Biological Use Authorization Application

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IBC Protocol Submission Checklist
REQUIRED FOR ALL PROTOCOL SUBMISSIONS
IBC Main Form
Acknowledgment of Responsibilities “signed” (last page)
PI Biosketch
Biosketch of any co-PIs
Personnel and Training Form
Biosafety Manual
Agents and Materials Summary completed (last page)
PROTOCOL-SPECIFIC DOCUMENTS FOR PROTOCOLS INVOLVING RECOMBINANT/SYNTHETIC DNA
Exemption Form: For protocols involving experiments that are considered exempt in the NIH Guidelines
rDNA in cells/tissues: For protocols introducing recombinant/synthetic DNA into cells and/or tissues; or
the use of cells that already contain recombinant/synthetic DNA.
rDNA in Pathogens: For protocols introducing recombinant/synthetic DNA into agents classified as RG2
and/or RG3; or the use of RG2/RG3 agents that have already been modified.
rDNA in Animals: For protocols introducing recombinant/synthetic DNA into animals; or the use of animals
that have already been modified.
rDNA in Plants: For protocols introducing recombinant/synthetic DNA into plants; or the use of plants that
have already been modified.
OTHER PROTOCOL-SPECIFIC DOCUMENTS AND INFORMATION
Large Cultures Form: For protocols involving the use of 10 liters or more of a culture at any one time.
This form is used whether or not the cultures include recombinant DNA.
General Risk Assessment Worksheet: A separate risk assessment is required for each RG2 and/or RG3
agent. Do not use this template for the use of human and/or non-human primate agents.
Human and/or non-human primate agent Risk Assessment Worksheet: Use this risk assessment
template for the use of human and/or non-human primate cells, tissues, organs, bodily fluids, etc.
Lab Sketch: Required for all BSL-2 and BSL-3 labs. The sketch should include the location of
exits/entrances, BSL2/BSL3 equipment (centrifuges, incubators, etc.), biosafety cabinet(s), sinks, benches,
etc.
Toxin Form: Required if you are using biologically-derived toxins.
Synthetic Nucleic Acids Form: Required if you are introducing synthetic nucleic acid sequences into
vectors, animals, plants and/or microorganisms.
Submission Checklist
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Rev. 4/2014
Viral Vectors Form: Required if you are using viral vectors.
Animal Hazard Summary: Required for protocols involving the introduction of biohazardous agents to
animals. The approved file must also be submitted to the animal facility manager.
Self-Inspection Checklist: Required for all BSL-1 labs, and for annual reviews of BSL-1 and BSL-2 labs.
On-site Inspection: An on-site inspection must be scheduled for all BSL-2 and/or BSL-3 new and/or
renewal protocol submissions.
TRAINING
ONLINE CITI Training
“VT Researchers Tier 2” Course: Required for all personnel listed on all protocols except BSL-1
designated plant protocols.
“Biosecurity: VT Researchers- Plants” Course: Required for all personnel listed on BSL-1
designated plant protocols.
Online Autoclave Training: Required for all personnel listed on all protocols.
NIH Guidelines Training: Required for all personnel working with recombinant and/or synthetic nucleic
acids and/or modified organisms.
Online Biosafety Cabinet Training: Required for personnel listed on BSL-2 protocols.
Online Medical Surveillance Survey: Required for personnel listed on BSL-2 protocols. The survey must
be updated annually.
Blood-borne Pathogens Training: Required for personnel working with human and/or non-human
primate agents. This training must be completed annually.
Respiratory Training: Required for all personnel working with aerosol hazards. This training must be
completed annually. Fit-testing must be completed during the initial training.
Biohazard Awareness Training: Required for all personnel working in a lab shared by multiple PIs, in
which RG2 and/or RG3 agents are used. Each PI must train all personnel working in the lab with the agents
used in their specific area(s), the risks associated with the agents, safety precautions to be used in the area(s),
and how to handle any incidents that occur.
Submission Checklist
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Rev. 4/2014
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