An application is required for any proposed research project including Quality Assurance (QA), quality improvement, or audit activities, where there is an intention to publish or otherwise present the data beyond the hospital staff. Applications are assessed by RDU and relevant committees to ensure they meet ethical, governance, regulatory, legal, budget and resource requirements.
Researchers are encouraged to discuss projects early with their Manager and Head of Department to ensure support for ethics and governance submission.
To prepare an application, follow these steps:
Step 1. Contact RDU
RDU is here to help you plan your research project and submit your application. Email us at rdu@barwonhealth.org.au and a member of the RDU team will get back to you within 24 hours.
To help us provide you with the best support, please include in your email:
- The research question you want your project to answer
- A brief description of the project (3 – 5 sentences)
- Any documents you already have underway
- Your phone number
- Your Barwon Health reference number (if you have a current application)
New to research and not sure where to start? Click here for a handy video.
Want to submit your application for review at the next HREC meeting? Click here for meeting dates.
Step 2. Reference Number
All research applications submitted to Barwon Health for review must have a Barwon Health reference number. To generate a reference number, click here.
Please ensure that your Barwon Health reference number is included within your application (as the local reference) and in all correspondence with RDU.
Step 3. Risk Level
Application requirements vary depending on the level of risk involved to the participants and participating institutions, and Barwon Health’s role within the project.
To determine which risk level applies to your research project, review the table below or complete the Level of Risk Checklist.
| Risk Level | Criteria |
| QA/Minimal Risk | Minimal risk research is described as research in which there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. This includes research involving:
If the research involves the collection of new raw data, or sensitive and identifying information, then the research is not minimal risk. |
| Low Risk | Low risk research is described as research in which the only foreseeable risk is one of discomfort. |
| Greater than Low Risk | Where the risk, even if unlikely, is more than discomfort, the research is NOT low risk; it is greater than low risk. This includes research involving:
|
Step 4. Begin Your Application
Follow the application process that suits your research type by selecting one of the options below.
Single-site projects include projects that use data/specimens or seek participants from one site only.
Your project is single site if you are asking Barwon Health to review the project for one site only. Barwon Health is considered a single site, which includes all Barwon Health owned locations (i.e. Barwon Health North, McKellar Centre, etc.).
Review Process for Single-site Projects
Low and greater than low risk single-site research projects must follow BH HREC submission deadline dates to ensure they are reviewed at the next HREC meeting.
All other single-site research projects are accepted at any time for out of session review.
| Research Type | Ethics & Governance Review Process | Next Step |
|---|---|---|
| Single-site QA/Minimal Risk | Reviewed by RDU with advice from the BH HREC (out of session) | For instructions on submitting your application, visit: |
| Single-site Low Risk | Reviewed by BH HREC and RGO | For instructions on submitting your application, visit: |
| Single-site Greater than Low Risk | Reviewed by BH HREC, RGO and RMC | For instructions on submitting your application, visit: |
Multi-site projects include any projects that involve more than one site, institution or centre. The definition of multi-site is where the Barwon Health HREC is asked to provide ethical approval for more than one site. Each site should have its own Principal Investigator and recruit/collect data from that site.
Review Process for Multi-site Projects
Low and greater than low risk multi-site research projects involving Victorian regional sites only must follow BH HREC submission deadline dates to ensure they are reviewed at the next HREC meeting.
All other multi-site research projects, including research involving metro/interstate sites, are accepted at any time, for out of session review or governance only review.
Click here to download a handy Ethics Checklist developed by the Victorian Government Coordinating Office for Clinical Trial Research.
| Research Type | Ethics & Governance Review Process | Governance Only Review Process | Next Step |
|---|---|---|---|
| Multi-site QA/Minimal Risk | Research involving Metro/Interstate sites: First seek ethics review from NHMRC Certified Reviewing HREC*, then follow the Governance Only Review Process
Research involving VIC Regional sites only: Reviewed by RDU with advice from BH HREC (out of session) and RMC |
Reviewed by RGO (with advice from RMC) | For instructions on submitting your application, visit: |
| Multi-site Low Risk | Research Involving Metro/Interstate sites: First seek ethics review from NHMRC Certified Reviewing HREC*, then follow the Governance Only Review Process
Research Involving VIC Regional sites only: Reviewed by BH HREC, RGO and RMC |
Reviewed by RGO (with advice from RMC) | For instructions on submitting your application, visit: |
| Multi-site Greater than Low Risk | Research Involving Metro/Interstate sites: First seek ethics review from NHMRC Certified Reviewing HREC*, then follow the Governance Only Review Process
Research Involving VIC Regional sites only: Reviewed by BH HREC, RGO and RMC |
Reviewed by RGO and RMC | For instructions on submitting your application, visit: |
| Regional Health Service Collaborations | Reviewed by the BH HREC, RGO and RMC | Reviewed by RGO and RMC | For instructions on submitting your application, visit: Regional Health Service Collaborations |
| Deakin University Collaborations | Reviewed by BH HREC, RGO and RMC | N/A | For instructions on submitting your application, visit: Deakin University Collaborations |
*Click here to view the current list of Reviewing HRECs certified by the National Health & Medical Research Council (NHMRC) to provide ethics review for multi-centre research projects under the NMA initiative.
The guidelines for Clinical Quality Registries (CQRs) are currently under review within Australia.
For single-site CQRs being implemented at Barwon Health only: Please follow the application process for Single-site Low Risk Applications.
For multi-site CQRs: RDU recommends contacting Alfred Health’s Research Office to provide ethics oversight of your registry under the NMA initiative.
In certain circumstances, a patient may require access to medicines or medical devices that are not listed on the Australian Register of Therapeutic Goods (ARTG).
To enable supply of such unapproved therapeutic goods, a submission to the Therapeutic Goods Administration (TGA) can be made under one of the following schemes:
- The Special Access Scheme (SAS) facilitates supply of an unapproved therapeutic good for a single patient.
- The Authorised Prescriber Scheme (APS) facilitates ‘authorisation of a medical practitioner’ to prescribe an unapproved therapeutic good for multiple patients under their care.
For further information, please refer to the Access to Unapproved Therapeutic Goods page.
A case study report is an article that describes a particular patient’s diagnosis and treatment plan. Most of the cases chosen for published medical case studies are of unusual diagnoses, or include complications in treatment. A case study report is written in a specific format and can be submitted to peer-reviewed journals.
For further information, please refer to the Case Study Applications page.
For single-site clinical trials being conducted at Barwon Health only: Please follow the application process for Single-site Greater than Low Risk Applications.
For multi-site clinical trials: Please follow the application process for Multi-site Greater than Low Risk Applications.
For more detailed information on clinical trial ethics and governance requirements, please refer to the Clinical Trial Applications page.
Contact RDU with any queries or concerns
RDU is here to help. If you are not sure where to start or have a question regarding your research project, email us at rdu@barwonhealth.org.au and we’ll get back to you within 24 hours. If you have a current application underway, please ensure you include your Barwon Health reference number in your enquiry.
Page last updated: May 22, 2026