The Health Research Authority (HRA) has published the findings from its pilot on researchers and sponsors of clinical trials and clinical investigations developing and submitting an Inclusion and Diversity Plan.
During the pilot, which ran for 6 months in 2025, the Medicines and Healthcare products Regulatory Agency’s (MHRA) and the HRA’s draft guidance on developing a plan was tested by a small group of commercial and non-commercial researchers and sponsors.
The group submitted a Plan alongside their application for a Research Ethics Committee (REC) review.
The Plan helps researchers consider and demonstrate how they plan to enrol the full range of people who will use the drugs, devices or intervention they are testing.
The Plan also helps RECs to understand decisions researchers have made about who to recruit into their trials, to support discussions at the research ethics review meeting.