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.
  • From 31 August 2017, the Australian Capital Territory, New South Wales, Queensland, South Australia, Victoria and Western Australia are participating in NMA.

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 below.

NMA ethics application

All NMA ethics applications should utilise the Human Research Ethics Application (HREA) form from 31 August 2017. Any existing National Ethics Application Form (NEAF) applications can continue to be processed.

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

The new Ethics Review Manager (ERM) system will replace Online Forms in Victoria and Queensland on 16 July 2018. 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.

All jurisdictions except NSW do not accept Bellberry review under NMA review.

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.

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 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).

  • Victorian Specific Module (VSM) if project has VIC site(s) (available on the How to make an HREC application page)
  • 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 

Guidance for New South Wales

  • NSW Privacy Form if project has NSW site(s) and participants include ‘adult persons who are unable to give consent’ (available below).
  • 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.
  • All new adult early phase clinical trials proposed to be conducted in a NSW public health organisation site must be submitted to Bellberry HRECs for ethics review.

NMA research governance/site specific assessment (SSA) application

Organisations that participate in NMA are listed in the HRECs, RGOs and Organisations document (available 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 and/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 register the project once only (project owner).
  • Copies of HREA and ethics documents are uploaded during registration. From the Project Details home page, the CPI creates and submits a 'New Site' registration form
  • The SSA can then be created for site PI to complete and submit to their site RGO in NSW or ACT
  • More information: 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 and creates one Minimal Data Form (MDF), uploads HREA and 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) and 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
  • More information: REGIS How-To Guides
NSW or ACT
NSW and ACT
  • The CPI uses REGIS to complete the HREA for ethics submission
  • The project is registered in REGIS by the CPI (project owner)
  • When the HREA is created and submitted in REGIS, SSAs can then be generated for NSW sites
  • Check with ACT Health for SSA arrangements
  • More information: 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 and 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 and 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)
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 and creates one Minimal Data Form (MDF), uploads HREA and 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) and 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 and 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 and 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)
 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 register the project once only (project owner)
  • Copies of HREA and ethics documents are uploaded during registration. From the Project Details home page, the CPI creates and submits a 'New Site' registration form
  • The SSA can be created for site PI to complete and submit to their site RGO in NSW or ACT
  • More information: 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 and 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 and 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)
 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 register the project once only (project owner)
  • Copies of HREA and ethics documents are uploaded during registration. From the Project Details home page, the CPI creates and submits a 'New Site' registration form
  • The SSA can be created for site PI to complete and submit to their site RGO in NSW or ACT
  • More information: 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 and creates one Minimal Data Form (MDF), uploads HREA and 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) and 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 Framework and Monitoring and Reporting Tables describe 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.