Amendments are changes made to a research study after favourable opinion from a review body has been given. These changes can be made to the protocol, essential documentation considered as part of the NHS Permission process, or other aspects of a study’s arrangements.
An amendment to a research study can be either substantial or non-substantial. Amendments are regarded as substantial when they have a significant impact on:
- the safety or physical or mental integrity of the subjects
- the scientific value of the project
- the conduct or management of the study
- the quality and safety of any investigational medical product used a clinical trial (CTIMP)
A non-substantial amendment can be defined as a change to the details of a study which will have no significant implication on participants, the conduct, management or scientific value.
All amendments and supporting documentation should be uploaded and submitted for review via online submission. In the first instance, complete the Amendment Tool:
https://www.myresearchproject.org.uk/help/hlpamendments.aspx#Amendment-Tool
For all studies sponsored by Swansea University in 2022 and previously, please then submit the completed Amendment Tool, along with any study documents that have been updated, to the Research Governance team (researchgovernance@swansea.ac.uk).
PLEASE NOTE: For studies receiving sponsorship from Swansea University in 2023, and subsequently, your study application will have been progressed through the Research Healthcare Sponsorship online portal. In this case please complete the Amendment sub-form available on the online portal (accessed through My Apps under the ‘Research Ethics Applicant’ tab. Please use the form entitled ‘Healthcare Sponsorship’ and 'Amendment sub-form).
Subsequently, submit the locked Amendment Tool and updated documents via IRAS
https://www.myresearchproject.org.uk/help/hlpamendments.aspx#Online-Submission
You may need to notify the study review bodies of the amendment, and a favourable opinion from the main REC must be received before amendments can be implemented.
The links below contain helpful information also:
https://www.hra.nhs.uk/approvals-amendments/
