Research ethics amendment requests

What is a research ethics amendment?

A research ethics amendment is a process used to document a change to a research ethics application that has already been reviewed and has received a favourable ethical opinion. During the research data collection, situations can arise whereby a researcher may wish to implement a change to their research that was not covered in their original ethics application. 

Ethics application amendments are for relatively minor changes (for example expanding the recruitment pool, making changes to a questionnaire, or changing the data collection dates), and significant changes may require another ethics application altogether. 

How do I make amendments to my ethics application?

To submit an amendment request the following process should be followed:

• Log onto the Online Research Ethics Management System (OREMS);
• Select the ethics application in your work area that you intend to submit a study amendment.
• In the Actions section, select 'Create a Sub Form', select 'Amendment Notification Form' from the drop down menu and select 'Create'.
• Complete the Amendment Notification Form outlining your proposed changes and upload any newly created or revised study documents (with the changes highlighted or track changed) for review.
• Once submitted your Amendment Request will be validated for completeness by a member of the Research Governance Team.
• The Chair will review the amendment request and revised study documentation and make their decision. The Chairs decision will be communicated to the Research Governance and Ethics Officer who will feedback the chairs decision to the appropriate researcher.
• The decision reached will be either a favourable, conditional or unfavourable opinion. A letter will accompany the decision, explaining the reasoning, that will be sent to you.