Key message

  • The new Ethics Review Manager (ERM) system will replace the Online Forms website in Victoria on 16 July 2018. 
  • For all ethics applications in Victoria and Queensland, ERM must be used to complete and submit the HREC application
  • The central allocation system (CAS) will no longer be required to allocate a multi-site research project to a Victorian reviewing HREC.. 
  • The Online Forms website will continue to be used to complete and submit HREC applications for SA. 
  • The coordinating principal investigator is responsible for an application for ethical approval. 
  • HREC approval must be provided before research governance/site specific assessment (SSA) authorisation can be given by an organisation.

Scope

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.

ERM

The ERM website is used for completion and submission of Victorian or National Mutual Acceptance (NMA) ethics applications.

Note advice on acceptance of electronic signatures using Ethical Review Manager (ERM) system.

How to make an HREC application for a clinical trial

1. Preparation

Meeting dates for reviewing HRECs are available on the HREC Applications page.

Ethics 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 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.

Additional summarised Quick tips for applicants when using ERM include:

  • Create an HREA application in ERM
  • Creating SSAs for Sites – by HREA owner
  • Creating SSAs for Sites – by SSA owner
  • Creating SSAs for Sites – for Accepting site
  • Upload Documents
  • Request Signatures
  • Post Approval and Post Authorisation

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.

Victorian specific module

Victorian specific module guidelines

The following documents regarding legal information are referred to in the Victorian Specific Module:

Medical Treatment Planning and Decisions Act 2016
2002'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 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 (multisite.ethics@dhhs.vic.gov.au).

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

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).

NHMRC guidance on payment of participants in research can be found here.

For studies that involve a European site, the General Data Protection Regulation (GDPR) may also apply. See advice here for further information. 

'The documents below are the recommended Participant Information and Consent Form (PICF) templates for interventional clinical trial research projects, genetic research and other research.

PICF interventional for self

PICF interventional for parent & guardian

PICF interventional for person responsible/medical treatment decision maker

Participant partner pregnancy PICF

PICF genetic for self

PICF genetic for parent & guardian

PICF genetic for person responsible/medical treatment decision maker

PICF non-interventional for self

PICF non-interventional for parent and guardian

PICF non-interventional for person responsible/medical treatment decision maker

PICF health and social science for self

PICF health and social science for parent and guardian

PICF health and social science for person responsible/medical treatment decision maker

6. Submission of the HREC application to the reviewing HREC

When the HREC application is complete with all supporting documents uploaded, to submit your application 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.