisis, generally without adequate input from impacted communities. Efforts informed by big data are saving lives, yielding significant benefits. Uses of big data may also undermine public trust in government and cause other unintended harms. Objectives We aimed to identify concerns and recommendations regarding how to use big data on opioid use in (...) ethical ways. Methods We conducted focus groups and interviews in 2019 with 39 big data stakeholders who had interest in or knowledge of the Public Health Data Warehouse maintained by the Massachusetts Department of Public Health. Results Concerns regarding big data on opioid use are rooted in potential privacy infringements due to linkage of previously distinct data systems, increased profiling and surveillance capabilities, limitless lifespan, and lack of explicit informed consent. Also problematic is the inability of affected groups to control how big data are used, the potential of big data to increase stigmatization and discrimination of those affected despite data anonymization, and uses that ignore or perpetuate biases. Participants support big data processes that protect and respect patients and society, ensure justice, and foster patient and public trust in public institutions. Recommendations for ethical big data governance offer ways to narrow the big data divide, enact shared data governance, cultivate public trust and earn social license for big data uses, and refocus ethical approaches. Conclusions Using big data to address the opioid epidemic poses ethical concerns which, if unaddressed, may undermine its benefits. Findings can inform guidelines on how to conduct ethical big data governance and in ways that protect and respect patients and society, ensure justice, and foster patient and public trust in public institutions. (shrink)