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New clinical trials guidance published
We’ve published new guidance to accompany the updated clinical trials regulations which come into force on 28 April 2026.
The guidance explains what will change in terms of processes, legal requirements, and expectations for anyone involved in setting up or delivering clinical trials.
Our guidance covers the following updates to the regulations which have been a key focus for the Health Research Authority:
Shaping the guidance
Earlier this year, we invited feedback on a draft version of the guidance.
We received more than 800 comments which have helped to inform and shape the new guidance.
Thank you to everyone who reviewed the draft guidance and for sharing your feedback.
Further opportunity to share your thoughts
If you have any further comments or would like to share feedback on the new published guidance, please complete our online survey.
You do not have to share feedback on every section of the guidance, just skip to the relevant sections in the survey and add your comments.
The deadline for sharing your feedback is 5pm on Wednesday 10 September 2025.
If you would prefer to provide your feedback on how our guidance is written by email, or you have any questions, please email the HRA's engagement team.
We’ll use the feedback we receive to update the final guidance which we plan to publish later this year.
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MHRA guidance
We’ve been working in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA) to update the clinical trials regulations.
Their guidance covers the key areas of the regulations which they have been focusing on:
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Be part of our Inclusion and Diversity Plan pilot
We’re inviting sponsors and researchers to take part in a pilot project to support the work we’re doing to develop new inclusion and diversity guidance.
The pilot involves developing an Inclusion and Diversity Plan and submitting it as part of an application for review by a Research Ethics Committee (REC).
The pilot opened in May and will run for approximately 6 months before closing towards the end of 2025.
The first Inclusion and Diversity Plan has already been submitted and reviewed by a REC as part of a study application involved in the pilot. We’ll share more on the findings from the pilot in the coming months.
Share your feedback
To help us make sure we’re sharing the right information in these updates, please complete our short two question survey.
If there’s anything you would like to hear about in future updates, please let us know by emailing communications@hra.nhs.uk
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