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Ensuring that COVID-19 research is inclusive: guidance from the NIHR INCLUDE project
Miles D Witham1,2, Eleanor Anderson2, Camille B Carroll3
1NIHR Newcastle Biomedical Research Centre, Newcastle University, Newcastle upon Tyne, UK miles.witham@newcastle.ac.uk.
Insights
Ensuring inclusive COVID-19 research is vital for equitable health outcomes. This guidance helps researchers engage under-served populations, addressing historical inequities in clinical research participation.
Area of Science:
- Public Health
- Clinical Research Methodology
- Health Equity
Background:
- COVID-19 disproportionately affects various under-served groups, including older adults, ethnic minorities, and individuals with chronic conditions.
- These populations have historically been under-represented in clinical research, limiting the generalizability of findings.
- There is an urgent need to improve inclusivity in COVID-19 research to generate evidence relevant to all affected communities.
Purpose of the Study:
- To provide guidance for researchers, funders, regulators, and study teams on conducting inclusive COVID-19 research.
- To ensure research actively includes groups disproportionately impacted by COVID-19 and historically under-served.
- To offer a framework and checklists for designing and delivering inclusive research projects.
Main Methods:
- Development of a framework and checklists based on the National Institute for Health Research (NIHR) INnovations in CLinical trial design and delivery for the UnDEr-served (INCLUDE) project roadmap.
- Emphasis on community engagement, co-development of research priorities, and representation of under-served groups on review committees.
- Recommendations for minimizing exclusion criteria, simplifying intervention delivery and outcome measures, and tailoring approaches for specific communities.
Main Results:
- Key strategies include strong community engagement and co-prioritization of research questions.
- Under-served groups should be represented on funding and ethics panels, which must address participation barriers.
- Exclusion criteria should be minimal, with flexible and tailored intervention delivery and outcome measurement.
Conclusions:
- Inclusive COVID-19 research is essential for benefiting all communities.
- Achieving inclusivity requires engagement with under-served groups throughout the research lifecycle—from topic selection to dissemination.
- Attention to study design, delivery, analysis, and dissemination is crucial for equitable research outcomes.
Objective:
To provide guidance to researchers, funders, regulators and study delivery teams to ensure that research on COVID-19 is inclusive, particularly of groups disproportionately affected by COVID-19 and who may have been historically under-served by research.
Summary Of Key Points:
Groups who are disproportionately affected by COVID-19 include (but are not limited to) older people, people with multiple long-term conditions, people with disabilities, people from Black, Asian and Ethnic minority groups, people living with obesity, people who are socioeconomically deprived and people living in care homes. All these groups are under-served by clinical research, and there is an urgent need to rectify this if COVID-19 research is to deliver relevant evidence for these groups who are most in need. We provide a framework and checklists for addressing key issues when designing and delivering inclusive COVID-19 research, based on the National Institute for Health Research INnovations in CLinical trial design and delivery for the UnDEr-served project roadmap. Strong community engagement, codevelopment and prioritisation of research questions and interventions are essential. Under-served groups should be represented on funding panels and ethics committees, who should insist on the removal of barriers to participation. Exclusion criteria should be kept to a minimum; intervention delivery and outcome measurement should be simple, flexible and tailored to the needs of different groups, and local advice on the best way to reach and engage with under-served communities should be taken by study delivery teams. Data on characteristics that allow identification of under-served groups must be collected, analyses should include these data to enable subgroup comparisons and results should be shared with under-served groups at an early stage.
Conclusion:
Inclusive COVID-19 research is a necessity, not a luxury, if research is to benefit all the communities it seeks to serve. It requires close engagement with under-served groups and attention to aspects of study topic, design, delivery, analysis and dissemination across the research life cycle.
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