FOR COMPLIANCE OFFICE
USE ONLY:
IBC #:
Date Received:
IBC PROTOCOL APPLICATION
☐ Revision
Institutional Biosafety Committee (IBC)
Institutional Biosafety Committee
Registration Document
Research involving any of the agents listed below must be approved by the Prairie View A&M University Institutional Biosafety
Committee (IBC) prior to initiation:
 Pathogens and potential pathogens of humans, animals or plants;
 Materials potentially containing human pathogens (including human blood, tissue, and cell lines; non-human primate blood,
tissue, and cell lines);
 Recombinant DNA (and RNA) including creation or use of transgenic plants and animals.
Select agents and toxins including strains and amounts exempted from the select agent regulations
Refer to: http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html
Any material requiring a CDC import license or a USDA permit




The Principal Investigator (PI) is responsible for completing all appropriate parts of the registration document and for
notifying the IBC when information submitted in the registration changes, such as personnel, laboratory location,
procedures, funding, etc. The PI will be required to fill out an Amendment Form if such changes occur.
Lab inspections must be completed prior to initiation.
Protocols are currently approved for three (3) years with required annual renewals and laboratory inspections.
A copy of CITI training completion for biosafety for all personnel – application will not be processed without certification
of training
Only typed forms will be accepted. Only the most current forms will be accepted and reviewed; therefore access the IBC
website for a new form with every submission. The application must be completed, signed by all appropriate personnel, and
submitted for review and approval prior to initiation of research to: research@pvamu.edu
Compliance notification:
Content and revision:
Dr. Marcia Collins Shelton
Dr. Michael Gyamerah
Director, Research Regulatory Compliance
Chair, Institutional Biosafety Committee
Office of Research & Graduate Studies
migyamerah@pvamu.edu
936.261.1588
936.261.9408
Scheduling and compliance notification:
Ms. Crysta Mendes, Program Coordinator
v: 936.261.1553
For Deliveries - Physical Location: Wilhemina Delco Building - Room164
Submit all grant proposals pertaining to your research as well at the time of submission. Failure to provide all information
requested, including requested signatures, will lead to a delay in processing the request. Please contact a member
of the
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15 IBC
or the Research Compliance Office at, research@pvamu.edu or 936.261.1553, 936.261.1590, 936.261.1588 or
936.261.1589 for additional information.
Checklist and Table of Contents for Institutional Biosafety Protocols
The following is a list of the items included in an IBC Protocol Application. All applicable sections, a copy of the
grant proposal and, if for course credit or degree award a thesis or undergraduate project, a copy of the
literature review and methodology must be provided to the IBC for research to be approved.
ORIGINAL SIGNATURES ARE REQUIRED.
Part I, II, and IV are required and must be completed and submitted. Part III and V should be completed and
submitted, as applicable. Do not submit blank or non-applicable pages to the IBC.
Only typed applications will be processed for review.
A copy of CITI training completion for Biosafety for all personnel must be provided – application will
not be processed without certification of training
Deliverables: For Deliveries - Physical Location: Wilhemina Delco Building - Room164
Six (6) hard copies for review + one electronic copy + one copy with original signatures (scanned is
acceptable)
Please send completed IBC Protocol Applications to Research Compliance Office by email at
Research@pvamu.edu. Please note IBC Protocol in Subject Line when sent via email. The Research
Compliance Office may be contacted at 936.261.1553 or by email at Research@pvamu.edu.
Review of the protocol will be delayed if it is missing any required information.
Please allow sufficient time for processing of your application. IBC approval may take 30-60 days
☐ Part I: IBC Protocol Application (required for all applications)
☐ Part III: Risk Management (required for all applications)
☐ Part IV: Exposure Control Plan (required of Biosafety Level 2 (BSL 2) see references)
☐ Part V: Select Agent Plan Review Form (required if applicable)
☐ Grant Proposal (required if applicable)
☐ Biosafety Manual (required for all BSL2 and above research)
☐ Thesis or Course work leading to an academic degree- (funded or unfunded)- committee members signature,
objectives & methodology
☐ CITI Biosafety Training Certificate for all personnel, available through www.citiprogram.org
☐ Most recent IBC Laboratory Permit Number:
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PART I: IBC PROTOCOL APPLICATION
This form may be used to submit multiple projects under one research design protocol IF all projects will utilize
the same protocol. Please identify all funding sources, grant proposals and submit required descriptions of all
projects if submitting under one research protocol. Note: For thesis and Undergraduate projects, students are
listed as the Co-Investigator.
INVESTIGATOR INFORMATION
A. Principal Investigator Information:
Name:
Address:
Please include Mail Stop & Office Number if address is on campus
Phone Number (Office):
Phone Number (Laboratory):
Phone Number (Emergency):
Fax Number:
Email Address:
Department:
College:
B. Co-Principal Investigator Information:
Name:
Address:
Please include Mail Stop & Office Number if address is on campus
Phone Number (Office):
Phone Number (Laboratory):
Phone Number (Emergency):
Fax Number:
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Email Address:
Department:
College:
C. Co-Principal Investigator Information:
Name:
Address:
Please include Mail Stop & Office Number if address is on campus
Phone Number (Office):
Phone Number (Laboratory):
Phone Number (Emergency):
Fax Number:
Email Address:
Department:
College:
D. Co-Principal Investigator Information:
Name:
Address:
Please include Mail Stop & Office Number if address is on campus
Phone Number (Office):
Phone Number (Laboratory):
Phone Number (Emergency):
Fax Number:
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Email Address:
Department:
College:
INVESTIGATOR ASSURANCE (Dean/Director Signature also required)

 I attest that the information contained in the IBC Protocol Application is accurate and complete.
 I agree to comply with all Prairie View A&M University IBC requirements regarding research involving
biohazardous and/or recombinant materials.
 I agree not to initiate this research project until the IBC has approved it.
 I agree to notify the IBC via the Research Compliance Officer immediately of incidents involving
biohazardous and/or recombinant agents
 I have read and agree to comply with the NIH Guidelines for Research Involving Recombinant DNA (NIH
Guidelines). I acknowledge my responsibility for the conduct of this research in accordance with Section IVB-7 of the NIH Guidelines.
 I have the knowledge and training required to safely handle the materials described.
 I agree to train all of my laboratory personnel according to the BSL of the laboratory.
 Entry doors to the laboratory will be closed and locked when the laboratory is unattended.
 I agree to provide all personnel working in the laboratory notification, information and training on the hazards,
laboratory security and emergency policies and procedures associated with working in my laboratory.
I agree to inform any personnel working in the laboratory that potentially all microorganisms can be pathogens
under certain conditions. When necessary, work procedures and protocols are in place to prevent aerosols and
exposure to microorganisms. All personnel are provided training in sterile technique, the use of automatic
pipetters and the proper disposal of biohazardous materials. All personnel are advised that if they are in an
immunocompromised/immunosuppressed condition that they are at risk for infection from the general
environment and susceptible to infections that would normally not be a problem for an immunocompetent
individual. All personnel are further advised that working in a laboratory that conducts experiments using live
microorganisms could increase their risk of infection and be hazardous to their health.
A. Principal Investigator Certification:
Principal Investigator (Typed):
Principal Investigator (Signature):
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Date:
B. Co-Principal Investigator Certification
Co- Principal Investigator (Typed):
Co- Principal Investigator (Signature):
Date:
C. Co-Principal Investigator Certification:
Co- Principal Investigator (Typed):
Co- Principal Investigator (Signature):
Date:
D. Dean/ Director Certification:
Dean/ Director (Typed):
Dean/ Director (Signature):
Date:
PROTOCOL INFORMATION
This form may be used to submit multiple projects under one research design protocol IF all projects will use the same protocol. Please identify all
funding sources, grant proposals and submit required descriptions of all projects if submitting under one research protocol.
Protocol Title:
Title
Funding Source(s)
(Please check all that apply. Indicate number of proposals for funding sources in the space provided if multiple projects are
submitted under one protocol.)
☐NIH #:
☐NSF #:
☐DOD #:
☐USDA #:
☐Other
List agency & Number of
proposals:
GRANT PROPOSAL
Please include a copy of all grant protocols associated with this IBC Permit. The submission should include all
sections of the grant that contain information pertaining to the research. (Budget information is not required.)
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Grant PI
Grant title(s):
Must be exact wording as appears
on funded proposal
LAY DESCRIPTION OF THE PROJECT(S)
Provide a brief summary of the project( s) describing the goal( s], methodology, and use of biohazardous or
recombinant material using terms understandable to a non-scientist, Provide more than one description if
multiple projects are submitted under one protocol.
Description:
TECHNICAL DESCRIPTION OF THE PROJECT(S)
Attach a technical summary of the project(s). Provide information detailed enough so IBC members can perform
a risk assessment of the protocol. Attach a technical summary for each project if multiple projects are submitted
under one protocol. Include the following information:
 Procedures, practices, and manipulations involving biohazardous or recombinant agents (e.g. cloning of
genes in E.coli for sequencing; creation of transgenic mice by means of lentiviral vectors; isolation of
bacteria from sewage - may include human pathogens).
 Identify all manipulations that may increase risk to personnel or the environment; describe how
these risks will be mitigated (e.g. all manipulations involving agents listed in this protocol will be
conducted in a biosafety cabinet; transgenic plants will be grown in locked growth chambers and
will not be allowed to flower)
 Briefly describe your experience with the manipulations described in this section (e.g. I have use
identical methodology to generate transgenic mice over 100 times in the last 10 years; I have never
used this method to isolate proteins from pathogenic bacterial before, however Dr. Mendes, who
developed this method 6 years ago, has agreed to assist me for the first 5 runs.)
 Decontamination and waste disposal methods
Part II: Agent Information
AGENT USE AND STORAGE LOCATIONS
Table A. Enter building name and room number. Indicate room use, current biosafety level and shared lab
status. Please indicate the Principal Investigator if the laboratory is shared.
Location ID
Building
Room Number
Room Use
(Storage/Use)
Current
Biosafety Level
Shared Lab
(Y/N)
PI
(If Shared Lab)
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1
2
3
4
5
6
REGULATORY COMPLIANCE
Please check below for all subjects involved in the protocol:
☐Human Subjects
If yes, enter the institutional Review
Board (IRB) Protocol Number:
☐Animal Subjects
If yes, enter the Institutional Animal Care &
Use Committee (IACUC) protocol number:
☐Plants
AGENT CHARACTERISTICS
Please check below for all agents used or stored as part of the protocol:
☐
☐
☐
☐
☐
☐
☐
Agents potentially affecting humans
Agents potentially affecting animals
Agents potentially affecting plants
Materials potentially containing human pathogens (including human cell lines, human blood, unfixed human tissue)
Biological Toxins
Select Agents and Toxins (including exempt strains and exempt quantities of toxins)
Any material requiring CDC or USDA permit
If you answered yes to any of the above questions, enter the agent name(s) and information into Table A of Part II.
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RECOMBINANT DNA
Please check below all that apply to the protocol:
☐ The use, but not creation, of recombinant agents
☐ Cloning in bacteria or yeast non-pathogenic to humans, plants, or animals
☐ Cloning in bacteria or yeast potentially pathogenic to humans, plants, or animals
☐ Use of viral vectors
☐ The creation of transgenic animals
☐ The creation of transgenic plants
☐ The use of transgenic animals or plants? (excluding the use of commercially obtained transgenic rodents kept at BL-1)
If you answered “Yes” to any of the above questions you must enter information into Tables A and B of Part II.
- Enter host (target) name (e.g. Mus musculus) and information into Table A of Part II;
- Enter vector, if used, name (e.g. adeno-associated virus (AAV)) and information into Table A of Part II;
- Enter information regarding the cloned DNA insert (e.g. insulin) into Table B (Part II).
VIRAL VECTORS CHRACTERISTICS
If viral vectors are used, complete a separate Part Ill for each.
INSERT CHRACTERISTICS
Please check below all that apply to the inserts listed in Part II:
☐
☐
☐
☐
From a Risk Group 2 Agent
From an animal or plant pathogen not affecting humans
From a Select Agent or coding for a Select Toxin
Encodes for a known or suspected oncogene
☐ Encodes for a toxin molecule (whole or partial)
If Yes, please describe the LD50 of the toxin
and whether the insert will code for an
active toxin:
☐ Antibiotic resistance will be transferred to microorganisms
If Yes, please describe what antibiotic
resistance genes will be transferred to
which agents (microorganism?):
Explain why this action would not fall under
Section III-A-l-a of the NIH Guidelines.
Include relevant references.
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NIH GUIDELINES
Under which sections of the NIH Guidelines does research described in this protocol fall?
List all that apply for each agent.
Table A ID
Agent Genus,
Strain
BL/ABSL/BL-P
Sections of the NIH Guidelines that
Species
(select)
cover experiments (list all that apply)
A-1
A-2
A-3
A-4
A-5
A-6
Rules pertaining to Sections III-A, III-B, III-C, III-D, III-E, and III-F of the NIH Guideline can be found at
http://oba.od.nih.gov/rdna/nih_guidelines_oba.html
Part III: RISK ASSESSMENT & MANAGEMENT
RISK ASSESSMENT
1. ☐ Yes
☐ No
2. ☐ Yes
☐ No
3. ☐ Yes
☐ No
4. ☐ Yes
☐ No
5. ☐ Yes
☐ No
6. ☐ Yes
☐ No
Will any experimental procedures result in acquisition of new characteristics such as
enhanced virulence, infectivity, or change in host range?
If yes, please explain:
Will any procedures with the agent be conducted outside of a biological safety
cabinet?
If yes, please explain:
Will any of the agents be transported outside of the laboratory?
If yes, please explain:
Will more than 1 liter of agent be generated at more than one time?
If yes, please explain:
Will any of the agents be administrated to animals? If yes please describe the
experiment in detail as an attachment.
(e.g. animal species, how is the agent given, how long will the animal be
followed.)
If yes, please explain:
Does this project involve the environmental release of genetically engineered
material?
If yes, please explain:
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7. ☐ Yes
☐ No
8. ☐ Yes
☐ No
9. ☐ Yes
☐ No
10.☐ Yes
☐ No
11.☐ Yes
☐ No
Does this project involve the environmental release of pathogenic or
potentially pathogenic material (other than recombinant agents)?
If yes, please explain:
Will human tissue or cells be transplanted into animals?
If yes, please explain:
Will animal tissue or cells be transplanted into a different species of animal?
If yes, please explain:
Do any of the agents you intend to work with require pre-project serum samples,
immunization, medical monitoring, and/or health surveillance?
If yes, please explain:
Will the deliberate aerosolization of any agent occur?
If yes, please explain:
If you answered yes to any of the above questions, please see the chart below.
Risk Management Matrix
Seriousness of Risk
Probability That Something May Go Wrong
I
A
B
C
D
Likely to occur
immediately or in a
short period of time,
expected to occur
frequently
Probably may
occur in time
May occur in time
Unlikely to occur
5
5
4
3
5
4
3
2
4
3
2
1
3
2
1
1
May result in death
II
May cause severe
injury, major damage
or low, and/or result
in negative publicity
for the participant
involved
III
Participation presents
a minimal threat to
safety, health and
well-being of
participants
IV
No more than
minimal risk
MEDICAL RISKS ASSESSMENT: Describe the health risks associated with the use of all pathogens used in the
laboratory and list the symptoms/disease(s) that may occur.
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Agent ID
Health Risks/ Symptoms/ Disease/ Target organ(s)
A-1
A-2
A-3
A-4
A-5
A-6
MEDICAL TREATMENT/ EMERGENCY RESPONSE
What are the treatment options/plans available
in case of a potential exposure to pathogens?
Part IV: EXPOSURE CONTROL
EXPOSURE CONTROL
Indicate the personnel protective equipment you will use. Please check the applicable boxes.
☐ Face Mask
☐ Boots/Crocks
☐ Gloves
☐ N 95 (HEPA)
☐ Disposable Outers
☐ Other
Specify:
☐ Eye Protection
☐ P100 (HEPA)
☐ Lab Coats
☐ Face Shield
☐ Head Covers
☐ PAPR (HEPA)
☐ Shoe Cover
☐ Double Gloves
BIOLOGICAL SAFETY CABINET
Indicate the type of Biological Safety Cabinet(s) (BSC) intended for use. Please check the applicable boxes and enter
the building and room number:
☐ Class II A (recirculating)
Building & Room Number
☐ Class B1 (70% exhausted- ducted outside)
Building & Room Number:
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☐ Class II B2 (100% exhausted- ducted outside)
Building Room Number:
☐ None
☐ Other
Specify Type and Building & Room Number
DISPOSABLE/ DECONTAMINATION OF LABORATORY FACILITIES
The following materials must be sterilized, decontaminated or inactivated before disposal:
All materials containing infectious agents (including materials potentially exposed to infectious agents, for
example gloves)
As per NIH Guidelines: All materials containing recombinant DNA (or items potentially exposed to recombinant
DNA, such as pipette tips, tubes, gloves). The guidelines include any recombinant DNA containing cell cultures,
microorganisms, plants, animals (vertebrate, invertebrate, protists)
All biological toxins (or materials potentially exposed to biological toxins)
Human blood or other potentially infected body fluids
Decontamination or inactivation procedures must also be in place for working surfaces (benchtops) and equipment
that may become contaminated with infectious agents, recombinant DNA or biological toxins.
Materials Sterilization/Decontamination/ Disposal Methods.
Indicate the methods and laboratory procedures that are in place for decontamination and disposal of contaminated
waste.

See below for suggested autoclave temperature and exposure times.

For chemical disinfection: (i) indicate final concentration of disinfectant & contact time required to achieve
th
decontamination. Please refer to BMBL (5 edition), Appendix B (pp. 326-335), available at:
http:/cdc.gov/od/ohs/biosafety/bmbl5/BMBL_5th_Edition.pdf.

For incineration please indicate the facility to be used.
Type of Waste
Potential Hazard
Decontamination/ Sterilization/ Disposal Procedures
Liquids
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Solids
Glassware
Animals
Surface/equipment decontamination:
Indicate the methods/laboratory procedures in place for decontamination of work surfaces and equipment. Please
refer to BMBL (5th edition), Appendix B. available at: http://cdc.gov/od/ohs/biosfty/bmbIS/BMBL 5th Edition.pdf.
Methods/ Laboratory Procedures:
Disposal, Autoclave Testing, Autoclave Efficacy and Recordkeeping
Suggested temperatures and exposure times for autoclaving from NIH Biohazards Guidelines:
Liquids
Laundry
Trash
Glassware
121°C (250°F) 1 hour, (each gallon)
121°C (250°F) 30 minutes
121°C (250°F) 1 hour
121°C (250°F) or 160°C (320°F) 1 hour to 4 hours (dry heat)
Please provide assurance below that you will use the guidelines listed above or provide
scientific rationale for using an alternate method.
☐ I give assurance that the method indicated above will be used.
☐ Other (Please attach explanation and include science rationale for the use of alternate conditions, i.e.: time,
temperature, etc.)
Explanation:
Autoclaves should be tested before being placed into service and then periodically for effectiveness
☐ The autoclave departmentally operated
Contact Name:
Phone Number:
Location (Building & Room Number):
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Indicate Testing Frequency
☐ Minimum- 1 time every other week (BL2)
☐ Minimum- 1 time per month (BL1)
☐ The autoclave is individually operated (supervised by Principal Investigator)
Location (Building & Room Number):
☐ Minimum- 1 time every other week (BL2)
☐ Minimum- 1 time per month (BL1)
A commercially available test indicator kit that uses bacterial spores (Bacillus (Geobacillus) stearothermophilus) is
the required method of testing autoclave efficiency.
☐ I give assurance the method indicated above will be used.
The IBC requires the treatment of each load of biohazardous waste be documented on an autoclave waste treatment
record. The record should contain the date of treatment, the amount of waste treated, the method/conditions of
treatment, and the printed name and initials of the person performing the treatment. If provided for, charts or
printout strips should be kept with the record as documentation. Documentation of the date and results of all
verification tests using biological indicators is also required.
☐ I give assurance the method indicated above will be used.
Contact Environmental Health & Safety at (936) 261-1743 or (936) 261-1745, and by email at ehs@pvamu.edu
for information on disposal of hazardous materials or instructions regarding select agent disposal.
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