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 Document1 v2 Page 1 of 11 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: Document1 v2 Date: Page 2 of 11 ☐ 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? Document1 v2 Page 3 of 11 ☐ 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 Document1 v2 enter a date. enter a date. Page 4 of 11 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. Document1 v2 Page 5 of 11 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 Document1 v2 Page 6 of 11 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 Document1 v2 Page 7 of 11 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. ________________________________________________ Document1 v2 Page 8 of 11 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? _________________________________________________________________________ Document1 v2 Page 9 of 11 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. __________________________________________________________________________ __________________________________________________________________________ Document1 v2 Page 10 of 11 ☐ 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 Document1 v2 Model Detector Page 11 of 11 Calibration date