Instructions for Preparation of OGTR DNIR form

Below is a section-by-section guide to completing this form, based on the experience of the Monash IBC in reviewing previous applications from researchers working with a variety of vectors and GMOs.  You can cut and paste sections of this text directly into the form.

Preliminary information

1a
Notifying organisation Specify your organisation of primary affiliation

1b 
Project supervisor  Please complete

1c
Project title   Please complete

1d
IBC project identification - DO NOT COMPLETE - the office will complete this section

2
Please complete

3
Please complete

Part 1

Organisation Name
Monash University

Accreditation Number
Accr 058/2002

Name
Dr Souheir Houssami

Position
Research Compliance Officer, Monash University IBC

Business telephone number
(03) 9905 5162

Mobile telephone number
N/A

Facsimile number
(03) 9905 3831

Email address
gene.technology@adm.monash.edu.au

Street Address

Gene Technology Office
Building 3d Room 104
Monash University
CLAYTON VIC 3800

Postal address

Gene Technology
Research Office
Building 3d
MONASH UNIVERSITY VIC 3800

Part 2

Fill in the project supervisor's details. 

"Relevant experience" relates to work with Genetically Modified Organisms (GMOs) and training relevant to this.

Part 3

3A 
Please complete.

3B  
You can state 'ASAP'.  However, please take into consideration that:

• DNIR applications take up to 90 days to process
• Work cannot commence until the regulator has issued a licence authorising the dealings

3C  
Please take into consideration taht Licences are generally issued for a maximum 5 years duration.

3D  
In addition to naming key personnel, it is useful to name "classes of persons" to allow flexibility for your future research situations.  It has been acceptable to the OGTR to see listed a variation on the following general listing: Research Assistants, Postgraduate students and Postdoctoral researchers and Animal Technicians who are suitably trained, supervised and / or experienced.

3E  
State the general aim(s) of the research and provide a detailed description of the procedures involved and the expected outcomes. List the proposed "dealings" to be undertaken.

3F
Provide a brief description of your project, project title, name of the organisation and status of the application will be placed on the OGTR web
site. This is a public record of the DNIR applications received by the OGTR.

3G
Provide up to 1 page of scientific background of your project. You can also submit copies of key papers as this may assist the assessment process.

3H
Provide up to 1 page outline of experiments.  Include experimental design and techniques to be used (but not detailed protocols). Also include, if appropriate, the acquisition and the proposed fate of all GMO(s) at the completion of the dealings. You may use dot points in your answer.

Part 4

4A 
Please complete.

4B 
Please complete. Provide copies of references (or vector maps) for novel vectors or methods of transfer. Also include the name of the company supplying any commercially obtained vectors.

4C 
Please refer to the following site for the list of host/vector systems for Exempt Dealings in Part 2 Schedule 2 of the GT Regulations.

4D 
Please complete the table

4E 
Please complete.

4F 
Please complete. Refer to Table 2 at the end of Part 4 for examples.Please complete.

4G 
Please complete.

4H 
Please complete.

4I   
Information that you provide here will help to reduce the level of uncertainty in the risk assessment.

Part 5

Part 6 - Additional information for a GMO that is a whole plant or is to be used in conjunction with a whole plant

Please complete if applicable.

Part 7 - Additional information for a GMO that is an animal or is to be used in connection with an animal

Please complete if applicable.

Part 8 - Additional information for a GMO that is for use in clinical trials with human beings

Please complete if applicable.

Part 9 - Risk assessment and management

9A
Relates to the occupational health and safety of staff performing the work.

Examples: Potential risks from exposure to GMO
"The project involves the use of replication deficient viruses. These have been specifically designed to eliminate the likelihood of generating replication competent, wild type virus. The use of species-specific envelope genes means that most viruses used for mice/rats will not infect human cells. All work will be carried out in a restricted PC2 facility".

"The XXX virus construct to be used in this dealing does not express the necessary envelope proteins and lacks xx gene. Therefore, no wild type virus will be produced.  All work will be performed in a PC3 laboratory in accordance with the OGTR Guidelines for Certification of PC3 Facilities. All staff will be trained and periodically monitored in the appropriate PC3 level work practices".

"The proposed dealing will be conducted in a PC2 or PC3  facility by trained staff. All staff are immunised against XXX. Mammalian cells, E.coli and XXX virus can be readily killed by standard laboratory disinfectants".

9B
Relates to the general population exposed to a GMO that is unintentionally released from containment.
"An unintentional release for the XXX GMO into the environment could occur following a spill of contaminated material or leakage out of the PC2/PC3 laboratory or transfer of contaminated material out of the PC3 laboratory. XXX Virus is not transmitted by aerosols, and an unintentional release into the environment does represent an efficient transmission pathway. "

"It is unlikely that infected, cultured cells would survive for an extended period outside the CO2 incubator, therefore, there is very low risk of unintentional releseas of the genetically modified cells. Unintentional release of the replication-deficient XXX virus may result in transient expression in organisms, however, will not lead to disease given that the virus is unable to replicate."

9C
Relates to the environment exposed to a GMO that is unintentionally released from containment. Examples.

"Retroviruses cannot survive outside the host, therefore, they are not hazardous. E. coli XX strain is a highly attenuated bacterial strain that cannot survive in the environment. In the event of any spills, cells can easily be killed with appropriate disinfectants"

"Genetic modification of the bacteria will pose little risk if the organisms are released unintentionally.  The bacteria will probably lose the plasmids in the absence of antibiotic selection.  The inserted sequences do not encode toxins and the virus cDNA will not be expressed in bacteria.  Mention should be made of the AS/NZS 2243.3 (2002) Risk Group that the microorganism is classified under & the precautions listed for this group.

"Release of the recombinant XXX virus is unlikely, as the virus will always be handled within a class 2 Biosafety Cabinet.  However, should this occur, it is unlikely that the XXX virus would be transmitted readily. Administration of this virus as a vaccine involves introduction under the skin.  The virus is not readily transmitted by aerosol, but may be if the dose is sufficiently high. Mention should also be made of the AS/NZS 2243.3 (2002) Risk Group that the microorganism is classified under & the precautions listed for this group.

9D
Please provide the following (use table format for multiple applications):

• reference number provided by the OGTR
• title of project;
• date of application; and
• project supervisor

9E
List all Facilities to be used
If using just 1 facility then complete the initial part of the question.
Of using more than 1 facility then please complete the table
Copy and paste the table if more than 2 facilities.

9F
Transport also includes: between the facilities listed in your answer to Part 9.E; from a laboratory to an autoclave or animal house; across corridors which are not part of a certified facility etc. Refer to the following examples:

"When required, animals will be transported in closed boxes (standard animal house transport boxes) inside a second closed box that is clearly labeled with the name of the investigator and the contents of the box.  Transport of tissue samples will likewise involve enclosure within two sealed and clearly labeled containers. All transfers, in private or University vehicles, will be undertaken by researchers or animal house staff who have been trained in correct handling of GMOs.  All transport will be carried out in accordance with the OGTR Guidelines for Transport of GMOs, Part B of the Handbook on the Regulation of Gene Technology in Australia, Appendix 5.

"Any GMOs to be transported will be done so according to Part B of the Handbook on the Regulation of Gene Technology in Australia, Appendix 5 (Guidelines for the transport of GMOs) and IATA Regulations.  Thus all GMOs will be transported in sealed primary containers packed within secondary sealed and unbreakable containers marked with a label to indicate that they contain GMOs.  The address and telephone number of the contact person in the event of an emergency or package misplacement will be prominently displayed on the outside of the package".

9G 
Please complete. Refer to the following examples:
"Carcasses of all animals inoculated with GMOs, and any liquid or solid waste from this work will be collected and transported from the certified facility according to the Guidelines for Transport of GMOs to an EPA-certified "high temperature" incinerator for disposal. Equipment will be wiped down or treated with a solution of 1% Virkon or 0.6% Diversol".

"GMOs will be disposed of by autoclaving.  The material will be double wrapped in autoclaveable bags, placed in a rigid plastic container with a lid, and transported to the autoclave according to the OGTR Transport Guidelines.  The material will be placed directly into the autoclave by an appropriately trained staff member.  After autoclaving, the material will be deposited into a designated bin for biohazardous waste for collection and incineration by a commercial operator (named here)".

9H
Please complete. Refer to the following examples:
"Equipment will be wiped down or treated with a solution of x% sodium hypochlorite/Virkon/Decon".

"Flasks will be decontaminated for 30 min in 1% hypochlorite solution prior to disposal. Contamination through spills will be decontaminated with 1% sodium hypochlorite and collected by absorption into paper towel. These will be disposed of according to the OGTR guidelines".

9I
Please complete. Refer to the following examples:
"In the event of the unintentional release, every effort would be made to trap the animal.  The animals are maintained within the PC2-certified animal house facility at Monash University, where the presence of barriers (drain traps and door barriers) would retain any animal that escaped from its handlers within the room.  The Monash IBC would be notified immediately if this occurred and the animal was not recovered. The IBC would then notify the OGTR

"In the event of unintentional release, the release or spill will be physically contained and the area decontaminated with suitable disinfectants such as 80% ethanol or 1% sodium hypochlorite.  All materials used to contain the spill will be disposed of as described above.  The secretary of the Monash IBC will be notified, as will the project supervisor and all other laboratory staff in the immediate vicinity.  A review of the circumstances leading to any spill will guide the choice of appropriate steps to minimise a repeat event. The IBC will notify the OGTR".

9J
Please complete. Refer to the following examples:
"All laboratory and animal house staff and students are trained in the correct procedures for working with genetically modified organisms as they join the lab.  This involves wearing gloves and gowns and knowing the correct handling and disposal procedures.  They receive regular updates and reminders of correct PC2 procedures in lab meetings and Departmental/ Institute staff meetings.  All work involving transport of these mice or their tissues is done with clear signage to indicate that they must be handled appropriately".

"All work is performed within a PC2 laboratory and all staff will have been trained to handle infectious agents.  Laboratory gowns, gloves and safety glasses are worn at all times.  Work involving infection of mammalian cells with the recombinant XXXX virus will be carried out in a class 2 Biosafety Cabinet (or other containment devices approved in writing by the OGTR).  Cell cultures will be performed in sealed culture vessels.  Sharp instruments or blades are banned".

9K
Please complete. Example: "All staff covered by the licence issued will receive individual copies of the License issued by the Regulator. All staff must indicate in writing that they understand the license requirements before commencing the work".

Part 10: References

Part 11: IBC evaluation of this application

Part 12: Suitability of the proposed licence holder

Part 13: Signatures

• You must obtain the signature of the Notifying Organisations Representative.
• OGTR will not accept applications without this signature.
• Most departmental heads are eligible to sign as CEO or delegate of Applicant Organisation.
• If you are the Project supervisor and the Notifying Organisations Representative, please obtain the signature of another Notifying Organisations Representative.

Authorised Signatories for Part 13 (CEO or Institutional Delegate)

Professor Richard Larkins   Vice Chancellor & President
Professor Edwina Cornish   Deputy Vice Chancellor Research

Correct as at 21 May 2006

CLAYTON CAMPUS

MONASH MEDICAL CENTRE CAMPUS

MMS ALFRED CAMPUS (AMREP)

BOX HILL HOSPITAL CAMPUS

VICTORIAN COLLEGE OF PHARMACY, PARKVILLE CAMPUS

SCHOOL OF APPLIED SCIENCES AND ENGINEERING, GIPPSLAND CAMPUS

EXTERNAL