A proposal that could be considered a quality assurance activity may or may not require review. Each project requires individual consideration.
Find more information about what is quality improvement vs research here.
Low & Negligible Risk 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 serious than discomfort is NOT low risk.
Risk associated with the project includes actual or potential risk for participants (patients, staff, students and volunteers) and for the project to infringe upon the rights, privacy or professional reputation of carers, health professionals and/or institutions.
IMPORTANT: The Office of Health and Medical Research (OHMR) has released a new guideline regarding Low/Negligible research (released 31 May 2018). You can also look at the National Statement Chapter 2.1.
LNR research may include surveys/interviews/focus groups, observational studies or retrospective audits if the only foreseeable risks are those of minimal discomfort and inconvenience.
If in doubt please contact the Research Support Office and provide a 1-2 page outline of your proposed study.
- Draft your study protocol.
- You are welcome to contact the Research Support Office and request an appointment to discuss your proposal before submitting.
- Finalise your study protocol.
- Complete the HREA and submit your Protocol and related study documents via REGIS
Select the correct type of PISCF template for your study and adapt as required. The templates for a PISCF and letter of invitation can be found here.
This depends on the quality of your submission. Meeting dates and closing dates can be found here.
Where further information is requested by the committee for their review, the relevant closing dates and time (9am on the closing date) should be observed when submitting a response.
Good quality and transparency!
The purpose of the Human Research Ethics Application (HREA) is to enable applicants to provide sufficient detail about the research project to allow a Human Research Ethics Executive Committee to make an informed decision about the ethical and scientific acceptability of the proposal.
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.
- Submit a good quality submission!
- Make sure your application is complete with all required documents
- Provide prompt responses to queries.
- An ill prepared, or poorly thought out protocol results in more delays
- Include all required supporting documents
- If you are unsure about what is required, seek clarification from the Executive/Ethics Officer
- A timely response to any queries received from the Research Support Office will help expedite your review
- Observe closing dates for responses to the Executive or LNR Committees
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 activities 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.
No, you do not need to send a hard copy of your application, just the submission electronically in REGIS.
We can only accept electronic copies submitted via REGIS.
We have two offices:
- Prince of Wales Hospital in Randwick
- St George Hospital in Kogarah.
Find more information here.
- 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):