The streamlined system for ethical and scientific review of multi-site research projects applies to any form of human research, as defined in the National Statement on Ethical Conduct in Human Research (2007) or any replacement of that document published by the National Health and Medical Research Council (NHMRC), for which an application must be made to an HREC for the purpose of conducting research at a Public Health Organisation. This will include low and negligible risk research review.
The ERM is used for completion and submission of Victorian or National Mutual Acceptance (NMA) ethics applications.
The application process
HREC meetings occur monthly throughout the year. A full list of meeting dates and submission closing dates is available on the HREC applications page.
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 may submit the Ethics Checklist when submitting the ethics application in ERM.
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. Create an HREC application in ERM
All HREC applications are created on the ERM website. See Applicant user guide to ERM for detailed instructions on how to create an HREC application.
3. Completing the HREC application form
All applications must be completed on the ERM 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 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 do 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. The Victorian Low and Negligible Risk application form (LNR VIC) is available for completion on the ERM website.
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.
The following documents regarding legal information are referred to in the Victorian Specific Module:
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 RGS-Home.
For further information refer to the following guidance documents:
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 department’s Radiation Team. The project may commence prior to notification being submitted to the department.
If the dose of radiation is below the dose constraint of the ARPANSA Code and approval has been given by the HREC, no departmental notification is required.
5. Participant information and consent forms
Patient Information Consent Forms (PICFs) require Local Sponsors and any person or organisation to whom a trial participant's personal information is transferred to comply with Australian privacy laws, the Health Records Act 2001 (Vic) and where applicable the Victorian Privacy and Data Protection Act 2014 (Vic). For studies that involve a European site, the General Data Protection Regulation (GDPR) may also apply. See advice on Dealing with requested amendments to the Patient Information Consent Form as part of Human Research Ethics Applications for further information.
The documents below are the recommended Participant information and consent form (PICF) templates for health and medical research projects and genetic research.
6. Submission to the reviewing HREC
When the HREC application is complete with all supporting documents uploaded, to submit your applicatin see the ERM Signatures and Submission Quick Reference Guide for information on electronic signatures and submission process. In the national form HREA there are three signature options; the Quick Reference Guide provides information on these options.
Refer to the Applicant user guide to ERM
Section 7 & 8 for further information on electronic signatures and submission of Victoria only ethics forms and Section 9 & 10 for Site Specific Assessment forms.
7. Post-HREC approval reports and amendments
For the duration of an approved research project, the reviewing HREC is responsible for monitoring the ethical conduct and safety of the research. In Victoria, standard forms must be used for reporting to the reviewing HREC and/or the site research governance officer (RGO).
Further information and standard reporting forms are available on the Monitoring and Reporting page of the Clinical Trial Research website.