Ethics of emerging infectious disease outbreak responses: Using Ebola virus disease as a case study of limited resource allocation.

Emerging infectious diseases such as Ebola Virus Disease (EVD), Nipah Virus Encephalitis and Lassa fever pose significant epidemic threats. Responses to emerging infectious disease outbreaks frequently occur in resource-constrained regions and under high pressure to quickly contain the outbreak prior to potential spread. As seen in the 2020 EVD outbreaks in the Democratic Republic of Congo and the current COVID-19 pandemic, there is a continued need to evaluate and address the ethical challenges that arise in the high stakes environment of an emerging infectious disease outbreak response. The research presented here provides analysis of the ethical challenges with regard to allocation of limited resources, particularly experimental therapeutics, using the 2013-2016 EVD outbreak in West Africa as a case study. In-depth semi-structured interviews were conducted with senior healthcare personnel (n = 16) from international humanitarian aid organizations intimately engaged in the 2013-2016 EVD outbreak response in West Africa. Interviews were recorded in private setting, transcribed, and iteratively coded using grounded theory methodology. A majority of respondents indicated a clear propensity to adopt an ethical framework of guiding principles for international responses to emerging infectious disease outbreaks. Respondents agreed that prioritization of frontline workers' access to experimental therapeutics was warranted based on a principle of reciprocity. There was widespread acceptance of adaptive trial designs and greater trial transparency in providing access to experimental therapeutics. Many respondents also emphasized the importance of community engagement in limited resource allocation scheme design and culturally appropriate informed consent procedures. The study results inform a potential ethical framework of guiding principles based on the interview participants' insights to be adopted by international response organizations and their healthcare workers in the face of allocating limited resources such as experimental therapeutics in future emerging infectious disease outbreaks to ease the moral burden of individual healthcare providers.

Contractualist age rationing under outbreak circumstances.

Age rationing is a central issue in the health care priority-setting literature, but it has become ever more salient in the light of the Covid-19 outbreak, where health authorities in several countries have given higher priority to younger over older patients. But how is age rationing different under outbreak circumstances than under normal circumstances, and what does this difference imply for ethical theories? This is the topic of this paper. The paper argues that outbreaks such as that of Covid-19 involve special circumstances that change how age should influence our prioritization decisions, and that while this shift in circumstances poses a problem for consequentialist views such as utilitarianism and age-weighted consequentialism, contractualism is better equipped to cope with it. The paper then offers a contractualist prudential account of age rationing under outbreak circumstances.

Radiology practice in sub-Saharan Africa during the COVID-19 outbreak: points to consider.

COVID-19 is a rapidly growing pandemic that has grown from a few cases in Wuhan, China to millions of infections and hundreds of thousands of deaths worldwide within a few months. Sub-Saharan Africa is not spared. Radiology has a key role to play in the diagnosis and management of COVID-19 as literature from Wuhan and Italy demonstrates. We therefore share some critical knowledge and practice areas for radiological suspicion and diagnosis. In addition, emphasis on how guarding against healthcare acquired infections (HAIs) by applying "red" and "green" principle is addressed. Given that pandemics such as COVID-19 can worsen the strain on the scantily available radiological resources in this region, we share some practical points that can be applied to manage these precious resources also needed for other essential services. We have noted that radiology does not feature in many main COVID-19 guidelines, regionally and internationally. This paper therefore suggests areas of collaboration for radiology with other clinical and management teams. We note from our local experience that radiology can play a role in COVID-19 surveillance.

Clinical and ethical challenges for emergency departments during communicable disease outbreaks: Can lessons from Ebola Virus Disease be applied to the COVID-19 pandemic?

EDs fulfil a frontline function during public health emergencies (PHEs) and will play a pivotal role during the COVID-19 pandemic. This perspective article draws on qualitative data from a longitudinal, ethnographic study of an Australian tertiary ED to illustrate the clinical and ethical challenges faced by EDs during PHEs. Interview data collected during the 2014 Ebola Virus Disease PHE of International Concern suggest that ED clinicians have a strong sense of professional responsibility, but this can be compromised by increased visibility of risk and sub-optimal engagement from hospital managers and public health authorities. The study exposes the tension between a healthcare worker's right to protection and a duty to provide treatment. Given the narrow window of opportunity to prepare for a surge of COVID-19 presentations, there is an immediate need to reflect and learn from previous experiences. To maintain the confidence of ED clinicians, and minimise the risk of moral injury, hospital and public health authorities must urgently develop processes to support ethical healthcare delivery and ensure adequate resourcing of EDs.

How Should Clinicians Respond to International Public Health Emergencies?

This case analysis examines obligations health care workers have to support relief efforts when an infectious disease outbreak could impact us all. How clinicians, institutions, and local communities ought to balance increased need for global solidarity in response to global disease outbreaks with concerns of local stakeholders is one specific tension this article investigates. We explore how emphasizing global health solidarity in the face of highly hazardous communicable diseases can help mitigate global risk.

Five Things Students and Clinicians Should Know About "Biocontainment".

Biocontaining was one way that Western, affluent, allopathic cultures tended to respond and make meaning during the 2013-2015 Ebola virus disease (EVD) pandemic. It became a pathway to restore trust in biomedicine itself, which had been shaken by unease across the globe when the EVD threat was at its height. Yet biocontaining barely qualifies as a public health measure. Successful public health efforts rely on trust, which is difficult to maintain during a pandemic. Such efforts require balancing the need to be close to patients to care well for them against the need to remain distant from a virulent pathogen. Biocontainment tries to navigate this tension and, in so doing, simultaneously frustrates and supports public trust. This article suggests 5 things clinicians and health professions students should consider about the project of biocontainment that could affect their orientation to their public health duties.

How Should the WHO Guide Access and Benefit Sharing During Infectious Disease Outbreaks?

In response to the 2013-2016 Ebola virus disease (EVD) outbreak primarily affecting Guinea, Sierra Leone, and Liberia, the World Health Organization (WHO) set out Guidance for Managing Ethical Issues in Infectious Disease Outbreaks, which covered social distancing, research in outbreak settings, and clinical care. This article assesses the Guidance's recommendations on research and long-term storage of biological specimens during infectious disease outbreaks and argues that the Guidance does not provide adequate direction for responders', researchers', and organizations' actions. It considers local persons' access to benefits of research in the aftermath of outbreaks and preparedness for outbreaks, drawing on lessons from both the 2013-2016 EVD outbreak and ongoing research in the Democratic Republic of the Congo.

Making Emergency Use of Experimental Vaccines Safer.

Ethical and logistical challenges of deploying experimental vaccines in humanitarian emergencies are exacerbated by a paucity of safety and efficacy data. For outbreaks caused by pathogens with high mortality rates and few treatments, such as Ebola virus disease, not offering access to experimental vaccines with some evidence of efficacy can also be ethically suspect. This article recommends (1) gathering more preclinical data about experimental vaccines' safety and (2) improving research infrastructure to enable participation of a wide range of subjects in affected communities over long trial periods. Motivating these goals would facilitate clearer definitions of population vulnerability and risk acceptability.

Ethical issues in the COVID-19 pandemic control preparedness in a developing economy.

Adequate preparation for highly pathogenic infectious disease pandemic can reduce the incidence, prevalence and burden of diseases like COVID-19 pandemic. An antidote to the spread of the disease is adequate preparation for its control since there is no proven curative measure yet. Effective management of identified cases, social distancing, contact tracing and provision of basic infrastructure to facilitate compliance with preventive measures, testing are proven management strategies. Although these measures seem to be the best options presently, it is important to pay attention to ethical issues arising from the implementation process to ensure best practice. While disease epidemic is not alien to human societies, lessons from previous outbreaks are vital for addressing future outbreaks. For effective control of this pandemic, there should be a clear definition of social distancing in terms of distance and space in line with the WHO definition, adequate provision of basic amenities, screening and testing with specific criteria for selecting those to be screened. Also, there should be a free testing procedure, access to treatment opportunities for those who test positive, ethical free contact tracing practice, respect for the autonomy of those to be tested, and global best practice of open science, open data and data sharing practices. In conclusion, a framework/guideline for epidemic/pandemic ethics guidance should be developed while an ethical sensitive communication manual should be prepared for public engagement on epidemic and pandemic.

Ethics preparedness: facilitating ethics review during outbreaks - recommendations from an expert panel.

BACKGROUND: Ensuring that countries have adequate research capacities is essential for an effective and efficient response to infectious disease outbreaks. The need for ethical principles and values embodied in international research ethics guidelines to be upheld during public health emergencies is widely recognized. Public health officials, researchers and other concerned stakeholders also have to carefully balance time and resources allocated to immediate treatment and control activities, with an approach that integrates research as part of the outbreak response. Under such circumstances, research "ethics preparedness" constitutes an important foundation for an effective response to infectious disease outbreaks and other health emergencies. MAIN TEXT: A two-day workshop was convened in March 2018 by the World Health Organisation Global Health Ethics Team and the African coaLition for Epidemic Research, Response and Training, with representatives of National Ethics Committees, to identify practical processes and procedures related to ethics review preparedness. The workshop considered five areas where work might be undertaken to facilitate rapid and sound ethics review: preparing national ethics committees for outbreak response; pre-review of protocols; multi-country review; coordination between national ethics committees and other key stakeholders; data and benefit sharing; and export of samples to third countries. In this paper, we present the recommendations that resulted from the workshop. In particular, the participants recommended that Ethics Committees would develop a formal national standard operating procedure for emergency response ethical review; that there is a need to clarify the terminology and expectations of pre-review of generic protocols and agree upon specific terminology; that there is a need to explore mechanisms for multi-country emergency ethical consultation, and to establish procedures for communication between national ethics committees and other oversight bodies and public health authorities. In addition, it was suggested that ethics committees should request from researchers, at a minimum, a preliminary data sharing and sample sharing plan that outlines the benefit to the population from which data and samples are to be drawn. This should be followed in due time by a full plan. CONCLUSION: It is hoped that the national ethics committees, supported by the WHO, relevant collaborative research consortia and external funding agencies, will work towards bringing these recommendations into practice, for supporting the conduct of effective research during outbreaks.

The Ebola outbreak's real cause: Letting industry drive the research agenda

Julia Belluz and Steven Hoffman

Social value, clinical equipoise, and research in a public health emergency.

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.

Ethics of Outbreaks Position Statement. Part 1: Therapies, Treatment Limitations, and Duty to Treat.

OBJECTIVES: Outbreaks of disease, especially those that are declared a Public Health Emergency of International Concern, present substantial ethical challenges. Here we start a discourse (with a continuation of the dialogue in Ethics of Outbreaks Position Statement. Part 2: Family-Centered Care) concerning the ethics of the provision of medical care, research challenges and behaviors during a Public Health Emergency of International Concern with a focus on the proper conduct of clinical or epidemiologic research, clinical trial designs, unregistered medical interventions (including vaccine introduction, devices, pharmaceuticals, who gets treated, vulnerable populations, and methods of data collection), economic losses, and whether there is a duty of health care providers to provide care in such emergencies, and highlighting the need to understand cultural diversity and local communities in these efforts. DESIGN: Development of a Society of Critical Care Medicine position statement using literature review and expert consensus from the Society of Critical Care Medicine Ethics committee. The committee had representation from ethics, medical philosophy, critical care, nursing, internal medicine, emergency medicine, pediatrics, anesthesiology, surgery, and members with international health and military experience. SETTING: Provision of therapies for patients who are critically ill or who have the potential of becoming critically ill, and their families, regarding medical therapies and the extent of treatments. POPULATION: Critically ill patients and their families affected by a Public Health Emergency of International Concern that need provision of medical therapies. INTERVENTIONS: Not applicable. MAIN RESULTS: Interventions by high income countries in a Public Health Emergency of International Concern must always be cognizant of avoiding a paternalistic stance and must understand how families and communities are structured and the regional/local traditions that affect public discourse. Additionally, the obligations, or the lack of obligations, of healthcare providers regarding the treatment of affected individuals and communities must also be acknowledged. Herein, we review such matters and suggest recommendations regarding the ethics of engagement in an outbreak that is a Public Health Emergency of International Concern.

A Radical Approach to Ebola: Saving Humans and Other Animals.

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.

Addressing vaccine hesitancy requires an ethically consistent health strategy.

BACKGROUND: Vaccine hesitancy is a growing threat to public health. The reasons are complex but linked inextricably to a lack of trust in vaccines, expertise and traditional sources of authority. Efforts to increase immunization uptake in children in many countries that have seen a fall in vaccination rates are two-fold: addressing hesitancy by improving healthcare professional-parent exchange and information provision in the clinic; and, secondly, public health strategies that can override parental concerns and values with coercive measures such as mandatory and presumptive vaccination. MAIN TEXT: It is argued that such conflicting, parallel approaches seriously risk undermining trust that is crucial for sustaining herd immunity. Although public health strategies can be ethically justified in limiting freedoms, a parent-centered approach seldom acknowledges how it is impacted by contemporaneous coercive measures. In addition, the clinical encounter is not well suited to helping parents consider the public dimensions of vaccination, despite these being important for trust formation and informed decision-making. Efforts to address vaccine hesitancy require more consistent engagement of parental and citizen views. Along with evidence-based information, debates need to be informed by ethical support that equips parents and professionals to respond to the private and public dimensions of vaccination in a more even-handed, transparent manner. CONCLUSION: Efforts to address vaccine hesitancy need to avoid simple reliance on either parental values or coercive public policies. To do this effectively requires increasing citizen engagement on vaccination to help inform a parent-centered approach and legitimize public policy measures. In addition, cultivating a more ethically consistent strategy means moving beyond the current silos of health ethics - clinical and public health ethics.

Disease detection, epidemiology and outbreak response: the digital future of public health practice.

Inequalities persist when it comes to the attention, resource allocation and political prioritization, and provision of appropriate, adequate, and timely health interventions to populations in need. Set against a complex socio-political backdrop, the pressure on public health science is significant: institutions and scientists are accountable for helping to find the origins of disease, and to prevent and respond effectively more rapidly than ever. In the field of infectious disease epidemiology, new digital methods are contributing to a new 'digital epidemiology' and are seen as a promising way to increase effectivity and speed of response to infectious disease and public health events. New types of health data and access to personal information that are available through diverse channels will continue to have wide implications for epidemiology and public health practice. The purpose of this short paper is to introduce the emerging backdrop of practical and ethical challenges for those involved within the practice of public health as they face increasing collaborations with those from fields that have not traditionally applied their methods to epidemiology.