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Ensuring that COVID-19 research is inclusive: guidance from the NIHR INCLUDE project.
Witham, Miles D; Anderson, Eleanor; Carroll, Camille B; Dark, Paul M; Down, Kim; Hall, Alistair S; Knee, Joanna; Maher, Eamonn R; Maier, Rebecca H; Mountain, Gail A; Nestor, Gary; O'Brien, John T; Oliva, Laurie; Wason, James; Rochester, Lynn.
  • Witham MD; NIHR Newcastle Biomedical Research Centre, Newcastle University, Newcastle upon Tyne, UK miles.witham@newcastle.ac.uk.
  • Anderson E; NIHR Clinical Research Network Cluster E, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.
  • Carroll CB; NIHR Clinical Research Network Cluster E, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.
  • Dark PM; Faculty of Health, University of Plymouth, Plymouth, Devon, UK.
  • Down K; NIHR Manchester Biomedical Research Centre, The University of Manchester and Northern Care Alliance NHS Group, Manchester, UK.
  • Hall AS; NIHR Clinical Research Network Cluster E, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.
  • Knee J; Cardiology Department, Leeds General Infirmary Department of Cardiology, Leeds, West Yorkshire, UK.
  • Maher ER; NIHR Clinical Research Network Coordinating Centre, University of Leeds, Leeds, West Yorkshire, UK.
  • Maier RH; Department of Medical Genetics, University of Cambridge and NIHR Cambridge Biomedical Research Centre, Cambridge, UK.
  • Mountain GA; Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.
  • Nestor G; Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.
  • O'Brien JT; Centre for Applied Dementia Studies, University of Bradford, Bradford, West Yorkshire, UK.
  • Oliva L; NIHR Clinical Research Network Cluster E, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.
  • Wason J; Department of Psychiatry, University of Cambridge, Cambridge, Cambridgeshire, UK.
  • Rochester L; NIHR Clinical Research Network Coordinating Centre, Guy's and St Thomas' NHS Foundation Trust, London, UK.
BMJ Open ; 10(11): e043634, 2020 11 05.
Article in English | MEDLINE | ID: covidwho-913772
ABSTRACT

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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Full text: Available Collection: International databases Database: MEDLINE Main subject: Biomedical Research / SARS-CoV-2 / COVID-19 / Minority Groups Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: BMJ Open Year: 2020 Document Type: Article Affiliation country: Bmjopen-2020-043634

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Biomedical Research / SARS-CoV-2 / COVID-19 / Minority Groups Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: BMJ Open Year: 2020 Document Type: Article Affiliation country: Bmjopen-2020-043634