How to Apply for Approval to Conduct Research with GMOs

The purpose of the following guide is to simplify the process of applying for approval to conduct research that uses or creates genetically modified organisms (GMOs). 

Preamble

All work that uses or creates GMOs must be approved by the University of Wollongong Gene Technology Review Committee (UoW GTRC), and in some cases, by the Australian Office of the Gene Technology Regulator (OGTR).  Failure to obtain approval can lead to prosecution.

Research with GMOs is divided into 3 categories.  In increasing order of risk, these are Exempt Dealings, Notifiable Low Risk Dealings (NLRDs), and Licensed Dealings.  The following information is designed to help researchers determine which category their proposed research falls under, and to guide them through the application process.
 

1. Exempt Dealings 

These are dealings with GMOs that are considered to pose negligible risks.  If the proposed research meets the following three criteria, it is probably an Exempt Dealing.  (1) It will employ standard laboratory strain host/vector systems, and will clone DNA that (2) does not code for a vertebrate toxin, and (3) is not derived from a micro-organism able to cause disease in humans.  To determine whether the proposed research is an Exempt Dealing, check that your host/vector system is listed here, and whether your donor DNA (i.e. the fragment that will be cloned) fully meets the Exempt Dealings criteria.

 Exempt Dealings require approval from the UoW GTRC, but not by the OGTR.  Examples are given below.  Research involving Exempt Dealings does not need to be carried out in a certified laboratory, but the laboratory should meet a number of conditions.  Once you have decided that you should apply for an Exempt Dealing, you should complete a Notification of Exempt Dealing.  An example is provided. 
This should then be forwarded to the UoW GTRC (Penny Potter, Research Office), for assessment at its next meeting.  You will be notified as to whether you may proceed soon thereafter.
 

Examples of Exempt Dealings

A.  The cloning (including the expression) of non-toxic genes or gene fragments into standard bacterial strains  is generally an Exempt Dealing.

B.   Any dealing with an animal into which genetically modified somatic cells have been introduced, if:

i. the somatic cells are not capable of giving rise to infectious agents as a result of the genetic modification; and
ii. the animal is not infected with a virus that is capable of recombining with the genetically modified nucleic acid in the somatic cells.

C.  Any dealing involving shot-gun cloning of mammalian DNA into these exempt host/vector systems.
 

2. Notifiable Low Risk Dealings (NLRDs)

These are dealings with GMOs that are considered to pose low risks provided certain risk management conditions are complied with.  NLRDs are now divided into those that should be conducted in a certified PC1 laboratory, and those that should be conduced in a certified PC2 laboratory.

Examples of NLRDs that can be conducted in a PC1 laboratory – complete details are available here

A. Any dealing with genetically modified mice or rats, unless:

i. an advantage is conferred on the animal by the genetic modification; or
ii. because of the genetic modification, the animal is capable of secreting or producing an infectious agent.

B. A dealing involving a replication defective vector derived from Human adenovirus in a host considered Exempt, if the donor nucleic acid:

i.  cannot restore replication competence to the vector, and
ii.  does not confer an oncogenic modification in humans.

Examples of NLRDs that can be conducted in a PC2 laboratory – complete details are available here

A.   Any dealing involving a host and vector that are not considered Exempt (i.e. are not listed as an Exempt host/vector system), providing:

i.  the host or vector are incapable of causing disease in otherwise healthy human beings, animals, plants or fungi;
ii. the donor DNA is fully characterised and is unlikely to increase the capacity of the host or vector to cause harm.

B.   Any dealing involving a host and vector that are considered Exempt (i.e. as an Exempt host/vector system), but the donor nucleic acid:

i.  is pathogenic; or
ii. is uncharacterised nucleic acid from an organism known to cause disease in otherwise healthy human beings, animals, plants or fungi.

C.  A dealing involving the introduction of a replication defective viral vector unable to transduce human cells into a host not considered Exempt if the donor nucleic acid cannot restore replication competence to the vector.

Once you have decided that you should apply for an NLRD, you should complete an Application form.  An example will be provided.  Such dealings require approval from the UOW GTRC, as well as the OGTR.  The completed application form should be forwarded to the UoW GTRC (Penny Potter, Research Office), for assessment at its next meeting.  This will then be forwarded to the OGTR for consideration.

Any NLRDs involving micro-organisms classified as Risk Group 3 must be undertaken in a PC3 Facility.
 

3. Licensed Dealings (Dealings that are not Notifiable Low Risk Dealings) 

These are any dealings with GMOs that fail to meet the criteria for either Exempt Dealings or NLRDs and may be classified as DNIRs (Dealings Not Involving Intentional Release) or DIRs (Dealings involving an Intentional Release). These dealings must be licensed by the Gene Technology Regulator. 

 Examples of dealings that must be licensed are the cloning of genes that code for vertebrate toxins, and cases in which the host and/or vector are capable of causing disease in humans.  Complete details of those dealings that should be licensed are available here.

Once you have decided that you should apply for a licensed dealing, you should complete either an Application for a DNIR or an Application for a DIR.  Such dealings require approval from the UoW GTRC, as well as the OGTR.  Research involving Licensed Dealings must be carried out in a laboratory certified to at least Physical Containment Level 2 (PC2).