How to Apply
If you have any research enquiries, please see our Contact Us page.
Correct Institution Details for SWSLHD
South Western Sydney Local Health District
Administration Building, Eastern Campus, Liverpool Hospital
Locked Bag 7279, Liverpool BC 1871, ABN: 46 738 965 845
If coming from external mail, please ensure a prepaid envelope is included for return of counter-signed research agreements. If sending via internal mail, please ensure details are provided on a separate note in regard to the Internal Department to send the counter-signed agreement. Please note that the Research Directorate is not responsible for any mail lost in transit.
For further guidance on COVID-19, please refer to the below links:
NHRMC COVID-19: Guidance on clinical trials for institutions, HRECs, researchers and sponsors:
www.nhmrc.gov.au/research-policy/COVID-19-impacts
Research Ethics and Governance Application Metrics
The Office for Health and Medical Research (OHMR) sets metrics to govern the timelines of medical research ethics and governance applications in NSW. Historically, these metrics were focused on the time taken by the Research Directorate to review and process both ethics and governance applications. Beginning in 2021; however, OHMR has changed the focus of the metrics to now concentrate on the total time taken for an application to be approved. As a result of this shift to focusing on end-to-end time, these metrics now include all stakeholders in the research ethics and governance processes, including not only the Research Directorate, but also Heads of Departments, and the researchers themselves. The new OHMR metric benchmarks are:
• 90 days for Greater than Low Risk Ethics applications
• 60 days for Greater than Low Risk governance applications.
As a result of this shift in the OHMR metrics to focus on total time rather than just research office time, it is now more important than ever that all stakeholders involved in the research ethics and governance processes play their role to ensure that all applications are processed, reviewed, and approved efficiently.
To support this new approach, the REGIS system now has a timeline of 30 calendar days for researchers to to respond requests for further information. If a response is not received within this time, the REGIS system will automatically withdraw the application. This is a mandated NSW Health timeline requirement.
The SWSLHD Research Directorate is committed to ensuring the timely review of all ethics and governance applications. If you are experiencing any delays in your study, please don’t hesitate to contact us so that we can assist you with your application.
National Mutual Acceptance Scheme
Australian state and territory health departments have signed a Memorandum of Understanding for the mutual acceptance of ethical and scientific review of multi-centre human research projects undertaken in public health organisations. NMA helps to reduce duplication in ethical and scientific review, as under the NMA program, multi-centre human research projects will only need to be reviewed once in most cases (there are some exceptions).
As of late 2020, all Australian State and Territory jurisdictions now participate in NMA.
Exemptions from NMA
• Projects involving persons in custody or staff of the jurisdictional Justice Health departments – in NSW, these require review by the NSW Justice Health Human Research Ethics Committee.
• Projects specifically affecting the health and wellbeing of Aboriginal and Torres Strait Islander people and communities – in NSW, these may require approval from the Aboriginal Health and Medical Research Council Ethics Committee
• Projects involving access to coronial material
• First Time in Human, Phase 0 and Phase 1 clinical trials (in NSW and SA only).
Please see the NSW Health NMA page for further information.
How to apply
Before submitting a new application to the Research and Ethics Office and if you are not sure what level of risk your project is (i.e. should you complete a Low Risk HREA or a Greater than Low Risk HREA, we initially recommend that you fill in a Decision Aid. The Decision Aid will determine the level of risk the project is and which application you should complete.
NOTE: The National Statement (document that governs the Ethical principles in Australia and is used by the Ethics Committee in reviewing applications) has been updated in 2018. Further information in relation to the update can be found at https://nhmrc.gov.au/research-policy/ethics/national-statement-ethical-conduct-human-research
Please note a Site Specific Application (SSA) form, for all SWLSHD sites, must also be completed when you apply for either an LNR or GTLR application.
.jpg)
Step 1 - Decision Aid:
- Complete the Decision Aid form
- Email the Decision Aid to SWSLHD-Ethics@health.nsw.gov.au with subject line: Decision Aid Review.
- The Research and Ethics Office will email you back with a decision regarding what type of application you should fill in.
Step 2 - Ethics Application and SSA Application (please submit in parallel):
- Please use REGIS to submit your application. Online Forms applications are no longer acceptable.
For the REGIS guidelines for submitting an Ethics Application Click here
For the REGIS guidelines for submitting an SSA (Site- Specific Assessment) Click Here
NOTE: If you would like the Research and Ethics Office to review your draft application, Protocol, Participant Information Sheet, etc, please email your drafts to SWSLHD-Ethics@health.nsw.gov.au and/or set up a teleconference or face-to-face meeting.
OHMR REGIS Videos
Please click here for helpful how to information and video content from eHealth NSW REGIS and the Office for Health and Medical Research's Ethics and Governance Unit.
These videos will support those submitting applications through REGIS.
|
