Infectious Dealing Application
SAHMRI Biosafety Committee
This application form should be completed for all Infectious dealings of risk group 2 or higher classification (ref. to AS/NZS
2243.3-2010) to be undertaken by SAHMRI or by other personnel within SAHMRI. Completed applications should be
submitted electronically to SAHMRI Biosafety Committee Executive Officer: dorota.gancarz@sahmri.com
Please note: Applications should be signed by obtaining physical signatures on a paper copy and then scanning the
document and submitting as a pdf or submitting as a pdf followed with email from every co-applicant agreeing to their
inclusion on the application with “authority to sign” statement referring to applicable declarations in this application.
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
Is this dealing reviewed/authorised by
another IBC?
SAHMRI Biosafety Committee
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
DNIR
PC2 NLRD
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
Yes
No
If yes, complete details below
Provide short description of the
dealing:
Does this dealing involve the use of
If yes, complete following details
unsealed radioisotopes?
Yes – provide comment
Has the waste disposal procedure
been discussed with the site
Radiation Safety Officer or delegate?
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
Infectious Dealing Application
SAHMRI 0055/1
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?
Training
Yes
No
if no what additional procedures have been
implemented
Yes
No
Yes
No
Yes
No
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?
PPE (Personal Protective Equipment)
In addition to gowns, gloves and safety glasses, is any
specific PPE required?
Vaccination
Is vaccination against the infectious agents required?
If yes specify
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 microorganisms 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
Yes
No
If yes please provide DAFF Permit Number or DAFF
Infectious Dealing Application
SAHMRI 0055/1
Import” and Permit to Use Quarantine Material”
6
application reference number
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
Students
Name
Name
Other persons
Personnel of the facilities listed on this application
Name
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)
7
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
OGTR Certified?
Yes
Facility 2
No
Yes
Facility 3
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
Infectious Dealing Application
Facility 5
Facility 6
SAHMRI 0055/1
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
8
Comments for the IBC
9
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
10
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.
Infectious Dealing Application
SAHMRI 0055/1
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
11
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
Infectious Dealing Application
Senior Manager Signature
Date
SAHMRI 0055/1