University of California, Irvine
Institutional Biosafety Committee
(IBC) Modification Form
IBC USE ONLY
Biosafety Level Required:
Date Received:
IBC Approval #
This form is to be used to request approval for modification(s)
of previously approved IBC protocols.
Modifications include changes in methods or procedures, location of research facilities, personnel, rDNA, or other biological
materials. Changes must not be implemented until IBC approval is granted. E-mail the complete application to
ibc@uci.edu. Fax or mail a signed copy of the Investigator’s Acknowledgment of Responsibilities to Fax (949) 824-1325 or
4600 Health Sciences Rd ZOT 2725
Principal Investigator:
Phone:
Fax:
IBC Protocol #
Project Title:
UCI E-mail:
MODIFICATIONS: Check all that apply
Investigator contact information, Personnel, Location – complete Section A
rDNA – complete Section B
Generation of transgenic animals (including cross breeding, knock outs, breeding of two different strains) or
other genetically animals - complete Section B-1
Generation of transgenic plants- complete Section B-2
Infectious Agents – complete Section C
Whole animals (vertebrates vs invertebrates) – complete Section D
Human/Primate Materials- complete Section E
Biological Toxins – complete Section F
Project Description
1.
Explain how the requested modification(s) will affect the scope of work:
a. In lay language, provide a one paragraph summary of your overall research objectives.
b. Summarize the purpose and goals and anticipated outcomes
c. Explain why and how specific agents are used.
2.
Explain what precautions, decontamination, and disposal methods will be employed as a result of the
modification.
3.
Why should the new procedure(s) be a modification of the existing project rather than a new protocol
submission?
4. Describe how personnel have been (or will be) trained in the handling of the new or changed material.
Section A:
Contact Information Change only:
New Mailing Address:
Telephone
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Fax
UCI e-mail address
1
New emergency number
Personnel
Action
Complete the sections below only if you are adding personnel
Name: Last,
First
UCI E-Mail
e.g. anteater@uci.edu
Position
Title
e.g. Staff
researcher
Add
Delete
Add
Delete
Add
Delete
EH&S training completed
Bloodborne pathogens (BBP) (required annually)
Laboratory Core and Hazardous Waste required every (3
years). Fulfills CalOSHA requirements
Select Agents
BBP
Viral Vectors
Hazardous Waste
BSL-3
Laboratory Core
Other:
Select Agents
BBP
Viral Vectors
Hazardous Waste
BSL-3
Laboratory Core
Other:
Select Agents
BBP
Viral Vectors
Hazardous Waste
BSL-3
Laboratory Core
Other:
Add
Delete
Select Agents
Hazardous Waste
Other:
BBP
BSL-3
Viral Vectors
Laboratory Core
Occupational
Health
Requirements
Check all that apply
None
Vaccine
Hep B
Respirator
Other:
None
Vaccine
Hep B
Respirator
Other:
None
Vaccine
Hep B
Respirator
Other:
None
Hep B
Other:
Vaccine
Respirator
Location of Study
Action
Building:
e.g. Hewitt Hall
Room #
e.g.103
Shared room or
open bench
space
Add
Delete
Add
Delete
Add
Delete
Add
Delete
Bench
No
Yes, PI’s name:
Bench
No
Yes, PI’s name:
Bench
No
Yes, PI’s name:
Bench
No
Yes, PI’s name:
Room functions
Check all that apply
Bench work
Agent storage
Tissue culture
Animal procedure
room
Other:
Other:
Bench work
Agent storage
Tissue culture
Animal procedure
room
Other:
Other:
Bench work
Agent storage
Tissue culture
Animal procedure
room
Other:
Other:
Bench work
Agent storage
Tissue culture
Animal procedure
room
Other:
Other:
Aerosol containment control
equipment
Check all that apply
Biosafety Level
BSL1, BSL2,
BSL2+,
BSL3, or ABSL1, 2,
3,
Fume hood
Cert Date:
Biosafety cabinet Cert Date:
Glove box
Cert Date:
Sealed centrifuge cups
Sealed rotors on centrifuge
Fume hood
Cert Date:
Biosafety cabinet Cert Date:
Glove box
Cert Date:
Sealed centrifuge cups
Sealed rotors on centrifuge
Fume hood
Cert Date:
Biosafety cabinet Cert Date:
Glove box
Cert Date:
Sealed centrifuge cups
Sealed rotors on centrifuge
Fume hood
Cert Date:
Biosafety cabinet Cert Date:
Glove box
Cert Date:
Sealed centrifuge cups
Sealed rotors on centrifuge
Section B
rDNA Check one
Addition of a new rDNA host – vector system and/or
Change(s) to an approved rDNA
host-vector system
Identify the nature of the DNA sequence,
Identify host (s) to be used: Example E. Identify the vector(s) to be used: Examples:
coli, S. cerevisiae, human/animal cells, whole
animals, humans.
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Bacterial plasmids, yeast plasmids, cultured cell plasmid
vectors, baculoviruses, transforming viruses
2
including the species of origin (i.e., specific gene,
promoter, expressed product and function (if known).
Will an attempt be made to purify any of the foreign gene product(s)?
Yes
No
If yes, indicate which foreign gene product will be purified and describe the procedures for purification
If replication-incompetent vectors will be used, explain how incompetent vectors will be tested for reversion mutations
(e.g., endpoint dilution analysis, plaque assay).
Change(s) to the experiments covered by NIH guidelines –
SUMMARY OF EXPERIMENTS COVERED BY THE “NIH GUIDELINES”
The NIH Guidelines can be found at http://oba.od.nih.gov/oba/index.html
Mark the appropriate section(s) that describes this project. If experiment does not fall into any of these categories, contact
Biosafety Office for assistance at extension 49888 (check all that apply): Appendix B of this application describes Risk
Groups (RG).
1. III A....must receive approval from IBC, Recombinant DNA Advisory Committee, and NIH Director before
initiation of experiments.
III-A-1-a: The deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally if such
acquisition could compromise the use of the drug to control disease agents in humans, veterinary medicine, or agriculture. (Note that
antibiotic resistance markers used for selecting and propagating plasmids in E. coli are not included.)
2. III B….must receive approval from NIH/OBA and IBC before initiation of experiments.
III-B-1: Experiments involving the cloning of toxin molecules with LD50 of <100ng per kg body weight (e.g., microbial toxins such as
botulinum toxin, tetanus toxin).
3. III C.....must receive approval from IBC, IRB, and RAC review before research participant enrollment.
III-C-1: Experiments involving the deliberate transfer of rDNA, or DNA or RNA derived from rDNA, into one or more human research
participants.
NOTE: Attach response to Points to Consider under: Appendix M of the NIH Guidelines and submit any
supplemental documents such as investigator brochure, clinical study, correspondence with NIH, etc
4. III D....must receive approval from IBC before initiation of experiments.
III-D-1
Experiments using Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents as host-vector systems
III-D-2
Experiments in which DNA or RNA from Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents is cloned into
nonpathogenic prokaryotic or lower eukaryotic host-vector systems
III-D-2-a
Experiments in which DNA from RG- 2, RG- 3 agents, or RG-4 agents is transferred into nonpathogenic prokaryotes or
lower eukaryotes.
III-D-2-b Containment conditions for experiments in which DNA from restricted agents is transferred into nonpathogenic
prokaryotes or lower eukaryotes shall be determined by NIH/OBA following a case-by-case review (see Section V-L, Footnotes and
References of Sections I-IV). A U.S. Department of Agriculture permit is required for work with plant or animal pathogens (see Section
V-G, Footnotes and References of Sections I-IV)
III-D-3
Experiments involving the use of infectious DNA or RNA viruses or defective DNA or RNA viruses in the presence of
helper virus in tissue culture systems (Section III-D-3)
III-D-3-a
Use of infectious or defective RG-2 viruses in the presence of helper virus.
III-D-3-b
Use of infectious or defective RG-3 viruses in the presence of helper virus may be conducted at BL3 containment.
III-D-3-d
Use of infectious or defective restricted poxviruses in the presence of helper virus shall be determined on a case-bycase basis following NIH/OBA review. A USDA permit is required for work with plant or animal pathogens.
III-D-3-e
Use of infectious or defective viruses in the presence of helper virus not covered in Sections III-D-3-a through III-D-3-d.
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3
5. III D 4
III-D-4III-D-4-a
III-D-4-b
rDNA Involving Whole Animal
Experiments involving whole animals in which the animal's genome has been altered by introduction of DNA or RNA into
the germ line (transgenic animals) and experiments involving viable recombinant DNA-modified microorganisms tested
on whole animals.
rDNA, or DNA or RNA molecules derived therefrom, from any source except for greater than two-thirds of eukaryotic
viral genome may be transferred to any non-human vertebrate or any invertebrate organism and propagated under
conditions of physical containment comparable to BSL1 or BSL1-N and appropriate to the organism under study.
Animals that contain sequences from viral vectors, which do not lead to transmissible infection either directly or indirectly
as a result of complementation or recombination in animals, may be propagated under conditions of physical
containment comparable to BSL1 or BSL1-N and appropriate to the organism under study. Experiments involving the
introduction of other sequences from eukaryotic viral genomes into animals are covered under Section III-D-4-b.
Investigator must demonstrate that the fraction of the viral genome being utilized does not lead to productive infection.
Experiments involving rDNA, or DNA or RNA derived therefrom, involving whole animals, including transgenic animals,
and not covered by Sections III-D-1 or III-D-4-a, may be conducted at the appropriate containment determined by the
IBC.
III-D-4-c-1 Experiments involving the generation of transgenic rodents that require BSL1 containment as described under Section
III-E-3
III-D-4-c-2 Purchase or transfer of transgenic rodents that are exempt from the “NIH Guidelines” under Section III-F but must be
registered with the IBC (Section III-D-4-c-2)
III-D-6
Experiments involving more than 10 liters of culture. (The appropriate containment will be decided by the IBC. Where
appropriate, Appendix K of the “NIH Guidelines” will be used to determine containment conditions.)
6. III E – Experiments that require IBC notice prior to initiation
III-E-1
Experiments involving the formation of R-DNA molecules containing no more than 2/3 of the genome of any eukaryotic
virus (all viruses from a single Family being considered identical) which may be propagated and maintained in cells in
tissue culture using BL1 containment? (It must be shown that the cells lack helper virus for the specific Families of
defective viruses used. The DNA may contain fragments of the genome of viruses from more than one Family but each
fragment shall be less than two-thirds of a genome.)
III-E-2-b-5 Experiments with recombinant DNA-modified arthropods or small animals associated with plants, or with arthropods or
small animals with recombinant DNA-modified microorganisms associated with them if the recombinant DNA-modified
microorganisms have no recognized potential for serious detrimental impact on managed or natural ecosystems.
III-E-3
Experiments involving the generation of rodents in which the animal’s genome has been altered by stable introduction of
recombinant DNA, or DNA derived therefrom, into the germ-line (transgenic rodents)? (Only experiments that require
BL1 containment are covered under this section; experiments that require BL2, BL3, or BL4 containment are covered
under Section III-D-4.)
7. III F – Experiments that are exempt from the NIH Guidelines but require submission prior to initiation
III-F-1
Recombinant DNA molecules that are not in organisms or viruses
III-F-2
Recombinant DNA molecules that consist entirely of DNA segments from a single nonchromosomal or viral DNA source,
though one or more of the segments may be a synthetic equivalent
III-F-3
Recombinant DNA molecules that consist entirely of DNA from a prokaryotic host including its indigenous plasmids or
viruses when propagated only in that host (or a closely related strain of the same species) or when transferred to
another host by well established physiological means.
III-F-4
Recombinant DNA molecules that consist entirely of DNA from a eukaryotic host including its chloroplasts, mitochondria,
or plasmids (but excluding viruses) when propagated only in that host (or closely related strain of the same species).
III-F-5
Those that consist entirely of DNA segments from different species that exchange DNA by known physiological
processes though one or more of the segments may be a synthetic equivalent.
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4
III-F-6
Those that do not present a significant risk to health or the environment as determined by the NIH Director, with the
advice of the RAC, and following appropriate notice and opportunity for public comment.
ADDENDUM B-1
Use and Creation of Transgenic or Genetically Modified Animals
1.
Yes
No Are you creating a new strain of genetically engineered (e.g transgenic or knock out) animals?
This includes cross breeding two strains of genetically engineered animals.
2. If "Yes", please describe (procedure and technique) how the transgenic animal will be created.
2a. If the animal is created by use of viral vectors, describe the vector and promoter.
3. Provide the gene name and function
4. Provide a description of the possible hazards associated with the alteration
5.
Yes No Has the source animal already been genetically modified?
If yes, describe the genetic modification(s)
6. Yes No Is the transgenic/knockout line created at the UCI Transgenic Core Facility?
If no, provide an alternate facility location.
7.
Yes
followed.
No
Does the transgenic animal pose a potential hazard to animal caregivers? If yes, describe the precautions that must be
ADDENDUM B-2
Use and Creation of Transgenic or Genetically Modified Plants.
1. What is the source of the material:
PI laboratory
Collaborator at UCI Provide PI name:
Outside of UCI: Provide name:
2.
Yes No Have you received authorization from the appropriate federal, state, and local regulatory agencies to acquire these
materials?
3. List all applicable authorizing agencies:
4. Describe how the transgenic plant is constructed (check and describe all that apply):
Yes No Agrobacterium:
Yes No Rhizobium:
Yes No Electroporation :
Yes No Microprojectile bombardment :
Yes No Viral directed transformation or viral infection :
Yes No Other :
SUMMARY OF EXPERIMENTS COVERED BY THE NIH GUIDELINES SECTION VIII FOR RESEARCH INVOLVING
RECOMBINANT DNA (rDNA) IN PLANTS
Mark the appropriate section(s) that describes this project.
III D....must receive approval from IBC before initiation of experiments.
III-D-5
Experiments involving whole plants
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5
III-D-5-a BL3-P (Plants) or BL2-P + biological containment which is recommended for experiments involving most exotic (see Section
V-M, Footnotes and References of Sections I-IV) infectious agents with recognized potential for serious detrimental impact on managed or
natural ecosystems when recombinant DNA techniques are associated with whole plants (Section III-D-5-a)
III-D-5-b BL3-P or BL2-P + biological containment which is recommended for experiments involving plants containing cloned genomes
of readily transmissible exotic infectious agents with recognized potential for serious detrimental effects on managed or natural ecosystems in
which there exists the possibility of reconstituting the complete and functional genome of the infectious agent by genomic complementation in
planta
III-D-5-d BL3-P containment is recommended for experiments involving sequences encoding potent vertebrate toxins introduced into
plants or associated organisms (also refer to Section III-B-1)
III-D-5-e BL3-P or BL2-P + biological containment is recommended for experiments with microbial pathogens of insects or small
animals associated with plants if the rDNA-modified organism has a recognized potential for serious detrimental impact on managed or
natural ecosystems
III E …..Experiments that require IBC notice prior to initiation
III-E-2
Experiments involving R-DNA-modified whole plants, and/or experiments involving R-DNA-modified organisms associated with
plants, except those that fall under Section III-A, III-B, III-C, III-D, and III-F? (See Section III-E-2 for recommendation of containment levels.)
III-E-2-a BL1-P which is recommended for all experiments with recombinant DNA-containing plants and plant-associated
microorganisms not covered in Section III-E-2-b or other sections of the NIH Guidelines? Examples of such experiments are those involving
recombinant DNA-modified plants that are not noxious weeds or cannot interbreed with noxious weeds in the immediate geographic area,
and experiments involving whole plants and recombinant DNA-modified non-exotic (see Section V-M, Footnotes and References of Sections
I-IV) microorganisms that have no recognized potential for rapid and widespread dissemination or for serious detrimental impact on managed
or natural ecosystems (e.g., Rhizobium spp. and Agrobacterium spp.)
III-E-2-b
BL2-P or BL1-P + biological containment is recommended for the following experiments:
III-E-2-b – (1) Plants modified by rDNA that are noxious weeds or can interbreed with noxious weeds in the immediate geographic area.
III-E-2-b – (2) Plants in which the introduced DNA represents the complete genome of a non-exotic infectious agent.
III-E-2-b – (3) Plants associated with rDNA-modified non-exotic microorganisms that have a recognized potential for serious detrimental
impact on managed or natural ecosystems.
III-E-2-b – (4) Plants associated with rDNA-modified exotic microorganisms that have no recognized potential for serious detrimental
impact on managed or natural ecosystems
Section C
Infectious Agents
Agent
(Adenovirus)
Risk
Group
RG2
Biosafety Level
(BSL1-4)
BSL2
Building
Med Sci C
Room
Number
123
Room Use
(experiment, storage or both)
Section D
Whole animals (vertebrates vs invertebrates)
Biological Materials used
(Infectious agents, vectors, or
human cell lines used in live
animals?)
e.g. MLV retrovirus
Animal
species
e.g. Mice
Max
infectious
units/dose
e.g.10^8 ml
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Max dose
per
animal
e.g. 5
Method of
delivery: e.g
Intravenous,
Intranasal,
Subcutaneous,
Intramuscular
6
Specify route(s) of
shedding/excretion
of infectious
agents: e.g. Urine,
Feces, Saliva, Blood,
Unknown
Please explain the measures
your lab will take to prevent
accidental exposure to
Section E
Human Material
Material – List each
material per line
e.g. Established cell line
Type
e.g. HEK
Source
e.g. Human
Origin of materials
Check all that apply
Clinical specimens
Known
Pathogens
e.g. None
Building
e.g. Med Sci
Room
Number
e.g.123
Commercial vendor
Clinical specimens
Field
Primate center
None
Other
Commercial vendor
Clinical specimens
Field
Primate center
None
Other
Commercial vendor
Clinical specimen
Field
Primate center
None
Other
Section F
Biological ToxinS
Toxin
Building
Room #
Room Used
Amount
Purchased
(experiment,
storage, or
both)
Physical stage
of agent
Beginning
concentration
Final concentration
use
1. Describe the type of work being done with Toxin(s) listed above (1-2 sentences only)
2. Describe the dilution procedures.
3. Describe safe handling and disposal procedures that will be used for this
toxin.
Acknowledgement of Responsibilities
I attest that the information contained in this IBC modification is accurate and complete. I agree to comply with all requirements pertaining to the
use, handling, storage and disposal of biohazardous agents and recombinant DNA molecules as outlined in my approved IBC protocol and this
modification request.
Typed Name of Principal Investigator
Signature of Principal Investigator
Approval for inclusion of this modification into the referenced protocol has been granted by the IBC
Signature of IBC Chair or designee
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Date
7
Date