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HRA publishes findings from pilot of clinical trial Inclusion and Diversity Plans

🇬🇧 MHRA · Tue 03 Nov 2026

A six-month pilot with seven studies found benefits in drawing up a plan at study design, while the HRA refines guidance ahead of a 12-month voluntary phase from early 2027.

The Health Research Authority (HRA) has published the findings of its pilot on Inclusion and Diversity Plans for clinical trials and clinical investigations. The pilot ran for six months in 2025 and tested draft guidance from the MHRA and the HRA on how to develop a plan.

Seven studies took part, drawn from commercial and non-commercial sponsors. Five were phase 3 clinical trials of investigational medicinal products and two involved medical devices. Participants submitted a plan alongside their application for Research Ethics Committee (REC) review. The plan is intended to help researchers show how they intend to enrol the full range of people who will use the product or intervention under test, and to help RECs understand recruitment decisions during ethics review meetings.

The findings indicate that participating researchers and sponsors saw benefit in developing a plan at the point of study design. They also show that the information RECs need to see, and how it is presented, requires further consideration, and that the guidance format could be refined so key information is easier to find. The latest version of the guidance has been updated in response.

From early 2027, more researchers and sponsors will be asked to volunteer to submit a plan with their applications. Feedback will be gathered over 12 months, and plans will go to one of a small number of participating RECs. Interested parties can email engagement.team@hra.nhs.uk.

The HRA stresses that submitting a plan is encouraged but is not a legal requirement and is not part of the new clinical trials regulations introduced in April. The work forms part of the MHRA and HRA effort to update the UK's clinical trial regulations and feeds into the UK Clinical Research Inclusion Group's wider work.

What it means for your team

  • Submission of an Inclusion and Diversity Plan remains voluntary; it is not part of the clinical trials regulations introduced in April.
  • Sponsors interested in the 2027 implementation phase can volunteer to submit a plan to one of a small number of participating RECs and should contact the HRA engagement team.
  • Teams planning trial design may wish to review the updated guidance, which was revised after the pilot, and consider addressing recruitment diversity at the study design stage.
  • Expect further refinement of what RECs need to see in a plan, as this was identified as an area needing more work.

Official source: MHRA ↗

Article written by VigiEye from the official source (MHRA). AI-assisted; check the source before acting.

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