Forms and TemplatesPlease note that SWSLHD has migrated to soft copy for all forms and correspondences. All forms and applications are to be submitted on the REGIS platform or via email. The Research Directorate is not responsible for any hardcopy mail lost in transit.
Research Ethics Governance Information System (REGIS)All applications have now been migrated to REGIS since 1 April 2019. The link to the platform is: https://regis.health.nsw.gov.au/
Below is a useful list of the reference numbers used by REGIS: PID – Project Registration ETH – Ethics Application STE – Site Specific Application
Please quote the relevant reference number (e.g. 2025/ETH01234) in all correspondences with our office.
Additional Forms to be added to your REGIS submissions:Further Information Response - Ethics/SSA When you have received a request to provide further information to either an Ethics application or an SSA, please complete the SWSLHD Ethics/SSA Response Cover Letter.
Is your project low risk, greater than low risk or quality improvement?If you need advice, we strongly encourage you to submit a Decision Aid so that we can provide a determination of the best application pathway for your project. Please email the Decision Aid to SWSLHD-Ethics@health.nsw.gov.au.
Study DocumentsIt is strongly recommended that if you are conducting an investigator initiated study, to use the Protocol Template. Please use the instructions in the below document to prepare your Master Documents and Site Specific Documents. Preparing Site Specific Documents (SSD)
Clinical Trial FormsFM_002_Contact Report version 1
Participant Information Sheet templates This folder contains the following types of Participant Information Sheets:
This folder contains the following types of Consent Forms:
Ethics AmendmentsIt is a condition of ethics approval to submit an Ethics Amendment when you have made changes or modifications to your research study and/or study documents. If SWSLHD is the lead HREC for your project, please submit an Ethics Amendment via REGIS.
Documents for an Ethics Amendment In addition to the ethics amendment form you will need to fill out in REGIS, please submit your documents in tracked and clean versions, with an updated version number and date on REGIS. Please follow this Quick Reference Guide for how to complete an Ethics Amendment on REGIS:
The general steps are:
Please quote the project number in all correspondence relating to your application to our office. For clinical trials, please refer to the fees page for HREC and RGO review fees.
Addition of Investigators (where SWSLHD is the lead HREC) Please submit this as a General Amendment to your study in REGIS. Please submit the following documents via REGIS to add any investigators:
*Working on-site involves physically coming to any SWSLHD site to conduct research on/with participants (including patients and/or staff) and/or reviewing SWSLHD data.
Annual ReportSWSLHD currently does NOT accept Annual Reports via email. For projects where SWSLHD HREC is the lead HREC, please complete the annual report via REGIS following the 'Submitting a Progress/Final Report' Quick Reference Guide which can be found here: https://regis.health.nsw.gov.au/media/1724/qrg-resapp-submitting-progress-final-report-milestone.pdf. For projects where the lead HREC is a NSW Public Health Organisation, the acknowledgement of the Annual Report will automatically submit to the relevant Research Governance Officers for review, therefore researchers are not required to submit to SWSLHD RGO. The lead HREC also confirms this in their email with the following statement: 'Each authorised site in REGIS has been notified and will only contact you if they require more information. Please accept this notification on behalf of the HREC and NSW sites listed in the form'. For projects where the lead HREC is not a NSW Public Health Organisation, please still submit using the Site Amendment cover letter and submit this as a site amendment on REGIS along with the lead HREC’s acknowledgement of the report.
Safety Reporting for Clinical TrialsAs of October 3, 2017, the NSW OHMR has formally accepted the updated NHMRC Safety Reporting Guidance. This aligns with national and international standards. This is effective now, and applies to new and existing trials. Fewer reports are required, and all safety reporting to the HREC and/or RGO is the responsibility of the sponsor of the trial. For more information click here. The new policy can be found at: http://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2017_039.pdf Annual Safety reports can be reported in the Annual Progress Report, on the sponsor’s template or in the form of the most recently updated Investigator’s Brochure or DSUR/DSMB report.
For SUSAR/USADE/URSAEs occuring at the site, please complete the Notification Form and upload to 'Reporting Local Safety Events to the Institution' in the Forms tab of the relevant Site Project on REGIS.
Site Amendments Site amendments are for projects with a different lead HREC, i.e., not SWSLHD HREC. These include Addition of Investigators and Governance Amendments such as CTRA amendments. It is a condition of site authorisation to submit a site amendment for any amendments made to your research study which may affect the site.
Documents for a Site Amendment In addition to the site amendment form you will need to fill out in REGIS, please submit the HREC approval, all the documents listed in the approval, as well as the site specific documents in tracked and clean versions. You will also need to prepare and submit a Site Amendment Cover Letter as part of your submission. The cover letter can be downloaded here. Please follow this Quick Reference Guide for how to complete a Site Amendment on REGIS:
The general steps are:
Please ensure to number the file name of your documents following the numbering order in your Cover Letter.
Addition of Investigators (where SWSLHD is NOT the lead HREC) Please submit the following documents via REGIS to add any investigators:
*Working on-site involves contacting patients and/or viewing SWSLHD patient data.
TRANSLATED DOCUMENTS Please note that the translated documents are required to be translated by a NAATI accredited translator and submitted to the research directorate for review/approval prior to use for all projects. Link: https://www.naati.com.au/ NSW Health Statewide Biobank Consent Toolkit CALD (Culturally and Linguistically Diverse) Research is a focus for SWSLHD. Please see this link for useful resources if you are considering incorporating some CALD elements into your research and/or would like access to resources to potentially include CALD groups in your study. The resources included in the link are reviewed by NSW Health for accuracy. |
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Research and Ethics Office |
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