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Dealings Not Involving Intentional Release (DNIR)

Is my proposal DNIR?
All dealings that pose high risk are and do not involve release of the GMOs into the environment. There are 14 classes of DNIRs as outlined in Part 2 Dealings that are not notifiable low risk dealings (doc 31kb) (Amend Regs 2006).

Dealings involving certain viral vectors (in vitro or in vivo) to introduce foreign genes into cells/animals. Refer to Viral vector guide (pdf 109kb) for more information.  The requirements are as follows:
  1. Work is not allowed to commence until a Licence is issued by the OGTR.
  2. Researchers are responsible for complying with all conditions listed on their licence.
  3. All DNIRs must be contained within a Certified Facility (minimum PC2).
  4. Transport of GMOs between various facilities at the University (in the same/different department(s)) or to other external destinations must comply with the Transport guidelines (pdf 72kb) and any specific conditions listed on the licence.

Download Form
Dealings Not Involving Intentional Release (DNIR) Form (doc 154kb)

Download Cover Sheet
DNIR Cover sheet 

Download Guidelines
Instructions for Preparation of OGTR DNIR Form  

Submission requirements

  1. Fill the Dealings Not Involving Intentional Release (DNIR) Form (doc 154kb) and DNIR Cover sheet.
  2. The following Guidelines have been prepared to help you fill out the DNIR application form. (These are still the same as the OGTR has not released new forms yet, so link to the existing website)
  3. Send an electronic copy to the IBC Secretary. 
  4. Send the signed original and 2 hard copies to:
    Secretary, Monash IBC
    Research Office
    Bldg 3D, Room 103
    Monash     University
    Clayton 3800

After submission
Following initial review, the IBC forwards the original application to the OGTR for a risk assessment and risk management (RARMP) process which may take up to 90 working days (weekends and public holidays are not included). 

  • The OGTR then issues a licence containing various conditions.
  • Licence holders must comply with all conditions on their licence.
  • Licence holders must ensure that all staff covered by a licence have read and signed a statement that they are aware of and will comply with all the conditions of the licence.
  • A template declaration form (doc 61kb) is provided for your convenience.

Timeframes

Once application is submitted to the IBC:

  1. All applications are databased and receipted, via email, by the Friday of each week;
  2. On Friday afternoon, applications are posted onto the secure IBC website for members toreview out of session.  The original copy is held at Research Compliance Office for our records;
  3. Members are given 2 weeks to send their comments back to the Secretariat. Once 50% of the comments are received, an email will be sent to all named researchers within 1 week, stating the issues raised by the Committee, or notification of full approval.
  4. You are given 4 weeks to address the issues raised by the IBC before a reminder email is sent to all named researchers on the research project.  Please reply via email or hardcopy, although, email is faster and more convenient. 
  5. Once you have submitted your reply to the Secretary, the amendments are reviewed by the relevant readers for further amendments again, or full approval. 
  6. Once your research is approved, you will be notified via email and hardcopy because the letter of approval must be on Monash University IBC letterhead, and signed by the Chair of the IBC. 
  7. This full approval letter is sent via the post to all the researcher addresses listed on the application form.
  8. Approval can take 3- 4 weeks, so the Committee recommend that you prepare early and give yourself ample time to answer the Committee's concerns.
  9. DNIRs may not begin until you have received the Licence from the OGTR.

Annual Reports

Download Annual Report Form
Annual Report (rtf 1724kb)