The Health Research Authority (HRA) has launched a new service offered to pharmaceutical companies and research organisations which will accelerate the ethics review stage of clinical trials approval.
The HRA will offer the new swift review to global trials and first-in-human studies that are developing medicines in ‘key areas of patient need’ including heart disease and diabetes.
The service will run in pilot form for the next three months, offering researchers a 75% reduction on the statutory timeline for ethics review.
Ethics review ensures that patients and health volunteers taking part in clinical trials, as well as other research, are protected.
This process includes the involvement of expert committees, which examine the participant-facing aspects of trials including how participants are recruited, what information they receive and how they can join or withdraw from the trial.
The pilot fast-track services builds on the HRA’s COVID-19 approval service, which has offered accelerated reviews for around 700 COVID-19 research studies.
“Ethics review provides important protection for patients and healthy volunteers taking part in research,” said Professor Sir Terence Stephenson, chair of the HRA.
“During the pandemic, the HRA has offered swift ethics review of COVID-19 research whilst maintaining robust standards. We now want to use our experience of responding to COVID-19 research to help rebuild a strong research environment and ensure that the UK maintains its world-leading reputation for health and social care research,” he added.
The HRA is one of a number of bodies within the UK that are responsible for the regulation and governance of health and social care research.