The laws which regulate the way clinical trials of medicines are carried out in the UK are changing.
One of the proposed changes to the law is to simplify the way that informed consent is sought and recorded in low risk clinical trials.
It is important that these proposed changes work for everyone, using an approach that people can trust.
We want to hear feedback on the proposals from people who have taken part in research, people who may be considering taking part in research, members of the public, Research Ethics Committee members and the wider research community.
Your feedback will be used to help inform the future Clinical Trials regulations in the UK and supporting HRA guidance.
Complete our survey
To share your feedback we are asking you to complete our short survey.
It is an opportunity for you to tell us what you think of the proposal and you will not be asked to share any identifiable information in the survey.
The survey will close on Friday 10 January 2025.
What do we mean by a ‘low risk’ clinical trial?
When a medicine is prescribed in the UK, we know it has already reached a certain standard of safety, quality and effectiveness to be used.
There are often lots of different medicines available to treat an illness. What someone prescribing a medicine might not always know, is which medicine is the best option.
Clinical trials can provide answers to these questions.
Because these medicines have already been approved, and a participant is given the medicine as part of routine care, clinical trials that compare different pre-approved medicines are deemed low risk.
Low risk clinical trials involve no additional treatment or diagnostic procedures. Participants might however need to take part in extra monitoring such as having their blood pressure taken more often or the completion of questionnaires.
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.
This will include explaining why the trial is taking place, how their data will be used, the treatment that is being prescribed and how to withdraw consent if they wish to do so in the future.
The participant can also request an alternative treatment in line with standard clinical practice. All information provided should be clear, concise and understandable.
The participant and prescriber then read, review and sign a consent form.
What changes are we proposing?
The process for discussing a clinical trial with a potential participant will remain unchanged.
The change we are proposing 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.
It will still be a legal requirement for informed consent to be sought from the potential research participant before taking part, and participants will be able to withdraw at any time during a clinical trial.
The approach for other types of clinical trials will remain unchanged.
Example case study
The below case study gives a practical example of the current process and the changes we are proposing.
John is aged 72 and has recently been advised by his GP to start a regime of statins to treat his high cholesterol. Statins are a commonly prescribed treatment in the UK, used by millions of patients, but medical professionals are still unsure which treatment regime is the best.
To gain a better understanding, a trial, the STARE 123 study, has been set up in the NHS. John’s GP is part of the research team that is recruiting participants.
The STARE 123 study will compare statin A with statin B to determine which medicine offers less side-effects and better quality of life for patients over 70 years of age.
If John decides to take part in the trial, he will be randomly allocated to receive either statin A or statin B. Both are standard treatments routinely prescribed for John’s condition. In addition, if John decides to participate, he will have his blood pressure monitored more often than usual and will be asked to complete a weekly diary recording his symptoms.
John’s GP will follow all the usual steps in seeking informed consent, having a conversation with John about the benefits and risks in taking part, providing information about the trial including how his data will be used and how to withdraw consent if he wishes to do so in the future.
However, under our new proposals, John would not be required to fill out and sign a consent form. Instead, John’s GP would record consent in John’s medical records.
Get in touch
If you have any questions about the survey please email communications@hra.nhs.uk