Ebola

This book contains original essays that look at contagious/infectious disease pandemics and the ethical public policy and administration these have entailed. In particular, the pandemics of the 1918 flu pandemic, HIV in the 1990s, SARS in 2003, Ebola from 2014–2016 and the novel COVID-19 in 2020 are highlighted. The contributions in this work offer the reader insights in these and several other recent pandemics that present differently—either via contagion or mortality rate—and how each should be addressed by countries of various (...) sorts. This book is a must for the ongoing debate on how we should treat public health crises, such as the one we have all just encountered in the novel COVID-19 pandemic. (shrink)

The global public health threat posed by infectious disease is well recognised. The obligation to treat whilst exposed to risk, and its limits, is debated with each novel serious and communicable pathogen. Within national jurisdictions, different responses are forthcoming. Some, like France in 2009, give government the power to require healthcare staff to work, and even to requisition staff, including retired professionals. Others rely on notions of solidarity and professional duty, with scope for individual discretion. Our research with staff in (...) the West Midlands in 2008/2009– including non-professionals – suggested a strong correlation between feeling a duty to work and willingness to work during a pandemic. This was more influential than removing other barriers to working. Medical military personnel can already be ordered into risky situations. Our research in 2015/16 with those who worked in the Ebola treatment unit in Sierra Leone suggested that their concerns about risk were complex: the perceived magnitude of the risk was only one factor, even though tolerance was high. The type of risk and circumstances requiring that risk to be taken were also influential.Against this background, it will be argued, with caveats, that:military medical personnel should be willing to accept greater risk than civilian medical staff;and that to maintain national health services during a communicable disease emergency:civilian medical staff ought to accept greater risks than they currently appear willing to tolerate;conscription – from civilian or military populations – is permissible, even though it may elevate personal risk. (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)

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)

Older adults prefer positive over negative information in a lab setting, compared to young adults. The extent to which OA avoid negative events or information relevant for their health and safety is not clear. We first investigated age differences in preferences for fear-enhancing vs. fear-reducing news articles during the Ebola Outbreak of 2014. We were able to collect data from 15 YA and 13 OA during this acute health event. Compared to YA, OA were more likely to read the fear-enhancing (...) article, select hand-sanitizer over lip balm, and reported greater fear of Ebola. We further investigated our research question during the COVID-19 pandemic with 164 YA and 171 OA. Participants responded to an online survey about the COVID-19 pandemic across 13 days during the initial peak of the pandemic in the United States. Both YA and OA preferred to read positive over negative news about the coronavirus, but OA were even more likely than YA to prefer the positive news article. No age differences in the fear of contraction were found, but OA engaged in more health-protective behaviors compared to YA. Although OA may not always report greater fear than YA or seek out negative information related to a health concern, they still engage in protective health behaviors. Thus, although positivity effects were observed in attention and emotional reports, OA still modified their behaviors more than YA, suggesting that positivity effects did not hamper OA ability to respond to a health crisis. (shrink)

ABSTRACTThe provision of gifts and payments for healthy volunteer subjects remains an important topic in global health research ethics. This paper provides empirical insights into theoretical debat...

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)

As the usual regulatory framework did not fit well during the last Ebola outbreak, innovative thinking still needed. In the absence of an outbreak, randomised controlled trials of clinical efficacy in humans cannot be done, while during an outbreak such trials will continue to face significant practical, philosophical, and ethical challenges. This article argues that researchers should also test the safety and effectiveness of novel vaccines in wild apes by employing a pluralistic approach to evidence. There are three reasons to (...) test vaccines in wild populations of apes: i) protect apes; ii) reduce Ebola transmission from wild animals to humans; and iii) accelerate vaccine development and licensing for humans. Data obtained from studies of vaccines among wild apes and chimpanzees may even be considered sufficient for licensing new vaccines for humans. This strategy will serve to benefit both wild apes and humans. (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)

AimTo examine the views of Guinean lay people and healthcare providers regarding the acceptability of HCPs’ refusal to provide care to Ebola patients.MethodFrom October to December 2015, lay people and HCPs in Conakry, Guinea, were presented with 54 sample case scenarios depicting a HCP who refuses to provide care to Ebola patients and were instructed to rate the extent to which this HCP’s decision is morally acceptable. The scenarios were composed by systematically varying the levels of four factors: the risk (...) of getting infected, the HCP’s working conditions, the HCP’s family responsibilities and the HCP’s professional status.ResultsFive clusters were identified: 18% of the participants expressed the view that HCPs have an unlimited obligation to provide care to Ebola patients; 38% held that HCPs’ duty to care is a function of HCPs’ working conditions; 9% based their judgments on a combination of risk level, family responsibilities and working conditions; 23% considered that HCPs do not have an obligation to provide care and 12% did not take a position.ConclusionOnly a small minority of Guinean lay people and HCPs consider that HCPs’ refusal to provide care to Ebola patients is always unacceptable. The most commonly endorsed position is that HCPs’ duty to provide care to Ebola patients is linked to society’s reciprocal duty to provide them with the working conditions needed to fulfil their professional duty. (shrink)

The 2016 CIOMS International ethical guidelines for health‐related research involving humans states that ‘health‐related research should form an integral part of disaster response’ and that, ‘widespread emergency use [of unproven interventions] with inadequate data collection about patient outcomes must therefore be avoided’ (Guideline 20). This position is defended against two lines of criticism that emerged during the 2014 Ebola outbreak. One holds that desperately ill patients have a moral right to try unvalidated medical interventions (UMIs) and that it is therefore (...) unethical to restrict access to UMIs to the clinical trial context. The second holds that clinical trials in contexts of high‐mortality diseases are morally suspect because equipoise does not exist between a standard of care that offers little prospect of clinical benefit and a UMI that might offer some clinical advantage. (shrink)

Online participation in research is used increasingly to recruit geographically dispersed populations. Obtaining online consent is convenient, yet we know little about the acceptability of this practice. We carried out a serostudy among personnel returning to the UK/Ireland following deployment to West Africa during the 2014–2016 Ebola epidemic. We used an online procedure for consenting returnees and designed a small descriptive study to understand: how much of the consent material they read, how informed they felt and if they preferred online (...) to traditional face-to-face consent. Of 261 returnees, 111 completed the consent survey. Participants indicated a high level of engagement with the consent materials, with 67 per cent reporting having read all and 20 per cent having read ‘most’ of the materials. All participants indicated feeling completely or mostly informed about the purpose, methods and intended uses of the research, as well as what participation was required and what risks were involved. Only three participants indicated a preference for face-to-face consent. Free-text comments suggested that online consent may be an acceptable modality for uncomplicated and low-risk studies. The study sample was largely composed of health professionals, suggesting acceptability of online consent within this population. (shrink)

Many countries in Africa, and more generally those in the Global South with tropical areas, are plagued by illnesses that the wealthier parts of the world (mainly ‘the West’) neither suffer from nor put systematic effort into preventing, treating or curing. What does an ethic with a recognizably African pedigree entail for the ways various agents ought to respond to such diseases? As many readers will know, a characteristically African ethic prescribes weighty duties to aid on the part of those (...) in a position to do so, and it therefore entails that there should have been much more contribution from the Western, ‘developed’ world. However, what else does it prescribe, say, on the part of sub-Saharan governments and the African Union, and are they in fact doing it? I particularly seek to answer these questions here, by using the 2013-16 Ebola crisis in West Africa to illustrate what should have happened but what by and large did not. (shrink)

During the recent Ebola epidemic, some commentators and stakeholders argued that it would be unethical to carry out a study that withheld a potential treatment from affected individuals with such a serious, untreatable disease. As a result, the initial trials of experimental treatments did not have control arms, despite important scientific reasons for their inclusion. In this paper, we consider whether the duty to rescue entails that it would be unethical to withhold an experimental treatment from patient-participants with serious diseases (...) for which there are no effective treatments, even when doing so is scientifically necessary to test the effectiveness of the treatment. We argue that the duty to rescue will rarely apply. The context of medical research also throws new light on the content of the duty to rescue, since the interests of future patients—who stand to benefit from the fruits of medical research—are relevant to whether the duty applies. (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 disease. Given this situation, patients with Ebola had a strong interest in accessing potential treatments even if they were unproven. This was especially true in the early phases of the epidemic when fatality rates were very high and seemingly safe ‘repurposed’ treatments were proposed for study. Individuals at high risk of contracting Ebola—for example, frontline workers or informal carers in the community—equally had a strong interest in accessing experimental vaccines, once their safety and ability to induce an immune response had been established in phase 1/2 testing. At the same time, the exponential spread of Ebola in the second half of 2014 created a strong public interest in rigorous research results that could support the rapid marketing authorization, mass production and widespread implementation of any proven effective treatments or vaccines, as well …. (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 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)

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)

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)

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 this article, we contribute to the ongoing investigation of the social significance of biomedicine by examining a very specific site: the activity of bio-containing in Nebraska during the recent Ebola outbreak. We do this by taking up key insights of Mary Douglas and Victor Turner concerning the essential meaning-making tasks of culture. We demonstrate how biocontaining as an activity contributed to the ongoing meaning-making work in U.S. society during the Ebola crisis in 2014. The analysis is based in significant (...) part on fieldwork done at the Nebraska Biocontainment Unit, study of NBU educational materials, and follow-up conversations with personnel staffing that unit.Biocontaining during the Ebola... (shrink)

As part of its response to the 2014 Ebola outbreak in west Africa, the United Kingdom government established an Ebola treatment unit in Sierra Leone, staffed by military personnel. Little is known about the ethical challenges experienced by military medical staff on humanitarian deployment. We designed a qualitative study to explore this further with those who worked in the treatment unit. Semi-structured, face-to-face and telephone interviews were conducted with 20 UK military personnel deployed between October 2014 and April 2015 in (...) one of three roles in the Ebola treatment unit: clinician; nursing and nursing assistant; and other medical support work, including infection control and laboratory and mortuary services. Many participants reported feeling ethically motivated to volunteer for deployment, but for some personal interests were also a consideration. A small minority had negative feelings towards the deployment, others felt that this deployment like any other was part of military service. Almost all had initial concerns about personal safety but were reassured by their pre-deployment 'drills and skills', and personal protective equipment. Risk perceptions were related to perceptions about military service. Efforts to minimise infection risk were perceived to have made good patient care more difficult. Significantly, some thought the humanitarian nature of the mission justified tolerating greater risks to staff. Trust in the military institution and colleagues was expressed; many participants referred to the ethical obligation within the chain of command to protect those under their command. Participants expected resources to be overwhelmed and ‘empty beds’ presented a significant and pervasive ethical challenge. Most thought more patients could and should have been treated. Points of reference for participants’ ethical values were: previous deployment experience; previous UK/National Health Service experience; professional ethics; and, distinctly military values. We report the first systematic exploration of the ethical challenges face by a Western medical military in the international response to the first major Ebola outbreak. We offer unique insights into the military healthcare workers’ experiences of humanitarian deployment. Many participants expressed motivations that gave them common purpose with civilian volunteers. (shrink)

Background As part of its response to the 2014 Ebola outbreak in west Africa, the United Kingdom government established an Ebola treatment unit in Sierra Leone, staffed by military personnel. Little is known about the ethical challenges experienced by military medical staff on humanitarian deployment. We designed a qualitative study to explore this further with those who worked in the treatment unit. Method Semi-structured, face-to-face and telephone interviews were conducted with 20 UK military personnel deployed between October 2014 and April (...) 2015 in one of three roles in the Ebola treatment unit: clinician; nursing and nursing assistant; and other medical support work, including infection control and laboratory and mortuary services. Results Many participants reported feeling ethically motivated to volunteer for deployment, but for some personal interests were also a consideration. A small minority had negative feelings towards the deployment, others felt that this deployment like any other was part of military service. Almost all had initial concerns about personal safety but were reassured by their pre-deployment 'drills and skills', and personal protective equipment. Risk perceptions were related to perceptions about military service. Efforts to minimise infection risk were perceived to have made good patient care more difficult. Significantly, some thought the humanitarian nature of the mission justified tolerating greater risks to staff. Trust in the military institution and colleagues was expressed; many participants referred to the ethical obligation within the chain of command to protect those under their command. Participants expected resources to be overwhelmed and ‘empty beds’ presented a significant and pervasive ethical challenge. Most thought more patients could and should have been treated. Points of reference for participants’ ethical values were: previous deployment experience; previous UK/National Health Service experience; professional ethics; and, distinctly military values. Conclusion We report the first systematic exploration of the ethical challenges face by a Western medical military in the international response to the first major Ebola outbreak. We offer unique insights into the military healthcare workers’ experiences of humanitarian deployment. Many participants expressed motivations that gave them common purpose with civilian volunteers. (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)

The Médecins Sans Frontières ethics review board has been solicited in an unprecedented way to provide advice and review research protocols in an ‘emergency’ mode during the recent Ebola epidemic. Twenty-seven Ebola-related study protocols were reviewed between March 2014 and August 2015, ranging from epidemiological research, to behavioural research, infectivity studies and clinical trials with investigational products at early development stages. This article examines the MSF ERB’s experience addressing issues related to both the process of review and substantive ethical issues (...) in this context. These topics include lack of policies regarding blood sample collection and use, and engaging communities regarding their storage and future use; exclusion of pregnant women from clinical and vaccine trials; and the difficulty of implementing timely and high-quality qualitative/anthropological research to consider potential upfront harms. Having noticed different standards across ethics committees, we propose that when multiple ethics reviews of clinical and vaccine trials are carried out during a public health emergency they should be accompanied by transparent communication between the ECs involved. The MSF ERB experience should trigger a broader discussion on the ‘optimal’ ethics review in an emergency outbreak and what enduring structural changes are needed to improve the ethics review process. (shrink)

In this article, I consider the virtual absence of an African voice and perspective in global discourses of medical research ethics against the backdrop of the high burden of diseases and epidemics on the continent and the fact that the continent is actually the scene of numerous and sundry medical research studies. I consider some reasons for this state of affairs as well as how the situation might be redressed. Using examples from the HIV/AIDS and Ebola epidemics, I attempt to (...) show that the marginalization of Africa in medical research and medical research ethics is deliberate rather than accidental. It is causally related, in general terms, to a Eurocentric hegemony derived from colonialism and colonial indoctrination cum proselytization. I end by proposing seven theses for the critical reflection and appraisal of the reader. (shrink)

In the midst of the recent Ebola outbreak, scientific developments involving infection challenge experiments on nonhuman primates 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, based upon recommendations in an influential 2011 Institute of Medicine 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)

“The Ethics of Infection Challenges in Primates,” by Anne Barnhill, Steven Joffe, and Franklin Miller, is an exceptionally timely contribution to the literature on animal research ethics. Animal research has long been both a source of high hopes and a cause for moral concern. When it comes to infection challenge studies with nonhuman primates, neither the hope—to save thousands of human lives from such diseases as Ebola and Marburg—nor the concern—the conviction that primates deserve especially strong protections—could be much higher. (...) Coming just a few years after the National Institutes of Health adopted the Institute of Medicine's recommendations regarding chimpanzees, Barnhill and colleagues attempt to nudge the clarification and specification—one might say the evolution—of NHP research ethics and regulation. They assert that NHP challenge studies “are not justified by marginal gains in human safety or by efficacy gains that are unlikely to translate directly into saving human lives or preventing morbidity.” How, in turn, is their standard—which, although stringent, does permit causing NHPs to suffer and die for human benefit—to be justified? (shrink)

Ethical concerns about randomising persons to a no-treatment arm in the context of Ebola epidemic led to consideration of alternative designs. The stepped wedge design, in which participants or clusters are randomised to receive an intervention at different time points, gained popularity. Common arguments in favour of using this design are when an intervention is likely to do more good than harm, all participants should receive the experimental intervention at some time point during the study and the design might be (...) preferable for practical reasons. We examine these assumptions when considering Ebola vaccine research. First, based on the claim that a stepped wedge design is indicated when it is likely that the intervention will do more good than harm, we reviewed published and ongoing SW trials to explore previous use of this design to test experimental drugs or vaccines, and found that SW design has never been used for trials of experimental drugs or vaccines. Given that Ebola vaccines were all experimental with no prior efficacy data, the use of a stepped wedge design would have been unprecedented. Second, we show that it is rarely true that all participants receive the intervention in SW studies, but rather, depending on certain design features, all clusters receive the intervention. Third, we explore whether the SW design is appealing for feasibility reasons and point out that there is significant complexity. In the setting of the Ebola epidemic, spatiotemporal variation may have posed problematic challenges to a stepped wedge design for vaccine research. Finally, we propose a set of points to consider for scientific reviewers and ethics committees regarding proposals for SW designs. (shrink)

BackgroundThe global interest in developing therapies for Ebola infection management and its prevention is laudable. However the plan to conduct an emergency immunization program specifically for healthcare workers using experimental vaccines raises some ethical concerns. This paper shares perspectives on these concerns and suggests how some of them may best be addressed.DiscussionThe recruitment of healthcare workers for Ebola vaccine research has challenges. It could result in coercion of initially dissenting healthcare workers to assist in the management of EVD infected persons (...) due to mistaken beliefs that the vaccine offers protection. It could also affect equity and justice. For example, where people who are not skilled health care professionals but who provide care to patients infected with Ebola are not prioritized for vaccination. The possibility of study participants contracting Ebola infection despite the use of experimental vaccine, and the standard of care they would receive, needs to be addressed clearly, transparently and formalized as part of the ethics review process. Future access to study products in view of current status of the TRIPS agreement needs to be addressed. Finally, broad stakeholder engagement at local, regional and international levels needs to be promoted using available communication channels to engage local, regional and international support. These same concerns are applicable for current and future epidemics.SummarySuccessful Ebola vaccine development research requires concerted efforts at public dialogue to address misconceptions, equity and justice in participant selection, and honest discussions about risks, benefits and future access. Public dialogue about Ebola vaccine research plans is crucial and should be conducted by trusted locals and negotiated between communities, researchers and ethics committees in research study sites. (shrink)

_BMC Medical Ethics_ is an open access journal publishing original peer-reviewed research articles in relation to the ethical aspects of biomedical research and clinical practice, including professional choices and conduct, medical technologies, healthcare systems and health policies. _BMC __Medical Ethics _is part of the _BMC_ series which publishes subject-specific journals focused on the needs of individual research communities across all areas of biology and medicine. We do not make editorial decisions on the basis of the interest of a study or (...) its likely impact. Studies must be scientifically valid; for research articles this includes a scientifically sound research question, the use of suitable methods and analysis, and following community-agreed standards relevant to the research field. Specific criteria for other article types can be found in the submission guidelines. _BMC series - open, inclusive and trusted_. (shrink)

Excellent patient care within the emergency department requires interdisciplinary training, teamwork, and communication to manage the chaos of the environment. Specifically, invasive procedures required to manage airway, breathing, and circulation via intubation, chest compressions, and establishing intravenous access can provide a direct benefit to save lives but also have the potential to harm both patients and health care clinicians alike; emergency health care clinicians can be exposed to significant amounts of blood and body fluids as well as other threats of (...) physical and psychological harm. The ethical components of care in this environment are often under‐recognized due to the need for rapid patient assessment and immediate action. Moreover, challenges to practice that can include lack of qualified personnel, equipment, and other resources to provide safe care to a large volume of patients can lead to moral distress in ED staff. Because the ED is a high‐uncertainty, high‐acuity environment, continuing interprofessional communication, collaboration, and planning is critical. Opportunities for multidisciplinary policy dialogue and the development of professional guidelines can make the ED a safer environment for both patients and providers. (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)

The Ebola epidemic in West Africa is not merely a biomedical problem that can be seen in isolation and dealt with only through emergency medical rescue processes. The ethical dilemmas surfaced by this epidemic are also not confined to the usual micro-ethical problems associated with medical care and medical research. The pandemic, as one of many manifestations of failed human and social development that has brought the world to dangerous ‘tipping points’, requires deep introspection and action to address upstream causal (...) processes. (shrink)

There can be little doubt about the ethical imperative to ensure adequate vaccination uptake against certain infectious diseases. In the face of vaccine refusal, health authorities and providers instinctively appeal to coercive approaches or increased education as methods to ensure adequate vaccine uptake. Recently, some have argued that public fear around Ebola should be used as an opportunity for such approaches, should an Ebola vaccine become available. In this article, the author describes the difficulties associated with coercion and education when (...) addressing vaccine opposition. Both coercion and education can cause opposite effects than intended in certain circumstances. The correct area of focus is to address the breakdown in trust within clinical relationships. The author presents suggestions for an approach towards vaccine refusal that may be more promising. (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)