IBC-1
Rev.: 03/2009
For IBC ADMINISTRATIVE USE ONLY:
Date received by IBC __________________
IBC Control Number: _____________ Date reviewed by IBC: _________________
Status __________________________________________________________________
Thomas Jefferson University Institutional Biosafety Committee
FORM IBC-1: Registration for Research
All faculty investigators conducting research at Thomas Jefferson University are required to
register their research activity with the TJU Institutional Biosafety Committee. This provides the
necessary information to determine the nature of the work being conducted, and the
appropriate levels of laboratory training, containment, or other steps necessary to ensure that
the work is carried out safely and in compliance will pertinent guidelines and regulations. In
addition to the basic information regarding your research that is requested in this IBC-1 form,
please answer the questions on the following pages and if indicated as a result of your answers,
also complete the additional forms as indicated and/or contact the appropriate university office
in addition to the IBC.
Protocol Information:
Date Submitted to IBC: sss New Submission
Amended Submission
(IBC Protocol # :
)
Title of Protocol: :
Pre-Reviewed by:
Principal Investigator Information:
Name:
Campus Key:
Title:
Department:
Office Location:
Laboratory Location:
Phone:
Fax:
Email:
Co-Investigator:
Current Biosafety Level if previously approved: BL1
BL2
BL2/3
For an amended submission, is a change in biosafety level anticipated? Yes
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BL3
No
Level
IBC-1
Rev.: 03/2009
Research summary: In layman’s terms, please provide a description of the purpose and nature
research to be conducted in your laboratory, not to exceed the space provided. This abstract MUST be
written in a manner such that a non-scientist could understand the purpose of the research and the
general approach used in the research.
__________________________________________________________________________________
__________________________________________________________________________________
Please answer all of the following questions and provide the additional requested information on the
appropriate forms, and/or contact the appropriate university office as indicated. These questions
request information that will help to determine the nature of the research being conducted in your
laboratory, the types and level of training required, and the biosafety level or other special
circumstances required for conduct of the work.
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IBC-1
Rev.: 03/2009
1. Does your work involve human, animal or plant pathogens, oncogenes, any human-derived
materials (cell lines, blood, tissue, body fluids), or biological toxins? Yes
No
If yes, please complete and submit FORM IBC-2 in addition to this Form IBC-1.
2. Does your work involve the transfer of genetic material into humans? Yes
No
If yes, this research is considered a human gene transfer study. Please contact the Office of
Human Research at 215-503-0203 as this work will require review and approval of both the IBC
and the IRB.
3. Does your work involve recombinant DNA and/or viral vectors? Yes
No
If yes, please complete and submit FORM IBC-2 and FORM IBC-3 in addition to this
Form IBC-1. NIH Guidelines for work with recombinant DNA are available at:
http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html
4. Does your work involve the use of bacterial or other biological toxins? Yes
No
If yes, please complete and submit FORM IBC-2 and FORM IBC-14 in addition to this Form
IBC-1. This work may be classified at the BL2 level or higher depending on the toxin. Please
contact the Institutional Biosafety Officer at 215-503-7422 for assistance.
5. Does your work involve the use of Select Agents? Yes
No
[Note: A list of select
agents may be found at http://www.jefferson.edu/ohr/ibc/australia.cfm ]. If yes, please
complete and submit FORM IBC-2 in addition to this Form IBC-1. This work may be classified
at the BL2 level or higher depending on the agent. Please contact the Institutional Biosafety
Officer at 215-503-7422 for assistance as this work must be registered with the CDC prior
to beginning the research, and special training will be required.
6. Does your work involve the use of HIV or agents that may be infectious via an aerosol route?
Yes
No
If yes, this work may be classified at the BL3 level and special training will be
required.
7. Does your work involve non-human primates or non-human primate-derived materials?
Yes
No
If yes, please complete and submit FORM IBC-2 and FORM IBC-4 in addition
to this Form IBC-1.
8. Does your work involve pathogens or recombinant DNA in animals? Yes
No
If yes,
please complete and submit FORM IBC-5 in addition to this Form IBC-1. Your work must
additionally be reviewed and approved by the Office of Animal Resources and the IACUC. Call
215-503-5885 for further information.
9. Does your work involve pathogens or recombinant DNA in plants Yes
please complete and submit FORM IBC-6 in addition to this Form IBC-1.
No
If yes,
10. Does your work involve radiation or radioactive isotopes? Yes
License #
No
If yes your work must additionally be reviewed and approved by the Office of Radiation Safety,
which may be contacted at 215-955-7813.
11. Does your work involve toxic chemicals? Yes
No
If yes, please contact the Institutional Biosafety Officer at 215-503-7422 or the Environmental
Safety Office at 215-503-6260 for further instructions. Depending on the nature of the work, you
may need to complete and submit FORM IBC-14 in addition to this Form IBC-1.
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IBC-1
Rev.: 03/2009
12. Does your work involve the shipping of recombinant DNA, pathogens, or biohazardous or toxic
materials? Yes
No
Depending on the nature and quantity of the material, special
training may be required.
Certifications
If this protocol falls under the OSHA Bloodborne Pathogens Standard, I accept the responsibility to:
a. use Universal Precautions
b. offer all employees Hepatitis B Vaccine
c. make sure all new employees have OSHA Bloodborne Pathogens Training with refresher
training annually
I accept responsibility for the safe conduct of research in my laboratory. I will inform all personnel of
the hazards associated with this work and will adhere to the level of containment required to perform
this research safely. I will also ensure that all personnel receive training in regard to proper safety
practices and personal protective equipment needed for this work.
If there is any accident, incident, or exposure in my laboratory involving a recombinant DNA molecule,
the occurrence will be reported immediately to the TJU Department of Environmental Health and Safety
at 215-503-6260.
If my work involves the use of recombinant DNA, I agree to conduct this work as prescribed in the NIH
Guidelines for Use of Recombinant DNA, which I have read and which is available at:
http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html
In addition, I will contact the TJU Institutional Biosafety Officer and the Institutional Biosafety Committee
to comply with the NIH Guidelines requirement to report any significant problems, violations of the NIH
Guidelines, or any significant research-related accidents and illnesses to the Biological Safety Officer
(where applicable), Greenhouse/Animal Facility Director (where applicable), Institutional Biosafety
Committee, NIH/OBA, and other appropriate authorities (if applicable) within 30 days. Reports to
NIH/OBA shall be coordinated by the Institutional Biosafety Officer to the Office of Biotechnology
Activities, National Institutes of Health, 6705 Rockledge Drive, Suite 750, MSC 7985, Bethesda, MD
20892-7985 (20817 for non-USPS mail), 301-496-9838, 301-496-9839 (fax)” Section IV-B-7-a-(3)
Principal Investigator Name: _________________________________________________________
Signature: ________________________________________________________________________
Department Chairman Name: ________________________________________________________
Signature: ________________________________________________________________________
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