Research governance updates

From 28 April 2026, the terminology used to describe amendments to HRA and/or NHS REC studies is changing. 'Amendments' will be called 'Modifications'. 

The amended Clinical Trial Regulations will come into effect on the 28th of April 2026. Consequently, the term 'amendment' will be changed to 'modification'. This is being implemented to align with the European Union and the changes to terminology for clinical trials of an investigational medicinal product (CTIMP). 

This change of terminology is being rolled out to all types of studies with HRA and/or NHE REC review. 

For researchers:

• If you are planning to submit a change to a study in advance of the 28 April 2026, carry on as planned under the current system by completing an 'Amendment Tool' and submitting to the Research Governance Team for review and sign off. 
• If you are planning to make a change that can be submitted after 28 April 2026, the Research Governance Team recommends that you wait for the new 'Modification Tool' to be issued and progress under the new terminology. The Research Governance Team still need to review your amendment prior to submission. 

Further information about the changes can be found on the HRA website:

The approvals process for modifications (amendments) - Health Research Authority

Update to ‘amendment’ terminology - Health Research Authority

Update to ‘amendment’ terminology for non-CTIMPs - Health Research Authority

If you have any questions or would like to discuss further please contact the Research Governance Team at research-governance@bristol.ac.uk 

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Update published 08.04.2026