Amendments are the proposed changes made to a research project after approval from a review body has been given.
Sponsors (the funders) of the research are asked to decide whether the amendment is substantial or non-substantial, using our guidance and decision tool.
Depending on the nature of the substantial amendment it may mean that it needs to be reviewed by a Research Ethics Committee (REC), reviewed for HRA and HCRW Approval or reviewed by another organisation.
A non-substantial amendment does not require REC review but may require other reviews.
Number of substantial and non-substantial amendments reviewed
Between 2018 and 2023 we have seen an increase in the number of non-substantial amendments and a small decrease in the number of substantial amendments.
The total number of substantial amendments reviewed in 2018 was 8,506, falling to 7,431 in 2023. This decrease is largely down to the overall reduction in the number of studies submitted for review. We also saw higher than usual substantial amendments submitted between 2018 and 2020. These higher levels were associated with preparations and changes linked to Brexit, as well as further amendments made necessary during the COVID-19 pandemic.
Conversely, we saw a rise in the number of non-substantial amendments which have risen from 9,803 in 2018 to 13,386 – a 36% increase.
This significant increase is due to a new amendment type that was introduced in 2020 (non-substantial, no study wide review amendments) which helped clarify whether an amendment should be classified as substantial or non-substantial.
Previously, changes for new NHS sites and Principal Investigators for CTIMPS were classified as a substantial amendment, but not reviewed by a REC. In 2020 these were reclassified as non-substantial.
The launch of our amendment tool in 2020 to help researchers determine what type of amendment may be needed can also help explain the rises and falls, which we can visibly see starting to change in 2020 in the graph below.
Review times
Between 2018 and 2023 our review times for substantial amendments remained consistently below our target of 35 calendar days.
Other than a small increase in 2019 due to resources being re-focused on fast-track review for COVID-19 related studies, the median time between 2018 and 2023 for a final opinion for a substantial amendment was around 19 days for REC (UK wide) review and 29 days for HRA and HCRW Approval.
Latest review times
Between January 2024 and March 2024 (quarter four 2023/24) the median time taken for a final opinion for a substantial amendment was:
- 20 days (REC UK wide)
- 29 days (HRA and HCRW Approval)
Between April 2024 and June 2024 (quarter one 2024/25) the median time taken for a final opinion for a substantial amendment was:
- 20 days (REC UK wide)
- 28 days (HRA and HCRW Approval)
Quarterly breakdown of review times
Below you can see a quarterly (every three months) break down of review times for 2018 to 2023:
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.