The National One Stop Shop - a national platform for health-related human research
The Commission has been engaged by the Australian Government Department of Health, in partnership with all jurisdictions via the Clinical Trials Project Reference Group, to conduct consultations to develop the requirements and specifications of the National One Stop Shop for health-related human research approvals and the National Clinical Trials Front Door.
Goal of the National One Stop Shop and National Clinical Trials Front Door
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.
- 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-related human research.
Eliminate long-standing challenges with duplication, delays, navigation and fragmentation as a result of different research ethical 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.
Creating sustainable efficiencies within the heath related 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 Health and Medical Research Advisory Group chaired by Professor Ian Chubb AC, former Chief Scientist and clinical trial participant has been established to guide the consultation process.
Consultations update and early insights
The Commission is undertaking a two-phased consultation to ensure high impact stakeholders participate in the consultations, receive information on the evidence for a national platform and have the opportunity to share their information and preferences. The Commission has over 5000 stakeholders representing the health-related human research sector who have received updates on this work, including 1200 stakeholders registered to participate in the consultations. Fifty-four targeted consultations were completed between October and December 2021.
Consultation participants included jurisdictional health departments, health service organisations, industry, universities, medical research institutes, government agencies, Aboriginal and Torres Strait Islander groups, consumers and other individuals with an interest in the sector.
An outcome of the first phase of consultations will be the development of a high-level interactive One Stop Shop prototype for refinement through the second phase of national consultations, to commence in early 2022.
Key elements proposed for a single National One Stop Shop
To date, the consultations have revealed wide-spread support for the incorporation of single national ethics and site-specific approvals (SSA), linked to authorisation and notification systems of the Therapeutic Goods Administration and the Gene Technology Regulator and incorporation of an embedded and real-time national health-related human research registry.
There is also widespread support for a next generation national health-related human research registry to be embedded into the approvals platform to underpin the cutting edge-website for the community.
The sector supports in-built processes and notifications including local level research management functionality (clinical trial management system), analysis and reporting functionality with dashboards tailored to meet the needs of different users. Embedding and automating new site accreditation obligations for public and private health services, and associated data/reports/processes to support the accreditation process, is seen as essential.
Following implementation, this platform would replace other national and jurisdictional systems. To achieve the desired reform outcomes, cross-jurisdictional governance arrangements with representation from all jurisdictional health departments, or their equivalent, and the Therapeutic Goods Administration, the Office of the Gene Technology Regulator, the National Health and Medical Research Council and the Australian Commission on Safety and Quality in Health Care, will be needed to harmonise the approvals processes nationally. Such governance arrangements were strongly supported by key stakeholders during the consultations. Many stakeholders expressed the view that an innovative and intuitive approvals platform combining the functionality and with jurisdictional governance arrangements would make the research process significantly easier and less burdensome in Australia.
Consultations on the single national Site-Specific Assessment (SSA)
As part of the second phase of consultations, the Commission is conducting consultations on the core elements of the national SSA. These consultations are being guided by an expert reference group, the Health and Medical Research Advisory Group and the Clinical Trials Project Reference Group. The aim of the single national SSA is to ensure a single process for local site risk assessment and authorisation for health-related human research. The goals of the national SSA are to:
- Minimise duplication and the administrative burden related to local site research authorisation
- Include above the line (national) requirements
- Include below the line (jurisdictional) requirements (these requirements do not include the consideration of jurisdictional legislation that would be undertaken at the time of ethical review)
- Enable direct sign-off to authorising officers
National Clinical Trials Front Door
A range of views and options have been forthcoming so far in relation to the national recruitment portal and will continue to be explored throughout the consultations. There is broad support for a National Clinical Trials Front Door that acts as a central access point to facilitate connectivity for health researchers, sponsors, industry, primary carers, allied health and the community.
Several stakeholders have identified sensitivities due to the many recruitment providers already successfully operating across Australia.
National SSA survey
The Commission has developed a survey to gather feedback from the research community minimum core SSA requirements. You are invited to complete the survey by 11 March 2022.
Public consultation webinar
The Commission is holding a public consultation webinar on Wednesday 9 March from 10am to 11am.
The purpose of this consultation webinar is to provide an update on the research community on the work undertaken to date and gather feedback on the minimum core SSA requirements.
The closing date for written submissions was 31 January 2022. There will be an opportunity to provide further feedback throughout the second phase of consultations commencing in April 2022.
National One Stop Shop Survey and Consumer Survey
The Commission has developed two surveys to gather information from the sector and the community on the requirements for a national health and human research platform.
The Consumer Survey aims to gather information from community members about their experiences with health and human research to inform the development of this important initiative. People from across the community are encouraged to complete the consumer survey by 30 March 2022.
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.
The National One Stop Shop Survey gathered information on the current approach to managing research workflows and, to gain an understanding of stakeholder needs in the proposed national platform. The National One Stop Shop Survey closed on 17 December 2021.
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.