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. Biosafety and Radiation Safety Application Form – V1.2 – May 2017 1 2.2.8. Role in Project: ☒ Student WSU ID: Click here to enter text. ☐ Investigator 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. ☐ Professional Staff WSU ID: 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? 3.1.1. Is this a: Repeat of a previously conducted project? Continuation of an expired project? Continuation of an existing project that has been significantly revised? ☐ Yes ☐ No – Answer 3.1.1. ☐ Yes ☐ Yes ☐ Yes ☐ No ☐ No ☐ 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. Biosafety and Radiation Safety Application Form – V1.2 – May 2017 2 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. Organisation: Click here to enter text. Provide a copy of the application and approval letter if available. Position: Click here to enter text. Role in this Project: Click here to enter text. ☐ Yes 3.4. Is the collaborator an overseas organisation? ☐ 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 Date of Approval Expiry Date Biosafety and Radiation Safety Application Form – V1.2 – May 2017 3 Human participants or their data (HREC) ☐ Yes ☐ No (if applicable) Hxxxxx (if applicable) (if applicable) Click here to enter a date. Click here to enter a date. Click here to enter a date. Click here to enter a date. The use of Animals in Australia or overseas (ACEC) Dealings with Genetically Modified Organisms ☐ Yes ☐ No Axxxxx ☐ 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 Biosafety and Radiation Safety Application Form – V1.2 – May 2017 4 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 Click here to enter text. Facility Type PC Level OGTR Certificate No. (Lab, Animal, Plant, Aquatic) (PC1 / PC2 if relevant) (if relevant) Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. 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 Biosafety and Radiation Safety Application Form – V1.2 – May 2017 5 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) 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 ☐2 ☐3 ☐ 3A ☐4 ☐5 Notifiable Low Risk Dealing – PC1 (Schedule 3 Part 1) Notifiable Low Risk Dealing – PC2 (Schedule 3 Part 2.1) ☐ 1.1 (a) ☐ 1.1 (c) ☐ 2.1 (a) ☐ 2.1 (c) ☐ 2.1 (e) ☐ 2.1 (g) ☐ 2.1 (b) ☐ 2.1 (d) ☐ 2.1 (f) ☐ 2.1 (h) ☐ 2.1 (i) ☐ 2.1 (k) ☐ 2.1 (m) ☐ 2.1 (j) ☐ 2.1 (l) 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. 5.9. List all host/vector systems to be used Host Vector Biosafety and Radiation Safety Application Form – V1.2 – May 2017 6 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. Biosafety and Radiation Safety Application Form – V1.2 – May 2017 7 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) Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. 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. Biosafety and Radiation Safety Application Form – V1.2 – May 2017 8 Section 7: For Radiation Work Only Delete this section if not required 7.1. Radiation Licence Details: Radiation Licence Number Expiry Date Click here to enter text. Click here to enter a date. 7.2. Details of unsealed isotopes to be used: Radionuclide Physical Form Chemical form Max. Activity MBq per Experiment Purpose Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. 7.3. Details of sealed sources or irradiating apparatus to be used: Radionuclide and activity Apparatus – make/model/serial No. KV/mA Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. 7.4. Provide a brief description of how radioactive material will be stored and disposed 7.5. Provide a brief description of emergency spill response / decontamination provisions in place 7.6. Location(s) of project: Define the areas/laboratories at Western Sydney University in which samples, sources or apparatus are to be handled (include campus location, building number and laboratory number): 7.7. Will this project be undertaken in an off campus facility? 7.7.1. If Yes, has the project been approved by that facility’s Radiation Safety Officer (RSO)? ☐ Yes ☐ No ☐ Yes ☐ No 7.7.2. Provide the name of the RSO and the outcome of the review. Biosafety and Radiation Safety Application Form – V1.2 – May 2017 9 7.8. Radiation Safety Details: Identified hazards Control Methods External alpha/beta Click here to enter text. External X/gamma/neutron Click here to enter text. Laser Click here to enter text. Internal Click here to enter text. Environmental contamination Click here to enter text. Other Click here to enter text. Personal Click here to enter text. Area Click here to enter text. Contamination Click here to enter text. 7.9. Emergency Information: Provide details of the Emergency Procedures 7.10. 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 7.11. Additional risk management information for projects involving the use of radioactive materials: Describe your formal experience handling radioactive materials, including location, radio-isotope(s) and amounts handled. 7.12. List safety training courses completed. Also include those completed by personnel you will be supervising Name Location / Institution Month/Year Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. 7.13. List monitoring equipment Make Model Detector Calibration Date Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter a date. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter a date. Biosafety and Radiation Safety Application Form – V1.2 – May 2017 10
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