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The INCLUDE Ethnicity Framework

SCOPE


The INCLUDE Ethnicity Framework aims to help trial teams think specifically 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, the Framework needs to be used at the trial design stage before funding is in place. Ethnicity is a complex matter that can influence personal identity and group social relations. The specific ethnic groups that a trial should involve depends on many things, including the geographic location of the trial, and the disease or condition targeted among others.

 

WHY IS IT IMPORTANT FOR TRIALS TO BE ETHNICALLY DIVERSE?


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). Ensuring that a trial is designed so that the people in the trial reflect those who might benefit from the results, or be spared harms, is key to the potential benefits of the trial reaching all they should. However, this does not always happen due to narrow eligibility criteria, reliance on recruitment strategies that work only for some, assuming everyone has the same trust in health research, and a perception that some groups are more difficult or costly to recruit. Ethnic minority groups are often under-represented in trials despite being 1 in 8 of the UK population and frequently having most to gain clinically.  
 

The INCLUDE initiative


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.’)  Read a blog on INCLUDE– The forgotten, the ignored and the under-served – trials cannot continue to fail large parts of society. An article describing how the INCLUDE Ethnicity Framework was developed has been published in the journal Trials.  An evaluation of the Framework has been published in Trials too. Finally, our 2022 Trial Forge Guidance 3 gives practical help on how to recruit and retain participants from ethnic minority backgrounds.
 

Four Key Questions and worksheets

The INCLUDE Socioeconomic Disadvantage 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]].

Download the INCLUDE Ethnicity Framework bundle

This document provides some background to the INCLUDE Ethnicity Framework, including how we think the Framework should be used.

Download the background document

This appendix summaries the ethnic categories we use with the Framework.

Download the appendix

This document lists the development phases of the INCLUDE Ethnicity Framework and all the people involved.

Download the development phases and contributors document

EXAMPLES

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 info@trialforge.org.

Currently we have 28 examples:

  • By Band Sleeve (bariatric surgery)
  • PROSPER (breast cancer)
  • SCOT (colorectal cancer)
  • PROTECT (prostate cancer)
  • STAR-TREK (rectal cancer)
  • EXTRAS (cardiovascular)
  • OUTREACH (cardiovascular)
  • PARAMEDIC 2 (cardiovascular)
  • REACH-HF (cardiovascular; cardiac rehab)
  • SENIOR RITA (cardiovascular)
  • TOPSAT 2 (cardiovascular)
  • PRINCIPAL (COVID-19 treatment)
  • RECOVERY (COVID-19 treatment)
  • COVAC 1 (COVID-19 vaccine)
  • REPOSE (type 1 diabetes)
  • PROPELS (type 2 diabetes)
  • TriMaster (type 2 diabetes)
  • LONG LIMB (type 2 diabetes and obesity)
  • CLARITY (diabetic retinopathy)
  • WILL (maternal health)
  • ANTLER (mental health)
  • PANDA (mental health)
  • Prodigy (mental health)
  • IMPACT (mental health; psychosis)
  • REMEDY (mental health; psychosis)
  • WHELD (mental health; dementia)
  • iQuaD (periodontal disease prevention)
  • Smoking relapse prevention

The underlined trials also have recommendations on what the trial team could have done regarding the proportion of people from different ethnic groups from the STRIDE panel.

PROSPER is a UK study examining the impact of exercise in patients with breast cancer.

Download the completed Framework example

Download the STRIDE panel’s recommendations for the trial team

PROTECT is a UK trial evaluating the effectiveness of treatment for clinically localised prostate cancer.

Download the completed Framework example

Download the STRIDE panel’s recommendations for the trial team

EXTRAS is a UK trial to determine the clinical and cost effectiveness of an extended stroke rehabilitation service .

Download the completed Framework example

Download the STRIDE panel’s recommendations for the trial team

OUTREACH is a UK trial to examine if an ultra-sensitive and highly specific biochemical assay used to detect urinary biomarkers of antihypertensive treatment was superior to standard clinical care in improving clinical, behavioural, and health-economy outcomes in hypertensive patients.

Download the completed Framework example

Download the STRIDE panel’s recommendations for the trial team

PARAMEDIC 2 is a UK trial comparing the effects of administering adrenaline with the effects of not administering adrenaline to those experiencing an out-of-hospital cardiac arrest.

Download the completed Framework example

Download the STRIDE panel’s recommendations for the trial team

REACH-HF is a UK trial investigating rehabilitation enablement in chronic heart failure.

Download the completed Framework example

Download the STRIDE panel’s recommendations for the trial team

SENIOR RITA is a UK trial to investigating the benefit of medical therapy versus angiography and stenting in patients ≥ 75 years of age with heart attack.

Download the completed Framework example

Download the STRIDE panel’s recommendations for the trial team

RECOVERY is a UK platform trial evaluating treatments for COVID-19.

Download the completed Framework example

REPOSE is a UK trial comparing insulin pumps and injections in type 1 diabetes.

Download the completed Framework example

Download the STRIDE panel’s recommendations for the trial team

TriMaster is a UK type 2 diabetes treatment trial.

Download the completed Framework example

CLARITY is a UK trial evaluating a potential treatment for diabetic retinopathy

Download the completed Framework example

Download the STRIDE panel’s recommendations for the trial team

ANTLER is a UK trial examining the clinical effectiveness and cost-effectiveness of antidepressant medication in preventing relapse in UK primary care.

Download the completed Framework example

Download the STRIDE panel’s recommendations for the trial team

Prodigy is a UK trial examining social recovery therapy for young people with emerging severe mental illness.

Download the completed Framework example

Download the STRIDE panel’s recommendations for the trial team

WHELD is a UK trial aiming to improve mental health and reduce antipsychotic use in people with dementia in care home.

Download the completed Framework example

Download the STRIDE panel’s recommendations for the trial team

iQuaD is a UK community-based periodontal disease prevention trial.

Download the completed Framework example

By Band Sleeve is a UK trial evaluating three surgical procedures to treat severe and complex obesity.

Download the completed Framework example

SCOT is a UK trial studying adjuvant chemotherapy in colorectal cancer.

Download the completed Framework example

Download the STRIDE panel’s recommendations for the trial team

STAR-TREK is a UK trial investigating different treatment impact on saving the rectum in early rectal cancer.

Download the completed Framework example

Download the STRIDE panel’s recommendations for the trial team

TOPSAT2 is a European trial evaluating treatment of poor-grade subarachnoid haemorrhage.

Download the completed Framework example

Download the STRIDE panel’s recommendations for the trial team

PRINCIPLE is a UK trial for community-based treatment of COVID-19.

Download the completed Framework example.

COVAC 1 is a UK trial evaluating a potential vaccine for COVID-19.

Download the completed Framework example

PROPELS is a UK trial investigating an intervention to support physical activity in people with pre-diabetes.

Download the completed Framework example

Download the STRIDE panel’s recommendations for the trial team

LONG LIMB is a UK trial examining the impact on gut hormone changes on improving type 2 diabetes.

Download the completed Framework example

Download the STRIDE panel’s recommendations for the trial team

WILL is a UK trial examining when to induce labour to limit risk in pregnancy hypertension.

Download the completed Framework example

Download the STRIDE panel’s recommendations for the trial team

PANDA is a UK trial examining antidepressant treatment with sertraline for adults with depressive symptoms in primary care.

Download the completed Framework example

Download the STRIDE panel’s recommendations for the trial team

REMEDY is a UK trial examining switching antipsychotic medication to reduce sexual dysfunction in people with psychosis.

Download the completed Framework example

Download the STRIDE panel’s recommendations for the trial team

IMPACT is a UK trial examining physical health and substance use in psychosis.

Download the completed Framework example

Download the STRIDE panel’s recommendations for the trial team

This is a UK trial examining smoking relapse prevention.

Download the completed Framework example

Download the STRIDE panel’s recommendations for the trial team

Insights

The INCLUDE Ethnicity Framework is new and we thought some insights from people who have used it might be useful.

Katie Banister, University of Aberdeen, and one of the developers of the INCLUDE Ethnicity Framework talks about why the Framework is important, how it will start conversations with the public and patients and why it isn’t prescriptive.




Peju Oshisanya, a researcher in the pharmaceutical industry, and one of the developers of the INCLUDE Ethnicity Framework, talks about why the Framework should be a must-use tool for trialists, reducing inequalities in research, and building partnerships and trust with communities.

Heidi GardnerHeidi Gardner, University of Aberdeen, and one of the developers of the INCLUDE Ethnicity Framework talks about thinking broadly about communities, fixing the simple things and consistency.





Shaun Treweek, University of Aberdeen, and one of the developers of the INCLUDE Ethnicity Framework talks about why the Framework should be used at the design stage, working as a team and taking your time.


SLIDES SETS AND MATERIALS FOR PRESENTATIONS

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FUNDERS AND OTHERS SIGNPOSTING RESEARCHERS TO INCLUDE AND THE ETHNICITY FRAMEWORK

NIHR signposts grant applicants to INCLUDE and the Ethnicity Framework in its Stage 2 Standard Guidance for Applicants when applying for Health Technology Assessment funding.

The Belgian Health Care Knowledge Centre, KCE, signposts applicants to INCLUDE and the INCLUDE Ethnicity Framework in its Useful links & resources for investigators.

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.

The Wellcome Trust signposts applicants to INCLUDE (and therefore to the Ethnicity Framework) in its Clinical Trials Policy guidance.

The NHS Research and Development Forum includes the INCLUDE Ethnicity Framework in its resources to support health care research in the UK.

ADDITIONAL RESOURCES

Below we list some resources which we hope you might find useful:

RECRUITING AND RETAINING ETHNIC MINORITY INDIVIDUALS IN TRIALS: TRIAL FORGE GUIDANCE 3

This new Trial Forge guidance presents recommendations for designing and running trials that include the ethnic groups needed by the trial. Each recommendation comes with best practice advice, public contributor testimonials, examples of the inclusion problem tackled by the recommendation, or strategies to mitigate the problem, as well as a collection of resources to support implementation of the recommendations.

HOW TO DECIDE WHICH ETHNIC GROUPS YOUR TRIAL NEEDS

These recommendation from the Trial Forge STRIDE project aims to help trial teams grappling with how to decide which ethnic groups their trial needs.

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.

IMPROVING INCLUSION OF UNDER-SERVED GROUPS IN CLINICAL RESEARCH: GUIDANCE FROM THE INCLUDE PROJECT

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.

Download general INCLUDE guidance
Download COVID-19 specific INCLUDE guidance

UK POPULATION BY ETHNICITY

Population data from the 2021 UK census. Data are available for:

Patient reported outcome assessment must be inclusive and equitable

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.

ETHNIC INEQUALITIES IN HEALTH AND CARE SHOW DIVERSITY IN NEED AND DISADVANTAGE

A 2023 publication in the BMJ presenting data from the UK government, NHS, Office for National Statistics, and the Nuffield Trust showing wide variations across the life course. Among other things the article highlights inconsistencies in recording ethnicity in health records that affect ethnic minority groups more than white groups.

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).

INCREASING PARTICIPATION OF ETHNIC MINORITY GROUPS IN HEALTH AND SOCIAL CARE RESEARCH

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 Research Design Services (RDS) Equality, Diversity and Inclusion Toolkit

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 rb358@le.ac.uk or Dr Chris Newby Christopher.newby@nottingham.ac.uk

INCREASING PARTICIPATION OF ETHNIC MINORITY GROUPS IN HEALTH AND SOCIAL CARE RESEARCH

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.

PUBLIC PERCEPTIONS TOWARDS VACCINE TRIAL RESEARCH WITHIN ETHNIC MINORITY AND VULNERABLE COMMUNITIES

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.

COVID-19 AND ETHNICITY: WHO WILL RESEARCH RESULTS APPLY TO?

Lancet article on why it is so important for COVID-19 research to involve everyone in the community.

RECRUITING DIVERSE POPULATIONS FOR TRIALS

This white paper was produced by COUCH Health and provides some recommendations for recruiting diverse populations in trials.

FUNDING

This work has received funding from:

COLLABORATORS

This work been a collaboration between Trial Forge, INCLUDE and the following networks and groups.

Trial Forge will make trials more efficient by looking for marginal gains across all trial processes, from research question to implementation into routine care. It will encourage everyone connected with trials to be more sceptical of what we do by asking for the evidence behind all of our trial decisions.
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