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.
Important -before commencing your application, please see:
- REGIS how to guides: https://regis.health.nsw.gov.au/how-to/
- Initially you will need to register your project which will generate your project number (year/PIDXXXXX). An instructional video is available: https://www.youtube.com/watch?v=V15DNwCxI4E
- Then to create your application, which will generate an ethics reference number (year/ETHXXXXX), see instructional video:https://www.youtube.com/watch?v=86ouOdwx6Pk
- For REGIS technical issues please contact the REGIS F1 health desk: 1300 073 447.
Please check the SESLHD research website for the upcoming meetings and cut-off dates.
Please remember that you must also obtain Site Specific Governance approval in order to commence your study.
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. Protocol, Patient Information and Consent Forms, data collection sheets, brochures etc.). You should allow sufficient time to complete your submission to ensure that it is thorough and can be easily 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 eligible 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.
- An instructional video is available: https://www.youtube.com/watch?v=5jFdCsGueBc
- Please ensure the version number, date and page number is in the footer of all documents (e.g. Version(3) 26-05-2020, page 2 of 5).
- If required: Provide two copies of amended documents including one with tracked changes and a clean copy. Make this clear in each of the title of the documents (e.g.: Protocol v(3)26-05-2020- tracked)
- Submit your reply via REGIS.
- Please ensure that you have uploaded your documents in the correct category in REGIS e.g.: Protocol to be uploaded within Study Protocol category, Patient Consent form into Patient Consent form category etc. This will enable the reviewer to find your documents quicker and facilitate approval.
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:
(Important: version, date and page numbers are in footer of all documents and within the title of the uploaded file).
- 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