A new research governance system
The Research Ethics and Governance Information System (REGIS) is the new portal to help manage ethics and site governance approvals of human research projects in NSW and ACT public health organisations (PHOs) and local health districts (LHDs). The system is being rolled out progressively across all PHOs and LHDs in a soft launch phase where certain types of applications are being accepted in REGIS and others in the current system. Visit Transitioning to REGIS for more details and to access interim guidance.
Full implementation of REGIS will occur by 1st April 2019. By this point, all stakeholders need to be using REGIS.
REGIS will replace AU-RED and Online Forms as one system, accessible by PHOs/LHDs and researchers, including investigators and clinical trial coordinators. It will facilitate the creation, processing and storage of:
- ethics (HREA) and site specific assessment (SSA) applications
- post-approval and authorization forms
- progress reports
- safety notifications and amendments.
REGIS incorporates the National Health and Medical Research Council’s ethics application form, the Human Research Ethics Application (HREA) and the Site-Specific Assessment (SSA) application.
- Researchers will be able to track the progress of their ethics and governance applications, in terms of approvals and authorisations.
- Researchers will be able to navigate through REGIS more easily, due to more consistent policies and processes.
- REGIS will enable research office staff to track applications through pre- and post-approval, and develop more comprehensive reports.
- For PHO executives, better reporting will lead to more informed decisions to promote growth and innovation in health and medical research.
In 2012, the NSW Government undertook a strategic review of health and medical research in NSW. The review recognised the role and value of health and medical research in supporting innovation, improving health services and delivering better treatments and outcomes for the people of NSW in both hospitals and the community.
This review lead to the establishment of the NSW Office for Health and Medical Research (OHMR). Recommendations for human research ethics and governance reform were adopted by this office. Among these recommendations was the need to improve the information system to streamline ethics approval and site assessment processes.
As the contract end approached for the AU-RED/Online Forms, under Government policy, NSW Health was obliged to undertake a competitive procurement process. This process, designed to objectively assess what was in the marketplace, was also an opportunity to identify specific requirements for a best-fit solution. Solution developer, F1 Solutions Pty Limited, won this tender in early 2017.
The project and system has become known as REGIS – the Research Ethics and Governance Information System.