UC Irvine Environmental Health & Safety
SECTION:
TITLE: Transgenic Animals
INITIATOR: IBC/ EH&S
WASTE/ULAR
REVISION DATE 1/2008
1. Program Description
2. Scope
3. Definitions
4. Responsibilities
5. Program Components
6. Reporting Requirements
7. Training Requirements and Competency Assessment
8. Information and External References
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1. Program Description
This policy describes the Institutional Biosafety Committee (IBC) review and approval
procedures required for all research or teaching activities involving animals in which the
animal's genome will be altered by introduction of recombinant DNA into the germ-line
(production of transgenic, knock-out and knock-in animals).
The National Institutes of Health (NIH) have established strict guidelines on the
proper use and disposal of transgenic animals, plants, and other forms of
recombinant DNA (rDNA) in research. The document entitled NIH Guidelines for
Research Involving Recombinant DNA Molecules (NIH Guidelines), outlines
institutional and investigator responsibilities and can be accessed at: NIH Guidelines
for Research Involving Recombinant DNA Molecules
All NIH-funded projects involving rDNA must comply with NIH Guidelines; in addition, all
non-NIH funded projects involving rDNA conducted at or sponsored by an institution
that receives NIH funding must also comply with the NIH Guidelines.
Failure to follow NIH guidelines can result in the suspension, limitation, or termination of
NIH funds for all rDNA research at the University. In addition, any intentional failure to
comply has the potential to be defined as academic misconduct as outlined by
University policy.
As an NIH-funded institution, the University of California, Irvine has developed both a
policy and a protocol which is outlined in the Transgenic Animal Research Factsheet
(add hyperlink later), through which investigators may obtain institutional authorization
to work with transgenic animals. All investigators working with transgenic animals are
responsible for meeting these requirements.
2. Scope
Principal Investigators are required to comply with the NIH Guidelines for Research
Involving Recombinant DNA Molecules and all applicable University policies. Research
(with or without grant funding) and teaching activities that are conducted with the goal of
creating transgenic animals using rDNA technologies must be reviewed and approved
by the Institutional Biosafety Committee (IBC). Methods for transgenic animal creation
include DNA microinjection, retrovirus-mediated gene transfer, embryonic stem cell
mediated gene transfer and any new methods that develop in the future. IBC and
IACUC review and approval are required for transgenic animal breeding programs.
This policy defines animals as all organisms in the Kingdom Animalia (Metazoa),
including vertebrates, invertebrates, insects, and all other members of the animal
kingdom.
This policy applies to all Principal Investigators (PIs) and University of California, Irvine
personnel. Companies operating in University facilities are expected to comply with the
same standards and procedures as the University research community.
3. Definitions
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ANIMALS
BSO
IACUC
IBC
MTA
NIH
PI
rDNA
TRANSGENIC ANIMAL
ULAR
Organisms in the Kingdom Animalia (Metazoa)
Biological Safety Officer
Institutional Animal Care and Use Committee
Institutional Biosafety Committee
Material Transfer Agreement
National Institutes of Health
Principal Investigator
Recombinant DNA
Whole animals in which the animal’s genome has been
altered by stable introduction of recombinant DNA, or DNA
derived therefrom, into the germ-line.
University Laboratory Animal Resources
4. Responsibilities
Before initiating any research that is expected to create a new strain of transgenic
animals, the PI must notify the IBC and IACUC in writing by completing both an IBC and
an IACUC application. The PI must clearly indicate if the gene encodes a toxin or other
hazardous agents. Projects involving the use of transgenic animals that have already
been created do not need to be registered with IBC, but these animals still need to be
disposed of by the procedures outlined below.
Based on the written information from the PI, the IBC and IACUC will determine the
subsequent review procedures. Although some projects will qualify as exempt from the
NIH Guidelines, all projects that involve the creation of transgenic animals (vertebrate
or invertebrate) must be registered with the IBC. In very rare cases, the project may
need to be referred to the NIH Office of Biotechnology Activity for federal review.
Registration forms or further information may be obtained on the EH&S website at:
http://www.ehs.uci.edu/programs/biosafety/ibc/index.html. For previously registered
projects, investigators must update registration information whenever there are changes
in the facilities, personnel, and experimental protocols associated with the project.
For projects involving the transfer of live vertebrate animals (including geneticallymodified animals), between University of California, Irvine and other institutions or
companies, follow the instructions on the ULAR web site,
http://apps.research.uci.edu/ular/uci/transfers.cfm?. Note that IACUC approval may be
required if researchers are adding a new species, changing procedures, or changing
the experimental use of animals. Additionally, a Material Transfer Agreement (MTA)
may be required in order to import or export genetically modified animals, including both
vertebrate and non-vertebrate animals.
5. Disposal of Transgenic Animals
When a transgenic animal is euthanized or dies, the carcass must be disposed of by
incineration or other method approved by the IBC and EH&S. This applies to confirmed
transgenic animals, potentially transgenic animals, “no-takes” in the production of
transgenic animals, and progeny of transgenic animals. No changes to the approved
disposal protocol are allowed without prior review and written approval.
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6. Reporting Requirements
University policy requires that significant research-related adverse incidents be reported
immediately to the Institutional Biosafety Committee via the BSO. Such incidents
include research-related accidents and illnesses as well as inadvertent release or
improper disposal of biohazardous or recombinant DNA materials. EH&S can be
contacted at (949) 824-6200.
7. Competency Assessment and Training Requirements
The PI is responsible for ensuring that their students, teaching assistants, and other
staff receive training about the policies and procedures for animal handling and
appropriate carcass disposal.
8. Information and External References
Contact the IBC via e-mail at ibc@uci.edu or visit our web site: http://www.ehs.uci.edu/
Other Biosafety Fact Sheets are available from the Biological Safety Section of our web
site: http://www.ehs.uci.edu/programs/biosafety/ibc/index.html
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