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.
- tell you whether you need to notify a review body and if so, in what capacity.
- provide detailed instructions on submission of amendments.
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.
Implementing amendments at NHS organisations in England
Please see information on IRAS Help.
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 below:
- Template email for sponsors to share category A or B amendment documents with sites (regulatory approvals outstanding)
- Template email for Category A or B amendment documents with sites – where regulatory approvals in place
- Template email for sponsors to share category C amendment documents with sites
- Template email for sponsors to confirm implementation of an amendment
Can I start my research project while waiting for amendment approval?
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.