CLINICAL TRIALS AND RESEARCH

Ethics Application

    Early Phase Trials and Teletrials

    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@ecodev.vic.gov.au.

    Teletrials

    The National Teletrials Compendium supports a national approach to teletrials and consists of two publications:

    • National Standard Operating Procedures for Clinical Trials, including Teletrials in Australia
    • National Principles for Teletrials in Australia

    The National Standard Operating Procedures will help organisations to standardise their procedures for clinical trials and teletrials. A Supervision Plan for teletrial sites is included in this document.

    Guidance for Teletrials

    The Multisite Clinical Trials v Teletrials Matrix outlines specific details and compares Teletrials with multisite trials.

    A teletrial governance checklist is available for investigators which includes the governance requirements for teletrials. See the Research Governance Checklist .

    Clinical Trial Research Agreement (CTRA) Teletrial subcontract is available for studies under a teletrial model.

    The Victorian Comprehensive Cancer Centre (VCCC) Teletrials Program provides additional information on teletrials.

    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 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

    If the research project involves exposing participants to ionising radiation, specific supporting documents must be included in the ethics application, and there are regulatory requirements.

    If radiation exposure is additional to that received as normal clinical management/care, an independent assessment report by a Medical Physicist (one for each site) must be included in the ethics application.

    If radiation exposure is part of normal clinical management/care, the site Principal Investigator should complete a letter to this effect; it should be based on the HREC radiation notification letter template and included in the ethics application. For a multi-site research project, the site Principal Investigator provides the letter to the Coordinating Principal Investigator for inclusion in the ethics application.

    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 organisation (licence holder) must notify the Radiation Team at the Department of Health (DH). The project may commence prior to notification being submitted to DH.

    If the dose of radiation is below the dose constraint of the ARPANSA Code and approval has been given by the HREC, no DH notification is required.

    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.

    pdf
    Ethics Checklist
    Pro-forma checklist to assist with preparing an ethics application (MS Word Document - 1.5 MB)
    May-2021
    pdf
    HREC Radiation Notification Letter
    Template letter to use if Ionising radiation exposure in a research project is not considered to be additional to normal clinical management/care at the site and the reviewing HREC is in Victoria (MS Word Document - 21.0 KB)
    Nov-2019
    pdf
    NMA ethics application: Projects with a Western Australia site
    Additional supporting documents that address state legislation e.g. Western Australian Specific Module (WASM) and Victorian Specific Module (VSM) may be required for some research projects. (MS Word Document - 1.5 MB)
    May-2021
    pdf
    Participant Information Consent Form and European Union General Data Protection Regulation
    Dealing with requested amendments to the Participant Information Consent Form (PICF) following implementation of the European Union’s General Data Protection Regulation (GDPR). (MS Word Document - 1.5 MB)
    21-Jul-2021
    pdf
    Participant partner pregnancy PICF
    In the event that a participant in an approved interventional clinical trial (or the participant’s partner) becomes pregnant during the course of the research, this Participant Information Sheet/Consent Form should be provided to the pregnant participant/partner. (MS Word Document - 62.0 KB)
    21-Jul-2021
    pdf
    PICF genetic for parent and guardian
    Use this PICF for genetic research that is non-interventional OR genetic research that has an interventional component that does not involve research on a drug or device. Refer to The National Statement on Ethical Conduct in Human Research (Chapter 3.5) for information on genetic research. (MS Word Document - 199.7 KB)
    Jun-2020
    pdf
    PICF genetic for person responsible/medical treatment decision maker
    Use this PICF for genetic research that is non-interventional OR genetic research that has an interventional component that does not involve research on a drug or device. Refer to The National Statement on Ethical Conduct in Human Research (Chapter 3.5) for information on genetic research. (MS Word Document - 198.6 KB)
    Jun-2020
    pdf
    PICF genetic for self
    Use this PICF for genetic research that is non-interventional OR genetic research that has an interventional component that does not involve research on a drug or device. Refer to The National Statement on Ethical Conduct in Human Research (Chapter 3.5) for information on genetic research. (MS Word Document - 198.9 KB)
    Jun-2020
    pdf
    PICF health and social science for parent and guardian
    A Participant Information sheet should be aimed at parents/guardians when the potential participant is a child. Refer to The National Statement on Ethical Conduct in Human Research (Chapter 4.2) for more information. Consideration should also be given to explaining the procedure to the child themselves in a manner appropriate to their maturity level. (MS Word Document - 175.6 KB)
    Aug-2019
    pdf
    PICF health and social science for person responsible/medical treatment decision maker
    A Participant Information sheet should be aimed at persons responsible/medical treatment decision makers when the potential participant does not have decision making capacity or not competent to provide consent for themselves. Refer to The National Statement on Ethical Conduct in Human Research (Chapters 4.4 & 4.5) for more information. This Participant Information Sheet/Consent Form should not be used for parents/guardians of minors; an alternative template is available for parents/guardians. (MS Word Document - 175.0 KB)
    Aug-2019
    pdf
    PICF health and social science for self
    (MS Word Document - 174.1 KB)
    Aug-2019
    pdf
    PICF interventional for parent and guardian
    An Interventional Study is defined as administration of a drug, device or procedure that is not part of routine care, including all phases of a clinical trial. (MS Word Document - 202.1 KB)
    Jun-2020
    pdf
    PICF interventional for person responsible/medical treatment decision maker
    A Participant Information sheet should be aimed at persons responsible when the potential participant does not have decision making capacity or not competent to provide consent for themselves. Refer to The National Statement on Ethical Conduct in Human Research (Chapters 4.4 & 4.5) for more information. This Participant Information Sheet/Consent Form should not be used for parents/guardians of minors; an alternative template is available for parents/guardians. (MS Word Document - 200.9 KB)
    Jun-2020
    pdf
    PICF interventional for self
    Adult providing own content. An Interventional Study is defined as administration of a drug, device or procedure that is not part of routine care, including all phases of a clinical trial. (MS Word Document - 203.7 KB)
    Jun-2020
    pdf
    PICF non-interventional for parent and guardian
    A Participant Information sheet should be aimed at parents/guardians when the potential participant is a child. Refer to The National Statement on Ethical Conduct in Human Research (Chapter 4.2) for more information. Consideration should also be given to explaining the procedure to the child themselves in a manner appropriate to their maturity level. (MS Word Document - 194.8 KB)
    Jun-2020
    pdf
    PICF non-interventional for person responsible/medical treatment decision maker
    A Participant Information sheet should be aimed at persons responsible/medical treatment decision makers when the potential participant does not have decision making capacity or not competent to provide consent for themselves. (MS Word Document - 193.0 KB)
    Jun-2020
    pdf
    PICF non-interventional for self
    Adult providing own consent. A Non-Interventional research project involves clinical research where no interventional treatment is given to participants other than their routine care. It does not involve the administration of an investigational product, treatment or procedure. Examples include observational research and monitoring of participants. (MS Word Document - 189.5 KB)
    Jun-2020
    pdf
    Roles and Responsibilities in a Research Project
    (MS Word Document - 1.5 MB)
    May-2021
    pdf
    Statutory Guidelines on Research
    (PDF File - 217.3 KB)
    Feb-2002
    pdf
    Victorian Specific Module (VSM) in ERM
    For each research project that utilises the Human Research Ethics Application (HREA) form and has a site in Victoria, the Victorian Specific Module (VSM) must be completed and submitted to the reviewing Human Research Ethics Committee (HREC) as part of the ethics application. (PDF File - 423.9 KB)
    Nov-2018
    pdf
    Victorian Specific Module Guidelines
    These guidelines provide useful information and specific instructions for completing Sections 1, 2 and 3 of the Victorian Specific Module. (PDF File - 351.8 KB)
    Oct-2021