Cycle 1

Conceptual work was undertaken to identify a theory or theories of global justice from political philosophy capable of serving as the basis of a framework linking global health research to the reduction of global health inequities. To serve such a role, a theory needed to: (1) establish health-related obligations of justice that apply to actors that perform global health research, (2) provide a second-tier mechanism that allocates specific duties (toward the fulfilment of the health-related obligations) to specific global health research actors and (3) offer additional direction that can substantively guide the model of global health research.4 The reason for focussing on theories of global justice was that they ground ethical obligations between actors from different countries. Theories of global justice could thus conceivably be applied to identify the ethical responsibilities of external researchers to researchers and communities in host countries. This is important in global health research since it frequently involves researchers working in countries that they do not live in and/or of which they are not citizens. (It should be noted, however, that debate continues within philosophy over whether obligations of justice are owed to individuals outside one’s own nation-state. Cosmopolitan theorists argue that whatever the correct principles of distributive justice are, they ought to apply identically to everyone worldwide. Anti-cosmopolitans or social liberal theorists contend that certain principles of ‘humanity’ may apply identically to everyone worldwide, but principles of ‘justice’ only apply among citizens of the same state. Others take a middle position, saying that, while some principles of justice do apply globally, these principles are different and/or much less demanding than the robust (ie, ‘egalitarian’) ones that apply domestically.31 Relevant to this paper, Henry Shue and Thomas Pogge both take a cosmopolitan position and Jennifer Ruger and Norman Daniels take a middle-ground position.)

The health capability paradigm was identified as meeting all four criteria, while the other theories did not.4 Most problematically, the three other theories did not have a second-tier mechanism that allocates specific duties. They went no further than affirming that (affluent) parties worldwide owe health-related obligations to individuals in LMICs. Without second-tier principles for distributing responsibilities, these theories of justice offered little argument for why specific actors like researchers ought to act in specific ways to advance global health equity.4 In contrast, the health capability paradigm’s functional requirements principle assigns actors obligations based on their functions in the global health architecture. Clinical researchers’ functions, for example, identify them as being specifically charged with working with LMICs to (1) create new health interventions, (2) adapt existing health interventions for use, (3) strengthen their clinical research capacity, (4) provide ancillary care and (5) promote research uptake and translation.4

The health capability paradigm is a theory of global justice that extends the capability approach of Amartya Sen and Martha Nussbaum and specifically addresses health. It establishes a universal obligation to efficiently reduce shortfall inequalities in individuals’ health capabilities. The theory has several main principles (ie, justice should be assessed in terms of shortfall inequalities in health capabilities, functional requirements, priority to the worst-off, efficiency) and offers guidance on how global health justice should be promoted (direct assistance, capacity-building,shared health governance). Health capabilities refer to individual ability and freedom to achieve certain health functionings (ie, avoiding pre­ventable morbidity and mortality) and health agency (ie, being able to make effective health choices). As health capabilities are not directly observable, reducing shortfall inequalities in individuals’ health capabilities refers to diminishing the gap in their health status from the optimal level (the highest level of health achieved worldwide in terms of morbidity and mortality indi­cators). Health functionings or achievements map directly on to health capabilities, so individuals’ health status can be used as a rough proxy indicator of their health capability.32 Priority is given to addressing shortfalls in the health capabilities of those farthest from the optimal level of health.33 The functional requirements principle assigns parties obligations because the functions they typically assume make them particularly capable of fulfilling the obligations.33 The health capability paradigm applies efficiency considerations to equity goals. States and global actors should fulfil their obligation to reduce shortfall inequalities in individuals’ health capabilities using as few resources as possible.32

According to the health capability paradigm, achieving justice in health means first meeting the health entitlements of people who are worst-off in health terms in countries worldwide.33 Where nation-states are unable to ensure their own population’s health capabilities, justice requires that global actors assist states to meet their obligation and build states’ capacity to do so on their own.33 Shared health governance describes the type of governance needed to achieve global health justice and identifies five components as essential: advancing the goals of health justice, shared sovereignty, shared resources, shared responsibility and mutual collective accountability.34 35

It is important to note the health capability paradigm’s principles and concepts are consistent with other theories of justice, primarily other capability theories, cosmopolitan theories and prioritarian theories. As reported in Pratt et al,22 capability theorists, Martha Nussbaum and Sridhar Venkatapuram, have purported that all individuals are entitled to a set of basic capabilities, including health. The health capability paradigm’s focus on the worst off is consistent with other prioritarian theories of justice such as that of Madison Powers and Ruth Faden.22 Where states are unable to ensure health justice for their populations, numerous cosmopolitan theories support an obligation for external actors to improve the health of individuals in these states. The health capability paradigm calls for global actors to not only assist states to meet their obligation but also build states’ capacity to do so on their own. Other theorists’ work supports this a dual role for global actors, including Henry Shue and Iris Marion Young.22 Additionally, recent work has compared the health capability paradigm’s principles of shared health governance to those of Ubuntu, an African moral theory used predominantly in Southern African countries. That work shows that the principles of shared health governance are largely shared by Ubuntu.36

Once the health capability paradigm was selected, Research for Health Justice requirements for international basic science and clinical research were derived from it. This starting point reflected the fact that basic science and clinical research are/were the most common types of global health research being performed. Medical and clinical research had also been the primary focus of concerns of exploitation and injustice in the ethics literature9 37 and thus seemed an important target of equity-oriented ethical guidance. Elements of the health capability paradigm were applied in light of basic science and clinical research’s distinctive features. These elements include the paradigm’s requirements for health systems, the theory’s main principles and its guidance on how global health justice is promoted (direct assistance, capacity-building, shared health governance). (According to the health capability paradigm, a just health system has two main features: (1) equal access to high quality goods and services (ie, public health goods and services, healthcare goods and services and health-related social services) and (2) equitable health financing. Equal access consists of four core elements: horizon­tal equity, quality, agency and norms.32) The conceptual work applying elements of the health capability paradigm generated initial guidance on how to design basic science and clinical research to produce new knowledge that contributes to increased freedom for those considered disadvantaged and marginalised to achieve good health.19

Empirical work was next performed to test the framework’s initial guidance against the practices and experiences of those involved in equity-oriented international clinical research. The Shoklo Malaria Research Unit’s vivax malaria treatment trial was selected because, for the past 30 years, Shoklo has been consciously designing its clinical trials to meet the health needs of its host community. It conducts its research with the population of Karen and Myanmar refugees, migrants, and displaced persons living on the Thai-Myanmar border. Shoklo’s vivax malaria treatment trial aimed to describe the epidemiology and compare the efficacy of three treatments for vivax malaria—chloroquine/primaquine, chloroquine and artesunate.

For the case study, data on the vivax malaria treatment trial were collected using a triangulation approach that relied on in-depth interviews, direct observation and document analysis. Semi-structured in-depth interviews were conducted with four types of trial stakeholders—researchers, Tak Province Border Community Ethics Advisory Board members, trial participants and Wellcome Trust science portfolio advisors. Interview data were supplemented by direct observation at four of the five trial sites over a 5-week period and by an examination of trial-related documents. Data were thematically analysed.38 39 In light of case study findings, revisions to the initial Research for Health Justice framework were proposed.14 21 Major findings of Cycle 1 are reflected in the framework’s guidance on the outputs of research topic and question selection for biomedical and clinical research, the provision of ancillary care and much of the guidance on research capacity development.

Cycle 2

Conceptual work was performed to expand the Research for Health Justice framework’s guidance to health systems research. Health systems research has repeatedly been identified as an indispensable means to the goal of achieving health equity.6 7 Externally-funded health systems research is also increasingly being performed in LMICs40 and has distinctive features relative to basic science and clinical research that restrict the applicability of existing ethical guidance.41 Alternative or nuanced guidance was needed to link health systems research to the reduction of health disparities between and within countries.23

The aforementioned elements of the health capability paradigm were, therefore, applied in light of health systems research’s distinctive features.23 Additionally, in some instances, the health capability paradigm was supplemented by other accounts that considered certain matters with greater specificity. For example, the paradigm calls for inclusive, deliberative decision-making but does not describe what inclusion or deliberation entails in sufficient detail. As such, Iris Marion Young and other philosophers’ work on inclusion in decision-making in contexts of power disparities was applied to generate more specific guidance on shared decision-making in setting research agendas. Those philosophers’ work and the guidance derived from it is comprehensively described in Pratt et al (2016, p. 37-39).22 That guidance is included in the ‘research for health justice’ framework and describes who should be included in priority-setting from the research team, when research team members should participate, what being deliberative means and how the deliberative process should be undertaken (ie, that it is structured to pay attention to power disparities between participants and to ensure that LMIC participants have a greater or equal chance to speak) (see table 1, Column 3 ‘How to uphold the guidance in research practice’ for research topics and questions).

Empirical work was conducted to test the framework’s guidance for health systems research against the experiences and practices of those involved in equity-oriented health systems research in LMICs. Case study research was carried out on the Future Health Systems consortium and one of its projects: the Maternal and Neonatal Implementation for Equitable Health Systems (Manifest) project in rural Uganda. Future Health Systems was selected because it was performing health systems research to improve the equity of service delivery in LMICs, specifically Bangladesh, China, India and Uganda. The Manifest project was selected as a nested case study. It was undertaken by researchers from Makerere University in partnership with district health teams in three rural Ugandan districts. The project aimed to develop sustainable mechanisms for improving access to, and the quality of, maternal and child health services in rural Uganda. Within Uganda, a sizeable disparity in access exists between urban and rural areas. Again, case study data were collected using a triangulation approach. In-depth interviews were performed with senior Future Health Systems researchers from HICs and LMICs, junior Future Health Systems researchers from LMICs, Makerere researchers working on the Manifest project, health provider partners (district health teams) on the Manifest project, local implementing partners (village health workers, community development officers) on the Manifest project and funders (the UK Department for International Development and Comic Relief). For the nested Manifest case, interview data were supplemented by direct observation in two of the three host districts over a 2-week period and by an examination of study-related documents. Data were thematically analysed.38 39

To further test the framework’s guidance for funders, a qualitative study was done to examine how the largest health systems research funders design their grants programmes. Semi-structured, in-depth interviews were performed with 16 grants officers working for 11 funders and organisations that support health systems research in LMICs. Interviews focussed on each funder’s largest health systems research grants programme in LMICs and data were thematically analysed.38 39

In light of the three studies’ findings, ways to improve the Research for Health Justice framework’s guidance for health systems research were proposed and new conceptual work was undertaken. That work again used additional theories to supplement the health capability paradigm.25–27 29 Based on the finding that, in practice, research populations were selected due to being worst-off in terms of health or overall well-being,25 28 theories of social justice that address disadvantage and well-being (eg, the work of Madison Powers, Ruth Faden, Jonathan Wolff and Avner de-Shalit) were applied to generate more comprehensive guidance on selecting research populations based on overall levels of well-being (rather than health alone). That guidance is described comprehensively in Pratt and Hyder et al (2016)24 and is included in the Research for Health Justice framework (see table 1, Columns 2 ‘Guidance’ and 3 ‘How to uphold the guidance in research practice’ for Selecting Research Populations).

Other major findings of Cycle 2 were more comprehensive guidance on how to select research populations that are worst-off in terms of health, balancing selecting worst-off research populations with safety concerns and the outputs of research topic and question selection for health systems research. Much of the guidance presented in table 1 on creating lasting change (aside from that related to product development partnerships) and in table 2 for funders reflect Cycle 2 findings.

Cycle 3

The Manifest case raised questions about the nature of shared decision-making between academic researchers and community partners that the Research for Health Justice framework did not answer. Cycle 3 was, therefore, performed to strengthen framework’s guidance around inclusive research priority-setting with communities, particularly those considered disadvantaged or marginalised. Sharing decision-making power with such communities in agenda-setting is essential to ensure their voices and knowledge are reflected in the research topics and objectives of global health research projects. This, in turn, can help address epistemic injustice and generate research topics and objectives that are more explicitly focussed on improving access and affordability of healthcare and services for them.42 43 (Epistemic injustice occurs when those considered disadvantaged or marginalised are susceptible to unjust credibility deficits, which prevents their views from being solicited. They are not asked to provide their knowledge, opinions, thoughts or judgements.44 Epistemic justice means giving proper respect to individuals as knowers and sources of information.44)

To identify how global health research priority-setting should be designed to share power with communities, six key bodies of literature that discuss participation in contexts of power disparities were analysed for components of engagement and their associated sites of power. Sites of power are features of priority-setting (eg, ground rules, facilitation) that affect who shapes priority-setting processes, who participates and who is heard in them. The bodies of literature included development studies, political philosophy, ethics, health priority-setting, public deliberation and community-based participatory research. Conceptual work was then undertaken to identify ethical considerations related to power-sharing at each site in global health research priority-setting.45

Empirical work was next performed to explore key informants’ perspectives on what is necessary to share power with communities, especially those considered disadvantaged and marginalised, in global health research priority-setting. Here, components of engagement, sites of power and ethical considerations identified by the conceptual work were tested against the experiences and perspectives of researchers, ethicists, community engagement practitioners, community-based organisation staff and people with lived experience and members of the public who have been engaged in health research. Fifty-one in-depth interviews and one focus group were performed. Those recruited for in-depth interview came primarily from Australia, the UK and Europe, and Africa as well as, to a lesser extent, from North America, Latin America and Southeast Asia. The 13 researchers who were interviewed worked in multiple fields of health research, including genomics, clinical, public health and health systems research.

Two retrospective case studies of health research priority-setting processes, where communities were involved as partners, were conducted as well. The cases looked at priority-setting in a health systems research project in India and a public health research project in the Philippines. For each, in-depth interviews were performed on-site in Bangalore and the BR Hills (India) and Manila (Philippines), respectively, with academic researchers, community partners, field investigators from the community and community members who participated in priority-setting. Interview data was again thematically analysed.38 39

The conceptual and empirical work generated guidance on how priority-setting should be designed so that that community partners and their communities’ knowledge and voices are visible in research projects’ topics and questions.45 46 In this paper, that guidance (some published and some currently under review) has been incorporated into the ‘research for health justice’ framework. All framework guidance on how community members should be involved in the process for selecting research topics and questions is drawn from Cycle 3 findings. Guidance on scope, space, facilitation and ground rules for the process are also drawn from Cycle 3 findings (see table 1, Column 3 ‘How to uphold the guidance in research practice’ for Selecting Research Topics and Questions).