Section - Office of Research Compliance

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ORCS
Main Section
2011
IBC Application Form
Main Section
INSTRUCTIONS FOR COMPLETING THE IBC APPLICATION FORM
Instructions:
1. You are encouraged to contact the Biological Safety Officer (BSO) to determine the level of
oversight required for your research.
2. All 13 sections of the Main form must be completed. In the event that there is a box for
which there is no entry or the item does not apply, please respond using N/A. If you need
assistance or have questions concerning the form, contact the Institutional Biosafety
Committee (IBC) Chair or the BSO.
3. Fill out the Individual Biohazard Section(s) that applies to your research. The
categories include:
a. Known Human/Zoonotic Pathogen or Biohazard
b. Unknown Human/Zoonotic Pathogen or Biohazard
c. Recombinant DNA
d. Animal Pathogens/Biohazard
e. Plant Pathogens/Plant Pests
f. Animals Used in the proposed research
4. Send both the Main Section and each Individual Biohazard Section to the BSO.
5. The Biosafety Office will accept either a signed hard copy or an electronically signed copy
of the application.
6. Principal Investigators (PIs) will receive electronic notification of the IBC approval date,
expiration date and IBC approval number.
7. The PI must notify the BSO in writing when changes occur in the project. Changes that
require proposal amendments include but are not limited to the following:
 Change in personnel
 Change in laboratory location
 Change in experimental methods
 Change in infectious agents
 Change in human/nonhuman primate cell lines
 Change in facility containment level.
8. This application form must be typed or printed legibly.
9. Please append any documentation you feel is needed to explain the work being proposed.
10. Please read and initial the Responsibilities listed on the next page.
Page 1 of 7
ORCS
Main Section
2011
Principal Investigator Responsibilities
Please initial beside each item indicating that you have read and understood it.
____Develop specific protocols to ensure the safe use of biohazardous materials by following
instructions set forth in the University Biosafety Manual and ensure that all laboratory personnel
comply with the specific safety protocols.
____ Make the initial determination of the required levels of physical and biological containment
as well as the appropriate microbiological practices and laboratory techniques.
____ Ensure that the containment equipment and facility requirements for activities performed
under his/her direction meet the criteria for the appropriate BSL level.
____ Ensure that all maintenance work in, on or around contaminated equipment is conducted
only after that piece of equipment is thoroughly decontaminated by the laboratory staff. Ensure
that all equipment is decontaminated before removal from laboratory.
____ Develop specific protocols that outline proper emergency procedures for response to an
accidental exposure of personnel or the environment to the biological agents and ensure that all
laboratory staff are familiar with and comply with the emergency procedures.
____ Submit an IBC application and obtain approval from the IBC prior to commencement of the
work. In, addition, the PI is responsible for submitting any changes to the IBC-approved project
using the IBC Update/Amendment Form.
____ Obtain approval from the other regulatory committees if required: IACUC – animal care
and use; IRB - human subjects research; RSC – radiation safety.
____ Comply with all applicable University policies and federal, state, and local laws.
____ Ensure that all laboratory staff under his/her supervision are appropriately trained in the
safe use of biohazardous materials. Training includes animal care personnel who provide
husbandry and care for infected research animals.
____ Comply with medical waste laws in the handling and disposal of biohazardous waste.
____ Ensure that all laboratory staff, maintenance personnel and visitors are informed of the
potential risk and the practices/procedures used to minimize that risk.
____ Report any significant problems or violations or any significant research related accident
or laboratory acquired infection to the Biological Safety Officer or IBC Chair.
____ Comply with import/export/shipping requirements of biohazardous materials.
Page 2 of 7
ORCS
Main Section
2011
Mississippi State University
Institutional Biosafety Committee Application Review Form
Principal Investigator (PI):
Phone:
Mailstop:
Department:
Email Address:
Co-Investigator:
Email Address:
Address:
Phone:
Project Title:
IBC #
Anticipated Dates of Performance:[mm/dd/yy]






I certify that the information provided in this application is complete, accurate and
consistent with any proposal(s) submitted to a funding agency.
I agree that I will not begin this project until receipt of official approval from the
appropriate committee(s).
I agree that modification to the originally approved project will not take place without
prior review and approval by the appropriate committee(s), and that all activities will be
performed in accordance with all applicable federal, state, local and University policies.
I will follow applicable biosafety level requirements, comply with all shipping
requirements and required waste management practices.
I will ensure that all personnel have appropriate training including but not limited to:
biosafety principles and techniques, hazard identification, accidental spills, shipping
regulations, proper handling of biohazardous materials and waste management.
I am aware that the IBC reserves the right to conduct inspections of the research
facilities at any time.
_______________________________
Signature of Principal Investigator
____________________________
Date
I have reviewed the proposed research and approve its submission:
_______________________________
Signature of Department Chair
____________________________
Date
Page 3 of 7
ORCS
Main Section
2011
INSTITUTIONAL BIOSAFETY COMMITTEE ONLY
DATE RECEIVED:
IBC APPLICATION NUMBER:
PROPOSAL APPROVAL:
APPROVED
APPROVAL PENDING CONDITION(S)
NOT APPROVED
DEFERRED
REGISTERED
EXEMPTED
DATE OF FINAL APPROVAL:
EXPIRATION DATE:
_______________________________
Signature of IBC Chair
____________________________
Date
_______________________________
Signature of Biosafety Officer
____________________________
Date
Page 4 of 7
ORCS
Main Section
2011
1. KEY PERSONNEL: List all project personnel and describe experience and training with
biohazardous agents in GENERAL and with this SPECIFIC project. Additional personnel can be
grouped into the last box.
NAME DEGREE(S)
GENERAL
Years of
Training/Experience with
Biohazardous Material
SPECIFIC
Duties
Related to
This Project
SPECIFIC
Describe the Training
& Experience Level
with the Specific
Duties
2. LOCATION OF WORK:
Building/Room Where Work Will Be
Conducted
Building/Room Where Materials Will Be
Stored
3. CLASSIFICATION: Check the biological material(s) to be used.
Virus
Bacterium
Fungus
Parasite
Human Tissue
Human Body
Fluid
Prion
Toxin
Cell Culture
Species:
rDNA
Other
4. PROJECT SUMMARY: In lay terms, understandable by a nonscientist, give a general
description of the project including the objectives.
5. EXPERIMENTAL DESIGN INCLUDING WORK PRACTICES: In the space below, provide a
description of the experimental design. Include information on procedures, methods, and/or
manipulations with the biohazardous material. Describe the work practices that will be in place
to mitigate risk of exposure. The intent is to provide information such that the IBC can
understand and assess biological risk.
Page 5 of 7
ORCS
Main Section
2011
6. SECURITY MEASURES: The access requirements and training specified by the BMBL for
BSL-2 laboratories may provide sufficient security for the agent(s) being handled. However,
additional measures may be required for precursors of select agents, select agents, agents of
high commercial value such as a new vaccine candidate or agents with high public
health/agricultural impact. Please describe any security measures you will take to protect the
study agent(s) if applicable.
7. PERSONAL PROTECTIVE EQUIPMENT: Check the types of appropriate PPE that will be
used.
Lab coat
Goggles
Wrap-around gown
Gloves
N-95 mask*
*must be fit tested
Head covering
Safety Glasses
Foot Covers
Face Shield
Tyvek cover-alls
Other
Explain:
8. PRIMARY BARRIERS: Check the types of primary barriers that will be used to contain the
agent(s).
Biological Safety Cabinet
Chemical Fume Hood
Plexiglass Shielding
Animal Caging
Type:
Glove Box
Other
Explain:
Vacuum Protector/Trap
Sharps Container
9. EQUIPMENT: Will you work with the biohazardous material in any of the following aerosolproducing devices/procedures?
Centrifuge
Does the rotor have a
cover or do the
buckets have lids?
Tissue
grinders
Sonicators
Vortexers
Blenders
Shakers
Pressurized vessels
(besides autoclaves)
Page 6 of 7
Other
Explain:
ORCS
Main Section
2011
10.DECONTAMINATION: Check the specific decontamination method(s) to be used for all
biohazardous waste (except animal carcasses) and contaminated equipment. Decontamination
may include autoclaving, chemical disinfection etc. If a chemical disinfectant is used, state type
and concentration.
Bleach
Concentration
Autoclave
70% ethanol
Autoclave Verification Program
Yes
No
Other
Explain:
11. SPECIAL PRECAUTIONS: Please list any special precautions, in addition to the PPE and
use of primary barriers, which may be employed in the laboratory for safety.
12. MEDICAL SURVEILLANCE: Medical surveillance requirements are usually determined on
a case-by-case basis. Identify any medical surveillance requirements or practices for this
project. If none, state “None”.
13. OTHER INSTITUTIONAL APPROVALS: If an approval has been received from the
responsible review committee, indicate the registration number in the corresponding box below.
If the application is in progress, check “Pending”.
YES
NO
PENDING
IACUC
IRB
RSC
IACUC – Institutional Animal Care and Use Committee
IRB – Institutional Review Board
RSC – Radiological Safety Committee
Page 7 of 7
REGISTRATION NO.
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