Consultation: Strengthening mutual acceptance of ethical review – Development of a National Accreditation Scheme for National Mutual Acceptance (NMA) Human Research Ethics Committees and Expansion of the NMA Scheme
All Australian governments are collaborating to streamline clinical trial and research approval processes.
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 now participate 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) and with oversight by the Clinical Trials Project Reference Group. 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 will commence in mid 2022. An expert Advisory Committee has been established to advise on the consultations. The Advisory Committee Chair is Adjunct Professor Dr Conor Brophy MBBS, MD, MBioethics, FRCP, AFRACMA.
This work builds on the revitalised clinical trials agenda agreed by all Health Ministers to further strengthen Australia’s clinical trial and research sector and represents a unique level of national agreement for streamlining and strengthening clinical trial and research processes.
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.
All Australian governments invite your participation in these important consultations to inform further development for the scheme.
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If you have any questions relating to this consultation, please contact HMR@safetyandquality.gov.au.