[Skip to content]

National Research Ethics Service
Search our Site
Health Research Authority
National Patient Safety Agency - National Research Ethics Service - facilitating and promoting ethical research
.

Notification of amendments

Amendments are changes made to the research after a favourable ethical opinion has been given. They can be ‘substantial’ or ‘non-substantial’.

Amendments which need to be notified

A substantial amendment is defined as an amendment to the terms of the application, or to the protocol or any other supporting documentation, that is likely to affect to a significant degree:  

  1. the safety or physical or mental integrity of the subjects of the trial;  
  2. the scientific value of the trial;  
  3. the conduct or management of the trial; or  
  4. the quality or safety of any investigational medicinal product used in the trial.


Substantial Amendment Forms

For CTIMPs
For all other research

Overview

Flowcharts showing the process of ethical review of substantial amendments to approved research

Is my amendment substantial?

For all studies, it is the responsibility of the sponsor to determine whether an amendment is substantial.
Any valid amendment submitted as a substantial amendment will be accepted for review. If the sponsor is satisfied that an amendment is not substantial, there is no requirement to notify the REC although non-substantial amendments may be notified for information only at the sponsor’s discretion. Sponsors and CIs may seek advice from the REC office on whether an amendment should be considered substantial.
 
You must inform the main REC of all substantial amendments by completing the notice of substantial amendment available in IRAS or by using the links on this page.

Further guidance

You can find further guidance in section 5 of the NRES Standard Operating Procedures.