We’ve made some important changes to our Research Ethics Committee (REC) processes for progress reports and safety reports to help reduce the burden on researchers.
The changes were applied to research approved by RECs in England and Wales from 1 June and came into effect in Scotland and Northern Ireland from Thursday 1 August.
What's changing
There have been two changes to the process for studies approved by RECs across the UK.
The changes are:
- removal of the requirement to submit annual progress reports
- changes to how we acknowledge Suspected Unexpected Serious Adverse Reactions (SUSARS) and annual safety reports
Changes to annual progress reporting
Based on feedback we've removed the requirement to submit annual progress reports to RECs to help reduce the burden on researchers:
- 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
- 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 to the REC.. This means that the Research Ethics Committee and wider community still receives information regarding the outcome of the research
Changes to SUSARS and annual safety reports
We’ve made changes to how we acknowledge 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
- 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 the clinical trials regulations and prevents unnecessary work for our teams
What happens next?
The changes will apply to the whole of the UK from 1 August 2024.
Alongside our colleagues across the UK, we will monitor the impact of these changes to ensure that their implementation benefits the research community.
If you have any questions or need further advice, please email us or call 0207 104 8000.