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UM/IBC/NPP/12/FORM A IBC REF. NO : INSTITUTIONAL BIOSAFETY COMMITTEE (IBC) UNIVERSITY of MALAYA BIOSAFETY ACT 2007 & BIOSAFETY REGULATION 2010 UM/IBC/NPP/12/FORM A NOTIFICATION OF SUBMISSION OF A PROJECT PROPOSAL INVOLVING MODERN BIOTECHNOLOGY ACTIVITIES UM/IBC/NR/12/FORM A is used to identify new project proposal(s) involving modern biotechnology activities. This form is compulsory for all biological research and to be sent to Research Grant Management Unit (UPGP) or Research Cluster together with the grant application form. A. Researcher Information Name : Faculty /Center/Institute: Telephone (office) : Telephone (laboratory) : Mobile number (optional) : Fax : Email : Postal Address : B. Project Information Project Title : Grant scheme applied to: Date / cycle of application: Please tick (√) the appropriate box Project Description : Activities involving the following: ( ) Deliberate transfer of a drug resistance trait to microorganism(s). ( ) Deliberate transfer of rDNA or DNA/ RNA derived from rDNA into human research participants (human gene transfer). ( ) Deliberate formation of rDNA containing genes for the biosynthesis of toxin molecules lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight. ( ) Use of Risk Group 2, Risk Group 3 or Risk Group 4 agents as host-vector systems (refer Appendix 1) ( ) Cloning of DNA from Risk Group 2 or greater agents (refer Appendix 1) into non-pathogenic prokaryotes or lower eukaryotic host-vector systems. ( ) Use of infectious or defective Risk Group 2 or greater agents (refer Appendix 1) ( ) Use of whole animal in which the animal’s genome has been altered by stable introduction of rDNA or DNA/ RNA derived from rDNA into a germ-line (transgenic animal) 1/3 UM/IBC/NPP/12/FORM A IBC REF. NO : ( ( ( ( ) Viable rDNA-modified microorganism tested on whole animals. ) Genetically engineered plants by rDNA methods. ) The formation of rDNA material containing two-thirds or more of the genome of a eukaryotic virus. ) Others. Please specify : Living Modified Organism(LMO)/ Genetic Modified Organism (GMO) Involved : ( ( ( ( ( ( ) ) ) ) ) ) GM Microorganism GM Plant GM Animal (other than arthropod / aquatic organism) GM Arthropods GM Aquatic Organism No LMO/GMO involved I hereby declare that all information given above is true and accurate. I understand that if any of the information given is found to be false or misleading, I will be held fully responsible and actions can be taken against me under the prescribed Act and other related Malayisan legislations or regulations. Signature : Name : Date : 2/3 UM/IBC/NPP/12/FORM A IBC REF. NO : APPENDIX 1 Risk Group (RG) and Pathogenicity Features of Living Modified Microorganisms Risk Group (RG) Pathogenicity Features RG1 low individual and community risk A microorganism that is unlikely to cause human disease or animal disease of veterinary importance. RG2 moderate individual risk, limited community, livestock or environment risk A pathogen that can cause human or animal disease but is unlikely to be a serious hazard to laboratory workers, the community, livestock or the environment Laboratory exposure may cause serious infection. Infectious risk is via direct contact, ingestion or inhalation. Effective treatment, preventive and control measures are readily available and can be implemented to control disease transmission. Risk of spread to a community is limited. RG3 high individual, low community risk Organism, which may be an exotic or indigenous agent with potential to transmit disease mainly via aerosols. Disease caused is severe and may result in death. It could present a risk if spread in the community however effective treatment, preventive and control measures are available RG4 high individual and community risk Organism, which may be an exotic agent or new agent usually able to cause life-threatening human disease. The infectious disease is readily transmissible from one individual to another. Infectious disease may be transmitted via aerosol or via an unknown route. Effective treatment, preventive and control measures are not readily available. Institutional Biosafety Committee (IBC) Tingkat 2, Kompleks IPPP & Makmal Kemudahan Penyelidikan Berpusat Universiti Malaya Tel : 03 79677827 [email protected] http://um.edu.my 3/3