Institutional Biosafety - How to Apply
About the Institutional Biosafety Committee
The Institutional Biosafety Committee (IBC) reviews proposals for studies involving the use of Genetically Modified Organisms to ensure the research meets the requirements of the Gene Technology Act 2000 and the Gene Technology Regulations 2001. The IBC assists supervisors, sponsors and OGTR licence holders with obtaining proper authorisation for their research.
About GMO dealings
The use, transport or storage of a Genetically Modified Organism (GMO) is known as a GMO dealing.
Clinical trials and basic or translational research may involve GMO dealings.
GMO dealings are divided into classes under the Gene Technology Regulations 2011.
The classes of GMO dealings most relevant to medical research are:
Notifiable Low Risk Dealings (NLRDs) (PC1, PC2 or PC3)
Dealings Not Involving Intentional Release (DNIRs)
Dealings Involving Intentional Release (DIIRs)
The Gene Technology Regulations 2001 provide information about each class of GMO dealing. The Regulations may be found on the Office of the Gene Technology Regulator (OGTR) web page (http://www.ogtr.gov.au)
How and when to apply to the IBC
Studies involving Genetically Modified Organisms (GMOs) require early consultation with the IBC, including exempt GMO dealings, OGTR licenced GMO dealings and GMO dealings reviewed by another IBC. The first step is to contact the IBC Executive Officer for advice about whether or not an application to the IBC is required and, if so, how to apply.
The aim of the IBC’s assessment is to assist researchers, sponsors and OGTR licence holders to ensure proper authorisation, compliance with OGTR licence conditions and the safe conduct of the study at the local site.
To avoid delay it is advisable to contact the IBC well before or close to the time of applying to ethics committees depending on the nature of the work.
Guidelines on human clinical trials
Guidelines on regulatory requirements under the Gene Technology Act 2000 for human clinical trials involving genetically modified organisms (GMOs) can be accessed at: http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/clinicaltrial-htm
Exempt and NLRD application forms:
Please contact the IBC Executive Officer (IBC EO). Registration may be required.
DNIR or DIR application forms:
These are available on the OGTR website. Please contact the IBC EO before completing or submitting.
OGTR certification of a Physical Containment Facility application form:
This is available on the OGTR website. Application is made directly to the OGTR.
IBC meeting schedule: Please see the IBC meeting schedule for the closing and meeting dates.
RPAH IBC CONTACTS
Chairperson: Professor John Rasko AO
Deputy Chairperson: Associate Professor Bing Yu
Executive Officer and Primary Contact: Dr. Gabrielle O'Sullivan
Email (best): Gabrielle.OSullivan@health.nsw.gov.au
Mobile (next best): 0414 785 471
Telephone: 02-9515 6772
Mailing address: Royal Prince Alfred Hospital Institutional Biosafety Committee (RPAH IBC), c/- Research Ethics and Governance Office (REGO), Royal Prince Alfred Hospital, Missenden Road, Camperdown, NSW 2050, Australia
Delivery address: Royal Prince Alfred Hospital Institutional Biosafety Committee (RPAH IBC), c/- Research Ethics and Governance Office (REGO), RPAH Medical Centre, Suite 210A, 100 Carillon Avenue, Newtown, NSW 2049
OGTR Web address: http://www.ogtr.gov.au