Amendments are changes made to a research project after approval from a review body has been given. If you plan to make an amendment to your research project, you will need to determine whether you need to notify the review bodies from whom you have received approvals.
For advice on amendments to health and social care research during the COVID-19 pandemic, please see our special guidance.
It is the sponsor’s responsibility to decide whether an amendment is substantial or non-substantial. To help you with this categorisation, we have provided examples of substantial and non-substantial amendments.
If you are seeking guidance on whether you need to take any action for your research project in order to comply with the new General Data Protection Regulations, please refer to our GDPR guidance.
Additionally, we have produced a series of email templates to support sponsors when notifying NHS organisations in England of an amendment and to confirm when an amendment can be implemented.
The use of these email templates is optional, however we believe their contents will allow sponsors to provide NHS organisations with the information they need to enable amendments to be implemented. The templates can be found on the IRAS application website.
No. With the exception of urgent safety measures, if your amendments require approval your changes cannot be implemented until the relevant approvals are in place.