Research Review for Biosafety - Office of Research Compliance

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Office of Regulatory Compliance & Safety
2013
Research Review for Biosafety
Some research does not require full IBC approval. This form will help both the PI and the BSO evaluate research
that may be eligible for notification only.
INSTRUCTIONS FOR COMPLETING THE FORM
Instructions:
If you are planning to work with ANY infectious agent, rDNA or synthetic nucleic acids, nanoparticles, toxins,
transgenic plants/animals and/or human/primate specimens and are unsure if the research will require a full IBC
application, fill out this form and send to the BSO for evaluation.
Principal Investigator (PI):
Phone:
Mailstop:
Department:
Co-Investigator:
Address:
Project Title:
Time Frame:
BSO ONLY
DATE RECEIVED:
IBC NUMBER:
ACTION:
NOTIFICATION
REQUIRES IBC APPLICATION
Reviewed/Approved by:
_______________________________
Biosafety Officer
____________________________
Date
Reviewed/Approved by:
_______________________________
IBC Chair
____________________________
Date
1
Office of Regulatory Compliance & Safety
2013
1. LOCATION OF WORK:
Building/Room Where Work Will Be Conducted
Building/Room Where Materials Will Be Stored
2. CLASSIFICATION: Check the biological material(s) to be used.
□
Virus
Bacterium
□
□
Fungus
Parasite
□
Cell Culture
□
Species:
□
Tissue
Species:
Fluid
□
□
Prion
Toxin
□
rDNA
□
Type:
Species:
□
Synthetic
Nucleic Acids
Nanoparticles
Type:
□
Other
□
3. PROJECT SUMMARY:
In the space below, provide a description of the project including the objectives and a brief experimental
design. If the research involves recombinant DNA, synthetic nucleic acids or nanoparticles, discuss the
source of the DNA, the nature of the inserted sequences (functional or structural gene etc.) the cloning
vector, the recipient organism, discussion on any protein to be expressed, type of nanoparticle, function
of synthetic nucleic acids and what you are going to do with each type.
4. ACTIVITIES/PROCEDURES/DECONTAMINATION
Describe the activities that will be done with the material. For example: centrifugation, sonication,
inoculation of animals or plants, cloning, mixing, etc. Discuss decontamination procedures and required
PPE.
5. RECOMBINANT/SYNTHETIC NUCLEIC ACID MOLECULES
List the section of the NIH Guidelines under which this research falls.
□ Section III-A
□ Section III-B
□ Section III-C
IBC Approval, RAC Review and NIH Director Approval Before Initiation
NIH/OBA, IBC Approval Before Initiation
IBC, IRB Approval and RAC Review Before Initiation
2
Office of Regulatory Compliance & Safety
□ Section III-D
□ Section III-E
□ Section III-F
IBC Approval Before Initiation
IBC Notification Simultaneous With Initiation
Exempt Experiments
3
2013
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