The UK Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have published findings from a joint pilot evaluating Inclusion and Diversity Plans in clinical research. The regulators have also updated their guidance for sponsors and researchers, highlighting the practical benefits of early diversity planning and areas requiring further clarification.

Background to the pilot

The HRA and MHRA began developing joint guidance on Inclusion and Diversity Plans following a public consultation launched in September 2024. After reviewing feedback on the initial draft, the regulators revised the guidance and launched a voluntary pilot in May 2025.

The pilot, which closed at the end of 2025, involved seven studies: five sponsored by commercial organisations and two by non-commercial organisations. Five studies were Phase III clinical trials of investigational medicinal products (CTIMPs), while two were clinical investigations of medical devices.

The initiative aimed to assess the benefits of developing Inclusion and Diversity Plans, evaluate their use during Research Ethics Committee (REC) reviews and identify areas where sponsors and researchers needed additional guidance.

Key findings: benefits and practical challenges

The pilot identified several benefits, particularly for commercial sponsors. Developing a Plan provided a structured framework for considering inclusion and diversity during study design and supported discussions with clinical trial sites about recruitment.

Non-commercial sponsors reported less additional value from the process, primarily because they had already addressed diversity considerations when preparing applications for research funding.

Feedback from REC members was mixed. Reviewers considered concise Plans with a clear, conversational presentation useful, particularly when they demonstrated that inclusion and diversity had been considered during study design. However, lengthy documents repeating information already available in the study protocol or application materials were viewed as adding an unnecessary review burden.

Participants also suggested alternative ways of presenting the information, including integrating relevant questions into the Integrated Research Application System (IRAS) or adding a clearly identified section to the clinical trial protocol.

Access to reliable UK-specific epidemiological data emerged as the main practical challenge for sponsors developing recruitment targets and identifying relevant patient populations.

Some commercial sponsors had anticipated receiving specific comments from RECs on their Plans. The regulators clarified that REC discussions focus on ethical issues arising from the overall application. Where all necessary information has been provided, a Plan may not be discussed separately during a committee meeting. Sponsors seeking early scientific input can use the MHRA scientific advice service.

Submission remains voluntary

The updated HRA-MHRA guidance confirms that submitting an Inclusion and Diversity Plan is voluntary. Failure to submit a Plan will not result in the rejection of a clinical trial application or an unfavourable ethical opinion.

The Plan is not a formal submission document directly assessed as part of the clinical trial authorisation process under the UK Medicines for Human Use (Clinical Trials) Regulations 2004, as amended, or the Medical Devices Regulations 2002.

The MHRA has also clarified the limits of GCP inspection in this area. Inspectors will not examine how a Plan was developed, written or approved, or assess compliance with the Plan as a standalone document. However, commitments incorporated into other trial documents, such as the clinical protocol, may be subject to routine inspection.

The guidance covers CTIMPs, clinical investigations of medical devices, combined studies involving medicines and devices, and other clinical trials involving novel interventions or randomised comparisons of interventions in clinical practice. Observational studies are outside its scope.

Updated guidance and next steps

Following the pilot, the HRA and MHRA revised the guidance to improve its structure and make information easier to locate. Particular attention was given to early-phase and rare-disease studies, for which population selection and justification may require additional consideration.

The updated guidance recommends developing an Inclusion and Diversity Plan at the study design stage. It is structured around four key questions: which populations are affected by the disease or condition being investigated; whether the research design and objectives allow findings to be generalised to those populations; what the recruitment targets are; and how the proposed study population will be recruited and retained.

From early 2027, the regulators plan to invite additional sponsors and researchers to submit Plans voluntarily alongside their applications to a selected group of participating RECs. Feedback will be collected over a 12-month period to provide further evidence on the benefits of developing Plans and inform subsequent decisions on their implementation.

The HRA and MHRA will use this next phase to further evaluate how information from Inclusion and Diversity Plans should be presented and considered during research ethics review.