Biosafety, biosecurity and gene technology research
Researchers who conduct dealings using gene technology are bound by the Gene Technology Act 2000 and other relevant Australian State and Commonwealth legislation and regulations together with University regulations and policies. All research has additional research integrity responsibilities. Find out here about Research Integrity at La Trobe.
All research and teaching projects involving gene technology and or biosecurity sensitive materials must be reviewed and approved by the La Trobe University Institutional Biosafety Committee (LTIBC) before the project begins. Please contact the Ethics, Integrity and Biosafety team if you are not sure if an ethics approval is required.
The scope and functions of the La Trobe University Institutional Biosafety Committee (LTIBC) are defined in the LTIBC Terms of Reference 2024.
+61 3 9479 3338
Getting your project approved
How to apply
- Download and complete the Application Form - Exempt and Notifiable Low Risk Dealings (updated November 2022), the Personnel Training Record for Dealings with GMOs (updated May 2024) and where relevant the GMO Summary Spreadsheet (updated May 2024).
- Log in to PRIME Researcher portal to create a new IBC Application:
- Under Ethics Applications, click “+ New IBC Application”
- Add all research personnel undertaking dealings
- Upload all completed forms (as separate documents) including any SOPs related to managing the risks of undertaking your GM dealings
- Click on “Submit to Research Office” by the relevant closing date (see below)
To help with training and feedback please see below:
- Training opportunities:
- Schedule a personalised session for help with your first submission using the contact details below
- Attend drop in sessions on the first Monday of every month at midday https://latrobe.zoom.us/j/84839776836
- If you would like to book a time to discuss your needs and preferred option/s please contact the Ethics, Integrity and Biosafety Team:
Time to approval
2017 | 2018 | 2019 |
---|---|---|
57 days | 22 days | 20 days |
17 projects | 9 projects | 13 projects |
Committee meeting dates
2023 IBC New & deferred applications - pre-review, closing and meeting dates
Pre-review cut-off (voluntary) | Application deadline | Meeting date |
---|---|---|
Midday Monday 23 October 2023 | Midday Monday 30 October 2023 | Thursday 16 November 2023 |
Midday Monday 27 November 2023 | Midday Monday 4 December 2023 | Thursday 21 December 2023 |
2024 IBC New & deferred applications - pre-review, closing and meeting dates
Pre-review cut-off (voluntary) | Application deadline | Meeting date |
---|---|---|
Midday Thursday 25 January 2024 | Midday Friday, 2 February 2024 | Thursday, 15 February 2024 |
Midday Friday, 1 March 2024 | Midday Friday, 8 March 2024 | Thursday, 21 March 2024 |
Midday Wednesday, 27 March 2024 | Midday Friday, 5 April 2024 | Thursday, 18 April 2024 |
Midday Friday, 26 April 2024 | Midday Friday, 3 May 2024 | Thursday, 16 May 2024 |
Midday Friday, 31 May 2024 | Midday Friday, 7 June 2024 | Thursday, 20 June 2024 |
Midday Friday, 28 June 2024 | Midday Friday, 5 July 2024 | Thursday, 18 July 2024 |
Midday Friday, 26 July 2024 | Midday Friday, 2 August 2024 | Thursday, 15 August 2024 |
Midday Friday, 30 August 2024 | Midday Friday, 6 September 2024 | Thursday, 19 September 2024 |
Midday Thursday, 26 September 2024 | Midday Friday, 4 October 2024 | Thursday, 17 October 2024 |
MiddayFriday, 1 November 2024 | Midday Friday, 8 November 2024 | Thursday, 21 November 2024 |
Midday Friday, 29 November 2024 | Midday Friday, 6 December 2024 | Thursday, 19 December 2024 |
IBC Subject to - closing and meeting dates
Closing Date | Meeting Date |
---|---|
Thursday - every week | Thursday the following week |
DNIR (Dealings involving Non-Intentional Release)
Dealings with GMOs in contained facilities which do not meet the criteria for classification as Exempt Dealings or Notifiable Low Risk Dealings and do NOT involve an intentional release of GMOs into the environment. DNIRs are higher risk dealings than NLRDs.
DNIRs must be licensed by the Regulator. The kind of dealings classified as DNIRs are described in Schedule 3 Part 3 of the Regulations
Contained dealings with viral vectors can be classified in the DNIR, NLRD, and exempt categories. To correctly classify dealings with viral. vectors the OGTR has provided the following guides:
· Tables for the classification of contained dealings with viral vectors
Application process
- Read the Licence Application & Assessment Process information provided by the OGTR.
- Ensure the dealing meets the classification criteria listed in Schedule 3 Part 3 of the Regulations.
- Ensure dealings involving viral vectors meet the correct classification criteria.
- Download an OGTR Application Form - Dealings Not involving Intentional Release (DNIR)and save a copy to your computer.
- The completed application and all supporting documentation must be submitted electronically to biosafety@latrobe.edu.au from the Chief Investigator's La Trobe University email account.
- DNIR licence applications must be reviewed and supported by the LTIBC. The LTIBC will forward reviewed and supported licence applications to the Regulator.
Evaluation of a licence application by the Regulator can take up to 90 working days. Work cannot commence the Regulator has issued a licence.
DIR (Dealings involving Intentional Release)
Dealings with GMOs outside contained facilities and involving an intentional release into the environment are classified as DIR.
DIRs must be licensed by the Regulator and are included on the GMO Record. The evaluation process of DIR licence applications is comprehensive and involves the preparation of a risk assessment and risk management plan (RARMP).
Application process
- Read the Licence Application & Assessment Process information provided by the OGTR.
- Download an OGTR Application Form - Dealings involving Intentional Release (DIR) and save a copy to your computer.
- The completed application and all supporting documentation must be submitted electronically to biosafety@latrobe.edu.au from the Chief Investigator's La Trobe University email account.
- DIR licence applications must be reviewed and supported by the LTIBC. The LTIBC will forward reviewed and supported licence applications to the Regulator.
Evaluation of a licence application by the Regulator can take up to 255 working days. Work cannot commence the Regulator has issued a licence.
Internal facility certification
Legislation requires certain dealings with GMOs must be conducted within physical containment facilities.
For research involving or potentially involving Risk Group 1 or Risk Group 2 organisms that do not include genetically modified organisms, the LTIBC oversees an internal certification program that verifies our laboratories comply with Australian New Zealand Standards, 2982:2010 and 2243:3:2010.
Please contact the Senior Biosafety Officer at biosafety@latrobe.edu.au for any questions regarding La Trobe's internal certification or external OGTR certification.
Do you require explanatory information on the OGTR Guidelines for Certification of Physical Containment Facilities
IBC Membership
Feedback and Complaints
If you wish to provide feedback or make a complaint please email biosafety@latrobe.edu.au or call the Senior Biosafety Officer on (03) 9479 1443
Managing post-approval requirements
PRIME Ethics Researcher Portal
For support and training with the PRIME Ethics Researcher Portal see below:
- Training opportunities:
- Schedule a personalised session for help with your submissions through the Portal;
- Attend drop in sessions on the first Monday of every month at midday: https://latrobe.zoom.us/j/84849823999
- Training will cover the following self-serve Ethics Requests:
- New Applications
- Unexpected Adverse Events/Safety Reports
- Modifications
- Annual/Final Reports
- Milestones and tasks
- If you would like to book a time to discuss your needs and preferred option/s please contact the Ethics, Integrity and Biosafety Team:
Post approval requirements
Modifications
Following application approval, researchers may require a modification to their project.
Modifications may include:
- addition of personnel to the project
- removal of personnel from the project
- change of PI for the project
- addition of dealings within the scope of the existing project approval
- change of facility in which the dealings will be conducted
- change to the approved import/export/transport conditions
Modifications may NOT include:
- addition of dealings NOT within the scope of the existing project approval – new application must be submitted
- extension of the approval period - new application must be submitted
The PI must submit an LTIBC Amendment Request Form (updated May 2024) to the committee electronically via PRIME. The proposed modifications must be included in a copy of the approved application form and a track changed and clean copy should be submitted for review.
How do I submit a modification request?
- Download and complete the LTIBC Amendment Request Form (updated May 2024)
- Log in to PRIME Researcher portal to create a modification request:
- To find your ethics project click on the “My Ethics & IBC Projects” tile and select the Ethics Approval Number you wish to modify. Download and add modifications to the current LTIBC approved application. Make sure to save a tracked and clean copy of the application
- At the top right of the PRIME project screen, select “Create Modification” from the drop-down menu
- Upload the completed LTIBC Amendment Request Form
- Upload the tracked and clean copies of the modified approved application
- If requesting change to personnel, upload an updated Personnel Training Record for Dealings with GMOs
- If requesting addition of dealings, upload an updated GMO Summary Spreadsheet
- In the progress bar at the top of the page, select "Review by Research Office" and then click "Mark as Current Status" to the right.
NOTE: Amendment requests for a project that has overdue annual reports will not be considered by the LTIBC and project approval may be suspended if an annual report is not submitted after notification of the overdue milestone.
Progress Reports
NOTE: If your project has expired you will not be able to upload your progress report in PRIME, please email your completed report form to biosafety@latrobe.edu.au. A Research Ethics Advisor will upload it and mark your milestone as complete on your behalf.
It is a condition of approval that all approved applications must submit an Annual Report Form providing detail on the preceding year’s progress of the research on the anniversary of their approval date annually throughout the life of their project approval and a Final Report Form within 6 months of project completion. Up to date personnel training records and GM strain lists must be submitted with the annual progress report.
PRIME will provide automatic notice of the upcoming report date.
NOTE: New project applications for replacement of a project that has overdue milestone reports or for a PI that has overdue milestones in other approved projects may not be considered by the LTIBC until those overdue milestones are submitted.
How do I submit an annual/final report?
- Download and complete the Annual Report Form (DOC 63KB) or Final Report Form (DOC 60KB)
- Log in to PRIME Researcher portal to lodge an annual/final report:
- To find your ethics project click on the “My Ethics & IBC Projects” tile and select the Ethics Approval Number for which you wish to submit an annual or final report:
- At the top right of the screen, select “Create Annual Report” or "Create Final Report" from the drop-down menu
- Upload the completed annual/final report
- Upload an up to date Personnel Training Record for Dealings with GMOs
- Upload an up to date GMO Summary Spreadsheet
- In the progress bar at the top of the page, select "Review by Research Office" and then click "Mark as Current Status" to the right.
Incident Reporting
The LTIBC Incident Report Form should be used to report:
- Unintended presence or unintended release of GMOs from a PC certified facility
- Unintended escape and spread of biosecurity goods (including live organisms) outside an approved arrangement (AA) site
- Potential non-compliance in your dealings
- Suspected non-compliance in others’ dealings
It is the responsibility of the Principal Investigator to report any incidents involving GMOs and biosecurity goods to the LTIBC. Please download and complete the Incident Report Form and submit to the Biosafety Team as soon as possible.
Please contact the Biosafety Team (+61 3 9479 3338) for any questions regarding risk group levels, containment, import and export, legislative requirements.
FAQs and Guidance
Training and Guidelines
For staff and students, you can access the Biosafety training om LMS by clicking on this link.
Guidelines:
Templates
Coming soon