Research in the UK is carried out by different types of organisations that broadly fall into one of two categories – commercially or non-commercially sponsored research.
A sponsor is the organisation or partnership that takes on overall responsibility for arrangements being in place to set up, run and report a research project.
All health and social care research should have a sponsor. This includes all research that involve NHS patients, their tissue or information.
Commercially sponsored health and social care research takes place in NHS or non-NHS settings and is funded and sponsored by private sector organisations, for example pharmaceutical companies.
These studies tend to be predominantly Clinical Trials of an Investigational Medicinal Product (CTIMPs).
Non-commercially sponsored health and social care research is sponsored and funded by public bodies such as the NHS, local authorities, universities or charities.
These studies cover a much broader range of study types, including surgical, observational, diagnostic and screening studies, as well as CTIMPs.
Non-commercial studies can be funded by a commercial organisation via grants.
Between 2018 and 2023 we have seen a year-by-year reduction in the number of studies submitted for review by a REC (UK wide) or for HRA and HCRW Approval.
This overall 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 to be reviewed by a REC.
Below we show the total number of studies submitted, broken down by approval type and sponsor.
Studies receiving final opinion from a REC (UK wide)
The number of non-commercially sponsored studies receiving a final opinion from a REC has fallen year-on-year from 3,860 in 2018 to 2,758 in 2023, although the drop has levelled out between 2022 and 2023.
This drop is linked to a reduction in capacity for non-commercial sponsors during the COVID-19 pandemic, as well as changes in March 2020 to the way student research is carried out in the NHS.
Student research is classed as non-commercial research and dropped from 1,607 in 2019 (accounting for 32% of the total studies given a final opinion by a REC) to 1,059 in 2020 (24% of the total studies given a final opinion by a REC).
For research that was commercially sponsored or had no sponsor set the number of studies has stayed broadly the same between 2018 and 2023.
Studies with ‘sponsor not set’ were not categories at the time of submission, but are checked as part of the review process to determine the type of sponsor prior to review.
Studies receiving HRA and HCRW Approval
Similarly to non-commercial studies receiving a final opinion from a REC (UK wide), the number of non-commercial studies receiving HRA and HCRW Approval also dropped year-on-year from 2018 to 2023, falling from 3,846 in 2018 to 2,719 in 2023.
For student research that received HRA and HCRW Approval the numbers dropped from 1,206 (28% of the total number of studies receiving HRA and HCRW Approval) in 2019 to 790 in 2020 (20% of the total number of studies receiving HRA and HCRW Approval).
For research that was commercially sponsored or had no sponsor set the number of studies has stayed broadly the same between 2018 and 2023.
Review times
The time taken for a final opinion from a REC or for HRA and HCRW Approval to be given is provided in a different section:
On these pages you can also see the targets times we are working towards.
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.