Biosafety and Radiation Safety Application University of Western Sydney

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University of Western Sydney
BIOSAFETY AND RADIATION SAFETY COMMITTEE
Biosafety and Radiation Safety Application

Use this application to seek permission to carry out teaching or research activities involving the use
of: human blood, tissues or other biological materials; recombinant DNA; ionising radiation sources; or
other activities with significant biosafety-related issues.

In completing your application several sources of information may be helpful: General
Laboratory Safety Guidance, Radiation Safety Guidelines and the Biological and Gene
Technology Work Safety Policy.

Only completed applications submitted using the current version will be considered by the
Committee.

Appendices should show the project title and the question number they relate to.

An application will only be approved for a maximum of 3 years. If the project needs to extend beyond 3
years, a new application is required.

A Chief Investigator may nominate a project duration of less than 3 years.

Lodge this proposal at least 1-2 months prior to the proposed start of the project.

Lodge an electronic copy of the application to biosafetyradiation@uws.edu.au
Does your project involve:
Please tick
The use of animals in Australia
or overseas
☐Yes ☐ No
Human participants
☐Yes
Approval number
(or pending)
Date of approval
(or pending)
☐ No
Indicate which sections of this proposal have been completed:
☐ Section A – Administration
☐ Section B – Overview of Project
☐ Section C – For Biological and Recombination Work Only
☐ Section D – Notification of Intention to Import Biological Materials Directly
from an Overseas Supplier
☐ Section E – For Radiation Work Only
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Expiry date
(or pending)
SECTION A - ADMINISTRATION
1.
Short project title or name of the teaching unit being offered.
2.
Chief Investigator
Name of Chief Investigator:
School/Institute:
Contact phone/fax, email address:
After hours phone/fax:
Relevant qualifications, experience and training:
Address for correspondence:
Signature:
3.
Date:
Others directly involved in the project.
3a. Name:
Role:
☐ Student Investigator
☐ Investigator
☐ Professional Staff
School/Institute/Organisation:
Degree being undertaken:
Contact phone/fax, email address:
After hours phone/fax:
Relevant qualifications, experience and training:
Signature:
Date:
3b. Name:
Role:
☐Student Investigator
☐ Investigator
School/Institute/Organisation:
Degree being undertaken:
Contact phone/fax, email address:
After hours phone/fax:
Relevant qualifications, experience and training:
Signature:
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Date:
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☐ Professional Staff
Note: Copy and paste additional entries, as necessary
3c. Declaration to be signed by School Dean / Research Institute Director
In signing, I certify that the project is appropriate to the facilities available, and that I am
prepared to have the project carried out in my School/Institute.
Full name of signatory:
Signature:
Date:
4.
Project details
4a.
Type of project: Please tick the appropriate box.
☐
Research involving human blood or tissues or other biological material.
☐
Teaching involving human blood or tissues or other biological material.
☐
Recombinant DNA. If yes, tick the appropriate Class of Dealing below ☐ Exempt dealing
☐ Notifiable Low Risk Dealings (NLRD)
If yes, attach NLRD Record of Assessment Form
☐ Dealings Not involving Intentional Release (DNIR)
If yes, attach the DNIR Application Form
☐ Dealings involving an Intentional Release (DIR)
If yes, attach the DIR Application Form
☐
Other:
4b.
Is this a new project?
☐ Yes ☐ No
4b. Is this a project which has (previously or simultaneously) been submitted to this
or another IBC?
☐ Yes ☐ No
If Yes, provide reasons for re-submission or simultaneous submission and the name of
the IBC(s). ____________________________________________________________
4c. Has an application for this or a similar project been refused by this or another
IBC?
☐ Yes ☐ No
If Yes, provide details: ___________________________________________________
4d. Indicate the source and grant identifier number of project funds:
_____________________________________________________________________
Has a copy of the grant application been attached?
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☐ Yes
☐ No
4e. Research category codes
Enter the Type of Activity and Field of Research Codes below after referring to the Research
Category Codes.
Type of Activity (a)
%
FOR Code (b)
%
Pure Basic
Strategic
Applied
Experimental
4g. Is any of the specified information contained in this application confidential,
commercial information?
☐ Yes ☐ No
If Yes, provide details: ___________________________________________________
4h. Project duration (Maximum 3 years)
Start Date: Click here to
Finish Date: Click here to
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enter a date.
enter a date.
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SECTION B – OVERVIEW OF PROJECT
5.
Describe the project aims in lay (non-scientific language) terms.
6.
Rationale
Provide a justification for undertaking this project. This should be based on an
assessment of the scientific/educational value and the potential impact.
7.
Outcomes/benefits of the project in lay terms (non-scientific language).
Specify what you hope to achieve.
8.
Outline of the research plan: Include the project’s empirical and theoretical
background, experimental protocol, description of samples, time line, data
gathering/fieldwork and data analysis.
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SECTION C - FOR BIOLOGICAL AND RECOMBINANT WORK ONLY
9.
Location(s) of activities.
9a. For biological and recombinant work that will be conducted, list the campus
location, building number and laboratory room number.
_____________________________________________________________________
9b. For genetically modified organisms (as defined in the Gene Technology Act,
2000), where will they be stored?
List the campus location, building number and laboratory room number.
_____________________________________________________________________
9c.
Will this project be undertaken in a NSW health facility?
☐ Yes
☐ No
If Yes, have all personnel associated with the project complied with occupational
screening and vaccination against infectious diseases, as detailed in NSW Health
Policy directive?
☐ Yes ☐ No
___________________________________________________________________
9d.
Will this project be undertaken in an off-campus facility?
☐ Yes
☐ No
If Yes, list the facility and the name of the approving IBC or safety committee:
___________________________________________________________________
10.
Containment Level
10a. Does the work require special containment?
☐ Yes
☐ No
If Yes, what level? ___________________________________________________
10b. Are personnel involved in this project authorised to enter physical containment
PC2 laboratories?
☐ Yes ☐ No ☐ Not Applicable
10c. Have personnel involved in this project been inducted and trained in the PC2
work practices and signed a declaration stating their compliance with the practices
when working in such facilities?
☐ Yes ☐ No
10d. Describe the storage facilities and security that will be used in the containment
area: _______________________________________________________________
____________________________________________________________________
10e. Does the containment area have the appropriate signage for the activities
proposed?
☐ Yes ☐ No
If No, please elaborate: ________________________________________________
10f. Are aerosols likely to be produced?
☐ Yes ☐ No
If Yes, will a biological safety cabinet (Class II) be used?
☐ Yes ☐ No
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11.
Origin of Biological Material
11a. If material of human origin is to be used, has consideration been given to using
non-human sources?
☐ Yes ☐ No ☐ Not Applicable
Provide details of consideration: __________________________________________
11b. If a cell line is to be used, list the type of cell line. _________________________
____________________________________________________________________
11c. Does this project involve the use of a biological material to be imported directly
from an overseas supplier?
☐ Yes ☐ No
If Yes, has the Notification to Import Biological Materials directly from Overseas form
been attached?
☐ Yes ☐ No
☐ Yes
11d. Has the AQIS permit(s) been attached?
☐ No
If No, comment: ________________________________________________________
11e. Provide the AQIS approval number: ____________________________________
12.
Dealings with genetically modified organisms
12a. Has an OGTR form for NLRD, DNIR or DIR been attached to this application for
approval?
☐ Yes ☐ No ☐ Not Applicable
12b. List the host/vector system used:
Host
1. _______________________________
Vector
1. _____________________________
2. _______________________________
2. _____________________________
3. _______________________________
3. _____________________________
13.
Microorganisms or other biological material
Identify the types of microorganisms used or potentially present in samples to be used
and their risk group as defined by Australian Standards AS/NZS 2243.3, Safety In
laboratories—Microbiology and containment (2010)
13a. Bacteria
13b. Parasites
13c. Fungi
13d. Viruses
13e. Exotic animal viruses
13f. Other
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14.
Cytotoxic substances
14a. Will the project involve the use of cytotoxins or potential cytotoxins that are, or
may be, carcinogens, mutagens, teratogens?
☐ Yes ☐ No
14b. What is the nature or possible nature of the cytotoxin?
Carcinogen ☐
Mutagen ☐
Teratogen ☐
14c. List the cytotoxin to be used in this project.
Name of
cytotoxin
Form
ordered
Quantity
ordered
Storage
location
(room and
campus)
14d. Is the carcinogen you intend to use listed in the Work Health and Safety
Regulation 2011, Schedule 10?
☐ Yes ☐ No
If Yes, have you lodged a formal notification and received acknowledgement from the
Work Cover Authority of NSW?
☐ Yes ☐ No ☐ Pending
15.
Risk management information
15a. Risk Assessment: Are there any significant safety or health risks related to the
proposed work that may affect staff or students?
☐ Yes ☐ No
Provide details of your considerations:
__________________________________________________________________________
__________________________________________________________________________
15b. Risk control: Provide details of actions to be taken by the applicant to eliminate or
control the risks identified in the question above.
If any Genetically Modified Organism (GMO) material is to be stored and secured after the
completion of the project how will this be done?
Provide details: _____________________________________________________________
__________________________________________________________________________
15c. Has a 1:15 staff to student ratio been applied for teaching proposals involving potentially
infectious materials?
☐ Yes ☐ No ☐ Not Applicable
If not, please justify your reason. ________________________________________________
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SECTION D – NOTIFICATION OF INTENTION TO IMPORT BIOLOGICAL
MATERIALS DIRECTLY FROM AN OVERSEAS SUPPLIER
The importation of biological materials directly from an overseas supplier is controlled by the
Federal Department of Agriculture. An overview of the department’s requirements are
available at Importing to Australia - Biological Materials
16. Does this proposed work involve the importation of biological materials directly form an
overseas supplier?
☐ Yes ☐ No
16a. If Yes, has a copy of the authorization to import biological materials been attached to this
application?
☐ Yes ☐ No ☐ Pending
__________________________________________________________________________
17.
What is the nature of and intended use of this imported biological material?
__________________________________________________________________________
18. Please indicate the laboratory location and the level of containment required for use:
________________________________________________________________________
18a. Is access to a Registered ‘Quarantine Approved Premise’ (QAP) required?
Refer to QAP and the Importation of Biological Material
☐ Yes ☐ No
18b. If Yes, please provide QAP location details and a copy of the approval to operate a
QAP?
_________________________________________________________________________
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SECTION E – FOR RADIATION WORK ONLY
19. Radiation Licence Details
Radiation Licence No.
Expiry Date: Click
here to enter a date.
20. Details of unsealed isotopes to be used:
Radionuclide
Physical
form
Chemical
form
Max.
activity
MBq per
experiment
Purpose
21. Details of sealed sources or irradiating apparatus to be used:
Radionuclide and activity
Apparatus – make/model/serial No.
KV/mA
22. Give a brief description of how radioactive material will be stored and disposed:
22a. Give a brief description of emergency spill response / decontamination provisions
in place.
23. Location(s) of project
Define the areas/laboratories at UWS in which samples, sources or apparatus are to be
handled (include campus location, building number and laboratory number): ___________
________________________________________________________________________
Will this project be undertaken in an off campus facility?
☐ Yes ☐ No
If Yes, has the project been approved by that facility’s RSO?
☐ Yes ☐ No
Provide the name of the RSO and the outcome of the review.
__________________________________________________________________________
__________________________________________________________________________
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☐ Yes ☐ No
24. Is this facility a registered designated radiation area?
If Yes, specify EPA registration no. ________________________________________
24a. Do you have approval to use this facility (room, laboratory)?
(Attach written confirmation if not located at professional place of work)
☐ Yes ☐ No
25. Radiation safety details:
Identified hazards
Control Methods
External alpha/beta
External X/gamma/neutron
Laser
Internal
Environmental contamination
Other
Personal
Area
Contamination
25a. Emergency information
Emergency procedures: _______________________________________________________
___________________________________________________________________________
A list of the relevant standard operating procedures and emergency
procedures (include details of the issuing Department/School, Document
number and title) is attached
☐ Yes ☐ No
26. Additional risk management information for projects involving the use of
of radioactive materials:
Describe your formal experience handling radioactive materials, including location, radioisotope(s) and amounts handled.
27. List safety training courses completed. (Also include those completed by personnel
you will be supervising)
Name
Location/Institution
Month/Year
28. List monitoring equipment
Make
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Model
Detector
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Calibration date
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