University of Tennessee Health Science Center
Project #
Institutional Biosafety Committee
(Assigned by the IBC)
910 Madison Avenue, Suite 650
Memphis, TN 38163
Tel: (901) 448-2164
Fax: (901) 448-5222
IBC Protocol Form
Please Type
Principal Investigator
Co-Investigator (If applicable)
First Name
Last Name
Degree
First Name
Last Name
Degree
Institution / School (if within UTHSC)
Department
Office Address (include Office Rm Number)
Mailing Address (if different)
Telephone #
Fax #
E-mail
New
Amendment
Renewal
Proposed Dates (maximum of 3 years per registration)
From:
to
Project Title
Supporting Agency (if applicable)
Co-Investigators, Assistants, Technicians (List ALL persons actively involved with this project):
Specify the alternative contact when the PI and/or co-PI are unavailable.
Name
Department
Phone
Location of Research (Building and Room #s)
Key Words: Please select all key words that apply to this registration.
Prokaryote/Bacteriophage
Plasmids
Eukaryotic organisms *
Non-human mammalian cell lines
human and/or other primate cells/tissue/blood**
Vertebrate Animal Studies * * *
Plant Studies
Eukaryotic viruses
Adenovirus / Adenoviral
Adeno-Associated Virus (AAV)
Retrovirus / Retroviral
Lentivirus / Lentiviral
* includes arthropods (insects, etc.), fungi (yeasts, etc.), and protozoans
* * requires BSL-2 containment and compliance with OSHA BBP standard. May also require
IRB approval
* * * requires IACUC approval
Note: If any material used for experiments was obtained under a Material Transfer Agreement (MTA), please attach
a copy of the agreement to the end of this registration.
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1. Provide a non-technical description of the proposed work below (explaining all acronyms).
Your abstract should explain in layman’s terms what you are going to do with the recombinant
DNA. Give a brief narrative of the goals and experimental procedure so as to provide a basis for
review. **If this is a renewal, indicate what was accomplished during the previous 3-year
period and what new work is planned (required).
2a. Nature and species of recombinant DNA or RNA sequences that will be used. List each
sequence individually.
Sequence Name:
Function of the gene, cDNA, or sequence
Species
b. Will you attempt to obtain expression of a foreign gene (one originally exogenous to the host
vector)?
Yes
No
c. Does the gene encode a toxin or oncogene?
Yes
No
3. Prokaryotic - Please identify organisms (e.g. E. coli), the strain (e.g. DH5-) and their source
(e.g. where you obtained them).
a. Organisms / Strains:
b. Source
c. Will you be growing cultures in ≥10L?
Yes
No
4. Eukaryotic - Please identify eukaryotic materials and their source.
a. Strains, cell lines (indicate species) and /or tissues: b. Source
Note: If human cells are used, an IRB approval or exemption letter must be obtained and a copy
must be attached to this registration.
c. Eukaryotic Viruses
d. Source
e. Fraction of Eukaryotic Viral Genome in
Recombinant DNA?
<1/2
>1/2 but <2/3
f. Will you be growing ≥10L of eukaryotic material (e.g. cells, or viral vectors)?
Yes
No
g. Plant or Animal Experiments
Species
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Strain
Source
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>2/3
h. Transgenic plants or animals?
Yes
i. Source(s) of transgenics?
No
5. List the vectors (plasmid, phage and/or eukaryotic viral vectors) to be propagated, the source,
and the host used for propagation. Vectors for prokaryotic and eukaryotic hosts should be listed
separately.
Vector/Plasmid
Source of Vector
Host for propagation
a. If you are going to use viral vectors, justify the use of an infectious agent over methods that do
not involve infectious agents.
b. If a viral vector is used, describe the modifications to its genome that limit its infectivity.
c. If viral vectors will be used, describe the method by which the vectors will be assayed for the
presence of replication-competent virus and state what will be done with the vector productions
that contain replication-competent virus.
6. Describe the proposed experiments IN DETAIL. Include manipulation and analysis of
materials transformed, transfected or infected with rDNA vectors. Also include information on
whether infectious materials will be transported between labs, or between buildings on campus.
7a. Perform a Risk Assessment and describe the biohazard potential of these experiments.
Specifically, investigators should address the potential risks for all experiments utilizing
recombinant DNA. For example, what effect might there be if a vector expressing your inserted
genes were inadvertently introduced (via abrasion, injection or ingestion) into and expressed in a
lab worker? All lab workers should also recognize that the use of human cell lines carries a
potential risk of exposure to unknown agents that may be present in the cell line, even if the cells
have been screened for “adventitious agents”. The PI should specifically address the risk of
working with human materials and cells lines.
7b. Will you be transporting infectious materials between labs, or between buildings on campus?
Yes
No
8. Address how you will mitigate the potential hazards from Section 7. (Refer to the BMBL and
the condensed guidelines for rDNA work for assistance with this section). Describe the facilities
and engineering controls, the precautions (i.e. spill kit and signage) and any personal protective
equipment that will be used to maintain the proper biosafety level containment. Also, describe
how infectious materials will be packaged if transported between labs, or between buildings on
campus.
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9. Based on your risk assessment and the materials being used, indicate the appropriate
classification and biosafety level for your work. Refer to the NIH Guidelines on the IBC website
for a description of the classifications and biosafety levels
(http://www.uthsc.edu/research/research_compliance/IBC/biosafety.php).
Suggested classification
IIIA
IIIB
Suggested biosafety level(s):
BSL-1
BSL-2
BSL-3
IIIC
IIID
ABSL-1
IIIE
ABSL-2
IIIF
ABSL-3
10. Enrollment in Occupational Health is required when an N-95 respirator will be used and /or
human materials / cell lines are used. N-95 respirators use requires medical clearance and fittesting. Contact Occupational Health Services in the Office of University Health Services
(448-5630) to schedule an appointment for N-95 mask fitting, to schedule blood-borne
pathogen post-exposure monitoring, and/or vaccinations. Human materials / cell lines are
covered by OSHA 1910.1030.
10a. Have you and your lab personnel enrolled in the Occupational Health Services blood-borne
pathogen post-exposure monitoring and management program, undergone N-95 fit testing
and/or enrolled in the chemical exposure monitoring and medical evaluation program?
Yes
No
10b. Is there a need for additional health surveillance for the project?
Yes
No
10c. If yes, explain below:
10d. Will pre-performance serum samples be taken from personnel performing the studies?
Yes
No
11. If you are performing work that requires BSL-2 or BSL-3 containment, you need to have
your biosafety cabinet certified annually. Has your BSC been certified within the past year?
Yes
No
Note 1: All registration must be submitted by 5 PM on the second Friday of the month in order
to give the IBC office time to pre-review your registration and assist you in making changes
prior to the full committee review at the next IBC meeting. Registrations do not need to be
signed for pre-review.
Note-2: For projects involving the transfer of rDNA molecules into human subjects, additional
information must be submitted (See the simplified NIH Guidelines on the IBC website for
specific information).
Note-3: For registrations utilizing agents that require BSL-3 containment, the project must be
reviewed and approved by the Committee On Biocontainment and Restricted Entities (COBRE),
which is a subcommittee of the IBC. Prior to submitting rDNA registrations for work with BSL3 agents, contact the IBC office for specific instructions.
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Signatures: The individuals signing this registration indicate their understanding and approval
of this project to be conducted at The University of Tennessee Health Science Center. The
Principal Investigator accepts full responsibility for the biosafety training of laboratory personnel
and must notify the UTHSC IBC and Occupational Health Services if any member of the
laboratory develops symptoms consistent with the agents used in the laboratory. The approval of
this registration is for the work explicitly described within the registration. The PI acknowledges
she/he has read the appropriate sections of the NIH Guidelines for Research Involving
Recombinant DNA Molecules (http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html) and
agrees to use the appropriate procedures when performing the studies described in this
registration.
Signatures
Principal Investigator
Department Chair
Date
Date
__________
__________
For Institutional Biosafety Committee Use Only:
Registration # _____________ is approved at project class:
IIIA
IIIB
IIIC
IIID
Research is approved to be conducted at Biosafety Level(s):
BSL-1
BSL-2
BSL-3
ABSL-1
ABSL-2
Signature
Chair, IBC
Date
__________
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IIIE
ABSL-3
IIIF