New inclusion and diversity guidance pilot

Jump to: Take part in the pilot for the updated Inclusion and Diversity Plan

Background

In September 2024 the Health Research Authority (HRA) launched an informal consultation to ask for feedback on the first draft of their newly developed guidance for how to develop an Inclusion and Diversity Plan.

This is part of their work with the Medicines and Healthcare products Regulatory Agency (MHRA) to update the UK’s clinical trial regulations.

Whilst there will be no legislative changes for inclusion and diversity as part of the regulatory reforms, it was agreed by the government that this was best addressed through guidance.

As a result, they are working to develop accompanying best practice and supporting guidance to help researchers design more inclusive trials.

The Inclusion and Diversity Plan is a document to be developed by sponsors and researchers when planning a clinical trial or investigation.

Developing a Plan using the set of questions in the guidance will help researchers consider and demonstrate how they will include a diverse range of people that is relevant for their trial.

They hope the Plan will also help Research Ethics Committees (RECs) to understand the justification for decisions researchers have made about who to recruit into their trials, inform their understanding of the overall application and support discussions at the REC meeting.

The response to the consultation

The aim of the informal consultation was to gather feedback from sponsors and researchers on the clarity of the draft guidance and where they could provide further guidance or support in developing an Inclusion and Diversity Plan.

In the consultation HRA asked for thoughts on whether it would help researchers design more representative studies, and the potential challenges in developing a Plan.

HRA want to say a huge thank you to everyone who responded.

They received more than 300 responses, and the majority of the feedback recognised the importance of this work and thought an Inclusion and Diversity Plan would have a positive impact on study design.

There were a number of themes identified in the responses relating to challenges in creating a Plan, including the need to clarify expectations around data, specific guidance for Phase I, healthy volunteer studies or observational studies, and how to set realistic recruitment goals considering the practical challenges of recruitment.

Read a summary of the key themes and findings from the consultation. 

Take part in the pilot for the updated Inclusion and Diversity Plan

The feedback received in the informal consultation has been used to create an updated second draft of the guidance.

HRA are now launching a pilot project to ask sponsors and researchers to volunteer to develop a Plan and submit it as part of an application for review by a Research Ethics Committee.

The aim for the pilot is to assess the benefits of developing the Plan and they will be asking for further feedback from researchers and RECs on their experience.

The pilot is now open and will run for approximately 6 months before closing towards the end of 2025.

If you would like to take part in the pilot, please email engagement.team@hra.nhs.uk

After the pilot has been completed, HRA will review any new feedback received and make a decision on next steps.