Clinical Trials update - August 2025

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New report published on simplified means of seeking and recording consent in clinical trials

We’ve published the findings of a survey we ran earlier this year to understand people’s views on using simplified arrangements for consent in certain clinical trials.

As part of the updated clinical trials regulations, sponsors will be allowed to use simplified arrangements for obtaining and evidencing consent in clinical trials that present a lower risk to participants because they meet specific criteria.

Almost 1,000 people completed our survey which asked for feedback on these proposals. Thank you to everyone who shared their thoughts.

55% of respondents said they would not support a doctor recording their consent to participate in a ‘lower risk’ clinical trial in their medical record, rather than signing a consent form.

Next steps 

It’s important that simplified arrangements work for everyone, using an approach that people can trust.

We’re now setting up an advisory group made up of a range of people who will have the appropriate expertise, skills, and experience to inform the development of simplified means of seeking consent that maintain people’s trust.

We expect the group to be established by autumn and we’ll share more on their work in the coming months.

Guidance to support the updated clinical trials regulations

In June, we published new guidance to help you prepare for the changes that will happen when the updated clinical trials regulations 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 HRA:

• definitions and terminology
• pharmacovigilance
• the approvals process for clinical trials
• Research Ethics Committees (RECs) that review clinical trials
• simplified arrangements for consent in clinical trials
• research transparency requirements for clinical trials

The Medicines and Healthcare products Regulatory (MHRA) has also published separate guidance to accompany the new regulations which you can read on their clinical trials hub.

What the guidance applies to

The guidance outlines the review and assessment processes for clinical trials of investigational medicinal products (CTIMPs) by RECs and the MHRA.

It does not cover changes to other reviews of CTIMPs, for example study wide review, or non-CTIMP applications. This is because the amended regulations do not apply to these types of studies.

We’ll share separate guidance and information with you if changes are made to these review processes.

Share your feedback on our guidance

Thank you to everyone who has shared feedback so far on our guidance to accompany the updated clinical trials regulations. 

If you have any comments or would like to share feedback on the new published guidance, please complete our online survey by 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 this autumn.  

Draft inclusion and diversity guidance pilot

In May, we launched a pilot following the publication of the updated second draft of guidance for how to develop an Inclusion and Diversity Plan.

The pilot involves asking sponsors and researchers to volunteer to develop an Inclusion and Diversity Plan and submit it as part of an application for review by a REC.

Four studies taking part in the pilot have now submitted plans with their applications which 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.

We’re looking for further studies to take part. If you’re a sponsor or researcher who will be submitting an application between now and the end of 2025 or early 2026 and would like to take part in the pilot, please email engagement.team@hra.nhs.uk  

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