Single-site ethics

If you’re starting a new project at Grampians Health, it might be a Quality Assurance (QA) project, or a Low Risk (LR) research project, or a greater-than-low-risk research project (needing full review via a Human Research Ethics Application, or HREA).

This page has information about how to:

1. choose the correct pathway, and 
2. submit an application to each of these pathways. 

This ultimately depends on your project plan/protocol. This checklist can help determine if you are doing research. But also, feel free to contact us, even if you don’t have a formal plan/protocol yet.

If yes → Research Ethics approval is required (don’t worry, it’s often helpful, and not as daunting as it sounds).

Please see the LR and HREA pathway sections, below.

If you’re doing a QA project, but there are ethics triggers (e.g. extra patient info being collected, difficult questions, vulnerable groups, potential distress) → you may still need to get ethics review. Again, consider this checklist, and please contact us to discuss.

You need organisational oversight for quality/improvement projects via one of two pathways:

• REGO QA pathway (submit to Research Ethics and Governance Office – see QA section, below)
  • You must use this pathway if:
    (a)    You plan to share results externally (journal, conference, Masters/PhD).
    (b)    You need to access individual patient records.
    (c)    The project might evolve into research.
• Quality/Improvement teams (track in RiskMan Q)
  • If it’s not research, and there are no ethics triggers – and none of (a), (b) or (c), above, apply – then you can proceed via Quality/Improvement teams and RiskMan Q. Still be ethical of course!

Please review the fee schedule.

If fees apply, complete the Grampians Health HREC and Governance Fees Form and include this in your submission documents.

This form makes sure we have the correct information to issue your invoice.

First, complete your Project Plan, using this template. This includes prompts that will help you complete each section.

You will also need to finalise your project team – all those involved in data collection/analysis, as well as project design/oversight, should be on the team, with one person taking overall responsibility as Principal Investigator – and ensure you have the support of your Head of Department.

You must finalise all study documents, for example:

• Project Plan, surveys, data collection tools (perhaps a spreadsheet or REDCap tool)
• Recruitment and consent materials (posters, Plain Language Statements, etc)
• Don’t forget to add version control (e.g. V1 01-01-2027) to all files, both inside the document, and in the filename!
• Also prepare investigator documents: CV and evidence of professional registration for each investigator (e.g. current AHPRA certificate). For CVs, you can use this template [link to Researcher CV template Word file] if preferred to your regular CV.
• When everything for your project is ready, you apply for QA approval via the online platform ERM (you’ll need to create an account – it doesn’t take long)
• Create a new project in ERM, selecting the “Quality Assurance Victoria” form
• this will ask you some questions about the project
• you’ll need to upload all project documents, as well as investigator documents
• you’ll also need to get Head of Department approval, by getting their signature on the form (if the HOD is on the project team, then they cannot sign approval – rather, the person to whom they report must sign as approving HOD)
• ERM has a signing function that should make this pretty straightforward for anyone who has an ERM account
• you’ll then need each investigator to sign the QA form → then submit to us! We will let you know if there are any omissions/errors/issues with the application and how you can fix it – otherwise, we’ll send you an approval letter!

This pathway is only available for truly low-risk projects. We encourage you to contact us to discuss the risk level – no project is risk-free, and sometimes the risks are not obvious, especially to new researchers. 

If there will be any risk to participants greater than discomfort, or if you are going outside standard care processes, then the project is unlikely to be considered low risk, and the HREA pathway (below) is likely to be the correct one. The two pathways are not that different, so keep your focus on what you want the project to achieve, rather than what pathway you want to go down.

Again, this checklist can help determine the correct pathway, and we are always here to help.

To submit on the LR pathway:

• First, complete your Protocol, using this template. This includes prompts that will help you complete each section.
• You will also need to finalise your project team – all those involved in data collection/analysis, as well as project design/oversight, should be on the team, with one person taking overall responsibility as Principal Investigator – and ensure you have the support of your Head of Department.
• In addition to your Protocol, you must finalise all study documents, for example:
  • Protocol, surveys, data collection tools (perhaps a spreadsheet or the REDCap tool which is available via your Grampians Health log into SharePoint)
  • Recruitment and consent materials (posters, Plain Language Statements, etc, 
  • Close attention to Participant Information and Consent Forms (PICFs) is required, or if you are seeking a waiver of the requirement to obtain consent, there is a particular way you must do this – see here for more information
  • When everything is ready, you must have the project reviewed by someone independent of the project, but with the appropriate expertise – this is peer review of the project. You ask the peer reviewer to use this form and have that ready for your submission.
  • Don’t forget to add version control (e.g. V1 01-01-2027) to all files, both somewhere inside the document (e.g. footer), and in the filename!
  • Also prepare investigator documents: CV, evidence of professional registration (e.g. current AHPRA certificate), and a GCP certificate for each investigator. For CVs, you can use this template [link to Researcher CV template Word file] if preferred to your regular CV.
  • When everything for your project is ready, you apply for LR review and approval via the online platform ERM (you’ll need to create an account – it doesn’t take long)
• Create a new project in ERM, selecting the “Low Risk VIC” form
  • this will ask you a number of questions about the project
  • you’ll need to upload all project documents, as well as investigator documents – here’s a quick reference list (which won’t suit every project):
    • Protocol
    • Recruitment materials and consent documents
    • Data collection tools, workshop plans, etc
    • Everything has version control?
    • Peer review
    • All investigator documents
    • Fee form
  • When the submission is ready to submit (and not before!) you’ll need each investigator to sign the LR form. ERM has a signing function that should make this straightforward for anyone who has an ERM account, otherwise it provides wet-ink options.
  • Then submit to us! We’ll let you know if there are any omissions/errors/issues with the application and how you can fix it – otherwise, it will proceed to review by the Low-Risk Review Sub-committee.
  • We will send the review outcome to you – this is normally a couple of weeks later, but depends on a number of factors, including the quality of the application (so take care!). It may be Approved, Approved subject to conditions (things you must address to obtain approval), or Not Approved.

Keep in mind, there is an extra step that’s required AFTER you’ve secured your ethics approval.

You need to obtain research governance authorisation of the project. 

This is also done via ERM – with more information available here  – and essentially involves obtaining the signature of the relevant Head of Department to demonstrate their approval of the study, and making sure that any required agreements are in place with external organisations.

Again, this checklist can help determine the correct pathway, and we are always here to help - Contact Us.

To submit on the HREA (full HREC review, greater-than-low-risk) pathway:

• First, complete your Protocol, using this template. This includes prompts that will help you complete each section.
• You will also need to finalise your project team – all those involved in data collection/analysis, as well as project design/oversight, should be on the team, with one person taking overall responsibility as Principal Investigator – and ensure you have the support of your Head of Department.
• In addition to your Protocol, you must finalise all study documents, for example:
  • Protocol, surveys, data collection tools (perhaps a spreadsheet or the REDCap tool which is available via your Grampians Health log into SharePoint)
  • Recruitment and consent materials (posters, Plain Language Statements, etc)
  • Close attention to Participant Information and Consent Forms (PICFs) is required, or if you are seeking a waiver of the requirement to obtain consent, there is a particular way you must do this – see here for more information
  • Applications on this pathway must complete the “Victorian Specific Module (VSM)” to address Victoria-specific legal requirements – this is available here 
  • When everything is ready, you must have the project reviewed by someone independent of the project, but with the appropriate expertise – this is peer review of the project. You ask the peer reviewer to use this form and have that ready for your submission.
  • Don’t forget to add version control (e.g. V1 01-01-2027) to all files, both somewhere inside the document (e.g. footer), and in the filename!
  • Also prepare investigator documents: CV, evidence of professional registration (e.g. current AHPRA certificate), and a GCP certificate  for each investigator. For CVs, you can use this template [link to Researcher CV template Word file] if preferred to your regular CV.
  • When everything for your project is ready, you apply for LR review and approval via the online platform ERM  (you’ll need to create an account – it doesn’t take long)
• Create a new project in ERM, selecting “HREA” (Human Research Ethics Application) form
  • this will ask you a number of questions about the project
  • you’ll need to upload all project documents, as well as investigator documents – here’s a quick reference list (which won’t suit every project):
    • Protocol
    • Recruitment materials and consent documents
    • Data collection tools, workshop plans, etc 
    • VSM 
    • Everything has version control? 
    • Peer review 
    • All investigator documents 
    • Fee form 
    • Extra document for clinical trials (see below)
  • When the submission is ready to submit (and not before!) you’ll need each investigator to sign the LR form. ERM has a signing function that should make this straightforward for anyone who has an ERM account, otherwise it provides wet-ink options.
  • Then submit to us! We’ll let you know if there are any omissions/errors/issues with the application and how you can fix it – otherwise, it will proceed to review by the Low-Risk Review Sub-committee.
  • We will send the review outcome to you – this is normally a couple of weeks later, but depends on a number of factors, including the quality of the application (so take care!). It may be Approved, Approved subject to conditions (things you must address to obtain approval), or Not Approved.

Keep in mind, there is an extra step that’s required AFTER you’ve secured your ethics approval.

You need to obtain research governance authorisation of the project. This is also done via ERM – with more information available here – and essentially involves obtaining the signature of the relevant Head of Department to demonstrate their approval of the study, and making sure that any required agreements are in place with external organisations.

Final note

If you plan to conduct a clinical trial, some further documents are required (e.g. Investigator Brochure (IB) for drug and device studies; indemnity and insurance paperwork; CTN form from the TGA; radiation paperwork; etc) – as well as extra investigator training requirements. Please contact us to discuss.