 What: we're removing the requirement to submit annual progress reports and changing what happens when you submit a safety report
Who: anyone carrying out research approved by a REC in England and Wales
When: from 1 June 2024
What's changing
To help streamline some of our processes for researchers and for our staff we are making some changes from 1 June 2024.
From this date:
- study teams will no longer be required to submit annual progress reports
- there will be changes to how we acknowledge SUSARS and annual safety reports
These changes apply to research approved by RECs in England and Wales only.
Changes to annual progress reporting
Annual progress reports are currently required for all applications (excluding Proportionate Review) that are expected to last longer than two years. In practice, only 30% of applicants routinely submit annual progress reports in England.
We have previously committed to reviewing annual progress reports and based on feedback we are now removing the requirement to help reduce the burden on researchers.
You still need to report anything that materially affects the ethics of an application. There is no change to the expectation that this should be submitted as an amendment by the Sponsor or Chief Investigator.
As part of our ongoing commitment to research transparency we will still ask you to submit an end of study declaration and final study report. This means that the Research Ethics Committee and wider community still receive information regarding the outcome of the research.
Changes to SUSARS and annual safety reports
There will also be a change to our process for acknowledging some Suspected Unexpected Serious Adverse Reactions (SUSARS) and annual safety reports.
Fatal and life-threatening SUSARS should continue to be reported to the Medicine and Healthcare products Regulatory Agency (MHRA) and the REC as soon as possible.
SUSARS and safety reports for CTIMPs which were approved by combined review should be submitted to the MHRA only. If the safety report requires action, the MHRA will instruct the study team to submit a substantial amendment to the REC.
Any other SUSARS or annual safety report submitted to the HRA will be acknowledged by email by the REC. The submitted cover report for the SUSAR or annual safety report will not be signed and returned, the email will act as the formal acknowledgement.
This approach is in line with clinical trials regulations and prevents unnecessary work for our teams.
What happens next?
We are updating our guidance to reflect the changes with 1 June 2024 as an implementation date.
Pre-election period
You might see and hear less from the HRA in the run up to the General Election on 4 July.
As an arm's length body of a government department, we need to pause some of our communications until after the polling.
Our social media channels might be quiet, but you can always contact us via our website with questions or feedback
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