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 (DOC 104KB) (last updated 18.09.2020)
  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 completing a Notifiable Low Risk Dealings application, please see the IBC Exemplar application (Exempt Dealing and NLRD Suitable for PC1 and PC2) (PDF 481KB)

To help with training and feedback please see below:

  1. Training opportunities:
  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

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

Midday Monday 29 March 2021

Midday Monday 05 April 2021

Thursday 15 April 2021

Midday Monday 03 May 2021

Midday Monday 10 May 2021

Thursday 20 May 2021

Midday Monday 31 May 2021

Midday Monday 07 June 2021

Thursday 17 June 2021

Midday Monday 28 June 2021

Midday Monday 05 July 2021

Thursday 15 July 2021

Midday Monday 02 August 2021

Midday Monday 09 August 2021

Thursday 19 August 2021

Midday Monday 30 August 2021

Midday Monday 06 September 2021

Thursday 16 September 2021

Midday Monday 04 October 2021

Midday Monday 11 October 2021

Thursday 21 October 2021

Midday Monday 01 November 2021

Midday Monday 08 November 2021

Thursday 18 November 2021

Midday Monday 29 November 2021

Midday Monday 06 December 2021

Thursday 16 December 2021

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 will launch on 4 September 2020

PRIME Ethics Researcher Portal will launch on 04 September 2020. What this means for you is a change in the way you will submit and manage your ethics requests. To help with training and feedback please see below:

  1. Training opportunities:
    • Schedule a personalised session for help with your first submission through the Portal;
    • Attend PRIME daily drop in session: Occurs daily 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 screen the “down” arrow and click “Create Annual Report” or “Create Final Report”
    • Upload completed annual/final report
    • At the top of the screen click on “Submit to Research Office”

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