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.
The Ethics Committee Advisory Group
List of Ethics Committee Advisory Group members (2022-2023)
The role of the Ethics Committee Advisory Group is to provide high level guidance and advice on the deliverables of the project and provide a point of liaison between the Commission and peer groups.
|Committee member name||Committee contribution||Role title and organization||State|
|Adjunct Professor Dr Conor Brophy||Chair||Adjunct Professor Dr Conor Brophy, MBBS, MD, MBioethics, FRCP, AFRACMA||National|
|Ms Adele Kay||Jurisdictional Representative||Research Governance Officer Clinical Quality Regulation and Accreditation (CQRA), Department of Health||National|
|Mr Adrian Barnett||Expert||Professor of Statistics at Queensland University of Technology||QLD|
|Associate Professor Alwin Chong||Expert||Director of Arney Chong Consulting||National|
|Professor Andrew McLachlan||Expert||Head of School and Dean of Pharmacy in the Faculty of Pharmacy at the University of Sydney||NSW|
|Ms Anne McKenzie AM||Consumer representative||Head of the WA Consumer and Community Health Research Network.||WA|
|Mrs August Marchesi||Jurisdictional Representative||Senior Director, Research Ethics and Governance, Centre for Health & Medical Research, ACT Health Directorate||ACT|
|Mr Colin Thomson AM||Expert||Former Professor of Health Law and Ethics at the University of Wollongong (retired)||NSW|
|Mr David Van De Hoek||Jurisdictional Representative||South Australia Health Research Governance Officer||SA|
|Professor Edward Santow||Expert||Former Human Rights Commissioner, Australian Human Rights Commission (Aug 2016-Jul 2021) Industry Professor – Responsible Technology||NSW|
|Dr Gary Allen||Expert||National Health and Medical Research Council (NHMRC) Managing Director and Senior Consultant, Australian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)||NSW|
|Professor Heather D’Antoine||Expert||Program Manager National Network First Nations Research at the University of Queensland||WA|
|Mr James Cokayne||Jurisdictional Representative (NSW)||Research Ethics and Governance Unit, REGIS Team, NSW Office for Health and Medical Research (OHMR)||NSW|
|Ms Jillian Barr||National Health and Medical Research Council (NHMRC)||Acting Executive Director, Evidence, Advice and Governance Branch, NHMRC||National|
|Dr Jodi Glading||Jurisdictional Representative||Deputy Principal Medical Advisor, Acute Planning and Strategy Unit, Planning, Purchasing & Performance Group, Department of Health & Human Services||Tas|
|Professor Simon Barrett||Expert||Director, Research Ethics and Integrity, Monash University||VIC|
|Dr Suzanne Hasthorpe||Jurisdictional Representative||Manager, Coordinating Office for Clinical Trial Research, Department of Jobs Precincts and Regions||VIC|
|Dr Tahli Fenner||Department of Health Representative||Director – Risk Management Section Medicines Regulation Division, Health Products Regulation Group, Pharmacovigilance Branch, Department of Health||National|
|Ms Terrie O’Brien||Department of Health Representative||Director, Clinical Trials Section Health and Medical Research Office, Health Economics and Research Division, Department of Health||National|
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.
Register your interest
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If you have any questions relating to this consultation, please contact HMR@safetyandquality.gov.au.