On Sunday the 6th of August 2017, the Global Health Ethics Unit of the World Health Organization (WHO) organised a pre-conference workshop on ‘The Ethics of Epidemics, Research and Surveillance’, as part of the 9th TEPHINET Global Scientific Conference, which was held from the 7th until the 11th of August at the Empress Hotel and Convention Centre in Chiang Mai in Northern Thailand. Created in 1997, TEPHINET (Training Programs in Epidemiology and Public Health Interventions Network) is a professional network of 69 field epidemiology training programs working in more than 100 countries.

The workshop was facilitated by Dr Abha Saxena and Dr Calvin Ho; the workshop rapporteur was Karel Caals. It was the aim of this workshop to assist policymakers, first responders, field epidemiologists and researchers in preparing for infectious disease outbreak (IDO) situations by anticipating and preparing for the critical ethical issues that are likely to arise. The objectives of this one-day course were (1) to describe the ethical principles that apply in epidemics and health emergencies; (2) to identify frequent ethical issues that arise in response, research and surveillance during epidemics and emergencies and outline steps on how to address them; and (3) to demonstrate the application of international guidance and policies on ethics in epidemics and emergencies. The workshop drew participants from 13 countries, and this report is intended to provide a summary for the presentations and discussions, with a focus on three documents recently published by WHO, namely (a) Ethics in epidemics, emergencies and disasters: research, surveillance and patient care—WHO training manual (World Health Organization 2015); (b) Guidance for managing ethical issues in infectious disease outbreaks (World Health Organization 2016) and (c) Guidelines on ethical issues in public health surveillance (World Health Organization 2017). For the purposes of this report, the aforementioned documents are collectively referred to as ‘WHO IDO Ethics Documents’.

Ethical Principles That Apply in Epidemics and Health Emergencies

The workshop began with a presentation on the ‘Ethics in a Public Health Response to Infectious Disease Outbreaks’, where ethical evaluation is explained as broadly (but not exclusively) concerned with what is right and wrong and with moral duties, obligations and rights, and providing a process for reaching agreement when values are in conflict. In ethical decision-making, two levels can be distinguished: ethical principles that apply at an individual level and those that apply at a societal or population level. Ethical principles, furthermore, can be substantive as well as procedural. Ethical evaluation is also dependent on context. An IDO typically entails a sense of urgency, scientific uncertainty, an inadequate knowledge base, inadequate information, fear and mistrust, social and institutional disruption, a lack of resources, a shortage of medicines or vaccine and inadequate legal, ethical and regulatory structures, and is worsened when it coincides with natural disasters or armed conflict.

During an IDO, frontline response workers are often faced with dilemmas that arise from the need to carefully balance collective interests against individual ones, often in decisions that relate to resource allocation, protecting the most vulnerable, gaining and sustaining trust and initiating research or not. In recent years, these challenges became apparent in the Ebola outbreak in West Africa and in other global IDOs, such as the severe acute respiratory syndrome (SARS), as well as in relation to pandemic influenza and multi-drug-resistant tuberculosis (MDR-TB). Responding ethically and effectively to these challenges necessitates the set-up of decision-making systems and procedures in advance, taking into account the local social, cultural and political context. Decisions should as far as possible be evidence-based and grounded in international obligations, such as those in the WHO’s International Health Regulation and the Siracusa Principles (UN Commission on Human Rights 1984). The goals of the WHO IDO Ethics Documents include highlighting cross-cutting ethical issues that apply to IDOs and examining how these principles can be adapted to different epidemiological and social circumstances.

Clinical Care and Research

In determining which ethical principles apply, it is necessary to be clear about whether an intervention, activity or programme is intended for treatment, research or surveillance. Clinical ethics and research ethics are now well-developed areas of bioethics and would apply to treatment and research, respectively.

In clinical practice and in research, the ethical principles of autonomy, beneficence, non-maleficence and justice are widely recognised to apply. In an IDO, healthcare providers have an additional duty to do or support research and to share clinical and medical data. This obligation could, however, cause a tension between therapeutic and research goals. For instance, it was noted in discussion that foreign-funded research during an IDO could cause tension and political instability; while it might bring in much needed funds, it could ignore or neglect the interests of the local community or might have a hidden agenda. Crucially, it is imperative that patient care remains the priority in an IDO; that resources are not diverted from patient care to research; that patients are properly informed and that their confidentiality is protected. Community interests matter as well, but come secondary to patient interests.

Medical interventions should always be offered in accord with professional medical standards, and the informed consent of the patient should be obtained since she or he has the right to refuse treatment. However, in exceptional situations, there may be legitimate reasons to override an individual’s refusal of a diagnostic, therapeutic or preventative measure that has proven to be safe and effective, and is part of accepted medical care. But the following points need to be considered: (1) public health necessity, (2) the existence of contraindications, (3) the feasibility of providing interventions to an unwilling patient and (4) impact on community trust.

In the absence of therapeutic or prophylactic interventions of proven safety and efficacy, the principles of patient autonomy and beneficence underscore the monitored emergency use of unregistered and experimental interventions (MEURI) during an IDO. MEURI can only be implemented when: (1) there is no treatment of proven effectiveness; (2) it is not possible to initiate clinical studies immediately; (3) the experimental intervention is recommended by a scientific advisory committee, based on a favourable risk-benefit analysis, involving data from at least laboratory or animal studies; (4) the experimental intervention is approved by the relevant authorities and ethics committees; (5) adequate resources for risk minimization are available; (6) informed consent is given by the patient and (7) the emergency use of the intervention is monitored, and results are documented and shared in a timely manner. MEURI is different from ‘compassionate use’ in that it ‘cannot’ be part of a trial (cf. (2)) and requires monitoring (cf. (7)). It was noted in discussion that the baseline infrastructural requirements for MEURI require careful consideration, as well as its potential application outside of public health emergencies, and how it could be bridged to regular research.

Public Health Surveillance

Public health ethics, which applies to public health surveillance (PHS), is increasing in importance, with for example, a greater role attributed to it in the WHO International Health Regulations, revised in 2005, and with rapid technological advance in diagnostics and information and communication technologies. According to the US Centers for Disease Control and Prevention (CDC 2010), the distinction between PHS and research depends on the primary purpose of the activity in question, whether it is to reduce disease or improve health, or to generate generalizable knowledge. However, in many ways, PHS is similar to research. Both can involve similar methodologies and activities, like systematic investigation, medical record review or data mining. Both also involve human subjects and can raise similar ethical issues, including exposure of subjects to risk, standards of care and questions about informed consent. Although PHS is similar to research in many practical aspects, ethical emphasis and application differ. For example, where informed consent is a basic tenet of research ethics, it may not be as strongly emphasised in the context of surveillance. The 2017 WHO guidelines outline four core ethical principles that apply to PHS: (1) the common good, as in shared benefits, but understood in a broader sense than the more narrowly economic term ‘public good’; (2) equity, to create just and fair conditions for human flourishing; (3) respect for persons, in order to make protection possible and to minimise the risk of harm and (4) good governance, promoting accountability and openness to public scrutiny. In contrast to conventional clinical and research ethics principles, the emphasis of public health ethics tends to be on collective good and social justice.

Involving the Local Community

Community engagement has been emphasised in all of the WHO IDO Ethics Documents as a critical component of any IDO response effort. Ethically, it is important to ensure the relevance of research (if conducted); to avoid exploitation by ensuring a fair distribution of the benefits of research and to take into account the ethical pitfalls that may be part of the social, economic and political landscape of the community. But practically, it is also essential in order to establish and maintain trust and cooperation and to preserve social order. It therefore has consequences for the effectiveness and impact of the IDO response. For example, effective community engagement facilitates information collection and risk communication. The hallmarks of a community-centred approach to IDO response are inclusiveness, specific attention to vulnerable people in the community, openness to diverse perspectives and transparency and accountability. In their approach to seeking informed consent, researchers should take care to avoid treating traditional communities condescendingly. For successful community engagement, the whole IDO response team needs to be involved, including epidemiologists, logistics specialists, laboratory workers, hygiene experts and various other specialised professions. Experience has shown that social anthropologists and other social scientists could provide insights on how community engagement could be done effectively.

One of the participants elaborated on how mistrust can potentially cripple an IDO response. In a crisis, people often fill a vacuum caused by a lack of knowledge, with rumours. By sharing information and solutions, community engagement can play a crucial role in building trust and preventing panic. Sincerely communicating what is known and not known, actions that are intended and resources that are available is crucial. Ideally, strong media relations should be maintained from ‘peace time’ onwards, i.e. before a crisis breaks out. Participants recognise that community engagement, including media relations, should be cultivated as part of their ongoing work, rather than only during an IDO.

Ethical Issues and Considerations

Storage and Sharing of Data and Samples

The example of access to clinical trial data on Tamiflu was used to discuss data ownership and sharing, and how a lack of access to data can hinder effective response to a public health emergency. Data sharing (such as in genomic research) can reduce duplication of research, increase scientific progress and produce more career opportunities for researchers. In other words, making data available and accessible can also inform researchers of what data exists and where future research can be directed.

In the context of an IDO, rapid data sharing helps to identify etiological factors, predict the spread of the disease, evaluate existing and novel treatment, establish symptomatic care and preventive measures and guide the deployment of limited resources. Data that could be shared include PHS data, clinical research studies, individual patient encounters (including MEURI) and findings from epidemiological, qualitative and environmental studies. Especially during an IDO, researchers have an ethical obligation to share data before they appear in a peer-reviewed publication, and academic journals should facilitate this. But challenges and barriers to sharing exist, and these include the requirement for scholars to publish, commodity-driven interests of pharmaceutical companies, intellectual property rights and concerns about confidentiality. A response to such challenges and barriers is to devise a framework that facilitates the sharing of data and samples for public health purposes. Ideally, the key features of such a global governance framework (Chen and Pang 2015) should include respecting donors of biological samples; informing donors of potential risks through initial consultations; sharing samples, data and benefits in a fair, transparent and equitable manner; ensuring quality and interoperability of samples and their associated data; improving public awareness, trust and participation and defining the role of the private sector in the use of knowledge derived.

The ‘Pandemic Influenza Preparedness’ (PIP) framework established following the avian influenza A (H5N1) outbreak is an example of such a framework. It contractually obliges researchers and manufacturers to share benefits of the research. Other data and sample sharing frameworks could be developed under the broad aegis of the ‘Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization’, which is supplementary to the ‘Convention on Biological Diversity’. The Nagoya Protocol has as one of its objectives the fair and equitable sharing of benefits arising out of the utilisation of genetic resources. Apart from frameworks, sharing of benefits can also be achieved through material transfer agreement (MTA), although drafting of such a document could be technically demanding. However, the difficulty of enforcing international frameworks was noted. For instance, unless WHO has a contractual agreement with a pharmaceutical company, the latter cannot be compelled to share the results of randomised controlled trials conducted or funded by it.

Rights and Obligations of Frontline Response Workers

During the 2014 Ebola crisis in West Africa, health workers were found to be between 21 and 32 times more likely to be infected than people in the general population. However, such infections are preventable: training, especially, makes all the difference.

Frontline response workers (FRWs) include not only healthcare professionals, traditional healers and ambulance drivers but also workers outside the healthcare sector, such as sanitation workers and burial teams. In determining the scope of their duties, it is important to note that the assumption of risk is inherent to some jobs such as physicians, nurses and funeral directors, but not to others. Their work obligations should always be determined alongside their reciprocal rights to training, tools and resources that are necessary to minimise the risks. Work obligations should also reflect a balance between the risks they are exposed to and the public health benefits that are anticipated. Assignment of duties should also be equitable and in a transparent manner. There are also additional duties that relate to participating in public health surveillance and reporting efforts, providing accurate information to the public, and avoiding exploitation.

Apart from the above, other rights of FRWs include priority access to healthcare, appropriate remuneration, reintegration into the community afterwards and benefits to their family such as death benefits or healthcare for family members that get infected.

Vulnerability and Resource Allocation in Public Health Surveillance

The concept of vulnerability was discussed at the workshop as it has been consistently emphasised in all of the WHO IDO Ethics Documents. While the exact meaning of vulnerability has proven to be elusive in the bioethics literature, the WHO IDO Ethics Documents have deployed it in three ways: first, vulnerability should not in itself be a reason to exclude ‘vulnerable’ individuals or groups from research or surveillance activities, since different characteristics that render them ‘vulnerable’ may co-exist and—depending also on context—some individuals or groups may be more vulnerable than others; second, vulnerability encourages a holistic treatment of actual and potential harms, including their identification, evaluation, minimization and disclosure; third, for individuals or groups that are of heightened vulnerability, their inclusion in research or surveillance activities should be conducted in ways that will empower them, as well as promote equity more generally.

Taking the concerns of vulnerability seriously has clear implications for priority setting and resource allocation in public health surveillance. Depending on equitable goals that are to be advanced, the choice of surveillance approaches could render particularly vulnerable individuals or groups less vulnerable. Specifically, the following considerations should be undertaken carefully: (a) what trade-offs are acceptable (in balancing timeliness with representativeness, sensitivity with specificity), (b) what are the cost implications (where costs could be operational, labour or political), (c) how much weight should be attributed to competing considerations or concerns and (d) what action thresholds and response actions are appropriate. For instance, disease control programmes produce high-quality data with timeliness that is appropriate for the disease in question. However, compartmentalisation that is entailed may create barriers to sharing of data and resources. In addition, activities that are intended for surveillance could also be treated as research. Sentinel surveillance could present such a dual effect, for example. Different ethical evaluations and administrative processes may be entailed based on the primary purpose of the activities, but inclusiveness and accountability should underscore these activities as they are equity-promoting characteristics.

Conclusion

There are many issues that a frontline response worker should consider in the event of an IDO. A crucial question is what the main purpose of the proposed intervention or activity is: is it clinical, research or surveillance? Which and how ethical principles apply will depend on the purpose of intervention or activity and on the context. Importantly, community engagement has been emphasised in all of the WHO IDO Ethics Documents. It should be considered if existing community engagement can be continued or does it need to be initiated? Community engagement is necessary to sustain trust and stable collaboration with affected individuals and communities. Equally important is the need to consider how affected individuals and communities are vulnerable, and how the proposed intervention or activity is likely to affect them. Ideally, resources should be deployed in a way that empowers the most vulnerable in an IDO. Policymakers should be mindful that frontline response workers could be rendered more vulnerable, and appropriate resources should be available to ensure their safety and wellbeing. Careful attention should also be paid to data and sample sharing, particularly where issues of access and benefit sharing are concerned. As an IDO is an eventuality which cannot be entirely averted, the WHO IDO Ethics Documents are also concerned with ethical responsibilities that should be assumed before an outbreak, or in ‘peace time’. Building public trust, clearly defining roles and responsibilities of frontline response workers and other stakeholders, setting aside adequate resources, and putting in place a mechanism that will enable ethics review to be fast-tracked are illustrative of these responsibilities.