NIHR INCLUDE: Improving inclusion of under-served groups in health research
by Guest Author on 18 Nov 2020
With support from the NIHR Clinical Research Network (CRN), the NIHR INCLUDE Steering Group has produced both general and COVID-19 specific guidance to help make health research more inclusive. Eleanor Anderson, NIHR CRN Project Coordinator, tells us more.
The INCLUDE project was commissioned in 2017 to explore how to improve the inclusion of under-served groups in clinical research. A steering group was formed, consisting of national leaders in health research across many specialisms, including: ageing, critical care medicine, genetics, academia, patient and public involvement and engagement (PPIE), research design and delivery.
Following a series of stakeholder events, research and literature reviews, it was clear that there is currently no single definition for an ‘under-served’ group, and no single, simple definition can encompass all under-served groups. However, some key characteristics that are common to several under-served groups include:
- Lower inclusion in research than one would expect from population estimates
- High healthcare burden that is not matched by the volume of research designed for the group
- Important differences in how a group responds to or engages with healthcare interventions compared to other groups, with research neglecting to address these factors
In short, the definition of ‘under-served’ is highly context-specific. It will depend on the population, the condition under study, the question being asked by research teams, and the intervention being tested.
It became apparent that in order to ensure that health research was truly inclusive, some transparent and comprehensive guidance would be welcomed by the research community. With this in mind, the NIHR INCLUDE Steering Group is delighted to announce that the INCLUDE guidance is available, and exists in both a general and a COVID-19 specific format:
The guidance has been designed for use in conjunction with research, particularly in the early stages of setting-up. It aims to get research teams thinking about ways of making health research more inclusive and to ensure under-served cohorts are more fairly represented in health research.
What is in the INCLUDE Guidance?
This new guidance:
- Summarises what an under-served group is
- Provides a roadmap suggesting intervention points to improve inclusion
- Provides examples of under-served groups
- Gives example of barriers to inclusion
- Offers a suggested framework of questions to guide the deliberations of funders, researchers and delivery teams as they design and assess clinical research proposals
The guidance shares examples of good practice and resources to guide teams seeking to engage with, and improve inclusion of, under-served groups in clinical research.
Other INCLUDE Developments
The group recently published an article in Trials entitled “Developing a roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process“. A further peer-reviewed article linked to COVID-19 and INCLDUE is scheduled to be published in the British Medical Journal.
Steering group member, Professor Miles Witham, explains how the group will now look to build on their findings over the next 12 months by generating customised resources:
“COVID-19 has really focussed everyone’s attention on how important it is to make sure that under-served groups can take part in research – these are the groups at highest risk from COVID-19. We have developed our COVID-19 guidance using the INCLUDE roadmap, and over the next few months we will be working across NIHR and other research organisations to promote the INCLUDE guidance to researchers designing studies, teams recruiting to studies, funders and regulators”
“Each disease or condition, and each region of the country, can use the INCLUDE roadmap to create their own guidance that is appropriate for different conditions and different under-served groups. One size doesn’t fit all, but the INCLUDE roadmap allows us to start meeting the needs of each different under-served group.”
Want to find out more?
Further information can be found at the NIHR INCLUDE webpage.
For enquiries or more information about INCLUDE, please contact Eleanor Anderson, NIHR CRN Project Coordinator, at firstname.lastname@example.org.