Download Medical College of Georgia

FOR BIOSAFETY OFFICE USE ONLY:
(Date Stamp)
For assistance completing this form, contact:
Biosafety Office
Laura Meyer Chapman, MA Biosafety Officer
Liesl DeSevilla, MS, Asst. Biosafety Officer
BSP Application #:
Email: [email protected]
Phone: 706-721-2663
Review Track: (Check Box)
Non-Exempt (Full IBC Review)
Return by email to:
Email: [email protected]
Exempt (Clinical Subcommittee)
Exempt (Basic Subcommittee)
Exempt (Administrative Review)
Biosafety Protocol (BSP) Application
Notes and Instructions:

BSPs must be approved by the Institutional Biosafety Committee (IBC) or the Biological Safety Office (Administrative Review) prior to the
initiation of research.

Approval is valid for the duration of the research proposed in this application, but MUST be amended as needed using the Biosafety
Protocol Amendment Application.

Whenever you amend your Animal Use Protocol (AUP) or Institutional Review Board (IRB) Protocol to add/delete agents, change
personnel/location, or modify a procedure, you must amend your BSP using the Biosafety Protocol Amendment Application.

BSPs requiring Full IBC review must be submitted to the Biosafety Office by the 1 st of the month to be placed on that month’s agenda.

Submit the electronic documents to the [email protected] email account. To authenticate, the PI must send from his/her University
email account/mailing address or the preparer must copy the PI in the email.
Required additional forms:
Standard Operating Procedures (SOPs) - These are a list of rules and procedures which are expected to be followed by those working in your
laboratory, and therefore should address the specific hazards and risks in your laboratory.
A template to help you get started in developing some basic SOPs is available online at: http://www.augusta.edu/research/ibc/apps.php
General Information:
Principal Investigator (PI):
PI email address:
Office Phone Number:
Department:
Laboratory Phone Number:
Email Address:
Fax number:
Campus Address:
Emergency Laboratory Contact
(Other than the PI):
Emergency Phone Number:
Emergency Contact Office Phone Number
(If different from lab number) :
Emergency Phone Number for
Emergency Contact:
Protocol Information:
BSP Title:
Mark all sections below that are applicable to your protocol.
Go to those sections and answer all questions.
Administrative
Recombinant and Synthetic Nucleic Acid Molecules (e.g., bacterial/mammalian
expression plasmids, replication incompetent viral vectors, chemically synthesized
nucleic acid molecules)
Human & Non-Human Primate Material (e.g., blood, fluids, tissues,
primary/established cell lines)
Microorganisms/Potentially Infectious Material (e.g., viruses, bacteria, yeast,
fungi, parasites, prions)
Whole Animals/Animal Material (e.g., introduction of biologicals/chemicals into
animals, use of animal cell lines and/or tissues)
Biological Toxins (e.g., cholera toxin, pertussis toxin, diphtheria toxin, tetrodotoxin)
Applicable
Mandatory
Yes
No
Sections
Complete Section 1
If “yes”, complete Section 2
Yes
No
If “yes”, complete Section 3
Yes
No
If “yes”, complete Section 4
Yes
No
If “yes”, complete Section 5
Yes
No
If “yes”, complete Section 6
1
Human gene transfer/therapy (e.g., DNA Vaccines)
Nanoparticles (e.g., use of Jet-Pei or Poly-L-Lysine to form nano-sized particles)
Arthropods (e.g., insects, spiders, crabs, lobsters, shrimp)
Plants (e.g., toxic/transgenic plants)
Investigator’s Assurance
Yes
No
Yes
No
Yes
No
Yes
No
Mandatory
If “yes”, complete Section 7
If “yes”, complete Section 8
If “yes”, complete Section 9
If “yes”, complete Section 10
Complete Section 11
SECTION 1: ADMINISTRATIVE
Description of research:
Outline the overall goal(s) of the projects to be covered by this application. Describe recombinant/synthetic nucleic
1.1
acid molecules and biohazardous materials and procedures (experimental set-up). Use separate paragraphs for
multiple projects. Use non-technical language to enable all Institutional Biosafety Committee members (those with nonscience backgrounds) to understand the research project and assess the risks.
List grant/study titles associated with
this application:
Grant/Info.Ed./HAC/CC
RI#:
Funding
Agency:
Funding Dates:
1.2
1.
2.
List additional BSPs required to cover the biological agents and manipulations, operations, personnel and locations
described in the grant/study title shown above.
BSP Approval
Describe how these BSPs will “dovetail” (i.e. which BSP
BSP #:
PI listed on BSP:
Date:
"covers" which portion of the grant/study title):
1.
2.
List all locations where work pertaining to this application will be performed in the table below:
Note: Collaborating Institutions/Companies should be listed below. If collaborating with a PI outside of Augusta University, the Biosafety Office
may request a copy of their Biosafety/IBC approval letter.
1.3
Facility: (e.g., cold rooms, tissue
culture)
Building Code
and Room
Number
(Address for
Off-site areas):
List Biological Agents
(e.g. Recombinant DNA; Mice or mouse cell lines,
tissues, fluids or organs; Human or Non-Human
Primate cell lines, tissue, fluids or organs,
Potentially infectious or infected material, Toxins
of biological origin, Microbial pathogens)
Biosafety
Level
(BSL) :
Augusta University Health Sciences Campus
Augusta University Summerville Campus
Augusta University Animal Facilities
Augusta University Core Facilities
Augusta University MC Hospital/Clinics
VA Medical Center
Off-site Clinic/Laboratory
Other (list):
1.4
Personnel:
List all individuals supervising or physically working on the research proposed in this application or that may be exposed
to the research materials including the PI, collaborators, technicians, post docs, graduate students, work-study students,
volunteers, etc. If extra space is needed, multiple individuals can be listed together if they will have the same
responsibilities; however, list the experience for each
Note: Clinical Sub-investigators that are NOT supervising those conducting research and do NOT handle the samples, but only
perform “standard of care” duties should not be listed below.
Name
(Last, First, Degree(s)
Email address
Job/
Position Title
Does the
person have
experience
with
materials
listed in this
applications:
*If yes, which
materials?
(e.g.,
lentivirus,
human tissues,
bacteria)
Please indicate if the
following trainings have
been completed:
Shipping
Biological
Biosafety & Substance
Bloodborne
and
Pathogen
Support
Training
Materials:
Please indicate if the
following vaccines or
other
tests/evaluations
have been
completed:
2
Principal Investigator
Lab Manager
Clinical Coordinator
Exposure to/Collection
of Biological Materials
Shipping Biological
Materials
Other, specify:
Principal Investigator
Lab Manager
Clinical Coordinator
Exposure to/Collection
of Biological Materials
Shipping Biological
Materials
Other, specify:
Principal Investigator
Lab Manager
Clinical Coordinator
Exposure to/Collection
of Biological Materials
Shipping Biological
Materials
Other, specify:
Principal Investigator
Lab Manager
Clinical Coordinator
Exposure to/Collection
of Biological Materials
Shipping Biological
Materials
Other, specify:
Yes*
No
Yes
No
Unsure
N/A
Yes
No
Unsure
N/A
Hepatitis B Vaccine
“Flu” Vaccine
Vaccinia Vaccine
Rabies Vaccine
Respirator FitTesting (i.e. N-95)
N/A
Yes*
No
Yes
No
Unsure
N/A
Yes
No
Unsure
N/A
Hepatitis B Vaccine
“Flu” Vaccine
Vaccinia Vaccine
Rabies Vaccine
Respirator FitTesting (i.e. N-95)
N/A
Yes*
No
Yes
No
Unsure
N/A
Yes
No
Unsure
N/A
Hepatitis B Vaccine
“Flu” Vaccine
Vaccinia Vaccine
Rabies Vaccine
Respirator FitTesting (i.e. N-95)
N/A
Yes*
No
Yes
No
Unsure
N/A
Yes
No
Unsure
N/A
Hepatitis B Vaccine
“Flu” Vaccine
Vaccinia Vaccine
Rabies Vaccine
Respirator FitTesting (i.e. N-95)
N/A
Laboratory/Agent-Specific SOPs:
Do you have laboratory/agent specific Standard Operating Procedures (SOPs)?
1.5
Yes
No*
*If no, see the Biosafety webpage for a guidance template to create your laboratory/agent-specific SOPs.
A copy of these SOPs must be submitted with this application and be available in your laboratory
Biosafety Binder.
SECTION 2: RECOMBINANT DNA AND SYNTHETIC NUCLEIC ACID MOLECULES
Section I-B.
Definition of Recombinant and Synthetic Nucleic Acid Molecules
In the context of the NIH Guidelines, recombinant and synthetic nucleic acids are defined as:
(i)
molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant
nucleic acids;
(ii) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or
otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids, or
(iii) molecules that result from the replication of those described in (i) or (ii) above.
These activities are regulated by the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
See the following for assistance in Risk Group classification and recommended Biosafety Level usage:




American Biosafety Association Risk Group Guide: http://www.absa.org/riskgroups/index.html
Public Health Agency of Canada MSDSs: http://www.phac-aspc.gc.ca/msds-ftss/
NIH Guidelines for Recombinant DNA Research:
http://ehs.research.uiowa.edu/files/ehs.research.uiowa.edu/files/forms/VAMC%20NIH%20guidelines%202014hs%20cm.pdf
CDC’s Biosafety in Microbiological and Biomedical Laboratories (BMBL): http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm
Note: Your answers to the questions in this section will determine the level of review that your experiments require.
2.1
2.2
Does your application involve recombinant and/or synthetic nucleic acid
molecules?
“Non-exempt” Recombinant/Synthetic Nucleic Acid Molecules
Experiments which require IBC approval prior to
Experiments that require IBC approval
Yes – Complete this Section
No – Skip Section 2 & Go to Section 3
“Exempt”
Recombinant DNA experiments that do not require IBC
3
initiation:
1. Deliberate transfer of a drug trait to a microorganism
not known to acquire it naturally (if it could
compromise the use of the drug to control disease
agents in humans, animals or agriculture). (Note: this
would likely exclude most sub-cloning procedures
using antibiotic selectable markers in E. coli K12
derivatives)
Section III-A-1
Yes No
2. Cloning of DNA encoding toxic molecules lethal to
vertebrates at an LD50 of <100 µg/kg body weight.
Section III-B-1
Yes No
simultaneous with initiation:
1. Experiments using rDNA/synthetic nucleic
acids containing < 2/3 of the genome of a
eukaryotic virus, demonstrated to be free
of helper virus or complementing helper
virus components may be contained at
BSL1.
Section III-E-1
Yes No
2. Whole Plants, except for those that fall in
Sections under III-A, B, D, or F.
Section III-E-2
Yes No
3. Human gene transfer/therapy experiments;
Section III-C-1
Yes No
3. Creation of transgenic or knockout rodents
for which BSL-14 containment is
appropriate
Section III-E-3
Yes No
4. Introduction of rDNA/synthetic DNA in risk group 2,
3, 4 or restricted agents (e.g., viral vectors or
biological materials treated with viral vectors)
Section III-D-1
Yes No
4. All experiments not specified in this chart
.
5. Cloning of DNA from all Risk Group4 2, 3, 4 or
agents into non-pathogenic prokaryotic or lower
eukaryotic host-vector systems (e.g., cloning an HIV
gene into bacteria)
Section III-D-2
Yes No
6. Experiments using more than 2/3 of the genome of
infectious animal or plant viruses or defective viruses
grown in the presence of helper virus or
complementing helper virus components (e.g.,
Adeno-associated virus in conjunction with
Adenovirus)
Section III-D-3
Yes No
7. Recombinant DNA/synthetic nucleic acid
experiments involving whole animals, including
transgenic or knockout rodent experiments requiring
BSL24 containment; or transplantation of genetically
engineered cells into animals.
Section III-D-4
Yes No
approval, but require registration with the Biosafety Office:
1. Those synthetic nucleic acids that: (1) can neither replicate
nor generate nucleic acids that can replicate in any living cell
(e.g., oligonucleotides or other synthetic nucleic acids that
do not contain an origin of replication or contain elements
known to interact with either DNA or RNA polymerase), and
(2) are not designed to integrate into DNA, and (3) do not
produce a toxin that is lethal for vertebrates at an LD50 of
less than 100 nanograms per kilogram body weight.
Section F-1
Yes No
2.
Those that are not in organisms, cells, or viruses and that
have not been modified or manipulated (e.g., encapsulated
into synthetic or natural vehicles) to render them capable
of penetrating cellular membranes.
Section F-2
Yes No
3.
Those that consist solely of the exact recombinant or
synthetic nucleic acid sequence from a single source that
exists contemporaneously in nature.
Section F-3
Yes No
4.
Those that consist entirely of nucleic acids 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.
Section III-F-4
Yes No
5.
Those that consist entirely of nucleic acids from a
eukaryotic host including its chloroplasts, mitochondria, or
plasmids (but excluding viruses) when propagated only in
that host (or a closely related strain of the same species).
Section III-F-5
Yes No
6.
Those 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.
Section III-F-6
Yes No
7.
Those genomic DNA molecules that have acquired a
transposable element, provided the transposable element
does not contain any recombinant and/or synthetic DNA.
Section III-F-7
Yes No
8.
rDNA containing less than 1/2 of an eukaryotic viral
genome propagated in cell culture (with the exception of
expression of DNA from Risk Group4 2, 3, 4 or restricted
agents5);
Appendix C-I
Yes No
9.
rDNA work involving E. coli K12 derivatives, S. cerevisiae,
Kluyeromyces, and B. subtilis /lichenformis host-vector
systems (with the exception of expression of DNA from
Risk Group 2, 3, 44 or restricted agents).
Appendix C-II, C-III, C-IV
Yes No
8. Whole plants (e.g., genetically engineered plants)
Section III-D-5
Yes No
9. Large scale DNA projects (>10 liter cultures at any
moment in time).
Section III-D-6
Yes
No
10. Influenza Viruses
Section III-D-7
Yes
No
10. The purchase or transfer of transgenic rodents that require
BSL1 containment.
Appendix C-VII
Yes No
11. Breeding of different strains of transgenic rodents. (1) Both
parental rodents can be housed under BL1
containment; and
(2) neither parental transgenic rodent contains the
following genetic modifications: (i) incorporation of more
than one-half of the genome of an exogenous eukaryotic
virus from a single family of viruses; or (ii) incorporation of
a transgene that is under the control of a gammaretroviral
long terminal repeat (LTR); and(3) the transgenic rodent
that results from this breeding is not expected to contain
more than one-half of an exogenous viral genome from a
single family of viruses.
Appendix C-VIII
Yes No
4
2.3
Use the table below to describe your rDNA/synthetic experiments
Vector
Technical
Name (e.g.
pKLO.1,
pcDNA) or
synthetic
nucleic acid
name
Backbone
Source (e.g.
bacterial,
yeast, MLV,
MSCV, HIV,
FIV, Vaccinia,
Adenoviral,
AAV,
Plasmids)
Full Name and
Abbreviation of
Inserted DNA
and source
(species/strain)
Product
Produced (e.g.
protein, siRNA)
Anticipated Effect
of the Insert?
Anti-apoptotic
Growth Factor
Tumor Inducer
Cytokine Inducer
Oncogene
Tumor Inhibitor
Cytokine Inhibitor
Toxic
Other (list):
Anti-apoptotic
Growth Factor
Tumor Inducer
Cytokine Inducer
Oncogene
Tumor Inhibitor
Cytokine Inhibitor
Toxic
Other (list):
Anti-apoptotic
Growth Factor
Tumor Inducer
Cytokine Inducer
Oncogene
Tumor Inhibitor
Cytokine Inhibitor
Toxic
Other (list):
Anti-apoptotic
Growth Factor
Tumor Inducer
Cytokine Inducer
Oncogene
Tumor Inhibitor
Cytokine Inhibitor
Toxic
Other (list):
What is the
largest fraction
of the
eukaryotic viral
genome
contained in
the rDNA
molecules?
<1/2
>1/2 but
<2/3
>2/3
N/A
Is the
vector
designed to
be
replication
competent?
Yes No
Name of
Packaging Cell
line(s) or
Helper
plasmids used
in co-transfect
ion to produce
viral particles
Tropism
(i.e. what species
of cells can the
virus infect?)
Ecotropic
(Rodents)
Amphotrophic
(mammals)
Pantropic (all
animals including
insects, birds, fish)
Ecotropic
Amphotrophic
Pantropic
<1/2
>1/2 but
<2/3
>2/3
N/A
Yes
No
Ecotropic
Amphotrophic
Pantropic
<1/2
>1/2 but
<2/3
>2/3
N/A
Yes
No
Ecotropic
Amphotrophic
Pantropic
<1/2
>1/2 but
<2/3
>2/3
N/A
Yes
No
Ecotropic
Amphotrophic
Pantropic
Will you
expose
humans,
animals,
plants,
arthropods,
or cells to
the rDNA?
Humans
Animals
(list):
Plants
(list):
Arthropods
(list):
Cells
(list):
Humans
Animals
(list):
Plants
(list):
Arthropods
(list):
Cells
(list):
Humans
Animals
(list):
Plants
(list):
Arthropods
(list):
Cells
(list):
Humans
Animals
(list):
Plants
(list):
Arthropods
(list):
Cells
(list):
5
2.4
What host organism will you use for DNA propagation? List the species and strain (i.e., E.coli DH5α)
2.5
How will you purify the recombinants and what measures will you take to avoid aerosol production during purification?
2.6
Will the recombinant (vector + insert) be purchased from a commercial vendor, provided by a collaborator and/or
created/packaged in the laboratory?
2.7
Have you provided restriction/vector maps for each vector listed above to the Biosafety Office?
Example:
Yes
2.8
2.9
*If not, email the maps to [email protected] to be distributed with your application for
review.
What regions/genes of the viral genome are deleted or altered (if any) to produce the viral vector? (i.e. what is the basis
of vector attenuation or replication incompetence, if any)
Will you be assaying for the production of wild-type/helper/replication competent viral particles?
*If yes, describe methods and stage in your experiment at which these assays will be performed.
2.10
No*
Yes*
No
Yes*
No
Will you handle more than 10 liters of culture of this agent(s) at any one time?
*If yes, special precautions may be required for large-scale cultures involving recombinant DNA. These can
be reviewed at:http://oba.od.nih.gov/rdna/nih_guidelines_new.htm#_Toc331174152m
Provide answers to Appendix K, with this application.
2.11
List any procedure that will be performed with this material which may be associated with increased potential for exposure
(i.e. generation of splashes, sprays or aerosols from centrifugation, sonication, homogenization, vortexing, FACS, use of
sharps (needles or glass).
2.12
What are the signs/symptoms of exposure to this material?
(Note: All accidents/injuries where exposure to recombinant DNA or synthetic nucleic acids should be reported to the Biosafety Office
after seeking medical attention, if necessary).
SECTION 3: HUMAN AND NON-HUMAN PRIMATE MATERIAL
3.1
Does your protocol involve the use of organs or tissues from living or dead
humans or non-human primates, cell lines (including established cell lines),
Yes – Complete this Section
blood, blood products and body fluids, including cell cultures purchased
No – Skip Section 3 & Go to Section 4
from commercial sources?
Use this section to describe the types of human/non-human primate materials that will be used in your research
Human and non-human primate materials must be handled using BSL2 facilities, practices and equipment. Per OSHA
requirements, all individuals with occupational exposure to any materials listed in the table below must complete Bloodborne
pathogen training. This training has been combined with the Initial Biosafety and Bloodborne Pathogen Training and the
Biosafety and Bloodborne Pathogen Refresher Training, offered through The Workforce Learn Online Training System.
The OSHA – Bloodborne Pathogen Standard and Letters of Interpretation can be found on the Biosafety webpage.
Origin
Material(s):
3.2
Human
Non-human
primate
Teeth
Blood
Sweat
Tears
Urine
Amniotic Fluid
Gingival Fluid
Feces
Semen
Vaginal Secretions
Nasal Secretions
Pleural Fluid
Pericardial Fluid
Sputum
Breast Milk
Peritoneal Fluid
Synovial Fluid
Cerebrospinal Fluid
Bones
Tissues (list):
Embryonic Stem Cells
Are these stem cells listed in the NIH human embryonic stem cell line registry?
The NIH human embryonic stem cell line registry is available at the following link:
Yes
No
6
http://grants.nih.gov/stem_cells/registry/current.htm
Induced Pluripotent Stem Cells (iPSCs)
Methods of induction:
Mesenchymal Stem Cells (MSCs)
Source(s) of the materials above:
Commercial Vendor (list):
Collected Specimens (list collection site in Section 1.3)
Provided by a collaborator (list Collaborator Name and Institution):
Other (list):
Cells/Cell lines (i.e.HEK239) (list them below)
Cells/Cell Line
Name
Primary
(Fresh)
Established
(Commercial)
e.g., ATCC
Established in
the Laboratory
Genetically
Engineered
Potentially
Tumorigenic
Will these be
cultured?
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Blood-derived products (i.e. red blood cells, plasma) (list):
Other (list):
3.3
Will you handle more than 10 liters of culture of this agent(s) at any one time?
Yes*
No
Yes*
No
Yes*
No
*If yes, special precautions may be required for large-scale cultures involving recombinant DNA. These can
be reviewed at:http://oba.od.nih.gov/rdna/nih_guidelines_new.htm#_Toc331174152m
Provide answers to Appendix K, with this application.
3.4
Did this human material originate outside of the United States?
*If yes, a CDC Etiologic Agent Import Permit (www.cdc.gov/od/eaipp/) may be required. The Biosafety
Office can assist you in determining permit requirements.
If permit(s) have already been obtained, submit a copy to [email protected]
3.5
Do these materials contain known pathogens? (i.e. blood samples from HIV positive patients)
*If yes, list the known pathogen(s) and the signs and symptoms of exposure:
3.6
Are you and your laboratory staff aware of the common signs and symptoms of exposure to
bloodborne pathogens present in human and non-human primate materials (i.e. fever, flu-like
symptoms, fatigue, and nausea)?
Yes
No
(Note: All accidents/injuries where exposure the human/non-human primate materials should be reported to
the Biosafety Office after seeking medical attention, if necessay).
3.7
List any procedure that will be performed with this material which may be associated with increased potential for
exposure (i.e. generation of splashes, sprays or aerosols from centrifugation, sonication, homogenization, vortexing,
FACS, use of sharps (needles or glass).
3.8
Explain any type of treatment the material has undergone prior to receipt (i.e. formaldehyde fixation, testing for viruses).
3.9
Will you be introducing these materials into animals?
3.10
Will you be introducing these materials into humans?
Yes* (also complete Section 5)
Yes*
No
No
*If yes, answer the following questions below:
a. Method of delivery?
b. Health status of the patients/patient population?
c. Frequency of administration?
d. The anticipated effect of the introduction of the agent upon the patient (if known)?
e. The expected persistence of the agents after administration (if known)?
f.How long after administration will you obtain specimens to be analyzed?
g. What types of specimens will be obtained?
h.What types of analyses will be performed? (e.g. behavioral analyses, in vivo instrumentation, blood tests, analyses of tissue
biopsies?)
7
i.What biosafety precautions will be taken to avoid inadvertent exposure to other patients, researchers, or health care
providers?
j.Indicate any safety tests or pathogen screening which will be performed on these cells/tissues prior to delivery into
humans?
k. Have these agents been passaged through animals or other cells/cell lines?
3.11
3.12
Do you obtain human blood from volunteers (for volunteer blood donation)?
Yes
No
Yes*
No**
Pending
Not Required
Do you have IRB approval?
*If yes, what is your application/IRB#:
**If no, contact OHRP 706-721-3110, for instructions on submitting an application
3.13
Do you conduct research in the Augusta VA facility?
Yes*
No
Yes*
No
Yes*
No
*If yes, answer the following questions:
Does your research involve GRU personnel, or transfer to Augusta University property?
Have you applied for and/or received VA Biosafety approval for your research?
Yes*
3.14
Yes*
No
No
Pending
Will you be exposing any of the material listed above to chemotherapeutic/antineoplastic agents
(i.e. BrdU, STZ, Tamoxifen)?
*If yes, list the agent:
Note: There may be special safety and handling requirements for these agents, contact Ken Erondu,
Chemical Safety Officer, for assistance at 706-721-2591
3.15
Will you be exposing live human subjects, non-human primates, human cells, or non-human
primate cells to recombinant/synthetic DNA?
*If yes, make sure you complete Section 2 – Recombinant DNA and Synthetic Nucleic Acid Molecules
SECTION 4: MICROORGANISMS/POTENTIALLY INFECTIOUS MATERIAL
4.1
4.2
Does your protocol involve microorganisms/potentially infectious material
Yes – Complete this Section
(i.e. viruses, bacteria, fungi, prions, parasites)?
No – Skip Section 4 & Go to Section 5
Will you introduce recombinant/synthetic DNA to any microorganism /potentially infectious agent,
use recombinant/synthetic DNA to change the genetic make-up of any microorganism/potentially
infectious agent, or use DNA from any microorganism/infectious agent to perform any recombinant
Yes*
No
DNA experiments?
*If yes, make sure you complete Section 2 – Recombinant DNA and Synthetic Nucleic Acid Molecules
4.3
Signs and symptoms of infection from exposure to this material:
4.4
List any procedure that will be performed with this material which may be associated with
increased potential for exposure (i.e. generation of splashes, sprays or aerosols from
centrifugation, sonication, homogenization, vortexing, FACS, use of sharps (needles or glass)
4.5
Will you be introducing this material into animals?
4.6
Will you be introducing this material into humans?
4.7
How long from the time of infection, will the agent(s) inactivated or lysed?
4.8
Will these experiments result in acquisition of new characteristics of these infectious agents, such
as altered virulence or infectivity, or changes in resistance/susceptibility to drug therapy or
changes in host range?
Yes* (also
complete Section 5)
No
Yes* (also
complete Section 3
)
No
Yes*
No
*If yes, please describe:
8
4.9
List each microorganism/potentially infectious agent to be used in this protocol
 For Risk Group Classification, link to the Risk Group Database or Appendix B – NIH Guidelines
 For a list of Select Agents/Toxins, link to the National Select Agent Registry
 The Risk Group an agent is placed in is not the Biosafety Level (BSL) suitable for containing the agent.
Risk
Is this a
Agent Name
Group
Select
(Genus,
Agent?
Is the agent
(see
Species &
Type (e.g.
Is the agent
This agent can spread
replication
above
(see above
Strain)
hazardous to:
via:
competent?
virus, bacteria)
link)
link)
Yes No
Humans
Blood
Yes No
Animals
Feces
Plants
Saliva/Nasal
Droplets
Other:
Direct Contact
Other:
Yes No
Humans
Blood
Yes No
Animals
Feces
Plants
Saliva/Nasal
Droplets
Other:
Direct Contact
Other:
Yes No
Humans
Blood
Yes No
Animals
Feces
Plants
Saliva/Nasal
Droplets
Other:
Direct Contact
Other:
Yes No
Humans
Blood
Yes No
Animals
Feces
Plants
Saliva/Nasal
Droplets
Other:
Direct Contact
Other:
Yes No
Humans
Blood
Yes No
Animals
Feces
Plants
Saliva/Nasal
Droplets
Other:
Direct Contact
Other:
4.10
Virulence
Has this materials been genetically
modified?
Yes No
If yes, list modification:
Yes
No
If yes, list modification:
Yes
No
If yes, list modification:
Yes
No
If yes, list modification:
Yes
No
If yes, list modification:
What are the signs/symptoms of exposure to this material?
(Note: All accidents/injuries where exposure to microorganisms should be reported to the Biosafety Office after seeking medical attention, if necessary).
9
SECTION 5: WHOLE ANIMALS/ANIMAL MATERIAL
5.1
Does your protocol involve working with animals or animal materials?
5.2
Does your protocol involve working with animals that are field caught?
Yes – Complete this Section
No – Skip Section 5 & Go to Section 6
Yes*
No
*If yes, describe:
5.3
Do you have Institutional Animal Care and Use Committee (IACUC) approval?
Yes*
No**
Pending
Not Required
*If yes, what is your AUP#:
**If no, contact Jenny Whitlock at 706-721-0198, IACUC Compliance Coordinator for instructions on submitting an AUP
5.4
Will you be exposing any animals to chemotherapeutic/antineoplastic agents (i.e. BrdU, STZ, Tamoxifin)?
Yes*
No
*If yes, list the agent(s):
Note: There may be special safety, handling and training requirements for these agents, contact Ken Erondu, Chemical Safety Officer, for assistance at 706721-2663
5.5
List each species/strain of laboratory animal that will be used in your research
Animal
Species/Strain
(List same species
in one row, different
species in separate
row)
Hazardous Agent
(i.e. vectors, human
cell lines,
microorganisms,
chemotherapy,
nanoparticles)
Housing Post
Introduction of Agent
Conventional ABSL-1
Conventional ABSL-2
Barrier ABSL-1
Barrier ABSL-2
ABSL-3
NHP Housing/Facilities
Other:
Conventional ABSL-1
Conventional ABSL-2
Barrier ABSL-1
Barrier ABSL-2
ABSL-3
NHP Housing/Facilities
Other:
5.6
5.7
Max
Dose/Animal
and Frequency
of
Administration
Method of Delivery
(Check all that apply)
Stereotactic Injection
IP Injection
IV Injection
IM Injection
SQ Injection
Intranasal
Oral
Ocular
Other:
Stereotactic Injection
IP Injection
IV Injection
IM Injection
SQ Injection
Intranasal
Oral
Ocular
Other:
Specify Route
of Shedding/
Excretion of
Agent
Urine
Saliva
Feces
Blood
Wound
Other:
None
Unknown
Urine
Saliva
Feces
Blood
Wound
Other:
None
Unknown
Are there special
housing/handling
procedures:
Disposable Cages
Microisolator Cages
All work done in a Biosafety
Cabinet
Animals handled by only
research staff
Use of Safety Engineered
Sharps
Cages labeled with Hazard
Other:
Disposable Cages
Microisolator Cages
All work done in a Biosafety
Cabinet
Animals handled by only
research staff
Use of Safety Engineered
Sharps
Cages labeled with Hazard
Other:
Do you intend to perform any safety tests or pathogen screening prior to introduction of biological agents into animals (i.e. viral assays of cells
or helper viral assays or MAP testing) or monitoring for agents after introduction of the agents into animals?
Yes*
No
*If yes, describe:
What is the anticipated effect of introduction of the agent(s) described above on the animal (if known)?
10
5.8
What is the expected persistence of the biological/chemical agent (i.e. cells, toxin, infectious agent) after administration
(if known)?
5.9
At what stage of your experiments will the infectious agent(s) be inactivated or lysed?
5.10
List the animal cells, cell lines, tissues or organs that you plan to utilize in your research?
Species
of Origin
Cells/Cell
Line/Tissues/Org
ans Name
Primary
(Fresh)
Established
(Commercial)
e.g., ATCC
Established in
the Laboratory
Genetically
Engineered
Potentially
Tumorigenic
Will these be
cultured?
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
5.11
Procedures – List any procedure that will be performed with this material which may be associated with increased
potential for exposure (i.e. cage changing, necropsies, injections, inoculations).
5.12
Signs and symptoms from exposure to this material (including via animal bite/scratch):
(Note: All animal-related accidents/injuries should be reported to the Biosafety Office after seeking medical attention, if necessary).
5.13
Is there special Personal Protective Equipment (PPE) that should be worn by laboratory personnel
and animal care staff when handling these animals?
Yes*
No
Yes*
No
*If yes, describe:
5.14
Will you be creating transgenic animals, breeding transgenic animals, exposing animals to
recombinant DNA, or purchasing/obtaining transgenic animals from a commercial vendor or
collaborator?
*If yes, make sure you complete Section 2 – Recombinant DNA and Synthetic Nucleic Acid Molecules and
answer the following questions:
1. Species/names of the animal strains:
2. Where will the animal be created:
3. Describe the genetic modification (i.e. genes inserted or knock-out and method such as
4.
5.
6.
7.
8.
6.1
6.2
viral or insertion into developing embryo):
Effect of the genetic modification on the animal:
Will this animal produce any toxins or other hazardous materials?
Will these animals require ABSL2 housing?
Describe the marking system that will be used to identify the transgenic animals:
Provide the breeding schematic:
SECTION 6: BIOLOGICAL TOXINS
Does your protocol involve biological toxins (i.e. tetrodotoxin cholera toxin, pertussis toxin,
diphtheria toxin, botulinum toxin)?
Note: Select Agents are in Bold above. More information and a complete list can be found on the
Select Agent Program Website.
Will you be performing experiments where you clone toxin molecules with an LD 50 of 100 ng/kg
or less?
6.3
Will you be introducing this material into animals?
6.4
Will you be introducing this material into humans?
6.5
List each biological toxin in the table below:
Toxin
LD50
Maximum
Quantity on
Hand
Where is it stored?
Building/Room#
Location
Yes – Complete
this Section
No – Skip Section
6 & Go to Section 7
Yes* (also
complete Section 2)
No
Yes* (also
complete Section 5 )
No
Yes* (also
complete Section 3)
No
Is the toxin a
HHS/USDA Select
Agent or Toxin?
11
Flammable Cabinet
Refrigerator
Freezer
Locked Cabinet
Locked Box
Other:
Flammable Storage
Cabinet
Refrigerator
Freezer
Locked Cabinet
Locked Box
Other:
6.6
6.7
*If you are working with a toxin that is a Select Agent, are you working with it within the
permissible amounts (see below)?
Toxins
Abrin
Botulinum neurotoxins
Short, paralytic alpha conotoxins
Diacetoxyscirpenol (DAS)
Ricin
Saxitoxin
Staphylococcal Enterotoxins (Subtypes A, B, C, D, and E)
T-2 toxin
Tetrodotoxin
What are the signs and symptoms of exposure to this material:
Yes*
No
Yes*
No
Yes*
No
Amount
100 mg
0.5 mg
100 mg
1000 mg
100 mg
100 mg
5 mg
1000 mg
100 mg
(Note: All accidents/injuries where exposure to toxins should be reported to the Biosafety Office after seeking medical attention, if
necessary).
6.8
Procedures – List any procedure that will be performed with this material which may be associated with increased
potential for exposure (i.e. generation of splashes, sprays or aerosols from centrifugation, sonication, homogenization,
vortexing, FACS, use of sharps (needles or glass)
6.9
What is the method of destruction or inactivation for the toxins listed:
6.10
Is there an antidote available for this toxin?
Yes*
No
*If yes, list:
7.1
SECTION 7: HUMAN GENE TRANSFER/THERAPY
Does your protocol involve deliberate transfer into human research participants of either:
 Recombinant nucleic acid molecules, or DNA or RNA derived from recombinant nucleic
acid molecules, or
 Synthetic nucleic acid molecules, or DNA or RNA derived from synthetic nucleic acid
molecules, that meet any one of the following criteria:
a. Contain more than 100 nucleotides; or
b. Possess biological properties that enable integration into the genome
(e.g., cis elements involved in integration); or
c. Have the potential to replicate in a cell; or
d. Can be translated or transcribed.
7.3
Yes – Complete
this Section
No – Skip Section
7 & Go to Section 8
Does this protocol fit the following criteria for exemption from the NIH/OBA requirements for
protocol submission, review and reporting process as described below (from Appendix M-VI-A of
the NIH Guidelines)(see below)?
Human studies in which induction or enhancement of an immune response to a vector-encoded
microbial immunogen is the major goal, such an immune response has been demonstrated in
model systems, and the persistence of the vector-encoded immunogen is not expected.
Yes
No
 If
“yes”, please address questions and provide material as described in Section A, below.
“no”, please provide material as described in Section B, below.
Section A: For DNA Vaccine Human Gene Therapy Protocols which fall under the Appendix M-VI-A exception:
a. Describe below what evidence exists to suggest that the vector-encoded immunogen expression is not expected
 If
7.4
12
to persist in the patient?
Attach a copy of the PI and co-PI’s Curriculum Vitae.
Attach responses to Appendices M-II through M-V of the NIH Guidelines
Attach a copy of FDA approval and relevant correspondence. Explain if not applicable.
Attach the Investigator’s Brochure.
Attach the Standard Operating Procedures for vaccine receipt, handling, transfer/transport, administration and
proper disposal.
g. Attach Informed Consent Documents
Section B: Human Gene Transfer protocols which do not fall under the Appendix M-VI-A exception:
a. Attach a copy of the complete protocol submitted to NIH OBA, as described in Appendix M-I-A (inclusive of the
Appendix M, the Description of Research and the Informed Consent Document).
b. Attach a copy of the written response from NIH OBA to the protocol submission that either:
i.
Indicates the submission does not present characteristics that warrant public RAC review and
discussion; or
ii.
Provides a summary of the RAC’s key comments and recommendations after public review.
c. Attach the Standard Operating Procedures for vaccine receipt, handling, transfer/transport, administration and
proper disposal.
SECTION 8: NANOPARTICLES
b.
c.
d.
e.
f.
7.5
8.1
Does your protocol involve the use/creation of nanoparticles?
8.2
List each nanoparticle in the table below:
Nanoparticle Name
Description (including structure, hazards, etc. –
attach
literature if necessary)
Yes – Complete
this Section
No – Skip Section
8 & Go to Section 9
Description of laboratory procedures
involving the Nanoparticle
1.
2.
What are the signs and symptoms of exposure to this material:
8.3
(Note: All accidents/injuries where exposure to nanoparticles should be reported to the Biosafety Office after seeking medical attention,
if necessary).
SECTION 9: ARTHROPODS
9.1
Does your protocol involve the use of arthropods?
9.2
Will you be using, creating, or breeding transgenic arthropods or exposing arthropods to
recombinant DNA?
Yes – Complete
this Section
No – Skip Section
9 & Go to Section 10
Yes*
No
Yes*
No
*If yes, make sure you complete Section 2 – Recombinant DNA and Synthetic Nucleic Acid Molecules
9.3
Indicate the arthropods that will be used?
9.4
Will this work involve the importation, movement and/or field release of genetically engineered
(GE) arthropods?
*If yes, a USDA/APHIS/PPQ permit may be required, see http://www.aphis.usda.gov/permits/ for more
information. The Biosafety Office can assist you in determining permit requirements.
If permit(s) have already been obtained, submit a copy to [email protected]
SECTION 10: PLANTS
10.1
Does your protocol involve the use of plants?
10.2
Will you be creating transgenic plants, exposing plant to recombinant DNA, transgenic
arthropods, or transgenic microorganism/infectious agents?
Yes No – Skip Section 10
& Go to Section 11
Yes*
No
Yes*
No
*If yes, make sure you complete Section 2 – Recombinant DNA and Synthetic Nucleic Acid Molecules
10.3
Indicate the plants that will be used?
10.4
Will this work involve the importation, movement and/or field release of genetically engineered
(GE) plants?
13
*If yes, a USDA/APHIS/PPQ permit may be required, see
http://www.aphis.usda.gov/import_export/index.shtml for more information. The Biosafety Office can assist
you in determining permit requirements.
If permit(s) have already been obtained, submit a copy to [email protected]
SECTION 11: INVESTIGATOR’S ASSURANCE
11.1
Please review each of the following terms of this agreement prior to electronically signing this agreement, below.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
I attest that the information contained in the attached application and supplements is accurate and complete. I also
understand that, should I use the project described in this application as a basis for a funding proposal, I am responsible for
ensuring that the description of the procedures in the funding proposal is identical to those contained in this application.
I have read and understand my responsibilities as a Principal Investigator outlined ion Section IV-B-7 of the NIH Guidelines
and agree to comply with these responsibilities.
I agree that biological waste will be disposed of within the biohazardous waste stream. Any potentially infectious material,
including but not limited to human or non-human primate fluids or unfixed tissues, and/or infectious recombinant DNA, will be
decontaminated prior to disposal in the GRU Biohazardous waste containers.
I agree that all shipping of biological materials, dry ice and other dangerous goods will be done in accordance with IATA/DOT
regulations. Shipping and transport will be performed only by those who can document training in hazardous materials
shipping requirements and procedures.
I agree that intramural transport of biological materials will be done in a sealed, primary container inside of a sealed, leak
proof durable secondary container.
I agree that if use of a Biosafety Cabinet is required by this application to control exposures to biological agents and aerosols
shall be tested annually or after any move or adjustments. It is my responsibility to maintain the integrity of safety equipment.
I agree that safety caps/sealed rotors will used when centrifuging biological specimen, or if unavailable, the lid will not be
opened until 15 minutes have passed after the samples have stopped spinning to allow aerosols to settle.
I agree that entry ways to areas where biological material is used or stored will be posted with “Biohazard” placard.
I agree to prevent unauthorized removal of biological material, biological material will be secured when not in use.
I agree that all containers of biological material will be properly labeled.
I will ensure that before entering my laboratory, any person is advised of the potential hazards.
I agree to accept responsibility and accountability that all laboratory personnel are familiar with and trained to employ the
proposed safety precautions, appropriate emergency procedures, and the practices and techniques described in this BSP.
I will ensure that all personnel listed in this application complete all Georgia Board of Regents and IBC training requirements.
I agree to immediately report the following to the Biological Safety Officer (x-12663), followed by completion of the incident
report found on the Biosafety webpage:
 A violation of these conditions or any other policy governing the use of biological material under this authorization.
 Any unauthorized transfer, disposal, or release of biological material including release to the sanitary sewer system,
air or as solid waste.
 The release or transfer of contaminated or potentially contaminated equipment to facilities for non- biological
material use.
 The use of biological material by unauthorized personnel.
 Lost, stolen, or unaccountable biological materials.
 Spills of biological materials or contamination of personnel with biological materials.
 Any exposures, potential exposures, releases from primary containment, or equipment failure that may result in
personnel exposure or environmental contamination.
I understand that the IBC may be obligated to report any non-compliance to Biosafety guidelines or regulations to my funding
agencies (e.g. NIH) or Federal authorities.
I will not carry out the work described in the attached application until it has been approved by the Institutional Biosafety
Committee (IBC) and/or the Biological Safety Office.
I agree to amend this protocol to include any changes in agents, personnel, locations, applications or major equipment (e.g.
biosafety cabinets, autoclaves) prior to implementation of the changes.
I will annually verify that the research associated with this protocol is currently active, and that no unauthorized changes have
been made to the protocol.
This authorization may be terminated at any time by the Institution Biosafety Committee or suspended by the Biosafety Officer
if the conditions of this authorization are violated or if necessary to preclude harm to staff, facilities, or the environment.
The PI may terminate this authorization at any time by notifying the Biological Safety Officer and completing an amendment
form. The PI shall notify the Biosafety Officer in a timely manner of the anticipated termination of biological material use.
11.2
Principal Investigator
(By electronically entering your name, you are indicating verification that all items are
Date
accurate and you agree to ensure compliance with the above items.)
***Please save this form and submit electronically to [email protected]***
14