Case Study

Research Ethics Governance Information System

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About REGIS

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 and local health districts.

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The Challenge

In 2012, the NSW Government undertook a strategic review of health and medical research. The review recognised the value of research in supporting innovation, improving health services and delivering better treatments and outcomes. This led to the establishment of the NSW Office for Health and Medical Research (OHMR), in which recommendations for human research ethics and governance reform were adopted. One was for an information system to streamline ethics approval and site assessment processes associated with human ethics. The goal was to attract more research projects to NSW.

The tender process, designed to objectively assess what was in the marketplace, was also an opportunity to identify a best-fit solution to deliver on these critical recommendations. F1 Solutions won this tender and commenced the challenge of implementing the new information system, known as Research Ethics and Governance Information System (REGIS).

The Solution

F1 Solutions proposed their OmniStar platform, running on Amazon Web Services (AWS) and compliant with industry, state and federal standards, to deliver OHMR’s vision. The OmniStar solution is used across Australia in universities, state and federal government bodies and government funded/not-for-profit organisations to provide research, grants and ethics management.

OmniStar powers systems such as the NHMRC’s Human Research Ethics Application (HREA). REGIS incorporates the HREA and Site-Specific Assessment (SSA) applications, in addition to other forms and processes, to support ethics and governance. REGIS transformed the ability of OHMR to implement online processes as a unified system, accessible by PHOs, LHDs and researchers alike. It facilitated the creation, processing and storage of ethics and SSA applications, post-approval and authorisation forms, progress reports, safety notifications and amendments.

REGIS was designed, developed and deployed in 2018 to over 20 LHDs. The project included a large-scale data migration activity that took information from disparate legacy systems, as well as penetration/security testing and training. Post go-live services are provided by F1 Solutions. These include a local help desk service, performance reporting, product support and training.

The benefits for REGIS

Since the implementation of the REGIS system in 2018, the solution has transformed research and ethics, and delivered the following benefits:

  • The integrated OmniStar solution has replaced multiple disparate legacy systems to streamline OHMR operations and dramatically reduce duplication of activities.
  • Integration with NHMRC’s HREA has removed the need to access multiple systems to complete ethics and site governance approvals.
  • Intelligent SmartForm technology, graphical work flow and configurable structures have provided seamless information management and unprecedented levels of configurability and control. This configuration and control is managed in-house by OHMR staff.
  • Automation and standardisation replaced cumbersome, time consuming, paper-based processes.
  • Enhanced reporting capabilities have enabled authorised users to access and clearly communicate the wealth of information collected by REGIS through user-defined dashboards and reports.
  • Ubiquitous access allows HREC EOs, Site RGOs and respective PHOs and LHDs to access centralised information from any device.

Currently over 20,000 users with over 30,000 applications, 40,000 projects and 110,000 documents are being managed through REGIS. The standout fact is that the system has already delivered significant benefits to the research community, reducing the average time required for site governance applications by 40%, with an average 32% time saving for an ethics application. And this is just the beginning!

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Intelligent SmartForm technology, graphical work flow and configurable structures have provided seamless information management and unprecedented levels of configurability and control, managed in-house.

Created with Lunacy

Intelligent SmartForm technology, graphical work flow and configurable structures have provided seamless information management and unprecedented levels of configurability and control, managed in-house.

Created with Lunacy

The integrated OmniStar solution has replaced disparate legacy systems to streamline operations and dramatically reduce duplication of activities.

Created with Lunacy

Integration with NHMRC’s HREA has removed the need to access multiple systems to complete ethics and site governance approvals.

Created with Lunacy

Tedious, time-consuming tasks are now automated, resulting in greater productivity from the same number of personnel, vastly improving quality of output and increasing engagement.

Created with Lunacy

Enhanced reporting capabilities have enabled authorised users to access and communicate the wealth of information collected by REGIS through user-defined dashboards and reports.

Created with Lunacy

ARENA engaged F1 Solutions on a time and materials basis to perform the agreed scope of work. Weekly project status meetings were held to manage the delivery of the scope of work to the agreed budget, time frame and risk management. F1 Solutions went the extra mile to ensure the delivery of the project.

Lloyd Monahan

ARENA, Project Manager

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