A simpler way of seeking and recording someone’s decision to take part in a low-risk clinical trial
Clinical trials aim to find out more about an illness, condition, treatment, therapy, or care. In a low-risk trial, medicines that have already been approved for use with patients are compared to see which might be the best option.
Before deciding whether to take part, you’d follow all the usual steps in seeking informed consent, this includes having a conversation about the benefits and risks in taking part, being provided information about the trial including how your data will be used and how to withdraw consent.
At the moment, you’d be asked to read, review and sign a consent form if you want to take part. To be more proportionate, we are thinking about changing this. We are proposing that if you decide to take part, the person recruiting you to the clinical trial would write down your consent in your medical records. And you wouldn’t need to sign a form.
We want to know if this proposed change would work for everyone, and if it’s an approach people can trust.
Tell us what you think in our short survey and feel free to share with others that may be interested.