Ethics Application - Clinical Trials and Research

Early Phase Trials

A scientific expert review toolkit has been developed for Investigators, sponsors, scientific expert reviewers and HRECs to support safety in early phase clinical trials for Victorian participants. Guidance on the Scientific Expert Review Toolkit is now available.

Scientific expert review proformas to assist in the assessment of an early phase clinical trial research application can be accessed by ethics committees/research offices by contacting the Coordinating Office at multisite.ethics@safercare.vic.gov.au

How to make an Ethics Application

To prepare an ethics application the following considerations need to be made. Before you start your application be sure to know the HREC you will submit to. For multisite trials and research the Submission Closing Date for the reviewing ethics committee meeting is accessible here.

Role and responsibilities for Investigators conducting single and multi-site research

For a single-site project, the Principal Investigator (PI) has overall responsibility for the ethics application and conduct of the research project.

For a multi-site project, the Coordinating Principal Investigator (CPI) has overall responsibility for the ethics application and conduct of the research project. Each site has its own Principal Investigator (PI) who is responsible for the site’s research governance/SSA application and conduct of the research project at that site.

The responsibilities of the CPI, PI and sponsor are summarised in the Roles and Responsibilities in a Research Project document.

Ethics Checklist

The Ethics Checklist assists the Coordinating Principal Investigator (CPI) or Principal Investigator (PI) to prepare the ethics application. The CPI or PI may submit the Ethics Checklist when submitting the ethics application in ERM.

The ERM website is used to create an ethics application and submit to a Victorian ethics committee (HREC).

Note advice on acceptance of electronic signatures using the ERM system can be found in the Help area of ERM and in ERM Training Tools.

Create a HREC application

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 and must have the Victorian Specific Module attached to the application to address Victorian legislation, as the HREA is a national form.

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.

The Minimal Dataset Form (MDF) is used when an ethics application is reviewed under National Mutual Acceptance by a jurisdiction outside Victoria and Queensland. A MDF is created once only for a research project.

All HREC applications are created on the ERM website. See the ERM Guidance section for detailed instructions on how to create an HREC application.

Complete a HREC application

All applications must be completed on the ERM website, and all supporting documents uploaded.

Victorian specific module

The Victorian Specific Module (VSM) 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.

The Victorian specific module has been designed so that the HREC can address legislative requirements.

In Victoria there is a requirement to comply with legislation relevant to human research involving information privacy (Privacy and Data Protection Act 2014) and 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 Laws relating to the provision of consent for persons that do not have decision making capacity to participate in research guidance document outlines the relevant legal requirements in Victoria regarding the provision of consent for an adult who does not have decision-making capacity to participate in human research.

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 WORD version and submit with the ethics application.

Refer to the Victorian Specific Module guidelines for further information.

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

Western Australia Specific Module

The Western Australian Specific Module is necessary for both ethics and research governance applications.

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 Projects with a West Australian site guidance document.

Submission of a HREC application

When the HREC application is complete with all supporting documents uploaded, to submit your application see the Signatures requests and Submission for information on electronic signatures and submission process.

Refer to the Applicant user guide to ERM Section 3 & 4 for further information on electronic signatures and submission of Victoria only ethics forms and Section 9 & 10 for Site Specific Assessment forms.

Use of ionising radiation

Procedures that involve ionising radiation include diagnostic imaging and nuclear medicine scans. If a research project involves exposing participants to ionising radiation, there are specific requirements for both ethics and governance applications, to ensure ethical protection and safety of participants.

The Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) develops codes, standards, guides and provides advice. The Radiation Protection Series No. 8 Code of Practice for the Exposure of Humans to Ionizing Radiation for Research Purposes ensures researchers provide radiation exposure information that allows consent to be properly considered by participants and the HREC. There can be issues applying the Code to multi-centre research, and the ARPANSA Radiation Health Committee has issued a Statement on ethical review for multi-centre trials.

The protocol’s ionising radiation level at each participating site should be determined i.e.,is the level additional to standard of care or standard care.

If radiation exposure is additional to standard care, a Medical Physicist completes an independent assessment report for each site. Depending on the reviewing HREC’s policy, either:

the CPI uploads all site assessment reports as supporting documents in the ethics application or
the CPI uploads one assessment report (from the site with the highest assessed dose) as a supporting document in the ethics application.

If radiation exposure is part of normal care, the site PI should complete a letter to this effect, based on the HREC radiation notification letter template and include in the ethics application.

See the Use of Ionising Radiation – flow diagram for additional information.

Reporting requirements for ionising radiation in research

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, the institution (licence holder) must notify the Radiation team at Department of Health (DH). The project may commence prior to notification.

If the dose of radiation is below the dose constraint of the ARPANSA Code and approval has been given by the HREC, DH notification is not required.

Participant Information and Consent forms

All research and clinical trial participants must provide consent and pro-forms are available below.

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 and 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.