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 . For questions or additional information, call 909 869-4987 or email . 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 .
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 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: 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 .
*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):
Use of 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 Animal*
(e.g., field, commercial supplier)

*Note: If the source of animal is from a commercial supplier, please indicate the name of the 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.
SECTION V: PERSONNEL
In addition to taking the required EH&S safety trainings, each person working on the project is required to receive formal, agent-specific 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 .
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
e.g. staff researcher / Responsibilities
Check all that apply / Biosafety Office Use Only
(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 MWM
BSL2 BBP
Herpes B ATD
HazWaste Respirator
Other:
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 MWM
BSL2 BBP
Herpes B ATD
HazWaste Respirator
Other:
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 MWM
BSL2 BBP
Herpes B ATD
HazWaste Respirator
Other:
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 MWM
BSL2 BBP
Herpes B ATD
HazWaste Respirator
Other:
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 MWM
BSL2 BBP
Herpes B ATD
HazWaste Respirator
Other:
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):
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 Biosafety Cabinet Storage
Centrifuging Chemical Fumehood Microscope
Core Facility (specify): Other (specify):
Bench work Biosafety Cabinet Storage
Centrifuging Chemical Fumehood Microscope
Core Facility (specify): Other (specify):
Bench work Biosafety Cabinet Storage
Centrifuging Chemical Fumehood Microscope
Core Facility (specify): Other (specify):
Bench work Biosafety Cabinet Storage
Centrifuging Chemical Fumehood Microscope
Core Facility (specify): 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 Animal housing room (Biohazard)
Euthanasia procedure Animal return room (nonBiohazard)
Other (specify):
Animal handling room Animal housing room (Biohazard)
Euthanasia procedure Animal return room (nonBiohazard)
Other (specify):
Animal handling room Animal housing room (Biohazard)
Euthanasia procedure Animal return room (nonBiohazard)
Other (specify):
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 storage
Drug/gene/vaccine administration Handling of clinical samples
Other (specify):
Drug/gene/vaccine preparation Drug/gene/vaccine storage
Drug/gene/vaccine administration Handling of clinical samples
Other (specify):
Drug/gene/vaccine preparation Drug/gene/vaccine storage
Drug/gene/vaccine administration Handling of clinical samples
Other (specify):
4.  List ALL locations for whole plant experiments
Building / Room(s) # / Room Functions (Check all that apply)
Laboratory Growth Chamber Greenhouse Field Plot
Other (specify):
Laboratory Growth Chamber Greenhouse Field Plot
Other (specify):
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.)