University of Colorado Denver
BIOSAFETY APPLICATION AND AUTHORIZATION
Instructions for Completing the Application Form, Review, and Authorization Process
If you have difficulty with this form please contact the Biosafety Office for assistance.
The Dept. of Environmental Health & Safety, Biosafety Office and the Institutional Biosafety
Committee, exercise oversight for all CU Denver and Anschutz Medical Campus activities involving
biological (infectious) agents or materials*, to include all research, academic and field activities, to
ensure that employees, students, the public and the environment are protected from biological hazards
associated with CU Denver operations.
Institutional Biosafety Committee (IBC) review and authorization† is mandatory for research
involving: any recombinant DNA materials, regardless of the source; and any work with Select Agents
and Toxins
Complete this form and any appropriate appendices for your research, electronically, and submit via
email to IBC@ucdenver.edu. Applications and authorizations will be subject to renewal and
review every three (3) years. Amendments for significant changes must be submitted immediately.
Risk Groups (RG) for human and some animal pathogens are as defined in the most current version of
the NIH Guidelines, Appendix B. If you have any questions regarding the infectious nature of your
research materials, contact the Biosafety Office, 303-724-0235. Biosafety Levels for laboratory
containment of materials are as defined in the NIH-CDC Biosafety in Microbiological and Biomedical
Laboratories.
Registration is required for the use or manipulation of any other infectious or potentially infectious
materials to include human blood, bodily fluids, tissues, organs, and cell culture materials.
Recombinant DNA Experiments
The use of any viral vector that may infect vertebrate cells requires IBC authorization prior to the
initiation of any experiments and includes all work with commercially obtained retro-, lenti-, & adenoviral
kits, as well.
The following experiments require Institutional Biosafety Committee review and approval before
initiation. See Section III-D NIH Guidelines for additional details.
 Experiments using Risk Group 2, RG 3, RG 4 ‡ or Restricted Agents as Host-Vector Systems.
 Experiments in which DNA from RG 2, RG 3, RG 4, or Restricted Agents is cloned into
nonpathogenic prokaryotic or lower eukaryotic Host-Vector Systems.
 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.
 Experiments involving all vertebrate and invertebrate animals and the use of recombinant DNA.
 Experiments involving plants and plant pathogens with recombinant DNA.
 Experiments involving more than 10 Liters of culture in a single vessel (Large Scale)
 Experiments involving influenza viruses, subject to IBC oversight.
*
Biological Agents and Materials are defined as: human blood, bodily fluids, tissues, organs,
pathological specimens; human and animal cell culture materials, tumor cell lines or hybridomas; all
bacteria, viruses (to include oncogenic viruses), parasites, other microorganisms; Select Agents and
biological toxins; and all recombinant DNA or RNA materials.
†
Authorization, prior to the initiation of research, is required for research involving non-exempt rDNA,
Select Agents & Toxins, and all Risk Group 3 infectious agents.
‡ Many, but not all microorganisms are listed in their respective Risk Groups in Appendix B, NIH
Guidelines. Additional Agent Summary information may be found in the CDC BMBL.
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IBC registration§ is required for viral vectors that contain less than 1/2 of the wild-type viral genome or
which do not infect or transduce vertebrate cells. Examples of such vectors include:
 Most replication defective retrovirus vectors (usually murine-based)
 Adeno-associated virus vectors (AAV vectors)
 Baculovirus vectors
The following experiments require Institutional Biosafety Committee registration simultaneous with
initiating research. See Section III-E of the NIH Guidelines.
 Experiments Involving the Formation of Recombinant DNA Molecules Containing No More than
Two-Thirds of the Genome of any Eukaryotic Virus.
 Experiments involving E. coli K-12 or Saccharomyces spp. host-vector systems.
Experiments involving the deliberate transfer of drug resistance trait(s) to microorganisms that are
unknown to acquire the trait naturally, require RAC** Review, and NIH Director Approval plus local IBC
approval prior to initiation, covered in Section III-A of the NIH Guidelines, as Major Actions.
Experiments involving the cloning of toxin molecules with an LD50 of <100 nanograms per kilogram of
body weight require RAC, NIH/Office of Biotechnology Activities review and approval and local
Institutional Biosafety Committee approval before initiation, covered in Section III-B of the NIH
Guidelines.
Human Gene Transfer
Experiments involving the deliberate transfer of recombinant DNA, or DNA or RNA derived from
recombinant DNA, into human subjects (Human Gene Transfer) require NIH/RAC registration and
Institutional Biosafety Committee and COMIRB approval before initiation. See the IBC website for
further details.
If you have any questions, please contact the Biosafety Office at 303-724-0235 or send an email to
IBC@ucdenver.edu
§
Registration is for those research projects which only require notification of the IBC and Biosafety
Office, per the University policies and NIH Guidelines.
**
RAC = the Recombinant Advisory Committee of the National Institutes of Health, at the Office of Biotechnology
Activities
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This application is designed to encompass the research activities of your laboratory in a comprehensive
manner. This is a laboratory registration, and is not intended to be limited to a specific grant or project.
Please complete and return the necessary forms by email to: IBC@ucdenver.edu
The form is locked so that the check boxes work. Type information in the indicated grey text boxes. To
expand tables with additional rows, please contact the Biosafety Office, 303-724-0235, 4-7395, 4-5954.
Part I.
Authorization #
Administrative Information
A. Principal Investigator (please only list name(s) of person(s)
Last Name, First Name
Employee ID Number
Email address
School/Dept/Division/Institute:
Mailstop:
Phone:
Fax:
B. Author (form completed by):
Last Name, First Name
Employee ID Number
Email address
C. Campus / Sites where laboratory activities/research will be conducted:
(Expand the table as necessary)
Anschutz Medical Campus
Downtown Campus
Laboratory Bldg & Space Number:
Room Type (Alcove, Module, Cold Room, Procedure Room)
Off-Site:
Complete Physical Address
D. Protocol Associates/ Lab/ Research Personnel:
List each employee/graduate student/pre- or
post-doc or student-worker, or volunteer/intern working in or assigned space in your laboratory.
(Expand this table as necessary by pressing return to move to the next line.)
Last Name, First Name
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Employee ID number
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Employee email address
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E. Funding Source(s): Include department funds, as well as public & private funding. (Expand this
table as necessary by pressing return to move to the next line.)
Funding
Agency
Grant Number
Grant Title
Period of Funding
(from/to)
I acknowledge all requirements and restrictions of the most current NIH Guidelines for the Biosafety
Level approved by the IBC. As the Principal Investigator I accept responsibility for the safe conduct of
the experiments conducted at the Biosafety Level approved by the IBC.
I understand that it is my responsibility to assure that all personnel working in my laboratory with any
hazardous materials are fully informed about their specific dangers, proper actions for safe use and
disposal, steps to take in case of accidents, and are provided with all necessary safety equipment and
instructions in its use.
I understand that it is my responsibility to assure that all personnel working in my laboratory with any of
these hazards are fully informed about their responsibility to report any spills, accidents, exposures, etc.
to the Biosafety Office/Dept. of Environmental Health & Safety and University Risk
Management/Workers Compensation Program as appropriate.
Date
Signature
PLEASE FILL OUT THE REST OF THIS FORM BY ANSWERING ALL SECTIONS APPLICABLE TO
YOUR RESEARCH ENDEAVORS.
The form is locked so that the check boxes work. Type information in the indicated grey text boxes. To
expand tables with additional rows, please contact the Biosafety Office, 303-724-0235, 4-7395, 4-5954.
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Part II.
Research Materials
A. We will use the following research materials: complete all Parts for “Yes”
1. Select Agent Pathogens (http://www.selectagents.gov)
Yes
If Yes, contact the University Responsible Official and Institutional Biosafety Officer for further
instructions and to complete all necessary documents for IBC review and approval.
No
2. Select Agent Toxins: (http://www.selectagents.gov)
If Yes, complete SA Toxins Form Appendix A and submit with this form.
Yes
No
3. Human, animal or plant pathogens or pests
If Yes, complete Part V of this form.
Yes
No
4. Human specimens, tissues, organs, blood, serum, feces, urine, etc.
If Yes, complete Part IV-A of this form.
Tissue bank or repository will be created and maintained.
Yes
No
Yes
No
5. Animal specimens, tissues or organs
If Yes, complete Part IV-B of this form.
Tissue bank or repository will be created and maintained.
Yes
No
Yes
No
6. Primary or immortalized cell cultures or cell lines
If Yes, complete Part IV-C of this form.
Yes
No
7. Toxins and/or chemical compounds, and/or radioisotopes in biological materials
Yes
No
8. Transgenic animals (vertebrate or invertebrate animals)
If Yes, complete Part III and Appendix T, and submit with this form.
Yes
No
9. Transgenic plants or plant pests
If Yes, complete Part III and Appendix P, and submit with this form.
Yes
No
10. Recombinant nucleic acid materials
If Yes, complete Part III of this form.
Yes
No
B. Research Objectives
Briefly describe the manner in which you are planning on using biological materials, pathogens and
chemical and/or radioisotopes in combination with any biological materials in your research.
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Part III.
Use of Recombinant DNA (rDNA)
Use of rDNA materials is regulated by the NIH Office of Biotechnology Activities. Identify the
appropriate class(es) of your research below, to allow the IBC to determine if the NIH Guidelines or
other federal regulations apply to your research. Indicate the appropriate categories of experiments in
the following section(s) for your research. You may need to select multiple categories for the various
types of experiments you will conduct.
A. Recombinant DNA Research, NIH Guidelines
1. Natural or synthetic recombinant DNA or RNA molecules will be used in (check all that apply)
Bacteria / rickettsia
Yeast / fungus
Viruses / viral vectors
Parasites
Primary culture or cell lines
Immortalized culture or cell lines
Whole animals (vertebrate or invertebrate; transgenic or non-transgenic)
Complete Appendix T, and submit with this form
Plants or plant pathogens or pests (transgenic or non-transgenic)
Complete Appendix P, and submit with this form.
2. Recombinant DNA in Culture
Checklist A.
Our experiments will use:
Escherichia coli K-12 or DH5 α host vector systems
Saccharomyces cerevisiae or S. uvarum host vector systems
To determine whether experiments with attenuated laboratory strains of E. coli (e.g. K-12, DH5α) and/or
RG 1 yeast strains are exempt from further IBC review per Section III-F of the NIH Guidelines:
Most experiments involving E. coli K-12 host vector systems and S. cerevisiae and S. uvarum host vector
systems are exempt under Section III-F the NIH Guidelines.
Experiments in E coli BL21 are not covered under this exemption.
If the answer to all 3 of the following questions is “No” your experiments are exempt under Section III-F,
Appendix C-II (for E. coli K-12) or Appendix C-III (for S. cerevisiae and S. uvarum).
Do any experiments involve introduction of genes coding for molecules toxic for vertebrates? (See NIH
Guidelines, Section III-B-1 and Appendix F)
Yes
No
Do any experiments in E coli or yeast host vector systems involve Risk Group 2, 3, or 4 organisms or
nucleic acids from Risk Group 2, 3, or 4 organisms? (See Appendix B, NIH Guidelines)
Yes
No
Will there be any large-scale experiments: more than 10 liters of culture in a single vessel? (See NIH
Guidelines, Section III-D-6)
Yes
No
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Checklist B.
Our experiments will use recombinant DNA in cell or bacterial culture, not listed above:
To identify those experiments subject to IBC review and approval prior to initiation under the NIH
Guidelines. (check all that apply)
Do any experiments involve the deliberate transfer of a drug resistance trait to microorganisms that
are not known to acquire the trait naturally, which could compromise the use of the drug to control
disease agents in humans, veterinary medicine, or agriculture?
Yes
No
If Yes, STOP here and contact the Institutional Biosafety Officer for further instructions.
Recombinant DNA Experiments involving Deliberate Transfer of Drug Resistance in Microorganisms
(NIH Guidelines, Section III-A-1) requires documentation of review and approval at NIH.
Do any of your experiments involve the introduction of genes coding for molecules toxic for
vertebrates with an LD50 of <100 nanograms?
Yes
No
If Yes, STOP here and contact the Institutional Biosafety Officer for further instructions.
Recombinant DNA Experiments Involving the Cloning of Toxin Molecules (NIH Guidelines, Section
III-B) requires documentation of review and approval at NIH.
Is any human or animal pathogen (Risk Group 2, 3, or 4) used as either the host organism or as a
vector? (NIH Guidelines, Section III-D-1)
Yes
No
Do recombinant DNA or RNA experiments involve the use of infectious animal or plant viruses in any
culture system? (NIH Guidelines, Section III-D-2)
Yes
No
Do recombinant DNA or RNA experiments involve the use of defective animal or plant viruses in
presence of helper virus in tissue culture systems? (NIH Guidelines, Section III-D-3)
Yes
No
Do recombinant DNA experiments involve whole animals (NIH Guidelines, Section III-D-4) or plants
(NIH Guidelines, Section III-D-5)?
Yes
No
Do experiments involve more than 10 liters of culture, in a single vessel? (NIH Guidelines, Section IIID-6)
Yes
No
Do any experiments involve influenza viruses? (NIH Guidelines, Section III-D-7)
Yes
No
B. Recombinant DNA Research Narrative
Briefly summarize your overall research objectives and specifically describe the manner in which you
are planning on using recombinant nucleic acids in sufficient detail to allow the comprehensive review
and approval of your research involving recombinant DNA or organisms containing recombinant nucleic
acids. (Please do not paste Grant Abstracts or Project Narratives into this section)
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Refer to the NIH Guidelines for Research Involving recombinant DNA Molecules, as applicable. Use
descriptive sentences such as:
We will use the following rDNA: synthetic siRNA, miRNA, plasmid-based, and viral-vector-based rDNA
We will deliver these rDNA by: transfection, infection….
rDNA will be used in: bacteria, yeast, primary culture or cell lines (human, mouse, rat…), nude mice, or
transgenic animals or plants.
C. Nature of Vectors
1.
My vector(s) is/are plasmid-based.
Describe the plasmids and inserts or the nature of synthetic nucleic acid, using plasmid maps if
available. Provide source of plasmid material: (e.g. purchased from Vendor X, obtained from Dr. Y,
etc.)
2.
My vector(s) is/are viral in origin.
Complete the following section for each viral vector in use. If human or amphotropic vectors will be
used, please provide a detailed description including species-specificity, as applicable.
Strain,
vector
backbone:
Wild type
deletions:
(Name of
deleted
genes)
Replication
status:
Envelope
packaging
system(s):
Helper
Virus
required
(Y/N, if
Yes,
specify)
Source of
vector (made in
lab X,
purchased from
Company Y, gift
from Dr. Z)
Adenovirus
Adenoassociated Virus
Alphavirus
(e.g. SFV, SIN)
Herpesvirus
Poxvirus (e.g.
Vaccinia)
Murine
Retrovirus
Human
Lentivirus
Other:
3. Provide the following information concerning the nature of the insert(s):
a. What is the source of the DNA insert? Please include genus and species names of the organism(s)
from which the DNA is derived.
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b. Please provide the full names and abbreviations of the gene(s), promoter(s) and/or transposable
elements to be studied, and a brief description of the biological function of the nucleic acid
sequence. (Indicate if this is cDNA, genomic DNA, or specific genes).
c. If the DNA is from a eukaryotic virus and it is to be introduced into a eukaryotic host, provide the
percentage of the viral genome to be cloned.
%
d. If this is a mutated gene, please describe.
e. What do you know of the oncogenic potential of the genes of interest? If this is a known or
suspected oncogene, please describe sufficiently for IBC review.
f.
What do you know of the potential insertional mutagenesis of the vectors or the genes of interest?
4. Please provide details of the target/recipient cells or systems of the vector-DNA combination. What
is the target cell/system, animal or plant host(s)? Please provide detailed information about the
host(s) (e.g., E. coli K-12 system, Saccharomyces, insect cells, plant cells, live animals, whole
plants, etc.)
5. Identify any known or potential hazards associated with the expression of the foreign nucleic
acids/proteins you will be working with.
6. Will you conduct Flow Cytometry or Cell Sorting or Laser Microdissection of any cells containing
recombinant DNA?
Flow Cytometry, Location:
Cell Sorting, Location:
Laser Microdissection :
7. Will you use any of the following materials in combination with recombinant DNA?
a.
Cytotoxic/Chemotherapy Agents (list the agents)
b.
Other chemical compounds (list)
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c.
Radioisotopes
Part IV.
Isotope:
Authorization Number:
Human Biological Materials, Specimens, Culture Materials
A. Exposure to Human Blood, Body Fluids, Tissues, or Organs
1. Will you collect, work with or bank any human blood, body fluids, tissues, or organs?
Yes
No
If Yes, complete the following section - please check or list all that apply. Also, consult with the UCD
COMIRB regarding human subjects’ research application requirements.
2. Specimens collected or manipulated:
Blood
Serum
Feces
Tissues/Organs
Urine
Semen
Spinal fluid
Other:
3. Types of manipulation(s):
Centrifugation
Pipetting
Dissection
Frozen Sections
Fixed/preserved in:
Blending/mixing
Sonication
Flow Cytometry, Location:
Cell Sorting, Location:
Other
4. Will the specimens be labeled with radioisotopes?
If yes,
Isotope:
Yes
No
Authorization Number:
5. Will you ship/import or export any human blood, body fluids, tissues, organs or other specimens as
part of your research?
Yes
No
B. Human Primary or Immortalized Cells in Culture
For all work with human cell or tissue cultures, complete the following section.
1. We will obtain and work with:
human, immortalized cell lines
human, primary cells
human Embryonic Stem Cells
Are your huESC currently on the NIH Human Embryonic Stem Cell Registry and eligible for NIH
funding?
Yes
No
2. Will you be immortalizing any primary cell cultures in your laboratory?
Yes
No
Will you use
Yes
No
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viral vectors or
oncogenes to immortalize cells?
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List agent to be used:
3. Will you use any of the following materials in cell culture?
a. Toxins derived from living organisms: including Select Agent Toxins (e.g. tetrodotoxin, botulinum, etc.)
Yes
No
If your toxin appears on the Select Agent List, you must complete and submit a Select Agent Toxin
Application- Appendix A.
Maximum Qnty.
of Each Purchase
Name of Toxin
b.
Maximum Qnty.
in Lab
Radioisotopes used in cell culture:
Isotope
Part V.
Authorization Number
Whole Animals or Transgenic Animals
1. Will you work with Whole animals and/or Transgenic animals?
If Yes, Complete Appendix T, and submit with this form
Yes
No
2. Will you be immortalizing any primary cell cultures in your laboratory?
Yes
No
3. Will you use
Yes
No
A. Animal Primary or Immortalized Cells in Culture
1. Will work with:
animal, immortalized cell lines
animal, primary cells (please identify species)
virus or
viral vectors or
oncogenes to immortalize cells?
List agent(s) to be used:
B. Animal Blood, Bodily Fluids, Tissues or Specimens
1. Will you obtain or import any animal blood, body fluids, tissues, organs or other specimens as part
of your research, not otherwise covered by a University IACUC protocol?
Yes
No
Specimens to be collected or manipulated (please identify species and materials)
2. Will the specimens be labeled with radioisotopes?
If yes,
Isotope:
Authorization Number:
Part VI.
Yes
No
Experiments with Other Biological or Infectious Agents
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Complete this section if you use microorganisms with the potential to infect animals, plants or humans,
not otherwise addressed above for recombinant DNA research.
1. Does your research involve the use of any of the following microorganisms not otherwise covered in
Part III above?
Yes
No
If No, continue to Part VII.
If Yes, complete this section for each of the microorganisms in your possession. Contact the
Biosafety Office if you need assistance with this section or reproduce for use of multiple pathogens.
Bacteria
Fungi
Rickettsia
Yes
Yes
Yes
No
No
No
Parasites
Viruses
Prions
Yes
Yes
Yes
No
No
No
a. List agent(s) by species, strain (& isolates) (expand this table as necessary). Include all viruses,
bacteria, fungi, rickettsia or parasites. To determine the correct Risk Group, refer to NIH
Guidelines, Appendix B, the CDC BMBL Agent Summary Statements, or discuss with the Biosafety
Office.
Species
Strain/Isolate
Risk Group
In Cell Culture (Y/N)
Yes
No
Yes
No
Yes
No
b. Does this material require a CDC or USDA or other permit?
Yes
No
2. Complete the following section for each organism to be used in the lab. Use additional pages as
necessary.
a. Location(s), building and laboratory rooms, where organism will be used/handled
Laboratory Bldg & Space Number:
Room Type (Alcove, Module, Cold Room,
Procedure Room)
b. Is the organism potentially infectious to humans or animals?
Yes
No
Yes
No
Yes
No
d. Is the organism capable of transducing or potentially infectious to plants?
If Yes, complete and submit Appendix P, with this form.
Yes
No
e. Does this material require a USDA-APHIS or USDA-PPQ permit?
Yes
No
If yes, is there a vaccine available?
c. Are animal or human pathogens to be used in animals?
If yes, IACUC Protocol Number:
UCD Vivarium Facility:
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If you possess a USDA permit, forward a copy with this application, including all the permit
stipulations. If you are awaiting a USDA permit, a copy must be forwarded to the Biosafety Office
upon receipt.
f.
Is this organism already available in your laboratory or on campus?
Yes
No
If No, you may need to apply for the appropriate permits, for the importation or transport of these
agents. Contact the Biosafety Office for additional assistance. To transport or import human
pathogens, contact the CDC Permit Program for animal and plant pathogens and animal and plant
products, contact the USDA-APHIS Permit Program.
g. Will the organism be labeled with radioisotopes?
Yes
No
Yes
No
k. (i). does this organism produce a known toxin?
(ii). Do you work with this toxin?
Yes
Yes
No
No
l.
Yes
No
Yes
No
Yes
No
Isotope:
Authorization Number:
h. Is antibiotic resistance expressed?
List antibiotic resistance markers:
i.
Other markers, if applicable:
j.
Largest volume of organisms used/produced in a single vessel is
liters
Is the organism inactivated prior to other lab manipulations?
Specify methods of inactivation.
m. Do you concentrate the organism?
Specify methods of concentration:
Centrifugation
Precipitation
Part VII.
Filtration
Other:
Risk Assessment and Containment
1. Is a Biological Safety Cabinet (tissue culture hood) available?
Biosafety Cabinet Information (expand this table as necessary)
BSC #
Manufacturer
Model
Class
Type
Serial
Number
Certification
Date
Bldg./Room #
2. Does this project constitute any other potential risk or hazards to human health or the environment
which are not described above?
Yes
No
If yes, explain. Use additional pages as necessary.
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Part VIII. Dual Use Research
Dual Use Research, as defined by the federal government, is under the oversight of the NIH, Office of
Biotechnology Activities (OBA), and National Science Advisory Board for Biosecurity (NSABB).
Are you are using one or more of the following agents or toxins (any quantity)?
Yes
No (this Part is now complete)
Agents and toxins
a) Avian influenza virus (highly pathogenic)
b) Bacillus anthracis
c) Botulinum neurotoxins
d) Burkholderia mallei
e) Burkholderia pseudomallei
f) Ebola virus
g) Foot-and-mouth disease virus
h) Francisella tularensis
i)
j)
k)
l)
m)
n)
o)
Marburg virus
Reconstructed 1918 Influenza virus
Rinderpest virus
Toxin-producing strains of Clostridium botulinum
Variola major virus
Variola minor virus
Yersinia pestis
If YES, check any categories of experiments below that apply to your research experiments or projects:
Enhances the harmful consequences of the agent or toxin
Disrupts immunity or the effectiveness of an immunization against the agent or toxin without
clinical and/or agricultural justification
Confers to the agent or toxin resistance to clinically and/or agriculturally useful prophylactic or
therapeutic interventions against that agent or toxin or facilitates their ability to evade detection
methodologies
Increases the stability, transmissibility, or the ability to disseminate the agent or toxin
Alters the host range or tropism of the agent or toxin
Enhances the susceptibility of a host population to the agent or toxin
Generates or reconstitutes an eradicated or extinct agent or toxin listed above
Check here if none of the above applies
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This space is for IBC and Biosafety Office Use
Authorization #:
Approval Date:
New
Expiration Date:
Amendment
Renewal
Biosafety Office Pre-review: Date
Personnel registered in EHS-A
Personnel training verified in EHS-A
HepB Vaccine Needs To Be Offered by OH
Lab Personnel and Training Status Letter to PI
Medical Surveillance / OH Review Needed for (list agent(s):
Pre-review Status:
No rDNA Research
Exempt rDNA Research
NIH Sections:
Requires IBC Review
N/A
Select Agents and Toxins:
Infectious Agents:
Human Tissue, Cells, Fluids
Biosafety Level:
BSL-1
Animal Biosafety Level:
Non-Human Primate Tissue, Cells, Fluids
BSL-2
ABSL-1
Animal Tissue, Cells, Fluids
BSL-3
ABSL-2
ABSL-3
Animal Species
Protocol Review Sheet Routed to IBC
No Review Comments
Pre-Review Comments:
Training Required:
Full Committee Review: Review Date
Approval Date
Expiry Date
Authorization Memo Date
NIH Sections:
N/A
Approved
Modifications Required
Deferred
Denied
Medical Surveillance / OH Review Needed
Biosafety Level:
BSL-1
Animal Biosafety Level:
BSL-2
ABSL-1
BSL-3
ABSL-2
ABSL-3
Animal Species
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Information for IBC Minutes
Part II, III (1, 2 & 3) & IV
List of what materials handled:
Agent characteristics (e.g.
human, animal, cell lines, toxins,
virulence, pathogenicity,
transgenic animals,
environmental stability)
microorganisms/RG, pathogens
in animals
Part IV-A-1 & Part III-C-6:
Types of manipulations planned
manipulations
Source(s) of the nucleic
PART III-C-3-a
sequences (e.g., species)
Nature of the nucleic acid
sequences (e.g., structural gene, Part III-C-3-b
oncogene)
Host(s) and vector(s) to be used
Part III-C-4
Whether and attempt will be
made to obtain expression of a
Part III-C-5
foreign gene, and if so, the
protein that will be produced
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