In September 2024, a consultation on the first draft of the HRA-MHRA guidance for developing an Inclusion and Diversity Plan (Plan) was launched. A summary of the findings from the informal consultation was published in early 2025. The feedback we received in the informal consultation was used to create an updated second draft of the guidance.
In May 2025, we launched a pilot asking sponsors and researchers to volunteer to develop a Plan and submit it as part of an overall review of an application by a Research Ethics Committee (REC). The purpose of the pilot was to assess the benefits of developing a Plan, support refining the guidance further, and assess if there was any further support we could provide. The pilot formally closed at the end of 2025.
The following outlines the findings from the pilot.
Who took part
Seven studies took part in the pilot. Of the seven studies, five were from commercial sponsors and two non-commercial sponsors. Five of the studies were phase III CTIMPs and two were for medical devices.
Findings from the pilot
Below is an overview of the main themes that emerged from the analysis.
Benefits of developing a Plan for a study
The feedback from commercial sponsors who took part was that they found developing a Plan beneficial in supporting them to consider inclusion and diversity in a more structured way and that some had found the Plan helpful to support conversations with sites around recruitment.
Non-commercial sponsors found developing the Plan less beneficial. This was primarily due to having already considered inclusion and diversity to meet funding application requirements.
Overall, there was evidence that researchers/sponsors found benefit in developing a Plan, although there were a number of areas in the current draft guidance which would benefit from further clarity or detail.
Benefits of having a Plan as part of a review of an application
The feedback from REC members on the benefit of reviewing a Plan as part of an application was mixed. Whether the Plan was seen as beneficial to the review was primarily driven by what researchers/sponsor focused on and how it was presented in the Plan, the benefit vs burden of reviewing another document, and whether it is already common practice for a REC to consider these aspects as part of REC review. In discussion with REC members, the Plan that stood out as the most helpful was succinct, conversational in tone, and provided reassurance that inclusion and diversity aspects had been considered.
While there was agreement that a long document that repeated information from elsewhere was not helpful, there were different views on where additional information collated in developing the Plan should continue to be provided in a separate document. Alternative suggestions to a separate document were embedding the questions in IRAS or requesting the information to be included as a clearly flagged paragraph within the protocol.
The takeaway from this engagement was that the guidance is pointing researchers/sponsors in the right direction of what RECs feel researchers/sponsors should be considering, but the level of information RECs needs to see, and how this is presented, needs further consideration.
Access to sources of UK specific data
Accessing reliable sources of epidemiological data was highlighted as the biggest challenge in developing a Plan. It was suggested that a list of sources of data within the guidance and clearer guidance on when UK data is needed would be helpful.
Receiving feedback on a Plan
A number of commercial sponsors raised both during and post the pilot that they had expected feedback from the REC specifically on the Plan. It was clarified that as REC review focuses on where there may be ethical issues within the application, should an application provide all necessary information, the Plan may not be raised for discussion within the meeting. The draft guidance would benefit from further clarification on how the REC will review the Plan and encouraging the use of MHRA scientific advice meetings for early feedback.
Amendments to the draft guidance
The feedback indicated the draft guidance would benefit from specific amendments/updates.
- Guidance for early phase / rare disease studies could be made more prominent within the guidance.
- There was some feedback that the draft guidance was too ‘wordy’. A review of the layout of the guidance may support researchers/sponsors in having a clearer understanding of what they need to focus on
Next steps
Updates to the draft guidance
The guidance has been updated following pilot feedback, including a revised layout that makes information easier to find. Pilot findings indicated that sponsors found development of a Plan beneficial in supporting them in considering inclusion and diversity at the point of study design. However, the level of information RECs needs to see, and how this is presented, needs further consideration.
We are exploring potential options for how information from a Plan can be presented to RECs and the next step will be to engage further with a small group of stakeholders before beginning the next phase of the work.
Implementation phase
From early 2027 we will be asking more researchers and sponsors to volunteer to submit a Plan alongside their applications. Feedback will be collected over a 12-month period where we will gather further evidence on the benefits of developing a Plan.
During this period, researchers and sponsors will be able to submit a Plan for review to one of a small number of participating RECs.
Further information on this phase will follow shortly. You can express your interest in taking part by emailing engagement.team@hra.nhs.uk.