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.
RDU recommends talking to your Manager and Head of Department early about your intended research project. This ensures any concerns they may have can be ironed out, and that you have their support when it comes to ethics and governance application time.
RDU only accepts applications via ERM (Ethics Review Manager).
Quick links
To prepare an application, follow these steps:
Step 1. Contact RDU to discuss and plan your research project application
RDU is here to help you plan your research project and submit your application. Email us at [email protected] 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)
- attachments of any documents you already have underway
- your phone number
- your Barwon Health reference number in your enquiry (if you have a current application)
Need to check the level of risk of your project? Click here to download the Level of Risk Checklist
New to research and not sure where to start? Click here for a handy video
Want to submit your application at the next HREC meeting? Click here for HREC meeting dates
Step 2. Apply for a Barwon Health Reference Number
All research applications submitted to Barwon Health for review must have a Barwon Health reference number. To generate a Barwon Health Research 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. Follow the application process that suits your research type
Single site Project
Single site research projects include research 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 such as Barwon Health North and McKellar Centre.
Application requirements for single site projects vary depending on the level of risk involved to the participants and Barwon Health. If you are not sure which risk level applies to your research project, read on below, or download and complete the ‘Level of Risk Checklist’. You may also contact [email protected] with any queries.
Risk levels for single site projects
- Single site QA/Minimal Risk research
- Includes QA, quality improvement, audit activities, & service redesign
- Does not involve the collection of new raw data, or sensitive and identifying information
- Only collecting de-identified data, or information or data that is/would ordinarily be collected as part of patient management.
- Single site Low Risk research
- Low risk research is described as research in which the only foreseeable risk is one of discomfort
- Single site Greater than low risk research
- Where the risk, even if unlikely, is more than discomfort, the research is NOT low risk, it is greater than low risk.
- Interventions and therapies including clinical and non-clinical trials, and innovations
- Human genetics
- Women who are pregnant, and the human foetus
- People highly dependent on medical care who may be unable to give consent
- People with cognitive impairment, an intellectual disability, or mental illness
- Aboriginal and Torres Strait Islander Peoples
- Some categories of research with people who may be involved in illegal activities
- GMO and Gene Therapy Trials
- People in other countries
- Single-site Pilot studies
Application guidelines for single site projects
Note: Low and Greater than low risk single site and multi-site projects must follow BH HREC submission deadline dates to ensure they are reviewed at the next HREC meeting. All other project submissions are accepted at any time, for out of session review. Projects may also require Research Management Committee (RMC) Review. Student projects and greater than low risk projects also require Peer Review prior to submission.
| Research Type | Ethics & Governance application process | Next steps |
|---|
|
Single site QA/Minimal risk
|
Reviewed by the RDU with advice from the BH HREC (out of session)
Please submit your application within ERM on a QA form
Attach protocol and supporting documents
Include Head of Department Signoff
Include Peer Review Form (student projects only)
|
Visit
Single site QA/Minimal risk application page
|
|
Single site Low Risk
|
Reviewed by the BH HREC and RGO
Please submit your application via ERM on a HREA form
Attach supporting documents
Include Head of Department Signoff
Include Peer Review Form (student projects only)
|
Visit
Single site low risk application page
|
|
Single site Greater than low risk
|
Reviewed by the BH HREC, RGO and RMC
Please submit your application via ERM on a HREA form and SSA form
Include Head of Department/Director Signoff
Include supporting documents
Include Peer Review Form
|
Visit
Single site greater than low risk application page
|
Multi-site Project
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.
Risk levels for multi-site projects
Application requirements for multi-site projects vary depending on the level of risk involved to the participants and participating institutions, and on the role of Barwon Health within the project. If you are not sure which risk level applies to your research project, read on below, or complete the ‘Level of Risk Checklist’. You may also contact [email protected] with any queries.
- Multi-site Greater than low risk research
- Where the risk, even if unlikely, is more than discomfort, the research is NOT low risk; it is greater than low risk.
- Interventions and therapies including clinical and non-clinical trials, and innovations
- Human genetics
- Women who are pregnant, and the human foetus
- People highly dependent on medical care who may be unable to give consent
- People with cognitive impairment, an intellectual disability, or mental illness
- Aboriginal and Torres Strait Islander Peoples
- Some categories of research with people who may be involved in illegal activities
- GMO and Gene Therapy Trials
- People in other countries
- Multi-site Low Risk research
- Low risk research is described as research in which the only foreseeable risk is one of discomfort
- Multi-site QA/Minimal Risk research
- 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
- Includes QA, quality improvement, audit activities, & service redesign
- Does not involve the collection of new raw data, or sensitive and identifying information
- Only collecting de-identified data, or information or data that is/would ordinarily be collected as part of patient management.
- Regional health service collaborations
- Ethics
If your project involves only Regional Victorian health service collaborators, RDU may be able to provide one ethics review to cover all sites.
Barwon Health has arrangements in place to provide human research ethics review for the following sites:
- South West Health Care (SWHC)
- Warrnambool & Camperdown - please note that SWHC, Warrnambool, has a HREC and refers some projects to Barwon Health for review (SWHC also provides ethics review for Portland District Health)
- St John of God (SJOG), Geelong
- Colac Area Health
A number of other Victorian Regional and Metropolitan healthcare institutions may also accept Barwon Health HREC approval – including Western Alliance members. RDU advise contacting each sites Research Office to determine acceptance.
- Governance
Low and negligible risk multi-site Victorian regional projects may also be eligible for a regional streamlined governance process. Please contact [email protected] or call 4215 3373 to determine if your project is eligible.
Each site is responsible for its own research governance.
- Deakin University collaborations
- Ethics
- If your project involves Barwon Health and Deakin University, BH HREC must provide ethical review for clinical research involving staff, patient’s data, or specimens. Deakin Research Office will generally then accept BH HREC approval.
- Governance
Barwon Health has an ongoing Memorandum of Understanding (MOU) with Deakin University that requires each collaboration to be documented within an Annexure A agreement.
Barwon Health Head of Department/Director Signoff is required for all submissions
- An acting sponsor must be nominated for each research project. Either Deakin University OR Barwon Health may act as sponsor – the sponsor role cannot be shared. It is usually the institution responsible for Protocol development AND/OR distribution of funds.
Application guidelines for multi-site projects
Note: Low and Greater than low risk single site and multi-site projects must follow BH HREC submission deadline dates to ensure they are reviewed at the next HREC meeting. All other project submissions are accepted at any time, for out of session review OR Governance only review. Projects require Governance Only review if they have already received National Mutual Acceptance (NMA) HREC approval listing Barwon Health as an approved site. Governance only applications are reviewed by the Research Governance Officer (RGO) and Research Management Committee (RMC). Student projects and greater than low risk projects also require Peer Review prior to submission.
Click here to download a handy Ethics Checklist developed by the Victorian Government Coordinating Office for Clinical Trial Research.
| Research Type | Ethics & Governance application process | Governance Only application process | Next steps |
|---|
|
Multi-site QA/Minimal risk
|
Metro/Interstate sites included – seek VIC Metro Reviewing Site HREC review*
VIC Regional sites only - reviewed by the RDU with advice from the BH HREC (out of session) and RMC
Please submit your application within ERM on a QA form
Include protocol and supporting documents
Include list of all sites and PIs involved
Include BH Head of Department Signoff
A research agreement may be required
Include completed Peer Review Form (student projects)
|
Reviewed by RGO and potentially RMC
Please submit your application within ERM on an SSA form where possible OR QA form
Please include central HREC approval listing Barwon Health as an approved site
Include all supporting documents listed within the HREC approval
Include BH Head of Department Signoff
A research agreement may be required
|
Visit
Multi-site QA/Minimal risk application page
|
|
Multi-site Low risk
|
Metro/Interstate sites included – seek VIC Metro Reviewing Site HREC review*
VIC Regional sites only – reviewed by the BH HREC, RGO and RMC
Please submit your application via ERM on a HREA form, and SSA form
Include Head of Department/Director Signoff
Include supporting documents
Include a research agreement
Include completed Peer Review Form (student projects)
|
Reviewed by RGO and potentially RMC
Please submit your application within ERM on an SSA form
Please include central HREC approval listing Barwon Health as an approved site
Include all supporting documents listed within the HREC approval
Include BH Head of Department Signoff
Include a research agreement
|
Visit
Multi-site low risk application page
|
|
Multi-site Greater than low risk
|
Metro/Interstate sites included – seek VIC Metro Reviewing Site HREC review*
VIC Regional sites only – reviewed by the BH HREC, RGO and RMC
Please submit your application via ERM on a HREA form and SSA form
Include BH Head of Department/Director Signoff
Include supporting documents
Include completed Peer Review Form (Commercial Trials exempt)
Include a research agreement
|
Reviewed by RGO and RMC
Please submit your application within ERM on an SSA form
Please include central HREC approval listing Barwon Health as an approved site
Include all supporting documents listed within the HREC approval
Include BH Head of Department/Director Signoff
Include a research agreement
|
Visit
Multi-site greater than low risk application page
|
|
Regional health service collaborations
|
Reviewed by the BH HREC, RGO and RMC
Please submit your application via ERM on a HREA form, and SSA form
Include BH Head of Department/Director Signoff
Include supporting documents
A research agreement may be required
Include completed Peer Review Form
|
Reviewed by RGO and RMC
Please submit your application within ERM on an SSA form
Please include central HREC approval listing Barwon Health as an approved site
Include all supporting documents listed within the HREC approval
Include BH Head of Department Signoff
A research agreement may be required
|
Visit Regional health service collaborations page
|
|
Deakin University collaborations
|
Reviewed by the BH HREC, RGO and RMC
Please submit your application via ERM on a HREA form, and SSA form
Include BH Head of Department/Director Signoff
Include supporting documents
Include an Annexure A
Include completed Peer Review Form
|
NA
|
Visit Deakin collaborations page
|
* VIC Metro Reviewing Site HRECs The following Victorian human research ethics committees are officially recognised by the Victorian Co-Ordinating Office for Research as providers of ethical review for multi-site research projects:
- Alfred Health
- Austin Health
- Melbourne Health
- Peter MacCallum Cancer Centre
- The Royal Children’s Hospital
- Monash Health
- St Vincent’s Hospital (Melbourne)
Access to Unapproved Therapeutic Goods
This includes Special Access Scheme (SAS) applications and Authorised Prescriber Scheme (APS) applications.
Click here or contact [email protected] for assistance.
