Gene Technology Research Committee Approval Applications

Do I need approval?
  • From 8 October 2019, certain types of gene editing (including but not only CRISPR/Cas9) are now considered gene technology and organisms whose genomes have been altered using these techniques may require GTRC approval. More details can be found on the FAQ page. Please contact genetechnology@unsw.edu.au for advice.

  • Any research involving a dealing with a GMO requires approval from the UNSW Gene Technology Research Committee (GTRC) before work can start.
  • Project approvals from other organisations are not transferable to UNSW.
  • UNSW approval is required before GMOs are transported from - or to - another organisation or supplier.
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Frequently asked Questions about Gene Editing (CRISPR/Cas9) and GTRC approval

Q: I have included CRISPR/Cas9 experiments on an existing project approval do I need to put in a modification? A: No.

Q: Is work using CRISPR/Cas9 an exempt dealing? A: It depends on the experimental context and the gene modification. If the organism you are modifying is on the exempt list and the methods of introducing the nucleic acids is considered low risk (transfection and not viral transduction) then likely would be Exempt. However, to be exempt it also must satisfy the following: introduced nucleic mustn’t code for a toxin with LD50 >100ug/kg and not be an uncharacterised nucleic acid from a toxin-producing organism. Best to ask if unsure (genetechnology@unsw.edu.au).

Q: I am currently doing gene editing but its only to knockout genes in cells in culture, do I need to get GTRC approval? A: If, the repair of the single or double strand break/s is directed by a guide nucleic acid then yes you do need GTRC approval as its now considered gene technology. However, if the repair is by the organism’s endogenous repair system without an added guide, then it’s not considered gene technology and does not need GTRC approval.  Of course, as indicated in the answer to the previous question it also depends on how the nucleic acids are introduced.

Q: Does gene editing have to be performed in an OGTR certified facility. A: No provided its an Exempt dealing, but in this case at UNSW we would require it is a laboratory that meets PC1 requirements as defined in Australian/New Zealand Standard Safety in laboratories Part 3: microbiological safety and containment (AS/NZS 2243.3:2010). If the work is a NLRD then it would probably need to be performed in an OGTR PC2 facility, but there are exceptions. So best to ask: genetechnology@unsw.edu.au

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What type of approval do I need?
  • Your specific approval process will vary depending on a number of factors including the type of dealing, use of hosts / vectors (including viral), type of GMO and required containtment type.
  • Dealings with GMOs are classified into four areas as defined by the OGTR: Exempt, NLRD, DNIR and DIR. For information regarding these dealings please see the Classes of Dealings page.
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What are the approval processes and how do I submit an application?

Please ensure that you have read the information regarding 'What type of approval do I need?'. Then follow the relevant instructions:

Process for Exempt Dealings

Project Supervisor for projects involving only Exempt dealings must notify the GTRC of the proposed research via a Notification of Exempt Dealing and a GTRC Identification Number must be issued before work can commence.

NB. It is a legislative requirement that Exempt dealings must not involve an intentional release of a GMO into the environment.

The diagram below outlines the Notification process:

NRLD%20Image_0.jpg

A new dynamic Adobe form now replaces the previous Word form. This single smart form should be used for both Notifications of Exempt Dealings and NLRD Project Applications.

Once you have downloaded the form, check the Exempt box to access the Notification of Exempt Dealing version of the form.

Email a copy of your completed Notification of Exempt Dealing to the GTRC Support Officer.

 

NLRDs 

NLRDs are approved by the University's Gene Technology Research Committee.

Note: Where the research involves both NLRD and Exempt dealings, it will be treated as NLRD.

The diagram below outlines the process for NLRD Applications:

NRLD%202.jpg

A new dynamic Adobe form now replaces the previous Word form. This single smart form should be used for both Notifications of Exempt Dealings and NLRD Project Applications.

Once you have downloaded the form, check the NLRD or NLRD/Exempt box to access the NLRD Project Application version of the form.

Email a copy of your completed GTRC NLRD Project Application to the GTRC Support Officer 2 weeks prior to the relevant GTRC Meeting Date.

 

DNIR and DIR Applications

  • Approval for DNIRs and DIRs must be granted by the Office of the Gene Technology Regulator. The application process for these dealings, and in particular DIRs, is considerable and time consuming. In some cases it may take up to 2 years for a DIR licence to be granted by the OGTR.
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How do I modify my approval?

If you wish to make modifications to an existing approved project contact the GTRC Support Officer.

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