Frequently Asked Questions

Q1: I’m seeing a message stating “Project owner needs to update form” – what does this mean?

If you are seeing this message it is because you are not using the most recent version of the form(s). Only the Project Owner can update the form – if you are not the Project Owner, please ask the Project Owner to click on the blue ‘Update’ button to ensure you are using the latest version. This may result in some additional and/or different questions needing to be answered, and will require sign-off from the Chief Investigator before the completed and updated form can be submitted. Note: The Project Owner is the person who initiated the original application. If this person is no longer at Swinburne, please contact the Research Ethics Office for assistance (resethics@swin.edu.au).

Q2: My supervisor/collaborator can’t see my form – what should I do?

If your collaborator or supervisor can’t see your project/form in ERM it is likely that you have not shared it with them in the system. Please select the application and then click on the ‘Share’ icon at the left hand side of the screen. You will be prompted to enter the Swinburne email address of the person(s) you are wanting to share the application with (non-Swinburne personnel cannot access ERM). You can grant access for the collaborator to Read, Write, Submit, Share, Create Sub-forms and Receive Notifications. It is recommended that all options are selected.

Q3: Who can/should be the Chief Investigator on the ethics application?

The Chief Investigator must be a Swinburne staff member. External collaborators or Swinburne adjuncts cannot be the CI on an ethics application. For HDR students, the Chief Investigator should be the Primary Supervisor of the student at Swinburne.

Q4: What happens if there is a change in Chief Investigator?

The Chief Investigator is the person who takes overall responsibility for the ethics application and conduct of the project at Swinburne (and for HDR projects, would generally be the Primary Supervisor at Swinburne). If there is a change in Chief Investigator (or Principal Supervisor) a modification request needs to be submitted in ERM with all public documents updated to reflect the change in CI. Please note that ERM retains the details of the original CI and all communications will continue to go to that person, but the Ethics Office will forward all relevant information to the new CI.

Q5: Can an external collaborator or Swinburne adjunct access ERM?

ERM relies on users having a Swinburne email address. Adjunct Swinburne staff can therefore access ERM, but cannot be the Chief Investigator. External collaborators cannot access ERM. If you would like an external collaborator to see your ethics application, please create it in pdf format using the ‘print to pdf’ feature within the system and circulate it via email.

Q6: Can I share my ethics application with someone else?

As noted above, you can share your application with someone else within ERM but that person MUST have a current Swinburne email address. It is not possible to share the application on-line with an external person.

Q7: How do I modify my approved application?

To submit a modification request once logged into ERM: 1. Click on the project 2. Select ‘create sub form’ on the left-hand side 3. Select ‘Modification’ from the pull-down menu 4. Complete the modification form and ensure any new and/or modified documents are attached (in tracked changes) 5. Once completed please ensure the CI signs off and you click on ‘Submit’ 6. The Chief Investigator will receive an automated email confirming submission when done correctly.

Q8: How do I submit a Final or Progress report?

To submit a report once logged into ERM: 1. Click on the project 2. Select ‘create sub form’ on the left-hand side 3. Select report and select the option ‘Final Report’ at B1 (or if there is a student component select ‘Final Report INCLUDING a report on completing students’) 4. Once completed please ensure the CI signs off and you click on ‘Submit’ 5. The Chief Investigator will receive an automated email confirming submission when done correctly.

Q9: What does it mean if the status of my application/modification is ‘Out of Session Review’?

Once your revised application/modification has been resubmitted, it is allocated to one or more ethics committee members for review ‘out of session’. This means that reviewers assess the revised application between meetings (ie. you do not have to wait until the next meeting or comply with meeting submission deadlines). Reviewers are usually asked to complete their reviews of modifications, or revised applications, within 5 working days.

Q10: I am getting a message stating that my form is ‘locked’. What does this mean?

A form is locked in the following circumstances: (a) The application/modification/report form has been approved. This is the version of the form approved by the Ethics Office and cannot be changed. An approved application/form cannot be unlocked. (b) The application/modification/report has been sent to the Chief Investigator for signature. If changes are to be made at this stage, the CI must unlock the form by clicking on the ‘Unlock’ icon so that the changes can be made. A new signature request must then be sent to the Chief Investigator before the form can be submitted.

Q11: How will I know that my application/modification/report has been submitted?

When an application/modification/report is submitted, the Chief Investigator will receive an automated email confirming submission. The system does not send communications/notifications to all listed investigators and so the onus is on the Chief Investigator to share communications/notifications as needed within the project team.

Q12: What is a Research Ethics Advisor?

Research Ethics Advisors (REAs) are members of Swinburne’s Human Research Ethics Sub-committees (SHESC) and are available to advise on research ethics queries from staff and students. The role of REAs is not to write your ethics application, but to provide support by: • advising on whether your research requires ethics review and what level of review is needed (ie. SUHREC or SHESC); • highlighting discipline-specific ethical issues in research activities; • assisting with the design of your research to ensure compliance with the National Statement on Ethical Conduct in Human Research; • conducting a pre-review of draft ethics applications prior to submission (note: this is different to peer-review); • assisting with response to committee feedback post-review; • providing general advice on ethics processes at Swinburne. Please be respectful of the Advisors’ other commitments by allowing sufficient time for them to consider and respond to your queries. For student projects, assistance from a Research Ethics Advisor should be done in conjunction with your supervisor. Contact information for REAs and a description of their research areas is available here: https://www.swinburne.edu.au/research/ethics-integrity/human-research/

Q13: What are the submission deadlines for SUHREC and SHESC applications, or modifications?

Submission deadlines for SUHREC and SHESC applications are available here: https://www.swinburne.edu.au/research/ethics-integrity/human-research/how-to-apply-for-ethical-review/. Requests for expedited review applications (which have received prior ethics approval from another institution whose HREC is registered with the NHMRC) can be submitted at any time. Further information regarding expedited review applications is available here: https://www.swinburne.edu.au/research/ethics-integrity/human-research/how-to-apply-for-ethical-review/ Modification requests can be submitted at any time. Further information regarding modification requests is available here: https://www.swinburne.edu.au/research/ethics-integrity/human-research/monitoring-reporting-changes-after-approval/

Q14: I am a HDR student and need confirmation of my ethics approval and Final Report so that I can submit my thesis. Where can I obtain this information?

Graduate Studies requires HDR students to include: (a) a copy of their ethics approval and (b) acknowledgement of a satisfactory Final Ethics Report when the student submits their thesis. The initial ethics approval can be obtained from the Principal Supervisor/Chief Investigator. The Final Report needs to be submitted on completion of the study in ERM and will be processed by the Ethics Office. If there are any queries regarding the report it will be sent back to the CI/student for clarification. Once the report has been approved by the Ethics Office, confirmation of the approval will be sent to the Chief Investigator. This confirmation needs to be included in the thesis submission.

Q15: Are there any templates available for the supporting documentation for my ethics application?

Templates are available in the ‘Help’ section of ERM for the following documents: • Consent Information Statement and Consent Form • Peer review proforma • Photograph consent form • Self-audit tool • Form for obtaining parental consent for minors • Guide for point-by-point response to ethics review

Q16: What is the “point-by-point response” document?

Once your new ethics application has been reviewed by SUHREC or SHESC, you will be asked to resubmit the application in ERM, and attach a ‘point by point response’ document to Section K of the application form. This document lists each of the queries raised by the committee and a corresponding response outlining how you have addressed each particular query. If the queries result in changes being made to the online application form, these changes should be made in ERM, and, where relevant, any supporting documentation attached to the form in tracked changes format. Please note that the revised application cannot be reviewed by SUHREC or SHESC members if you have not attached the point-by-point response. A recommended template for the point-by-point response document is available in the ‘Templates’ section of ERM.

Q17: Can I transfer my ethics application to another researcher?

Yes, the ‘Project Owner’ can transfer the application to another Swinburne staff member by clicking on the ‘Transfer’ button. The original Project Owner will then no longer see the application in ERM, unless the new Project Owner shares the application with them as a collaborator. Please consider whether transferring the ethics application necessitates a corresponding modification request if there are any personnel changes on the study.

Q18: I am leaving Swinburne - what do I need to do with my approved projects?

If you are the Chief Investigator on a project and will be leaving Swinburne it is important that your ethics portfolio is up to date. This means: (a) For projects where ethics approval has expired and/or the project is no longer continuing under Swinburne auspices (ie. no Swinburne staff or students are involved), please submit a Final Report in ERM. (b) For projects that are still continuing at Swinburne with existing and/or additional personnel, please submit a modification request to change the Chief Investigator, ensuring that all supporting documentation is updated and attached to reflect the change in CI. If you are not the Chief Investigator on a project and will be leaving Swinburne, please ask the CI to submit a modification request to either remove you from the project or, if you are still continuing work on the project at a different institution, to update your affiliation on the study.

Q19: Is my research project a clinical trial?

Please see clinical trial decision tree template under 'help - templates' at the top of the page in ERM. This document can assist with determining if your projects fits the definition of a clinical trial.