Biosafety and Radiation Safety Application

Biosafety and Radiation Safety Application

Section 1: Overview

1.1. Short Project Title: Click here to enter text.

1.2. BRSC Number: BClick here to enter text.

1.3. Proposed Start Date: Click here to enter a date. 1.4. Proposed Finish Date: Click here to enter a date.

1.5. Western Sydney University School/Institute: Click here to enter text.

Section 2: Research Team Details

2.1. Chief Investigator Details
2.1.1. Title: Click here to enter text.
2.1.2. First Name: Click here to enter text.
2.1.3. Last Name: Click here to enter text.
2.1.4. WSU Staff ID: Click here to enter text.
2.1.5. School/Institute Name: Click here to enter text.
2.1.6. Work phone: Click here to enter text. 2.1.7. After hours phone: Click here to enter text.
2.1.8. E-mail address: Click here to enter text.
2.1.9. Provide details of relevant qualifications, experience and training: Click here to enter text.
2.1.10. Provide specific details of duties, tasks and procedures to be performed in this project: Click here to enter text.
I certify that I have read the application and understand my obligations and responsibilities and those of the research team.
Signature: Date: Click here to enter a date.
2.2. Investigator/Student/Staff involved in the project
Note: Insert a copy of this box below for each additional person
2.2.1. Title: Click here to enter text.
2.2.2. First Name: Click here to enter text.
2.2.3. Last Name: Click here to enter text.
2.2.4. School/Institute Name: Click here to enter text.
2.2.5. Work phone: Click here to enter text. 2.2.6. After hours phone: Click here to enter text.
2.2.7. E-mail address: Click here to enter text.
2.2.8. Role in Project:
☒ Student
WSU ID: Click here to enter text. / ☐ Investigator
WSU ID: Click here to enter text. / ☐ Professional Staff
WSU ID: Click here to enter text.
☐ Non-WSU Student
Institution: Click here to enter text. / ☐ Non-WSU Investigator
Employer: Click here to enter text.
2.2.9. Provide details of relevant qualifications, experience and training: Click here to enter text.
2.2.10. Provide specific details of duties, tasks and procedures to be performed in this project: Click here to enter text.
I certify that I have read the protocol and understand my obligations and responsibilities.
Signature: Date: Click here to enter a date.

2.3. Declaration by Technical Manager / Coordinator or delegate:

1. I am aware that this project may involve the use of any of the following: hazardous substances (including radioactive substances) and biological material including genetically modified organisms.

2. I can confirm that all risk assessments related to this application have been lodged with the School / Institute.

Signature: Date: Click here to enter a date.

Title of signatory: Click here to enter text.

Name of signatory: Click here to enter text.

2.4. Declaration by Designated School / Institute signatory
Full name of signatory: Click here to enter text.
Signature: Date: Click here to enter a date.

Section 3: Administration

3.1. Is this a new project? ☐ Yes ☐ No – Answer 3.1.1.
3.1.1. Is this a:
Repeat of a previously conducted project? ☐ Yes ☐ No
Continuation of an expired project? ☐ Yes ☐ No
Continuation of an existing project that has been significantly revised? ☐ Yes ☐ No
3.1.2. If Yes to any of the above, explain why and provide the BRSC No. and title.
3.2. Has this or a similar project been previously declined by the Western Sydney U BRSC or another IBC? ☐ Yes ☐ No
3.2.1. If Yes, provide the name of the committee and date of submission.
3.3. Does this project involve collaboration with an external organisation? ☐ Yes ☐ No
3.3.1. If Yes, provide the below details for each collaborator:
Name: Click here to enter text. Position: Click here to enter text.
Organisation: Click here to enter text. Role in this Project: Click here to enter text.
Provide a copy of the application and approval letter if available.
3.4. Is the collaborator an overseas organisation? ☐ Yes ☐ No
3.4.1. If Yes, provide the name and location of the organization:
3.5. If funding is associated with this project, provide the below details:
Refer to the Researcher Portal
Title Source / Click here to enter text.
Investigators / Click here to enter text.
Grant Identifier / Click here to enter text.
3.6. Is any of the specified information contained in this application confidential, commercial information? ☐ Yes ☐ No
3.6.1. If Yes, provide details

Section 4: Details of the Project

4.1. Describe the project aims in lay (non-scientific language) terms (max 250 words).
Include a glossary of terms, as appropriate.
4.2. Rationale (max 500 words)
Provide a justification for undertaking this project. This should be based on an assessment of the scientific /educational value and the potential impact.
4.3. Outcomes/Benefits of the project in lay terms (non-scientific language) (max 500 words)
Specify what you hope to achieve.
4.4. Summarise the research plan by providing the following:
Include the project’s empirical and theoretical background, experimental protocol, description of samples, time line, data gathering/fieldwork and data analysis.
4.5. Does your project involve: / Please tick / Approval number
(if applicable) / Date of Approval
(if applicable) / Expiry Date
(if applicable)
Human participants or their data (HREC) / ☐ Yes ☐ No / Hxxxxx / Click here to enter a date. / Click here to enter a date.
The use of Animals in Australia or overseas (ACEC) / ☐ Yes ☐ No / Axxxxx / Click here to enter a date. / Click here to enter a date.
Dealings with Genetically Modified Organisms / ☐ Yes ☐ No / If Yes, Complete Section 5
Use of cytotoxic substances (Carcinogens, mutagens, teratogens) / ☐ Yes ☐ No / If Yes, Complete Section 6
Use of ionising or non-ionising radiation including lasers / ☐ Yes ☐ No / If Yes, Complete Section 7
4.6. Type of project:
Mark (X) all relevant boxes

☐ Research involving human blood or tissues or other biological material.

☐ Teaching involving human blood or tissues or other biological material.

☐ Research or teaching involving GMO dealings.

Select appropriate category:

☐ Exempt dealing

☐ Notifiable Low Risk Dealings (NLRD) - attach the NLRD Record of Assessment Form

☐ Dealings Not involving Intentional Release (DNIR) - attach the DNIR Application Form

☐ Dealings involving an Intentional Release (DIR) - attach the DIR Application Form

☐ Other – provide details

Section 5: For Biological and GMO Dealings only

Delete this section if not required

Location(s) of Activities

5.1. Laboratory Locations at Western Sydney University
Room No. / Building Name & No / Campus / Facility Type
(Lab, Animal, Plant, Aquatic) / PC Level
(PC1 / PC2 if relevant) / OGTR Certificate No.
(if relevant)
Click here to enter text. / Click here to enter text. / Click here to enter text. / Click here to enter text.
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5.2. Non-Laboratory Locations: Describe the exact location

e.g. nearest road, distance from town or landmark or similar. Include a map, as required

5.3. Will this project be undertaken in a NSW health facility? ☐ Yes ☐ No

5.3.1. 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

5.3.2. Name of Facility

Click here to enter text.

5.3.3. Location of Facility

Click here to enter text.

5.4. Will any GMO activity related to this project be conducted at another institution? ☐ Yes ☐ No

5.4.1. If Yes, provide the name of the approving IBC or safety committee

Click here to enter text.

Origin of Biological Material

5.5. If material of human origin is to be used, has consideration been given to using non-human sources? ☐ Yes ☐ No ☐ Not Applicable

5.5.1. If Yes, provide the details. If No, provide an explanation

5.6. If a cell line is to be used, list the type of cell line

5.7. Does this project involve the use of a biological material to be imported directly from an overseas supplier? ☐ Yes ☐ No

5.7.1. If Yes, what is the nature and intended use of the biological material (Culture media, diagnostic reagent, cell line, plant material etc)

5.7.2. Has the Notification to Import Biological Materials directly from Overseas form been attached

☐ Yes ☐ No

5.7.3. Has the Biosecurity Import Conditions (BICON) permit(s) been attached? ☐ Yes ☐ No

5.7.5. BICON Approval Number: Click here to enter text.

5.7.6. If No, provide an explanation:

Dealings with Genetically Modified Organisms (GMOs)

5.8. Complete the table below if you have marked any of the GMO Dealings in Question 4g.

Exempt Dealing
(Schedule 2 Part 1) / ☐ 2
☐ 3
☐ 3A
☐ 4
☐ 5 / A dealing is an exempt dealing if it:
a) is a kind mentioned in Schedule 2 Part 1; &
b) does not involve a genetic modification other than a modification described; &
c) does not involve an intentional release of the GMO into the environment; &
d) does not involve a retroviral vector that is able to transduce human cells
Notifiable Low Risk Dealing – PC1
(Schedule 3 Part 1) / ☐ 1.1 (a)
☐ 1.1 (c) / A dealing is not a notifiable low risk dealing if it:
a) is also a dealing of a kind mentioned in Part 3 of Schedule 3; or
b) involves an intentional release of the GMO into the environment.
A dealing that is not an exempt dealing or a notifiable low risk dealing must be authorised under an OGTR licence.
Notifiable Low Risk Dealing – PC2
(Schedule 3 Part 2.1) / ☐ 2.1 (a) ☐ 2.1 (b)
☐ 2.1 (c) ☐ 2.1 (d)
☐ 2.1 (e) ☐ 2.1 (f)
☐ 2.1 (g) ☐ 2.1 (h)
☐ 2.1 (i) ☐ 2.1 (j)
☐ 2.1 (k) ☐ 2.1 (l)
☐ 2.1 (m)
5.9. List all host/vector systems to be used
Host / Vector

5.10. Transportation: Outline the arrangements for the transport of GMOs between

- University buildings

- University campuses

- External institutions and the University (and vice versa)

(Refer to Guidelines for the transport, storage and disposal of GMOs, OGTR Sept 2011)

5.11. Spill / Escape Response: Outline the action to be taken in the case of a spill or escape of GMOs including containment and decontamination procedures.

Refer to any relevant SOPs (SOP No., Title and Expiry Date)

5.12. If any Genetically Modified Organism (GMO) material is to be stored and secured after the completion of the project, how will this be done?

Microorganisms or Other Biological Material

5.13. 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)

☐ Bacteria

☐ Parasites

☐ Fungi

☐ Viruses

☐ Exotic Animal Viruses

☐ Other

Risk Management Information

5.17. Risk Assessment: Are there any significant safety or health risks related to the proposed work that may affect staff or students? Refer to Laboratory Safety Guidelines

☐ Yes ☐ No

5.18. Provide details of your considerations

5.19. Risk control: Provide details of actions to be taken by the applicant to eliminate or control the risks identified in the question above.

Section 6: For Cytotoxic Substances Only

Delete this section if not required

Cytotoxic Substances

6.1. Will the project involve the use of cytotoxins or potential cytotoxins that are, or may be, carcinogens, mutagens, teratogens? ☐ Yes ☐ No

6.1.1. What is the nature or possible nature of the cytotoxin?

☐ Carcinogen ☐ Mutagen ☐ Teratogen

6.2. List the Cytotoxin(s) to be used in this project
Name of Cytotoxin / Form Ordered / Quantity Ordered / Storage location (room and campus)
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6.3. Is the carcinogen you intend to use listed in the Work Health and Safety Regulation 2011, Schedule 10?

☐ Yes ☐ No

5.16.1. If Yes, have you lodged a formal notification and received acknowledgement from the WorkSafe NSW? ☐ Yes ☐ No ☐ Pending

Risk Management Information

6.7. Risk Assessment: Are there any significant safety or health risks related to the proposed work that may affect staff or students? Refer to Laboratory Safety Guidelines

☐ Yes ☐ No

6.8. Provide details of your considerations

6.9. Risk control: Provide details of actions to be taken by the applicant to eliminate or control the risks identified in the question above.

Section 7: For Radiation Work Only

Delete this section if not required