UK aims to simplify consent rules for low risk clinical trials
UK drug research authorities want to simplify the informed consent process for “low risk” clinical trials.
The NHS Health Research Authority (HRA) – which is tasked with protecting the interests of patients in research in Wales, Northern Ireland, England and Scotland – proposed the move, explaining the idea is to streamline the way consent is sought and recorded.
“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.”
In a low risk trial the patient only receives the drug under examination. They do not have additional treatment or undergo any diagnostic procedures. Participants might need to take part in extra monitoring such as having their blood pressure taken more often or the completion of questionnaires.
Current consent rules for such studies require a physician to discuss the trial with the potential participant and talk about the benefits and risks of taking part. This discussion must detail why the trial is taking place, how the data will be used, and how the patient can withdraw consent.
Feedback
The HRA asked for feedback on the proposed changes, requesting that stakeholders respond before January 10, 2025.
The proposal is in line with recommendations in a 2023 government-backed assessment of the UK clinical trial landscape.
At the time, the government authors argued “a simplified informed consent process for lower-risk trials which will aid proportionality, ensuring patients will still receive the critical information to consider participation but will be supported to give their consent in an easier way.”
The drive to simplify the consent process also fits with the wider trend that has seen the use of so-called “explainer” animations increase in clinical trials carried out in the UK.
DepositPhotos/tashatuvango