COVID-19: Guidance for Researchers & Sponsors
Please find below guidance from the NSW Office for Health and Medical Research (OHMR) and the Commonwealth Department of Health for conducting clinical trials and other relevant clinical research affected by the COVID-19 situation.
NSW OHMR Guidance: https://www.medicalresearch.nsw.gov.au/covid-19-clinical-trial-guidance/
The Commonwealth Department of Health Guidance: https://www1.health.gov.au/internet/main/publishing.nsf/Content/Clinical...
Please note that the SCHN Research Ethics and Research Governance Offices will operate based on these guidelines.
Please also note that we are prioritising applications and correspondence related to COVID-19 that are critical to patient safety. We endeavour to manage all other applications and correspondence as per standard timelines; however there may be some delays depending on volume.
Thank you for your patience and understanding.
The SCHN Research Ethics and Governance teams
Research governance is defined as ‘the framework by which institutions, investigators and their managers share the responsibility and accountability for research conducted according to ethical principles, scientific, regulatory and professional standards and the principles of risk management’. (NSW Health Guidelines Research Governance in NSW Public Health Organisations GL2011_001)
Research conducted across the Sydney Children’s Hospitals Network (SCHN) must be conducted in accordance with applicable legislation and regulation including the NHMRC National Statement on Ethical Conduct in Human Research and The Australian Code for the Responsible Conduct of Research.
In addition to ethics approval, you will need Research Governance authorisation to commence a research project at any New South Wales Public Health Organisation site. This is called site specific authorisation.
The Research Governance Office offers education, advice and guidance to researchers on:
Sponsorship arrangements for investigator and collaborative group driven clinical trials
Insurance and Indemnity arrangements for researchers on SCHN campus and coverage for research activities
Access to unapproved therapeutic products and TGA compliance
Screening of non-SCHN employees for access to SCHN site for conducting research.
Site Specific Authorisation
Phone: (02) 9845 3011
Research Governance team members:
- Research Governance Manager: Dr Lucia Smith – (02) 9845 1272
- Research Governance Officer: Dr Geraldine Bicol – (02) 9845 3029
- Research Governance Officer: Melizza Aniciete – (02) 9845 0851
- Research Governance Support Officer: Meera Heidary – (02) 9845 3011
Please click here for the Research Governance Invoice Authorisation Form
|Type of Application LNRSSA or SSA||Support / Funding||Fee (GST Inclusive)|
|Research Project||Full Industry Funding||$3740|
|Research Project||Investigator Initiated with Industry Funding||0.5% of total (funding) contract value up to $3740|
|Research Project||Collaborative group funded or sponsored studies||$165|
|Investigator or Student Research Project||Investigator initiated or student project without an external funding source or competitive internal funding source||$0|