REGIS Implementation

Research Ethics & Governance Information System

REGIS is the Research Ethics and Governance Information System to assist in managing ethics and site governance of health and medical research projects in NSW Public Health Organisations (PHOs) and Australian Capital Territory. REGIS will replace AU-RED and the Online Forms portal as one system, accessible by researchers and public health organisations administering research.

The system will be used to manage single and multi-site human research projects. As a web-based platform, it will be available 24/7, with technical support within business hours.

The REGIS soft launch will commence in mid-January 2018, gradually rolling-out across NSW and ACT with implementation anticipated to be complete by May. To stay informed of when REGIS is coming to your site, please visit https://regis.health.nsw.gov.au/.

The system will incorporate the National Health and Medical Research Council’s new ethics application, Human Research Ethics Application (HREA), replacing the National Ethics Application Form (NEAF), as well as a new Site Specific Application (SSA) for site governance.

REGIS will enable a number of key changes to the existing research governance process within NSW. For example, the SSA questions will be redeveloped based on industry best practice. Further, investigators will have the ability to share visibility of their projects with Sponsors and other key stakeholders as appropriate.

Who will use the system?

  • Research applicants
  • Research office staff
  • Human Research Ethics Committees
  • Local site executives
  • NSW Health

How does it work?

The research applicant, also known in the system as the Coordinating Principal Investigator (CPI) and/or the Principal Investigator (PI). The CPI will take responsibility for establishing their research application in REGIS. The CPI will register themselves and their project, completing the ethics application, if required. At project registration, the CPI will nominate Principal Investigators (PIs) in the system (if the project is spread across multiple sites) to later trigger the site specific application process for research to be conducted in each location. Nominated PIs will be called (via automated email) to register in REGIS to complete the site application if current profile not found. Both CPIs and PIs will continue to use REGIS post-approval to meet reporting and other notification obligations for the duration of the research project.

Research Office staff includes Executive Officers, Research Governance Officers, Ethics Officers, and research office administration staff. Depending on their role, research office staff will process ethics and/or site specific applications within REGIS - ensuring that each application meets the relevant criteria and facilitating approval/authorisation processes.

The Executive Officer also arranges and records the outcomes of ethics committee meetings within REGIS. The agenda, minutes and all projects under review can be seen within REGIS by those with appropriate access.

For the first time, research office staff will be able to generate extensive, real-time reporting for their site to provide greater oversight of the projects being conducted at their site.

Human Research Ethics Committee (HREC), as the decision-making body reviewing and approving research ethics applications, includes HREC Chairs and all HREC members. The committee agenda, all projects under review for the meeting and the minutes post-meeting will be visible within REGIS for all committee members.

Local site executives include PHO Chief Executives and department heads. They will approve (ethics) and authorise (site governance) research applications within REGIS. The system will operate using an electronic form of approval via direct email. Local executive may receive regular ‘dashboard’ type reports to monitor KPI and metrics performance.

NSW Health includes relevant staff in the NSW Ministry of Health. The Office for Health and Medical Research (OHMR) will provide metrics and oversee research being conducted from a NSW perspective. This information will be provided to the Deputy Secretary for Population and Public, the NSW Health Secretary, and where appropriate, the NSW Minister for Health and Mental Health.

What are the benefits?

REGIS will enable process and practice changes in NSW, to help offer a more seamless experience for the research applicant in obtaining ethics approval and site authorisation for their human research project. These changes will bring:

a.Consistency

  • No matter the research location, pre-approval and post-approval requirements and processes for human research will be similar across all NSW Health PHOs
  • REGIS will hold the most up-to date information for all NSW and ACT health locations.

b.Transparency

  • The system will enable visibility of the application as it tracks throughout the ethics and site governance processes.
  • Pre-approval and post-approval project monitoring processes will be clearly communicated with system notifications and reminders.

c.Efficiency

  • The system is based on processes designed to enable approval/authorisation of research projects in NSW and ACT
  • Best practice benchmarks are used to monitor performance, linked to LHD Services Agreements.

 

For more information:

e. regis@health.nsw.gov.au

w. regis.health.nsw.gov.au