Clinical Trials update - February 2025

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Update on progress of new Clinical Trials regulations

The statutory instrument to amend the Medicines for Human Use (Clinical Trials) Regulations 2004 was laid before Parliament in December last year.

The House of Commons approved the proposed updates to the regulations on 3 February, with the House of Lords following on 10 February. 

The proposed updates have now been shared with the Northern Ireland Assembly, and if approved, the 12 month implementation process will begin.

This would see the new regulations coming into force in early 2026.

Guidance to accompany the new regulations

We are developing guidance to accompany the new regulations. The guidance is designed to make it clear what the expectations are for research carried out in the UK when the amended regulations come into force in 2026.

The Medicines and Healthcare products Regulatory Agency (MHRA) and the HRA will be publishing separate guidance to clarify the changes that are being made as part of the updated Clinical Trials regulations.

Our guidance will address aspects of these regulations that the MHRA will also cover in guidance. However, the HRA guidance will provide more detail on elements of the regulations relating to areas such as research ethics committees and transparency.

Although we are creating separate guidance, we have collaborated throughout the process to ensure that both pieces of guidance are consistent and clear.

We plan to complete the first draft by mid-March. Once it is finished, we will share the draft guidance with stakeholders to gather their feedback.

The draft will not be published online. Instead, we will share it with individuals and organisations that have contacted us and expressed interest in reviewing it.

If you would like to participate, please email engagement.team@hra.nhs.uk.

We will take into account feedback received and make any necessary revisions before officially publishing the guidance at the end of April.

Simplified means of seeking and recording consent

One of the proposed changes in the new Clinical Trials regulations is to simplify the way that informed consent is sought and recorded in ‘lower risk’ clinical trials.

In November 2024 we launched a survey asking for feedback on these proposals and received nearly 1,000 responses.

Since the survey closed on 10 January 2025, we have been analysing the responses. So far, we have identified some clear themes from the feedback.

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.

We will continue to analyse the survey responses and use the evidence to inform our next steps.

Inclusion and diversity guidance

We have been working alongside the MHRA to develop a set of questions and supporting guidance for researchers to consider when they design clinical trials and investigations. The questions and supporting guidance will help researchers develop an Inclusion and Diversity Plan.

This will ensure that clinical research is designed to include people who could benefit from the findings, and that people underserved by research are not overlooked. 

Between October and December 2024, we held an informal consultation asking for feedback on the draft questions and guidance.

We are currently reviewing the draft questions and guidance, and making changes based on the feedback we received.

The second draft, as well as a summary of the feedback, will be shared soon.

We will then pilot the use of the questions and supporting guidance with sponsors and researchers who will be invited to submit an Inclusion and Diversity Plan as part of their application on IRAS.

The plan will be reviewed by Research Ethics Committees as part of the overall application, and we will ask for feedback on the experience of using the plan.

If you are planning to submit an application for a clinical trial or clinical investigation in 2025 and would be interested in taking part in the pilot please email engagement.team@hra.nhs.uk

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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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