National Mutual Acceptance (NMA) is the system of single scientific and ethical review of multi-centre human research projects across Australian jurisdictions (public health organisations only). Australian Capital Territory, New South Wales, Queensland, South Australia, Victoria and Western Australia are current participants in NMA, and other jurisdictions may join in the future. The system has been in operation for review of multi-centre clinical trials since 1 November 2013 and it was agreed to expand the system to include all human research commencing 14 December 2015.

Last updated: 21 November 2017
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Aims
Reviewing Human Research Ethics Committees (HRECs)
Ethics application forms
Scope of research
HREC monitoring and reporting
Site specific assessment (SSA)
Types of human research projects excluded from single ethical and scientific review under NMA – participating jurisdictions
Jurisdiction contacts and websites

Aims

  • enable public health organisations of participating jurisdictions to accept a single ethical and scientific review of human research projects
  • inform the ongoing development of the national system of single ethical and scientific review of multi-centre research.

Under the National Mutual Acceptance agreement a multi-centre human research project is reviewed for ethical and scientific merit once only. There will be exceptions to some areas of research that will apply in each jurisdiction and these are listed below.

Reviewing Human Research Ethics Committees (HRECs)

The single ethical and scientific review of a multi-centre human research project is conducted by an NHMRC certified HREC of a participating jurisdiction and certified in a relevant area of research. A list of current certified HRECs including the certification categories of each HREC is available from NHMRC website. The HRECs, RGOs and Organisations guidance document contains contact details for NMA and can be found on jurisdictional websites.

Selecting a reviewing HREC

For applicants to select a reviewing HREC:

  • in Queensland, through the Central Co-ordinating Service form (online booking).
  • in Victoria, through the Central Allocation System (Phone: (03) 9096 7395).
  • in Australian Capital Territory, New South Wales and the Northern Territory the choice of HREC is at the discretion of the applicant.
  • in South Australia and Western Australia, applications should be to the certified HREC associated with the site at which the applicant is conducting the research and if this is not applicable, the selection of a suitable certified HREC is at the discretion of the applicant.
  • through the Tasmanian HREC once certified; prior to that at the discretion of the applicant.

Ethics application forms

A Human Research Ethics Application (HREA) is required to be used for application to a certified HREC.

For studies in Victoria, the Victorian Specific Module must be completed in addition to the HREA.

For studies in Western Australia, the Western Australian-Specific Module must be completed in addition to the HREA.

Scope of research

The scope of NMA is all human research.

Human research is defined in the National Statement on Ethical Conduct in Human Research (2007, p7) as research conducted with or about people, or their data or tissue.

Clinical trial is defined as interventional research involving a drug/device trial, radiation therapy, surgery, treatment or diagnostic procedure and studies associated with ongoing activities relating to trials that have been conducted. This may include post-trial activities such as observational research and evaluation of a trial, developing a registry and other post-marketing surveillance activities.

This includes commercially sponsored, collaborative groups and investigator-initiated clinical trial research

HREC monitoring and reporting

The reviewing HREC will have oversight of the human research project and ensure that it complies with all ethical, scientific and safety requirements, as appropriate. Investigators will be required to provide regular progress reports, other required reports and safety reports to the reviewing HREC (according to the NHMRC Position Statement).

The NMA Monitoring and Reporting Tables outline the requirements for each participating jurisdiction including local site reporting requirements and can be found on jurisdictional websites.

Site specific assessment (SSA)

The National Mutual Acceptance scheme provides for ethical and scientific approval only. Each participating public health organisation must undertake a site specific assessment (SSA) of a multi-centre human research project and be authorised in compliance with the relevant jurisdictional standard operating procedures.

Each jurisdiction will have an SSA form for use within that jurisdiction.

Types of human research projects excluded from single ethical and scientific review under NMA – participating jurisdictions

For research conducted in the Australian Capital Territory

  • Phase 0 and Phase I (first time in human) clinical trials will not be accepted under the single ethical review system for institutions under the ACT public health system and must be reviewed by ACT Health HREC.
  • All human research projects requiring access (including linkage) to territory data collections owned or managed by the ACT Government must be reviewed by the ACT Health HREC.
  • All human research projects involving persons in custody in the ACT and/or staff of ACT Justice Health require review by the ACT Health HREC.
  • Research studies involving access to coronial material must be reviewed by the ACT Health HREC.
  • Approval from the ACT Health HREC is required where the research project involves research in, or concerning:
    • the experience of Aboriginal and Torres Strait Islander peoples of the ACT as an explicit focus of all or part of the research
    • data collection explicitly directed at Aboriginal and Torres Strait Islander peoples of the ACT
    • Aboriginal and Torres Strait Islander peoples of the ACT, as a group, are to be examined in the results
    • the information has an impact on one or more Aboriginal and Torres Strait Islander communities of the ACT
    • Aboriginal and Torres Strait Islander health funds, from the ACT, are a source of funding

For research conducted in New South Wales

All human research projects involving persons in custody in NSW and/or staff of NSW Justice Health require review by the NSW Justice Health HREC.

Approval from the Aboriginal Health and Medical Research Council Ethics Committee is required where the research project involves research in, or concerning, NSW and any one of the following applies:

  • The experience of Aboriginal people is an explicit focus of all or part of the research
  • Data collection is explicitly directed at Aboriginal people
  • Aboriginal peoples, as a group, are to be examined in the results
  • The information has an impact on one or more Aboriginal communities
  • Aboriginal health funds are a source of funding

All human research projects requiring access (including linkage) to statewide data collections owned or managed by NSW Health or the Cancer Institute (NSW) must be reviewed by the NSW Population and Health Services Research HREC.

For research conducted in Queensland

Research studies involving access to coronial material must be referred to the Forensic and Scientific Services Human Ethics Committee (FSS-HEC) for ethical and legal approvals.

Research studies that specifically target Aboriginal and Torres Strait Islander peoples must be reviewed by ethics committees closest to the communities that are involved in the research.

For research conducted in South Australia

Phase 0 and Phase 1 clinical trials will be exempt from single ethical review in South Australia.

Approval from the Aboriginal Health Research Ethics Committee (AHREC), South Australia, will also be required where:

  • the experience of South Australian Aboriginal and Torres Strait Islander people is an explicit focus of all or part of the research
  • data collection is explicitly directed at South Australian Aboriginal and Torres Strait Islander people
  • it is proposed to separately identify South Australian Aboriginal and Torres Strait Islander people in the results
  • the information has an impact on one or more South Australian Aboriginal and Torres Strait Islander communities
  • the geographic location of the research is such that a significant number of the population are likely to be of Aboriginal and Torres Strait Islander origin (based on 4.7.6 of the National Statement, 2007)
  • terms such as ‘resilience’, ‘well-being’, ‘cultural safely’, ‘cultural health’ and ‘language and culture’ are used in the description and design of the project indicating that the project has important health implications for South Australian Aboriginal and Torres Strait Islander people
  • South Australian Aboriginal and Torres Strait Islander health funds are a source of funding

For research conducted in Victoria

Research studies involving access to coronial material must be referred to the Victorian Institute for Forensic Medicine HREC.

Research studies involving persons in custody require review by the Justice HREC of Victoria.

For research conducted in Western Australia

All research projects, where Aboriginality is a key determinant or is explicitly directed at Aboriginal people, must be reviewed by the Western Australian Aboriginal Health Ethics Committee (WAAHEC). That is, where the project involves the following categories:

  • Aboriginality is a key determinant
  • Data collection is explicitly directed at Aboriginal people
  • Aboriginal people, as a group, will be examined in the results
  • the information has an impact on one or more Aboriginal communities
  • Aboriginal health funds are a source of funding

All research projects that require access to coronial samples, data or information must be reviewed by the Coronial Ethics Committee, WA.

All research projects that require the use and disclosure of personal information from the Department of Health data collections or data linkage must be reviewed by the Department of Health WA HREC.

NMA member jurisdictions: contacts and websites

Australian Capital Territory

Research Office
Phone: (02) 6174 7968
Email: acthealth-hrec@act.gov.au

New South Wales

The Office for Health and Medical Research
Email: researchethics@doh.health.nsw.gov.au

Northern Territory

Royal Darwin Hospital and Flinders University
Email: ethics@menzies.edu.au

Queensland

Health and Medical Research Unit
Phone: (07) 3708 5071
Email: hiiro_reg@health.qld.gov.au

South Australia

Office for Research
Phone: (08) 8226 7461
Email: health.humanresearchethicscommittee@sa.gov.au

Tasmania

Office of the Chief Medical Officer

Victoria

Coordinating office for Clinical Trial Research
Phone: (03) 9096 7394
Email: multisite.ethics@health.vic.gov.au

Western Australia

Research Development Unit, Office of the Chief Medical Officer
Department of Health WA
Phone: (08) 9222 4332
Email: cmoresearchdevelopment@health.wa.gov.au

Page Updated: Tuesday 21 November 2017