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Is your research inclusive?

This page explains how we can help commercial sponsors of research to embed an inclusive approach when designing and delivering health and care research in the UK.

Why is it important to ensure your research is inclusive?

The NIHR is committed to equality, diversity, and inclusion (EDI). Through our services and support, most of which are free of charge, we can help commercial research sponsors to adopt inclusive approaches at different points along the research pathway.

For all research, it’s important that participant cohorts are reflective of the country’s demographics so study results can be extrapolated to the wider population. Different groups of people may respond differently to an intervention due to differences in physiology or disease state. Studying the effects of an intervention in a range of groups is essential to generate robust and reliable safety and efficacy data.

Being able to clearly demonstrate that your research has been designed and delivered with EDI in mind will also help to ensure your research progresses smoothly through the different stages of the research pathway, resulting in faster adoption of new treatments into health and care services. For example:

  • When seeking research regulatory approval: Research regulators require research teams to ensure that people who have the potential to benefit from the research have an opportunity to take part. This includes people from underserved groups. A new HRA and MHRA Inclusion and Diversity Plan with guidance for researchers will be available in 2024.
  • When your study is underway: An inclusive recruitment strategy needs to consider potential barriers to participation for different groups and how to overcome them. This approach will help your research to meet recruitment targets within planned timescales, and may also improve retention rates.
  • Market access - seeking approval for use in health and care services: In the UK the National Institute for Health and Care Excellence evaluates treatments and health technologies for use in the NHS. If there is a lack of safety or efficacy evidence for a particular group or sub group, your product is unlikely to be approved for use in that group.
  • Adoption and dissemination: Your research findings provide part of the evidence necessary for decision-making by clinicians and patients. If clinicians lack evidence of the impact of an intervention in a particular group, they may be reluctant to offer the intervention to that group.

What do we mean by EDI in research participation?

EDI is multifaceted. As well as encompassing aspects of diversity often associated with categories of personal characteristics that are protected by law, EDI should be considered more broadly in the research participation context.

A truly inclusive approach will aim to ensure that as many people as possible have opportunities to take part - especially those who have the potential to benefit from the research. This means ensuring that people are not excluded for reasons such as:

  • where they live - can they easily travel to a trial site within a reasonable timescale?
  • their income - can they afford the upfront travel expenses to attend a research site and wait to be reimbursed?
  • their availability - can you offer appointments outside of working and school hours?

In the UK, the NIHR and other research organisations have adopted the term ‘underserved groups’. This term reflects the view that the research community needs to provide a better service for people in these groups.

How we can support you to make your research more inclusive

It is essential to explore EDI questions and opportunities in the planning stage of your research, before you submit your protocol for regulatory approvals. This will help to avoid the need for protocol amendments, which will delay the delivery of your research. We can also support you as you progress along the research pathway to ensure your approach remains inclusive.

Study planning

Guidance from the NIHR INCLUDE project

Read our guidance on improving inclusion of under-served groups in clinical research. It summarises what an underserved group is, suggests intervention points to improve inclusion, and provides examples of underserved groups and barriers to inclusion. It also provides a suggested framework of questions to guide researchers and delivery teams as they design research proposals. It ends with examples of good practice and additional resources.

Engage directly with patients to improve your trial design

Involving people with lived experience of a condition in the early stages of your research journey can help identify EDI challenges and creates an opportunity to explore solutions. We can organise and facilitate engagement activities with patients to get their perspective on your draft trial protocols, recruitment strategies and patient-facing materials. Learn more about our Patient Engagement in Clinical Development Service. (This is a paid for service operating a full cost recovery model).

Smaller companies and enterprises working with specific NIHR-funded facilities to develop a research project or protocol may prefer to seek patient input via the NIHR team you are working with.

Study placement

An inclusive approach to site identification

Our site identification service will help you to find and engage the right sites for your research. It is the only UK-wide site identification service. By using this service you are helping to distribute research equitably; you are providing an opportunity for all sites, nationwide, to express their interest in bringing your research to their patients. This inclusive approach helps ensure that the people taking part in your clinical trials are representative of those most in need. You can still use this service if you have already identified some, but not all, of your sites. Read a related article on the PharmaTimes website: Right time, right place, right research.

National Contract Value Review (NCVR)

NCVR is the UK-wide standardised, national approach to costing and contracting for commercial contract research. NCVR supports better distribution of research across the UK. It incorporates equity of access elements, such as population diversity and coastal rurality factors, into the NCVR processes and tools. As a result, sites that may not have been on a sponsor's radar previously, now enjoy better visibility and offer opportunities to reach different patient populations. Learn more about NCVR on our website. Read a related article about NCVR on the Pharmaphorum website.

Study delivery

Delivering research beyond the hospital

Our research delivery support is not limited to health and care settings. Through our Direct Delivery Teams we have developed the capability to support research in other settings such as prisons, schools and people’s homes. This offers unique opportunities to engage underserved groups.

These regional teams comprise highly skilled, experienced and forward-thinking professionals who are committed to innovating and path-finding non-traditional approaches to research delivery. By developing new, flexible ways of working and adaptable models for deploying research delivery support, these specialist teams can span organisations, care settings, medical specialties and even geographies. They are not tied to a specific site or therapeutic area. Instead, they respond to local research delivery needs as they emerge. Learn more about how we help life science companies deliver research beyond the hospital.

Dedicated Patient Recruitment Centres

Our Patient Recruitment Centres (PRCs) are the first family of NIHR-funded research facilities that are 100% dedicated to delivering commercial research. They also have the ability to recruit participants beyond specialist hospital clinics and offer distinct opportunities to access diverse patient populations in areas of high disease prevalence. Learn more about our Patient Recruitment Centres.

Related content

Webinar: EDI in clinical research: The case for adaptive strategies at every step

In this webinar (recorded 30 January 2024) a panel of experts delves beneath the surface of EDI in research. They examine common obstacles in offering equal participation opportunities in the UK and explore examples of good practice and solutions to EDI challenges.

NHS England guidance on increasing diversity in research participation

This document provides practical insights for researchers on how to engage more diverse participants in health research. Visit the NHS England website to access: A good practice guide for engaging with underrepresented groups.