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 Online Forms website is used for completion and submission of Victorian or National Mutual Acceptance (NMA) ethics applications. The Online forms handbook provides assistance for applicants.
How to make an HREC application for a clinical trial
Meeting dates for reviewing HRECs are available on the HREC Applications 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
Approximately two weeks before a multisite HREC application is ready to submit, call the Central Allocation System (CAS) to allocate the application to a reviewing HREC. CAS requires applicants to identify a discipline that applies to the research project.
Identify the primary category from the NHMRC Categories.
Central Allocation System: (61 3) 9096 7395, Monday to Friday 10am to 5pm EST.
The phone call involves answering questions about the research and takes approximately fifteen minutes.
3. Completing the HREC application form
All applications must be completed on the Online Forms website, 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 replaces the National Ethics Application Form (NEAF).
On the Online Forms website, the NEAF will be available until the end of August 2017, thereafter the HREA will be available. For more information, refer to the E-bulletin.
The HREA or NEAF 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 or NEAF. 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 or NEAF 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 (Information Privacy Act 2000), health information (Health Records Act 2001) and the use of ionising radiation (Radiation Act 2005).
In addition, consent under circumstances where the Guardianship and Administration Act 1986 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.
Victorian specific m
Victorian specific module g
The following documents regarding legal information are referred to in the Victorian Specific Module:
Guardianship and Administration Act 1986 - information
Guideline for the definition of 'medical research procedure' refer to the Chief Psychiatrists Guidelines - define medical
'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
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 (email@example.com).
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 clinical trial 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 Online Forms 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 Online Forms 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 related to clinical trials
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