Biosafety, biosecurity and gene technology research

2024 IBC New & Deferred Applications

2025 IBC New & Deferred Applications

PLEASE NOTE:

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

IBC 'Subject to' re-submission

La Trobe University Research Project Complaints

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.

The Senior Manager, Ethics, Integrity and Biosafety, will review the complaint to determine if there is an apparent ongoing impact to a participant’s, animal’s welfare, or immediate risk to the environment (depending on the type of complaint received) that extends beyond those described in the approved ethics submission. If that is determined to be the case, the Senior Manager will notify the Executive Director of the Research Office and subsequently advise the Principal Investigator to cease research activities until a review has been undertaken.

Where the complaint relates to activities that would normally require Ethics Committee or Review Body approval, the complaint will be considered by the Senior Manager, or nominee, and the Chair of the relevant Ethics Committee or Review Body, who will determine the level of investigation required in accordance with the relevant guidelines.  Where further investigation is called for, the Ethics, Integrity and Biosafety Team will undertake a full risk-based monitoring investigation and prepare a report for relevant leadership. The report will detail the investigation and any findings and recommendations for further action.

The Ethics Committee or Review Body decides on any required actions relative to participant safety, animal welfare and environmental impact and informs the relevant parties. These actions may include but are not limited to:

• a caution
• increased reporting requirements and/or monitoring
• the requirement for modifications to the project
• suspension of ethical approval
• withdrawal of ethical approval.

Where the investigation finds that the complaint involves a breach of the relevant ethical guidelines, legislation or policy, the Senior Manager will work with the relevant Ethics Committee or Review Body and/or School/Centre to avoid a recurrence.

Where the review or investigation finds that the breach of the relevant ethical guidelines may also represent a breach of the Australian Code or research misconduct, the Senior Manager will refer it to the La Trobe University Designated Officer who will handle it in line with the La Trobe Research Misconduct Procedure.

Where the review or investigation determines the complaint to be unfounded or unsupported, the Senior Manager will dismiss the complaint and the reason/s for dismissal will be provided to the complainant and to the committee.

Where the review or investigation finds that the complaint should be dealt with under other institutional provisions, the Senior Manager will refer it on as appropriate.

The Ethics, Integrity and Biosafety team will inform the researcher(s) in writing, of the result of and any actions arising out of the investigation, within five (5) business days.

The complainant will be advised by the Ethics, Integrity and Biosafety team in writing of the outcome of the investigation of the complaint.

The Ethics, Integrity and Biosafety committee Secretariat will update the records and the database of research proposals accordingly.

A summary of complaints will be included on the Ethics, Integrity and Biosafety regular report to the Research and Graduate Studies Committee.

All Complaints will be recorded in the Ethics, Integrity and Biosafety Complaints Register.

Complaints will remain confidential.

Review Body Conduct Complaints

Where a complaint cannot be readily resolved by communication between the complainant and the Ethics Committee or Review Body, a complaint 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.

Following receipt of a complaint the Senior Manager or their nominee will seek further information from the relevant Ethics Committee or Review Body Chair; Ethics, Integrity and Biosafety Research Staff; or other relevant La Trobe staff or students as necessary to establish the veracity of the complaint, and whether any La Trobe University policies or procedures have been compromised.

The Senior Manager, or nominee will provide a report to the relevant Ethics Committee or Review Body and the complainant on the outcome of the investigation of the complaint and include a recommendation for any further actions.

The ultimate decision regarding the ethical acceptability of an activity lies with the relevant ethics committee and must not be overridden.

A summary of complaints will be included in the regular Ethics, Integrity and Biosafety report to the Research and Graduate Studies Committee.

All Complaints will be recorded in the Ethics, Integrity and Biosafety Complaints Register.

Complaints will remain confidential.

For queries about this process, contact the Senior Manager Ethics, Integrity and Biosafety

T: +61 3 9479 1383

E: eib@latrobe.edu.au

For support and training with the PRIME Ethics Researcher Portal see below:

1. Contact our Research Ethics and Biosafety Advisors with your specific questions OR
2. Book a personalised training session to get an overview of navigating PRIME

• biosafety@latrobe.edu.au
• + 61 3 9479 3338

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
• 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 - 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 track changed 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  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 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: 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 and Biosafety 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 (Updated August 2024) providing detail on the preceding year’s progress of the research on the anniversary of their approval date throughout the life of their project approval and a Final Report Form (Updated August 2024) within 3 months of project completion. Up to date personnel training records and GM strain lists must be submitted with the annual progress report and final report if they differ from the last approved version saved in PRIME.

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 or Final Report Form
• 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
• 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.

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 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, 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_2025_Refresh - Biosafety & Biosecurity Awareness Training REFRESHER 2025

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_2024-2025
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 prior to commencement.

The Ethics , Integrity and Biosafety (EIB) Team must be notified of all works planned within PC1 & PC2 facilities via 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 prior to 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 external boundaries of the facility
• No notification or advance warning to OGTR

Minor Works Notification

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

Facility suspension or variation to remove 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) and  must be notified of your works prior to commencement.

The Ethics , Integrity and Biosafety (EIB) Team must be notified of all works planned within Approved Arrangement facilities via submission of 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 prior to 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 works have been completed.

• Confirmation of Completion of Works Form