FOR BIOSAFETY OFFICE USE ONLY:
(Date Stamp)
BSP Application #:
Review Track: (Check Box)
Institutional Biosafety Committee (IBC)
Full IBC Review
Biosafety Protocol (BSP) Amendment Application
Expedited Clinical Subcommittee Review
Expedited Basic Subcommittee Review
Administrative Review




Amendments must be approved by the IBC prior to initiation of the modified
protocol.
If you have any significant changes in procedures and/or biological materials
please submit a new full application. NOTE: If an initial review of the amendment
indicates that an adequate risk assessment cannot be performed, you may be
asked to submit additional information or a new full application.
Complete this form electronically (must be typed) and save as Amend_PI name
(First, Last). Example: Amend_JohnDoe
Submit the electronic documents to the Biosafety@gru.edu 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.
For assistance completing this form, contact:
Biosafety Officer
Danielle Daniely, Ph.D.
Email: ddaniely@gru.edu
Phone: 706-721-2918
Assistant Biosafety Officer
Laura Meyer, MA
Email: lmeyer@gru.edu
Phone: 706-721-7458
General Information:
Principal Investigator (PI):
Department:
Laboratory Phone Number:
Fax number:
Biosafety Protocol Number:
Office Phone Number:
Email Address:
Campus Address:
Proposed Changes:
Please answer questions 1-8. If you answer “yes” to any question, please provide the appropriate details for each change to allow
the IBC to make an adequate review.
1. Are there any new titles associated with this project? If yes, please list the new titles below.
Yes
No
NOTE: By providing this information, the PI verifies that the agents, experiments, personnel, operations, and locations involved in
the Sponsored Project or IRB Application are fully detailed in the associated BSP(s). Random reviews will be performed by the Biosafety Office,
and grant/protocol material may be requested for review at that time. A title may be added to an existing approved protocol only if the research
project agents, operations, procedures,equipment, locations, and personnel remain the same. If there are any changes required to cover this
study, amend the BSP to reflect the changes using the following questions.
1. List grant/study titles associated with this application:
Grant/Info.Ed.
/IRB/CCRI#:
Funding Agency:
Funding Dates:
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):
2. List grant/study titles associated with this application:
Grant/Info.Ed.
/IRB/CCRI#:
Funding Agency:
Funding Dates:
List additional BSPs required to cover the biological agents and manipulations, operations, personnel and locations described
inthe 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):
2. Are there any changes in project location (i.e. relocating, termination)? If yes, please list changes below.
Yes
No
NOTE: If adding new locations, you will need to schedule an inspection of the new location after the area has been set-up and prior
to starting work.
Add
Remove
Building
Code/Name and
Room Number
(Address for Offsite Areas):
List Biological Agents
(e.g. Recombinant DNA; Animals or animal 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) :
3. Are you leaving the Institution?
Yes
No

Would you like to inactivate this protocol?
If yes, please indicate the date the inactivation should go into effect:
Yes
No

Would you like to transfer this protocol to a different PI?
If yes, please indicate the date the transfer should go into effect and complete the section below:
Yes
No
NOTE: Prospective Principal Investigator must be copied on the email submission of this form to Biosafety@gru.edu
New PI Name:
Department:
New PI’s Phone
Emergency Contact
Emergency Contact’s
Number:
Name:
Phone Number:
State the prospective PI’s previous work experience with the agents/materials specified in this protocol below:
4. Are there any new personnel/staff to be added? If yes, complete the following sections.
Yes
No
List new individuals (including the PI, collaborators, technicians, post docs, graduate students, work-study students, volunteers,
etc.) physically working on the research proposed in this application or that may be exposed to the research materials (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
Job/Position Title
Does the person
have experience with
materials listed in
this applications:
Yes
No
Yes
No
Yes
No
If yes, which materials? (e.g., lentivirus,
human tissues, bacteria)
Training Requirements:
Have all personnel listed on this protocol completed Initial Biosafety Training (didactic – required once)
or an Annual Biosafety Refresher Training Module (online – required annually after completing the initial
training) as per NIH?
If yes, where was
this experience
obtained and number
of years?
Yes
No*
Have all personnel listed on this protocol who may have occupational exposure to human blood, other
potentially infectious materials (OPIM) of human origin (e.g., cell/cell lines, unfixed tissues) or human
bloodborne pathogens (BBP) completed BBP Training (online – required annually) as per OSHA?
Yes No*
Not Applicable
Have all personnel in your laboratory who plan to ship, transport, export, pack, label, mark, or
complete/sign paperwork for shipping biological materials (including diagnostic/clinical specimens, cell
cultures, tissues, genetically modified organisms and/or infectious agents, toxins of biological origin) or
items on dry ice, liquid nitrogen or in fixative completed Shipping Biological Substance and Support
Materials Training (online – required by DOT and IATA)?
*If no, or unsure, contact the Biosafety Office at Biosafety@gru.edu to be assigned the training or for verification of
Yes No*
Not Applicable
training.
Medical Surveillance and Vaccinations:
Vaccines or other tests/evaluations may be required for the work being conducted in this application. (Check all that apply):
Hepatitis B Vaccine or signed Waiver (required for all individuals having occupational exposure to human blood, other potentially
infectious materials (OPIM) of human origin (cells/cell lines, unfixed tissues) or human bloodborne pathogens (BBPs), required as per
OSHA.
Seasonal Influenza Vaccine
Respirator evaluation and annual fit test (e.g., N95, PAPR, full/half face respirators)
Other (list):
Contact Employee Health and Wellness, 706-721-3418, to schedule an appointment for the services indicated above.
5. Are there any personnel/staff to be removed? If yes, please list below.
Name(s)
1.
2.
Yes
No
Name(s)
3.
4.
6. Are there any changes in agents?
If yes, please describe the change below. If there are multiple changes, separate each change by paragraph.
Yes
No
NOTE: Provide specific details (ie. animal/bacterial strain names, cell line names) and attach additional documents if necessary
(i.e.vector maps, MSDS).
Recombinant and Synthetic Nucleic Acid Molecules (e.g., bacterial/mammalian expression plasmids, replication
incompetent viral vectors, chemically synthesized nucleic acid molecules) (Complete the rDNA table and questions).
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, creating transgenic animals, breeding transgenic animals, exposing animals to recombinant DNA, or
purchasing/obtaining transgenic animals from a commercial vendor or collaborator)
Biological Toxins (e.g., cholera toxin, pertussis toxin, diphtheria toxin, tetrodotoxin)
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)
7. Use the table below and questions to describe your rDNA experiments
Vector
Technical
Name and
Provider (e.g.
pLKO.1,
Invitrogen)
Backbone
Source (e.g.
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):
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
<1/2
>1/2 but <2/3
>2/3
N/A
Is the
vector
designed to
be
replication
competent?
Yes No
Yes
Name of
Packaging Cell
line(s) or
Helper
plasmids used
in co-transfect
ion to produce
viral particles
No
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
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):
What host organism will you use for DNA propagation? List the species and strain (i.e., E.coli DH5α)
Will the recombinant (vector + insert) be purchased from a commercial vendor, provided by a collaborator and/or created/packaged in the laboratory? Indicate which and
give the name.
Provide restriction/vector maps for each vector listed above to the Biosafety Office at Biosafety@gru.edu with your amendment.
Example:
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.
8. Are there any changes in laboratory procedures (i.e. new technique, new equipment)?
If yes, please summarize below or attach revised laboratory specific SOPs.
Yes
No
PRINCIPAL INVESTIGATOR’S ASSURANCE
Please review each of the following terms of this agreement prior to electronically signing, below.
1.
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.
2. I have read and understand my responsibilities as a Principal Investigator outlined in Section IV-B-7 of the NIH Guidelines and agree to
comply with these responsibilities.
3. I agree to comply with the requirements pertaining to the use, shipment and transfer of biological agents.
4. I will ensure that before entering my laboratory, any person is advised of the potential hazards.
5. 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 as amended.
6. I agree to report any accident that results in overt exposure of personnel or the environment to biological agents or recombinant DNA
including inoculation, ingestion, mucous membrane exposure or inhalation by personnel of any agent to the Biosafety Officer (x1-2663),
followed by completion of the accident report found on the Biosafety webpage.
7. I agree to immediately report any high hazard spills (large volumes, high risk group agents) or spills in public (non-laboratory) areas to the
Biosafety Officer (x1-2663).
8. I agree to report any problems pertaining to operation and implementation of biological and physical containment safety procedures or
equipment or facility failures to the Biosafety Officer (x1-2663) as soon as possible, followed by a written report to the IBC.
9. I understand that the IBC may be obligated to report any non-compliance with Biosafety guidelines or regulations to my funding agencies
(e.g. NIH) or Federal authorities.
10. I will not carry out the work described in the attached application until it has been approved by the Institutional Biosafety Committee
(IBC).
Principal Investigator
Date
(By electronically entering your name, you are indicating verification that all
items are accurate and you agree to ensure compliance with the above items.)
***Please save this form as Amend_PI name (First, Last) and submit electronically to
Biosafety@gru.edu***