Research in Global Health Emergencies: Ethical Issues

"The agencies, communities, and people who are brought together in the conduct of research within global health emergencies bring with them different moral concerns, commitments, and values....[I]mportant...in such contexts - and moral decision-making - are the overlaps, interconnections, and potential for productive conversations between the moral perspectives of those involved on the basis of shared experiences, concerns, and values." - Professor Michael Parker, Chair of the working group

The pressures and distressing circumstances of emergency situations such as the coronavirus outbreak in Wuhan, China, can lead to uncertainty about what is ethically acceptable with regards to conducting research, which may mean that valuable research is impeded or that unethical practices could creep in undetected. The result of a 2-year in-depth inquiry, this report (also available in a short, summary version) from an international working group established by the Nuffield Council on Bioethics explores how research can be conducted ethically during major health emergencies and humanitarian crises.

The Council's concern with "research" encompasses a wide range of evidence-generating activities whose primary aim is to improve the health-related aspects of emergency preparedness, mitigation, and response. These include clinical trials of novel treatments and vaccines, social science research, epidemiological studies, implementation research, and health systems research, as well as less formalised ways in which data are used to improve response within the humanitarian sector.

This report makes the case for broadening the traditional understanding of "research ethics". Health-related research in many health emergencies takes place in the context of historical inequities and ongoing imbalances in power and influence, raising questions such as: Whose voices are being heard at different points in the research endeavour, and whose benefit is being considered and prioritised? What is required to promote trust between participants, researchers, and local health professionals in contexts where the grounds for such trust may be absent?

Structure of the report:

• Chapter 1 explains the broad approach taken to what constitutes a "global health emergency" and the nature of the research and other evidence-gathering activities with which the report it concerned. It also sketches out the regulatory background against which research takes place.
• Chapter 2 presents the experiences of those affected by various kinds of emergency both in leading / participating in emergency response and in participating in associated research (e.g., during the 2014-16 West African Ebola outbreak, where the issue of trust emerged as a particular theme). It then presents the experiences of researchers on the ground.
• Chapter 3 provides an overview of some of the organisational and structural factors that control and influence how research may be conducted in an emergency, with a particular focus on the role of nation states, intergovernmental organisations, and multi-country / multi-agency collaborations in emergency preparedness.
• Chapter 4 explores the ethical questions emerging from the evidence presented in these first 3 chapters and sets out an "ethical compass" to guide both policy and practice.
• Chapter 5 examines questions of power and influence throughout the research endeavour, with a focus on how the voice of affected populations and other stakeholders can be meaningfully included in determining what research takes place, where, and how.
• Chapter 6 looks at study design and review, with links to the earlier discussion of stakeholder engagement.
• Chapter 7 considers the role of the wider ethics ecosystem alongside participant consent in ensuring the fair treatment of research participants.
• Chapter 8 is concerned with ethical and effective collaborations both within the research sector, and between response and research actors.
• Chapter 9 outlines the issues that arise in sharing data and samples.
• Chapter 10 delves into the role of frontline research workers, and what might be required to ensure they are better supported.
• Chapter 11 draws together common themes across the report, with emphasis on the moral and ethical work undertaken every day by frontline research workers, health professionals, and volunteers.

The report makes 24 recommendations (to duty bearers, such as research funders, research organisations, governments, and researchers) for ways to align the policies and practices of global health emergency research with 3 core values:

• Fairness - including both duties of non-discrimination in the treatment of others, and of the equitable distribution of benefits and burdens;
• Equal respect - treating others as moral equals, including respecting their dignity, humanity, and human rights; and
• Helping reduce suffering - acting in accordance with fundamental duties, founded on solidarity and humanity, to help those in need or suffering from disease.

These values are reflected in a call for action that highlights a number of proposals, such as investing in more community engagement so that local voices can be heard and that everyone involved in research in global health emergencies is treated fairly and respectfully. ("[E]qual respect demands clear communication from research teams from the very beginning, accompanied by real commitment to start developing the relationships necessary to build two-way processes as quickly as possible. Fairness demands that those efforts include consideration of the experiences and views of marginalised parts of those communities, alongside those of more influential and powerful members.")

To elaborate a bit on community engagement, components of good practice (excerpted from Chapter 5 of the report - footnote numbers removed) include:

• "Focusing on the importance of developing mutual understanding - and recognising that this is not necessarily the same as agreement. Consensus may not always be achievable, but understanding different perspectives is a necessary part of a respectful approach. Being clear about what is not possible and avoiding promising what cannot be delivered is an essential part of developing mutual trust and respect.
• Recognising that everyone engaged in research will influence local perceptions of the research - while community engagement activities will be conducted by those with particular expertise, everyone in the research team has a part to play in creating respectful relationships...This highlights the importance of research teams investing in communications training for all workers involved in a study, hence increasing cultural sensitivity and awareness, and reducing the risk of team members inadvertently contributing to disengagement.
• Working with social scientists, using methods such as 'power-mapping', to understand power dynamics within a society and the breadth and complexity of the populations affected.....This may be particularly important at the outset, so that contracts for community engagement are appropriately allocated, taking into account that some marginalised groups may be suspicious of mediators drawn from majority groups, or the likely importance of enabling engagement with women to be led by female workers.
• Working with existing networks and structures, both in terms of those with official roles of status (for example, administrative or cultural leaders and religious leaders), and those with less formal standing who in practice can speak for, or facilitate access to, parts of the community...
• Planning upfront for practical aspects, for example around language and cost....Moreover, understanding community engagement in the context of building relationships helps explain the importance of meeting local norms of hospitality...Budgets should be flexible to enable engagement practitioners to respond appropriately to the needs that they may encounter...for example, taking a small gift when visiting people's homes...
• Using a wide variety of methods, appropriate to the setting, to reach different parts of the community and ensure diverse voices are heard (and importantly that people feel able to speak once present). A willingness to travel to remote villages as well as holding information sessions in more populated settings, offering one-on-one, focus group, and women-only discussions, producing targeted messaging and FAQs in a variety of forms, using broadcast media, jingles and songs,and text messages are all cited...
• Ensuring that iterative systems are in place to allow for what is learned in both community engagement activities, and through complementary social science research, can feed back into the research process. Genuine scope for feedback to influence research processes on the ground is essential, alongside honesty and transparency about what is not open to change...
• Recognising the essential role of the media - for example through research teams working with local and national media organisations, and with patient / survivor groups to increase journalists' awareness of science and help avoid media communications contributing to panic during an emergency..."

That said, Professor Michael Parker, Chair of the Council's working group, stresses that ensuring that research conducted during global health emergencies is ethical is not something that can be achieved by community engagement alone - or by better ethics frameworks, more coherent regulation, or independent ethical review. "These may be necessary conditions, but they are not sufficient. The successful conduct of research to high ethical standards depends crucially upon the moral and ethical work undertaken every day by front-line research workers, health professionals, and volunteers."

Click here for a short, policy-focused version of the report and its recommendations.