Office of Research Ethics and Integrity

Gene technology

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Do I need to apply for approval?

All research and teaching activities involving a dealing with a Genetically Modified Organism (GMO) requires University Biosafety Committee review, approval and monitoring.

Do not begin your project until you've received approval.

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What is a dealing with a Genetically Modified Organism (GMO)

The full definition of a GMO appears under section 10 of the Gene Technology Act 2000 (the Act). In essence, a GMO means:

  • an organism that has been modified by gene technology; or
  • an organism that has inherited particular traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology.

The term 'dealings', in relation to a GMO is also defined in the Act.

deal with, in relation to a GMO, means the following:

  • conduct experiments with the GMO;
  • make, develop, produce or manufacture the GMO;
  • breed the GMO;
  • propagate the GMO;
  • use the GMO in the course of manufacture of a thing that is not the GMO;
  • grow, raise or culture the GMO;
  • import the GMO;
  • transport the GMO;
  • dispose of the GMO;

and includes the possession, supply or use of the GMO for the purposes of, or in the course of, a dealing mentioned in any of the above.

The Act and the Gene Technology Regulations 2001, amendment 2011, describe a number of classes of dealings with GMOs and corresponding approval processes, depending on the nature of the GMO and of the activities involving the GMO, such that the level of regulatory scrutiny is proportional to the level of risk. Please visit the Office of the Gene Technology Regulator (OGTR) website for more information.

Techniques that are not Gene Technology

The following information is taken from Schedule 1A of the Gene Technology Regulations 2001, amended 2011:

  1. Somatic cell nuclear transfer, if the transfer does not involve genetically modified material
  2. Electromagnetic radiation-induced mutagenesis
  3. Particle radiation-induced mutagenesis
  4. Chemical-induced mutagenesis
  5. Fusion of animal cells, or human cells, if the fused cells are unable to form a viable whole animal or human
  6. Protoplast fusion, including fusion of plant protoplasts
  7. Embryo rescue
  8. In vitro fertilisation
  9. Zygote implantation
  10. A natural process, if the process does not involve genetically modified material (e.g, conjugation, transduction, transformation and transposon mutagenesis)

Organisms that are not GMOs

The following information is taken from Schedule 1A of the Gene Technology Regulations 2001, amended 2011:

  1. A mutant organism in which the mutational event did not involve the introduction of any foreign nucleic acid (that is, non-homologous DNA, usually from another species).
  2. A whole animal, or a human being, modified by the introduction of naked recombinant nucleic acid (such as a DNA vaccine) into its somatic cells, if the introduced nucleic acid is incapable of giving rise to infectious agents.
  3. Naked plasmid DNA that is incapable of giving rise to infectious agents when introduced into a host cell.
  4. An organism that results from the exchange of DNA if:
    (a) the donor species is also the host species; and
    (b) the vector DNA does not contain any heterologous DNA.
  5. An organism that results from an exchange of DNA between the donor species and the host species if:
    (a) the exchange can occur by naturally occurring processes; and
    (b) the donor species and the host species are micro-organisms that:
    • satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 1; and
    • are known to exchange nucleic acid by a natural physiological process; and
    (c) the vector used in the exchange does not contain heterologous DNA from any organism other than an organism that is involved in the exchange.
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Applying to 'deal with' GMOs

All research and teaching activities involving a dealing with a Genetically Modified Organism (GMO) require University Biosafety Committee review, approval and monitoring, including:

  • exempt dealings
  • Notifiable Low Risk Dealings (NLRDs)
  • Dealings Not involving Intentional Release (DNIRs)
  • Dealings involving Intentional Release (DIR)

Complete the relevant application form; a guide is available to assist you:

Note: work with genetically modified vertebrate animals requires animal ethics approval. Work with human cell lines requires human research ethics approval.

Do not begin your project until you've received approval.

I am a QUT TRI occupant, which committee do I apply to?

As of 1 February 2018, QUT TRI occupants must submit their GM or high risk biological applications through the QUT University Biosafety Committee (UBC). The submission procedure is detailed here.

Any QUT TRI occupants with GM dealings approved through the UQ Institutional Biosafety Committee (IBC) prior to the 1 February 2018 must contact the QUT Senior Biosafety Officer.

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Submitting your application

When to submit

Applications are reviewed by the University Biosafety Committee at their meetings. Check the meeting dates and deadlines to ensure you submit in time for a specific meeting.

How to submit

Email your complete application to biosafetyethics@qut.edu.au

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Exempt dealings

  • Have a very low level of inherent risk that can be easily reduced or managed
  • Must not involve intentional release of the GMO into the environment
  • Must be approved by the University Biosafety Committee prior to commencement of work
  • Must be conducted in a facility that meets PC1 containment requirements, but does not need to be conducted in a certified facility

Examples of exempt dealings:

  • Shot-gun cloning using an exempt host vector system provided that the donor nucleic acid is not derived from a pathogen or a toxin-producing organism
  • Cloning into common laboratory strains of E.coli provided that the donor DNA satisfies certain criteria (as defined in the List of Exempt Dealings)
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Notifiable Low Risk Dealings

  • Have a level of inherent risk but this can be easily reduced or managed
  • Must not involve intentional release of the GMO into the environment
  • Must be approved by the University Biosafety Committee prior to commencement of work
  • Must be conducted in a certified facility, the containment level will depend on the type of work
  • Must be conducted in accordance with the OGTR's Guidelines for Transport, Storage and Disposal of GMOs
  • Cannot be varied or amended once approved (a new application will need to be submitted)

Examples of PC1 NLRDs:

  • Use of a genetically modified mouse where no selective advantage has been conferred as a result of the modification
  • Use of a replication defective viral vector derived from Human adenovirus or Adeno associated virus provided that the donor nucleic acid meets certain criteria (as defined in the List of NLRDs)

Examples of PC2 NLRDs:

  • Work with GM plants
  • Use of genetically modified mice and rats that have a selective advantage as a result of the genetic modification
  • Some types of work with replication-defective viral vectors
  • Some types of work with host and vectors that can cause disease

Examples of PC3 NLRDs:

  • A dealing that satisfies the NLRD criteria but involves a Risk Group 3 agent (e.g. HIV in cell culture)
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Dealings Not involving Intentional Release (DNIRs)

  • Have a higher level of risk than exempt dealings or NLRDs
  • Must NOT involve the release of the GMO into the environment
  • Must be conducted in a facility that is certified to at least PC2 level by the OGTR
  • Can only be conducted if a DNIR licence for the work is issued by the OGTR
  • Must be conducted in accordance with the specific conditions listed on the DNIR licence
  • The University Biosafety Committee performs an initial assessment of DNIR applications but cannot authorise commencement of work.
  • Work can only commence if the OGTR issues a DNIR licence. The entire assessment process can take up to 6 months, including a 90 working day OGTR assessment period.
  • DNIR Licences can only be varied or amended with the prior approval from the OGTR (a new licence is issued each time the DNIR is varied).

Examples of DNIRs:

  • Cloning an expression of a full length toxin gene in any host/vector system
  • Creation of a novel replication competent virus that is more virulent than its parent strain
  • Creation of a GM animal or plant that is able to secrete or produce infectious agents as a result of the modification
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Dealings involving Intentional Release (DIRs)

Any dealing that involves intentional release of a GMO into the environment requires a DIR licence. The application process is considerable and in some cases it may take up to 2 years for a licence to be granted by the Office of Gene Technology Regulator (OGTR).

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Varying an approved dealing

It is recognised that during the course of an approved activity, updates or variations will need to be made to the general conduct of the study.

It is important that these changes are conveyed to the Office of Research Ethics and Integrity for appropriate review and approval, prior to implementation of the change.

Variations to Exempt and NLRD dealings

The OGTR does not allow changes or variations to be made to a NLRD, therefore it is imperative that the original approval is broad enough to cover the work you are undertaking.

Examples of major variations (new application required):

  • material changes to the GMO description table e.g. a new gene that changes the toxicity or induces a toxin
  • changes in the classes of facilities and/or persons appropriate for the dealings

Examples of minor variations:

  • the addition of facilities and/or persons that do not affect the classes already approved.

Variations should be track-changed on the application in order for the UBC to readily identify the requests. The amended application should be submitted to the Office of Research Ethics and Integrity with a justification for the change.

Variations to DNIRs and DIRs

Section 71 of the Gene Technology Act 2000 (the Act) states that OGTR may vary the conditions of either on the Regulator's initiative or on application from the licence holder. See OGTR Policy on the variation of GMO licences.

All applications for variation to the licence must go through the Office of Research Ethics and Integrity.

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