Download Form 1 - Cal Poly Pomona

CALIFORNIA STATE POLYTECHNIC UNIVERSITY, POMONA
INSTITUTIONAL BIOSAFETY COMMITTEE (IBC)
FORM 1 Registration of Research Involving the Use of Biological Materials
INSTRUCTIONS:
All submissions – must be typed. E-mail a complete form to Michael DeSalvio, Biosafety Specialist, Environmental Health and Safety
– Attn.: Institutional Biosafety Committee at [email protected]. For questions or additional information, call 909 869-4987 or email
[email protected]. Keep a copy of this application for your records.
Use Form 1 for research involving:
 Research Involving Recombinant and Synthetic Nucleic Acids as covered under the NIH Guidelines (refer to Section VIII of
this form and http://osp.od.nih.gov/sites/default/files/NIH_Guidelines.html). NOTE: Use Form 3 for genetically modified whole
plants requiring BSL1-P containment only. Use Form 4 for the generation and use of genetically modified animals requiring
ABSL1 containment only. Purchase and transfer of rodents requiring ABSL1 containment does not require registration.
 Infectious Agents (Bacteria, Virus, Yeast, Fungi, Prions, Rickettsias, & Parasites)
SECTION I: GENERAL PROJECT INFORMATION
APPLICATION STATUS:
New
Renewal (every 3 yrs), previous IBC #:
Amendment, IBC#:
IF AMENDMENT, mark amended section(s). Check all that apply: Revise applicable section(s) and email revised Form1 to [email protected].
I - Contact Information
IV - Research Description
VII – Location
X – Infectious Materials
II - Summary of Project
V – Personnel
VIII – NIH Guidelines
Other (specify):
III -Ancillary Committee
VI - Occupational Health Issues
IX – rDNA Construct
Principal Investigator’s Name (last, first):
Degree:
Department:
Position: Faculty If other, specify:
Campus Address:
Office Phone:
Lab Phone:
Emergency Phone:
Fax:
Email:
Co-Principal Investigator’s Name (last, first):
Degree:
Department:
Position: Faculty If other, specify:
Campus Address:
Office Phone:
Lab Phone:
Emergency Phone:
Fax:
Email:
Alternate Contact Name (e.g., lab supervisor, etc.) if applicable:
Email of Alternate Lab Contact:
Office Phone or Lab Phone:
Fax:
Faculty Sponsor’s Name (Required if not Cal Poly faculty):
Degree:
Department:
Email:
Campus Address:
IBC ADMINISTRATIVE USE ONLY
IBC RECEIPT DATE
IBC Application #:
IBC Meeting Date:
Status:
Approved
Inactivated
Cal Poly Pomona – Institutional Biosafety Committee
Form 1, IBC Application 10/28/14
Date:
Page 1
Michael DeSalvio M.Bt., Biosafety Specialist
SECTION II: GENERAL SUMMARY OF PROJECT
Mark the materials that will be used in this project:
YES
NO
Use of Recombinant DNA, gene transfer, host vector systems.
Use of Infectious Agents (Bacteria, Virus, Yeast, Fungus, Prions, & Parasitic Agents)
If ‘Yes’ check the risk group(s) which apply. See http://www.absa.org/riskgroups/ for risk group of the agent(s).
Risk Group 3*.....must receive approval from IBC before initiation of experiments.
Risk Group 2.....must receive approval from IBC before initiation of experiments.
Risk Group 1.....some experiments may be exempt from IBC review. If there is no recombinant or synthetic
nucleic acid research, you do not need to submit an application.
To request an official exemption letter, email [email protected].
*If Risk Group 3 is selected. Stop and contact Environmental Health and Safety 909-869-4987 before proceeding.
Currently at this time, Cal Poly is not approving any work with recommended containment levels exceeding BSL2.
Use of Human subjects (Clinical Trials)
Use of CDC Select Agent (See http://www.selectagents.gov/Select Agents and Toxins List.html for list of select agents)
Use of Human Material (including all fluids, tissues, excretions, secretions, or cell lines)
Use of Nonhuman Primate Material (including live animals, all fluids, tissues, excretions, secretions, or cell lines)
Use of transgenic or other genetically modified whole plants
Use of transgenic or other genetically modified whole animals
Use of animals or animal specimens known to be reservoirs/vectors of zoonotic diseases.
EXEMPT: Animals obtained from vendors known to Cal Poly Pomona ACUC to provide pathogen-free animals.
(See http://publichealth.lacounty.gov/vet/guides/vetzooman.htm for list of zoonotic animals)
Other (specify):
Species
Use of Animals
known to be
vectors/reservoirs of
zoonotic diseases.
Specify Materials
(e.g. cell lines, blood, bodily fluids, tissue, culture, etc.):
(Exempt: Rodents
from DLAM approved
vendors)
*Note: If the source of animal is from a commercial supplier, please indicate the name of the supplier.
Cal Poly Pomona – Institutional Biosafety Committee
Form 1, IBC Application 10/28/14
Page 2
Source of Animal*
(e.g., field, commercial supplier)
SECTION III: ANCILLARY COMMITTEES
Committee
Yes
No
N/A
Pending
(date submitted)
Protocol Number
Most Recent
Approval Date
IRB (Institutional Review Board) for use
of human subjects
ESCRO (Embryonic Stem Cell Research
Oversight)
ACUC (Animal Care and Use Committee)
Radiation Safety Committee
Other (specify):
SECTION IV: RESEARCH DESCRIPTION
The IBC is made up of a diverse group of members. It is therefore important to use language useful for a scientific evaluation as well
as general enough to be understood by members with non-scientific backgrounds. Provide sufficient information to evaluate the work
for the purposes of determining an appropriate biohazard risk assessment.
Grant and/or committee applications (e.g. ACUC) can be referenced below in lieu of resubmitting the following items
provided the referenced applications adequately describe the proposed research to the extent that an appropriate risk
assessment can be made. Additional information or clarification may be required to adequately review this application.
Referenced applications should be submitted with this application. References should also include respective page numbers.
1. List all Project/Grant Title(s):
2. Please identify the source(s) of funding that will be used to support the research:
3. Provide a brief non-technical description and objectives of the research project. If this is a renewal, provide updated information.
4. Describe in detail the procedures and techniques to be used in the research project. If applicable, incorporate description of any
animal work (in vivo and/or ex vivo), human subjects, use of radiological materials, or other associated hazards in this project.
Cal Poly Pomona – Institutional Biosafety Committee
Form 1, IBC Application 10/28/14
Page 3
SECTION V: PERSONNEL
In addition to taking the required EH&S safety trainings, each person working on the project is required to receive formal, agentspecific training in the handling of biohazardous materials prior to beginning of the project from the PI or lab supervisor. Provide a
proof of formal training for each person listed in the form of a written training document at the time of biosafety inspection or prior to
personnel approval. Contact the EH&S if you have questions: 909-869-4987 or [email protected].
1.
Principal Investigator’s Experience – Describe qualification and training of the PI and/or co-PI(s) pertaining to the biohazardous
materials and procedures in this project. For human gene therapy studies, include a copy of current CV or biosketch. This section
may reference an existing grant or committee application if applicable.
2.
Other personnel (Visit the Biosafety Portal for required/recommended EH&S training). This section must be completed regardless of
existing grant or committee applications. http://www.cpp.edu/~ehs/biosafety/portal.shtml
3.
Supplemental page for additional personnel (if needed): http://www.cpp.edu/~ehs/biosafety/IBC.shtml
Supplemental Pages Attached?
Yes
Name (last, first)
Position Title
Responsibilities
Biosafety Office Use Only
e.g. staff researcher
Check all that apply
(Training Record. Must be current)
Directly handle biohazardous material including medical waste
Use equipment where biohazards are present
Directly handle animals exposed to biohazardous material
Shipping biohazardous materials
Handling of hazardous chemicals with biohazard
Other (specify):
BSC
BSL2
Herpes B
HazWaste
Other:
MWM
BBP
ATD
Respirator
Directly handle biohazardous material including medical waste
Use equipment where biohazards are present
Directly handle animals exposed to biohazardous material
Shipping biohazardous materials
Handling of hazardous chemicals with biohazard
Other (specify):
BSC
BSL2
Herpes B
HazWaste
Other:
MWM
BBP
ATD
Respirator
Directly handle biohazardous material including medical waste
Use equipment where biohazards are present
Directly handle animals exposed to biohazardous material
Shipping biohazardous materials
Handling of hazardous chemicals with biohazard
Other (specify):
BSC
BSL2
Herpes B
HazWaste
Other:
MWM
BBP
ATD
Respirator
Directly handle biohazardous material including medical waste
Use equipment where biohazards are present
Directly handle animals exposed to biohazardous material
Shipping biohazardous materials
Handling of hazardous chemicals with biohazard
Other (specify):
BSC
BSL2
Herpes B
HazWaste
Other:
MWM
BBP
ATD
Respirator
Directly handle biohazardous material including medical waste
Use equipment where biohazards are present
Directly handle animals exposed to biohazardous material
Shipping biohazardous materials
Handling of hazardous chemicals with biohazard
Other (specify):
BSC
BSL2
Herpes B
HazWaste
Other:
MWM
BBP
ATD
Respirator
Cal Poly Pomona – Institutional Biosafety Committee
Form 1, IBC Application 10/28/14
Page 4
SECTION VI: OCCUPATIONAL HEALTH/ IMMUNIZATIONS PROGRAM
In accordance to the NIH Guidelines and CDC Biosafety in Microbiological and Biomedical Laboratories (5th ed):
 All persons entering the laboratory must be advised of the potential hazards and meet specific entry/exit requirements.
Laboratory personnel must be provided medical surveillance and offered appropriate immunizations for agents handled or potentially
present in the laboratory.
1. Prospective workers/current workers must be educated about the biohazard(s) listed in this protocol.
YES
NO
Mark if these items are/will be implemented in the laboratory.
All personnel must attend the appropriate EH&S safety training prior to start of experiments.
All personnel must read the biosafety manual (with applicable agent specific hazard information) and adhere to the
standard operating procedure related to this protocol.
All personnel must receive a laboratory orientation from the PI or lab supervisor prior to start of experiments to be
knowledgeable with, but not limited to the following, entry/exit procedure, contact information in case of an emergency,
and location of life safety equipment (e.g., eye wash, shower, fire extinguisher, spill kit, first aid, etc.).
All personnel must demonstrate proficiency in standard and special microbiological practices before start of
experiments.
Other Educational Training (specify):
2. If any, describe additional medical surveillance for personnel who are more vulnerable to infection with the agents listed in this
protocol (e.g., non-vaccinated individuals, immunodeficient workers or non-immune pregnant female workers, health issues).
3. List applicable health surveillance/immunization programs that have been or will be offered to personnel identified in Section V.
The IBC upon review may change any of these items based on current federal, state, and local Occ. Health recommendations.
None
Hepatitis B Vaccination (declination must be documented)
Human Papilloma Virus Vaccination
Orthopoxviruses (vaccinia and others): medical screening, vaccination and contraindication awareness and training
Annual Respirator Fit Testing
Serological Banking/Testing (Contact EH&S Biosafety for research applicability and additional information)
Other (specify):
4. In case of an exposure incident, describe the procedure that will be implemented for personnel to obtain consultation and
treatment (check all that apply):
Undergraduate and Graduate students shall go to Student Health & Services during regular business hours or can call
(909) 869-4000. For after hours or weekends/holidays, go to urgent care or call (909) 869-4945.
Faculty and Staff shall immediately notify their supervisor and/or Risk Management to initiate a claim. In the event of a
medical emergency, dial 911 from any campus phone or call (909) 869-3070 from a cell phone to contact the University
Police Department. For non-emergency incidents, provide the injured worker with a Medical Service Order form and a
Workers’ Compensation Claim form (DWC1) and Notice of Potential Eligibility forms within 24 hours of notice. The injured
worker may be treated at the designated industrial clinic, U.S. HealthWorks, unless he or she had previously filed with Risk
Management a Physician Pre-Designated form. It’s important to promptly and accurately document the facts of the
employee’s claim of injury/illness. Use the Manager’s/Supervisor’s Report of Injury/Illness to report the incident to Risk
Management within 24 hours. Risk Management Contact Information: Maribel Nerio, Workers’ Compensation Coordinator
(909) 869-3725; Valerie Eberle, Risk Manager (909) 869-4846; Fax: (909) 869-2926; Website: RMS/Workers’ Compensation
Other (specify):
Cal Poly Pomona – Institutional Biosafety Committee
Form 1, IBC Application 10/28/14
Page 5
SECTION VII: LOCATIONS OF STUDY – COMPLETE WHERE APPLICABLE
Supplemental page for additional entries (if needed): http://www.cpp.edu/~ehs/biosafety/IBC.shtml
Supplemental Pages Attached?
Yes
1. List ALL locations for laboratory experiments.
Building
Room(s) #
Room Functions (Check all that apply)
Bench work
Centrifuging
Core Facility (specify):
Biosafety Cabinet
Chemical Fumehood
Storage
Microscope
Other (specify):
Bench work
Centrifuging
Core Facility (specify):
Biosafety Cabinet
Chemical Fumehood
Storage
Microscope
Other (specify):
Bench work
Centrifuging
Core Facility (specify):
Biosafety Cabinet
Chemical Fumehood
Storage
Microscope
Other (specify):
Bench work
Centrifuging
Core Facility (specify):
Biosafety Cabinet
Chemical Fumehood
Storage
Microscope
Other (specify):
2. List ALL locations for biohazard animal experiments, if exact room # is unknown, mark unassigned.
Building
Room(s) #
Room Functions (Check all that apply)
Animal handling room
Euthanasia procedure
Other (specify):
Animal housing room (Biohazard)
Animal return room (nonBiohazard)
Animal handling room
Euthanasia procedure
Other (specify):
Animal housing room (Biohazard)
Animal return room (nonBiohazard)
Animal handling room
Euthanasia procedure
Other (specify):
Animal housing room (Biohazard)
Animal return room (nonBiohazard)
3. List ALL locations for human subjects study, if exact room # is unknown, mark unassigned. For off-site, provide address.
Building
Room(s) #
Room Functions (Check all that apply)
Drug/gene/vaccine preparation
Drug/gene/vaccine administration
Other (specify):
Drug/gene/vaccine storage
Handling of clinical samples
Drug/gene/vaccine preparation
Drug/gene/vaccine administration
Other (specify):
Drug/gene/vaccine storage
Handling of clinical samples
Drug/gene/vaccine preparation
Drug/gene/vaccine administration
Other (specify):
Drug/gene/vaccine storage
Handling of clinical samples
4. List ALL locations for whole plant experiments
Building
Room(s) #
Cal Poly Pomona – Institutional Biosafety Committee
Form 1, IBC Application 10/28/14
Room Functions (Check all that apply)
Laboratory
Other (specify):
Growth Chamber
Greenhouse
Field Plot
Laboratory
Other (specify):
Growth Chamber
Greenhouse
Field Plot
Page 6
SECTION VIII: NIH GUIDELINES ASSESSMENT FOR RESEARCH INVOLVING RECOMBINANT DNA (rDNA)
Mark the appropriate section(s) that describes this project. If experiment does not fall into any of these categories, contact
Environmental Health and Safety for assistance (check all that apply):
III A....must receive approval from IBC, Recombinant DNA Advisory Committee, and NIH Director before initiation of
experiments.
Section 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.)
III B….must receive approval from NIH/OBA and IBC before initiation of experiments.
Section 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).
III C.....must receive approval from IBC, IRB, and RAC review before research participant enrollment.
Section 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: Appendix M of the NIH Guidelines and submit any supplemental documents
such as investigator brochure, clinical study, correspondence with NIH, etc.
III D....must receive approval from IBC before initiation of experiments.
III-D-1-a
Introduction of rDNA into Risk Group 2 (RG-2) agents.
III-D-1-b
Introduction of rDNA into Risk Group 3 (RG-3) agents.
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-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-by-case 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.
rDNA Involving Whole Animal
III-D-4-a 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.
III-D-4-b
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 animals that require BSL1 containment.
III-D-4-c-2 Purchase or transfer of transgenic rodents requiring ABSL1 containment is exempt from the “NIH Guidelines”.
rDNA Involving Whole Plants: For rDNA experiments falling under Sections III-D-5-a through III-D-5-d, physical containment requirements may be
reduced to the next lower level by appropriate biological containment practices, such as conducting experiments on a virus with an obligate insect
vector in the absence of that vector or using a genetically attenuated strain.
III-D-5-a
BSL3-P (Plants) or BSL2-P + biological containment is recommended for experiments of most exotic infectious agents with
recognized potential for serious detrimental impact on managed or natural ecosystems using rDNA techniques with whole plants.
Cal Poly Pomona – Institutional Biosafety Committee
Form 1, IBC Application 10/28/14
Page 7
III-D-5-b
BSL3-P or BSL2-P + biological containment 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-c
BSL4-P containment is recommended for experiments with a small number of readily transmissible exotic infectious agents, such as
the soybean rust fungus (Phakospora pachyrhizi) and maize streak or other viruses in the presence of their specific arthropod
vectors that have the potential of being serious pathogens of major U.S. crops.
III-D-5-d
BSL3-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
BSL3-P or BSL2-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-D-6
Experiments involving more than 10 liters of culture. The appropriate containment will be decided by the IBC.
III E….must notify IBC simultaneously upon initiation of research.
III-E-1
Experiments involving the formation of rDNA molecules containing no more than 2/3 of the genome of any eukaryotic virus (All
viruses from a single Family being considered identical.) may be propagated and maintained in cells in tissue culture using BSL1.
III-E-2-a
BSL1-P is recommended for all experiments with rDNA-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 rDNA-modified plants
that are not noxious weeds or that cannot interbreed with noxious weeds in the immediate geographic area, and experiments
involving whole plants and rDNA-modified non-exotic 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.).
Use FORM 3 Registration of rDNA modified Whole Plants.
III-E-2-b
BSL2-P or BSL1-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.
III-E-2-b-(5) Experiments with rDNA-modified arthropods or small animals associated with plants, or with arthropods or small animals with
rDNA-modified microorganisms associated with them if the rDNA-modified microorganisms have no recognized potential for
serious detrimental impact on managed or natural ecosystems.
II-E-3
Experiments involving the generation of rodents in which the animal’s genome has been altered by stable introduction of rDNA, or
DNA derived therefrom, into the germ0line (transgenic rodents). Use FORM 4 Registration of Transgenic Animals.
III F......exempt from IBC Review. To request an official exemption letter email [email protected].
III-F-1
rDNA molecules that are not in organisms or viruses.
III-F-2
rDNA 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
rDNA 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
rDNA 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
III-F-6
rDNA molecules 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.
rDNA experiments that do not present a significant risk to health or the environment as determined by the NIH Director, RAC and
following appropriate notice and opportunity for public comment.
Cal Poly Pomona – Institutional Biosafety Committee
Form 1, IBC Application 10/28/14
Page 8
SECTION IX: RECOMBINANT DNA/ VECTOR STUDIES
1. Vector Source
(check all that apply):
PI’s Laboratory
Vector Core
Other (specify – PI’s Name and/or facility):
Commercial Vendor
2. Nature of the Vector (s), if applicable include helper virus
Vector (Check all that apply, use separate page for each host-vector systems)
Replication Defective
(Yes, No, N/A)
Attach Vector
Map
(Yes, No, N/A)
Bacterial Plasmids
Name plasmids:
Baculovirus
Adeno-associated virus
Adenovirus, specify name of strain:
Describe wild type deletions:
Vaccinia Virus
Name strain:
Retrovirus
Vector backbone:
Murine, specify strain:
Other (specify):
Host range (explain):
amphotrophic
ecotrophic
Other (specify):
Lentivirus
Name HIV genes present:
Name envelope packaging system(s):
Host range (explain):
Agrobacterium spp.
Name species:
Other (specify):
4.
Nature of the Inserted DNA (attach additional pages if needed)
5.
Supplemental page for additional entries (if needed): http://www.cpp.edu/~ehs/biosafety/IBC.shtml
Supplemental Pages Attached?
Yes
Source Organism of DNA
(List genus/species or common
name e.g., Human, E. coli, etc.)
List each inserted DNA and describe function/activity
(transgene name, biological markers, sequences, promoters, etc.)
Cal Poly Pomona – Institutional Biosafety Committee
Form 1, IBC Application 10/28/14
Page 9
Explain Potential Hazard
If applicable,
(e.g., oncogenic, toxic,
describe foreign
increase virulence/risk,
gene product
affect known treatment, etc.)
4. Host(s) and Containment Conditions (Consult the NIH Guidelines):
HOST – (propagation, expression, transfection of vector construct)
Check all that apply
Lab Containment
(e.g., BSL-1 to BSL-2)
If use in animal/plant, list
host species /containment
Lab Containment
Animal/Plant Containment
Lab Containment
(e.g., BSL-1 to BSL-2)
For transplant, specify
species host /containment
(e.g., mouse /ABSL1 to ABSL2)
E. coli K12 Name derivative or strain:
Other bacteria (list genus/species/strain)
TISSUE CULTURE
Source (Species)
(e.g. Human, Mouse,
Rhesus macaque, etc.)
Type
(e.g. established,
primary, etc.)
Specific Cell Designation
(e.g. HEK, 293, etc.)
Animal (Infection) Subjects (list species):
Animal Containment
Human Subjects
ABSL-1
ABSL-2
ABSL-2+
ABSL-1
ABSL-2
ABSL-2+
ABSL-1
ABSL-2
ABSL-2+
ABSL-1
ABSL-2
ABSL-2+
ABSL-1
ABSL-2
ABSL-2+
BSL-1
BSL-2
BSL-2+
Plant Subjects (list genus and species):
Plant Containment
Other Host (specify):
BSL-2P
BSL-2+P
BSL-1P
BSL-2P
BSL-2+P
Containment
For large scale vector-construct propagation of >10Liters of culture.
Cal Poly Pomona – Institutional Biosafety Committee
Form 1, IBC Application 10/28/14
BSL-1P
Page 10
BSL-1Large Scale
BSL-2Large Scale
BSL-2+Large Scale
SECTION X: INFECTIOUS MATERIALS
For any of these items, list each material separately (attach additional page if needed):
Supplemental page for additional entries (if needed): http://www.cpp.edu/~ehs/biosafety/IBC.shtml
Supplemental Pages Attached?
Yes




Infectious organism (Bacteria, Fungi, Parasites, Prions, Rickettsias, Viruses, Yeasts, etc.) not containing recombinant DNA.
When listed, include name of the infectious agent and strain (e.g., Adenovirus type 5, HIV-1 NL4-3, Influenza Virus A/WSn/33,
etc.)
Human and nonhuman primate materials including all fluids, tissues, excretions, secretions, or cell lines not containing
recombinant DNA. When listed, include species source and any known viral contaminants/components (e.g., human blood from
HIV patients, Macaque tissue, etc.)
Animals or animal specimens known to be reservoirs/vectors of zoonotic diseases. EXEMPT: Animals from Cal Poly ACUCapproved vendors. When listed, specify animal species and any known contaminants.
Other known or potentially infectious materials.
Name of Material
(Identify genus, species,
strain, or known
contaminants, etc)
Example:
Staphylococcus aureus
Risk
Group
2
Source
(Check all that apply)
PI’s Lab
Commercial vendor
Field
Clinical specimens
Primate Center
Univ. Collaborator (specify PI’s name):
Other:
PI’s Lab
Commercial vendor
Field
Clinical specimens
Primate Center
Univ. Collaborator (specify PI’s name):
Other:
PI’s Lab
Commercial vendor
Field
Clinical specimens
Primate Center
Univ. Collaborator (specify PI’s name):
Other:
PI’s Lab
Commercial vendor
Field
Clinical specimens
Primate Center
Univ. Collaborator (specify PI’s name):
Other:
PI’s Lab
Commercial vendor
Field
Clinical specimens
Primate Center
Univ. Collaborator (specify PI’s name):
Other:
Cal Poly Pomona – Institutional Biosafety Committee
Form 1, IBC Application 10/28/14
Page 11
Laboratory
Containment
Animal/Plant/Human
Subjects Exposure
Host
Species
BSL2
Mouse
Rat
Containment
ABSL2
ABSL2
Large
Scale
(>10L of
culture)
N/A
SECTION XI: PROGRESS REPORT – MUST BE COMPLETED IF THIS IS A RENEWAL
Please indicate the statement that applies to your project:
1.
YES
NO
NOT APPLICABLE
Have any adverse events occurred in the last approval period?
2.
YES
NO
NOT APPLICABLE
Have there been any overt spills related to this protocol?
If yes, please provide details of events (including notification being sent to the IBC) and what was done to prevent this
type of event from recurring?
3.
YES
NO
Have there been any accidental exposures related to this protocol, not limited to your lab staff?
If yes, please provide details of events (including notification being sent to the IBC and/or Worker’s Compensation) and
what was done to prevent this type of event from recurring?
4.
YES
NO
Has there been accidental release to the environment of any of the regulated biohazard agent
including transgenic animals/plants related to this protocol?
If yes, please provide details of events (including notification being sent to the IBC and/or other oversight committees)
and what was done to prevent this type of event from recurring?
5.
YES
NO
Were any of these events described above reported to the IBC immediately following the
incidents? If no, please explain.
Cal Poly Pomona – Institutional Biosafety Committee
Form 1, IBC Application 10/28/14
Page 12
SECTION XII: PRINCIPAL INVESTIGATOR’S ASSURANCE
1. I attest that the information contained in the attached application is accurate and complete to the best of my
knowledge.
2. I agree to comply with the requirements pertaining to the possession, use, transfer, and disposal of all regulated
biologically hazardous materials in accordance to all applicable federal, state, and local laws and regulations and in
alignment with University and EH&S policies and procedures.
3. I have read and understand my responsibilities as Principal Investigator outlined in Section IV-B-7 of the NIH
Guidelines and agree to comply with these responsibilities.
4. I attest that prior to the start of this project, all persons involved (including my collaborators) will be:
 adequately trained in good microbiological techniques and practices,
 have received instruction on any specific hazards associated with the project and worksite,
 aware of any specific safety equipment, practices, and behaviors required for the procedures and use of the
facilities, and
 familiar with appropriate emergency procedure response (e.g., spills, accidental exposure, environmental release)
to ensure safety will be followed.
5. I hereby adopt the current edition of CDC/NIH Biosafety in Microbiological and Biomedical Laboratories as the
principal biosafety manual for my laboratory with laboratory specific standard operating procedures, or, I will provide a
supplemental manual in addition to, or in place of, the CDC/NIH manual as deemed necessary or when specifically
requested by the IBC. I understand that this biosafety manual must be approved by the IBC before research can
commence.
6. I will abide by the reporting requirements and submit a report to the IBC for activities that may include, but not limited to
the following:
 All accident that results in exposure to the infectious agents or recombinant DNA or danger of environmental
contamination.
 All spills outside a physical containment equipment (e.g., outside biosafety cabinet, outside centrifuge, etc).
 All problems pertaining to operation, implementation of containment safety procedures or equipment, facility failure,
or breach in security (facility and/or biological agent).
 Any new information bearing on the Guidelines such as technical information relating to hazards and safety
procedures or innovations.
7. I understand my responsibility with regard to laboratory safety and certify that the protocol as approved by the IBC will
be followed during the period covered by this research project. I certify that no work will be initiated or modified until
approval has been issued by the IBC, other appropriate oversight committees and all sponsoring agency requirements
have been met.
Signature of Principal Investigator (either electronic signature or a scanned/emailed version)
Date:
Signature of Faculty Sponsor (Required if PI is non-Cal Poly faculty member)
Date:
Cal Poly Pomona – Institutional Biosafety Committee
Form 1, IBC Application 10/28/14
Page 13