Principal Investigator:Click here to enter text. Protocol #Click here to enter text.
For IBC use onlyNIH Guidelines: Exempt ☐Yes ☐ NoClick here to enter text. / Protocol #:Click here to enter text.
Risk Group:☐RG-1 ☐ RG-2 ☐ RG-3 ☐ RG-4 / DURC: ☐Yes ☐ No
Agents: Click or tap here to enter text.
Principal Investigator
Name: Click here to enter text.Project Title: Click here to enter text.
Department: Click here to enter text.
Office Phone: Click here to enter text.
GSU Email: Click here to enter text.
Laboratory Safety Representative
Phone: Click here to enter text.
GSU Email: Click here to enter text.
Building and Laboratory Room Number: Click here to enter text.
Laboratory Personnel Information
Name of Laboratory Personnel / Title (e.g. faculty, technical staff, graduate students, undergraduate, etc.) / GSU Email Address / Phone Number / GSU Biosafety Training Completed?Click or tap here to enter text. / Click or tap here to enter text. / Click or tap here to enter text. / Click or tap here to enter text. / ☐Yes ☐ No
Click or tap here to enter text. / Click or tap here to enter text. / Click or tap here to enter text. / Click or tap here to enter text. / ☐Yes ☐ No
Click or tap here to enter text. / Click or tap here to enter text. / Click or tap here to enter text. / Click or tap here to enter text. / ☐Yes ☐ No
Click or tap here to enter text. / Click or tap here to enter text. / Click or tap here to enter text. / Click or tap here to enter text. / ☐Yes ☐ No
1. Project Description
Outline the overall goal(s) of the project in the space below. Give enough information to assure that the purpose of the experiments and the techniques used are clear. Please use reasonably lay terms and spell out all acronyms/initialisms.
Click or tap here to enter text.
2. Protocol Summary
Is this project part of a course or teaching laboratory? ☐Yes ☐ NoWill all experimentation occur at Georgia State University? ☐Yes ☐ No
Will live animals or Non-Human Primates be used for this project? ☐Yes ☐ No
IACUC protocol associated with this project: Click here to enter text.
Animal Biosafety Level: ☐ABSL-1 ☐ ABSL-2 ☐ ABSL-3
Check all that apply:
☐ / Fish / ☐ / Lizards / ☐ / Mice / ☐ / Rats / ☐ / Hamsters / ☐ / Non-Human Primates
☐ / Insects / ☐ / Cell lines / ☐ / Primary cells / ☐ / Birds / ☐ / Venomous invertebrates or Vertebrates
☐ / Other / Click or tap here to enter text. /
☐ / Yes / ☐ / No
☐ / Yes / ☐ / No
☐ / Yes / ☐ / No
Will Radiological Isotopes be used for this project?
Will X-ray radiation be used for this project?
Will other types of radiation be used for this project?
RPC protocol associated with this project: Click here to enter text.
Will you be using any Human Biological Material? ☐Yes ☐ No
IRB protocol associated with this project: Click here to enter text.
Yes / No
Has everyone in the laboratory completed the online
Bloodborne Pathogen Training Course for the Board of Regents of the University System of Georgia?
( / ☐ / ☐
Was a health screening done on the source material? If yes, please attach a copy of the report. / ☐ / ☐
Will human and/or non-human primate material be administered to animals? / ☐ / ☐
If you are using biological material that may contain Bloodborne Pathogens, do you have an Exposure Control Plan (ECP) on file with the biosafety officer and Safety and Risk Management? / ☐ / ☐
If Human Source or Non-Human Primate Material is being used, has the material been treated prior to use in the laboratory (such as formalin fixing or heat treatment)? / ☐ / ☐
Check all that Apply:
☐ / Blood / ☐ / Serum / ☐ / Cell lines / ☐ / Primary cells / ☐ / Tissue / ☐ / Does not Apply
☐ / Bones / ☐ / Saliva / ☐ / Hair / ☐ / Urine / ☐ / Feces
☐ / Other / Click or tap here to enter text. /
Will you be using infectious material? ☐Yes ☐ No
Risk Group Level: (Check all that apply) ☐RG-1 ☐ RG-2 ☐ RG-3 ☐ RG-4
Check all that apply:
☐ / Prions / ☐ / Viral Agents / ☐ / Fungal Agents / ☐ / Bacterial Agents / ☐ / Rickettsia Agents
☐ / Arboviruses and Related Zoonotic Viruses / ☐ / Toxic Agents from Microorganisms/Animals
☐ / Does Not Apply
What type of wastes will be generated?
☐ / Radiological / ☐ / Biological / ☐ / Chemical
☐ / Mixed Radiological/Biological / ☐ / Mixed Biological/Chemical
Will you be using toxic agents? ☐Yes ☐No
Are you working with a select agent? ☐Yes ☐No
List all that apply: Click here to enter text.
Are you working with a select toxin? ☐Yes ☐No
List all that apply: Click here to enter text.
Will you be conducting research that meets criteria for Dual Use Research of Concern DURC? ☐Yes ☐ No
Will this project involve recombinant or synthetic nucleic acid molecules? ☐Yes ☐No
Check all recombinant or synthetic nucleic acid molecules that apply:
☐ / Encodes and expresses proteins
☐ / Encodes and expresses toxins
☐ / Nucleic acid molecules from USDA regulated plant or animal
☐ / Other Click or tap here to enter text.
☐ / Does Not Apply
Will you be performing any of the following?
☐ / Moving non-indigenous species of plants or animals (including offspring) into Georgia
☐ / Moving pathogens that adversely affect plants or animals into Georgia
☐ / Moving indigenous species of plants or animals infected with pathogenic microorganisms into or out of Georgia
☐ / Does Not Apply
Are you growing more than 10 liters of recombinant material or any type of cultures? ☐Yes ☐ No
If yes, please identify the building, room, and type of equipment used for large scale culture growth? Click here to enter text.
Will Laboratory Workers require Medical Monitoring? ☐Yes ☐ No
Check all that apply:
☐ / Serum Banking / ☐ / Hepatitis B Vaccine / ☐ / Influenza (seasonal) vaccine / ☐ / Tetanus Vaccine
☐ / Proof of MMR / ☐ / Other Click or tap here to enter text.
Which Medical Monitoring are you affiliated?
☐Division of Animal Resources or ☐ BSL-4 (high containment laboratory)
(check here if you have an IACUC protocol) (check here if you work in the BSL-4)
3. Material and Methods
Outline of the overall experiment(s) that will be performed in the space below. Give enough information to assure that the procedures of the experiments and the techniques used are clear to allow members of the IBC to assess the safety of the procedures. Please use reasonably lay terms and spell out all acronyms/initialisms. Include how much of the agent(s) will be manipulated at a time. Include infectious doses and concentrations if known.
Click here to enter text.
4. Specific Biosafety Procedures (including transport procedures)
Describe the safety procedures involving the use of biological agent(s) or toxin(s). Describe how the agent will be used in the lab (biosafety cabinet, open lab bench), what PPE will be worn, how will spills be cleaned, and waste removed. Please state GSU SOP’s will be followed including the Hazardous transport guidelines if transporting between buildings and laboratories.
Click here to enter text.
5. The biosafety cabinets and laboratory bencheswill be disinfected by:
Yes / NoEthanol, 70% with a 15 minute contact time. / ☐ / ☐
Freshly made 1:10 solution of bleach (5% or more of the active ingredient, sodium hypochlorite) with a 3 minute contact time. / ☐ / ☐
Glutaraldehyde solution with a 10 minute contact time.
Name commercial disinfectant here: Click here to enter text. / ☐ / ☐
Ortho-phthalaldehyde solution with a 5 minute contact time.
Name commercial disinfectant here: Click here to enter text. / ☐ / ☐
Other method of disinfecting and contact time.
Name disinfectant here: Click here to enter text. / ☐ / ☐
Animal vivarium will be disinfected by:
Yes / NoChlorine Dioxide (MB10) will be used in the animal facility. The disinfectant is provided by DAR.
10 minute contact time
If MB10 cannot be used, please provide alternative agent for disinfecting: Click here to enter text. / ☐ / ☐
6. Waste Materials will be sterilized by:
Yes / NoAutoclave: 30 minutes at 121°C (15 PSI) / ☐ / ☐
Incineration of infectious material and/or animal carcasses: / ☐ / ☐
Sharps containers will be incinerated according to GSU policies: / ☐ / ☐
List other method of Sterilization:
Click here to enter text. / ☐ / ☐
7. Laboratory Equipment and Personal Protective Equipment
Building/Room(s) / Biosafety Level
Click here to enter text. / BSL-1 Required: Laboratory Coat
BSL-1 Recommended / ☐ / Gloves / ☐ / Safety Glasses/Side shields/Safety Goggles
☐ / Biosafety Cabinet / ☐ / Fume Hood
☐ / Off campus location / (check here if samples will not be collected/experimentation will not be done at GSU)
Click here to enter text. / BSL-2 Required: Laboratory Coat, Gloves, Safety Glasses/Side shields/Safety Goggles
BSL-2 Recommended / ☐ / Booties / ☐ / N-95 Mask (training and fit testing required)
☐ / Surgical Mask / ☐ / PAPR
☐ / Biosafety Cabinet / ☐ / Fume Hood
☐ / Other Click or tap here to enter text.
Click here to enter text. / BSL-3 Required: Laboratory Coat/Closed front gown/Scrubs, 2 Pairs of Gloves, Safety Glasses/Side shields/Safety Goggles, Booties
BSL-3 Recommended / ☐ / PAPR / ☐ / N-95 Mask (training and fit testing required)
☐ / Biosafety Cabinet / ☐ / Fume Hood
☐ / Other Click or tap here to enter text.
Click here to enter text. / BSL-4 Required: Laboratory Coat/Closed front gown/Scrubs, 2 Pairs of Gloves, Safety Glasses/Side shields/Safety Goggles, Booties
BSL-4 Recommended / ☐ / PAPR / ☐ / N-95 Mask (training and fit testing required)
☐ / Biosafety Cabinet / ☐ / SCBA
☐ / Fume Hood / ☐ / Tyvek w/ hood and foot covers
☐ / Other Click or tap here to enter text.
Click here to enter text. / ABSL-1 Required: Laboratory Coat/Gown, Gloves
ABSL-1 Recommended / ☐ / Surgical Mask / ☐ / N-95 Mask (training and fit testing required)
☐ / Biosafety Cabinet / ☐ / PAPR
☐ / Cage Change Station
☐ / Other Click or tap here to enter text.
Click here to enter text. / ABSL-2 Required: Laboratory Coat/Gown, Gloves, Safety Glasses/Side shields/Safety Goggles, Booties, Biosafety Cabinet
ABSL-2 Recommended / ☐ / Surgical Mask / ☐ / N-95 Mask (training and fit testing required)
☐ / PAPR / ☐ / Cage Change Station
☐ / Other Click or tap here to enter text.
Click here to enter text. / ABSL-3 Required: Scrubs, Tyvek or equivalent, Gloves with cuffs, PAPRs, Booties, Biosafety Cabinet
ABSL-3 Recommended / ☐ / Surgical Mask / ☐ / N-95 Mask (training and fit testing required)
☐ / PAPR / ☐ / SCBA
☐ / Other Click or tap here to enter text.
☐ / Field work outside of laboratory
8. Are you working with genetic elements, synthetic nucleic acids, recombinant nucleic acids, recombinant DNA (rDNA) or recombinant organisms? ☐Yes ☐No If yes, you must complete questions below. If no, go to question 10.
Specify the Recombinant or Synthetic Nucleic Acid Molecules, including as much information as possible about:
- Source (s) of the nucleic sequences (e.g. species) Click here to enter text.
- Nature of the nucleic acid sequences: Click here to enter text.
- Protein that may be expressed;Click here to enter text.
- Host(s) and vectors(s) to be used: Click here to enter text.
- Percentage of any viral genome in the construct;Click here to enter text.
- Recipient host cell lines (human, animal, plant, etc.) or bacterial strains; Click here to enter text.
- Are you working with CRISPR or similar technology (TALENs, Zinc Fingers,etc)? ☐Yes ☐ No If yes, also complete #9
Additional Information: Click here to enter text.
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules / Yes / No
a. / Have you completed the NIH required NIH Guidelines training in iCollege?
Contact for access to the online safety training. / ☐ / ☐
b. / Are you deliberately transferring a drug resistance trait to microorganisms that are not known to acquire the trait naturally which could compromise the ability to control disease agents in humans, veterinary medicine, or agriculture?
See Section III-A-1-a of the NIH Guidelines for more information. / ☐ / ☐
c. / Are you deliberately producing recombinant or synthetic nucleic acid containing genes for the biosynthesis of toxin molecules lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight (e.g., microbial toxins such as the botulinum toxins, tetanus toxin, diphtheria toxin, and Shigella dysenteriae neurotoxin).
See Section III-B-1 of the NIH Guidelines for more information. / ☐ / ☐
d. / Are you deliberately transferring Recombinant or Synthetic Nucleic Acid Molecules, or DNA or RNA derived from Recombinant DNA or Synthetic Nucleic Acid Molecules, into human research participants?
See Section III-C-1of the NIH Guidelines for more information. / ☐ / ☐
e. / Are you performing experiments Using Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents as Host-Vector Systems?
See Section III-D-1of the NIH Guidelines for more information. / ☐ / ☐
f. / Are you performing experiments in which DNA from Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents is cloned into Nonpathogenic Prokaryotic or Lower Eukaryotic Host-Vector Systems?
See Section III-D-2 of the NIH Guidelines for more information. / ☐ / ☐
g. / Are you performing experiments involving the use of Infectious DNA or RNA Virus or Defective DNA or RNA Viruses in the presence of Helper Virus in Tissue Culture System?
See Section III-D-3 of the NIH Guidelines for more information. / ☐ / ☐
h. / Are you performing experiments involving Whole Animals at ABSL-2 (medium level) or higher and
See Section III-D-4 of the NIH Guidelines for more information. / ☐ / ☐
i. / Are you performing experiments involving Transgenic Rodents that only require ABSL-1(low level) containment
See Section III-E-3 of the NIH Guidelines. / ☐ / ☐
j. / Are you performing experiments involving Whole Plants?
See Section III-D-5 of the NIH Guidelines for more information. / ☐ / ☐
k. / Are you performing experiments involving More than 10 Liters of culture?
See Section III-D-6 of the NIH Guidelines for more information. / ☐ / ☐
l. / Are you performing experiments involving Influenza Viruses including but not limited to:
See Section III-D-7 of the NIH Guidelines for more information. / ☐ / ☐
m. / Are you performing experiments involving the Formation of Recombinant DNA Molecules Containing No More than Two-Thirds of the Genome of any Eukaryotic Virus?
See Section III-E-1 of the NIH Guidelines for more information. / ☐ / ☐
o. / Are you performing experiments that do not present a significant risk to health or the environment?
See Section III-F-8 of the NIH Guidelines for more information. / ☐ / ☐
Exempt Experiments: The following recombinant or synthetic nucleic acid molecules are exempt from the NIH Guidelines; however, other federal and state standards of biosafety may still apply to such research (for example, the Centers for Disease Control and Prevention (CDC)/NIH publication Biosafety in Microbiological and Biomedical Laboratories)
If you answered “Yes” to Section III-F-8, your research must also fall under one or more of the below guidelines.
p. / Are you performing experiments that include synthetic nucleic acids that:
- can neither replicate nor generate nucleic acids that can replicate in any living cell; and
- are not designed to integrate into DNA; and
- do not produce a toxin that is lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight?
q. / Are you performing experiments that are:
- not in organisms, cells, or viruses; and
- that have not been modified or manipulated to render them capable of penetrating cellular membranes?
r. / Are you performing experiments that consist solely of the exact recombinant or synthetic nucleic acid sequences from a single source that exists contemporaneously in nature?
See Section III-F-3 of the NIH Guidelines for more information. / ☐ / ☐
s. / Are you performing experiments 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?
SeeSection III-F-4 of the NIH Guidelines for more information. / ☐ / ☐
t. / Are you performing experiments that consist entirely of nucleic acids from an 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)?
SeeSection III-F-5 of the NIH Guidelines for more information. / ☐ / ☐
u. / Are you performing experiments 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?
See Section III-F-6 of the NIH Guidelines for more information. / ☐ / ☐
v. / Are you performing experiments with those genomic DNA molecules that have acquired a transposable element, provided the transposable element does not contain any recombinant and/or synthetic DNA?
See Section III-F-7 of the NIH Guidelines for more information. / ☐ / ☐
9. Gene editing/CRISPR technology information: If you are not working with gene edition, go to question 10.
- Which organism(s) is being modified?Click here to enter text.
- Is the gene being knocked-in or out? ☐Knocked in ☐Knocked out ☐Neither
- Is the work in cell culture? ☐Yes ☐No If yes, please list the cell lines:Click here to enter text.
- Is the work in whole organism? ☐Yes ☐NoIf yes, please list the organism(s)Click here to enter text.
- What is the function of the gene(s) being modified?Click here to enter text.
- What will be the function of the gene(s) once modified?Click here to enter text.
CRISPR Information: Discuss the desired effect of gene editing on the animal or cell line. You must address the potential effects due to accidental worker exposure. Ifunknown, state that. Points to consider are:
- Are the guide RNA gene and the Cas 9 gene physically linked on the same piece of DNA? ☐Yes ☐No
If yes, please describe:Click here to enter text.
- Is the guide RNA sequence specific to animals, humans, or could it affect both?☐Animals ☐Humans ☐Both
Describe any similarity between human and animal guidesequences? Click here to enter text.
- What is known about off-target effects with the system you are using?Click here to enter text.
- How much genotype change (dose) is needed for a physical effect?Click here to enter text.
- How does route of exposure affect outcome?Click here to enter text.
- Can the mutation potentially drive through a population?Click here to enter text.
- What should be done in the event of an accidental exposure (e.g., needle stick) to the gene editing system?Click here to enter text.
- What safety precautions should be in place for the work?Click here to enter text.
10. Are you are working with biological material or a toxin? ☐Yes ☐No If yes, then you must complete the questions below. If No, then go to question 11.