Download Exempt Dealing Application Form - Macquarie University

Office of the Deputy Vice Chancellor (Research)
Macquarie University Institutional Biosafety Committee
Exempt Dealing Application Form
Name of Principal Investigator:
Project title:
For completion by IBC.
IBC Reference Number
Approval Date
Section 1: Investigator Details
1. Name and contact details of principal investigator and co-investigator/s
List the details of the project supervisor, co-investigators and other personnel (including
students) undertaking dealings with GMOs.
Project supervisor’s name:
MQ Staff Number (Mandatory):
Position within the organisation:
Relevant qualifications:
Relevant experience:
Contact details of the Project Supervisor
Business telephone number:
Mobile telephone number:
Facsimile number:
E-mail address:
Postal address:
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Investigator details (cont):
Please list all personnel undertaking dealings with GMOs (please copy and paste more tables if
required).
Name:
MQ ID:
Staff
Student
Relevant qualifications:
Relevant experience:
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Section 2: Exemption Category – Please place an X in the appropriate box/s
OGTR
Item #
2
Mark
with
an X
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.
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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.
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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.
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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.
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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.
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Section 3: Research Overview
1. Please describe the aim of the research
2. Please describe the main experimental procedures of the work
3. 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.
4. 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.
5. 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 your project involves the use of a replication defective
viral vector (unable to transduce human cells), please provide an explicit description of the
assay you intend to perform to exclude the presence of replication competent virus.
6. If you believe the protein/gene is characterised, and unlikely to increase the capacity of the
host or vector to cause harm, or secrete a toxin, briefly explain why, referring to what is known
about its structure, function and/or genetics.
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7. Where will the research be conducted?
Facility No.
Room Number and
Building Number
Facility Type (animal
house, laboratory etc)
Physical Containment Level (eg
PC1, PC2)
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8. What is the proposed date of commencement of the project?
9. What is the proposed date of completion?
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Section 4: Signatures
I declare that to the best of my knowledge, having made reasonable inquiries, the information herein
is true and correct. I understand that providing misleading information to the OGTR, deliberately or
otherwise, is an offence under Commonwealth law.
Project Supervisor
Signature: ________________________Date: ______________________________
Printed Name: _______________________________________________________
IBC Chair
Signature: ________________________Date: ______________________________
Printed Name: Associate Professor Subramanyam Vemulpad
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