New applications involving NSW Health should be created in and submitted through the NSW Health Research Ethics and Governance Information System (REGIS). REGIS has been partially operational for several months and will fully replace the current application process in 2019.
Basic information, including details of the transition from IRMA, can be accessed here (link to REGIS page - above). For full details, including processes for multi-site research involving other health jurisdictions, please see the NSW Health REGIS information page
Please note that all applications involving ISLHD clients must include a researcher who is a staff member of ISLHD.
Governance approval must be obtained from the relevant Local Health District. The application form for this (Site Specific Application or SSA) is automatically created in REGIS when you create the project record.
Your application should include:
- The appropriate application form – this is created in REGIS
- Research Protocol
- Participant Information Sheet/document/script
- Consent Form/text/script
- Scripts for any planned verbal presentations of information e.g. presentation of research to a potential participant group, debriefing
- Copies of research instruments e.g. questionnaires, interview questions, telephone scripts
- All advertising material
- Any other documentation being provided to participants
- Any approvals from other organisations that will be involved
- Evidence of completion of Human Research Ethics training in the last three years for each UOW investigator
- Study Budget
- Details of who should be invoiced
If you are conducting a Clinical Trial your application should also include:
- Investigator's Brochure
- Indemnity Forms for HREC review
Applications for sponsored clinical trials should include Indemnity Forms for the study and for HREC review. The forms can be downloaded from the Medicines Australia website.
The Standard Indemnity Forms should be addressed to:
[name of site e.g. The Wollongong Hospital],
Illawarra Shoalhaven Local Health District
The HREC Review Indemnity Forms, should be addressed to:
The University of Wollongong (ABN 61 060 567 686) of Northfields Avenue, Wollongong, NSW 2522, acting through the University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical HREC.