Applications involving NSW Health

UOW-ISLHD HREC Separation

As of 1 July 2023, the University of Wollongong and Illawarra Shoalhaven Local Health District have agreed to end the operation of its joint Human Research Ethics Committee (HREC)

What does this mean for me?

For new applications that involve NSW Health:

  • From 1 July 2023, the UOW HREC is unable to review new ethics applications that involve NSW Health. If your research involves NSW Health, the ethics review will need to be conducted by an HREC associated with the Local Health District (LHD) involved in the research.  All ethics applications for research involving NSW Health must be submitted via the Research Ethics and Governance Information System (REGIS), which is the ethics submission portal for NSW Health.  For research involving ISLHD, ethics applications should be submitted via REGIS to the Greater Western HREC, ISLHD’s new partner HREC.
  • For UOW researchers (including students) that submit an application to another HREC for review, once this project is approved it must be submitted in IRMA as an ‘Acceptance of Approval by an External HREC’, with the formal letter of approval, ethics training certificates (for UOW researchers only) and all approved documentation attached. The application will receive an administrative check, to ensure the approval is from an NHMRC certified HREC and covers the work that will involve UOW.  The ethical oversight of the project will remain with the approving HREC.

For existing applications in REGIS that involve NSW Health:

  • For projects in REGIS that already have UOW HREC approval, these will continue to be monitored by the UOW HREC until they are transferred to the relevant LHD HREC at the end of 2023 (as above, this will be the Greater Western HREC if the study involves ISLHD). Until then, all amendments, adverse events and annual reports will be reviewed by the UOW HREC in REGIS, as normal.
  • If your existing project in REGIS has expired or a progress report is overdue, please submit your progress/final report by November 2023.If this is not received, your project may be closed and you may be required to re-apply with Greater Western HREC if you wish to continue with your project.
  • If your project is a clinical trial that has been approved in the REGIS system, it will not be transferred to Greater Western HREC and will remain with the UOW HREC until other arrangements are made.  Further advice will be provided regarding the review of clinical trials when these new arrangements are finalised.

Further Information on this Change

If you have any questions about this change or require further information, you can contact the UOW Human Ethics team at uow-humanethics@uow.edu.au, or the ISLHD Research Office at ISLHD-Research@health.nsw.gov.au.

Access REGIS

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All research conducted involving NSW Health needs to be submitted through the NSW Health Ethics Portal, REGIS.

The Research Ethics and Governance Information System (REGIS) is an ethics submission 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).

As noted above, the UOW HREC is no longer able to conduct ethics reviews for new applications submitted in REGIS.  Instead, researchers will need to submit applications in REGIS to an LHD HREC involved in the research.

REGIS requires you to prepare and upload all parts of the submission other than the HREA before you can generate a HREA form.

  • Step 1: Prepare the research protocol and all supporting documentation
  • Step 2: Create a project (generate a record) in REGIS
  • Step 3: Upload the supporting documents
  • Step 4: Complete the HREA (ethics application form) and SSA (Site Specific Application form) in REGIS
  • Step 5: Sign off electronically in REGIS

For assistance on using the REGIS system, please see the REGIS Quick Reference Guides (QRG) for step-by-step guidance in navigating REGIS.

You can also access the REGIS Help Desk, FAQs and other REGIS support information on the REGIS website.

If you are submitting a new application in REGIS and require further assistance, please contact the Ethics Office of the LHD HREC that will conduct the review.

A record has been created in REGIS for all research projects involving NSW Health that were current at the time the REGIS portal went live in 2019.

Amendments and reports for these projects must be submitted in REGIS, you will no longer need to access IRMA.

Please note the REGIS records do not include the documents submitted through IRMA, or any related correspondence. If you wish to access documentation in IRMA, such as correspondence you have received or forms that have been submitted in IRMA, you will need to maintain your UOW account to retain access to IRMA.  Please contact uow-humanethics@uow.edu.au if you need assistance.