Monitoring, reporting and changes after approval

Modifications to your application

Common modifications to research applications include but are not limited to:

• Personnel changes (addition or removal of staff or students, including changes to student supervisors)
• Changes to the project title
• Changes to research aims and/or methodology 
• Changes to recruitment, advertising or consent processes and/or documentation 
• Changes to participant group(s) and/or participant numbers
• Changes to data management 
• Extension of ethics approval period.
   

Note: Approval from the Swinburne University Human Research Ethics Committee (SUHREC) or Swinburne Human Ethics Sub-Committee (SHESC) is required before implementing any changes to your approved research protocol.
 

How to request a modification to your human research ethics application:

1. Go to the Swinburne Ethics Review Management website. 
2. Click ‘Log in’ in the top right-hand corner of the menu bar and enter your Swinburne email address and password.
3. Find the approved application that you wish to modify.
4. Click on ‘Create a Sub-form' on the left Action Tab.
5. From the drop-down list select ‘Human Ethics Modification Request’.
6. Complete the modification request. You will be asked to obtain Chief Investigator sign-off if you are not the Chief Investigator.
7. Attach tracked and clean copies of any amended documentation. 
8. Submit the signed form using the ‘Submit’ button on the left action tab. You will receive an automated email confirming that the application has been submitted.
9. Your modification will be reviewed and either a request for more information or an approval letter will be sent to the Chief Investigator via email.
    

Reporting requirements

A standard condition of ethics clearance for all human research is that the Chief Investigator is responsible for submitting reports on the conduct of a project in compliance with the approved protocol.
 

Reports are required:

• At least annually on the anniversary of the approval date (Progress Report) 
• Upon completion of active human research activity (Final Report)
• Upon abandonment of the project
• As required by Swinburne and/or the Swinburne ethical review body or external authority
• When a higher degree by research (HDR) student’s involvement in the project has ended but the project is otherwise still continuing.
   

The HDR student will receive a statement from the Research Ethics Office confirming that ethics reporting requirements were met. The student should provide a copy of this statement to the Graduate Studies Office as part of their thesis submission.

Note: If the end of a student’s involvement coincides with the end of the study overall, only a Final Report is required.

Please see our ERM Human Ethics Applicant Guide for detailed information on how to submit an annual or final report.

Incidents and adverse events

Incidents and adverse events are any unforeseen incidents or events that might affect the ethical acceptability of the research, particularly those that adversely affect research participants, Swinburne and its researchers, or the general community. Examples include harm or significant distress to participants, harm to a researcher, loss of data or breaches of confidentiality.

If your research experiences an adverse event or incident, this should be reported to the Research Ethics Office as soon as possible via the ‘Adverse Events’ form in the Ethics Review Management (ERM) system.

Please see our ERM Human Ethics Applicant Guide‌ for detailed information on how to submit an incident or adverse event in ERM.