Research and Ethics Office

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Welcome to the Research Directorate website for the South Western Sydney Local Health District (SWSLHD).

This site explains the work of this Office and the processes a researcher must follow in order to undertake research on humans within the SWSLHD.

The policies and processes governing authorisation of human research have been developed in accordance with the National Health & Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research 2007 and NSW Health policy directives and guidelines.

We hope this site is informative and helpful. Should you wish to make any comments or suggestions about this site please provide feedback to SWSLHD-Ethics@health.nsw.gov.au.

How to Obtain Research Ethics Approval and Research Governance Authorisation


Each research project requires:

  • Research Ethics Approval (by submitting a HREA – Human Research Ethics Application)
  • Research Governance Authorisation (by submitting a SSA – Site Specific Authorisation)

If research is conducted without BOTH of the above requirements, the project is considered to be misconduct in accordance with the NHMRC, National Statement and NSW Health Policy.


Who reviews?


SWSLHD Human Research Ethics Committee (HREC) is a Committee delegated by the SWSLHD Chief Executive to issue Ethics Approval upon review of HREA. SWSLHD HREC is NHMRC Accredited.


The SWSLHD Research Governance Office is delegated by the SWSLHD Chief Executive to review SSA and to issue Research Governance Authorisation for SWSLHD hospitals.


Is your project research?


Ethics Approval and Research Governance Authorisation is not provided to projects that are not research (i.e. Case Reports or Quality Improvement Projects). Research projects are categorised into:

  • Low Risk
  • Greater than Low Risk

To find out if your project satisfies one of the two categories above, please submit a Decision Aid by filling in the form and emailing to SWSLHD-Ethics@health.nsw.gov.au We strongly recommend doing this before you spend a lot of time and effort on an incorrect application.


What is the difference between Low Risk and Greater than Low Risk?


See our presentation slides which summarises the requirements of the National Statement in regard to this. Essentially, if your project involves a vulnerable group as per the National Statement (examples are children, ATSI, refugees, those without capacity, etc) then the project will be low risk. Clinical trials are also greater than low risk.


NOTE: your project will be reviewed in the SAME way – i.e. obtaining a low risk ethics approval is not easier than a greater than low risk ethics approval. The same requirements of the National Statement apply. The only thing that is different, is the submission process. Greater than low risk projects are required to be submitted to full HREC meetings as per the National Statement, and therefore we require the HREA to be submitted by a closing date to allow for the Agenda and documents to be circulated to SWSLHD HREC prior to the meeting date (see dates HERE). Low risk HREA do not have closing dates, so can be submitted at any time. This is the only difference.

Quick Links
Greater than Low Risk HREA Low Risk HREA
Site Specific Applications Decision Aid
FAQ's Progress Report Form
Amendment Form Participant Information Templates
Free Training on Research Ethics Principles      Adding Investigators to Studies

 

 

 


 

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Last Updated: 25 February, 2019
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