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Transcript
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)
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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
:
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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
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