Role
In 2023, the Australian Government and state and territory ministers for health agreed to establish an enduring IGPRG. The group leads national initiatives to improve the medical research ecosystem.
Key IGPRG priorities include:
- establishing a National One Stop Shop to ensure Australia is an attractive destination for medical research including clinical trials
- supporting health services in the implementation of the National Clinical Trials Governance Framework
- developing quality standards and an accreditation scheme for Human Research Ethics Committees (HRECs) and their host institutions
- continuously maintaining the National Standard Operating Procedures for Clinical Trials in Australia
- future reform initiatives to improve health outcomes for all Australians.
The government appointed Emeritus Professor Ian Chubb AC, FAA FTSE as Chair of the IGPRG. Senior officials from state and territory governments are part of the IGPRG along with other key stakeholders.
A key objective of the IGPRG is to make Australia a preferred destination for clinical trials. This will:
- benefit participants
- ensure a continuously improving health system
- build productivity
- contribute to an innovation economy.
Work of the IGPRG
National One Stop Shop program
The National One Stop Shop program is a national framework and digital solution that will:
- strengthen and harmonise policies, systems and processes for the administration, regulation and execution of health and medical research
- join up the clinical trial whole-of-life cycle into one operational system – including approval, registration, execution and publication of results
- help find, conduct, participate and invest in high-quality and ethical medical research – including clinical trials.
Access the National One Stop Shop consultation report and addendums for more information.
Subscribe to receive regular updates on the progress of the National One Stop Shop and work that is underway to drive national reforms in health and medical research.
Find previous updates on the National One Stop Shop.
Benefits
The National One Stop Shop provides:
- a single location for information on clinical trials and research
- national co-design and consultation
- earlier access to more life-changing treatments
- improved capacity for patients, researchers and industry to find, conduct and participate in clinical trials and ethical medical research.
Read the media release from the Minister for Health and Aged Care on transforming health and medical research in Australia.
National Clinical Trials Governance Framework
The National Clinical Trials Governance Framework strengthens governance arrangements for clinical trial services. It also provides clarity to those responsible for delivering clinical trials, including:
- governments
- health service organisations
- hospital administrators
- clinicians.
The Governance Framework ensures that:
- clinical trial service is embedded in routine health service clinical and corporate governance systems, and is considered core health service business
- the governance of clinical trials is a fundamental part of the health services governing body’s responsibilities and accountabilities
- clinical trials are conducted in a safe environment for the best possible outcomes for participants and the community.
From May 2023, all health services conducting clinical trials are assessed to the National Safety and Quality Health Service (NSQHS) Standards as provided in the Governance Framework. The NSQHS Standards apply to all:
- public and private Australian hospitals
- day procedure services
- public dental services.
For the first 3 years, health services are assessed against the Maturity Scale as having Established, Growing or Initial systems in place. Beyond the first 3 years, health services will be assessed as either Met or not-Met actions for clinical governance and partnering with consumers to receive health service accreditation.
Access resources for health services to support implementation of the Governance Framework on the ACSQHC website.
HREC quality standards and accreditation scheme
The IGPRG is leading the development of national quality standards and accreditation scheme for HRECs and their host institutions to:
- enhance consistency and efficiency of the review processes
- build reciprocal confidence in HREC review decisions.
National Standard Operating Procedures for Clinical Trials in Australia
In Australia, all public and private health service organisations and their employees involved in conducting all categories of clinical trials must follow the National Standard Operating Procedures for Clinical Trials in Australia (National SOPs) and principles as a minimum. These guidelines are outlined in the National SOPs.
The National SOPs help organisations engaged in conducting clinical trials in Australia to standardise their procedures. We aim to review the National SOPs every 2 years.
Publications
IGPRG initiatives have produced these publications.
COVID-19: Guidance on clinical trials for institutions, HRECs, researchers and sponsors
Collaborative research agreement template – for projects not involving clinical trials
Contact
Please contact us for more information about the IGPRG.