Modifications (previously 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.
A modification to a research study can generally either be substantial or non-substantial. Modifications 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 modification 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 modifications and supporting documentation should be uploaded and submitted for review via online submission. In the first instance, complete the Modification 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 Modification 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 Modification 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 'Modification sub-form).
Subsequently, submit the locked Modification Tool and updated documents via IRAS
https://www.myresearchproject.org.uk/help/hlpamendments.aspx#Online-Submission
For substantial modifications, the study review bodies will review the modification, and a favourable opinion from the main REC and/or HRA must be received before these modifications can be implemented.
The links below contain helpful information also:
https://www.hra.nhs.uk/approvals-amendments/
