Monitoring, reporting and changes after approval
Approval from SUHREC or SHESC is required before implementing any changes to your approved research protocol.
Common modifications 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
- Changes to data management
- Extension of ethics approval period
How to request a modification to Human Ethics applications
Please see our ERM Human Ethics Applicant Guide for detailed information on the following steps:
- Log into ERM (www. ethicsapps.swin.edu.au)
- Find the approved application in ERM that you wish to modify (if you cannot find a migrated application it may be because the CI has not shared it with you. Please ask the CI to share the application with you- see applicant guide for more information).
- Whilst in the project, click on create a Sub-form button on left hand side Action Tab.
- From the drop down list select “Human Ethics Modification Request”.
- Complete the modification request. You will be asked to obtain CI sign off if you are not the CI.
- Attach tracked and clean copies of any amended documentation.
- Submit signed form using the Submit button on the left hand side action tab.
- Your modification will be reviewed and either a request for more information or approval letter will be sent to you via email.
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
- Additionally as required by Swinburne and/or the Swinburne ethical review body or external authority
- On completion of a HDR student’s involvement in the project*
* This section of the ‘Progress/Final Report’ form should be completed when a higher degree by research student (professional doctorate, PhD or Masters by research student) has completed their involvement in a project that is otherwise still continuing. The student will receive a statement from the Ethics Office confirming that ethics reporting requirements were met. The student should provide a copy of this statement to the Graduate Studies unit as part of their thesis submission. [Note that if the end of a student’s involvement coincides with the end of the study overall, only a Final Report is required.
How to submit an annual or final report in ERM
Please see our ERM Human Ethics Applicant Guide for detailed information on how to submit an annual or final report.
If your research experiences an adverse event or incident, this should be reported to the Swinburne Ethics Office as soon as possible via the ‘Adverse Events’ form in ERM. Incidents/adverse events, are any unforeseen incidents or events that might affect continue ethical acceptability of the project, particularly those that adversely affect research participants, Swinburne and its researchers, or the general community. Examples of this include harm or significant distress to participants, harm to a researcher, loss of data, breaches of confidentiality, etc.
How to submit an incident report or adverse event in ERM
Please see our ERM Human Ethics Applicant Guide for detailed information on how to submit an incident or adverse event in ERM.