Sponsored Programs Administration
Research, Creative Activities and Technology Transfer
1735 NDSU Research Park Drive, Dept. 4000, PO Box 6050
Fargo, ND 58108-6050, Phone (701) 231-8908, Fax (701) 231-8098
Office Use Only:
IBC #: ______________________ Date Received: __________________ Full Board ___________ DR ___________
Approval Date: __________________ Protocols, PTF associated: __________________________________________________
Institutional Biosafety Application
For institutional review only
Project Title
Principal Investigator
Department
Campus Address
Contact Phone
E-mail Address
Co-Investigators
Anticipated duration of the study:
to
Funding agency:
N/A
Principal Investigator
Date
Chair, Head, Director or Dean
(If PI is Dept. Chair/Head/Director, the Dean must sign)
Date
The signature above certifies acknowledgment that this research is in keeping with the standards set by your department/unit, all NDSU policies and
that facility, equipment and personnel are appropriately committed to this project
IBC Chair
Date
Carefully review the application to ensure it is complete and contains sufficiently detailed responses to all
questions and attachments. Incomplete applications will be returned or held until completed, without IBC
review or approval, potentially delaying the research. Contact the IBC office for questions or assistance at
231-8908.
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1.
Compliance Checklist
A. Does the project involve the use of animals?
No
Yes
IACUC Protocol Number
B. Does the project involve the use of human subjects?
No
Yes
IRB Protocol Number
C. Does the project involve the use of radioisotopes?
No
Yes (Please contact the Radiation Safety Committee)
D. Does the project involve the use of a biological toxin or chemical?
No
Yes (Please contact the Lab and Chemical Safety Committee)
E. Does the project involve the use of Select Agents?
No
Yes (Please contact the NDSU Responsible Official)
2.
Identification of Potential Biohazards
A. Does the project involve recombinant or synthetic nucleic acid molecules?
No
Yes (Please complete sections 2, 3, 4, 5, 8, 9, 10)
*The required training can be found at www.citiprogram.org You will be requried to complete the Basic
Biosafety Training and NIH Recombinant DNA (rDNA) Guidelines courses.
B. Does the project involve the use or creation of infectious agents?
No
Yes (Please complete sections 2,3, 4, 6, 8, 9, 10)
*The required training can be found at www.citiprogram.org You will be requried to complete the Basic
Biosafety Training course.
C. Does the project involve the use of human blood, bodily fluids or tissues?
No
Yes (Please complete sections 2, 3, 4, 7, 8, 9, 10)
*The required training can be found at www.citiprogram.org You will be requried to complete the Basic
Biosafety Training and OSHA Bloodborne Pathogens courses.
If you answered no to each of the questions in Section 2, you are not
required to submit an IBC Protocol.
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3. Description of Research Project:
4. Location of Laboratory:
Building:
Room:
Biosafety Level:
Additional Information:
5. Recombinant or Synthetic Nucleic Acid Molecules
N/A
A. Identify applicable section(s) and subsection(s) of the NIH Guidelines:
Section III-A: Requires NIH, RAC, and IBC approval before initiation.
Section III-B: Requires NIH and IBC approval before initiation.
Section III-C: Human gene transfer.
Section III-D: Requires IBC approval before initiation.
Section III-E: Requires IBC notice simultaneous with initiation.
Section III-F: Exempt experiments.
B. Please list source(s) of DNA.
C. Please list specific gene(s) and specific functions.
D. Please list vectors.
E. Please list host(s) for propagation.
F. Will genes coding for the biosynthesis of molecules toxic for vertebrates be cloned?
No
Yes
Not Applicable

If yes, please provide the LD50 information.
G. Will a protein be expressed?
No
Yes

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If Yes, please answer following questions.
o Name and Function of Protein
o Toxic Properties
H. Are you proposing to grow cultures containing rDNA or synthetic nucleic acids that
contain more than 10 Liters in a single experiment?
No
Yes
I. Do any study procedures being conducted have the potential to create aerosols?
No
Yes

If yes, how will this be minimized/contained?
J. Based on NIH Guidelines, what is the appropriate biosafety containment level for the
study procedures described?
K. Please list method of inactivation.
6. Infectious Agents
N/A
A. What infectious agent(s) will be used or created in this project (please indicate
strain/isolate)?
B. Agent will be used:
In Vivo
Other
C. What BSL is required?
BSL-1
BSL-2
BSL-3
BSL-4
D. Agent is infectious for:
Humans
Animals
Plants

In Vitro
If infectious for humans please indicate risk group.
RG 1
RG 2
RG 3
RG 4
E. Is there a vaccine available and recommended for persons working with this agent?
No
Yes
F. Where will the infectious agent(s) be stored?
Building
Room
G. Describe any procedures that may have the potential to create aerosols and how
they will be minimized and/or contained.
H. Method of disinfection or inactivation.
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7. Human Blood, Bodily fluids, Tissues or Cell Cultures
A. Check all that you plan to use:
Blood
Bodily Fluid
Tissues
N/A
Cultured Cell Lines
B. Indicate the source (e.g. hospital, university, commercial vendor) of blood, tissue or
bodily fluid:
a. Please state how the blood, bodily fluids, or tissues will be transported to
NDSU.
C. Please describe the use of and infectious potential of blood, bodily fluids or tissues
used in this project?
D. Please describe the method of disinfection/disposal.
E. Bloodborne pathogens training is required for all research team members that will
be working with the blood, bodily fluids, or tissues. The Hepatitis B Vaccine series is
available to personnel who have routine exposure to bloodborne pathogens.
Please list study team members and date of bloodborne pathogen training in table
below.
Name
Training Date
Hep B Series
Offered (Y/N)
8. Permits
Are any permits required for this project (permits for transgenic material, Import/exports,
etc.)?
No
Yes – attach permit(s)
If the appropriate permits have already been obtained please list the applicable permit
numbers:
Permit
Permit
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9. Training Documentation
Complete below for each person who will be involved in this project.
Name
Position
within
University
If the PI is not the person responsible for supervision of students or employees, provide the
supervisor's name.
Study-related project
duties
For IBC Office
use only
For IBC Office
use only
For IBC Office
use only
Biosafety
Training
NIH
Guidelines
OSHA
Bloodborne
10. Assurance by Principal Investigator
I agree to conduct this project in accordance with the compliance policies of North
Dakota State University.
I certify that all individuals listed as personnel on this project are trained and
qualified for their protocol specific duties.
I agree to conduct the protocol using the appropriate containment level(s) as
specified by the IBC.
I have consulted Section IV-B-7 of the NIH Guidelines which describes the
responsibilities of the PI and hereby agree to comply fully with all provisions of the
Guidelines.
I understand that all changes in the research protocol or research personnel must be
reported in writing to the IBC.
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I understand that any research-related accidents or injuries must be reported to the
appropriate safety office (NDSU personnel to NDSU safety office, USDA personnel to
USDA safety office).
The information within this application is accurate to the best of my knowledge.
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