Innovations in Clinical Trial Design and Delivery for the Under-served (INCLUDE)

The purpose of the guidance

The NIHR-INCLUDE Framework and Guidance are the result of a co-design process ensuring they are fit for purpose. Throughout the project we engaged with a diverse range of stakeholders across the research lifecycle which has helped us to reach the audiences NIHR-INCLUDE needed to engage with to initiate the step change in culture required to tackle inclusivity in health and care research.

Together the Guidance and Roadmap summarise what an under-served group is and suggest intervention points to improve inclusion, examples of under-served groups and barriers to inclusion. It also provided a framework of questions to guide teams seeking to engage with, and improve inclusion of, under-served groups in health and care research. NIHR-INCLUDE has achieved widespread reach and impact to make health and care research more inclusive. It informs the wider work of the NIHR and is a key cornerstone of the NIHR’s Strategy - ‘Best Research For Best Health: The Next Chapter’.

A detailed description of the work undertaken to inform these guidelines is provided in our publication:  Witham M, et al (2020) Developing a roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process.

For the NIHR-INCLUDE Guidance (General):

To cite this report: NIHR (2020) Improving inclusion of under-served groups in clinical research: Guidance from the NIHR-INCLUDE project. UK: NIHR. Available at: www.nihr.ac.uk/documents/improving-inclusion-of-under-served-groups-in-clinical-research-guidance-from-include-project/25435 (date link accessed)

For the NIHR-INCLUDE Guidance (COVID-19 specific):

To cite this report: NIHR (2020) Ensuring that COVID-19 Research is Inclusive: Guidance from the NIHR CRN NIHR-INCLUDE project. UK: NIHR. Available at: www.nihr.ac.uk/documents/ensuring-that-covid-19-research-is-inclusive-guidance-from-the-nihr-crn-include-project/25441 (date link accessed)

Find out more

To view a selection of tools and resources to help deliver inclusive research, as well as examples of good practice, please head to the NIHR-INCLUDE webpage.

NIHR-INCLUDE Ethnicity Framework

The NIHR-INCLUDE Ethnicity Framework is a tool that helps trial teams think carefully about which ethnic groups should be included in their trial, and what challenges there may be to making this possible. The site also has some examples of how to use the Framework along with other resources linked to involving different ethnic groups in trials.

Journal articles

From BMJ Open: "Ensuring that COVID-19 research is inclusive: guidance from the NIHR-INCLUDE project" (https://bmjopen.bmj.com/content/10/11/e043634)
From Trials: "Developing a roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process" (https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04613-7)

NIHR-INCLUDE Steering Group Members

 Current Members

• Prof Lynn Rochester – Project Lead and Steering Group Chair, NIHR CRN and Newcastle University
• Dr Gary Nestor – Assistant National Specialty Cluster Lead, NIHR CRN Cluster E
• Dr Shamaila Anwar - Project Manager, NIHR CRN Cluster E
• Lesley Gibson - NIHR-INCLUDE Project Coordinator, NIHR CRN Cluster E
• Dr Camille Carroll – National Specialty Lead Neurodegeneration, NIHR CRN and Associate Professor and Honorary Consultant Neurologist, Plymouth University
• Theo Christie – Business Development Manager, NIHR CRN
• Prof Paul Dark – National Specialty Lead Critical Care, Chair in Critical Care Medicine, Manchester University
• Prof Alistair Hall – Clinical Director, CRN Yorkshire and Humber
• Prof Helen Hancock – Co. Director, Research Design Service, North East
• Dr Jennifer Harris – Head of Research Policy, Association of the British Pharmaceutical Industry
• Dr Joanna Knee – Head of Research Operations, NIHR CRN
• Prof Eamonn Maher – National Specialty Lead Genetics, NIHR CRN and Professor of Medical Genetics and Genomic Medicine, University of Cambridge
• Dr Rebecca Maier – Deputy Lead, Newcastle Clinical Trials Unit
• Prof John O’Brien – National Specialty Lead Dementias, NIHR CRN and Professor of Old Age Psychiatry, University of Cambridge
• Laurie Oliva – NIHR-INCLUDE Patient and Public Involvement and Engagement Lead, and Head of Public Engagement and Involvement, NIHR CRN
• Prof Sue Pavitt – National Specialty Lead Oral and Dental Health and Professor of Translational & Applied Health Research, University of Leeds
• Prof James Wason – Professor of Biostatistics, Population Health Sciences Institute Biostatistics Research Group, Newcastle University
• Prof Jane West – Director of Public Health Research, Bradford Institute for Health Research
• Prof Miles Witham – National Specialty Lead Ageing, NIHR CRN and Professor of Trials for Older People, Newcastle University

Past Members

• Ella Anderson - NIHR-INCLUDE Project Coordinator
• Kim Down - Cluster E Manager, NIHR CRN
• Mrs Shanin Butt - PPIE Member and Patient Research Ambassador
• Prof Lynne Corner – NIHR-INCLUDE Patient and Public Involvement and Engagement Lead, VOICE Lead, Director of Engagement for FMS Newcastle University
• Professor Gail Mountain – Professor of Applied Dementia Research, Bradford University
• Mr Gareth Powell - Patient Engagement in Clinical Development Service, NIHR CRN
• Amanda Tortice – Chief Operating Officer, NIHR CRN Yorkshire and Humber
• Ms Ellie-Rose White - Patient Research Ambassador