CLINICAL TRIALS AND RESEARCH

National Mutual Acceptance

National system for mutual acceptance of scientific and ethical review of multi-centre human research projects

    Overview

    National Mutual Acceptance (NMA) is a national system for mutual acceptance of scientific and ethical review of multi-centre human research projects conducted in publicly funded health services across jurisdictions. The Australian Capital Territory, New South Wales, Northern Territory, Queensland, South Australia, Tasmania, Victoria and Western Australia participate in NMA. Single ethical and scientific review for a multi-centre human research project can be provided across seven of the participating states/territories.

    Northern Territory and Tasmania are the most recent jurisdictions to join NMA.

    The scope of NMA 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 Human Research Ethics Committee (HREC).

    The NMA Brochure, NMA Fact Sheet and NMA Standard Principles for Operation provide detailed information; all are available in Downloads below.

    NMA ethics application

    All NMA ethics applications should utilise the Human Research Ethics Application (HREA) form.

    Reviewing HRECs are certified by the National Health and Medical Research Council (NHMRC) and are listed in the HRECs, RGOs and Organisations document.

    The Coordinating Principal Investigator (CPI) has overall responsibility for the research project, including the ethics application to the reviewing HREC.

    Standard Participant Information and Consent Forms (PICFs) should be used for all NMA research projects. Template PICFs are available in the Ethics section under Participant Information and Consent Forms.

    For all ethics applications in Vic and QLD, ERM must be used to create, complete and submit the HREA.

    For ethics applications in NSW and ACT, the REGIS website must be used to create, complete and submit the HREA.

    For ethics applications in SA, the Research GEMS website must be used to create, complete and submit the HREA.

    For guidance on ethics applications in WA, consult the WA Research Governance Service (RGS) website.

    For guidance on ethics applications in NT, consult the NT Health research webpage.

    For guidance on governance applications in Tas, consult the Tasmanian Research Governance Unit  website.

    For information on submitting an ethics application in Victoria, refer to the How to make an Ethics application page. For information on other states/territories, consult their jurisdictional websites.

    Data Linkage studies

    The NMA scheme has been revised to include multi-jurisdiction data linkage studies. Researchers undertaking studies involving linkage of data across participating NMA jurisdictions can apply for ethical review through a number of specialist NMA HRECs. The ethical and scientific approval of these HRECs will be accepted by participating NMA jurisdictions in accordance with standard NMA approval processes.

    As with all NMA HREC applications, data linkage projects will need to undergo any local research governance processes that may apply including the endorsement of relevant local data custodians.

    Refer to the NMA – data linkage guide for specialist NMA HRECs and further information.

    Jurisdiction-specific information

    The HREA addresses Commonwealth Government legislation. For information on state/territory legislation related to human research projects, refer to the Jurisdictional Legislative Requirements available in Downloads below.

    For some research projects additional supporting documents are required in order to address state/territory legislation. When applicable, these must be uploaded as supporting documents to the ethics application and submitted to the reviewing ethics committee (irrespective of the committee's location).

    Vic Site(s)

    The Victorian Specific Module (VSM) addresses state legislation; it must be included as a supporting document submitted to the reviewing ethics committee.

    Ethics review in Vic or QLD: use ERM for the VSM; refer to the VSM in ERM guidance document.

    Ethics review in ACT, NSW, NT, SA or WA: use the Word document of the VSM and submit with the ethics application.

    The Victorian specific module guideline provide further information.

    WA Site(s)

    The Western Australian Specific Module (WASM) is mandatory if project has WA site(s). The WASM is available on the WA Research Governance Service (RGS) website. For further information refer to the following Projects with a West Australian site guidance document.

    NSW Site(s)

    To identify the RGO for submitting a research governance / SSA application to a NSW Health Service refer to NSW RGO contact details in HRECs, RGOs and Organisations.

    Guidance for New South Wales

    NSW Health will exclude all adult early phase clinical trials from the NMA model. NSW public health organisation sites will not accept interstate HREC reviews for adult early phase clinical trials. The application will be reviewed by a NSW committee.

    NMA research governance applications

    Organisations that participate in NMA are listed in the HRECs, RGOs and Organisations document.

    Information on submitting a research governance/SSA application for a site in Victoria is available on the How to make a SSA Application page.

    The site Principal Investigator (PI) is responsible for the research governance/SSA application. The research project’s CPI must carry out certain actions before the PI can begin the research governance/SSA application process. Arrangements for research governance/SSA are described in the NMA Ethics and Governance Matrix table.

    pdf
    HRECs, RGOs and Organisations
    This document provides details and contact information for organisations taking part in the National Mutual Acceptance (NMA) initiative. (PDF File - 559.5 KB)
    Aug-2021
    pdf
    Jurisdictional Legislative Requirements
    This document aims to provide an overview of the various legislative and administrative frameworks that currently exist in Commonwealth, States and Territories and apply to the approval of human research under Mutual Acceptance of Ethics and Scientific Review. This document is not a substitute for legal advice. (PDF File - 207.5 KB)
    Nov-2019
    pdf
    National Mutual Acceptance (NMA) Ethics and Governance Matrix
    Arrangements for ethics and research governance/Site Specific Assessment (SSA) applications across the NMA jurisdictions are described in this NMA Ethics and Governance Matrix table. (PDF File - 398.7 KB)
    May-2021
    pdf
    NMA Brochure
    (PDF File - 247.5 KB)
    Aug-2021
    pdf
    NMA Data Linkage Guide
    The National Mutual Acceptance (NMA) scheme has been revised to better support researchers undertaking multi-jurisdiction studies involving linkage of data. (MS Word Document - 1.5 MB)
    Aug-2021
    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
    NMA Fact Sheet
    (PDF File - 211.1 KB)
    Aug-2021
    pdf
    NMA Standard Principles of Operation
    (PDF File - 366.9 KB)
    Aug-2021
    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 - 342.6 KB)
    Aug-2021
    pdf
    Victorian Specific Module WORD version
    For each research project that 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. (MS Word Document - 51.1 KB)
    Aug-2021