Ethics applications

To apply for research ethics approval involving NSW Health you will need to submit a Human Research Ethics Application (HREA) via the Research Ethics & Governance Information System (REGIS) website.

Ethics review process

1. Submit your ethics application via REGIS. The submission will involve the completion of an online form and will require you to upload your study protocol and any documents you intend to use in the study (E.g. Patient Information and Consent Forms, data collection sheets, brochures etc.). You should allow 2-3 hours to complete your submission to ensure that it is thorough and able to be understood by people who are unfamiliar with your project (i.e. the HREC members).

2. The Research Office will review your application to ensure that it is complete before assigning it to the next meeting and allocating reviewers.

3. Your application will be reviewed by two HREC members and presented at the HREC meeting for group input. The HREC will determine if your application is ethically acceptable, if more information is required or if aspects of your study need to be altered to meet ethical requirements.

4. The Research Office will relay the HREC determination and relevant feedback to you via REGIS. The Research Office relies on the HREC to approve the minutes of the meeting but endeavours to provide feedback within one week of the meeting.

Responses to Committee queries

To ensure that your application doesn't require multiple rounds of review, please make your responses and application amendments clear to the HREC. To do this, please:

  • Include a cover letter that specifies (1) the Committee's queries, (2) your response to each query and (3) amendments you have made to your application documents in response to the queries. Specifically state the document name, page number and section that has been amended. 
  • Provide two copies of amended documents including one with tracked changes and a clean copy.  
  • Include the version number, date and page number in the footer of all documents (e.g. Version 3 01/01/2018,  page 2 of 5).
  • Submit your reply via REGIS.
  • If your project was created in OnlineForms and has not yet been approved reply by email to
    SESLHD-RSO@health.nsw.gov.au

If you require assistance to respond to the HREC's queries, contact the Research Office.

Standard Forms and Templates

Please see our our forms and templates page for standard templates that can be used to create the following study documents:

  • Study Protocol template
  • Style guide for participant information
  • PISCF - Clinical Trials/Clinical Research
  • PISCF - Research Involving Genetic Testing/Tissue collection
  • Participant Invitation Letter
  • Participant Withdrawal Form