HRA Latest - 31 October 2025

This week we marked 6 months until the amended clinical trials regulations come into force.

To mark the milestone Janet Messer, Director of Approvals at the HRA, and James Pound, Interim Executive Director, Innovation and Compliance at the Medicines and Healthcare products Regulatory Agency (MHRA), have written a blog. 

The blog explores the benefits of the updated regulations, our joint commitment to support their successful implementation, a look ahead to the next 6 months, and information for sponsors and researchers on how to start preparing now.

Earlier this month, we also published our final clinical trials regulations guidance.

The guidance has been updated based on stakeholder feedback and should be used by anyone involved in setting up and conducting clinical trials to update their processes and policies before the regulations come into force on 28 April 2026.

Tony Calland MBE has stepped down from his role as Chair of the Confidentiality Advisory Group (CAG) after 15 years as part of the group, 8 years of which he served as Chair.

Lorna Fraser, Professor of Palliative Care and Child Heath at King's College London, will be taking up the role of Chair as of 1 November 2025.

In a farewell blog Tony shares his reflections on his time leading the CAG and why public trust in the use of confidential patient data without consent is more important than ever. 

Joshua Smith, a Royal Holloway, University of London student, writes about how he balanced being a Research Ethics Committee (REC) member with his studies. 

He shares how reviewing NHS research applications helped him gain skills in critical thinking and clear communication, and why you don't need healthcare experience to apply! 

We’re particularly looking for people like Josh, with no professional experience, to help us review research applications. 

It’s important that our committees have insight from different perspectives, so if you’re interested in gaining new skills, find out how you can become a REC member. 

On 7 October the World Health Organization launched a new Global Clinical Trials Forum (GCTF), a network designed to strengthen clinical trial environments and infrastructure across the world.

The Health Research Authority is proud to be one of the launch members of the Forum, with representatives from countries across the world.

The GCTF will support the implementation of the World Health Organization’s Guidance for Best Practices for Clinical Trials, which saw the UK recognised as a country with a strong clinical trial infrastructure.

We recently held the first of our new Research Revisited events which looked at the YouScreen study, the largest self-sampling cervical screening clinical trial.

The results of the trial directly led to the recent government decision to rollout self-sampling kits across the UK. 

We reflected on the crucial role that the questions raised during the REC and CAG review process played on the success of the trial. Watch the recording and read a blog with the perspectives from the researcher and REC member on the process. 

We also held a webinar earlier this month all about research transparency and sharing results with participants.  

Watch the recording to hear the transparency requirements in the new clinical trials regulations.

This month, we shared our first edition of our 'Building better research systems' newsletter, with updates on our work to improve the systems used in the UK to plan, manage and deliver health and social care research.

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