The St Vincent’s Hospital Institutional Biosafety Committee (IBC) is responsible for the review, approval and ongoing monitoring of all research involving Genetically Modified Organisms (GMOs) conducted in OGTR Accredited Organisations at St Vincent’s Hospital, Fitzroy Campus.
All dealings involving GMOs must receive approval from the St Vincent’s Hospital IBC before commencing.
The IBC reviews dealings conducted at the following OGTR Accredited Organisations:
For further information, please contact Melanie Asquith, IBC Secretary on 03 9288 3872 or email research.ethics@svhm.org.au
As of 16 July 2018 all fees are payable in full at the time of submission and invoices will no longer be issued.
Payments can be made by Credit Card, Internal Transfer, Electronic Funds Transfer or Cheque.
Please see the below information for the application requirements associated with each type of dealing.
Exempt Dealing Registration
Exempt Dealing Registration forms focus on what work is proposed and where it will be conducted.
Applications are reviewed by IBC members out of session and noted at the next scheduled IBC meeting.
There are no closing dates for submission of Exempt Dealing Registrations; they can be submitted at any time.
Submit signed application and fee form via email; no copies required.
Notifiable Low Risk Dealings (NLRDs)
NLRD applications are reviewed at IBC meetings and closing dates apply.
Submit signed application and fee form via email; no copies required.
Licensed Dealings (DNIR and DIR)
The OGTR encourage organisations to contact them before applying as they can advise about the appropriate application form and discuss information requirements.
Refer to OGTR website for more information relating to DNIR and DIR applications.
Apply for a DNIR licence
Apply for a DIR licence
Non-GMO Biohazards
The IBC is also responsible for assessing protocols utilising Risk Group 2 and higher non-GM micro-organisms, which are classified as non-GMO biohazards.
Please note: St Vincent’s Hospital (Melbourne) does not permit the use of micro-organisms on the Security Sensitive Biological Agent (SSBA) list
Non-GMO Biohazards applications are reviewed at IBC meetings and closing dates apply.
Submit signed application and fee form via email; no copies required
For further information, please contact Melanie Asquith, IBC Secretary on 03 9231 3872 or email research.ethics@svhm.org.au
Training is an integral part of working in a certified facility with GMOs, and is a minimum requirement set by the OGTR.
Before commencing work in a certified facility, all researchers must complete the online training program. Access to the training program is password locked. If you require the password, please contact research.ethics@svhm.org.au
To access the on line training program, please click on the below image:
Click here to access the training program
This program is mandatory for all researchers working with GMOs or working in a certified facility and does not take the place of laboratory based training in specific techniques.
At the completion of the training program, a certificate will be generated, based on the data inputted by the researcher. Please ensure the record is signed and kept in the laboratory in the training records.
For further information, please contact Melanie Asquith, IBC Secretary on 03 9231 3872 or email research.ethics@svhm.org.au
- Gene Technology Act 2000
- Gene Technology Regulations 2001
- Handbook on the Regulation of Gene Technology in Australia (OGTR)
- Guidelines for the Transport, Storage and Disposal of GMOs (OGTR)
- OGTR Operational Policies
- National Framework for the Development of Ethical Principles in Gene Technology (OGTR)
- Statement of Ethical Principles for Biotechnology in Victoria (DHS)
- Viral Vector flow chart
For further information, please contact Melanie Asquith, IBC Secretary on 03 9288 3872 or email research.ethics@svhm.org.au
Chapter 1 - Laboratories and Facilities
1.1 Certification of Physical Containment Facilities
1.2 Transportation and Storage of GMOs
1.3 Waste Management and Decontamination
1.4 Personal Protective Equipment
1.5 Sharps Management
1.6 PC2 Training
1.7 Live _GMO_ Animal Work
1.8 Facility Inspections
Chapter 2 - Applications and Projects
2.1 Exempt Dealings
2.2 Notifiable Low Risk Dealings
2.3 Licensed Dealings
2.4 Non-GMO Biohazard Dealings
2.5 Approvals and Extensions
2.6 Projects Involving Animals
Chapter 3 General Governance
3.1 Reporting and Accountability
3.2 Complaints Handling and Research Misconduct
3.3 Collaborative Research Groups
3.4 Management of Research Data and Primary Materials
3.5 Fees and Charges
3.6 Accredited Organisations
Chapter 4 - Committee
4.1 Appointment of New Members
4.2 Induction of New Members
4.3 Conflicts of Interest
4.4 Committee Training
4.5 Committee Membership
4.6 Delegation of Authority
4.7 Making and Communicating Decisions
4.8 Executive Group
4.9 Facility Inspections
4.10 Record Management
Chapter 5 - Researchers
5.1 The Gene Technology Act_Researcher Roles and Responsibilities
5.2 Creating Technical Standard Operating Procedures
5.3 Researcher Record Management and Reporting
Information
New SOP’s have been written to assist in answering Question 6 in the NLRD Application Form (How the GMOs will be decontaminated in the event of a spill) when animals are involved in a dealing.
Dealings involving animals can refer to the appropriate SOP (by number and title) as this will simplify answering the question as well as ensuring that standard practice and correct procedures are followed.
- OP BRC 090 Re-capture procedure for escaped animals
- SOP EMSU 001 Re-capture procedure for escaped animals
- SOP EMSU 002 Re-capture procedure for escaped animals
- SOP EMSU 003 Re-capture procedure for escaped animals
Resources
News
- Gene Technology Amended Regulations 2011
For further information, please contact Melanie Asquith, IBC Secretary on 03 9231 3872 or email research.ethics@svhm.org.au
- Fee Form
- Application to Change Members of a Research Team (IBC).docx
- Dealings involving Intentional Release (DIR) Storage - Application Form
- Dealings Not involving Intentional Release (DNIR) - Application Form
- Exempt Dealing - Application Form
- Notifiable Low Risk Dealing (NLRD) Application
- Use of non-GMO biohazards - Application
Gene Technology Amendment Regulations 2011
For further information, please contact Melanie Asquith, IBC Secretary on 03 9288 3872 or email research.ethics@svhm.org.au
- IBC Protocol #165 (Exempt)
- IBC Protocol #167 (Exempt)
- IBC Protocol #170 (NLRD)
- IBC Protocol #171 (NLRD)
- IBC Protocol #172 (NLRD)
- IBC Protocol #173 (Exempt)
- IBC Protocol #175 (NLRD)
- IBC Protocol #179 (NLRD)
- IBC Protocol #182(NLRD)
- IBC Protocol #185 (Exempt)
- IBC Protocol #186 (NLRD)
- IBC Protocol #187 (Exempt)
- IBC Protocol #191 (Exempt)
- IBC Protocol #192 (Exempt)
- IBC Protocol #194 (Non-GMO Biohazard)
- IBC Protocol #196 (Exempt)
- IBC Protocol #198(NLRD)
- IBC Protocol #201 (Non-GMO Biohazard)
- IBC Protocol #205 (Non-GMO Biohazard)
- IBC Protocol #206 (NLRD)
- IBC Protocol #207 (Exempt)
- IBC Protocol #209 (Exempt)
- IBC Protocol #211 (Non-GMO Biohazard)
- IBC Protocol #212 (Exempt)
- IBC Protocol #213 (Exempt)
- IBC Protocol #214 (NLRD)
- IBC Protocol #215 (NLRD)
- IBC Protocol #216 (Exempt)
- IBC Protocol #217 (NLRD)
- IBC Protocol #218 (Exempt)
- IBC Protocol #219 (NLRD)
- IBC Protocol #221 (NLRD)
- IBC Protocol #222 (NLRD)
- IBC Protocol #223 (NLRD)
- IBC Protocol #224 (Exempt)
- IBC Protocol #225 (NLRD)
- IBC Protocol #226 (NLRD)
- IBC Protocol #227 (NLRD)
- IBC Protocol #228 (Non-GMO Biohazard)
- IBC Protocol #229 (NLRD)
- IBC Protocol #230 (NLRD)
- IBC Protocol #231 (NLRD)
- IBC Protocol #232 (NLRD)
- IBC Protocol #234 (NLRD)
- IBC Protocol #235 (NLRD)
- IBC Protocol #236 (NLRD)
- IBC Protocol #237 (NLRD)
- IBC Protocol #238 (Exempt)
- IBC Protocol #240 (NLRD)
- IBC Protocol #241 (Exempt)
- IBC Protocol #242 (NLRD)
- IBC Protocol #243 (NLRD)
- IBC Protocol #244 (NLRD)
- IBC Protocol #245 (NLRD)
- IBC Protocol #246 (NLRD)
- IBC Protocol #165 (Exempt)
- IBC Protocol #167 (Exempt)
- IBC Protocol #170 (NLRD)
- IBC Protocol #171 (NLRD)
- IBC Protocol #172 (NLRD)
- IBC Protocol #173 (Exempt)
- IBC Protocol #175 (NLRD)
- IBC Protocol #179 (NLRD)
- IBC Protocol #182(NLRD)
- IBC Protocol #185 (Exempt)
- IBC Protocol #186 (NLRD)
- IBC Protocol #187 (Exempt)
- IBC Protocol #191 (Exempt)
- IBC Protocol #192 (Exempt)
- IBC Protocol #194 (Non-GMO Biohazard)
- IBC Protocol #196 (Exempt)
- IBC Protocol #198(NLRD)
- IBC Protocol #201 (Non-GMO Biohazard)
- IBC Protocol #205 (Non-GMO Biohazard)
- IBC Protocol #206 (NLRD)
- IBC Protocol #207 (Exempt)
- IBC Protocol #209 (Exempt)
- IBC Protocol #211 (Non-GMO Biohazard)
- IBC Protocol #212 (Exempt)
- IBC Protocol #213 (Exempt)
- IBC Protocol #214 (NLRD)
- IBC Protocol #215 (NLRD)
- IBC Protocol #216 (Exempt)
- IBC Protocol #217 (NLRD)
- IBC Protocol #218 (Exempt)
- IBC Protocol #219 (NLRD)
- IBC Protocol #221 (NLRD)
- IBC Protocol #222 (NLRD)
- IBC Protocol #223 (NLRD)
- IBC Protocol #224 (Exempt)
- IBC Protocol #225 (NLRD)
- IBC Protocol #226 (NLRD)
- IBC Protocol #227 (NLRD)
- IBC Protocol #228 (Non-GMO Biohazard)
- IBC Protocol #229 (NLRD)
- IBC Protocol #230 (NLRD)
- IBC Protocol #231 (NLRD)
- IBC Protocol #232 (NLRD)
- IBC Protocol #234 (NLRD)
- IBC Protocol #235 (NLRD)
- IBC Protocol #236 (NLRD)
- IBC Protocol #237 (NLRD)
- IBC Protocol #238 (Exempt)
- IBC Protocol #240 (NLRD)
- IBC Protocol #241 (Exempt)
- IBC Protocol #242 (NLRD)
- IBC Protocol #243 (NLRD)
- IBC Protocol #244 (NLRD)
- IBC Protocol #245 (NLRD)
- IBC Protocol #246 (NLRD)