Institutional Biosafety Committee
Protocol Submission Form
Institutional Biosafety Committee Use Only
Date Received
BSL
Protocol Number
Approved?
Yes
No Date
IBC Chair
Signature
The USC Institutional Biosafety Committee (IBC) is the institutional review body responsible for
oversight of all research activities that involve microbiological agents and/or toxins as required and
outlined in the National Institutes of Health Guidelines for Research Involving Recombinant DNA
Molecules (NIH Guidelines) and the Centers for Disease Control and Prevention (CDC) Biosafety in
Microbiological and Biomedical Laboratories.
ALL RESEARCHERS who work with one or more of the materials listed under “Materials Used”
MUST complete and submit this form to the IBC for approval via email to shedayati@caps.usc.edu. If
you have any questions, contact Environmental Health and Safety at (323) 442-2200.
GENERAL INFORMATION
Application Status:
Title of Project:
Principal Investigator:
Department:
New Application
Three Year Renewal
Degree:
Academic Title:
Mailing Address:
Telephone:
Co-Investigator(s):
Lab Supervisor/Manager:
Funding Agency:
Project Funded?
Y
N
List Research Location(s) – building/room(s):
UPC:
HSC:
Other USC site(s) including leased space:
Mail code:
Fax:
Tel:
Tel:
Email:
Email:
Email:
Proposed Start Date:
Did this facility grant approval for this study? (if
Non-USC Facility (list each below):
yes, attach a copy of IBC approval letter or equivalent
to this protocol)
Y
Y
Y
N
N
N
Institutional Biosafety Committee Protocol Submission Form – 8/16/2005
Pending
Pending
Pending
Not Required
Not Required
Not Required
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MATERIALS USED
Yes
No
Select all materials this project will use or produce:
Recombinant DNA, gene transfer, host vector systems
Creation of transgenic or other genetically modified plants or
animals
Animals inoculated with or exposed to hazardous materials
Human subjects
Radiation
Infectious agents (Bacteria, Virus, Yeast, Fungus, Parasitic Agents)
Human/Non-Human Primate material including established human
cell lines
CDC Select Agents
DEA Chemical Precursors
Known Carcinogens/Toxins/Mutagens
If “Yes,”
complete this
addendum:
I
I
II
III
IV
V
VI
VII
VII
VII
PERSONNEL / TRAINING
A. Describe the Principal Investigator(s)’s qualifications and training that are relevant to the
procedures this project will employ. Specify years of experience. If the Principal Investigator does
not have relevant qualifications or experience, explain how the required expertise and training will
be provided. New USC Faculty must attach a curriculum vitae or NIH biosketch to this form.
B. List ALL personnel working under this protocol. All such employees, including the Principal
Investigator, are required to receive formal training in the safe use and handling of potentially
hazardous materials prior to commencement of this project. The IBC may require that training be
provided by someone other than the Principal Investigator.
(List additional personnel together in last row; When personnel change, submit Modification Form.)
Name
ID #
Degree
Job title
Procedures Training
Years of performed Completed?
experience (from Project IBC use
Desc. below)
PI:
#
years
#
#
years
#
#
years
#
#
years
#
#
years
#
#
years
#
#
Institutional Biosafety Committee Protocol Submission Form – 8/16/2005
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#
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PROJECT DESCRIPTION
Provide a detailed summary of the project in lay language, including the overall experimental design:
To enable the IBC to evaluate the risks associated with this project, please specify any experimental
procedures associated with this project that may expose lab workers to hazardous agents (identified
above) and explain the procedures that personnel will use to reduce the risk. Describe any risk-reducing
devices (e.g., engineered sharps protective devices) that this project will employ.
List procedures and devices below. Cross reference each procedure with personnel in Section B.
1.
OCCUPATIONAL HEALTH
All employees who have occupational exposure to potentially hazardous materials must be aware
of their risk of exposure to the specific materials as well as control measures that reduce or
eliminate the exposure risk. Document discussion of this information.
Have all employees who work with human material been offered the Hepatitis B vaccine?
Are other test/vaccines required for this protocol?
Y
Y
N
N
If yes, identify each:
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SAFETY EQUIPMENT
Date of last laboratory inspection (IBC use only):
Biosafety cabinet type(s):
Location(s):
Certification date(s):
Fume hood used?
Y
Location(s):
Certification date(s):
N
N/A
List all engineered sharps employed (e.g., needles, cutting tools, etc). An ‘engineered sharp’ has a
physical attribute built into the device that effectively reduces risk of an exposure incident (e.g., hinged
needle shields, retractable needles, needleless IV connectors, etc.). Use of engineered sharps is
required, unless the IBC granted prior authorization.
Manufacturer(s) and Model(s):
If engineered sharps cannot be used, explain why:
Personal Protective Equipment worn while handling agents:
Disposable gloves
Eye protection
Dust mask
Lab Coat/ Overalls
Full face shield
Fitted respirator
Shoe covers
Head cover
Other:
Disinfectant(s) used:
Contact time:
Concentration:
(Bleach solutions must be made daily)
TRANSPORTATION / SHIPPING
Containers used to transport materials between locations must meet applicable Department of
Transportation requirements and be properly labeled, sealed, leak-proof, and puncture resistant.
Check ALL that apply:
Materials will not be transported outside of the laboratory where used.
Materials will be hand carried on campus from:
to:
Materials will be transported by vehicle from:
List all individuals who will transport materials in a vehicle:
to:
Materials will be transported to campus from the following off site location(s):
List all individuals who will transport materials from off-site:
Materials will be shipped off campus (using Fed-Ex, etc.).
Attach copies of current Shipper Training Certifications for persons who initiate
shipments (contact EH&S at (323) 442-2200 for training).
Contact Contracts and Grants Dept. if a Material Transfer Agreement Form is needed.
Institutional Biosafety Committee Protocol Submission Form – 8/16/2005
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SECURITY
Describe how you will secure and limit access to laboratories where hazardous materials
are used or stored:
Physical
Security:
Card key access
Keys issued by PI
Lock doors when unoccupied
Use Equipment Locks
Other:
No unauthorized personnel allowed
Internal
Security
Procedures:
Escort all Guests and Visitors
Escort Housekeeping and Maintenance personnel
Other:
WASTE DISPOSAL
My lab will produce (check appropriate boxes):
Biological Waste consisting of:
Sharps waste
Solid waste
Liquid waste
Pathological waste
Infected animal carcasses
Carcinogenic/Toxic Waste consisting of:
Solid waste
Excess and expired carcinogenic chemicals or toxins
Carcinogenic animal carcasses
Chemical remains and contaminated bedding
Other:
EMERGENCY PROCEDURES
In case of an exposure incident, my lab personnel are instructed to obtain treatment at the
following location:
Health Sciences Campus:
Ambulatory Health Care Center (Health Care Consultation II)
University Park Campus:
Faculty/Staff Clinic (Student Health Services)
After Hours/Weekends:
Good Samaritan Hospital 1225 Wilshire Blvd, Los Angeles 90017
Other:
Institutional Biosafety Committee Protocol Submission Form – 8/16/2005
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INVESTIGATOR’S ASSURANCE
1. I confirm that all persons involved with this project (including my collaborators) have been
adequately trained in good microbiological techniques, have received instruction on any specific
hazards associated with the project and worksite, and are aware of any specific safety equipment,
practices and behaviors required while conducting project procedures and using these facilities.
The IBC may review my records documenting this instruction.
2. I will immediately report to the Biosafety Officer any accident, injury, spill of biohazardous
material, equipment or facility failure (i.e., ventilation failure), and /or any breakdown in procedure
that could result in potential exposure of laboratory personnel, staff or the public to biohazardous
or toxic material.
3. I confirm that any proposed changes to my work that would result in an increased level of
biohazard will be reported to the IBC before the change is implemented.
4. I confirm that no work that requires IBC approval will be initiated or modified until approval is
received.
5. I will notify the IBC of all personnel changes or additions, including students and volunteers,
through use of the Protocol Modification Form.
6. I will provide refresher safety training that includes hazards specific to this project at least annually
for all personnel who work with or work near any hazards associated with this protocol. The IBC
may review my records documenting this instruction.
7. I have read and understand my responsibilities as Principal Investigator outlined in Section IV-B-4
of the NIH Guidelines, and agree to comply with these responsibilities.
8. I certify that the information provided within this application is accurate to the best of my
knowledge. I also understand that, should I use the project described in this application as a basis
for a funding proposal (either intramural or extramural), I am responsible for ensuring that the
description of procedures in the funding proposal is identical in principle to that contained in this
application.
9. I confirm that all persons involved with this protocol will comply with all environmental laws and
regulations and that this project does not significantly impact the environment.
Investigator’s Signature:
Date:
Institutional Biosafety Committee Protocol Submission Form – 8/16/2005
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ADDENDUM I.
Quick Reference to the NIH Guidelines for use of rDNA.
Yes
No
Does the protocol involve transfer of a drug resistance trait to an organism that does not
acquire it normally? (check “No” for standard drug resistance, e.g., ampicillin into E. coli)
Does rDNA contain gene coding for the synthesis of molecules toxic to vertebrates?
Will rDNA be used in human gene transfer experiments?
Are any human or animal pathogens used either as a host organism or as a vector?
Will any DNA from Risk Group 2, 3, or 4 agents or restricted organisms be cloned into
non-pathogenic prokaryotic or lower eukaryotic host vector systems?
Does any rDNA or RNA manipulation involve the use of defective animal or plant viruses
in the presence of a helper virus in tissue culture systems or in animals?
Does any rDNA or RNA manipulation involve the use of infectious animal or plant viruses
in tissue culture systems or in animals?
Do any rDNA molecules contain greater than one-half of any eukaryotic viral genome?
Does any rDNA manipulation involve whole animals or plants?
Will this protocol involve any large-scale experiments (i.e., more than 10 liters of culture)?
NATURE OF INSERT
List Genus/Species or common name of the source organism of the insert DNA.
List gene names, biological markers, sequences, promotors, etc., and describe the
function/activity of the DNA or its product.
Institutional Biosafety Committee Protocol Submission Form – 8/16/2005
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Which of the following host-vector systems will be used for this research?
(Check box(es) and provide further details as requested.)
VECTOR:
Bacterial plasmids
Name plasmids:
Retrovirus:
Vector backbone:
Murine Name strain:
Agrobacterium spp.
Name species:
Other:
Is the host range
Baculovirus
Adeno-associated virus
amphotropic or
ecotropic?
Lentivirus:
Name HIV genes present or attach map:
Adenovirus
Name strain:
Describe wild type deletions:
Name envelope packaging system(s):
Vaccinia virus
Other:
Host range:
If a virus-derived vector system that is engineered to be replication-incompetent will be used,
please explain below how this has been achieved using details, maps, references, etc. Also, describe
how you will assure that your vector material is free from contamination by replicationcompetent virus (RCV).
For all virus-derived vector systems, also complete Addendum V—even if you consider the formation
of an RCV to be a very remote possibility.
HOST
Indicate the host(s) used to propagate vector plasmid that will generate recombinant virus:
E. coli K12
Name derivative or strain:
Other bacteria
Give genus/species/strain:
Laboratory animals
Name species:
Tissue culture: Cell designation:
(Check all that
apply)
Human
Established cell line
Primary cell culture
Transformed cell line
Non human primate
Other:
Other host:
Will you attempt to express a foreign gene?
If so, what protein(s) will be produced?
No
Institutional Biosafety Committee Protocol Submission Form – 8/16/2005
Yes
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ADDENDUM II.
IACUC Protocol Number:
Approval Date:
Also complete the Animal Holding Room Door Sign on page 11.
(Questions? Contact Animal Resources at (323) 442-1692.)
Species of animal (include invertebrates and vertebrates):
Field caught?
Yes
No
(Use of animals that are potential reservoirs of zoonotic diseases)
Transgenic or other genetically modified animals?
Yes
No
A. Infectious agents or vectors used in live animals?
If yes, identify:
Yes
No
B. Hazardous chemicals/toxins in animals?
If yes, identify:
Yes
No
If question A. or B. above was answered “Yes,” complete questions below.
Maximum infectious/hazardous dose per animal:
Maximum infectious units per dose:
Method of Delivery:
Animal anesthetized during injections of agent:
Animal restrainers used for injecting hazardous materials:
Yes
Yes
No
No
Agent excreted/shed?
Yes
No
If yes, explain the measures your lab will take to prevent accidental exposure to employees, students,
visitors and other animals:
Institutional Biosafety Committee Protocol Submission Form – 8/16/2005
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University of Southern California
Environmental Health & Safety (323) 442-2200
ANIMAL HANDLER PRECAUTIONS
Building:
Room number:
Date:
IACUC PROTOCOL:
Radiation Safety Permit #:
IBC # (biologicals):
IBC # (chemicals):
The animals in this program are part of an approved experiment involving biohazardous organisms,
radioactive materials and/or chemical toxins. Precautions checked below apply to this experiment.
Principal Investigator:
Phone:
Emergency contact person:
Phone:
Identified hazard(s):
The researcher or his/her technicians are responsible for the feeding and care of these animals.
Individual cages are labeled with appropriate warning labels.
The following items must be assumed to be contaminated with hazardous materials and must be
handled only by the researcher or his/her technicians:
Cage
Water bottle
Bedding
Animal carcasses
Equipment (specify):
.
Environmental Health and Safety MUST dispose of animal carcasses; call EH&S at 323-442-2200.
ALL contaminated waste must be disposed of through EH&S at 323-442-2200.
Filter top cages MUST be opened in a biological safety cabinet.
The following personal protective equipment MUST be worn/used in this room:
Lab coat/Coveralls
Head cover
Eye protection
Shoe covers
Surgical mask
Gloves (double)
Respirator (list make/model/type filter):
Other:
.
Hands MUST be thoroughly washed upon leaving the room.
Current Medical Surveillance Clearance is required for entry.
Other:
.
Institutional Biosafety Committee Protocol Submission Form – 8/16/2005
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ADDENDUM III.
IRB protocol number:
If you have questions, contact:
Approval date:
HSC IRB (323) 223-2340
UPC IRB (213) 821-5272
Briefly describe any research involving human subjects:
Will rDNA be used in human gene transfer experiments?
Will rDNA be used in human subjects?
Yes
Yes
No
No
Institutional Biosafety Committee Protocol Submission Form – 8/16/2005
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ADDENDUM IV.
Radiation Safety permit number:
For questions contact Environmental Health and Safety at (323) 442-2200.
Indicate whether the following will be used.
Radioactive material(s)?
Identify:
Yes
Radiation producing device(s)?
Identify:
X-ray producing device(s)?
Identify:
No
Yes
Yes
No
No
Institutional Biosafety Committee Protocol Submission Form – 8/16/2005
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ADDENDUM V.
List ALL potentially infectious agents used in this project.
Agent
(e.g., E.coli)
Risk Biosafety
Group
Level
1-4* (BSL 1-4)
Aerosol Producing
Procedures
Building Room #
Room
Function
* Contact Environmental Health and Safety immediately at (323) 442-2200 if you plan to work with agents in
NIH Risk Group 3 or 4.
Institutional Biosafety Committee Protocol Submission Form – 8/16/2005
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ADDENDUM VI.
Human/Non Human Primate Material Used
Material
Name/Description
Source
Primary
Material
Whole blood/serum
Blood component
Unfixed tissue
Established cell
lines
Cells
OPIM (Other
Potentially Infectious
Materials)
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Types of manipulations:
Centrifugation
Blending/Mixing
Sonification
Other:
Dissection
Institutional Biosafety Committee Protocol Submission Form – 8/16/2005
Pipetting
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ADDENDUM VII.
Known Carcinogen/Toxin/Mutagen
(Include Floor Plan)
CDC Select Agent
(Include Floor Plan)
DEA Chemical Precursor
(No Floor Plan needed)
Complete one page for each substance.
Agent Name:
BSL (if appropriate):
Source Laboratory or Site:
Source Address:
Source Email:
Source Phone:
Total amount purchased:
Location stored:
Location used:
Initial concentration:
Final (usage) concentration:
Expected Frequency of Use (e.g., daily, 1x/month)
Expected Duration per Use (e.g., <1 hour, 2-4 hrs):
Dilution procedures:
Describe the safe handling and disposal procedures that will be used for this agent.
Describe the air-handling system for the location(s) where the work will be performed (e.g., passthough or recirculated, type of filters, method for handling safety cabinet and fume hood exhaust).
If working with a known carcinogen/toxin/mutagen or CDC Select Agent, attach a sketch/floor
plan (not blueprints) for laboratory(ies) where work will be performed.
Show location of entry points, fume hoods, biosafety cabinets, incubators, freezers, autoclaves and
other equipment specified in the BMBL, NIH Guidelines, 29 CFR 1910, or other reference document
as recommended for work with these agents. Mark air supply and exhaust vent locations.
Institutional Biosafety Committee Protocol Submission Form – 8/16/2005
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