The National Mutual Acceptance (NMA) scheme for Ethical and Scientific Review of Multi-Centre Research is consistently recognised as a key enabler for clinical trials and research conduct in Australia. All state and territory Public Health Organisations are now participating in the scheme facilitated by the Australian Government’s Encouraging More Clinical Trials in Australia measure.
Promoting mutual acceptance of ethical review remains a key priority, and all jurisdictions have agreed to transition to a revised and expanded NMA scheme, based on accreditation of ethics committees to a national quality standard to be developed by the Australian Commission on Safety and Quality in Health Care (the Commission) with oversight by the Clinical Trials Project Reference Group (CTPRG). A primary focus will be safety and quality, seeking to distinguish and leverage Australia’s competitive advantage and reputation for quality.
This approach recognises the benefits associated with formal recognition by an authoritative body with a mandate to accredit based on expert assessment of operations and performance against specified standards, and will ensure NMA accredited ethics committees operate to the high quality and safety levels expected in Australia.
Clarifying and strengthening arrangements for the NMA scheme in this way will enable further expansion of the scheme beyond the public sector to also include appropriately accredited ethics committees operating across more diverse settings.
The Commission has been engaged to develop the accreditation scheme for NMA ethics committees in collaboration with all jurisdictions, and consultations to inform this work are expected to commence in mid 2022.
This builds on the Revitalised clinical trials agenda agreed by all Health Ministers to further strengthen Australia’s clinical trials sector and represents a unique level of national agreement for streamlining and strengthening clinical trials process. A key achievement to date is the National Clinical Trials Governance Framework - a first step towards nationally consistent accreditation of health services undertaking clinical trials, and widely recognised as a significant and positive reform with implementation anticipated in 2022.
Current NMA arrangements will continue in the interim, including additional jurisdictional specific requirements for review of early phase and other trials where these have been established. The National Health and Medical Research Council (NHMRC) will also continue to maintain the Certification Scheme until the new scheme is agreed and in place, ensuring that all currently Certified Institutions continue to meet the requirements.
The CTPRG comprises senior officials from all jurisdictions, the NHMRC, and the Therapeutic Goods Administration.
The Commission invites your participation in important consultations to inform further development for the scheme.
Register your interest now to get updates on the consultations and how you can be involved.