The National One Stop Shop - a national platform for health and human research
The Commission is conducting national consultations on behalf of all jurisdictions to scope the requirements for a national health and human research approvals platform – a National One Stop Shop.
The aim of the National One Stop Shop is to make it easier for patients, researchers, industry representatives and sponsors to find, conduct, participate and invest in high quality and ethical research in Australia.
The concept for the National One Stop Shop was developed by the Australian Government Department of Health and the Clinical Trials Project Reference Group and presents a significant opportunity to achieve a national, interconnected, rapid and streamlined approvals platform to:
- address long-standing challenges with duplication, delays, navigation and fragmentation as a result of different research ethical approval and local site authorisation systems in the jurisdictions; separate processes for Therapeutic Goods Administration (TGA) notifications; a separate process for registration on the Australian and New Zealand Clinical Trials Registry; separate processes for other jurisdiction-specific and therapy-specific approvals and authorisations and, the absence of individualised and fragmented operational monitoring and reporting approaches
- enhance patient access to state-of-the-art treatments
- improve health outcomes
- contribute to the innovation economy and a self-improving health system
- strengthen Australia’s global positioning in health and human research.
Creating sustainable efficiencies within the heath and human research sector through a single national, interconnected, rapid and streamlined world-leading approvals platform in collaboration with all jurisdictions that will:
- provide a cross-jurisdictional ethics approval and site-specific authorisation platform that incorporates key application, notification and approval systems
- incorporate the Clinical Trials Notification and Clinical Trials Approval schemes administered by the TGA
- include an embedded and automated next-generation national clinical trials registry
- provide sophisticated monitoring and reporting functionality for different users.
Options for improving research participation through a related community volunteer recruitment portal, the National Clinical Trials Front Door will also be considered through the consultation process. This includes mechanisms that facilitate access to third party participant recruitment providers.
Additionally, the National One Stop Shop will:
- embed the National Clinical Trials Governance Framework accreditation obligations and automate data/reports/processes to support the accreditation process
- assist all governments to respond to areas of need in a rapid, coordinated and strategic manner based on real-time, accurate information regarding trial activity and site capability
- aim to extend beyond the public and private hospital sector to incorporate the university, primary care and independent medical research sectors
- protect data integrity and adhere to data security requirements.
The project advisory group chaired by Professor Ian Chubb AC, former Chief Scientist and clinical trial participant has been established to guide the consultation process.
The Commission is inviting written submissions in word or PDF format on the One Stop Shop and the National Clinical Trials Front Door proposal, including suggestions for additional functionality. Please send written submissions to HMR@safetyandquality.gov.au.
The Commission is also encouraging participation in the initial phase of sector-wide consultations from October - 17 December 2021.
Broad sector-wide consultations are being undertaken with state and territory health departments, health and human research organisations, universities, research networks, clinicians, consumers, healthcare providers, professional bodies and industry, on the needs and expectations of the sector to scope the requirements for a national health and human research platform – a National One Stop Shop. More than 45 targeted consultation workshops will be conducted through to 17 December 2021.
To date the Commission has consulted with representatives from:
- Aboriginal and Torres Strait Islander representative organisations
- ACT Health
- ARCS; Clinical research organisations
- Ausbiotech; Medicines Australia; Medical Technology Association of Australia; MTP connect
- Australian Clinical Trials Alliance
- Australian Institute of Health Innovation
- Australian Health Research Alliance and the Health Research and Translation Centres
- Cancer Australia; Cancer Council Australia; Cancer Trials Australia; Rare Cancers Australia; Clinical Oncology Society of Australia
- Clinical registries
- Clinical societies
- Clinical Trials Collaborative Forum
- Consumer groups
- Cooperative trials groups
- F1 Solutions (vendor of the NHMRC HREA system, NSW and ACT REGIS system and the GEM system in South Australia)
- Infonetica (vendor of the VIC, QLD and MATER ERM system)
- Medical Research Institutes
- NSW Health
- Northern Territory Health
- Office of the Gene Technology Regulator
- Public Health Association of Australia
- Queensland Health
- Research Australia
- South Australia Department of Health
- Tasmanian Health
- The Australian Research Data Commons; CSIRO
- The National Health and Medical Research Council
- The Therapeutic Goods Administration
- Universities Australia and Deans of Medicine and Nursing
- Victorian Department of Jobs, Precincts and Regions (DJPR)
- Western Australia Department of Health
National One Stop Shop Survey and Consumer Survey
The Commission has launched two surveys to collect input from the sector and the community on the requirements for a national health and human research platform.
The One Stop Shop Survey gathers information on the current approach to managing research workflows to gain an understanding of stakeholder needs in the proposed national platform.
The Consumer Survey aims to collect information from community members about their experiences with health and human research to inform the development of this important initiative.
The survey will take approximately ten minutes to complete. You are not required to share any personal information. The answers you provide will be confidential and stored securely.
Register your interest
Register your interest to receive updates on how to be involved.
If you have any questions relating to this consultation, please contact HMR@safetyandquality.gov.au.