How can we ensure that Australia’s priorities in health research benefit those in greatest need?

The COVID-19 pandemic served as a magnifier for many harsh realities of the world today. In relation to health research, it highlighted imbalances around who controls and sets health research agendas, and who benefits from them. High-income country research funders control the money and thus the research agenda, but their allocation of funding does not correlate with current levels of disease burden or the level of risk posed by infections with pandemic potential. Their allocation of funding also disproportionately responds to the health needs of the well-off relative to the health needs of the most vulnerable worldwide.

This, however, is not a new development. These gross imbalances have existed for decades because “the asymmetry of power and voice is a design feature of the system, not a bug”. And that is precisely why the World Health Organisation (WHO) released its first-ever guidance on the ethics of health research priority setting.

Better late than never, the guidance has the potential to reorient health research funders, research institutions and researchers towards designing their priority-setting processes to avoid reinforcing such imbalances and to better advance justice and equity in health. To do that, certain ethical considerations must be built into both the process through which priorities are set and the outcomes of that process. Those ethical considerations are laid out in the WHO guidance.

Worrying trends in health research priority setting

Health research priority setting is a process whereby decisions or recommendations are made about what health research questions or areas should be financially supported or conducted. It is carried out regularly by several different types of actors. Every few years, national or transnational bodies identify priority research areas for their country or globally respectively — one example is the Australian government’s National Science and Research Priorities.

Likewise, research funders set priorities when they undertake strategic planning, design grants programs, or allocate funding to specific research projects — such as when the Australian Medical Research Advisory Board sets the priorities of the Medical Research Future Fund. Research institutions undertake priority setting when they conduct strategic planning or allocate internal resources to specific research projects. The University of Melbourne’s “Grand Challenges” strategy, for instance, identifies three key areas of investment. Additionally, researchers and community organisations set priorities when they make decisions about what research questions or areas of focus to look at in their research projects.

Within health research priority setting, we often see imbalances when it comes to who controls or decides on priorities and who benefits from them. In relation to who controls, we see expert-driven, politics-driven and/or high-income country-driven health research priority setting processes. In the United States, for example, health research priority setting is currently highly politics-driven, with HIV, climate science and equity focused research under severe threat. These types of research generate knowledge that has the potential to benefit the most vulnerable. Thus, who controls more often than not has implications for who benefits and who doesn’t.

In relation to who benefits, we also see instances where the research priorities set fail to align with national or global burdens of disease, or where the research priorities are strongly disease-driven and fail to engage with cross-cutting issues related to health systems or the social determinants of health. Importantly, the full benefits of new and existing technologies cannot be equitably realised in practice without investment in research on health systems and the social determinants of health.

If we look to the US National Institutes of Health (NIH), for instance, its funding for biomedical and clinical research far outweighs its funding for health services research. Hence the finding that, in global health research, funding “has consistently privileged diseases over systems, the status quo over emancipatory structural change, a quest for novel universal truths over locally useful knowledge”.

Australia is not immune to these concerns. While there is public consultation around the development of the priorities of the Medical Research Future Fund (MRFF), not enough has been done to ensure active patient and public involvement in all MRFF processes and decision making. The disability burden of non-fatal disease is not reflected in the allocation of MRFF grants. Moreover, the Indigenous Health Research Excellence Criteria of the National Health and Medical Research Council (NHMRC) have been criticised for emphasising Indigenous engagement and benefit rather than Indigenous knowledges and control. This raises the specific concern that what is funded may generate racialised knowledge rather than knowledge that actually benefits Indigenous Australians. Like the NIH, the NHMRC grants far more money to biomedical and clinical research than other types of health research.

Why these trends constitute injustices

Concerns about who controls/decides and who benefits are ultimately concerns about justice. Why? To put it simply, the former has to do with reducing unfair power dynamics and ensuring inclusion, and the latter relates to securing health and wellbeing for everyone, especially those considered disadvantaged.

According to some philosophical accounts, just societies should achieve certain ends, including reducing unfair power dynamics and ensuring inclusion. Unfair power dynamics are morally problematic because they create an uneven playing field where some members of society have to work much harder than others to achieve a decent life — like running a race with heavy ankle weights on against others who don’t have to wear them.

Several types of power dynamics create playing fields where social rules and norms favour some over others. Relevant here are subordination — where decision-making is controlled by a handful of elites within a given society or globally — and coloniality — where decision-making silences or ignores the knowledge and ideas of Indigenous or other colonised peoples. Inclusion means ensuring those affected by a given decision meaningfully participate in the decision-making process. Those affected have the right to be present or represented (in diversity and numbers), to raise their voices (spoken, written or drawn) and to be heard.

Expert-driven, politics-driven and/or high-income country-driven health research priority-setting processes reinforce subordination and the exclusion of many of those affected by health research from decision-making, which then generates priorities that likely do not adequately encompass low and middle-income country, patient and/or community concerns. When patients and the public are consulted as part of expert-driven research priority-setting efforts, whether their voices are heard depends entirely on what “experts” — namely, the decision-makers — do with the information generated from the consultations.

Where Indigenous peoples are excluded from meaningful participation as decision-makers and the selection criteria used to assess grant applications do not require Indigenous health research projects to “respect and value Indigenous knowledges”, this reinforces coloniality — because Indigenous peoples’ voices and knowledge are silenced or devalued in both the process through which priorities are set and the outcomes of that process.

Just societies should also secure a sufficient level of health and wellbeing for members of society, especially for those considered disadvantaged. That requires ensuring equal access to high-quality public health measures, high-quality healthcare and services and the social determinants of health.

Decisions about what research to support or conduct are, at their heart, decisions about how to allocate a scarce and valuable social resource. Just as the allocation of health care resources — like organs and ventilators — influence the distribution of health and illness, so do decisions about the allocation of health research resources. Whether a sufficient level of health is secured and for whom depends, in part, on what health research has been prioritised and performed.

Where the health research being funded and carried out does not align with a country or a particular group’s disease burden — such as people living with disability — diagnostics, vaccines and medicines are less likely to be developed for a certain national or sub-national population’s common health conditions. And where health systems research is poorly funded, a country will not generate the knowledge needed for its health system to efficiently, effectively and equitably deliver and finance new medical interventions. An implementation gap will arise.

Finally, where health research generates racialised knowledge, it reinforces racial biases in our health knowledge, which then informs our healthcare systems. When healthcare systems are racist, they advantage the white population and disadvantage racial and ethnic minority populations, which in turn worsens health disparities. Similarly, whether global health disparities are reduced — and global justice promoted — depends in part on what global health research is prioritised and whether it generates knowledge that can improve healthcare and health systems for the most vulnerable.

How the WHO guidance helps

To help avoid priority setting that reinforces unfair power dynamics in decision-making and does little to reduce health inequities, certain ethical considerations are essential — such as following fair procedures, optimising social value and assessing risk. These considerations and their implications for research priority setting are laid out in the new WHO guidance.

I, along with six others — from Chile, India, the United States, the UK, South Africa and Ghana — comprised the group responsible for writing that guidance over the past two years. As part of that process, we shared and got feedback on the guidance from many different individuals and organisations globally and ran an online public consultation.

Follow fair procedures

The priority-setting process should be accountable, transparent and inclusive. Achieving inclusivity requires considering who should be included and how at each stage of priority setting — when planning it and when running it. It is especially important to do so for the planning stage, because that determines who leads the priority-setting process.

In terms of who to include, the guidance suggests consideration should be given to whether there is sufficient diversity and numbers of participants in each of the following categories:

• research producers — such as funders and researchers;
• research users — such as clinicians, nurses, healthcare managers and policy-makers;
• research beneficiaries — such as patients, carers and members of the public.

In terms of how to include participants, the guidance affirms:

meaningful inclusion occurs when participants are able to raise their voice and be heard. The amount of influence participants have depends on when they enter the priority-setting process and their level of participation. They have greater say when included earlier and at a higher level …

— which is to say, as decision-makers rather than consultants. Particular attention should be paid to including members of disadvantaged and marginalised groups in ways that give them meaningful opportunities to speak and be heard.

By requiring a diverse range of participants — including relevant patients, carers and/or members of the public, in sufficient numbers — the guidance helps avert expert-driven, politics-driven and/or high-income country-driven health research priority-setting processes. Consideration of who is included and how they are included when selecting the leadership group running a priority-setting process, as well as the participants in the process, supports the meaningful inclusion of Indigenous populations when setting priorities that affect them.

Optimise social value

Every priority-setting exercise involves comparing research options and priorities using some set of criteria. According to the WHO guidance, the criteria used should correspond to the three components of social value:

• the likelihood that the research will produce knowledge that will lead to health and wellbeing benefits for patients and populations;
• the magnitude of the health and well-being benefits if they were to result;
• the extent to which providing those benefits would reduce inequity.

The second of these criteria would thus take account of the burden of different diseases in a given country and help align research priorities more in accordance with them.

The third criterion would take account of to whom different research options would generate benefits and whether those individuals deserve priority as a matter of justice. It would, in effect, give added weight to research that benefits populations that experience disadvantage or marginalisation. For that reason, it can help address the skew in MRFF priorities away from the diseases that burden those living with disability. 

The WHO guidance also notes that different kinds of health research will generally require different criteria (corresponding to the three components of social value) to evaluate their social value. This is to avoid different types of health research being privileged over others when assessing social value and would help address uneven funding allocations to biomedical and clinical research. Where particular criteria are used to evaluate the social value of Indigenous health research, it would help address the risk of allocating funding to projects that reinforce racialised knowledge.

The WHO guidance further affirms:

in developing criteria, care should be taken to minimize the risk of epistemic injustice. Epistemic injustice occurs when individuals or groups are treated wrongly as potential sources of knowledge. This may be because they are treated as less credible (testimonial injustice) or because their experiences are not recognized in the dominant conceptual schemes used by science (hermeneutical injustice). More general information should not automatically be preferred to more locally relevant information.

This means that the criteria used to compare research options and priorities should value Indigenous knowledges equally to non-Indigenous knowledges. When setting priorities for both Indigenous health research and health research not specifically focused on Indigenous populations, research options that use Indigenous theories, concepts and research methodologies should then not be devalued by the criteria relative to options that use traditional Western theories, concepts and research methods.

Assess risks

When setting research priorities, any reasonably predictable harms from research priorities and options to populations who are not potential beneficiaries of the research should be assessed, minimised and justified. These include harms imposed on non-human animals during the course of research and potential harms generated by the research results themselves — such as reinforcing prejudices or generating serious environmental damage. There are times that some research should not be prioritised because the harms from its results are too high.

This consideration, in part, means assessing the risks of the findings of different research options to groups. If research options are likely to generate racialised knowledge, for example, that could be considered a harm that is too high.

Implications for Australian health research

The new WHO guidance is significant, then, for Australian health research. It calls for our funders, researcher institutions and researchers to think critically, when setting health research priorities, about:

• whether their priority-setting process achieves sufficient diversity and numbers of research producers, beneficiaries and users;
• whether their priority-setting process is designed to ensure all participants feel comfortable sharing their ideas and can influence decisions made about research priorities;
• whether their priority-setting process is transparent and accountable; 
• whether their selection criteria account for not only the magnitude of benefits but also the equity effects of the knowledge generated by different research priorities;
• whether their selection criteria privilege certain types of health research or certain forms of knowledge — such as non-Indigenous knowledge — over others;
• whether the research options they are considering could generate harms to humans or nature through their results.

In addition, these ethical considerations can be used as benchmarks against which to analyse current practices. If, as the WHO guidance states, governments, health research funders, research institutions and researchers have “an ethical obligation to set research priorities in a rigorous, ethically defensible way”, it is important that they be held accountable for doing so.

It is also important to note that the WHO guidance does not totally fix the power asymmetries in health research. For example, the fair procedures consideration supports Indigenous researchers and individuals being part of leading processes to set priorities for Indigenous health research and deciding on the final set of priorities. But it does not clearly call for putting Indigenous peoples alone in the driver’s seat of Indigenous health research priority-setting.

At the same time, given that resources for health research are shrinking and inequalities are widening in Australia — and, indeed, globally — it is especially important to ensure control and benefits of health research do not disproportionately accrue to those already well-off within our society. The new WHO guidance can help us do that.

Bridget Pratt is an ethics researcher and the Mater Associate Professor in Healthcare Ethics at Queensland Bioethics Centre at Australian Catholic University. She is an honorary in the School of Population and Global Health at the University of Melbourne.