Forms and TemplatesPlease also note that if you need to send a research agreement to the office, please do so by external mail (Research Directorate –Research Ethics and Governance Unit, Administration Building, Eastern Campus, Liverpool Hospital Locked Bag 7279, Liverpool BC 1871) or internal mail (Research Directorate – Research Ethics and Governance Unit, Level 2, Liverpool Hospital). If coming from external mail, please ensure a prepaid envelope is included for return of counter-signed research agreements. If sending via internal mail, please ensure details are provided on a separate note in regard to the Internal Department to send the counter-signed agreement. Please note that the Research Directorate is not responsible for any mail lost in transit. For COVID-19 guidance please refer to the below links: NHRMC COVID-19: Guidance on clinical trials for institutions, HRECs, researchers and sponsors: The NSW Office for Health and Medical Research (OHMR) COVID-19: Guidance for sponsors, researchers, HRECs and RGOs NOTE: All applications have now been migrated to REGIS. Please use the REGIS forms from 1 April 2019. The only form to be used outside of REGIS is the Multicentre Cover Letter for amendments where SWSLHD HREC is not the lead HREC.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 and Consent Form TemplatesInterventional Participant Information Sheet Self Health & Social Science Participant Information Sheet Self Non-Interventional Participant Information Sheet Self SWSLHD Ethics Amendment This Amendment Form is to be used where SWSLHD is the lead Ethics for your project. It is a condition of Ethics Approval to notify Ethics if you make any changes to your approved documents. 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 Amendment on REGIS - https://regis.health.nsw.gov.au/media/1355/qrg-resapp-ethics-amendment-completing-and-submitting-v11-final.pdf SWSLHD Annual ReportPlease note that REGIS has released an enhancement in the system for Annual Reports which is more user friendly and compliant with our requirements. Therefore as of 8 November 19, SWSLHD will NOT be accepting Annual Reports via email on the Annual Report template. 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 on their website. For projects where the lead HREC is not a NSW Public Health Organisation, please still submit using the MC Cover letter below and email the acknowledgement and annual report to our email address or as a site amendment on REGIS. 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'. 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. Amendment Form for Projects with a Different Lead Ethics (not SWSLHD) - including Addition of Investigators and Governance Amendments (including CTRA amendments)Please submit a site amendment in REGIS and attach the below Multi-Centre Cover letter, HREC approval, all the documents listed in the approval as well as the site specific documents in tracked and clean. Link to cover letter: Multi-Centre Cover Letter
Please submit the following documents via REGIS to add any investigators where SWSLHD is not the lead HREC:
Adding Investigators to an Approved Study by SWSLHDPlease submit this as a General Amendment to your study in REGIS - https://regis.health.nsw.gov.au/ Please follow this Quick Reference Guide for how to complete an Amendment on REGIS - https://regis.health.nsw.gov.au/media/1355/qrg-resapp-ethics-amendment-completing-and-submitting-v11-final.pdf 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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