NSW Government NSW Health
South Eastern Sydney Local Health District
nsw health

Ethics - New Application – Full Ethics Application

Intention to Submit

If your project is not a LNR or a quality improvement (QI) activity, you will have to submit a full ethics application on a National Ethics Application Form (NEAF). Please email the Research Support Office at RSOseslhd@sesiahs.health.nsw.gov.au prior to submitting an application to register your pending submission. Please specify that you plan to submit a full NEAF application and include project title, principal investigator, contact person and site. The reference number that will be given to you must be quoted in ALL correspondence.

 

Useful tools

HREC Committee Meetings and Closing Dates
Checklist for new full ethics application
NEAF application form
Guidelines for completing and submitting the NEAF
How to? Step by step demonstrations of how to negotiate the NEAF
How to? Step by step demonstrations of how to negotiate the NEAF
Study Protocol template
Style guide for participant information
Nomination of 2 expert reviewers for NEAF projects

 

Participant Information and Consent Form (PISCF) templates:

PISCF - Clinical Trials/Clinical Research
PISCF - Research Involving Genetic Testing/Tissue collection
Participant Invitation Letter
Participant Withdrawal Form
NHMRC suggested PISCF templates recommended for use in interstate studies reviewed under National Mutual Acceptance (NMA)

 

 Useful Information

Information for submission of interstate clinical trials under National Mutual Acceptance (NMA)
Full ethics application process - flow chart

HREC committee members

 

How to submit your application

NB Please note we do not have a link to the online forms submission process - you must submit the NEAF as a pdf via email to the Research Support Office (RSO)

 

You can make an appointment to discuss your application by phoning the Research Support Office on (02) 9382 3587 or by emailing RSOSESLHD@sesiahs.health.nsw.gov.au  

If the HREC considers a new application and has queries which must be addressed before ethical approval can be granted, the HREC may delegate consideration of the applicant’s response to the HREC Executive Committee or Executive Officer. Where responses are to be reviewed by the EXEC committee please be aware of the deadlines for committee meetings.

 

Responses to queries

When responding to queries please include the question/issue raised by the Committee & then provide your response. Please provide any updated documents in both tracked changes format and a clean copy.  Please include the version number, date and page number (eg Page 1 of 2) in the footer of all documents. Please email only an electronic copy of your response to RSOSESLHD@sesiahs.health.nsw.gov.au. We recommend you refer to the NHMRC’s National Statement on Ethical Conduct in Human Research, relevant legislation or other guidelines where appropriate (see useful links).