We’ve launched an informal consultation on draft inclusion and diversity guidance we’re producing with the Medicines and Healthcare products Regulatory Agency (MHRA).
The guidance will help ensure research is designed to include people who could be impacted by the findings, and that people underserved by research are not overlooked.
We hope that this will help increase the diversity of people taking part in clinical trials and clinical investigations.
This is part of our wider work with the MHRA to update the UK’s clinical trials regulations.
We have developed a set of questions and supporting guidance for researchers to consider when they design clinical trials and clinical investigations. The answers to these questions will form the basis of an Inclusion and Diversity Plan.
Researchers can submit this plan as part of their application to Research Ethics Committees (RECs), who will use the information in the plan as part of their overall review of the application.
The questions and guidance were developed alongside researchers, sponsors, REC members and public contributors.
Tell us what you think
To help make sure we're asking the right questions, and that the guidance is easy to understand we are asking you to complete a short survey as part of our informal consultation.
The survey takes around 20 minutes to complete and is your opportunity to help ensure the guidance works for everyone.
The deadline for completing the survey is Monday 9 December 2024.
Naho Yamazaki, Deputy Director of Policy and Partnerships at the HRAOur new guidance will help researchers and sponsors to carefully consider who they will recruit into a study, which we hope will lead to more inclusive research. Including a diverse group of people in clinical trials and clinical investigations provides a better understanding of how interventions for a condition or illness work across different groups.
Our work follows similar initiatives from organisations like the National Institute for Health and Care Research and the US Food and Drug Administration. We are really keen to hear back from as many people as possible so that we can refine the questions and check that our guidance is easy to understand.
Lucy Chappell, Chief Scientific Adviser for the Department of Health and Social Care (DHSC) and Chief Executive of the National Institute for Health and Care Research (NIHR)We welcome the launch of the HRA’s informal consultation on its Diversity and Inclusion Plan with the MHRA. It is vital that health and social care research reflects the diversity of our population so that more people, including underrepresented groups and underserved communities, will be able to benefit from research. This will reduce health inequalities and ensure that everyone is able to access lifesaving treatments and care.
Dr June Raine, Chief Executive of the MHRADeveloping the consultation with HRA on the new Inclusion and Diversity Plan and supporting guidance is another example of how the MHRA puts patients first in everything we do. Encouraging researchers and sponsors of clinical investigations and trials to consider equality, diversity and inclusivity will support the representativeness of their studies and ensure medicines and medical devices can work for everyone.
This is an exciting time for clinical trials in the UK. New clinical trials regulations, to be introduced later this year, will create a streamlined, risk-proportionate and agile regulatory framework with patient involvement at the core. This well-timed consultation on inclusion and diversity provides another important opportunity to influence proposals designed to make the UK a more attractive destination for groundbreaking, safe clinical investigations and trials that will deliver both strengthened patient safety and access to new treatments.
If you have any questions about the development of the inclusion and diversity guidance please contact the HRA Policy and Engagement Team.
You can sign up for regular updates on the work we are doing on the new Clinical Trials Legislation on our website.