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Ensuring that COVID-19 research is inclusive: guidance from the NIHR INCLUDE project
  1. Miles D Witham1,2,
  2. Eleanor Anderson2,
  3. Camille B Carroll3,
  4. Paul M Dark4,
  5. Kim Down2,
  6. Alistair S Hall5,
  7. Joanna Knee6,
  8. Eamonn R Maher7,
  9. Rebecca H Maier8,9,
  10. Gail A Mountain10,
  11. Gary Nestor2,
  12. John T O'Brien11,
  13. Laurie Oliva12,
  14. James Wason9,13,
  15. Lynn Rochester2,14
  16. On behalf of the NIHR CRN INCLUDE Steering Group
  1. 1NIHR Newcastle Biomedical Research Centre, Newcastle University, Newcastle upon Tyne, UK
  2. 2NIHR Clinical Research Network Cluster E, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK
  3. 3Faculty of Health, University of Plymouth, Plymouth, Devon, UK
  4. 4NIHR Manchester Biomedical Research Centre, The University of Manchester and Northern Care Alliance NHS Group, Manchester, UK
  5. 5Cardiology Department, Leeds General Infirmary Department of Cardiology, Leeds, West Yorkshire, UK
  6. 6NIHR Clinical Research Network Coordinating Centre, University of Leeds, Leeds, West Yorkshire, UK
  7. 7Department of Medical Genetics, University of Cambridge and NIHR Cambridge Biomedical Research Centre, Cambridge, UK
  8. 8Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK
  9. 9Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK
  10. 10Centre for Applied Dementia Studies, University of Bradford, Bradford, West Yorkshire, UK
  11. 11Department of Psychiatry, University of Cambridge, Cambridge, Cambridgeshire, UK
  12. 12NIHR Clinical Research Network Coordinating Centre, Guy's and St Thomas' NHS Foundation Trust, London, UK
  13. 13MRC Biostatistics Unit, University of Cambridge, Cambridge, Cambridgeshire, UK
  14. 14Brain and Movement Group, Translational Clinical Research Institute, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK
  1. Correspondence to Professor Miles D Witham; miles.witham{at}


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.

  • COVID-19
  • statistics & research methods
  • public health

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:

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  • Contributors MW: conceptualisation, wrote first draft, critical revision and editing, approval of final version. EA, CBC, PD, KD, ASH, JK, EM, RM, GM, GN, JO, LO, JW and LR: conceptualisation, critical revision and editing, approval of final version.

  • Funding This work was undertaken as part of the INCLUDE project, which is commissioned and funded by the UK National Institute for Health Research Clinical Research Network Coordinating Centre.

  • Competing interests None declared.

  • Patient consent for publication Not required.

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

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