Biosafety, Biosecurity and Gene Technology Research

Principal Investigators:

In submitting a project for ethics or institutional biosafety review, researchers are asked to note that the Principal Investigator on an application must be a fixed-term or ongoing La Trobe University employee or have Emeritus status conferred by Academic Board.

Projects by students and Honorary appointees other than Emeriti must be conducted with their academic supervisor as Principal Investigator on the ethics application.

Academic supervisors must be ongoing or fixed-term university employees. This approach is consistent with the Australian Code for the Responsible Conduct of Research (2018) and the La Trobe Honorary Appointments Policy.

NOTE: If you are a co-located partner needing to obtain LTIBC review, please contact eib@latrobe.edu.au to discuss your options.

New Applications:

1. Download and complete the Application Form - Exempt and Notifiable Low Risk Dealings (updated February 2026), the Personnel Training Record for Dealings with GMOs (updated May 2024) and, where relevant, the GMO Summary Spreadsheet (updated May 2024).
2. 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 (containment and spill management, storage and transport)
   • Click on “Submit to Research Office” by the relevant closing date (see below)

IBC meetings are held on the first Wednesday of the month. All submission cut-off times are at midday on the specified date

Pre-review Cut-off (voluntary)	Application deadline	Meeting date
Friday 16 January 2026	Friday 23 January 2026	Wednesday 11 February 2026
Friday 13 February 2026	Friday 20 February 2026	Wednesday 4 March 2026
Friday 20 March 2026	Friday 27 March 2026	Wednesday 1 April 2026
Friday 17 April 2026	Thursday 24 April 2026	Wednesday 6 May 2026
Friday 15 May 2026	Friday 22 May 2026	Wednesday 3 June 2026
Friday 12 June 2026	Friday 19 June 2026	Wednesday 01 July 2026
Friday 17 July 2026	Friday 24 July 2026	Wednesday 5 August 2026
Friday 14 August 2026	Friday 21 August 2026	Wednesday 2 September 2026
Friday 18 September 2026	Friday 25 September 2026	Wednesday 7 October 2026
Friday 16 October 2026	Friday 23 October 2026	Wednesday 4 November 2026
Friday 13 November 2026	Friday 20 November 2026	Wednesday 2 December 2026

IBC 'Subject to' Re-Submission

Re-submission close	Meeting date
Thursday - every week	Thursday the following week

1. Read the Licence Application & Assessment Process information provided by the OGTR.
2. Ensure the dealing meets the classification criteria listed in Schedule 3 Part 3 of the Regulations.
3. Ensure dealings involving viral vectors meet the correct classification criteria.
4. Download an OGTR Application Form - Dealings Not involving Intentional Release (DNIR)and save a copy to your computer.
5. 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.
6. 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 until the Regulator has issued a licence.

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 the Australian New Zealand Standards, AS 2982:2010 and AS 2243:3:2021.

Please contact the Senior Coordinator, Animal Ethics and Biosafety at biosafety@latrobe.edu.au for any questions regarding La Trobe's internal certification or external OGTR certification.

Any interested person may make a complaint about the conduct of a research project. Such a complaint will be made in writing and submitted electronically via email. A Complaints Form is available. The complaint should be forwarded to the attention of the Senior Manager, Ethics, Integrity and Biosafety, via eib@latrobe.edu.au. You will receive an acknowledgment of the complaint within two (2) business days of receipt of the complaint.

Where a complaint cannot be readily resolved through communication between the complainant and the Ethics Committee or Review Body, it may be submitted to the Senior Manager, Ethics, Integrity, and Biosafety, in writing via eib@latrobe.edu.au using the Ethics, Integrity, and Biosafety Complaints Form.

Modifications

Following application approval, researchers may need to make modifications 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
• addition of strains/lines within the scope of the existing project schedules
• 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 - a new application must be submitted

The PI must submit an LTIBC Amendment Request Form to the committee electronically via PRIME. The proposed modifications must be included in a tracked and clean copy of the previously approved application and should be submitted for review along with the amendment request form.

How do I submit a modification request?

• Download and complete the LTIBC Amendment Request Form
• Log in to the 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 a change to personnel, upload an updated Personnel Training Record for Dealings with GMOs
• If requesting additional GM strains within already approved 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: The LTIBC will not consider amendment requests for a project that has overdue annual reports, and project approval may be suspended if an annual report is not submitted after notification of the overdue milestone.

• Download and complete the Annual Report Form or Final Report Form
• Log in to the 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
• Upload a completed Amendment Request Form and supporting documents if you are also reporting changes to your project details
• 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.

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 it to the Ethics, Integrity and Biosafety Team as soon as possible.

Please contact the Ethics, Integrity and Biosafety Team (+61 3 9479 3338) for any questions regarding risk group levels, containment, import and export, and legislative requirements.

For staff and students, you can access the Biosafety_and_Biosecurity_Awareness_Training - BBAT on the LMS.

If you completed your BBAT training more than three (3) years ago, complete the BBAT_2026_Refresh - Biosafety & Biosecurity Awareness Training REFRESHER 2026

LTIBC Guidelines and Resources

1. Safe Use of Portable Devices in Laboratories
2. Waste Management Guideline
3. Transport of Biological Material

LTU & EIB Guidelines and Resources

1. La Trobe University Safety Manual_2025
2. DAFF Audit Guide and Checklist

OGTR Guidelines and Resources

1. Guidelines for the Transport, Storage and Disposal of GMOs

DAFF Guidelines and Resources

1. Approved arrangement 5.2 – Biosecurity containment level 2 (BC2) Informative text
2. Approved arrangement  Biosecurity containment level 2 (BC2) Conditions

Consult the OGTR facility certification guidelines and/or the DAFF guidelines to applying for an approved arrangement to ensure your facility meets the required criteria.

Contact biosafety@latrobe.edu.au to guide you through the next steps in the application process.

IMPORTANT: Always check with your facility manager and the biosafety team before starting any GM dealings or work with imported biological material.

Before Construction, Repair and Maintenance Works Commence

PC1 & PC2 Facilities

Consult the OGTR construction, repair and maintenance fact sheet & decision tree to determine the level of works, the actions that must occur before and after completing the works and whether the OGTR must be notified of your works before commencement.

The Ethics, Integrity, and Biosafety (EIB) Team must be notified of all works planned within PC1 & PC2 facilities via the submission of a Certified Facility Works Notification Form to biosafety@latrobe.edu.au.

• Notification of Works Form

The EIB will coordinate communication with the OGTR if it is determined that notification of the works is required or if the certification needs to be varied or suspended before the work begins. Confirmation of the completion of mandatory actions must be provided to the EIB before submitting notification or suspension requests.

• Confirmation of Mandatory Actions Form

What types/levels of OGTR notification are there?

No notification required for internal work

• For internal and low-risk work where the area can be isolated
• Internal work does not disrupt the external boundaries of the facility
• No notification or warning to OGTR

Minor Works Notification

• Less than 1m2 breach in external boundaries (external walls, flooring, or ceiling); and
• Work must be completed within 12 hrs to 3 days
• Must notify OGTR via the form one working day in advance

Facility suspension or variation to remove the affected area

• For extensive work
• Work that will take longer than three days to complete
• Must apply for variation and/or suspension via the form

Biosecurity Containment (Approved Arrangement) Facilities

Consult Approved Arrangement Biosecurity Containment Level 2 (BC2) Conditions (s1.2; s1.3, s2.1, s8.12.2 & s9.1) Informative Text (s8) to determine the level of works, the actions that must occur before and after completing the works and whether the Department of Agriculture, Fisheries and Forestry (DAFF) must be notified of your works before commencement.

The Ethics, Integrity, and Biosafety (EIB) Team must be notified of all works planned within Approved Arrangement facilities by submitting a Certified Facility Works Notification Form to biosafety@latrobe.edu.au.

• Notification of Works Form

The EIB will coordinate communication with DAFF if it is determined that notification of the works is required or if the certification needs to be varied or suspended before the work begins. Confirmation of the completion of mandatory actions must be provided to the EIB before submitting notification or suspension requests.

• Confirmation of Mandatory Actions Form

After Construction, Repair and Maintenance Works are Complete

PC1/PC2 & Biosecurity Containment (Approved Arrangement) Facilities

Contact biosafety@latrobe.edu.au to arrange an inspection of the facility once the work has been completed.

• Confirmation of Completion of Works Form