NMA Projects

The following information is for researchers who wish to submit their research proposals for review under the National Mutual Acceptance (NMA) scheme. This information will tell you where to complete Ethics applications and Site Specific Assessment (SSA) applications for NMA studies.

From late 2020, all Australian State and Territory jurisdictions now participate in National Mutual Acceptance. Applicants still only create and submit one Human Research Ethics Application (HREA) form. This is done in whichever online system is being used in the jurisdiction where the reviewing Human Research Ethics Committee (HREC) is located. For further information, please refer to the NSW Health & Medical Research website.

For research being submitted to the Sydney Local Health District HREC - RPAH, the HREA is completed in REGIS.

Creating an Ethics Application:

Applications for scientific and ethical review must be prepared using the Human Research Ethics Application (HREA) form:

NSW & ACT REGIS website: https://regis.health.nsw.gov.au/
QLD & VIC ERM website: https://au.forms.ethicalreviewmanager.com/
SA Research GEMS website: https://gems.sahealth.sa.gov.au/
WA RGS website: https://rgs.health.wa.gov.au/Pages/Home.aspx
NT: https://hrea.gov.au/
TAS: For guidance on governance applications in Tasmania, consult the Tasmanian Research Governance Unit website.

For research projects in:

VIC: a Victorian Specific Module (VSM) must be completed
WA: a WA Specific Module (WASM) must be completed via the RGS
ACT specific forms must be completed
NT specific forms must be completed and further ethical and scientific review may be triggered

Creating a Site Application:

SSA applications are created and submitted in the online system of the jurisdiction where the site is located.

Guidance on the Northern Territory site specific assessment (SSA) process and forms are available from the NT Health research website, or contact nthealth.rgo@nt.gov.au.

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

Guidance on submitting an SSA application for an SLHD site is available here.

Generating an SSA in REGIS for NMA projects

REGIS has been developed with the intention of supporting NMA projects. For projects that have been reviewed by a participating public health jurisdiction HREC (VIC/QLD/WA/SA) but involves a NSW Health site, the SSA for the NSW Health site should usually be generated in REGIS.

Each project should only be registered once in REGIS. If a study with this identifier has already been registered in REGIS DO NOT complete another project registration. A warning message will appear to advise of the Project ID, the CPI’s name and HREC. Contact the CPI/lead to request that they add your site to generate an SSA to complete.

For a step-by-step guide on how to register the project and create an SSA in REGIS, please refer to the quick reference guide here.

Definitions:

NMA - National Mutual Acceptance: the system of single scientific and ethical review of multi-centre human research across Australian jurisdictions (for research conducted in public health organisations).

CPI or CI – Co-ordinating Principal Investigator or Chief Investigator: the person who has overall responsibility for the research project and submits the project for ethical review. For single-centre research, Co-ordinating Principal Investigator and Principal Investigator are synonymous.

PI – Principal Investigator: the person responsible for the conduct of a study at a site.

HREC Location

Site Location(s)

Online System for SSA

NSW or ACT Health

NSW and/or ACT Health

Most NSW sites will require submission of SSA through REGIS but check with the individual NSW site first as some SSAs may still be attached to a HREA on the On-Line Forms site. (Check ACT Health for SSA requirements)

NSW or ACT Health

VIC/QLD/WA/SA (NMA participants)

SSA and minimum dataset form (MDF) to be completed in each jurisdiction’s portal:

VIC/QLD: ERM
WA: RGS
SA: SA Research GEMS
TAS: Refer to https://www.health.tas.gov.au/about/research/research-governance

NT: For NT Health SSA requirements, please consult the NT Health research governance office at nthealth.rgo@nt.gov.au or the NT Health research website: https://health.nt.gov.au/data-and-research

Please refer to the relevant jurisdiction’s website for further information - Victorian Health/ Queensland Health/ Western Australia Health/ Research Ethics SA Health

VIC/QLD/WA/SA (NMA participants)

Most NSW sites will require submission of SSA through REGIS but check with the individual NSW sites first as some SSAs may still be attached to a HREA on the On-Line Forms site.

The Western Australian Specific Module (WASM)

Studies to be conducted in Western Australia, that are approved by Australian HRECs outside Western Australia, require a “Western Australian Specific Module” (WASM) to be reviewed and approved by the non-Western Australia HREC.

The WASM is required for both public and private sites.

If the project will be conducted within a public health site(s) in Western Australia, researchers should create a project workspace in the Western Australian RGS and generate the WASM within this online portal. The WASM is an online form which should be saved as a PDF and then included in the ethics application in REGIS for ethics approval. When the Principal Investigator(s) for the site(s) in Western Australia then request site-authorisation, the Western Australian Research Governance Office will confirm the WASM has been completed. The project workspace will then be used for the Research Governance Office site-specific application.

Please click on this link for further guidance on the application process and navigating the RGS:

RGS Quick guide link https://rgs.health.wa.gov.au/rgshelp/Pages/Quick%20Start%20for%20Researchers.aspx

If a research project is only going to include private site(s), the Research Governance Service (RGS) online portal would not be used to generate the WASM. Researchers should contact Research Ethics and Governance, Office of Medical Research and Innovation Infrastructure at E: DoH.RGO@health.wa.gov.au, to request a paper copy. This is the only time a paper copy can be used.

Where a project involves Data Linkage

Where data linkage is included (for example, data from ISPD Client Services at the Department of Health or via PeopleWA), the WA Health Central HREC must be listed as an additional HREC to provide ethical review of the data linkage component.

If no data linkage is involved and data are obtained directly from the WA Health site only, WA Health Central HREC does not need to be listed as an additional HREC. In this scenario, the WASM is submitted solely to the Governance Office for the relevant site.