Biosafety, biosecurity and gene technology research

Getting your project approved

How to apply

  1. Download and complete the Application Form for Exempt and Notifiable Low Risk Dealings (last updated 08.11.2022) and the Personnel Training Record for Dealings with GMOs (last updated 19.09.2022).
  2. Log in to  PRIME Researcher portal to create a new IBC Application:
    • Under Ethics Applications, click “+ New IBC Application”
    • Add all researcher personnel
    • Upload all completed forms and study documentation (as separate documents)
    • Click on “Submit to Research Office” by the relevant closing date (see below)

To help with training and feedback please see below:

  1. 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/84849823999
  2. 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

This table show average time to approval (business days) for the IBC.
201720182019
57 days22 days20 days
17 projects9 projects13 projects

Committee meeting dates

2022IBC New & deferred applications - pre-review, closing and meeting dates
Pre-review cut-off (voluntary)Application deadlineMeeting date

Midday Monday 28 November 2022

Midday Monday 5 December 2022

Thursday 15 December 2022

 

2023

 
Midday Monday 23 January 2023Midday Monday 30 January 2023Thursday 16 February 2023
Midday Monday 20 February 2023Midday Monday 27 February 2023Thursday 16 March 2023

Midday Monday 27 March 2023

Midday Monday 3 April 2023

Thursday 20 April 2023

Midday Monday 24 April 2023

Midday Monday 1 May 2023

Thursday 18 May 2023

Midday Monday 22 May 2023

Midday Monday 29 May 2023

Thursday 15 June 2023

Midday Monday 26 June 2023

Midday Monday 3 July 2023

Thursday 20 July 2023

Midday Monday 24 July 2023

Midday Monday 31 July 2022

Thursday 17 August 2023

Midday Monday 28 August 2023

Midday Monday 4 September 2023

Thursday 21 September 2023

Midday Monday 25 September 2023

Midday Monday 2 October 2023

Thursday 19 October 2023

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

IBC Subject to - closing and meeting dates
Closing DateMeeting Date
Thursday - every weekThursday 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

· Flowchart for the classification of contained dealings with viral vectors

Application process

  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 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

  1. Read the Licence Application & Assessment Process information provided by the OGTR.
  2. Download an OGTR Application Form - Dealings involving Intentional Release (DIR) and save a copy to your computer.
  3. 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.
  4. 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

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:

  1. 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
  2. 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

  • Variations to Notifiable Low Risk Dealings are no longer required. Review your current Records of Assessment (LTIBC approval) to ensure that you have broad scope to undertake your teaching and research. Notify the Research Office via email of any changes in personnel associated with an approval and the LTIBC officer will email you with confirmation. If you are unsure whether a change is covered under your Records of Assessment please email the LTIBC officer. Your change will be assessed and  confirmation will be provided. If the change falls outside of your approval a new application will be required.
  • 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 IBC project click on “My Ethics Approvals” tile and select the IBC Approval Number you wish to submit an annual or final report for,
    • At the top of the IBC record click the “down” arrow and click “Create Annual Report” or “Create Final Report”
    • Upload completed annual/final report
    • 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.

Please contact the Biosafety Team for any questions regarding risk group levels, containment, import and export, legislative requirements.

FAQs and Guidance

Training and Guidelines

Templates

Coming soon