Project Title/ Infectious Agent

IBC use only / Application ID: BC______
Date of IBC Assessment:
Expiry Date for this Dealing:

1 General Information

Organisation responsible for dealing
Institutional Biosafety Committee / SAHMRI Biosafety Committee
Is this dealing reviewed/authorised by another IBC? / Yes No If yes, complete following details
Other IBC name
Dealing ID allocated by other IBC
Does this application replace another approved dealing? / Yes No If yes, complete following details
Dealing ID
Category of dealing / Exempt
PC1 NLRD PC2 NLRD
DNIR
If you’ve marked any fields above, you need to also apply for Exempt and NLRD project approval
Infectious
Has this dealing been submitted to an Animal Ethics Committee for Approval? / Yes No If yes, complete following details
AEC identifier
Does this dealing involve the use of carcinogenic/teratogenic or highly toxic chemicals including cytotoxic drugs? / Yes No If yes, complete details below
Provide short description of the dealing:
Does this dealing involve the use of unsealed radioisotopes? / Yes No If yes, complete following details
Has the waste disposal procedure been discussed with the site Radiation Safety Officer or delegate? / Yes – provide comment
No- Please contact SAHMRI Quality Manager for further details

2 Project Supervisor Details

Project supervisor
Address
Telephone
Email address
Has the project supervisor previously submitted a GMO dealing application to this IBC? / Yes No If no, please provide as an attachment a brief one page resume outlining relevant experience and qualifications in relation to GMO work.

3 Project Title/ Infectious Agent

4 About the dealing

Please ensure the information provided, including the description, accurately includes all aspects of the dealing. Investigators should ensure that all storage and proposed transport, including importation or exportation of the dealing is included as these aspects of a dealing also require approval. Include the aims of the proposed dealing, method of use. If more than one type of dealing is included on this application, please ensure that the work associated with each dealing type is clearly identified and outlined.
NOTE: Please use lay language to clearly describe your project.
Proposed commencement date / Expected completion date
Description of work
Benefits of the work (a brief statement in lay terms – no more than 200 words/15 lines of text)

5 Risk Assessment and Management

Describe the risks the proposed dealings pose to the health and safety of people and the environment (no more than 200 words/15 lines of text)
Control Measures to Minimise the Risk
Biological Containment
Does the organisation’s standard biosafety guidelines (eg Biosafety Manual) cover the requirements for this dealing? / Yes No
if no what additional procedures have been implemented
Training
Are all personnel named in this application appropriately trained to conduct the dealing including correct use of BSCs?
Are the training records kept by the Project Supervisor? / Yes No
Yes No
PPE (Personal Protective Equipment)
In addition to gowns, gloves and safety glasses, is any specific PPE required? / Yes No
If yes specify
Vaccination
Is vaccination against the infectious agents required? / Yes No
If yes specify
Storage
Provide details of storage location/s of the infectious agents and measures in place to restrict access
Biohazardous Waste Disposal
How will biohazardous waste be:
i) Decontaminated?
ii) Disposed of?
Provide details of any additional procedures to be implemented to maximise biosafety:
Please indicate the relevant Risk Group(s) (as per ASNZS 2243:3:2010 Safety in Laboratories) for all micro-organisms involved in this dealing. Select all that apply.
You can obtain the access to the Standard through the IBC /
Risk Group 1 micro-organisms involved in this dealing
Risk Group 2 micro-organisms involved in this dealing
Risk Group 3 micro-organisms involved in this dealing
Risk Group 4 micro-organisms involved in this dealing
Agent Listed as an SSBA under Part 3 of the National Health Security Act 2007 (http://www.health.gov.au/ssba#list)
If yes, contact the IBC Executive Officer before proceeding further
Will the dealing involve the import of the infectious agent (or other biological material) under DAFF “Permit to Import” and Permit to Use Quarantine Material” / Yes No
If yes please provide DAFF Permit Number or DAFF application reference number

6

Persons undertaking the dealing

The IBC must assess whether the persons or categories of persons have appropriate training and experience to undertake the dealing. This includes persons beyond the persons conducting the research, such as persons involved in importation, transportation and disposal of the dealing.
Indicate the categories of persons that will be involved with the dealing. For each relevant category list the name and staff/student for persons known at the time of writing this application.
Details of additional persons can be added later as they become known/involved with the dealing.
Research staff
Name / Students
Name
Other persons
Name / Personnel of the facilities listed on this application
Do all personnel involved in the dealing have appropriate training and experience?
NOTE: Appropriate training includes training for working with the particular dealing and procedures covering facilities where the dealing will be undertaken(e.g. PC2/ QC2 Facilities) / Yes No If no, complete following details
What measures are in place to ensure all personnel are adequately trained before commencing the dealing?

Facilities To Be Used

All facilities to be used, including places of storage, must be authorised. Storage of dealings outside of a certified facility is permitted, but must be authorised by the IBC. Unauthorised storage of dealings is an offence under the Act.
Facility 1 / Facility 2 / Facility 3
OGTR Certified? / Yes No / Yes No / Yes No
OGTR Certification No.
Room Number(s)
Building
Type of facility & PC level
Facility Contact
Experiments / aspects of dealing to be performed in this facility
Facility 4 / Facility 5 / Facility 6
OGTR Certified? / Yes No / Yes No / Yes No
OGTR Certification No.
Room Number(s)
Building
Type of facility & PC level
Facility Contact
Experiments / aspects of dealing to be performed in this facility

Comments for the IBC

Project Supervisor Declaration

Please initial each of the following statements to indicate that you understand your responsibilities and then sign the application form.
I am aware of my responsibilities in relation to ensuring that any personnel conducting this work are appropriately trained and are aware of and also follow the relevant guidelines and regulations.
I have considered the potential risks that the conduct of this dealing could pose to people and/or the environment and will implement appropriate actions and precautions to minimise these risks.
Where dealing is received from sources outside the institution responsible for the project, I will take steps to confirm its identity.
I will inform the IBC as soon as practicable of any incidents, accidents or unintentional releases involving dealing.
I am aware that breaches of the legislation are serious matters and that penalties could include loss of Accreditation and/or Certification status for the organisation, imprisonment and/or substantial fines.
Project Supervisor Name / Project Supervisor Signature / Date

Facility Manager Declaration

As Facility Manager I have been informed of the nature of and risks involved with this dealing and after consideration of them, I hereby consent to the work being performed in the listed facility.
I will ensure that the appropriate safety procedures are followed and that personnel are appropriately trained prior to undertaking work in the listed facility.
I will inform the IBC as soon as practicable of any incidents, accidents or unintentional dealing releases.
Facility 1 Facility Manager Name / Facility 1 Facility Manager Signature / Date
Facility 2 Facility Manager Name / Facility 2 Facility Manager Signature / Date
Facility 3 Facility Manager Name / Facility 3 Facility Manager Signature / Date
Facility 4 Facility Manager Name / Facility 4 Facility Manager Signature / Date
Facility 5 Facility Manager Name / Facility 5 Facility Manager Signature / Date
Facility 6 Facility Manager Name / Facility 6 Facility Manager Signature / Date

Senior Manager Declaration

As the Senior Manager responsible for the research activities of the project supervisor, I have been informed of the nature of and risks involved with this GMO dealing and after consideration of them, I hereby consent to the work.
Senior Manager Name / Senior Manager Signature / Date

Infectious Dealing Application SAHMRI 0055/1