La Trobe University > Researchers > Research Office > Ethics, Biosafety and Integrity > Biosafety, biosecurity and gene technology research

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


Application deadline		Meeting date
Monday 10 August 2020Thursday 20 August 2020
Monday 07 September 2020Thursday 17 September 2020
Monday 05 October 2020Thursday 15 October 2020
Monday 09 November 2020Thursday 19 November 2020
Wednesday 02 December 2020Monday 14 December 202

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/97343849155
    • 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.
  • Progress reports are not required for NLRDs and Exempt Dealings, you are required to submit a final report within 3 months of expiry. Download final report.

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

FAQs and Guidance

Training and Guidelines

Take the following steps to access the Biosafety training module for staff and students on the LMS:

  1. Log in to LMS;
  2. Sign on using your La Trobe staff or student ID;
  3. In the open search box, start typing “Biosafety”;
  4. At the subject site you will be able to self-enrol by selecting the “Enrol me” button; if you are not presented with the “Enrol me” button, click on the “Biosafety_and_Biosecurity_Awareness_Training";
  5. You will now be redirected to the Homepage to complete the module;
  6. To view instructions as a pdf (including screenshots) click on Accessing Biosafety Training on LMS for La Trobe staff and students (PDF 929KB)

Guidelines:

  1. Safe use of Portable Device in Laboratories - IBC Approved (PDF 923KB)
  2. Waste Management Guideline - IBC Approved (PDF 1.08MB)
  3. Transport of Biological Material -IBC Approved (PDF 3MB)

Templates

Coming soon