As the Health Research Authority launches a new three-month pilot to fast-track the vital ethics review stage of clinical trials approval, Lord Bethell, Minister for Innovation, blogs about the important lessons being learnt from the research response to COVID-19.
Lord Bethell of Romford, Parliamentary Under Secretary of State, the Department of Health and Social Care
We’re learning lessons from our research response to COVID-19 that can be applied more widely, to the cutting-edges of clinical research into a whole range of health conditions. A great example of this is the work the Health Research Authority (HRA) has begun which will pilot a new and faster research ethics review service for non-COVID-19 clinical trials. The statutory timeline for research ethics review is 60 days, but the new pilot aims to reduce this by 75% for global clinical trials and first-in-human studies for any disease area.
The new fast-track ethics review service will consist of:
- a shorter time period between submission and the Research Ethics Committee (REC) meeting
- review by a dedicated fast-track Committee composed of experienced REC members and a paid Chair
- faster turn-around of correspondence with applicants
Meanwhile, the fast-track service for urgent COVID-19 public health research – which has seen studies reviewed in as little as 24 hours from submission – will remain in place.
The HRA will also continue to ensure fast-track research approval does not mean cutting corners. As with COVID-19 ethics review, the fast-track ethics pilot will uphold high ethical standards of research, including the involvement of patients and the public in clinical trial design.
The HRA is learning fast from the lessons of COVID-19 and listening hard to the needs of the research community. Like many of you, I’m eager to see the results of this piloting work in the months ahead.
This initiative from the HRA is one example of an emerging array of transformative work across the UK health and care research landscape which aims to deliver more patient-centred UK clinical research, more efficient and more innovative clinical trials and improved digital tools and infrastructure to support the amazing work of our life sciences sector. Our work will ensure we not only restore the breadth and depth of studies we already had underway before the pandemic, but we also seize the opportunity to build back better and deliver on our commitment to make the UK the leading global hub for life sciences. I look forward to updating you on this work in the coming months.