Responsibilities for ensuring inclusion and representation in research: A systems perspective to advance ethical practices

People are increasingly moving across national borders, with 258 million international migrants worldwide in 2017. This trend is exemplified in Australian statistics, where approximately one-third of the population was identified as foreign-born in the 2016 Census. This number is high, even as compared to similar countries, and Australia is identified as having one of the largest proportions of migrants in the world. The growing diversity of the Australian population warrants increased research focused on culturally and linguistically diverse (CALD) populations; however, these populations remain severely under-represented in Australian health research.

Migrant health disparities

The literature investigating migrant health, though limited, indicates disparities when compared against the Australian-born population, especially in relation to key health concerns, mental health outcomes and health care utilisation. Migrants often experience better health than mainstream Australians on entry, which is attributed to the ‘healthy migrant effect’ given migrants must be healthy to migrate and pass immigration health assessments. However, this advantage tends to decrease with their length of stay in Australia, which is credited to the environments in which they live (e.g. greater reliance on automobiles resulting in higher levels of sedentary behaviour, marginalisation within the new environment) and acculturation processes. In Australia, as elsewhere, there are clear disparities for migrants across a wide range of health concerns, such as rates of suicide, mortality, cancer screening, obesity and the prevalence of diabetes and cardiovascular disease. The extent of these disparities can vary widely depending on migrants’ English proficiency, gender, length of stay in Australia and country of birth. Some subgroups of migrants may face unique health concerns and additional barriers to accessing services, due to histories of marginalisation and persecution.

Patterns of disparities in physical health extend to similar inequalities in the mental health of CALD populations in Australia. Certain migrant groups and people from a refugee background experience mental health conditions at higher rates than mainstream Australians. This is recognised as relating to higher rates of past torture and trauma and histories of being forcibly displaced from their homelands. However, the mental health of migrants can also deteriorate once in Australia due to the stressful challenges of acculturation and alienation. Post-migration stressors (e.g. discrimination, unemployment, social isolation) are increasingly acknowledged as playing an equally important role in influencing the mental health of migrants as pre-migration stress and trauma.

Despite known rates of physical and mental health concerns, widespread inequalities are apparent with respect to access and utilisation of Australian health care services by CALD populations. Key factors identified as inhibiting access to services include language barriers, financial limitations, lack of knowledge of health care services, limited translated health information and experiences of difficulties accessing culturally appropriate health care services. The low rates of access and utilisation of culturally competent health care services by CALD populations are contributing factors to health disparities, and efforts to evaluate systematic barriers to care and their remediation are critically needed. However, to begin to address these disparities requires a significant overhaul of the research ecosystem.

Migrant research disparities

Despite the rapid growth in diversity within Australia, there continues to be a widespread under-representation and exclusion of CALD populations in Australian health research. A review of theses investigating depression within Australia between 1990 and 2002 revealed that of the 228 relevant publications from 30 Australian libraries, only five (2.2%) focused on immigration, ethnic minority communities or language minority groups (Minas et al., 2007). Similarly, a systematic review of health literature between 1996 and 2008 revealed disparities given only 90 of the 4146 articles (2.2%) within three major Australian health publications focused on investigating CALD populations and addressing multicultural issues (Garrett et al., 2010). A systematic review of four key Australian mental health journals between 1992 and 2012 revealed only 9.7% of studies specifically considered CALD issues or included CALD populations in their sample, and 9.1% of studies reported a specific exclusion of CALD groups, typically for low English proficiency (Minas et al., 2013). The common practice of CALD exclusion due to low English proficiency also projects to Australian clinical trials. Examination of the World Health Organization International Clinical Trials Registry Platform found that, of the trials registered in Australia within a 3-month period in 2015, 21% excluded participants with low English proficiency (Stanaway et al., 2017). This repeated exclusion of low English proficient populations from health research undoubtedly propagates the lack of CALD inclusion and representation within Australian health research.

Finally, these disparities extend to research dollars. A recent study identified that migrants are disproportionately under-represented in Australian health research supported by the Australian Research Council (ARC) and National Health and Medical Research Council (NHMRC) (Renzaho et al., 2016). In their study, Renzaho et al. (2016) categorised funding initiatives into ‘people focused’, either migrant or mainstream related, or ‘basic science focused’, related to basic sciences or biomedical research. Between 2002 and 2011, 5.8% (n = 897) of ARC initiatives were ‘people focused’ and, of those, 7.8% (n = 70) were migrant related. Similarly, NHMRC ‘people focused’ initiatives constituted 3.6% (n = 447) of initiatives, and of those 6.2% (n = 28) were migrant related. The ARC contributed AUD$21.1 million (0.38%) of the total AUD$5.5 billion annual budget to migrant-related research and the NHMRC contributed AUD$4.9 million (0.09%) of the total AUD$5.6 billion annual budget to migrant-focused research throughout this period (Renzaho et al., 2016). Therefore, the disparities within the representation of CALD populations in health research is not simply by virtue of researcher discretion, but also is linked to massive gaps in research funding. This discrepancy in research support impacts the potential for research growth that affects one-third of the Australian population.

The implications of disparities

The significant under-representation and intentional exclusion of CALD populations from health research in Australia has implications for the validity and generalisability of research findings. Clinical trials and health research with participant samples that are not representative of the target population run the risk of producing findings and building a base for health policy that are not applicable to a large portion of the population. Furthermore, the direct exclusion of participants due to low English proficiency, when there are cost effective solutions to overcoming language barriers, introduces ethical implications. The evident health disparities between CALD populations and mainstream Australians can only be addressed by policy change within the research ecosystem to increase inclusion and representation of CALD populations in health research. Health and research disparities have been highlighted for decades, yet little progress has been made. We advocate that ethical frameworks and review processes offer an additional point of leverage to facilitate change and advance more equitable practices.

Ethical frameworks to guide inclusion

The National Statement on Ethical Conduct in Human Research 2007 (Updated 2018) was jointly written by the NHMRC, ARC and Universities Australia (UA) and addresses the regulatory and ethical mandates for research supported by the groups, which constitutes a significant proportion of Australian research. It explicitly states that for research to begin and for funding to be released, the study must meet the stated requirements and be deemed ethically acceptable by a Human Research Ethics Committee (HREC). In order to be ethically acceptable, the research must be evaluated on merit and the researchers involved in leading the endeavour deemed to have integrity. Moreover, the research plan must align with the values of respect, beneficence, and distributive and procedural justice. An expectation of the National Statement is that these values will be incorporated within the research design, review and implementation phases.

Specific to the value of justice, the National Statement supports research that considers the ‘fair distribution and the benefits and burdens of research’ (p. 9) and recruitment protocols that are inclusive of participants most likely to benefit from knowledge gained. With regard to beneficence, the focus is on evaluating the risk of harm against the potential benefits to those who are represented by participants as well as society at large. The domain of respect cuts across all values with a goal of considering research participants as well as the societal collective and the diversity of beliefs, customs and culture. The National Statement leaves no doubt that the entities involved in creating an ethical research ecosystem (e.g. NHMRC, ARC, UA) are committed to promoting responsible research practices involving human participants. However, the mounting evidence leaves questions about how or whether the values of merit, justice, beneficence and respect are operationalised when approving research. Moving forward, we make the following recommendations for consideration by funders, institutions, HRECs, researchers and research participants.

We first acknowledge that the research ecosystem, like most systems, is complex and there are likely many factors that impact the decisions that have led to the disparities described in this paper. In systems theory, the social ecological model consists of identifying influencers from the individual to societal and policy levels and recognises that ‘behaviours’ (for an individual up to the systems level) are influenced by interdependent relationships between levels. With the ecological model in mind, we propose a holistic approach to addressing the CALD research disparities problem, and rather than focus on a single level of influence, we have identified policy, funders, institutions, HRECs, researchers and citizens who may become research participants.

The recommendations that follow are a starting point for further conversation only and are not empirically informed nor comprehensive. Many recommendations have been made previously that emphasise the need for more research with CALD populations, representative national samples, equitable funding and the implementation of policies stipulating variables relevant to CALD populations to be included in research (e.g. Minas et al., 2007, 2013; Renzaho et al., 2016). However, concerns remain regarding how to move beyond awareness of disparities into substantive change. The National Statement and ethical review process provide important, but seemingly underutilised mechanisms to enforce core values around merit, justice, beneficence and respect.

Policy

The National Statement clearly requires that the benefits and burdens of research be fair in distribution. The problem is not policy, but the operationalisation of policy in practice. Requiring that ARC, NHMRC and UA support institutions implement the regulatory and ethical mandates of the policy through audits may be an initial first step. Aspirational targets for increasing representation and action plans to meet those targets would provide important first steps in shifting common practice. Such targets will require simultaneous shifts in the competence of researchers but also representation of diverse populations within research teams as the harm of shifting practice without requisite skills and respect for diverse populations may undermine any benefits from such changes.

Funders

An obligation of funding organisations is to ensure that proposals are inclusive of CALD populations. Moreover, funders could implement requirements that proposals address explicitly a rationale for non-inclusion that are not tied to additional costs of inclusion. Funders can encourage inclusion of CALD groups by allocating additional funding to support the potential additional costs associated with translation of documents and bilingual/bicultural team members. Including researchers on review panels who are diverse and have inclusive research programmes would ensure that methodologies to engage diverse populations are feasible, appropriate and given weight in the review process.

Institutions

Institutions are best placed to recognise their local communities and to evaluate whether research portfolios are matching the people and needs of their context. Federal policies cannot be dogmatically applied across contexts given every locale is unique in its demography and culture. Local institutions therefore retain responsibilities for reviewing and monitoring their portfolios at a systems level. Goals and action plans can provide a starting point for shifting practice at an institutional level.

HRECs

Ethics Committees play an integral role in ensuring individual protocols meet the ethical mandates outlined within the National Statement. Attention to the benefits and risks of inclusion must be weighed to ensure the values of respect, beneficence and justice are enacted within research protocols. New templates, guidelines and training for researchers and ethics committee members may be needed to ensure the requisite resources, skills and knowledge are available within the local research system. Representation of diverse populations within Ethics Committees is essential and should be reviewed within HRECs.

Researchers

Given the rapid shift in demography in an Australian context, further training and supports are essential for ensuring research teams are able to implement ethical, responsible and socially responsive health research. Efforts to shift training programmes to provide the skills, knowledge, and sensitivities involved in research engaging diverse populations are needed. Further bolstering representation within research and higher education more generally plays a critical role in increasing capacity for culturally safe practices.

Citizens

As citizens are in the greatest position to comment on the needs, strengths and concerns of their community, an increase in the involvement of the public throughout the research process should be a priority. The education of citizens regarding their potential for and the process of engaging in or leading research will facilitate community involvement in prioritising the research agenda. Efforts to increase funding for community engagement in research will allow citizens to be actively involved in co-designing research and contributing to the decision making that affects public health, thus enhancing the relevance and value of Australian research.

Conclusion

The vast under-representation of CALD populations within Australian health research compromises the generalisability of research findings and produces ethical implications relating to the values of merit, justice, beneficence and respect. Recommendations to address the lack of CALD inclusion within Australian research must begin with inclusion of diverse populations within the research ecosystem, including in higher education, research training programmes, leadership positions, funding bodies and review processes. Furthermore, it must include regulation of the operationalisation of policy, with targets for increasing representation for funding bodies, institutions, HRECs and researchers, and mechanisms to ensure this is done through culturally safe practices. Only with a holistic change within the research ecosystem, to encourage and facilitate CALD inclusion, will health research be representative and capable of meeting the needs of Australia’s diverse population.