GTRC Forms, Guidelines & FAQs


UNSW GTRC Forms, Guidelines and Procedures

  • Monitoring Report (Forthcoming)


External Resources


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Frequently Asked Questions

 

Q. Transduced cell lines – Exempt or NLRD?

A. If you are making stably transduced cell line, then you will at some point have a cell line capable of infecting human cells. This is NLRD dealing. Following verification tests to show the virus is no longer present, the stably transduced cell line can be used for further procedure. This is an Exempt dealing type. You need to list both the NLRD and Exempt dealing versions onto 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 is being introduced into somatic cells (and not germ-line cells) of animal, this 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 transgenic mice. Do I need to seek GTRC approval?

A. Chemical/physical/microscopic analysis is not considered gene technology. Except for platelets, the use of tissues from a transgenic mice is considered an Exempt dealing Type 4. This is because platelets do not have any nucleic acid, and so they should not be considered as an organism. If you house and breed the transgenic mice to collect the tissues yourself, this constitute a NLRD 1.1(a).

 

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Complaints and Grievances

 

Complaints about the conduct of research by UNSW Australia staff and students should be directed to the Senior Deputy Vice-Chancellor, Professor Les Field.  The contact details for Professor Field are Phone 02 9385 2700, Fax 02 9385 8008 and Email research.integrity@unsw.edu.au.

Grievances about ethics review and processes by UNSW Australia staff and students should be addressed 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.
 

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