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:
    • 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)
*Please note this service is currently limited
Application deadlineMeeting date

Midday Monday 31 January 2022

Midday Monday 07 February 2022

Thursday 17 February 2022

Midday Monday 28 February 2022

Midday Monday 07 March 2022

Thursday 17 March 2022

Midday Monday 28 March 2022

Midday Monday 04 April 2022

Thursday 14 April 2022

Midday Monday 02 May 2022

Midday Monday 09 May 2022

Thursday 19 May 2022

Midday Monday 30 May 2022

Midday Monday 06 June 2022

Thursday 16 June 2022

Midday Monday 04 July 2022

Midday Monday 11 July 2022

Thursday 21 July 2022

Midday Monday 01 August 2022

Midday Monday 08 August 2022

Thursday 18 August 2022

Midday Monday 29 August 2022

Midday Monday 05 September 2022

Thursday 15 September 2022

Midday Monday 03 October 2022

Midday Monday 10 October 2022

Thursday 20 October 2022

Midday Monday 31 October 2022

Midday Monday 07 November 2022

Thursday 17 November 2022

Midday Monday 28 November 2022

Midday Monday 05 December 2022

Thursday 15 December 2022

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 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