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National Mutual Acceptance

NHMRC Peter Doherty Fellow Dr Jiamei Lian at IHMRI. Photo credit Paul Jones

Australian state and territory health departments have signed a Memorandum of Understanding for the mutual acceptance of ethical and scientific review of multi-centre human research projects undertaken in public health organisations.

The scope of National Mutual Acceptance includes any form of human research as defined in the latest version of the National Statement on Ethical Conduct in Human Research (National Health and Medical Research Council) for which an application must be made to a Human Research Ethics Committee for the purpose of being conducted at a public health organisation.

Aims and intent

As part of broader ethics and governance reform, National Mutual Acceptance reduces 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 public health organisations within the participating jurisdictions will be ethically and scientifically reviewed once.

National Mutual Acceptances aims to:

  • 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 MoU 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.

Participating jurisdictions

From late 2020, all Australian State and Territory jurisdictions now participate in National Mutual Acceptance. Investigators, trial coordinators, sponsors, and Contract Research Organisations (CROs) should check with the relevant jurisdictions’ websites and the information below to confirm the status of participation in National Mutual Acceptance.

Reviewing Human Research Ethics Committee

The single ethical and scientific review of a multi-centre human research project is conducted by a National Health and Medical Research Council certified Human Research Ethics Committee of a public health organisation from one of the jurisdictions which is certified in the relevant area of research. A list of current certified Committees  including the certification categories of each is maintained by  the National Health and Medical Research Council. The “Human Research Ethics Committees, Research Governance Offices and Organisations” guidance document contains contact details for National Mutual Acceptance and can be found under the “Further Information and Resources” section below.

Selecting a reviewing Human Research Ethics Committee

For applicants to select a reviewing Human Research Ethics Committee:

  • in Queensland, through the ethics review manager (ERM).
  • 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 Human Research Ethics Committee is at the discretion of the applicant.
  • in South Australia and Western Australia, applications should be to the certified Human Research Ethics Committee associated with the site at which the applicant is conducting the research and if this is not applicable, the selection of a suitable certified Human Research Ethics Committee is at the discretion of the applicant.
  • through the Tasmanian Human Research Ethics Committee once certified; prior to that at the discretion of the applicant.

Exemptions from National Mutual Acceptance

The following types of study will continue to be excluded from National Mutual Acceptance 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 involving access to coronial material
  • First Time in Human, Phase 0 and Phase 1 clinical trials (in NSW and SA only).

Other jurisdiction-specific exemptions apply. Please review the information and the National Mutual Acceptance Standard Principles of Operation resources below for more information.

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 Human Research Ethics Committee.
  • 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 Human Research Ethics Committee.
  • All human research projects involving persons in custody in the ACT and/or staff of ACT Justice Health require review by the ACT Health Human Research Ethics Committee.
  • Research studies involving access to coronial material must be reviewed by the ACT Health Human Research Ethics Committee.
  • Approval from the ACT Health Human Research Ethics Committee 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.

Research conducted in New South Wales

Research involving persons in custody and/or staff of Justice Health

All human research projects involving persons in custody in NSW and/or staff of NSW Justice Health, require review by the NSW Justice Health Human Research Ethics Committee.

Research that may affect the health and wellbeing of Aboriginal people and communities

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.

Research requiring access to state-wide data collections

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 either (i) the NSW Population and Health Services Research HREC; or (ii) one of the nationwide specialist NMA HREC for multi-jurisdictional data linkage studies.

The NSW Population and Health Services Research Ethics Committee (PHSREC) is a specialist NMA HREC for multi-jurisdictional data linkage studies (see document attached below). Studies involving multi-jurisdictional data linkage are exempt from PD2010_055 and PD2015_037. Please contact MOH-ResearchEthics@health.nsw.gov.au for more information.

  • NMA Data Linkage Guide v1.5 August 2021

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Early Phase Clinical Trials

Early Phase Clinical Trials (EPCTs) (defined here) will not be accepted under the NMA scheme for clinical trials for New South Wales Public Health Organisations, except in the following circumstances:

  • EPCTs involving adult participants will be required to be submitted to the Bellberry HRECs;
  • For EPCTs involving paediatric participants:
    • Where the lead site is located in NSW, these applications will berequired to be submitted to the Sydney Children’s HospitalsNetwork HREC;
    • Where the lead site is located in other NMA jurisdictions, approvals will be accepted from a certified HREC hosted by a specialist paediatric health organisation operating under the NMA scheme.

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.

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.

Research conducted in Victoria

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

Research studies involving persons in custody require review by the Justice Human Research Ethics Committee of Victoria.

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 Human Research Ethics Committee.

Site specific assessment

The National Mutual Acceptance scheme provides for ethical and scientific approval only. Public health organisations 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 National Mutual Acceptance Standard Principles of Operation (see Further Information and Resources below).

Each jurisdiction will have a Site Specific Assessment form for use within that jurisdiction.

National Mutual Acceptance procedures

Under National Mutual Acceptance, applications for scientific and ethical review of studies must be submitted on a Human Research Ethics Form (HREA).

Whilst the National Mutual Acceptance scheme applies to public health organisations, private health organisations may accept the review of a National Health and Medical Research Council-certified reviewing Human Research Ethics Committee. Some jurisdictions may have certain ethical review requirements for private health organisations. Investigators should contact the relevant jurisdiction for more information.

Ethics application forms

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

For studies in the Australian Capital Territory, the Australian Capital Territory Specific Module must be completed in addition to the Human Research Ethics Application.

For studies in Victoria, the Victorian Specific Module (VSM) must be completed in addition to the Human Research Ethics Application. See the VSM Guidelines here.

For studies in Western Australia, the Western Australian Specific Module (WASM) will be created and completed within an RGS Project along with the Human Research Ethics Application.

Scope of research

The scope of National Mutual Acceptance includes all human research for which an application must be made to a Human Research Ethics Committee for the purpose of being conducted at a public health organisation..

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.

Human Research Ethics Committee monitoring and reporting

The reviewing Human Research Ethics Committee 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 Human Research Ethics Committee (according to the National Health and Medical Research Council).

The National Mutual Acceptance Monitoring and Reporting Tables outline the requirements for each participating jurisdiction including local site reporting requirements and can be found on jurisdictional websites or in the information and resources section below.

National Mutual Acceptance jurisdiction contacts

  • State/territory
  • Organisation
  • Phone
  • Email

 

Further information and resources

Standard Principles for Operation (Principles)

The National Mutual Acceptance Standard Principles of Operation describes some common principles relevant to National Mutual Acceptance. The Principles provide general guidance for investigators, trial coordinators, sponsors, Contract Research Organisations 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 National Mutual Acceptance Brochure is 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 Human Research Ethics Committee for review under National Mutual Acceptance.

Participating organisations and local contacts

HRECs, RGOs and Organisations provides lists and contact information in each of the participating jurisdictions (NSW, QLD, SA, VIC) for each:

  • certified reviewing Human Research Ethics Committee
  • participating Research Governance Office
  • participating organisation.

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.
  • Monitoring Reporting Matrix

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Frequently asked questions

APPLICATIONS

Where do I complete Ethics and Site Specific Assessment (SSA) applications for NMA studies?

As of early 2021, six NMA jurisdictions are using four different application platforms.  While research applicants proposing studies under NMA will need to work within multiple platforms, the theory behind the process for creating those applications remains the same:

  • Applicants still only create and submit one Human Research Ethics Application (HREA) form. This is done in whichever online system is being used in the jurisdiction where the reviewing Human Research Ethics Committee (HREC) is located (see Where do I create and submit HREAs? table below).
  • The study still undergoes one ethics review under NMA, where applicable.
  • Applicants at each study site still create SSA applications in each relevant jurisdiction, in that jurisdiction’s system (see Where do I create and submit SSAs? table below):
    • For sites that are in the same jurisdiction as the reviewing HREC, or are in another jurisdiction that is using the same online system as the reviewing HREC, the applicant creates the SSAs in that same online system.
    • For sites that are in another jurisdiction that is using a different online system (see table), applicants must log into the relevant system, enter minimal project-level information into the system (often on a “Minimal Data Form,”) and then generate and submit the SSA applications in that system.

Thus, a researcher may end up using between one and three different online systems to generate a full suite of NMA applications related to one project, depending on where the HREC and sites are located. However, the entry of duplicate data is kept at a minimum, because any HREAs created in one system, is then uploaded as a PDF into the other systems.

Where do I create and submit HREAs for NMA studies?

Where do I create and submit SSAs for NMA studies?

NMA procedures remain the same.

How do I create a NSW SSA for a study undergoing review or approved by an NMA HREC in QLD, VIC, SA or WA?

To create a NSW SSA application in REGIS for a study undergoing review or approved under National Mutual Acceptance (NMA) by a Human Research Ethics Committee (HREC) in Victoria, Queensland, South Australia or Western Australia, researchers should use the Project Registration Quick Reference Guide and follow the instructions for “Completing Project Registration – Ethics Submitted/Approved in another state/jurisdiction (VIC/QLD/SA/WA). Once submitted, the NSW SSA applications will generate for completion. Researchers should then use the Site Application – Completing, Requesting Support and Submitting Quick Reference Guide for submission guidance.

Updated 2 months ago