Make amendments or changes to the study

To protect the safety and wellbeing of participants, changes to the study may need to be checked with the bodies that provided approvals. You will need to consider whether any changes need such notification via the UK’s online integrated research application system (IRAS), using the protocol as your reference.

Changes to the study after initial approval by the review bodies are called amendments. Some changes may have impact on the study resources or timescales or may have impact on the participants. Some are more minor.

As well as considering changes against the protocol for submission as amendments via IRAS, you should consider whether the funder or study sponsor may have concerns or interest in how the changes affect the study.

Researchers can apply for amendments to the study in the UK through IRAS which allows the researcher to apply for and manage all permissions and ethical approval through a single application.

For more information contact the Health and Care Research Wales support and delivery service.