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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.
  • Work involving the use of higher order invertebrate or vertebrate animals also requires animal ethics approval.
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Frequently asked Questions about Gene Editing (CRISPR/Cas9) and GTRC approval

Q: I want to include CRISPR/Cas9 experiments on an existing GTRC project approval; do I need to submit request for 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 it likely would be Exempt. However, to be exempt it also must satisfy the following: introduced nucleic must not code for a toxin with LD50 >100ug/kg and not be an uncharacterised nucleic acid from a toxin-producing organism. It is best to ask if unsure (genetechnology@unsw.edu.au).

Q: I am currently doing gene editing but only to knock out genes in cells in culture; do I need to obtain 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 to obtain 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 is 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 it is an Exempt dealing in which case UNSW requires that it is conducted in 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 classified as a NLRD then it would probably need to be performed in an OGTR PC2 facility, but there are exceptions. Again, it is 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 iRECS and a GTRC Notification of Approval 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:

Log into iRECS to submit your application. You will receive a notification once this has been approved. 

 

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:

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. 

 

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, you must submit a request by email to genetechnology@unsw.edu.au outlining the updates. 

RECS will review the request and unlock the application in iRECS. you will receive a notification when your application has been unlocked and is ready to be modified.

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