 Clinical trials regulations – six-month countdown begins
 Today (28 October) marks the six-month countdown until the most significant update to UK clinical trials regulations in two decades come into force.
Sponsors, researchers and anyone involved in setting up and running clinical trials of medicines in the UK must follow the amended regulations from 28 April 2026.
We’ve published final guidance covering the areas of the regulations which have been a key focus for the Health Research Authority (HRA). The Medicines and Healthcare products Regulatory Agency (MHRA) has published separate guidance covering the key areas of the regulations which they have been focusing on.
We’re working closely with the MHRA to help you navigate the updates and we’ll continue to share more information over the next six months to make sure you have all the support you need.
Janet Messer, Director of Approvals at the HRA, and James Pound, Interim Executive Director, Innovation and Compliance at the MHRA, have written a blog to mark the six-month countdown.
Their blog explores the benefits of the updated regulations, our joint commitment to support their successful implementation, a look ahead to the next six months, and information for sponsors and researchers on how to start preparing now.
Simplified arrangements for consent advisory group is launched
We’ve established an advisory group and review network to help us develop a set of principles for simplified arrangements for seeking and evidencing consent in low-intervention trials.
The advisory group, which met for the first time last week, is made up of 12 members and includes HRA staff, members of Research Ethics Committees (RECs), researchers and sponsors, legal experts, and members of the public. The group will be supported by a wider review network who will offer additional insights and expertise.
The principles we’re developing will provide guidance for those looking to use simplified arrangements and will assist REC members in evaluating the ethical considerations of using simplified arrangements.
Join our draft inclusion and diversity guidance pilot
We’re looking for more studies to join our pilot to help us develop draft inclusion and diversity guidance.
The pilot is for sponsors and researchers who are invited to develop an Inclusion and Diversity Plan and submit it as part of an application for review by a REC.
We launched the pilot in May following the publication of the updated second draft of guidance for how to develop an Inclusion and Diversity Plan.
Five studies taking part in the pilot have now submitted plans with their applications, and they have been reviewed by an ethics committee.
We’re currently gathering feedback from the sponsors, researchers and ethics committee members on the experience of developing a plan and reviewing a plan as part of an application.
Ahead of the pilot closing, we would like more studies to take part.
If you’re a sponsor or researcher who will be submitting an application between now and the end of 2025 and would like to get involved, please email engagement.team@hra.nhs.uk
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