Data released by the Health Research Authority today (25 September) shows that the research approvals process in the UK is performing strongly.
An analysis carried out by the Health Research Authority (HRA) of performance data for research carried out in the UK between 2018 and 2023 shows that the review and approval of proposed health and social care research studies carried out in the NHS is meeting, and in many cases, exceeding targets.
The data focuses on three key areas of performance; satisfaction, review times and number of studies reviewed.
Some of the headlines from the 2018 to 2023 data include:
- overall review times for research were maintained during the COVID-19 pandemic and are now faster than pre-pandemic levels
- satisfaction with the service received from the HRA has increased
- the number of commercially sponsored research studies submitted for review each year has remained consistent while the total number of research studies has reduced
- the overall number of studies submitted for review has dropped by 23.5% (HRA and HCRW Approval) and 23.1% (REC UK wide)
- a large increase in the use of technical assurances
- a 15% reduction in the number of substantial amendments since the launch of the HRA’s amendments decision tool
- our Confidentiality Advisory Group gave on average 130 applications a final outcome every year
The HRA’s strong performance between 2018 and 2023 comes despite challenges faced during the COVID-19 pandemic and the implications of the UK leaving the European Union.
Satisfaction
Data from a monthly satisfaction survey sent to researchers using the HRA's approval process showed that satisfaction with the service they received has improved from 77% in 2018, to 83% in 2023.
Satisfaction has consistently remained above the target of 75% since 2020, reaching a peak of 91% in February 2024.
Review times
The Health Research Authority is responsible for overseeing different types of reviews for health and social care research applications.
Each of these reviews has a target for an outcome to be shared.
Between 2018 and 2023 the HRA has consistently met, and exceeded, its targets, in a number of areas:
- amendments - time taken for substantial amendments to be reviewed has been consistently below the 35 day target since 2020
- Confidentiality Advisory Group - final outcomes during this period were well below the target of 30 days for precedent set studies and 60 days for studies requiring a full review
- HRA and HCRW Approval - for non-commercially sponsored research the median number of days for a review have improved from 82 days in 2018, to 74 days in 2023
- REC (UK wide) final opinion - commercially sponsored research took just under 33 days for review and non-commercially sponsored research took just under 30 days, well below the 60 day target
- Proportionate Review - consistently within, or under, the target of 21 days, taking on average just under 20 days for approval
- Technical Assurance – the median days taken for Pharmacy Assurance was at or below the 30 day target every year other than 2020 (during the COVID-19 pandemic)
Number of studies reviewed
Between 2018 and 2023, the review identified a reduction in the number of studies submitted for review by a Research Ethics Committee or for HRA and HCRW Approval.
Our data showed that the overall number studies receiving HRA and HCRW Approval fell from 4,694 in 2018 to 3,588 in 2023.
For studies receiving a final opinion from a REC (UK wide) the overall number of studies fell from 5,276 in 2018, to 4,057 in 2023.
This reduction is a long-term trend seen across the UK health and social care research landscape, with a move towards more large multi-site studies, rather than smaller studies at individual sites.
Another contributing factor to this reduction is a change in the eligibility criteria for student research carried out in the NHS.
Prior to 2020, Research Ethics Committees were receiving hundreds of applications each year for research being done by students as part of their educational course. We heard that some of this activity was not giving students an experience of research that reflects how modern health and social care research is conducted.
We had originally planned to address this with universities in 2020, however, we had to accelerate our plans due to the COVID-19 pandemic. In March 2020 we paused all student research to create capacity for urgent COVID-19 related research.
In 2021, we confirmed the new arrangements with an updated eligibility criteria and toolkit to make it clearer what research students are able to carry out in the NHS.
When introduced in 2020 we saw student related applications for REC approval drop from 1,607 in 2019, to 1,059 in 2020. For studies receiving HRA and HCRW Approval these numbers dropped from 1,206 in 2019 to 790 in 2020. This represents around a 34% reduction in applications.
Our response to the data
Janet Messer, Director of Approvals Service“The past few years have been challenging for everyone working across the NHS. The COVID-19 pandemic showed just how important health research is. We were able to respond to the pandemic quickly, without lowering our high standards, and approved applications that would normally take weeks in just a few hours. That enabled UK researchers to make the single biggest contribution to the global fight against COVID-19.
“Despite these added pressures and new ways of working, the review of our performance data over this period shows that we continued to meet our targets, and in many cases exceed them. That is testament to the amazing efforts of our staff and volunteers who give their time freely to sit on our Research Ethics Committees and Confidentiality Advisory Group.
“We know how important it is for those planning research to have a consistent approvals process in the UK that they can rely on and know how long it will take. That predictability means that researchers can make plans around us, which in turn helps to accelerate the set-up of research.
“Whilst we are proud of our strong performance since the COVID-19 pandemic, there are still areas where we know we can make improvements in.
“As an organisation who champions transparency we are committing to sharing our performance data and from September 2024 we are trialling publishing our data every three months in this format to show how we are doing.”
Our performance data in more detail
We have published a more detailed analysis of our performance data between 2018 and 2023.
You can find a summary of our performance during this period, alongside the latest data for 2024 in the following areas:
Get in touch
If you have any questions about our data, please email communications@hra.nhs.uk