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.

Why?

  • 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.

How?

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.

National One Stop Shop consultations update

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.

The Commission conducted more than 70 consultation sessions since September 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. 

The purpose of the second phase of consultations is to refine functional and non-functional requirements for a national platform. To assist with the second phase of consultations, the Commission has developed a demonstration tool (Proof of Concept). The Proof of concept is not a final platform, but a high-level prototype with a subset of functions for demonstration and testing with the sector through the second phase of consultations.

The second phase of consultations commenced in May 2022 with focussed meetings with jurisdictional representatives and subject matter experts prior to open forums with the sector.

The subject matter experts meetings consist of targeted meetings with nominated individuals representatives from groups engaged in the previous phase of consultations. These groups include: 

  • Aboriginal and Torres Strait Islander representative organisations
  • Academies 
  • Accenture
  • ACT Health
  • ANZCTR
  • ARCS; Clinical research organisations
  • Ausbiotech; Medicines Australia; Medical Technology Association of Australia; MTP connect
  • Australian Clinical Trials Alliance
  • Australian Institute of Health Innovation
  • Australian Institute of Health and Welfare 
  • Australian Health Research Alliance and the Health Research and Translation Centres
  • Bellberry Ltd
  • Cancer Australia; Cancer Council Australia; Cancer Trials Australia; Rare Cancers Australia; Clinical Oncology Society of Australia
  • Clinical and non-clinical managers
  • Clinical registries
  • Clinical societies
  • Clinical Trials Collaborative Forum
  • Clinical trial companies
  • Clinical trials/health and medical research investigators
  • Clinical Trials Project Reference Group
  • Consumer groups
  • Cooperative trials groups
  • Directors of research
  • F1 Solutions (vendor of the NHMRC HREA system, NSW and ACT REGIS system and the GEM system in South Australia)
  • Foundations
  • Health administrators
  • Health service organisations (public and private)
  • Human Research Ethics Committees
  • Industry
  • Infonetica (vendor of the VIC, QLD and MATER ERM system)
  • Medical Research Institutes
  • NSW Health
  • Northern Territory Health
  • Office of the Gene Technology Regulator
  • Patient recruitment providers
  • Public Health Association of Australia
  • Queensland Health
  • Research Australia
  • Research governance officers
  • Research managers and coordinators
  • Research nurses and research pharmacists
  • 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.

Public consultations forum

The Commission is holding three public consultation forums on:

  • Friday 17 June 2022 from 10am to 12pm
  • Friday 24 June 2022 from 10am to 12pm
  • Wednesday 29 June 2022 from 10am to 12pm.

The purpose of these forums is to provide an update to the research community on the work undertaken to date and gather feedback on the user requirements for the national platform.

Register now

National SSA minimum requirements consultations update

As part of the second phase of consultations, the Commission is conducting consultations on the core elements of the national SSA. 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.

An SSA Expert Reference Group was established to guide the consultations on the national SSA core elements with members nominated by the Clinical Trials Project Reference Group. The Reference Group met twice and will continue to be engaged throughout the second phase of the National One Stop Shop consultations. The Commission conducted four targeted consultations and two public webinars to ensure engagement with the broader sector in March 2022.

A national SSA survey was developed to collect feedback on the existing draft National SSA from the research community. The survey was published on the Commission’s website for two weeks on Monday 28 February 2022 and received 582 responses. In total, more than 842 individuals and groups participated in the national SSA consultations.

The Clinical Trials Project Reference Group endorsed in principle the single national SSA core elements with agreed amendments for implementation via the National One Stop Shop subject to further feedback through the second phase of national consultations.

Written submissions

The Commission is inviting written submissions on the One Stop Shop and the National Clinical Trials Front Door until 30 June 2022. The Commission also invites submissions on the single national SSA core elements endorsed in principle by the Clinical Trials Project Reference Group. 

Please send written submissions to HMR@safetyandquality.gov.au.

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.

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. 

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.