Simplifying the process of seeking and recording consent in low risk clinical trials

The laws which regulate the way clinical trials of medicines are carried out in the UK are changing.

The Health Research Authority (HRA) is proposing changes to the UK’s Clinical Trials regulations to simplify the way that informed consent is sought and recorded in low risk clinical trials.

They want to ensure that the proposed changes work for everyone, using an approach that people can trust.

What is a ‘low risk’ clinical trial?

A clinical trial that is comparing readily available medicines and trying to find out which is most effective treatment is deemed to be a low risk clinical trial.

This is because medicines that are already available have already reached a certain standard of safety, quality and effectiveness to be approved.

What are the current arrangements for recording consent?

A prescriber will have a conversation with a potential participant, look at an information sheet about the trial and talk about the benefits and risks of taking part.

The participant and prescriber then read, review and sign a consent form.

What changes are being proposed?

The process for discussing a clinical trial with a potential participant will remain unchanged.

The change being proposed is a more proportionate approach to recording consent of anyone who wishes to take part in a low risk clinical trials.

Rather than completing a written consent form, prescribers would document consent in a participant’s medical record.

The approach for other types of clinical trials will remain unchanged.

Share your feedback

The HRA is asking for feedback on their proposed changes to the current process and are asking for the research community and members of the public to complete a short survey.

All of the feedback you share will be used to shape the new Clinical Trials regulations in the UK and the accompanying guidance that the HRA is producing.

The survey closes on Friday 10 January 2025.

If you have any questions about the survey please email the team.