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Research for Health Justice: an ethical framework linking global health research to health equity
  1. Bridget Pratt
  1. School of Population and Global Health, University of Melbourne, Carlton, Victoria, Australia
  1. Correspondence to Dr Bridget Pratt; bridget.pratt{at}unimelb.edu.au

Abstract

Global health research should generate new knowledge to improve the health and well-being of those considered disadvantaged and marginalised. This goal motivates much of the global health research being undertaken today. Yet simply funding and conducting global health research will not necessarily generate the knowledge needed to help reduce health disparities between and within countries. Global health research grants programmes and projects must be structured in a particular way to generate that type of information. But how exactly should they be designed to do so? Through a programme of ethics research starting in 2009, an ethical framework called Research for Health Justice was developed that provides guidance to global health researchers and funders on how to design research projects and grants programmes to promote global health equity. It provides guidance on, for example, what research populations and questions ought to be selected, what research capacity strengthening ought to be performed and what post-study benefits ought to be provided. This paper describes how the ‘research for health justice’ framework was generated and pulls together a body of work spanning the last decade to provide a comprehensive and up-to-date version of its guidance.

  • health services research
  • public health
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Summary box

  • Simply funding and undertaking global health research will not necessarily generate the knowledge needed to help reduce health disparities between and within countries.

  • Drawing on the rich justice literature from political philosophy and case studies of global health research and funding practice, the Research for Health Justice framework has been developed.

  • The framework offers ethical guidance to global health researchers and funders on how to design research projects and grants programmes to promote global health equity.

  • It provides guidance on the following domains:

    • Selecting research populations.

    • Selecting research topics and questions.

    • Developing research capacity.

    • Providing ancillary care.

    • Promoting knowledge translation.

Introduction

As a matter of health and social justice, bioethicists have argued that global health research should generate new knowledge to improve the health and well-being of those considered disadvantaged and marginalised, foster their participation in decision-making about its conduct and build research capacity in low- and middle-income countries (LMICs).1–3 Here, global health research is defined as research focussed on health problems typically (but not exclusively) experienced in LMICs. It encompasses research with groups considered marginalised or vulnerable in high-income countries (HICs) as well as research in LMICs. Theories of justice from political philosophy provide grounds for the claim that global health research should contribute to reducing health disparities between and within countries.4

This is consistent with positions adopted by the Commission on Health Research for Development, at ministerial summits on health research and by the WHO.2 5–7 In 1990, for example, the Commission on Health Research for Development identified international health research partnerships as a ‘powerful tool’ to reduce health inequities between and within countries.8 Helping improve healthcare and systems for those considered disadvantaged and marginalised is an important value motivating much global health research today. Over the past 30 years, there has been an increase in funding and conduct of global health research that addresses diseases and health system problems experienced in LMICs.9

Justice, understood as advancing equity, is then a key guiding value for global health research. Theory and practice both strongly connect global health research to reducing global health disparities. Yet simply undertaking global health research will not necessarily generate the knowledge needed to help improve healthcare and systems for those considered disadvantaged and marginalised. Global health research grants programmes and projects must be structured in a particular way to generate that type of information. But how exactly should they be designed to do so?

Ethical guidance is lacking on what form of global health research is required to promote global health equity: in terms of its research populations, research questions, capacity development and post-study benefits. As such, a programme of ethics research was initiated in 2009 to develop an ethical framework to fill this gap. That work is part of broader bioethics agenda of equity and population health.10 11 In 2000, prominent bioethicists Solomon Benatar and Peter A Singer argued that “a new, proactive research ethics… must ultimately be concerned with reducing inequities in global health and achieving justice in health research and healthcare” (Benatar and Singer, p826).12 Their call to expand the scope of research ethics was reiterated1 2 13 and motivated the scholarship described in this paper.

Embedded ImageThrough the programme of ethics research, an ethical framework called Research for Health Justice was developed. The framework offers ethical guidance to global health researchers and funders on how to design research projects and grants programmes to promote global health equity. This paper describes how the ‘research for health justice’ framework was generated and pulls together a body of conceptual and empirical work spanning the last decade to provide a comprehensive and up-to-date version of its guidance. The framework’s guidance for researchers and funders is presented in tables 1 and 2, respectively. This is to provide them with the guidance in a format that is easy to follow and use in their practice.

Table 1

Research for Health Justice guidance for designing and investing in global health research projects

Table 2

Research for Health Justice guidance for designing global health research grants programmes

The framework’s guidance differs from the justice requirements articulated in international research ethics guidelines.14 This reflects the fact that Research for Health Justice and international guidelines are intended to address different objectives—namely, justice at the macro-level (reduction of global health disparities) and justice at the micro-level (distributive justice in the context of single trials), respectively. Linking global health research to global health equity entails different ethical requirements than achieving a fair balance of benefits and burdens in individual global health research projects.14

Developing the Research for Health Justice framework

The methodological approach employed to develop the Research for Health Justice framework is called reflective equilibrium. Traditionally, reflective equilibrium entails working back and forth between theoretical considerations (intuitions, moral principles, theories) and empirical facts/information reported in the literature, testing existing theoretical considerations against new ones or newly reported empirical knowledge, revising and refining until coherence is achieved.15 Reflective equilibrium as a methodology in empirical work, despite using different tools and a wider set of judgements, is continuous with reflective equilibrium in conceptual work. In empirical ethics research, reflective equilibrium entails testing theoretical considerations against information gathered from practice—namely, the considered judgements of people who are involved the practice-under-study—using empirical methods (eg, interviews, surveys, case studies).16 17 That approach was used in this project and the considered judgements it used were those of people involved in global health research: research funders, academic researchers, ethicists, community engagement practitioners, health provider research partners, community organisation research partners, study participants and people with lived experience and members of the public who had been engaged in health research.

The empirical ethics approach to reflective equilibrium constitutes a robust methodological option for developing ethical guidance informed by both theory and practice.17 The resultant guidance reflects conceptual coherence by adapting conceptual analysis in light of empirical evidence, and, where appropriate, using social and ethical theory to challenge the intuitions evidenced in the empirical data.18 To derive the Research for Health Justice framework, three cycles of reflective equilibrium were undertaken and are described below. The case studies discussed in these cycles were approved by ethics committees at research institutions in Australia, Thailand, the UK, USA, Uganda, India and the Philippines. (In Cycle 1, the Shoklo Malaria Research Unit case study was approved by the Ethics Committee of the Faculty of Tropical Medicine at Mahidol University, the Tropical Research Ethics Committee at Oxford University and the Monash University Human Research Ethics Committee. In Cycle 2, the Future Health Systems case study was approved by the Johns Hopkins Bloomberg School of Public Health Institutional Review Board and the Makerere University School of Public Health Higher Degrees Research and Ethics Committee. In Cycle 3, the interviews and retrospective case studies of health research priority-setting processes were approved by the University of Melbourne Medicine and Dentistry Human Ethics Sub-Committee, the Institute of Public Health (Bangalore) Institutional Ethics Committee and the De La Salle University Research Ethics Review Committee.)

The research programme to develop the Research for Health Justice framework was led by Dr Bridget Pratt, starting as her PhD dissertation (2009 to 2012) and then as the focus of two subsequent fellowships (2013 to 2016 and 2017 to 2020) awarded to her by the National Health and Medical Research Council of Australia and the Australian Research Council, respectively. The development of the Research for Health Justice framework has involved many collaborators and research assistants over the years. This is reflected in the authorship (and acknowledgements) of the Research for Health Justice framework publications cited in this paper and those that are currently under review. In Cycle 1, the conceptual and empirical work was conducted in collaboration with Associate Professors Bebe Loff (Monash University) and Deborah Zion (then at Monash University), who are both ethics researchers with expertise in philosophical ethics and qualitative methods. The Cycle 1 case study was conducted in collaboration with Associate Professors Zion and Loff and clinical researchers at the Shoklo Malaria Research Unit: Dr Phaik Yeong Cheah, Dr Khin Maung Lwin and Dr Francois Nosten. These collaborations are reflected in the authorship of publications emerging from this work.4 14 19–21 In Cycle 2, the conceptual and empirical work was conducted in collaboration with Professor Adnan Hyder (then at Johns Hopkins Bloomberg School of Public Health and the Berman Institute of Bioethics), who has expertise in health systems research and empirical ethics methods. This collaboration is reflected in the authorship of publications emerging from that work.22–29 In the Future Health Systems case study, it was decided that researchers from Future Health Systems and Makerere University would not be involved as collaborators to minimise the risk of conflicts of interest affecting data collection and analysis. The case study was, however, designed and conducted with their approval and support. (For case studies, it is generally left up to researchers or others from the project-under-study to decide whether they want to be collaborators or have another role.) Additionally, Dr Katharine Allen (Johns Hopkins) served as a research assistant on the Future Health Systems case study, leading quantitative data analysis and assisting with qualitative data analysis. She is a co-author on papers reporting the quantative data.30 In Cycle 3, the two retrospective case studies were conducted in collaboration with health systems researchers from the Institute of Public Health (Bangalore, India)—Dr Prashanth N Srinivas and Dr Tanya Seshadri—and public health researchers from De La Salle University (Philippines) and the University of Melbourne—Associate Professors Jesusa M Marco and Cathy Vaughan. Five research assistants from the University of Melbourne, Institute of Public Health and the University of the Philippines helped to organise and conduct data collection and to assist with data analysis. Papers from these case studies are under review or in the process of being written, but authorship includes named collaborators in each case. This paper brings the work described in those publications together and its integration was conducted by Dr Pratt.

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).

The Research for Health Justice framework

The Research for Health Justice framework aims to help global health researchers and funders systematically link their practice to advancing global health equity. The framework assumes that the value of justice is central to and should guide global health research. Justice is understood in terms of equity. It should be noted that several other concepts of justice exist and have been the focus of substantial discussion in the philosophy and ethics literatures. For example, utilitarian theories of justice emphasise maximising the greatest benefits for the greatest numbers. However, as stated in the Introduction, linking global health research to justice as equity, in particular, is grounded in both theory and practice. Nonetheless, other concepts of justice and values beyond justice are also relevant to global health research (eg, non-maleficence, utility, solidarity). The framework thus considers the intersection of its guidance with upholding other values, particularly where doing so is in tension or conflict with upholding justice as equity. For example, it recommends that, where safety concerns exist in certain regions of a host country, researchers should work with worst-off populations or communities in regions of the country where it is safe to conduct research. This guidance attempts to balance tensions between justice and non-maleficence.

The Research for Health Justice framework offers guidance on what research populations and questions ought to be selected, what research capacity strengthening ought to be performed, what ancillary care ought to be provided and what post-study benefits ought to be provided and to whom in order to link global health research to global health equity. A comprehensive and up-to-date version of its guidance for researchers and funders is described in tables 1 and 2, pulling together a body of work spanning the last decade. (In health research, ancillary care is additional healthcare beyond what is essential to the conduct of the research. It is defined as healthcare that research participants need but that is not required by sound science to successfully answer the researchers’ scientific question or to avoid or mitigate harm resulting from participation in the research.47)

Global health researchers have an obligation of justice to conduct the form of global health research articulated by Research for Health Justice. This has implications for how they design their research projects (table 1). Research funders have an obligation of justice to incentivise and invest in that form of global health research. This has implications for how they design their grants programmes, allocate their resources and manage funded projects. Table 2 provides guidance on how research funders should design their grants programmes in terms of their requirements, grantmaking principles and selection criteria. Table 1 offers them guidance on what features they should look for when selecting projects in which to invest their resources.

The Research for Health Justice framework affirms that many types of global health research are required to promote global health equity, for example, genomics, basic science, clinical, health systems and public health research, including research on the social determinants of health. So far, framework guidance has been developed specifically for basic science, clinical and health systems research. Given this, and bearing the location of the case studies informing the framework in mind, its guidance is perhaps most directly applicable to basic science, clinical and health systems research in LMICs.

Nonetheless, the framework’s guidance is still relevant and can be applied, to some extent, to other types of global health research and to global health research with marginalised groups in HICs. For example, the framework’s general guidance on selecting research populations would apply to public health research, that is, where the research findings cannot be generalised to worst-off populations within a host country, studies should focus on research populations that exhibit a sizeable gap in their health or well-being status relative to the optimal level achieved in the host country. Inclusion of such populations’ samples in genomics research would also be essential where findings would not otherwise be generalisable to them. The framework’s specific guidance for basic science and clinical research is perhaps more directly relevant to fields like genomics research and its specific guidance for health systems research to fields like public health research, including research on the social determinants of health.

At a minimum, even where the framework’s guidance is not perfectly matched to a given field of health research, it will be useful for global health researchers to think about how its guidance could be interpreted within their research. Such reflective practice can help them more systematically link their research projects to advancing global health equity.

Limitations and next steps

Significant work has been undertaken to develop the Research for Health Justice framework, and it offers global health researchers and funders robust guidance on how to link their practice to global health equity. Nonetheless, the framework is open to revisions and negotiations in light of current and future research practice, new conceptual and empirical work, and the views of additional researchers, policymakers, community members who have been engaged in health research and others. This is not uncommon for ethics guidance. Leading international research ethics guidelines (eg, CIOMS, Declaration of Helsinki) are regularly revised and updated.

There are also conceptual and empirical limitations to the work done to develop the Research for Health Justice framework that should be recognised and born in mind while using it. While the framework has been developed by applying several leading theories of justice, the theories come largely from scholars in the USA and Europe, though the health capability paradigm’s principles of shared health governance have been shown to be consistent with the African moral theory of Ubuntu.36 Future work could usefully apply principles and concepts from non-Western theories of health and global justice to develop guidance that can inform and be incorporated into the Research for Health Justice framework. It is, however, important to note that, while the conceptual work to develop the framework has relied primarily on Western theories of justice, the case studies were performed on research projects in LMICs and with a consortium with four LMIC partners (of six partners total). The perspectives of LMIC researchers, health provider research partners, community research partners, study participants, ethicists and engagement practitioners have informed the framework’s guidance through case studies and interviews.

In addition, the framework’s guidance has not been specified for genomics research and public health research, which are essential for promoting global health equity.48 In relation to the latter, principles and concepts from theories of health and social justice that focus on the structural determinants of health inequities can inform the development of guidance.49–51 Case studies of public health research, including projects focussed on the social determinants of health, are necessary too. Thus far, the framework has mainly been tested against intervention studies in clinical and health systems research in LMICs. It has not been tested against descriptive, explanatory or scale up studies, or against studies with vulnerable populations in HICs or in fragile states.

Future and ongoing work is, therefore, expanding the framework’s guidance to additional domains like genomics research.52 It is testing the framework’s guidance against cases of research practice that ask different types of research questions and that are conducted in different settings to previous cases. For example, case study research is underway with the ‘Scale-Up Diabetes and Hypertension’ consortium. Unlike previous cases, this consortium’s research relates to scaling up effective health system interventions for type 2 diabetes and hypertension. It operates in a high-income country (Belgium) and two middle-income countries (Slovenia and Cambodia).

Finally, more work is needed to further explore where the framework’s guidance is in tension with other values relevant to global health research and to develop guidance on how to balance and/or navigate those tensions.

Conclusions

The Research for Health Justice framework offers robust ethical guidance to global health researchers and funders on how to systematically design research projects and grants programmes to promote health equity. Its development has been informed by leading theories of justice and the practices and experiences of funders and researchers working across Asia and Africa. Its use can help deliver global health research with study topics and questions that more accurately reflect the healthcare and system needs of those considered disadvantaged and marginalised, that fosters such populations’ participation in decision-making about projects’ design and conduct, and that generates new knowledge that is used to help improve their health.

Acknowledgments

The author would like to thank Bebe Loff (Monash University), Adnan Hyder (George Washington University) and Deborah Zion (Victoria University), with whom the conceptual and empirical work in Cycles 1 and 2 was undertaken, for their vital role in helping develop the Research for Health Justice framework. The author would also like to thank all the collaborators (Phaik Yeong Cheah, Khin Maung Lwin, Francois Nosten, Sara Bennett, David Peters, Elizabeth Ekirapa-Kiracho, Prashanth N Srinivas, Tanya Seshadri, Cathy Vaughan and Jesusa Marco), research assistants (Natalia Evertsz, Nityasri S N, Katharine A. Allen, Jessica Snir, Michelle Walters and Mona Pindog) and participants in the interviews and case studies performed as part of developing the ethical framework. Without the rich data from global health research and funding practice, the ethical framework would be a much weaker and less applicable guidance document. The author would like to thank Jantina de Vries (University of Cape Town), Joyce Brown (UMC Utrecht), Kerstin Klipstein-Grobusch (UMC Utrecht) and Rieke van der Graf (UMC Utrecht). Our discussions and work together informed the thinking that is reflected in the Research for Health Justice framework presented in this paper.

References

Footnotes

  • Handling editor Stephanie M Topp

  • Contributors BP conceived of the work and made substantial contributions to the conceptual analysis described in this paper. BP drafted the paper and gave final approval of the version to be published.

  • Funding BP is currently supported by a University of Melbourne R Douglas Wright Research Fellowship and a Faculty of Medicine and Health Sciences Bridging Fellowship. During the course of the research described in this paper, BP was supported by an Australian National Health and Medical Research Council (NHMRC) Early Career Sidney Sax Public Health Overseas Fellowship (Award No. 1052346) and an Australian Research Council (ARC) Discovery Early Career Researcher Award (Award No. DE170100414). BP was also supported by Future Health Systems, which was funded by the UK Department for International Development, and by an Australian Postgraduate Award scholarship (2009–2012) from the Australian Federal Government and Monash University. The contents of this article are solely the responsibility of the author and do not reflect the views of the NHMRC or the ARC. The NHMRC, the ARC and Future Health Systems did not play any role in the study design, data collection and analysis, decision to publish or preparation of the manuscript.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available upon request.

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