Summary

The Health Research Authority (HRA), working with the Medicines and Healthcare products Regulatory Agency (MHRA), provides guidance for sponsors and researchers on developing and submitting an Inclusion and Diversity Plan for clinical research. The guidance is intended to support consideration of inclusion from the study design stage and to help ensure that research populations and recruitment approaches are appropriately justified.

The guidance is structured around four central questions: which populations are affected by the disease or condition under investigation; whether the research design and objectives allow findings to be generalised to those populations; what recruitment targets are appropriate; and how the study population will be recruited and retained. It encourages sponsors to consider the populations relevant to the condition, the characteristics of the proposed study population and practical recruitment barriers.

The guidance applies to clinical trials of investigational medicinal products (CTIMPs), clinical investigations of medical devices and other relevant interventional clinical research, including studies involving novel interventions. Observational studies are outside its scope.

Submission of an Inclusion and Diversity Plan is voluntary. The absence of a Plan will not, by itself, lead to the rejection of a clinical trial application or an unfavourable ethical opinion. The Plan is not a standalone document directly assessed for clinical trial authorisation. MHRA GCP inspectors do not audit the preparation or implementation of the Plan as a separate document, although commitments incorporated into the clinical protocol may be subject to routine inspection.

The guidance reflects the HRA and MHRA pilot conducted from May to the end of 2025. The regulators reported that Plans helped some commercial sponsors structure diversity considerations and recruitment discussions, while also identifying challenges involving duplicated information in ethics submissions, REC review workload and access to reliable UK-specific epidemiological data. A further 12-month implementation phase is planned to begin in early 2027.