Australian state and territory health departments have signed a Memorandum of Understanding for 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 National Statement on Ethical Conduct in Human Research (National Health and Medical Research Council, 2007) 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 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.
Currently, New South Wales, Queensland, South Australia, Victoria, Australian Capital Territory and Western Australia participate in National Mutual Acceptance. The scheme is structured to admit further Australian jurisdictions 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 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 participating jurisdiction and certified in a 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 on jurisdictional websites.
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 studies 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 requiring access to statewide data collections
- projects involving access to coronial material
- First Time in Human, Phase 0 and Phase 1 clinical trials (in 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
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.
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 Human Research Ethics Committee.
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.
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). If at least one study site is located in Victoria, a Victorian Specific Module must also be completed.
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 must be completed in addition to the Human Research Ethics Application.
For studies in Western Australia, the Western Australian Specific Module (WASM) must be completed in addition to the Human Research Ethics Application.
Scope of research
The scope of National Mutual Acceptance 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.
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
- Research Office
- 02 6174 7968
- Health Innovation, Investment and Research Office
- 07 3708 5071
- Office for Research
- 08 8226 7461
- Coordinating office for Clinical Trial Research
- 03 9096 7394
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.
Frequently asked questions
Where do I complete ethics and Site Specific Assessment (SSA) applications for NMA studies?
In 2018, some National Mutual Acceptance (NMA) jurisdictions have moved – or are in the process of moving – from the common Online Forms research application platform, to various other platforms.
As of 16 July 2018, six NMA jurisdictions are using three 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?
- ACT – Please contact ACT Health for advice on how to submit applications to ACT Health HREC.
- NSW - Online Forms
- QLD – ERM (Ethical Review Manager)
- SA – Online Forms
- VIC – ERM. More information can be found in the Streamline E-bulletin ERM Special Edition.
- WA - RGS (Research Governance Service)
Where do I create and submit SSAs for NMA studies?
NMA procedures remain the same.
What about REGIS?
NSW Health is still using Online Forms for any HREAs and SSAs being generated for NMA Studies.
How do I use Online Forms and AU RED, for studies undergoing ethics review by an NMA HREC in Queensland, Victoria or Western Australia?
Follow the two links to the right of this page, for the relevant instructions.
How do I create a NSW SSA for a study approved by an NMA HREC in QLD, VIC or WA?
To create an NSW SSA form in Online Forms for a study approved under National Mutual Acceptance (NMA) by a Human Research Ethics Committee (HREC) in Queensland, Victoria, or Western Australia, researchers follow these steps:
- Complete the Minimal Dataset Form in Online Forms.
- The Ethics Form Type box will appear. Select ‘MDF (Minimal Dataset form for SSA Applications linked to WA, VIC or QLD HREC reviews.’ Do not select HREA, or it will require you to fill out an entire HREA.
- The new MDF form will now appear in the My Project tree on the left hand side of the screen.
- Click on that application. The MDF will become available for use.
- Complete the Study Type, title(s), and Coordinating Investigator information so that NSW Research offices will see this information in their IT system
- Save the MDF.
- Attach the HREA and supporting documents (now a required step).
- Navigate to the Documents – Upload tab, and attach any ethics-level supporting documents that the NSW RGO will also need to see. For example, you could attach the HREA application and the ethics approval letter.
- At a minimum, two documents of any type must be attached before you can submit the MDF.
- As usual, obtain any authorisations necessary via the Authorisation tab.
- Electronically submit the MDF application.
- Navigate to the Submission tab. Click on ‘submit your application electronically.’
- Click Submit when the Submit Application window appears.
- The submission code appears on the screen, in the footer of your MDF application PDF, and in the header of Online Forms when that application is being worked on. It is in the format of AU/, followed by the year (18 or 19), followed by six more alphanumeric characters.
- The HREC reference number now appears in the header of your MDF application PDF, and in the header of Online Forms when that application is being worked on.
- Retain your MDF submission code, as you’ll need to send it to the NSW RGO when you submit your NSW SSA form.
- Create the child SSA form(s) for the NSW SSA applications.
- You can create the SSA form(s) under an MDF application the same way you create an SSA under a HREA.
- With the MDF highlighted in the left hand tree, click on the SSA tab.
- Enter the number of SSA forms you wish to create, and select “Create a new SSA form.” The new SSA form will appear.
- Select New South Wales. Select SSA as the SSA form type.
- Click on the Navigate tab to open and complete the SSA as usual.
- Attach documents, complete electronic authorisations, and generate submission code as usual.
- Send the NSW RGO the SSA submission code, the HREC submission code, and your SSA application materials.
How to import a NSW SSA in AU RED for a study approved by a QLD, VIC or WA HREC?
There will be no extra steps for Research Governance Officers (RGOs) to register Site Specific Assessment (SSA) applications in AU RED if the HREA was reviewed under National Mutual Acceptance (NMA) by an Human Research Ethics Committee (HREC) in Queensland, Victoria or Western Australia. RGOs will merely enter the HREC submission code on the Application – New tab. RGOs should follow these steps:
- Create a new SSA application.
- As usual, select Application, New. Select Site Specific Assessment as the study type.
- Enter the HREC reference number generated in Online Forms by the applicant. The format of these numbers will be: HREC/YY/OTHER/##.
- The new application screen will pre-populate with the Online Forms data.
- Register the SSA application.
- Retain “Other” as the “correct committee.” Click “register Application.” AU RED will complete the SSA and will generate the SSA number. The Mode of HREC review will autopopulate as “National Mutual Acceptance,” and all other entered data will auto-populate.
- Navigate to the Details tab. Click Upload Online Form Data as usual.
- Enter the SSA submission code where prompted, and confirm the SSA.
- Enter the SSA reference number again when prompted, and confirm the contact information.
The system will import and register the SSA as usual. The fields that were provided in the MDF and the SSA will auto-populate into the relevant AU RED SSA fields (i.e. Study type and Major Sponsor type). A copy of the Minimum Data Form (MDF) and any MDF supporting documents will appear against the SSA application.
How to search for an MDF in AU RED?
- Navigate to the Application Search tab.
- Search by typing the project title into the Title Search field, if known, and by clicking “OTHER” in the State section, and “Application multi-site” in the Application Type section.
Updated 1 year ago