REGIS, NSW’s ethics and governance system

It became clear during a 2012 NSW Government review of health and medical research that reforming the human research ethics and governance application process was a top priority.

The previous system allowed public health organisations and local health districts in NSW to use their own forms and processes, making applications time consuming and labour intensive. Researchers and research officers establishing a study across multiple hospitals were required to fill out numerous forms for each site involved. Creating a centralised system to reduce heterogeneity across public health organisations and local health districts in NSW would make researchers’ jobs easier, more efficient and less stressful.

After the review, the NSW Office for Health and Medical Research chose REGIS (Research Ethics and Governance Information System) to replace the previous system and began the rollout in early 2017.

Streamlining governance and ethics applications

The REGIS ethics and governance application system incorporates the National Health and Medical Research Council’s ethics application form, the Human Research Ethics Application, the Site-Specific Assessment application, post-approval and authorisation forms, progress reports, safety notifications and amendments, bringing all forms and documentation into one portal. “Everything is now in one spot, and all researchers involved in a study can easily access the application from anywhere and at any time,” says Kylie Becker, REGIS specialist matter expert and eHealth NSW team leader.

The system has substantially reduced duplications, she says. Researchers are no longer required to submit separate governance applications to each study site but can instead submit all documents into REGIS once. “For researchers, that was frustrating because if they worked at multiple sites, they would have slightly different processes at every research office,” Becker says. Amanda Bryant, a Western Sydney Local Health District research governance officer, says REGIS has made the process much simpler and faster. “You just upload documents to REGIS and click submit.”

While the previous system used a combination of hard copy documents and emails, REGIS is entirely online, significantly reducing the amount of paper that had to be physically delivered to participant sites and allowing approvals to advance more quickly. When an application is reviewed, it advances to the next step automatically. “The system shares documents between all sites, so that research officers don’t have to do it manually,” Becker says.

Remote accessibility has several other advantages. Submissions are available to all parties involved in the study at all times. The system promptly updates all researchers on any changes to their ethics and governance applications. Researchers can easily track the progress of their applications and monitor approvals and authorisations. Bryant says that before the implementation of REGIS, chasing an application’s status was complicated and required a lot of back and forth via email between all parties. “Now I can click on the application’s status and see where it is at in a matter of seconds.”

REGIS also functions as an online database where all clinical study documentation, such as the study protocol, consent forms and annual reports, is stored and easily accessible. At a glance, researchers can see if there is any outstanding documentation and when deadlines fall.

Bryant says this online system has simplified the ethics and governance application process and substantially shortened approval times. It has also offered greater work flexibility, especially during the pandemic. “Having REGIS during COVID-19 was fantastic,” she says. “It allowed me to work from home safely.”

With the implementation of REGIS completed in 2019, researchers across NSW now using the system appreciate how it has reduced administration headaches when it comes to governance and ethics applications. “Although it took some time for all research offices to get used to REGIS, everyone has worked extremely hard to understand the system,” Becker says. Her team remains committed to improving the system’s efficiency and usability, but she is pleased with how well researchers have responded to the change. “We’re even seeing other states starting to look at the system to see how they can use it.”