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 all ethics applications in ACT, NSW or 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.

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)
  • NMA projects to continue to use Online Forms until further notice.

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
  • From the HREA in ERM, the CPI / delegate creates a SSA for each site in VIC &/or QLD.
  • 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, NSW or SA
  • 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 or SA  ACT, NSW or SA
  • From the Online Forms HREA, the CPI / delegate creates a SSA for each ACT, NSW or SA 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 or SA
QLD or VIC
  • 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.
  • 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).
ACT, NSW, QLD, SA or VIC
WA
  • Consult the WA Research Governance Service (RGS) website for information on how to create a research governance application.
WA
QLD or VIC
  • 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.
  • 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 ACT, NSW or SA
  • The CPI / delegate uses Online Forms to create a Minimal Dataset Form (MDF). MDF guidance is available below.
  • 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
  • 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.