Victoria-specific requirements
New to research or clinical trials? For an overview of the research life cycle, see Getting started with research and clinical trials.
Researchers in Victoria must meet the standard ethics and governance requirements that apply across Australia, as well as specific Victorian ethics, governance and regulatory requirements, before their research projects can commence.
Victorian-Specific Module
You must submit the Victorian-Specific Module (VSM) form as part of an ethics application for research projects being conducted at a Victorian site.
The VSM contains three sections, each relating to a different piece of Victorian legislation. It assists the reviewing Human Research Ethics Committee (HREC) to determine whether a research project should be approved.
You can complete the VSM in one of two ways:
- through the Ethical Review Manager (ERM)
- downloading and completing the Victorian-Specific Module fillable Word form.
Please check with the reviewing HREC office to determine the preferred submission method.
Access the Victorian-Specific Module fillable Word document
National Mutual Acceptance
If you are conducting eligible multi-centre research, you can use the National Mutual Acceptance (NMA) scheme, which supports a single ethical review across participating Australian states and territories.
Research governance authorisation and local requirements must still be completed at each participating organisation.
NMA-certified HRECs
View more View lessIn Victoria, there are seven institutions with certified reviewing Human Research Ethics Committees (HRECs) under the National Mutual Acceptance scheme. You should contact the relevant HREC office directly to discuss ethics application requirements.
These HRECs accept ethics applications via Ethical Review Manager:
Austin Health Human Research Ethics Committee
Alfred Hospital Ethics Committee
The Royal Melbourne Hospital Human Research Ethics Committee
Monash Health Human Research Ethics Committee
Peter MacCallum Cancer Centre Ethics Committee
The Royal Children’s Hospital Human Research Ethics Committee
St Vincent’s Hospital Melbourne Human Research Ethics Committee
Research requiring specialised ethics review
Some types of research require review by a designated specialist Human Research Ethics Committee (HREC).
Research involving coronial material
View more View lessResearch projects involving access to coronial material must be reviewed by the Victorian Institute of Forensic Medicine (VIFM) HREC.
Coronial material generally refers to information, records, reports, images and specimens obtained through a coronial investigation or held by the Coroners Court of Victoria or the Victorian Institute of Forensic Medicine.
Access resources for research requiring specialised ethics review
Research involving persons in custody
View more View lessResearch projects involving persons in custody must be reviewed by the Justice Human Research Ethics Committee.
Access resources for research requiring specialised ethics review
Research involving ionising radiation
View more View lessIonising radiation is a form of high-energy radiation commonly used in healthcare. Examples include:
- X-rays
- Radiotherapy
- Positron emission tomography (PET) scans
- Computed tomography (CT) scans
In Victoria, research projects involving ionising radiation are subject to additional requirements. All projects involving ionising radiation must be assessed by an approved medical physicist.
Access resources for research requiring specialised ethics review
Informed consent in research
You must provide potential participants with sufficient information to make an informed decision about whether to take part in a research project.
Information about informed consent, Participant Information and Consent Forms (PICFs), and consent from a medical treatment decision maker is available on the Informed consent in research page.
Research agreements
A range of standard research agreements are available to support research conducted in Victoria.
- Clinical Trial Research Agreements (CTRAs) for commercially sponsored or collaborative group drug trials.
- CTRA Teletrial Subcontracts for studies operating under a teletrial model.
- Clinical Investigation Research Agreements (CIRAs) and related agreements for commercially sponsored medical device studies.
- Investigator-Initiated CTRAs for investigator-initiated clinical trials. These agreements are available for use at Victorian sites only and were developed by the Victorian Managed Insurance Authority (VMIA).
Amendments to Medicines Australia CTRAs are considered by the National Clinical Trial Agreement (NaCTA) Panel, which comprises representatives from all Australian states and territories.
The joint position statement Electronic Signatures and Clinical Trial Research Agreement Execution in Australia provides guiding principles to support the use of electronic signatures when executing CTRAs.