Trial teams need to do everything possible to make their trial relevant to the people for whom the results are intended to apply (often patients) and those expected to apply them (often healthcare professionals).
The INCLUDE Ethnicity Framework aims to help trial teams think carefully about which ethnic groups should be included in their trial for its results to be widely applicable, and what challenges there may be to making this possible. Having identified potential challenges, the trial team can then consider ways to reduce those challenges. For this to work best, the Framework needs to be used at the trial design stage before funding is in place.
INCLUDE is an initiative from the UK’s National Institute for Health Research (NIHR) that aims to improve trial delivery for under-served groups. This will improve the applicability of the trial results and be in line with Principle 13 of the Declaration of Helsinki (‘Groups that are underrepresented in medical research should be provided appropriate access to participation in research.’)
An article describing how the INCLUDE Ethnicity Framework was developed has been published in the journal Trials.
Four Key Questions and worksheets
The INCLUDE Ethnicity Framework has four Key Questions, each of which is intended to prompt trial teams to think about who should be involved as participants, and how to facilitate their involvement as much as possible. These questions should be considered by trial teams in partnership with patient and public partners.
Answering the Key Questions can be tricky. To help with this we have developed some worksheets that give pointers to the sort of things to think about when answering the Questions.
The Key Questions and worksheets can be downloaded from the links below.
The INCLUDE Ethnicity Framework
The four Key Questions and the worksheets as a single download.
How to cite: National Institute of Health Research. The INCLUDE Ethnicity Framework, 2020. Available: https://www.trialforge.org/trial-forge-centre/include/ [Accessed [insert date]].
We have prepared some examples by applying the Framework to some existing trials. These examples are intended to be illustrative and not a definitive assessment of the trials. For the most part we were not involved with the trials so only had publicly available information with which to complete the worksheets. Moreover, doing this retrospectively rather than at the design stage is not ideal.
Hopefully though they will make it easier to see how the Framework can help identify potential problems with regard to involving the appropriate ethnic groups in a trial.
We would be delighted to add your examples to this list, or receive comments on the ones already listed. Contact us at firstname.lastname@example.org.
Currently we have six examples:
- By Band Sleeve (bariatric surgery)
- COVAC 1 (COVID-19 vaccine)
- iQuaD (periodontal disease prevention)
- PRINCIPAL (COVID-19 treatment)
- RECOVERY (COVID-19 treatment)
- TriMaster (type 2 diabetes treatment)
The INCLUDE Ethnicity Framework is new and we thought some insights from people who have used it might be useful.
Slides sets and materials for presentations
Funders and others signposting researchers to INCLUDE and the Ethnicity Framework
The Chief Scientist Office, Scotland, points grant applicants to the INCLUDE Ethnicity Framework for both its Health Improvement, Protection and Services Research Committee and its Translational Clinical Studies Research Committee.
Below we list some resources which we hope you might find useful:
Developing a roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process
Participants in clinical research studies often do not reflect the populations for which healthcare interventions are needed or will be used. This article describes a multicomponent project – called INCLUDE –to improve representation of under-served groups in clinical trials.
This guidance summarises what an under-served group is, a roadmap suggesting intervention points to improve inclusion, examples of under-served groups and example barriers to inclusion. It also has examples of good practice and other resources to guide teams seeking to engage with, and improve inclusion of, under-served groups in clinical research.
Guidance for researchers to involve patient, public and community contributors in the INCLUDE Ethnicity Framework
Development of this guidance involved Patient and Public Involvement Groups based at the University of Manchester and the University of Leicester.
It was supported by the National Institute for Health and Care Research (NIHR) Applied Research Collaborations (ARCs) for Greater Manchester, and East Midlands. Groups were primarily coordinated and facilitated by Lydia Morris (University of Manchester, NIHR ARC Greater Manchester) and Nasima Miah (The Centre for Ethnic Health Research, NIHR ARC East Midlands).
This has been developed as part of the RDS’s national priority work on EDI, led by RDS East Midlands. This toolkit can be used as a resource to support your clients to respond to the National Institute for Health Research’s requirements to address EDI considerations in funding applications.
If you have any questions or would like to offer any feedback about the toolkit or experiences of using it in your advising, please email Dr Rebecca Barnes email@example.com or Dr Chris Newby Christopher.firstname.lastname@example.org
This toolkit aims to capture best practice and provide researchers with a framework on how to improve the participation of minority ethnic groups in research.
The NIHR Clinical Research Network’s COVID-19 Vaccine Research Delivery Group ran this community consultation to support the understanding and thus delivery of the COVID-19 vaccine studies.
This white paper from Couch Health– recruiting diverse populations for clinical studies – guides you through important considerations you need to make to help make the process more accommodating for everyone.
Mel Calvert and colleagues describe why those using patient-reported outcomes need to think about strategies to include underserved groups in the design, selection, use and completion of patient-reported outcomes to avoid increasing health disparities.
This work been a collaboration between Trial Forge, INCLUDE and the following networks and groups.