National Mutual Acceptance (NMA)
The Northern Territory has agreed to be part of the National Mutual Acceptance (NMA) Scheme for single ethical review.
The Human Research Ethics Committee of the NT Dept of Health and Menzies School of Health Research (NT HREC) is registered with the NHMRC and has been certified by the NHMRC for multi-centre ethical review. (EC00153)
For clinical trials intending to enrol participants from the Northern Territory under the NMA scheme, the Chair of the HREC and the ethics administrator undertake a risk-based assessment of the application and determine if further review in the NT is warranted. This assessment includes the protocol, participant facing information, and associated consenting strategies including waiver of consent. This is described in the risk assessment sections of the NT HREC’s Terms of Reference and Standard Operating Procedures.
NMA guidelines for each Australian State and Territory can be found in the NMA Standard Principles of Operation
Projects with approval by another HREC
By participating in the NMA, the Northern Territory is generally agreeing to accept the ethical review from an accredited NMA reviewing HREC without further ethical review for research in the NT’s public health services. However, like other jurisdictions, specific requirements and exceptions will be in place (see Triggers for full NT HREC review below).
To be considered for reciprocal NT approval, the primary NMA reviewing HREC should be willing to provide ethical oversight of NT sites, and the NT sites should be listed in the lead HREC approval documents.
Triggers for full NT HREC review
Types of human research projects excluded from single scientific and ethical review:
- Phase 0 (first time in human) and Phase 1 clinical trials will not be accepted under the single ethical review for clinical trials for Northern Territory public health system institutions. Where a Certified HREC from another jurisdiction has provided prior approval for a Phase 0 or Phase 1 clinical trial application, these applications will be re-reviewed ethically by the appropriate HREC in the Northern Territory in addition to any research governance/specific assessment/institutional authorisation requirements.
Approval from the appropriate NT HREC is required where the research project involves research in, or concerning:
- The experience of Aboriginal and Torres Strait Islander people as an explicit focus of all or part of the research
- Data collection explicitly directed at Aboriginal and Torres Strait Islander people
- Aboriginal and Torres Strait Islander people, as a group, are to be examined in the results
- A significant number of the population are likely to be of Aboriginal and Torres Strait Islander origin
- The information has an impact on one or more Aboriginal and Torres Strait Islander communities
- Aboriginal and Torres Strait Islander health funds are a source of funding.
- NT Health is not currently accepting data linkage projects under NMA. Approval from the NT HREC will need to be sought.
NMA guidelines for each Australian State and Territory can be found in the NMA Standard Principles of Operation.
NMA application requirements for projects with approval from another HREC
To conduct research in the NT, NMA applications should include the following documents:
- Cover letter describing the study and its NT context including naming the NT sites and NT co-investigators, and the means of identifying and recruiting participants.
- Ethics application that was previously approved by the lead NMA-certified HREC, including all supporting documents e.g. HREA, protocol, PIS/CF
- Approval letter from lead NMA-certified HREC; and any correspondence such as amendment approvals from lead HREC acknowledging ethical oversight of NT sites if applicable and if not included on original approval letter.
- Part D attachment to HREA NMA
Submission documents should be combined as one pdf and emailed to NTHREC@menzies.edu.au
NMA review process
The Chair of the NT HREC and the ethics administrator will undertake a risk-based assessment of applications with prior ethical approval, based on elements of a project which affect vulnerable people or communities and determine if further review is warranted.
This assessment includes the protocol, participant facing information, and associated consenting strategies including waiver of consent. Risk factors are described in the NT HREC’s Terms of Reference and Standard Operating Procedures.
The Chair will either issue a reciprocal approval letter acknowledging the prior NMA ethics approval or refer the application to the NT HREC for further review.
Research in the NT through the NMA scheme must not commence until:
- the primary reviewing HREC has included NT sites under its ethics approval, and
- the NT HREC has provided endorsement of the primary HREC’s approval, and
- Site Specific Assessments with the relevant NT Health research governance offices are finalised.
NMA application requirements when NT HREC is to be the lead HREC
The NT HREC may accept NMA applications as the primary reviewing HREC when the lead site and Coordinating Principal Investigator are based in the Northern Territory.
NMA submissions to the NT HREC (as lead HREC) should include:
- Cover letter summarising the study including listing all sites
- CV for PI at each site
- Master PIS-CF (if applicable)
- Any other supporting documents (if applicable)
- For NT sites: Part D attachment to HREA https://www.menzies.edu.au/page/Research/Ethics_approval/Forms/PART_D_attachment_to_HREA_and_NMA/
- For Vic sites: Victorian Specific Module (VSM) https://www.clinicaltrialsandresearch.vic.gov.au/national-mutual-acceptance
- For WA sites: Western Australian Specific Module (WASM) https://rgs.health.wa.gov.au/Pages/Multi-centre-Research.aspx
Site Specific Assessment (SSA)
Please note, the NMA processes apply to ethics clearance. Participating organisations’ Site Specific Assessment (SSA) requirements still apply.