National Mutual Acceptance (NMA) Scheme

The National Mutual Acceptance (NMA) scheme is the Australian arrangement under which a single scientific and ethical review of a multi-centre human research project — conducted by one certified Human Research Ethics Committee (HREC) — is accepted across participating public health organisations in every state and territory, rather than each site independently re-running the same ethics review. It exists specifically to remove the duplicated administrative burden of a multi-site study needing separate HREC approval at every participating hospital or health service.

How the single review works

A researcher running a multi-centre study submits one Human Research Ethics Application (HREA) to a single reviewing HREC that holds certification under the NHMRC’s National Certification Scheme for the Ethics Review of Multi-centre Research — the accreditation that qualifies a committee to review on behalf of other participating sites, not just its own institution. Once that HREC approves the study, its ethical and scientific review is recognised by every other NMA-participating public health organisation the study runs at, without those sites conducting a duplicate ethics review of their own.

Site-Specific Assessment (SSA) still applies

Ethics review acceptance under NMA is not the same as site authorisation to begin research. Each participating site still completes its own Site-Specific Assessment (SSA) — a separate, local governance step assessing whether that specific site has the resourcing, facilities, indemnity and insurance arrangements, and institutional capacity to safely conduct the approved research, and formally authorising the study to proceed there. A study cannot open at a given site until that site’s own SSA is complete, even though the ethics review itself was already accepted nationally.

Scope and exclusions

NMA applies mainly to research conducted within publicly funded health services and to multi-centre projects as defined in the National Statement on Ethical Conduct in Human Research. Several categories of research are commonly excluded from the standard single-review pathway and instead follow their own distinct jurisdictional requirements — research specifically concerning Aboriginal and Torres Strait Islander health and wellbeing, research involving people in custody, and studies requiring access to statewide data sets or coronial material are the categories most consistently carved out across state and territory guidance. Because participation, certified-HREC lists, and category-specific exclusions are set and updated separately by each state and territory health department, a researcher planning a multi-centre study should confirm current participation and any site-specific exclusions with the relevant jurisdiction rather than assume national uniformity on every point.

How it relates to clinical trial approval

NMA governs the ethics-review pathway for a study, not the separate regulatory pathway a clinical trial may also need to satisfy — an interventional trial involving an unapproved therapeutic good still separately requires notification or approval under the TGA’s CTN or CTA scheme, and registration on the ANZCTR, alongside (not instead of) NMA ethics acceptance and per-site SSA.