Key messages

  • National Mutual Acceptance (NMA) is a system for mutual acceptance of scientific and ethical review of multi-centre human research projects conducted in publicly funded health services across jurisdictions.
  • Currently the Australian Capital Territory, New South Wales, Queensland, South Australia, Victoria and Western Australia are participating in NMA.

COVID-19 guidance

Refer to the following for general information and guidance on COVID-19:

In response to the unprecedented COVID-19 pandemic, Hospital Research Ethics & Governance Offices across Victoria are working to ensure that ethics and governance reviews of COVID-19 related clinical trials and health research projects are encouraged, supported and expedited to meet these challenging times.

We ask for patience, flexibility and creativity from all stakeholders as we work together to accelerate research during this rapidly evolving healthcare emergency.

The Hospital Research Managers Sub-Committee is supported by the Melbourne Academic Centre for Health, Monash Partners and Western Alliance.

Refer to the list of Victorian hospital Research Office for contact details.

Please contact Monash Partners Academic Health Science Centre on 03 8572 2637 for further information regarding Victorian HRECs.

For example:

 Jurisdiction Legislation
 Contact details
 Victoria Health Records Act 2001 (Vic)
Human Tissue Act 1982 (Vic)

Coordinating Office for Clinical Trial Research

See Victorian Specific Module guidelines

 New South Wales
Health Records and Information
Privacy Act 2002
(HRIP Act)
(NSW) 
The Office for Health and Medical Research
 Queensland Public Health Act 2005 (Qld)
Research, Ethics and Governance; Health Innovation, Investment and Research Office
 South Australia
Public Health Act 2011 (SA) Office for Research
 Western Australia
Health Service Act 2016
Information Access, Use and
Disclosure Policy 2017
(WA)
Research Development Unit Department of Health WA
 Australian Capital Territory
Health Records (Privacy and
Access) Act 1997
Public Health Act 1997
Research Ethics and Governance Office

Generic Standard Operating Procedures including Teletrials

The Generic Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia has been developed to provide guidance for good clinical practice in the conduct of clinical trials and medical research. It has been adapted to include teletrials in conjunction with the Teletrials Supervision Plan and the Teletrials Clinical Consultation User Guide.

Guidance for Teletrials

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

A 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.

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, Queensland, South Australia, Victoria and Western Australia participate in NMA. Single ethical and scientific review for a multi-centre human research project can be provided across the six participating states/territories.

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).

Western Australia is the most recent jurisdiction to join NMA (as of 31 August 2017). For existing projects:

  • A project with ethical approval from a NMA reviewing HREC can add a Western Australian site through an HREC amendment process
  • A project with ethical approval obtained in Western Australia before 31 August 2017 cannot be expanded to include sites in other jurisdictions.

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 (available in Downloads below).

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 on the How to make an HREC application page.

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

Multi-Jurisdiction 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).

Project with 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, SA or WA: use the Word document of the VSM and submit with the ethics application.

Victorian specific module guideline

Project with 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 guidance documents:

Guidance for Victorian HREC review including a Western Australia site 
Guidance for Western Australia Health HREC review including a Victorian site 

Project with 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 and on the SSA research governance page.

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/site specific assessment (SSA) application

Organisations that participate in NMA are listed in the HRECs, RGOs and Organisations document (available in Downloads below).

Information on submitting a research governance/SSA application for a site in Victoria is available on the SSA and research governance 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 following table.

 Location of reviewing HREC Location of site  Arrangements for research governance/SSA 
QLD or VIC QLD or VIC 
  • The CPI / delegate uses ERM to complete the HREA for ethics submission
  • From the HREA in ERM, the CPI / delegate creates a SSA for each site in VIC &/or QLD
  • From the SSA, the CPI/delegate uses Roles + function to enable the site PI access to the form
  • The site PI uses ERM to complete the SSA, upload site documents, electronically authorise the form (e-signature) and submit it to the site research governance officer (RGO)
QLD or VIC
ACT and NSW
  • The CPI / delegate uses ERM to complete the HREA for ethics submission
  • For governance applications, the CPI uses REGIS (must have a REGIS account) to create a ‘+ New Project’ then completes the ‘Project Registration’ section
  • ACT Health and NSW Health sites are entered under Part C – Research site(s)
  • Copies of HREA & ethics documents are uploaded in Part F. CPI submits ‘Project Registration’
  • SSAs or site application forms for sites are automatically generated in REGIS after project registration
  • The NSW PI completes the SSA in REGIS and submits to their site RGO.
  • More information on ACT SSA arrangements at ACT Health
  • More information on REGIS: REGIS How-To Guides
QLD or VIC
SA
  • The CPI / delegate uses ERM to complete the HREA for ethics submission
  • The CPI / delegate goes to Online Forms & creates one Minimal Data Form (MDF), uploads HREA & supporting documents
  • From the Online Forms MDF, the CPI / delegate creates a SSA for each site
  • The CPI / delegate uses Online Forms to transfer each SSA to the site PI
  • The site PI uses Online Forms to complete the SSA, upload site documents, electronically authorise the form (e-signature) & submit it to the site research governance officer (RGO)
ACT, NSW, QLD, SA or VIC WA
  • The CPI completes the HREA in reviewing state/territory system
  • Consult the WA Research Governance Service (RGS) website for information on how to create a research governance application
NSW or ACT
NSW and ACT
  • The CPI uses REGIS to complete the HREA for ethics submission
  • The CPI creates a ‘+ New Project’ and completes ‘Project Registration’
  • ACT Health and NSW Health sites are entered under PART C
  • SSAs or site application forms for sites are automatically generated in REGIS after project registration
  • The NSW PI completes the SSA in REGIS and submits to their site RGO
  • More information on ACT SSA arrangements at ACT Health
  • More information on REGIS: REGIS How-To Guides
NSW or ACT
QLD or VIC
  • The CPI uses REGIS to complete the HREA for ethics submission.

See REGIS How-To Guides

  • To generate a SSA for VIC or QLD, the CPI / delegate uses ERM to create a Minimal Data Form (MDF), upload HREA & supporting documents
  • From the ERM MDF, the CPI / delegate creates SSAs for sites in VIC or QLD
  • From the SSA, the CPI/delegate uses Roles + function to enable the site PI access to the form
  • The site PI uses ERM to complete the SSA, upload site documents, electronically authorise the form (e-signature) & submit it to the site research governance officer (RGO)
NSW or ACT
SA
  • The CPI uses REGIS to complete the HREA for ethics submission.

See REGIS How-To Guides

  • The CPI / delegate goes to Online Forms & creates one Minimal Data Form (MDF), uploads HREA & supporting documents
  • From the Online Forms MDF, the CPI / delegate creates a SSA for each site
  • The CPI / delegate uses Online Forms to transfer each SSA to the site PI
  • The site PI uses Online Forms to complete the SSA, upload site documents, electronically authorise the form (e-signature) & submit it to the site research governance officer (RGO)
 SA QLD or VIC
  • The CPI uses Online Forms to complete the HREA for ethics submission
  • To generate a SSA for VIC or QLD, the CPI / delegate uses ERM to create a Minimal Data Form (MDF), upload HREA & supporting documents
  • From the ERM MDF, the CPI / delegate creates SSAs for sites in VIC or QLD.
  • From the SSA, the CPI/delegate uses Roles + function to enable the site PI access to the form
  • The site PI uses ERM to complete the SSA, upload site documents, electronically authorise the form (e-signature) & submit it to the site research governance officer (RGO)
 SA  NSW or ACT
  • The CPI uses Online Forms to complete the HREA for ethics submission
  • For governance applications, the CPI uses REGIS (must have a REGIS account) to create a ‘+ New Project’ then completes the ‘Project Registration’ section
  • ACT Health and NSW Health sites are entered under Part C – Research site(s). 
  • Copies of HREA & ethics documents are uploaded in Part F. CPI submits ‘Project Registration’.
  • SSAs or site application forms for sites are automatically generated in REGIS after project registration
  • The NSW PI completes the SSA in REGIS and submits to their site RGO.
  • More information on ACT SSA arrangements at ACT Health
  • More information on REGIS: REGIS How-To Guides
 WA QLD or VIC
  • The CPI completes the HREA via the NHMRC website and uses RGS to upload HREA for ethics submission
  • To generate a SSA for VIC or QLD, the CPI / delegate uses ERM to create a Minimal Data Form (MDF), upload HREA & supporting documents
  • From the ERM MDF, the CPI / delegate creates SSAs for sites in VIC or QLD.
  • From the SSA, the CPI/delegate uses Roles + function to enable the site PI access to the form
  • The site PI uses ERM to complete the SSA, upload site documents, electronically authorise the form (e-signature) & submit it to the site research governance officer (RGO)
 WA NSW and ACT
  • The CPI completes the HREA via the NHMRC website and uses RGS to upload HREA for ethics submission
  • For governance applications, the CPI uses REGIS (must have a REGIS account) to create a ‘+ New Project’ then completes the ‘Project Registration’ section
  • ACT Health and NSW Health sites are entered under Part C – Research site(s). 
  • Copies of HREA & ethics documents are uploaded in Part F. CPI submits ‘Project Registration’.
  • SSAs or site application forms for sites are automatically generated in REGIS after project registration
  • The NSW PI completes the SSA in REGIS and submits to their site RGO.
  • More information for ACT SSA arrangements at ACT Health
  • More information on REGIS: REGIS How-To Guides
 WA  SA
  • The CPI completes the HREA via the NHMRC website and uses RGS to upload HREA for ethics submission
  • The CPI / delegate goes to Online Forms & creates one Minimal Data Form (MDF), uploads HREA & supporting documents
  • From the Online Forms MDF, the CPI / delegate creates a SSA for each site
  • The CPI / delegate uses Online Forms to transfer each SSA to the site PI
  • The site PI uses Online Forms to complete the SSA, upload site documents, electronically authorise the form (e-signature) & submit it to the site research governance officer (RGO)
 WA  WA
  • The CPI completes the HREA via the NHMRC website and uses RGS to upload HREA for ethics submission
  • Consult the WA Research Governance Service (RGS) website for information on how to create a research governance application

NMA monitoring and reporting

The Monitoring and Reporting Matrix describes obligations relating to the ongoing conduct of a research project. All safety reporting must align with Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (NHMRC, 2016).

Information for reporting in Victoria is available on the Monitoring and reporting page.