The Health Research Authority (HRA) and Medicines and Healthcare products Regulatory Agency (MHRA) are working to help researchers to improve the diversity of participants in their research. The aim is to ensure that clinical research can improve the health of the whole population. Including a diverse group of people in research provides a better understanding of the most effective treatment, device and care for different groups of people. This information can ensure people get the best healthcare for them and so reduce health inequalities.
Why is this important?
The UK population is made up of a wide range of communities, groups, and individuals from different backgrounds. To ensure that the whole population can benefit from research, there needs to be an understanding of how interventions work on different groups of people. Including a range of people in research provides an understanding of the safety and effectiveness of drugs, devices and information about an illness or condition across different groups.
All members of the research team should consider how they can ensure that those who have the potential to benefit from the research, including people from under-served groups, are given the opportunity to take part. Involving people who the research is for and about in the design stage, will help ensure that the research is more inclusive.
Health and social care research should be done with and for everyone. This is a guiding principle of the HRA’s strategy.
The HRA and MHRA Inclusion and Diversity Plan
We are developing a set of questions and supporting guidance for researchers to consider when they design clinical trials and clinical investigations. This will help ensure clinical research is designed to include people who could benefit from the findings, and that people underserved by research are not overlooked.
We have been working closely with a group of researchers, public contributors, and individuals from industry, research funding organisations, and Research Ethics Committees to develop the questions and supporting guidance. We have also been engaging widely with the research community. We will be publishing the first version of the questions and guidance for consultation in use in 2024.
Our other work
People-Centred Clinical Research
We’ve launched nine new principles and hallmarks of People-Centred Clinical Research and resources to help share them. As part of the project, we worked with members of the public, the University of Lincoln and researchers to identify barriers and enablers to research that puts people first.
Shared Commitment to Public Involvement
We have made a Shared Commitment to Public Involvement in health and social care research and are now working with all of the partners to embed excellent public involvement, which has been shown to improve the quality of health and social care research. The commitment explicitly states that we will work together to support improvements in equality, diversity, and inclusion in public involvement. It also states that we will work together and share best practice and promote the UK standards for Public Involvement.
UK Policy Framework for Health and Social Care Research
We will be clarifying our expectations of researchers by updating the UK Policy Framework for Health and Social Care Research regarding diversity of people taking part in research.
Research Ethics Committee shared ethical debate
Our RECs recently participated in a debate about the inclusion of under-served groups in health and social care research. Read the report summary.
Resources
The following resources provide further information and good practice on diversity in research, as well as tools to support researchers.
This is not an exhaustive list of resources available, but is intended to be a starting point for researchers to understand the important role they have in increasing diversity in research.
NIHR-INCLUDE was commissioned by the National Institute for Health and Care Research (NIHR) Clinical Research Network's (CRN) to address the lack of representation in health and care research.
They have developed NIHR improving inclusion of under-served groups in health and care research: guidance from the NIHR-INCLUDE project. This guidance summarises what an under-served group is, examples of under-served groups and barriers to inclusion. It also provides a suggested framework of questions to guide funders, researchers and delivery teams as they design and assess health and care research proposals.
The website also contains a range of tools and resources to support delivering research and to act as examples of good practice. There is also more information available on NIHR's under-served communities programme of work.
This framework, co-produced by NIHR and Care Research’s Race Equality Public Action Group (REPAG), is a tool to help organisations deliver the change needed to address inequities in health and care research.
The INCLUDE project has also developed a series of frameworks to help research teams think about how they might make it easier or more difficult for some people to take part. These frameworks aim to help research teams think carefully about which groups should be included in their research for its results to be widely applicable, and what challenges there may be to making this possible.
- The INCLUDE Ethnicity Framework
- The INCLUDE Impaired Capacity to Consent Framework
- The INCLUDE Socioeconomic Disadvantage Framework
This NIHR toolkit consists of comprehensive training, useful resources, and guidance to improve equality analysis, practice and outcomes.
Highlights work being done by NIHR partners for south east of England to explore the barriers to ethnic minority group involvement in research and links to the report Reaching Out: Building relationships to increase research impact.
The NIHR Research Design Service Equality Diversity and Inclusion (EDI) Toolkit resource has been developed to support researchers to better understand how to embed EDI in research design and to meet NIHR’s EDI requirements.
This document provides practical insight for researchers on how to engage more diverse participants in health research.
Trial Forge is coordinated from the Health Services Research Unit at the University of Aberdeen and aims to look across all trial processes with the intention of trying to improve them. They have developed some tools and guides to support diversity in trials.
How to decide which ethnic groups your trial needs - Trial Forge
Including older people in health and social care research - Trial Forge