University of Sydney Institutional Biosafety Committee

This form is to be completed by the Principal Investigator and must be submitted by the Principal
Investigator
Name of Principal Investigator:
Project title:
Type of project proposal:
□ Exempt Dealing
□ NLRD
□ DNIR
RIMS Project ID Code: (for projects that are part of a funded research grant )

For completion by IBC.
IBC Reference Number
Name of IBC Chair
Prof Anthony Weiss
Signature
Exempt Dealing application form – May 2015
Date of approval
Page 1
University of Sydney Institutional Biosafety Committee – Exempt Dealing
application form
1. Exemption Category – Please place an X in the appropriate box/s
OGTR Mark
Item # with
an X
2
Description of Dealing
A dealing with a genetically modified Caenorhabditis elegans,
whereby:
a) an advantage is not conferred on the animal by the genetic
modification; and
b) as a result of the genetic modification, the animal is not capable of
secreting or producing an infectious agent.
3
A dealing with an animal into which genetically modified somatic
cells have been introduced, if:
a) the somatic cells are not capable of giving rise to infectious agents
as a result of the genetic modification; and
b) the animal is not infected with a virus that is capable of
recombining with the genetically modified nucleic acid in the
somatic cells.
3A
A dealing with an animal whose somatic cells have been genetically
modified in vivo by a replication defective viral vector, if:
a) the in vivo modification occurred as part of a previous dealing;
and
b) the replication defective viral vector is no longer in the animal;
and
c) no germ line cells have been genetically modified; and
d) the somatic cells cannot give rise to infectious agents as a result of
the genetic modification; and
e) the animal is not infected with a virus that can recombine with the
genetically modified nucleic acid in the somatic cells of the animal.
Exempt Dealing application form – May 2015
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4
1) Subject to subitem 2) below, a dealing involving a host/vector
system mentioned in Part 2 of Schedule 2 and producing no more
than 25 litres of GMO culture in each vessel containing the resultant
culture.
2) The donor nucleic acid:
a) must meet either of the following requirements:
i) it must not be derived from organisms implicated in, or with a
history of causing, disease in otherwise healthy human beings,
animal, plants or fungi;
ii) it must be characterised and the information derived from its
characterisation show that it is unlikely to increase the capacity of
the host or vector to cause harm; and
b) must not code for a toxin with an LD50 of less than 100µg/kg; and
c) must not code for a toxin with an LD50 of 100µg/kg or more, if the
intention is to express the toxin at high levels; and
d) must not be uncharacterised nucleic acid from a toxin-producing
organism; and
e) must not include a viral sequence, unless the donor nucleic acid:
i) is missing at least 1 gene essential for viral multiplication that:
A) is not available in the cell into which the nucleic acid is
introduced; and
B) will not become available during the dealing; and
ii) cannot restore replication competence to the vector.
5
A dealing involving shot-gun cloning, or the preparation of a cDNA
library, in a host/vector system mentioned in item 1 of Part 2 of
Schedule 2, if the donor nucleic acid is not derived from either:
a) a pathogen; or
b) a toxin-producing organism.
2. Name and full professional address of Principal Investigator submitting proposal
Name:
Department:
Room No:
Building Name:
Tel:
Email:
3. Name(s) of other Principal Investigators responsible for the project. Please provide
their professional addresses if different from that above.
Exempt Dealing application form – May 2015
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4. Describe the aim of the work
5. Describe the main experimental procedures of the work
6. Details of biological system
Note: Any substantial change in the system will require submission of another
proposal
(a) Describe the biological source of the donor DNA to be used – include the genus,
species and strain or organ/tissue as applicable. Include the specific genes to be
involved in the dealing.
(b) Describe the host organism or tissue to be used – include the genus, species and
strain where applicable. If not a commonly used laboratory strain, include the name
of the strain from which it is derived.
(c) Describe the vectors or methods to be used to transfer donor DNA to the host.
Include information regarding the origin and properties of the vector and confirm that
all bacterial plasmid vectors are non-conjugative. If retroviral vectors are to be used,
include the viral envelope to be used.
(d) If your project uses GMOs created by replication defective viral vectors from a
previous dealing, select all system(s) that were used:
Retroviral/Lentiviral vectors unable to transduce human cells – Complete Q7
Retroviral/Lentiviral vectors that can transduce human cells – Complete Q8
Adenoviral/Adeno-associated viral vectors – Complete Q9
Exempt Dealing application form – May 2015
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7. Retroviral/Lentiviral vectors unable to transduce human cells
(a) Please give a name, reference (literature or website) and brief description of the
viral vector that was used to genetically modify the cell line or animal
(b) Please provide either:
i)
the USyd IBC reference number for the previous NLRD dealing and
viral envelope used.
OR
ii)
details of the company/collaborator providing the modified cell line or
animal transduced with replication defective viral vector, and the viral
envelope used.
8. Retroviral/Lentiviral vectors that can transduce human cells
(a) Please give a name, reference (literature or website) and brief description of the
viral vector that was used to genetically modify the cell line or animal
(b) Please provide either:
i)
the USyd IBC reference number for the previous NLRD dealing and
viral envelope used.
OR
ii)
details of the company/collaborator providing the modified cell line or
animal transduced with replication defective viral vector, and the viral
envelope used.
(c) Is the viral vector that was used a third generation* replication defective
retroviral/lentiviral vector?
Yes - proceed to 8(d)
No – Please provide an explicit description of the assay that was performed to
exclude the presence of replication competent virus. Please provide a copy of the
reference for your intended assay.
Exempt Dealing application form – May 2015
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* N.B. 3rd generation packaging systems fulfill the following criteria:
(i) all viral genes have been removed from the retroviral vector so that it
cannot replicate or assemble into a virion without these functions being
supplied in trans: and
(ii) viral genes needed for virion production in the packaging cell line are
expressed from independent, unlinked loci with minimal sequence overlap
with the vector to limit or prevent recombination; and
(iii) either:
(A) the retroviral vector includes a deletion in the Long Terminal
Repeat sequence of DNA that prevents transcription of genomic RNA
following integration into the host cell DNA;
or
(B) the packaging cell line and packaging plasmids express only viral
genes gagpol, rev and an envelope protein gene, or subset of these
(d) Have cell cultures been washed ≥2 times 4-6 hours after transduction with 3rd
generation lentiviral vectors and then incubated for ≥72h?
Yes
N/A
(e) For laboratory animals, has at least 3 days elapsed between exposure to the 3rd
generation lentiviral vectors and the proposed exempt dealing?
Yes
N/A
Exempt Dealing application form – May 2015
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9. Adenoviral/Adeno-Associated viral vectors
(a) Please provide either:
i)
the USyd IBC reference number for the previous NLRD dealing.
ii)
details of the company/collaborator providing the modified cell line or
animal transduced with AAV or Adenoviral vector.
(b) Please give a name, reference (literature or website) and brief description of the
viral vector that was used to genetically modify the cell line or animal, including the
strain of virus and biosafety characteristics (e.g. whether or not helper virus was used
to make it).
(c) For a cell line, please provide details of how many washes/passages have been
undertaken since the initial dealing
(d) For a dealing with an animal, please provide details of how much time will have
passed between the exposure of the animal to the vector and the proposed dealing.
(e) Please provide evidence of the half-life of each AAV or adenovirus used in your
chosen cell lines or animal models to justify why you believe no vector particles
remain.
Exempt Dealing application form – May 2015
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10. If you believe the protein/gene is characterised, and unlikely to increase the
capacity of the host or vector to cause harm, briefly explain why, referring to what is
known about its structure, function and/or genetics.
11. Does the DNA encode a toxin?
□ Yes
□ No
If yes, please provide the LD50
12. Where will this work be conducted? Please provide Room Number, Building
Name and Building Code.
13. Do you have approval to use this facility?
Yes [
]
No [
]
14. Proposed date of commencement of work.
15. Likely duration of work.
16. Signature of Principal Investigator submitting this proposal.
Date
Exempt Dealing application form – May 2015
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