The scope includes any form of human research as defined in the National Statement on Ethical Conduct in Human Research
(NHMRC, 2007), for which an application must be made to a HREC for the purpose of being conducted at a public health organisation.
The ERM is used for completion and submission of Victorian or National Mutual Acceptance (NMA) ethics applications.
How to make an HREC application for a clinical trial
Meeting dates for reviewing HRECs are available on the HREC page.
Ethics cover letter and checklist
The Ethics cover letter and checklist assists the Coordinating Principal Investigator (CPI) (multi-site project) or Principal Investigator (PI) (single-site project) to prepare the ethics application. The CPI or PI must submit the Ethics Cover Letter and Checklist with the ethics application.
Guidance for investigators and sponsors
The responsibilities of the Coordinating Principal Investigator (CPI), Principal Investigator (PI) and sponsor are summarised in the following documents.
Roles in single site research project
Roles in multi-site research project
2. Allocation of an HREC application to a reviewing HREC
The ERM system does not have the Central Allocation System (CAS) to obtain a HREC Reference Number. From 16 July 2018 use ERM to complete and submit a multi-site application. The HREC Reference will be generated automatically when the application is submitted.
3. Completing the HREC application form
All applications must be completed on the ERM , and all supporting documents uploaded.
The Human Research Ethics Application (HREA) form is an ethics application form developed by the National Health and Medical Research Council (NHMRC). The HREA replaced the National Ethics Application Form (NEAF) in August 2017.
The HREA is used for an ethics application to a Victorian HREC at a public health organisation.
For a single-site low and negligible risk (LNR) research project taking place in Victoria only, the LNR VIC application form may be utilised instead of the HREA. Some reviewing HRECs may not accept the LNR VIC; always discuss the research project with the reviewing organisation’s research office before creating an ethics application for a low risk research project.
Victorian specific module
The Victorian specific module is mandatory when the HREA is used. It must be uploaded as a supporting document and submitted as part of the ethics application. A Victorian specific module is not required for projects utilising the LNR VIC application form.
In Victoria there is a requirement to comply with legislation relevant to human research involving information privacy (Privacy and Data Protection Act 2014), health information (Health Records Act 2001).
In addition, consent under circumstances where the Medical Treatment Planning and Decisions Act 2016 and the Mental Health Act 2014 apply must meet legislative requirements in Victoria.
The Victorian specific module has been designed so that the HREC can address legislative requirements.
The VSM is completed in ERM as a sub-form of the HREA and is uploaded as a supporting document.
See the Victorian Specific Module (VSM) in ERM guidance document.
For non-ERM user jurisdictions, download the VSM and submit for NMA applications.
Victorian specific m
Victorian specific module g
The following documents regarding legal information are referred to in the Victorian Specific Module:
Medical Treatment Planning and Decisions Act
'Guidelines' - Health Records Act 2001 (Vic) statutory guidelines on research, issued for the purposes of Health Privacy Principles 1.1(e)(iii) & 2.2(g)(iii), February
Western Australia Specific Module
Ethics and site governance
The Western Australian Specific Module (WASM) is mandatory if the project has WA site(s). The WASM is available on the WA Research Governance (RGS) website
For further information refer to the following guidance documents:
- Guidance for Victorian HREC review including a Western Australia site
- Guidance for Western Australia Health HREC review including a Victorian site
4. Use of ionising radiation
If radiation exposure is additional to that received as normal clinical management/care, an independent assessment report by a Medical Physicist is required for review by the ethics committee. One report is required for each site. The report will include the total effective dose, relevant organ doses and a risk assessment. The report must be provided to the Coordinating Principal Investigator for inclusion in the ethics application.
The Medical Physicist may utilise Section 4 Use of Ionising Radiation for provision of their assessment, in line with the requirements of the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA). To obtain the Section 4 document, contact the reviewing organisation’s research office or email the Coordinating Office for Clinical Trial Research (firstname.lastname@example.org).
If radiation exposure is part of normal clinical management/care, the site Principal Investigator should complete a letter to this effect. The letter should be based on the template below, and must be provided to the Coordinating Principal Investigator for inclusion in the ethics application.
HREC radiation notification letter
If the dose of radiation is above the dose constraint of the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) Code and approval has been given by the HREC, then the organisation (licence holder) must notify the Radiation Team at DHHS. The project may commence prior to notification being submitted to DHHS.
If the dose of radiation is below the dose constraint of the ARPANSA Code and approval has been given by the HREC, no DHHS notification is required.
5. Participant information and consent forms
The documents below are the recommended Participant Information and Consent Form (PICF) templates for interventional clinical trial research projects and for genetic research.
PICF interventional for
PICF interventional for parent &
PICF interventional for person
Participant partner pregnancy
PICF genetic for
PICF genetic for parent &
PICF genetic for person
6. Submission of the HREC application to the reviewing HREC
Each Principal Investigator must provide the Coordinating Principal Investigator with site-related documents, if applicable, and these must be uploaded to the HREC application by the CPI as supporting documents.
When the HREC application is complete and has been electronically authorised, the owner of the application should submit the form electronically from the ERM website using the ‘Submission’ tab and following the steps. Following electronic submission, the application form can be printed and, if required, the Coordinating Principal Investigator can sign the document in hard copy.
7. Low and negligible risk research
For a single-site research project taking place in Victoria only, the Victorian Low and Negligible Risk application form (LNR VIC) is available for completion on the ERM website.
Discuss the research project with the reviewing organisation’s research office before creating an ethics application for a low risk research project.
8. Participant Information and Consent Forms for other research
PICF non-interventional for
PICF non-interventional for parent and
PICF non-interventional for person
PICF health and social science for
PICF health and social science for parent and
PICF health and social science for person