Biosafety, biosecurity and gene technology research
Getting your project approved
How to apply
- Download and complete the Application Form for Exempt and Notifiable Low Risk Dealings (DOC 104KB) (last updated 18.09.2020)
- 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:
- 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
- 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
| 2017 | 2018 | 2019 |
|---|---|---|
| 57 days | 22 days | 20 days |
| 17 projects | 9 projects | 13 projects |
Committee meeting dates
IBC New & deferred applications - pre-review, closing and meeting dates
| Pre-review cut-off (voluntary) | Application deadline | Meeting date |
|---|---|---|
| Monday 09 November 2020 | Thursday 19 November 2020 | |
| Wednesday 02 December 2020 | Monday 14 December 2020 | |
Midday Monday 01 February 2021 | Midday Monday 08 February 2021 | Thursday 18 February 2021 |
Midday Monday 01 March 2021 | Midday Monday 08 March 2021 | Thursday 18 March 2021 |
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 Date | Meeting Date |
|---|---|
| Thursday - every week | Thursday 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
- Read the Licence Application & Assessment Process information provided by the OGTR.
- Ensure the dealing meets the classification criteria listed in Schedule 3 Part 3 of the Regulations.
- Ensure dealings involving viral vectors meet the correct classification criteria.
- Download an OGTR Application Form - Dealings Not involving Intentional Release (DNIR)and save a copy to your computer.
- 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.
- 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
- Read the Licence Application & Assessment Process information provided by the OGTR.
- Download an OGTR Application Form - Dealings involving Intentional Release (DIR) and save a copy to your computer.
- 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.
- 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:
- 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
- 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 (DOC 60KB).
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:
- Log in to LMS;
- Sign on using your La Trobe staff or student ID;
- In the open search box, start typing “Biosafety”;
- 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";
- You will now be redirected to the Homepage to complete the module;
- To view instructions as a pdf (including screenshots) click on Accessing Biosafety Training on LMS for La Trobe staff and students (last updated December 2020) (PDF 936KB)
Guidelines:
Templates
Coming soon