Applying For Approvals

For teaching or research that falls under the following categories of dealings defined within the Gene Technology Act:

• Exempt dealings.
• Notifiable Low Risk dealings.
• Dealings Not Involving Intentional Release (DNIR) licences.
• Dealings Involving Intentional Release (DIR) licences.

Applications for exempt and NLRD dealings are submitted via the Adelaide Compliance and Ethics System (ACES) using the Biological Compliance - GMO Dealing Application form.

For DNIR and DIR licences, the University of Adelaide must submit the licence application to the Office of the Gene Technology Regulator (OGTR). Please contact the Research Compliance Officer to discuss the application process.

For research with non-genetically modified microorganisms meeting any of the following criteria:

• Storage of, or work with, risk group 2 microorganisms including bacteria, viruses, parasites, fungi, algae or prions that may cause disease in, or are pathogenic, allergenic or toxic to humans, animals, plants or aquatic organisms.
• Isolation or culture of microorganisms from human or animal bodily fluids or tissues.
• Handling plants or animals that are knowingly infected with a microorganism capable of causing disease – i.e., infected as part of the research, or obtained for the purpose of investigating a specific disease agent known to be present.
• Storage of, or work with, primary cells or cell lines that are known or reasonably suspected to contain risk group 2 microorganisms (excluding Mycoplasma contaminants).
• Isolation, culture or enrichment of unknown microorganisms from environmental samples where the methods used are designed or intended for isolation, culture or enrichment of risk group 2 (or higher) microorganisms.

For the following categories, please contact the Research Compliance Officer: Biosafety prior to starting work or preparing an application:

• Storage of, or work with Security Sensitive Biological Agents or samples believed to contain these.
• Storage of, or work with, viable or non-viable risk group 3 or 4 microorganisms or samples believed to contain these.

Microbiological research risk assessments are submitted via the Adelaide Compliance and Ethics System (ACES) using the Biological Compliance - Non-GM Microbiological Risk form.

Varying Exempt gene technology dealing approvals

Any changes to exempt dealings may be varied by modifying your approved application in ACES.

To modify an existing application in the ACES system, log in and navigate to your list of applications. Select the relevant application and click the ‘Request Variation’ option from the Actions menu to enable editing. After making the necessary changes, ensure the form is signed and submitted for assessment and approval.

Varying NLRD gene technology dealing approvals

Only certain changes to NLRD approvals can be considered as a variation. The following can be amended:

• Addition of facilities or personnel of the same class as those listed in the Record of Assessment.
• Removal of facilities or personnel from the project, other than a change of Chief Investigator.
• Addition of dealings with GMOs that retain the same dealing classification and fall within the scope of approved GMOs described in Part A of the application form, and in the Record of Assessment.

Where your changes meet these criteria, to modify an existing application in the ACES system, log in and navigate to your list of applications. Select the relevant application and click the ‘Request Variation’ option from the Actions menu to enable editing. After making the necessary changes, ensure the form is signed and submitted for assessment and approval.

If you wish to make changes outside the specified criteria, a new application must be submitted in the ACES system. You have two options:

1. Create a New Project – Log in to ACES and select ‘Create New Project’ from the left-hand menu on your Work Area page.
2. Duplicate an Existing Project – Use the ‘Duplicate Project’ feature in the same menu to replicate an existing application form as the basis for a new submission. Follow the system prompts to select and duplicate the desired project then add desired changes in the form.

Varying OGTR licences

Please refer to the OGTRs Policy on scope for variation of GMO licences.

Complete the OGTR’s application form to vary a licence and submit this to the Research Compliance Officers for review and submission to the OGTR.

• Application form to vary a DNIR licences
• Application form to vary a DIR licence

The Research Compliance Officer will submit a licence variation request to the OGTR. A decision on a variation request is usually made by the Regulator within 90 working days.

Varying a microbiological risk assessment

Your microbiological risk assessment should be varied any time that you change the scope of your work, the methods or organisms you are using, and following any incident or event. Any changes to microbiological risk assessments may be made by modifying your approved application in ACES.

To modify an existing application in the ACES system, log in and navigate to your list of applications. Select the relevant application and click the ‘Request Variation’ option from the Actions menu to enable editing. After making the necessary changes, ensure the form is signed and submitted for assessment and approval.

Applications are submitted directly to DAFF via the Biological Import Conditions database, BICON.

BICON applications must be submitted via the University’s multi-user account. To gain access to this account, contact the Research Compliance Officers who will register you in the system.

The following details should be used when applying for an import permit:

• Applicant and Importer Contact details should be your own name and contact details (or your supervisors' details where students are applying).
• The Importer should be listed as Adelaide University, at the appropriate address for your campus location.