 What: we're now applying the following changes to research studies reviewed by Research Ethics Committees (RECs) across all of the UK:
- removal of the requirement to submit annual progress reports
- changes relating to what happens when you submit a safety report
Who: anyone carrying out research approved by a REC in any of the four nations of the UK
When: from 1 August 2024
What's changing
A previous HRA Now outlined some changes taking place from 1 June 2024, designed to help streamline some of our processes for researchers and for our staff.
From this date:
- study teams were no longer required to submit annual progress reports
- there were changes to how we acknowledge Suspected Unexpected Serious Adverse Reactions (SUSARS) and annual safety reports
These changes originally only applied to research approved by RECs in England and Wales.
Our partners in Scotland and Northern Ireland have now had the opportunity to consider how these changes could impact local research environments and will be implementing these changes from 1 August 2024.
This means that from 1 August, RECs throughout the UK will now be aligned, and there will be no difference in approach in RECs in England, Wales, Scotland and Northern Ireland with respect to the above changes.
Changes to annual progress reporting
Based on feedback we are removing the requirement to submit annual progress reports to help reduce the burden on researchers. This change will take effect throughout the UK from Thursday 1 August.
Please be aware however that annual reviews should continue to be submitted to the Confidentiality Advisory Group (CAG) using the form on IRAS. This is because the legislation that CAG operates under requires the applicant to annually review how they are using confidential patient information and moving towards existing support. This annual review also allows for the public registers of approved applications to be updated and maintain an accurate record.
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
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 UK wide 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 UK alignment with 1 August 2024 as an implementation date. We will work together with our Devolved Administration partners to monitor the impact of these changes on an ongoing basis to ensure that their implementation continues to benefit staff, REC members and applicants, and ensure effective and efficient use of resources.
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