Forms and Templates
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.
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
Decision Aid
Study Documents
It is strongly recommended that if you are conducting an investigator initiated study, to use the Protocol Template.
Protocol Template
Please use the instructions in the below document to prepare your Master Documents and Site Specific Documents.
Preparing Site Specific Documents (SSD)
Participant Information Sheet and Consent Form Templates
Interventional Participant Information Sheet Self
Interventional Consent Form Self
Interventional Participant Information Sheet Person Responsible
Interventional Consent Form Person Responsible
Interventional Participant Information Sheet Parent Guardian
Interventional Consent Form Parent Guardian
Genetic Participant Information Sheet Self
Genetic Participant Information Sheet Person Responsible
Genetic Participant Information Sheet Parent Guardian
Health & Social Science Participant Information Sheet Self
Health & Social Science Information Sheet Person Responsible
Health & Social Science Information Sheet Parent Guardian
Non-Interventional Participant Information Sheet Self
Non-Interventional Participant Information Sheet Person Responsible
Non-Interventional Participant Information Sheet Parent Guardian
Consent Form Self
Consent Form Parent Guardian/Person Responsible
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 Report
For projects where SWSLHD HREC is the lead HREC, please use our Annual Report Template for the project which covers all sites.
Safety Reporting for Clinical Trials
As of October 3, 2017, the NSW OHMR has formally accepted the updated NHMRC Safety Reporting Guidance. This will now align 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.
Please log onto REGIS to submit a Significant Safety Issue, Serious Breach Notification of Safety Event form - https://regis.health.nsw.gov.au/
Amendment Form for Projects with a Different Lead Ethics (not SWSLHD)
Multi-Centre Cover Letter
Adding Investigators to an Approved Study
Please submit this as an 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
To add investigators to the study we require the following:
Confidentiality Form (if the investigator is not a NSW Health employee)
A Criminal Record Check done within the last 12 months if the investigator is coming onsite at SWSLHD, contacting patients and/or viewing SWSLHD patient data.
NSW Health Statewide Biobank Consent Toolkit
The NSW Office for Health and Medical Research (OHMR) in collaboration with the NSW Health Statewide Biobank (NSWHSB) released the NSW Health Statewide Biobank Consent Toolkit in February 2018.
The Consent Toolkit provides guidance to biobanking stakeholders on consenting including use of broad-based consent, the return of incidental findings, and data linkage to NSW Health datasets. Adoption of this robust consent process will better support ethical human research and provide a sustainable approach to managing human biobanks across the State.
Compliance with the Consent Toolkit is mandatory for prospective collections of the Statewide Biobank. It is encouraged that all NSW research biobanks seeking consent from potential biobanking participants comply with the Consent Toolkit.
The Consent Toolkit contains:
1. Consent Principles and Protocol
2. Participant Information Sheet
3. Consent Form
4. Ethically Defensible Plan
5. Compliance Checklist
CALD Resources
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.
|
