Health Research Authority (HRA) and Health and Care Research Wales (HCRW) Approval is a combined process for applying for approvals for all NHS and social care research taking place in England or Wales.
HRA and HCRW approval brings together the research ethics review and the governance and legal review, meaning that researchers wanting to do research in England and Wales can submit one single application for the whole NHS.
Before this approval process was in place, local governance and legal checks were repeated at each place where research was going to take place.
This type of approval is different to standalone REC approval as some studies submitted for HRA and HCRW Approval do not require REC approval, and others do.
In this section we share information on how many studies were provided HRA and HCRW Approval and how long it took for applications to be reviewed.
Number of studies given HRA and HCRW Approval
Between 2018 and 2024 we saw a reduction in the number of studies given HRA and HCRW Approval, dropping from 4,694 in 2018 to 3,408 in 2024.
This reduction levelled out in 2022 and 2023, with a slight increase in 2023 to 3,588, from 3,553 in 2022.
This overall reduction is a long-term trend seen across the UK 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 to be reviewed by a REC.
Total number of studies receiving HRA and HCRW Approval
The total number of studies receiving HRA and HCRW Approval between 2018 and 2023 was:
- 2018 – 4,694
- 2019 – 4,315
- 2020 – 3,929
- 2021 – 3,825
- 2022 – 3,553
- 2023 – 3,588
- 2024 – 3,408
Review times
Between 2018 and 2022 the time for HRA and HCRW Approval was consistently under 100 days and slightly improved each year.
In 2023 we saw a large increase in the time taken for reviews of commercially sponsored research due to delays with the Medicines and Healthcare products Regulatory Agency issuing joint approvals.
Our review times returned to normal levels in 2024, with the median number of days taken for commercially sponsored studies to receive HRA and HCRW Approval being 74 days.
Our review times are now faster than pre-pandemic levels for both commercially sponsored research (94 days in 2018 compared to 74 days in 2024) and non-commercially sponsored research (82 days in 2018 compared to 68 days in 2024).
Number of days taken for HRA and HCRW Approval
Commercially sponsored research
Below is the median number of days taken for HRA and HCRW Approval per year for commercially sponsored research:
- 2018 – 94 days
- 2019 – 96 days
- 2020 – 87 days
- 2021 – 76 days
- 2022 – 83 days
- 2023 – 113 days
- 2024 – 74 days
Non-commercially sponsored research
The median number of days taken for HRA and HCRW Approval per year for non-commercially sponsored research were:
- 2018 – 82 days
- 2019 – 91 days
- 2020 – 77 days
- 2021 – 70 days
- 2022 – 76 days
- 2023 – 74 days
- 2024 – 68 days
In the chart below you can see a comparison of the time taken to review commercially sponsored and non-commercially sponsored studies submitted for HRA and HCRW Approval.
Latest review times
Between October 2024 and December 2024 (quarter three 2024/25) the median number of days for HRA and HCRW Approval was:
- commercially sponsored - 73.5 days
- non-commercially sponsored - 70 days
Quarterly breakdown of HRA and HCRW Approval review times
You can take a look at quarter-by-quarter (every three months) breakdown of HRA and HCRW Approval review times between 2018 and 2023 below:
How we break down our data
For most applicants to the Health Research Authority, the REC review forms part of the overall HRA and HCRW Approval process. A favourable opinion from a REC is also required for studies which receive support from the Confidentiality Advisory Group.
We have separated our REC review data from our HRA and HCRW Approval data because HRA and HCRW Approval applies only to the NHS in England and Wales. This approval brings together the assessment of governance and legal compliance, undertaken by dedicated HRA staff, with the independent ethical opinion by a REC so that you only need to submit one application.
Some studies submitted for HRA and HCRW Approval do not require REC approval, others do. This is explained more fully in our guidance.
We have broken down our data to reflect this difference, as well as showing timelines for HRA approval of commercial and non-commercially sponsored research.