ROYAL NORTH SHORE HOSPITAL
INSTITUTIONAL BIOSAFTEY COMMITTEE
Notification of a
Notifiable Low Risk Dealing (NLRD)
Notifying Organisation Name: Royal North Shore Hospital
Accreditation Number*: ACCR 217
* If organisation is accredited by the Gene Technology Regulator
NLRD Project Title:
IBC Project Reference Number:
RESP/
IBC use only
Is this notification accompanied by an application for a declaration that certain information be
treated as Confidential Commercial Information (CCI)
Yes
No
If the CCI is covered by previous CCI application(s), please provide the CCI application number(s)
here:
____________________________________________
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General Information
Notification of a notifiable low risk dealing (NLRD)
This notification is for a new NLRD under the Commonwealth Gene Technology Act 2000 (the Act) and
corresponding State law.
As stated in Regulation 13 of the Gene Technology Regulations 2001 (as amended with effect from 1
September 2011 by the Gene Technology Amendment Regulations 2011);
13 Requirements for undertaking notifiable low risk dealings
(1) A person may undertake a notifiable low risk dealing only if:
(a) a person or an accredited organisation has prepared and submitted a written proposal for an
Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing;
and
(b) the Institutional Biosafety Committee has assessed the dealing to be a notifiable low risk
dealing mentioned in Part 1 or 2 of Schedule 3;
Accuracy of information
Please answer all questions unless otherwise indicated in terminology understandable by a nonscientist. Please check that the information provided in this notification is true and accurate. The Act
provides for penalties to a person who knowingly gives information to the Regulator that is false or
misleading.
Confidentiality
If you wish to make an application for a declaration that specifies information is Confidential
Commercial Information (CCI) for the purposes of the Act, you must also complete the CCI application
form available at www.ogtr.gov.au and submit it at the same time as this notification.
Privacy
Any personal information is safeguarded by the Privacy Act 1988. This prevents the submitted
personal information from being used for purposes other than assessing the certification application, or
other circumstances specified by the Gene Technology Act 2000 (Commonwealth). In certain
circumstances information supplied as part of a notification may, according to their specific needs, be
given to the following:
 an officer or employee of the Department of Health and Ageing;
 an officer or employee of a State government agency or organisation;
 Courts, Tribunals and/or other Commonwealth agencies where it is an obligation under law to
provide it;
 law enforcement authorities; and
 the relevant Minister.
Authorisation
Please ensure that if you are completing this notification on behalf of the organisation, you hold the
proper authority to submit this application on behalf of the organisation.
Resubmission of amended form
If amendments have been requested by the IBC committee, please provide a cover letter outlining
the amendments AND an amended version of the original IBC Application with all changes to the
protocol underlined and bolded.
For further information
Phone: 9926 4590 or E-mail: nslhd-research@heatlh.nsw.gov.au
The completed notification can be lodged at the following address:
Research Office
Secretary, RNSH IBC
Research Office, Level 13 Kolling Building (6)
Royal North Shore Hospital
In addition, a copy of the completed form should be emailed to:
nslhd-research@heatlh.nsw.gov.au
Please note: you should retain a copy of your completed notification for your own records.
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Part 1: Notification Contact Details
Details of the person the OGTR can contact regarding this notification (usually the
Project Supervisor)
Preferred first
name:
Surname:
Personal title:
(eg Ms/Mr/Dr)
Job title:
Phone number:
Fax number:
Mobile number:
E-mail
address:
Street number and name:
Town/City:
Postcode:
State:
Country:
Postal address:
(if different)
Details of the Institutional Biosafety Committee that has considered the
classification of this Notifiable Low Risk Dealing
Name of IBC:
Royal North Shore
Name of IBC Chairperson:
Anthony Ashton
Business telephone number:
9926 4500 (reception); 9926 4828 (office)
Facsimile number:
9926 5266
E-mail address:
anthony.ashton@sydney.edu.au
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Additional Project Personnel: Detail Personnel involved with this project including
name, qualifications, microbiological or other relevant PC2/GMO experience and
role in the project team (Delete or add personnel as required).
Additional Personnel 1
Surname
First Name
Title
Job Title
Phone Number
Fax Number
Mobile Number
Email
Project Role and
PC2/GMO Experience
Relevant to the dealings
in this project
Additional Personnel 2
Surname
First Name
Title
Job Title
Phone Number
Fax Number
Mobile Number
Email
Project Role and
PC2/GMO Experience
Relevant to the dealings
in this project
Additional Personnel 3
Surname
First Name
Title
Job Title
Phone Number
Fax Number
Mobile Number
Email
Project Role and
PC2/GMO Experience
Relevant to the dealings
in this project
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Part 2:Description of the Dealings and GMO(s)
Name of Organisation
1.
_______________________________________
Reference Number
__________________________
Briefly describe the proposed dealing(s) and the purpose of conducting these dealing(s), in the space (box) below.
The term 'dealings', in relation to a genetically modified organism (GMO), is defined in the Gene Technology Act 2000 (the Act) as any of the
purposes listed below:
(a) conduct experiments with the GMO;
(d) propagate the GMO;
(g) import the GMO;
(b) make, develop, produce or manufacture
(e) use the GMO in the course of
(h) transport the GMO;
the GMO;
manufacture of a thing that is not the GMO;
(i) dispose of the GMO;
(c) breed the GMO;
(f) grow, raise or culture the GMO;
and includes the possession, supply or use of the GMO for the purposes of, or in the course of, a dealing mentioned in any of paragraphs (a) to (i)
NB: If tumour cells are being implanted into mice please outline how researchers will minimise the risk of “accidental transfer” to the researcher during
implantation and collection.
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2.
Please outline the management and disposal strategy for GMO waste.
Please specify the strategies for solid waste, and liquid waste, biological spills, bacterial broth, viral/plasmid vectors, animal carcasses,
tumours, etc. as appropriate. Specify the decontamination agent, final concentration (v/v% or w/v%) and contact time.
[Please refer to OGTR guidelines and the Australian Laboratory Standard AS/NZ2243(.3) for approved waste management options]
3.
For Users of (retroviral/adenoviral/lentiviral) vectors/delivery systems please provide details of the experience of
project personnel with such vectors and details of any additional training as per OGTR guidelines.
As of 1 September 2011, the Gene Technology Regulator amended the Commonwealth Gene Technology Regulations (2001) on dealings with
viral vectors. The regulations now include criteria by which IBCs assess whether the listed personnel have the appropriate training and
experience to undertake the indicated dealings. [Please refer to OGTR guidelines:
http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/content/viralvec-assessment2011-htm]
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4.
Please provide details of the proposed dealings, other than viruses, in the table below.
This table is intended to generate a concise, accurate record of all the GMOs to be generated or used and the purpose of the proposed
dealings. The columns Schedule, Part and Kind of Dealing requires that you select one of the following categories which best describes the
dealing with the GMO(s) – as per Schedule 3 Part 1 or Part 2 of the Gene Technology Regulations 2001 (as amended by the Gene Technology
Amendment Regulations September 2011). Details of viral vectors, particles and packaging cell lines should be listed in section 5.
Part 1 of Schedule 3 describes the types of dealings with GMOs that are classified as NLRDs suitable for physical containment level 1.
Part 2 of Schedule 3 describes the types of dealings that are classified as NLRDs suitable for physical containment levels 2 and 3.
The current OGRT regulations are available via the OGTR website. Please refer to Parts 5 of this form for examples of responses.
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(include what is known regarding
pathogenic or oncogenic potential)
If the work involves animals
indicate acec approval no.
And expiry date
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Kind of
dealing
Vector(s) & method of transfer
Part
Scientific name of
parent organism
Sched
Common name of
parent organism
Identity & function of nucleic
acid & organism of origin
5.
Please provide details of the viral vectors in the table below.
This table is intended to generate a concise, accurate record of all viral vectors to be used in this protocol including (i) replication competent
viruses, (ii) replication defective retroviruses (includes lentiviruses), and (iii) replication defective non-retroviruses. Please refer to the
companies viral vector map for the following information. The columns Schedule, Part and Kind of Dealing requires that you select one of the
following categories which best describes the dealing with the GMO(s).
The current OGRT regulations are available via the OGTR website.
Self-inactivating
Dealing and characteristic
No virulence or accessory genes present.
Yes. U3 portion of 3’LTR ensures
self-inactivation
In vitro. Modification of a pathogenic
determinant
Replication defective
retrovirus/lentivirus
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Kind of
dealing
Human
immunodeficiency virus
Accessory and virulence genes present
(excluding gag, pol)
Part
Eg. pCignal LentiCMV-luc
Parent organism
Sched
Viral vector name
2
1
e
Part 3: Containment Facilities
Please provide information for all facilities to be used in connection with this NLRD
FACILITY NAME
eg. lab group/division
a. Please
FACILITY ADDRESS
TYPE
eg. room, level, building
eg.PC1a
PC2
OGTR ID
CERT
/
CERT
/
CERT
/
CERT
/
CERT
/
note that the RNS IBC have no certified PC1 laboratories
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EXPIRY DATE
Part 4: Declaration
Declaration of the organisation submitting this notification
This declaration must be signed by the CEO or another person with the authority to sign on behalf of the
organisation (laboratory).
PART A
Prior to submission of this application for review by the IBC, please provide approval for use of the
indicated laboratory in Part 3
PC2 Manager for the proposed laboratory
Printed
name:
Job title:
Signature:
Level ***; PC2 Floor Manager
Date:
Printed
name:
Job title:
Signature:
Level ***; PC2 Floor Manager
Date:
Kearn’s Facility Manager (as required)
Printed
name:
Giselle Bellamy
Signature:
Job title:
PC2 Manager, Kearn’s Facility
Date:
Laboratory Representative/Head of Group
Printed
name:
Signature:
Job title:
Date:
PART B
To be completed after the application has received review by the IBC.
I DECLARE THAT:

I am duly authorised to sign this declaration;
 The Institutional Biosafety Committee detailed in Part 1 of this form has confirmed that the dealings
listed in this notification are Notifiable Low Risk Dealings;

Persons undertaking these dealings have been notified in writing that the dealings are NLRDs; and

Personnel involved in the dealings have appropriate training and experience.
IBC Chair or Representative
Printed
name:
Job title:
Anthony Ashton
Signature:
IBC Chair
Date:
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Part 5: Examples of responses to Part 2 - Description of the GMO(s)
Note: “Parent Organism” means organism(s) (or tissue derived from organisms) that you propose to genetically modify. “Host” equates to “Parent”.
KIND of
DEALING
PART
SCHED
COMMON NAME OF
PARENT ORGANISM
SCIENTIFIC NAME OF
PARENT ORGANISM
VECTOR(S) & METHOD OF TRANSFER
IDENTITY & MODIFIED TRAIT/ FUNCTION OF GENE(S) &
ORGANISM OF ORIGIN
Rat
Rattus norvegicus
(list breed)
Human cell line
(list type)
Danio rerio
Transgene (type) microinjected into eggs
Overexpression of human metabolic enzyme from
transgene (description).
Expression of wild type and mutant metabolic
genes isolated from Homo sapiens.
Expression of green fluorescent protein (GFP)
from Aequorea victoria
3
1.1
(a)
3
1.1
(c)
3
2.1
(a)
Mus musculus
(list breed)
Arabidopsis
thaliana
Bacterial artificial chromosomes (BACs) microinjected into mouse embryos
Growth hormone from various Mus species
3
2.1
(a-1)
Non tumorigenic disarmed Ti plasmid via vacuum infiltration.
Expression of pigment related genes from
Arabidopsis species.
3
2.1
(b)
Vibrio
Vibrio harveyi
Standard non-conjugative plasmid expression vector by electroporation.
Expression of cell surface antigen fragments from
V. cholerae
3
2.1
(c)
Escherichia
Standard non-conjugative cloning vector pUC, pBluescript by
electroporation.
Expression of defective virulence genes from E.
coli
3
2.1
(d)
Human cultured
cells
Escherichia coli
(pathogenic
strains)
Human cell line
(list type)
Replication defective human adenoviral vector.
Expression of wild type and mutant oncogenes
isolated from Homo sapiens.
3
2.1
(e)
Human cultured
cells
Human cell line
(list type)
Standard non-conjugative plasmid expression vector transfected by
lipofeection into cells
Expression of wild type and mutant oncogenes
isolated from Homo sapiens
3
2.1
(e)
Escherichia
Escherichia coli
K12
Salmonella
enterica
Standard non-conjugative plasmids.
Expression of insulin gene from Homo sapiens
3
2.1
(f)
Conjugative plasmids.
Complementation of single virulence related
genes from S. enterica into knock-out host
3
2.1
(g)
Escherichia coli
K12
Ovis aries
Non-conjugative plasmids by electroporation.
3
2.1
(h)
3
2.1
(i)
Replication-defective vaccinia viral vector
3
2.1
(j)
Expression of green fluorescent protein (GFP)
from Aequorea victoria
Expression of green fluorescent protein from
Aequorea victoria
3
2.1
(k)
Human cultured
cells
Mouse 308
keratinocytes Cell
line
Mus musculus
C57Bl/6
Human cell line
(HEK-293)
cDNA library from Clostridium toxin producing
species
Any gene product that is NOT a pathogenic
determinant and NOT a toxin
Overepression of AP-1 and c-FOS protooncogene
isolated from Homo Sapiens
3
2.1
(l)
Rat
Rattus norvegicus
Expression of green fluorescent protein from
Aequorea victoria
3
2.1
(m)
Human cultured
cells
Zebrafish
Mouse
Thale cress
Salmonella
Escherichia
Sheep
Mouse cultured cell
line
Mouse
Transduction by replication defective human adenoviral vector.
Plasmid microinjected into embryos.
Replication defective retrovirus NOT able to transduce human cells
Replication-defective vaccinia viral vector
Replication defective retroviral vector with all viral genes required for virion
replication and assembly removed AND deletion in LTR or expression of
only an envelope protein gene
Replication defective retroviral vector with all viral genes required for virion
replication and assembly removed AND deletion in LTR or expression of
only an envelope protein gene
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