Institutional Biosafety Committee

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.

 

Terms of Reference 2015  

 

The four main classes of dealings involving GMOs are:

  • Exempt dealings
  • Non-GMO Biohazard dealings and Risk Group 2/3
  • Notifiable Low Risk dealings (NLRD)
  • Licensed dealings (DNIR and DIR)

Meeting dates:

2016 IBC Meeting Dates / Agenda Closing Dates

2017 IBC Meeting Dates / Agenda Closing Dates

The IBC reviews dealings conducted at the following OGTR-Accredited Organisations:

  • St Vincent’s Hospital, Fitzroy Campus
  • St Vincent’s Institute
  • O’Brien Institute
  • Bionics Institute
  • University of Melbourne at St Vincent’s
  • Centre for Eye Research Australia

For further information, please contact Melanie Asquith, IBC Secretary on 03 9288 3872 or email research.ethics@svhm.org.au

Quick links

Submitting and Application

Please see the below information for the application requirements associated with each type of dealing.

All applications must be submitted to a meeting of the IBC.

New applications will not be reviewed out of session. Therefore, please ensure all applications are submitted by the following dates:
 

  • 2016 IBC Meeting Dates / Agenda Closing Dates

Exempt Dealings

For Exempt Dealings please submit both an electronic copy, and a single hard copy of the following:
 

Changes to Exempt Dealing application process

The St Vincent’s Hospital Institutional Biosafety Committee (IBC) has recently simplified the process for all Exempt Dealings.
The Exempt Dealing application form has been replaced by an Exempt Dealing Registration form.
The new form is shorter and focuses on what work is proposed and where it will be conducted.

Exempt Dealing Registration forms 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.
 

  • Application Form - Exempt Dealing
  • Cover Sheet

Notifiable Low Risk Dealings (NLRDs)

For NLRD applications please submit both an electronic copy, and a single hard copy of the following:

  • Application Form - Notifiable Low Risk Dealing (NLRD)
  • Cover sheet

Licensed Dealings (DNIR and DIR)

DNIR
 

For DNIR dealings please submit both an electronic copy, and a single hard copy of the following:
 

  • Application Form - Dealings Not involving Intentional Release (DNIR)  
  • Cover Sheet

DIR
 

For DIR dealings please submit both an electronic copy, and a single hard copy of the following:
    

  • Application Form - Dealing involving Intentional Release (DIR) Storage   
  • Cover Sheet

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

For Non-GMO Biohazards please submit both an electronic copy, and a single hard copy of
the following:

  • Application for use of non-GMO biohazards    
  • Cover Sheet

All applications should be submitted to:

Research.Ethics@svhm.org.au

And
Research Governance Unit
Building E - Aikenhead Building, Level 5
27 Victoria Parade, FITZROY
PO Box 2900
FITZROY VIC 3065    

For further information, please contact Melanie Asquith, IBC Secretary on 03 9231 3872 or email research.ethics@svhm.org.au

PC2 Training

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

Guidelines/Regulations

  • 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

Accreditation and Laboratory Certification

Administrative SOPs

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

Facility SOPs

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

Resource for Researchers

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

Forms

  • Cover Sheet
  • 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

Links

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

Current Dealings (IBC Use Only)

  • 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)

Research Team Lists (IBC Use Only)

  • 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)

Contact Us

For more information visit the Research Governance Unit Contact page