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Application submission - log into iRECS to submit your application. You will receive a notification once your application has been assigned to a meeting. Please ensure you submit your application 2 weeks prior to the relevant GTRC meeting date.
- UNSW Biological Materials Research Procedure - defines responsibilities and requirements for staff and students dealing with GMOs
- Alerting the GTRC about incidents involving organisms or facilities identified in the UNSW Biological Materials Research Procedure: please refer to Section 8 and alert genetechnology@unsw.edu.au ASAP, in addition to other Health & Safety reporting requirements
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Annual Compliance Report - the Annual Compliance Report can be submitted through iRECS.
- Office of the Gene Technology Regulator (OGTR) website
- Gene Technology Act 2000
- Gene Technology Regulations 2001 (latest compilation which includes amendments that come into effect on 8th Oct 2020)
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OGTR DNIR Licence Variation Form - application form to lodge a variation in a DNIR licence with the OGTR
Q. Transduced cell lines – Exempt or NLRD?
A. If you are making a stably transduced cell line, then you will at some point have a cell line capable of infecting human cells. This is an NLRD dealing. Following verification tests to show the virus is no longer present, the stably transduced cell line can be used for further procedures. This is an Exempt dealing type. You need to list both the NLRD and Exempt dealing versions in Table 1 of the application.
If you are purchasing the stably transduced cell line (or receiving a verified-incompetent line from another group), then you only need to list the Exempt dealing type 4.
The table below describes the gene technology dealings involved in the process of creating a stably transduced cell line:
| a | b | c | d | e | f | g |
| GMO No. | Host: common and scientific name of parent organism | Vector(s) and non-vector nucleic acids description | Method of transfer | Identify and function of nucleic acid and organism of origin | Phenotype, modified trait | Classification of dealing |
| 1 |
Common Name: Bacteria Scientific Name: E.coli (strain Stbl3 and DH5alpha) |
Non-conjugative replication defective lentiviral vector. |
E coli will be transformed with the plasmid using heat shock. |
Describe here |
Transformed bacteria will have altered protein expression and will be resistant to antibiotics (ampicillin) • E. coli transformed with the packaging plasmid will not be able to produce lentiviral particles. |
Exempt Type 4 |
| 2 |
Common Name: Human embryonic kidney cells (HEK-293T). Scientific Name: Homo sapien (HEK-293T) |
Non-conjugative replication defective lentiviral vector. The viral packaging functions (genes) are supplied in trans i.e on separate packaging plasmids. |
The packaging cells will be transfected with the replication defective lentiviral vector and packaging plasmids using a standard liposome based method. |
Describe here |
The transfected HEK293T cells will: • Produce pseudotyped lentiviral particles that is able to transduce human cells, but unable to replicate. |
NLRD 2.1(L) |
| 3 |
Common Name: Human and mouse cell lines
Scientific Name: cell lines of Homo sapiens and Mus musculus origin |
Lentiviral particles (GMO#2 above) containing non-conjugative replication-defective lentiviral vectors. |
Lentiviral transduction |
Describe here | The transduced cells will... | NLRD 2.1(L) |
| 4 |
Common Name: Human and mouse cell lines
Scientific Name: cell lines of Homo sapiens and Mus musculus origin |
see GMO # 3 |
Lentiviral transduction and after tested to be free of viral particles |
see GMO # 3 | see GMO # 3 | Exempt Type 4 |
Q. Transformation of lymphoid cells with EBV (HHV-4) – GMO or not?
A. Cells that have been transformed as a result of infection with unmodified (wild type) Epstein Barr virus would not be considered a GMO.
Q. Is injecting siRNA into an animal making it a GMO?
A. Introduction of naked nucleic acid (i.e., without a viral coat or other packaging/coating to facilitate efficient entry into cells) which is incapable of giving rise to infectious agents into somatic cells (and not germ-line cells) of animal is not subject to regulation and the animal would not be a GMO. If germ-line cells are modified by the introduced nucleic acid, the animal would be considered a GMO and subject to regulation, most likely classified as an NLRD.
Q. My experiment includes chemical/physical/microscopic analysis of tissues collected from a collaborator's GM mice. Do I need to seek GTRC approval?
A. The use of tissues from a GM mouse is considered an Exempt dealing Type 4. If you house and breed the GM mice to collect the tissues yourself, this constitutes an NLRD 1.1(a).
Q. Are inbred mutant balb/c nu/nu mice considered GMOs?
A. As the mutation occurred naturally and does not involve the introduction of any foreign nucleic acid (that is, non-homologous DNA, usually from another species), the inbred mutant balb/c nu/nu mice are not considered GMOs. However, depending on what you plan to use these mice for, you may still need GTRC approval for the dealings involving these mice.
Q. Are RCS rats considered GMOs?
A. The Royal College of Surgeon (RCS) rat is the first known animal with inherited retinal degeneration. Due to the modification being spontaneously occurring, RCS rat is not considered a GMO. The housing & breeding of these rats are not considered gene technology dealings. However, depending on what you plan to use these rats for, you may still need GTRC approval for the dealings involving these rats.
Q. Does CRISPR and other site-directed nuclease work and GMOs created using this technology need GTRC approval?
A. In the new amendments to the Gene Technology Regulations 2011 that come into force on 8th October 2019 some gene editing will be considered gene technology.
The following applies: “organisms are genetically modified if the genomes are “edited” by a site-directed nuclease and if a template nucleic acid was added to guide homolog-directed repair of the single strand (s-s) or double strand (d-s) break/s. If the repair of s-s or d-s break/s is not homology directed by an added guide nucleic acid it is not genetically modified under the Regulations”
So, from now on organisms with genomes “edited” by a site-directed nuclease and a template nucleic acid was added to guide homology-directed repair of the s-s or d-s break/s will need GTRC approval. These dealings need to included on existing NLRD and Exempt applications (submit a modification) or submitted as a new application as outlined above.
Complaints about the conduct of research by UNSW staff and students should be directed to the Director Conduct and Integrity, Ms Bronwyn Greene. The contact details for Ms Bronwyn Greene are P: 9385 2983 and E: research.integrity@unsw.edu.au.
Grievances about ethics review and processes by UNSW Australia staff and students should be directed to the Director Research Ethics & Compliance Support, Dr Ted Rohr. The contact details for Dr Rohr are Phone 02 9385 4235, Fax 02 9385 7238 and Email ted.rohr@unsw.edu.au.