Explore the innovative strategies being employed by the HRA and MHRA to ensure that clinical research benefits the entire population.
The Health Research Authority (HRA) and Medicines and Healthcare products Regulatory Agency (MHRA) are collaborating to enhance the diversity of participants in clinical research. This initiative aims to ensure that research findings can improve the health of the entire population.
By including a diverse range of people, researchers can better understand the most effective treatments, devices, and care for different groups. This approach helps reduce health inequalities and ensures that everyone receives the best possible healthcare.
The UK population is incredibly diverse, encompassing various communities, groups, and individuals from different backgrounds.
To ensure that research benefits everyone, it is crucial to understand how interventions affect different groups. Including a wide range of participants in research provides valuable insights into the safety and effectiveness of drugs, devices, and information about illnesses or conditions across diverse populations.
The Importance of Inclusive Research
All members of the research team should consider how to include those who could benefit from the research, particularly people from underserved groups. Involving the people who the research is intended to help in the design stage ensures that the research is more inclusive. This principle is a cornerstone of the HRA’s strategy, emphasizing that health and social care research should be done with and for everyone.
Developing Inclusion and Diversity Guidance
The HRA and MHRA are developing a set of questions and supporting guidance for researchers to consider when designing clinical trials and clinical investigations. This initiative aims to ensure that clinical research includes people who could benefit from the findings and that underserved groups are not overlooked. In 2026, an informal consultation on the draft questions and guidance was held. The consultation is now closed, and a second draft of the questions and guidance has been published. This draft was trialed in a pilot with researchers and sponsors, and the feedback is currently being reviewed.
Collaborative Efforts and Other Initiatives
The development of the inclusion and diversity guidance involved close collaboration with researchers, public contributors, and individuals from industry, research funding organizations, and Research Ethics Committees. The HRA and MHRA have also been engaging widely with the research community to shape this work.
The HRA has launched nine new principles and hallmarks of People-Centred Clinical Research along with resources to help share them. This project involved working with members of the public, the University of Lincoln, and researchers to identify barriers and enablers to research that puts people first.
A Shared Commitment to Public Involvement in health and social care research has been made, with a focus on embedding excellent public involvement to improve the quality of research. The commitment explicitly states that efforts will be made to support improvements in equality, diversity, and inclusion in public involvement.
The UK Policy Framework for Health and Social Care Research will be updated to clarify expectations regarding the diversity of people taking part in research. Additionally, Research Ethics Committees recently participated in a debate about the inclusion of under-served groups in health and social care research.
The HRA has joined organizations across the UK medical research sector to support the development of policy and practice that fully accounts for sex and gender in biomedical, health, and care research. The Medical Science Sex and Gender Equity (MESSAGE) project aims to produce rigorous, sustainable science to reduce health inequalities. Sex and gender consideration is a key aspect of the Inclusion and Diversity Plan being developed with the MHRA.
Resources for Researchers
Several resources provide further information and good practice on diversity in research, as well as tools to support researchers. These resources are intended to help researchers understand their important role in increasing diversity in research. The INCLUDE better healthcare through more inclusive research website offers guidance and tools to support delivering research and examples of good practice. The NIHR Race Equality Framework is a tool to help organizations address inequities in health and care research. The Equality Impact Assessment (EqIA) Toolkit provides frameworks to help research teams think about how to make it easier for some people to take part in research. The NIHR RDS EDI Toolkit supports researchers in embedding equality, diversity, and inclusion in research design. The NHS Accelerated Access Collaborative provides practical insights for engaging with underrepresented groups. Trial Forge offers tools and guides to support diversity in trials.
