Overview and introduction
In 2013, NSW Ministry of Health in conjunction with the corresponding government health agencies in Queensland, South Australia, and Victoria (the ‘participating jurisdictions’) agreed to implement a scheme of National Mutual Acceptance (NMA) of single ethical review of multi-centre clinical trials conducted in each participating jurisdiction’s public health organisations.
In December 2015, the scope of NMA was expanded beyond clinical trials to all human research. Under the expansion, researchers and sponsors proposing to conduct a human research project at Public Health Organisation (PHO) sites in more than one participating jurisdiction may submit the study to one Certified Reviewing Human Research Ethics Committee (HREC). These HRECs have been certified by the National Health and Medical Research Council (NHMRC). Under NMA, participating organisations in the participating states and territories will then accept the scientific and ethical review of those Certified Reviewing HRECs.
Aims and intent
As part of broader ethics and governance reform, NMA will help reduce duplication in the conduct of scientific and ethical review of multi-jurisdictional research. Apart from some exemptions that apply within each jurisdiction, each proposal for a multi-centre human research study conducted in PHOs within the participating jurisdictions will be ethically and scientifically reviewed once.
Currently, New South Wales, Queensland, South Australia, Victoria, and Australian Capital Territory participate in NMA. The scheme is structured to admit further jurisdictions within Australia as and when they have developed their frameworks and are ready to participate. Investigators, trial coordinators, sponsors, and contract research organisations (CROs) should check with the relevant jurisdictions’ websites visit NMA Facts to confirm the status of participation in NMA.
Exemptions from NMA
The following types of studies will continue to be excluded from NMA because of jurisdiction-specific requirements:
Projects involving persons in custody or staff of the jurisdictional Justice Health departments
Projects specifically affecting the health and wellbeing of Aboriginal and Torres Strait Islander people and communities
Projects requiring access to state-wide data collections
Projects involving access to coronial material
First Time in Human (FTIH), Phase 0 and Phase 1 clinical trials (in SA only).
Other jurisdiction-specific exemptions apply. Please review the NMA Facts and the NMA Standard Principles for Operation for more information.
Site Specific Assessment
PHOs will continue to undertake a site-specific assessment (SSA) of all research projects that are to be conducted at institutions (sites) under their control, in compliance with the relevant jurisdictional standard operating procedures. These should also be read in conjunction with the NMA Standard Principles for Operation.
Under NMA, applications for scientific and ethical review of studies greater than low or negligible risk (LNR) must be submitted on a National Ethics Application Form (NEAF) via the Online Forms website . If at least one study site is located in Victoria, a Victorian Specific Module must also be completed.
Multijurisdictional LNR projects may either be submitted under NMA using a full NEAF application to be reviewed by a full HREC, or on an existing LNR application form submitted to each jurisdiction.
Whilst the NMA Scheme applies to public health organisations, private health organisations may accept the review of a NHMRC-certified reviewing HREC. Some jurisdictions may have certain ethical review requirements for private health organisations. Investigators should contact the relevant jurisdiction for more information.
Further information and resources
Standard Principles for Operation (Principles)
The Standard Principles for Operation describes some common principles relevant to NMA. The Principles provide general guidance for investigators, trial coordinators, sponsors, CROs and other parties undertaking clinical trials within health organisations. For details of operating procedures in each State or Territory, refer to the relevant jurisdictional websites listed at Appendix 3 of the Principles.
Information for investigators
The NMA Fatcs and National Mutual Acceptance Brochure are intended to provide information in an easy-to-use format for research offices to distribute to their research communities.
Research study checklist
The Ethics checklist should be completed by the Co-ordinating Principal Investigator and included with every new research project submitted to a certified HREC for review under NMA.
Participating organisations and local contacts
HRECs, RGOs, and Organisations provides lists and contact information for each:
- Certified Reviewing HREC
- Participating Research Governance Office
- Participating Organisation
in each of the participating jurisdictions (NSW, QLD, SA, VIC).
Jurisdictional legislative requirements
Jurisdictional Legislative Requirements aims to provide an overview of the various legislative and administrative frameworks that currently exist in the Commonwealth and the participating jurisdictions and applies to the approval of human research under NMA. The document is not a substitute for competent legal advice.
Monitoring and reporting
The Monitoring and Reporting Framework is intended as a guide for organisations and individuals involved with NMA and is designed to assist understanding of monitoring and reporting processes involved in ethical review and research governance of human research. It provides an overview of monitoring and reporting for clinical trials and sets out the responsibilities of researchers, sponsors, HRECs and institutions in the operation of mutual acceptance.
The Monitoring and reporting tables are designed to assist Investigators, HREC Coordinators and Research Governance Officers (RGOs). They provide information on the reporting requirements for multi-centre clinical trials taking place in States and Territories.
They cover, in the context of a multi-centre clinical trial:
- Coordinating Principal Investigator Reporting;
- Principal Investigator Site Reporting;
- Reviewing HREC Correspondence Regarding HREC Review & Post-
- Approval Monitoring;
- RGO Correspondence.