Researchers and sponsors found value in drafting an Inclusion and Diversity Plan at study design, but research ethics committees were divided on reviewing one, the Health Research Authority said on Tuesday.
The findings come from a pilot of seven studies, which the HRA and the Medicines and Healthcare products Regulatory Agency (MHRA) ran to test draft guidance on how to develop and submit a Plan.
Five were phase 3 trials of investigational medicines and two were medical device studies.
Five of the seven studies had commercial sponsors and two had non-commercial sponsors. The pilot was launched in May 2025 and closed at the end of 2025.
According to the HRA’s summary of the findings, commercial sponsors said a Plan helped them consider inclusion and diversity in a more structured way, and some found it useful in conversations with sites about recruitment.
Non-commercial sponsors found it less beneficial, mainly because they had already considered inclusion and diversity to meet funding application requirements.
Feedback from ethics committee members on reviewing a Plan was mixed. The HRA said views depended on what the researchers focused on and how it was presented, the burden of reviewing another document, and whether committees already considered such questions as routine.
The Plan that stood out as most helpful was succinct, conversational in tone and gave reassurance that inclusion had been considered. Committee members agreed that a long document repeating information from elsewhere was not helpful.
Some suggested embedding the questions in the IRAS application system or adding a flagged paragraph to the protocol instead of a separate document.
Accessing reliable sources of epidemiological data was the biggest challenge in developing a Plan. Participants suggested that the guidance list data sources and say more clearly when UK data is needed.
Several commercial sponsors had expected feedback from the committee specifically on the Plan. The HRA clarified that committee review focuses on possible ethical issues, so a Plan may not be raised at the meeting if the application contains all necessary information.
The guidance has since been updated, including a revised layout that makes information easier to find. The HRA said it is exploring how information from a Plan can be presented to committees and will first engage a small group of stakeholders.
From early 2027 more researchers and sponsors will be asked to volunteer to submit a Plan, with feedback gathered over 12 months. Participants will submit to one of a small number of participating committees, and those interested can contact the HRA’s engagement team.
Submitting a Plan is encouraged but is not a legal requirement. It is not part of the clinical trials regulations that came into force on 28 April 2026, and HRA guidance says failing to submit one will not lead to an application being rejected.
Information in Plans will not be collected to monitor the diversity of trial participants, although the HRA said it may explore that in future.
Naho Yamazaki, HRA Deputy Director of Policy and Partnerships, said: “The findings from our pilot show that there is clear benefit in developing an Inclusion and Diversity Plan at the point of study design.”
Lawrence Tallon, MHRA chief executive, said: “We want clinical research to reflect the diverse patient population we serve in this country.”
The HRA’s earlier informal consultation on the first draft, launched in September 2024, drew more than 300 responses, and most of the feedback said a Plan would have a positive impact on study design.
In its separate Public Perceptions of Research report, the HRA found that 88 per cent of people believe trials should involve a diverse group of participants.