Nanyang Technological University School of Biological Sciences APPLICATION FOR IBC’S APPROVAL OF GENETIC MANIPULATION Instructions: 1. 2. 3. Complete all sections of the form. Any incomplete section may result delay of review and approval of research protocol by NTU-SBS IBC. Indicate “Yes”, “No” or “NA” (for Not Applicable). Please attach additional pages where the provided space is not enough. Sign declaration form and send document to Mr. Tin Tun, Biosafety coordinator, SBS-02AHS2 , ttin@ntu.edu.sg. PART A: PROJECT INFORMATION Name of PI: ____________________________ Institution: ______________________________________________________________ Contact number: ____________________ E-mail: Project title: _____________________________________________________________ Experimental objective: Rationale for the experiment: Duration of project: PART B: BIOLOGICAL HAZARD 1. Name of agent: _______________________________________________ 2. GMAC Category: A / B / C (Refer to www.gmac.gov.sg) 3. BATA schedule (if applicable):_______________ (www.moh.biosafety.gov.sg) 4. Indicate risk level: High / Medium / Low / No risks Low (Level of risk is low and unlikely to increase during experiment) Medium (Unlikely to increase and will be effectively controlled) High (Level of risk is high but will be effectively controlled) Remark: Please provide relevant information about GMO and their possible risks. 5. What is source of biological agent / toxin / recombinant DNA? Human / Animal / Others (please specify): _________________ 6. Toxin producer (LD50 greater than 100ug/kg): Yes / No / NA 7. Viral vector whose host range includes human cell: Yes / No / NA 8. Introduction of DNA into organism which causes disease: Yes / No / NA 9. Introduction of pathogenic genes into microorganisms: Yes / No / NA 10. Cloning or transfer of entire viral genome: Yes / No / NA 11. Viral genome is used to produce infectious virus particles: Yes / No / NA 12. Genetic manipulation of oocytes, zygotes, embryos: Yes / No / NA 13. Experiment with approved host/vector system: Yes / No / NA (www.gmac.gov.sg) PART C: EXPERIMENTAL HAZARD 1. Can the biological agent / toxin / material / recombinant DNA be transmitted by airborne route? Yes / No / NA 2. State control measures taken to prevent or minimize generation of aerosol in experimental steps. (centrifuge / vortex/ sonicator / pipette) 3. State control measures in experimental steps to perform outside BSC. 4. State the volume and concentration of agent used. 5. Is the volume of cell culture produced larger than 10 litres? Yes / No / NA 6. Are intact live animals used in this project? Yes / No / NA 7. Are needles/ glass / sharp items used? Yes / No / NA 8. Are appropriate personal protective equipment (PPE) used? Yes / No 9. Comply with guidelines and regulations for storage, transfer, packing and transport etc of the agent if involved: Yes / No / NA 10. Describe disinfectants or sterilization methods used. PART D: PERSONNEL 1. List the names of laboratory personnel working for this project. Name Designation Years of experience 2. Lab personnel read and understand laboratory safety manual and standard operating procedures. Yes / No 3. Lab personnel know well laboratory emergency procedures. Yes / No 4. Lab personnel are trained for use of BSL-3 laboratory. Yes / No / NA 5. Lab personnel are trained for use of laboratory animal (IACUC). Yes / No PART E: OCCUPATIONAL HAZARD 1. Emergency Response procedures have been implemented at work? Yes / No 2. Is occupational health and periodic medical reviews of lab personnel involved in the research provided? Yes / No 3. Have work place health risk assessment been performed for the site where occupation hazards exist? Please attach the completed SBS Risk assessment form. (The PI is strongly advised to conduct risk assessments for chemical hazard, radioactive hazard and environmental hazard in additional to biological hazard risk assessment prior to commencement of the research project) 4. Is lab personnel provided with appropriate immunization prior to commencement of work? Yes / No 5. Are lab personnel exposed to carcinogens or agents with unknown long-tern effects? Yes / No 6. Is any medical insurance cover provided for lab personnel? Yes / No PART F: DECLARATION BY PRINCIPAL INVESTIGATOR I affirm that to the best of my knowledge, information provided in this form is complete and accurate. I will ensure that all laboratory personnel receive adequate training in regard to proper safety practices and strictly follow prescribed operating procedures. I accept full responsibility for the safe conduct of work in this research project. I understand that the relevant authority has the power to suspend this project if any safety requirements have been violated. ________________________ Signature Name of PI: _____________________________ Date: ____________________