California State Polytechnic University, Pomona

Institutional Biosafety Committee (IBC)

FORM 2 Registration of Research Involving

Use of Human, Nonhuman Primate Material, and Other Mammalian Cells and Tissues

(all fluids, tissues, excretions, secretions, and cell lines)

INSTRUCTIONS:

All submissions– must be typed. E-mail a complete form toMichael DeSalvio, Biosafety Specialist, Environmental Health and Safety – Attn.: Institutional Biosafety Committee . For questions or additional information, call 909 869-4987 or email . Keep a copy of this application for your records.

NOTE: Do not use Form 2if the project involves recombinant or synthetic nucleic acids, materials containing recombinant or synthetic nucleic acid molecules, and/ordirect use of infectious organisms (bacteria, virus, fungi, prions, rickettsias, yeasts, and parasites). Instead use Form 1.

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 Form 2 to .
I –General Project Info IV – List of Biological Materials VII – Occupational Health
II - Ancillary Committee V – Personnel VIII – Progress Report
III –Project Description VI –Location of Project IX – PI Assurance Other (specify):
Principal Investigator’s Name (last, first): / Degree:
Department: / Position: Faculty Staff Student Visiting Scholar Resident Post-doc Fellow Other If other, specify:
Campus Address:
Office Phone: / Lab Phone: / Emergency Phone: / Fax:
Email:
Co-Principal Investigator’s Name (last, first): / Degree:
Department: / Position: Faculty Staff Student Visiting Scholar Resident Post-doc Fellow Other 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 / Date:
SECTION II: ANCILLARY COMMITTEE
Type of Committee / Yes / No / N/A / Pending
(date submitted) / Protocol Number / Most Recent
Approval Date
IRB (Institutional Review Board)
ESCRO (Embryonic Stem Cell Research Oversight)
ACUC (Animal Care and Use Committee)
Radiation Safety Committee
Other (specify):
SECTION III: PROJECT DESCRIPTION
1.List 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 and how the materials will be used. For 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.
SECTION IV: LIST OF BIOLOGICAL MATERIALS: Check all that apply
Category / Type of Biological Material / Source of Materials
HUMAN MATERIALS
If any human materials are to be used in animals, indicate the species in the space provided. / Blood Blood components Blood products
Unfixed tissue Unfixed organs
Culture growth media/solutions
Cell lines (established, primary, secondary, etc) - specify:
Materials known to be infected with HIV, HBV, HCV, or other BBP (specify):
Other bodily fluids/tissues/excreta and/or cultures from humans (specify):
Use of Human Materials in Live Animals. If checked, list all animal species in which human materials will be used in the subsection below. / PI’s Laboratory
Clinical specimens
Field
Commercial vendor
Univ. Collaborator (name):
Other (specify):
Species / Specify Materials
(e.g. cell lines, blood, bodily fluids, tissue, culture, etc.): / Source of Materials
(e.g., field, primate center, etc.)
NONHUMAN PRIMATE MATERIALS / Species / Specify Materials
(e.g. cell lines, blood, bodily fluids, tissue, culture, etc): / Source of Materials
(e.g., field, primate center, etc)
Cells or Tissue from Animals known to be vectors/reservoirs of zoonotic diseases
(Exempt: Rodents from DLAM approved vendors) / Species / Specify Materials
(e.g. cell lines, blood, bodily fluids, tissue, culture, etc): / Source of Materials
(e.g., field, commercial vendor)
SECTION VII: LIST ALL PERSONNEL FOR THIS PROJECT (attach additional pages if needed)
Supplemental page for additional personnel (if needed): Supplemental Pages Attached? Yes
Name (last, first) / Position Title
e.g. staff researcher / Responsibilities
Check all that apply / Biosafety Office Use Only
(Records must be current)
Directly handle biohazard material including medical waste
User of equipment where biohazards are present
Directly handle animal exposed to biohazard material
Shipping biohazard materials
Handling of hazardous chemicals with biohazard
Other (specify): / BSC BBP
BSL2 ATD
Hep B MWM
Respirator HazWaste
Other:
Directly handle biohazard material including medical waste
User of equipment where biohazards are present
Directly handle animal exposed to biohazard material
Shipping biohazard materials
Handling of hazardous chemicals with biohazard
Other (specify): / BSC BBP
BSL2 ATD
Hep B MWM
Respirator HazWaste
Other:
Directly handle biohazard material including medical waste
User of equipment where biohazards are present
Directly handle animal exposed to biohazard material
Shipping biohazard materials
Handling of hazardous chemicals with biohazard
Other (specify): / BSC BBP
BSL2 ATD
Hep B MWM
Respirator HazWaste
Other:
Directly handle biohazard material including medical waste
User of equipment where biohazards are present
Directly handle animal exposed to biohazard material
Shipping biohazard materials
Handling of hazardous chemicals with biohazard
Other (specify): / BSC BBP
BSL2 ATD
Hep B MWM
Respirator HazWaste
Other:
Directly handle biohazard material including medical waste
User of equipment where biohazards are present
Directly handle animal exposed to biohazard material
Shipping biohazard materials
Handling of hazardous chemicals with biohazard
Other (specify): / BSC BBP
BSL2 ATD
Hep B MWM
Respirator HazWaste
Other:
Directly handle biohazard material including medical waste
User of equipment where biohazards are present
Directly handle animal exposed to biohazard material
Shipping biohazard materials
Handling of hazardous chemicals with biohazard
Other (specify): / BSC BBP
BSL2 ATD
Hep B MWM
Respirator HazWaste
Other:
Directly handle biohazard material including medical waste
User of equipment where biohazards are present
Directly handle animal exposed to biohazard material
Shipping biohazard materials
Handling of hazardous chemicals with biohazard
Other (specify): / BSC BBP
BSL2 ATD
Hep B MWM
Respirator HazWaste
Other:
SECTION VI: LOCATION(S) OF PROJECT
List all locations where the materials will be collected, handled, stored, transported, etc. including human cell line work in animals.
Building
(e.g. 4) / Room(s)
(e.g. 3-348) / Purpose
(e.g. Blood collection, tissue culture hood, etc)
SECTION VII: OCCUPATIONAL HEALTH/IMMUNIZATION PROGRAM
Check the box to ensure compliance:
All employees listed for this project must be offered the Hepatitis B Virus (HBV) vaccination at no charge to them and have been instructed on how to receive the vaccination (student health center, industrial clinic, designated health care provider or with their personal physician). This is documented and on file in the PI’s laboratory.
All employees who have declined the HBV vaccination have signed the HBV Vaccination Declination statement and this record is on file in the PI’s laboratory.
All employees, prior to initiation of work, will be given information on what to do in case of an accidental exposure including post-exposure evaluation and follow-up evaluation specific for the hazard (e.g., EH&SLabworker HIV/BBP Information Card 2008, First Aid Kit for Herpes B virus, etc).
SECTION VIII: PROGRESS REPORT – MUST BE COMPLETED IF THIS IS A RENEWAL
For new applications, check “Not Applicable” for all statements.
Please indicate the statement that applies to your project:
1. YES NO NOT APPLICABLEHave there been any spills related to this project?
2. YES NO NOT APPLICABLEHave there been any accidental exposures related to this project?
3. YES NO NOT APPLICABLEHave there been any accidental needlestick injuries related to this project?
4. YES NO NOT APPLICABLEHave there been any incidents of non-compliance related to this project?
If yes, please provide a description of the event(s) and what was done to prevent this type of event from recurring?
SECTION IX: 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.
  1. 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 including but not limited to, CAL/OSHA Bloodborne Pathogen Standard, the CDC Biosafety in Microbiological and Biomedical Laboratories (5th ed).
  1. I attest that prior to start of this project, I will have available a laboratory-specific Bloodborne Pathogen Exposure Control Plan that meets the CAL/OSHA requirement (8CCR§5193).
  1. All persons involved (including my collaborators) prior to initiation of project will:
  • have taken the initial in-class Bloodborne Pathogen training and annually thereafter through Environment, Health & Safety (EH&S) or other available BBP training that meets the CAL/OSHA requirement (8CCR§5193). Training certificates will be kept on file in the PI’s laboratory.
  • have received instruction on any specific hazards associated with the project and worksite and taken job-specific safety trainings to ensure safety of all personnel and the outside environment and to comply with regulations and guidelines. Training certificates will be kept on file in the PI’s laboratory.
  • have read the laboratory-specific Bloodborne Pathogen Exposure Control Plan that meets the CAL/OSHA requirement (8CCR§5193). Documentation will be kept on file in the PI’s laboratory.
  • aware of any specific safety equipment, practices, and behaviors required for the procedures and use of the facilities.
  • be familiar with appropriate emergency procedure response (e.g., spills, accidental exposure, environmental release) to ensure safety.
  1. 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.
  • Allovertspills and spills outside a physical containment equipment (e.g., outside biosafety cabinet, outside centrifuge, etc).
  • Any problems pertaining to operation, implementation of containment safety procedures or equipment, facility failure, or breach in security (facility and/or biological agent).
  1. 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) / Date:

Cal Poly Pomona IBC Application – Attachment A

Identification of High-Risk Procedures Involving Biohazardous Materials

Please identify any high-risk procedures that will be performed using the biohazard materials identified in the IBC application. Procedures performed using non-biohazardous materials do not need to be included. Please also provide safety precautions that will be employed by your laboratory when performing these procedures.

The procedures listed below could result in an exposure to biohazardous materials through:
  1. Aerosols,
  2. Splashes and/or Sprays,
or
  1. Physical Injury (e.g., needlestick, laceration)
/ Identify which procedures are performed for biohazard work by indicating YES/NO.
(include all procedures performed in the lab, animal facility and core facility if performed by lab staff or if lab staff will be present) / If yes, what biohazardous materials will be used during these procedures? / Specify all safety precautions that
will be employed for each procedure
(see examples below)
  • Engineering Controls
(e.g., biosafety cabinet, chemical fumehood, aerosol-tight centrifuge safety devices, sharps safety devices, benchtop splash shield)
  • Personal Protective Equipment (PPE)
(e.g., gloves, lab coat, N95 respirator, surgical mask, face shield, disposable gown)
  • Safety Practices
(e.g., no open vessels outside of the biosafety cabinet, special decontamination procedures, post signage/restrict access during procedure)
EXAMPLE: Centrifugation / Yes / Live human cells,
Lentivirus / Aerosol-tight centrifuge safety cups, gloves, lab coat, safety cups are only opened inside of the biosafety cabinet, safety cups are decontaminated before and after each use
Centrifugation
Sonication
Vortexing
Homogenization
Flaming of inoculating loops
Use of incubating shaker
Placing biohazard materials under pressure
Use of Needle/Syringe
Use of Sharps other than needles
Animal cage changing
Intranasal inoculation of animals
Necropsy of biohazardous animals*
Fluorescence activated cell sorting (live cells only)
Fluorescence activated cell analysis (live cells only)
Use of stereotactic devices/specialty equipment
Imaging of live cells
Other (please specify):

*Animal Care and Use Committee approval may be required before IBC approval can be given.

Cal Poly Pomona – Institutional Biosafety CommitteePage 1

Form 1, IBC Application 10/28/14