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)

The West African Ebola epidemic has set in motion a collective endeavour to conduct accelerated clinical trials, testing unproven but potentially lifesaving interventions in the course of a major public health crisis. This unprecedented effort was supported by the recommendations of an ad hoc ethics panel convened in August 2014 by the WHO. By considering why and on what conditions the exceptional circumstances of the Ebola epidemic justified the use of unproven interventions, the panel's recommendations have challenged conventional thinking about (...) therapeutic development and clinical research ethics. At the same time, unanswered ethical questions have emerged, in particular: the specification of exceptional circumstances, the specification of unproven interventions, the goals of interventional research in terms of individual versus collective interests, the place of adaptive trial designs and the exact meaning of compassionate use with unapproved interventions. Examination of these questions, in parallel with empirical data from research sites, will help build pragmatic foundations for disaster research ethics. Furthermore, the Ebola clinical trials signal an evolution in the current paradigms of therapeutic research, beyond the case of epidemic emergencies. (shrink)

It has been proposed that the urgency of having a vaccine as a response to SARS-CoV-2 is so great, given the potential health, economic and social benefits that we should override the established s...

The West African Ebola epidemic has set in motion a collective endeavour to conduct accelerated clinical trials, testing unproven but potentially lifesaving interventions in the course of a major public health crisis. This unprecedented effort was supported by the recommendations of an ad hoc ethics panel convened in August 2014 by the WHO. By considering why and on what conditions the exceptional circumstances of the Ebola epidemic justified the use of unproven interventions, the panel's recommendations have challenged conventional thinking about (...) therapeutic development and clinical research ethics. At the same time, unanswered ethical questions have emerged, in particular: the specification of exceptional circumstances, the specification of unproven interventions, the goals of interventional research in terms of individual versus collective interests, the place of adaptive trial designs and the exact meaning of compassionate use with unapproved interventions. Examination of these questions, in parallel with empirical data from research sites, will help build pragmatic foundations for disaster research ethics. Furthermore, the Ebola clinical trials signal an evolution in the current paradigms of therapeutic research, beyond the case of epidemic emergencies. (shrink)

In October 2015 the UK enacted legislation to permit the clinical use of two cutting edge germline-altering, IVF-based embryonic techniques: pronuclear transfer and maternal spindle transfer. The aim is to use these techniques to prevent the maternal transmission of serious mitochondrial diseases. Major claims have been made about the quality of the debates that preceded this legislation and the significance of those debates for UK decision-making on other biotechnologies, as well as for other countries considering similar legislation. In this article (...) we conduct a systematic analysis of those UK debates and suggest that claims about their quality are over-stated. We identify, and analyse in detail, ten areas where greater clarity, depth and nuance would have produced sharper understandings of the contributions, limitations and wider social impacts of these mitochondrial interventions. We explore the implications of these additional considerations for the protection of all parties involved, should the techniques transfer to clinical applications; the legitimacy of focussing on short-term gains for individuals over public health considerations, and the maintenance and improvement of public trust in medical biotechnologies. We conclude that a more measured evaluation of the content and quality of the UK debates is important and timely: such a critique provides a clearer understanding of the possible, but specific, contributions of these interventions, both in the UK and elsewhere; also, these additional insights can now inform the emerging processes of implementation, regulation and practice of mitochondrial interventions. (shrink)

In his article ‘The Ebola Clinical Trials: a precedent for research ethics in disasters’, Philippe Calain constructs a compelling case as to why and how experiences from the recent Ebola epidemic should be used to develop a framework for disaster research ethics. In particular, Calain proposes a useful model for assessing whether or not an unproven intervention could be suitable for human use in a disaster context, and makes a powerful argument against the separation of patient care from research goals. (...) In this commentary, I argue that the separation of patient care goals from research goals is also unhelpful in the context of other forms of participant disadvantage even when that disadvantage is less severe than an ongoing public health emergency. I contend that recognising that research in disadvantaged populations is an intervention that could and should aim to produce positive outcomes for participants, just as it should in disaster contexts, therefore seems a well-justified lesson that can be extrapolated from the experience of the Ebola epidemic. (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)

Background Fifteen years have passed since the outbreak of severe acute respiratory syndrome in Hong Kong. At that time, there were reports of heroic acts among professionals who cared for these patients, whose bravery and professionalism were highly praised. However, there are concerns about changes in new generation of nursing professionals. Objective We aimed to examine the attitude of nursing students, should they be faced with severe acute respiratory syndrome patients during their future work. Research design A questionnaire survey was (...) carried out to examine the attitude among final-year nursing students to three ethical areas, namely, duty of care, resource allocation, and collateral damage. Ethical considerations This study was carried out in accordance with the requirements and recommendations of the Central Research and Ethics Committee, School of Health Sciences at Caritas Institute of Higher Education. Findings Complete responses from 102 subjects were analyzed. The overwhelming majority (96.1%) did not agree to participate in the intubation of severe acute respiratory syndrome patients if protective measures, that is, N95 mask and gown, were not available. If there were insufficient N95 masks for all the medical, nursing, and allied health workers in the hospital (resource allocation), 37.3% felt that the distribution of N95 masks should be by casting lot, while the rest disagreed. When asked about collateral damage, more than three-quarters (77.5%) said that severe acute respiratory syndrome patients should be admitted to intensive care unit. There was sex difference in nursing students’ attitude toward severe acute respiratory syndrome care during pregnancy and influence of age in understanding intensive care unit care for these patients. Interestingly, 94.1% felt that there should be a separate intensive care unit for severe acute respiratory syndrome patients. Conclusion As infection control practice and isolation facilities improved over the years, relevant knowledge and nursing ethical issues related to infectious diseases should become part of nursing education and training programs, especially in preparation for outbreaks of infectious diseases or distress. (shrink)