All research involving humans occurring at NSW Health sites requires ethical review.
Quality Assurance and Quality Improvement projects do not require ethical review. If you require an exemption letter for publication purposes, you can seek this from your Head of Department or make a submission to the LNR Committee via REGIS.
Find more information about what is quality improvement vs research here.
LNR Research describes research in which the only foreseeable risk of harm is one of discomfort and any foreseeable risk is no more than inconvenience. Research in which the risk for participants is more than discomfort is NOT low risk.
LNR research may include surveys/interviews/focus groups, observational studies or retrospective audits.
When you make your submission via REGIS, the Research Office will allocate your application to the appropriate Committee (LNR or HREC) based on an initial review of your application.
- Prepare your Study Protocol using the template available on our Forms and Templates page. Review the National Statement to ensure that key ethical requirements are addressed within the Protocol.
- Prepare your supporting documents, e.g. Patient Information and Consent Form etc. using the templates on our Forms and Templates page. Ensure that the supporting documents reflect the content within your Study Protocol.
- Complete the HREA in REGIS. You will need to set aside 2-3 hours to provide thorough information that will assist the HREC to understand:
- Your study objectives
- Your methodology including participant selection and consent
- How you will collect, store and analyse data
- How you will cater to participant groups identified in the National Statement
- How you will conduct research involving bio-specimens or genomics.
Select the correct type of PISCF template for your study and adapt it to reflect your Study Protocol. The PISCF needs to be written in language that can be understood by your participants. The templates for a PISCF and letter of invitation can be found here.
Most submissions will not be approved by the Committees on the first review. It is important that you have considered the requirements of the National Statement prior to making your submission, as this will reduce the amount of feedback made by the Committees.
The Office of Health and Medical Research requires that ethical review takes no longer than 45 days, not including the time taken by research teams to respond to queries or amend submissions.
The Committee is reviewing your application to assess its compliance with the requirements of the National Statement.
A pre-read of the National Statement and incorporation of its requirements into your protocol, study documents and application will assure the Committee that your study is ethically acceptable.
Researchers must use REGIS.
You will need to submit:
- A covering letter, and
- Documentation for review by the HREC, for example:
- Protocol (mandatory for all projects)
- Participant Information Sheet and Consent Form
- Invitation Letter
- Telephone Scripts
- Data collection form
- Recruitment materials (e.g. advertisements, letter to potential participants or others such as doctors)
- Signed declaration & undertaking by the Data Custodian and Co-ordinating Investigator (if seeking access to a NSW Health owned or managed state-wide data collection)
- Curriculum vitae of the Co-ordinating Investigator and Principal Investigators.
Under normal circumstances consent must be sought to access and use the identifiable or potentially identifiable health information of an individual for purposes other than for which it was directly collected. However, the HREC may make exceptions under the Statutory Guidelines for Research if it is in the public interest.
If a proposed activity is to be conducted by a person who does not normally have access to the patient’s records for clinical care or a directly related secondary purpose, there is the potential for the privacy and confidentiality of that patient to be breached.
As a general principle, quality assurance and research activity data should not be identifiable where possible before being given to third parties who would not normally have access to them. Review of medical records or other health data by anyone who would not normally have access to information contained therein, unavoidably compromises the privacy of individuals.
Please contact the Research Support Office to discuss this further.
We can only accept electronic copies submitted via REGIS.
- Please see the Fee Policy for Review of Commercially Sponsored Research.
- Please note that Investigator led research does not incur a review fee.
Researchers are responsible for identifying and declaring their own conflicts of interest, including actual, potential or perceived conflicts.
Please check the NSW Health Policy related to Conflicts of Interest and Gifts and Benefits for further details or the SESLHD Internal Audit website (only available to view when connected to the network):