Approval Date:
Expiration date:
Protocol Number:
Institutional Biosafety Committee (IBC)
PROTOCOL SUBMISSION FORM
Submit the completed application by email to ibc@tulane.edu with “IBC-Application” in the subject line.
Section A: TITLE AND PERSONNEL
Title of the study:
Submission date:
Is this a new submission?
Principal investigator*:
Department:
Position/title:
School:
Email:
Phone:
Names of co-investigators or collaborators
Title:
Emergency phone:
Email:
Phone:
Name other personnel under your
supervision working on this project **
*Must be a Tulane Investigator
** If needed, add more names at the end of Section G
Section B: TYPE OF RESEARCH
The research described in this application involves: (select all that apply)
1. Recombinant DNA/RNA
Yes
If “YES” complete Sections A, B, C, D,G and H of this application
2. Infectious/Pathogenic microorganisms or toxins
Yes
If “YES” complete Sections A , B,C,E, G and H of this application
3. Select Agents (see appendix 1 in the IBC web page)
Yes
If “YES” complete Sections A, B,C, E, F, G and H of this application
No
No
No
Select Agents are certain microorganisms or toxins that HHS and/or USDA consider to have the potential to pose a severe
threat to human, animal or plant health. A list of these agents can be found in:
http://www.selectagents.gov/Select%20Agents%20and%20Toxins.html
4. Animals
If “YES” Species:
IACUC approval number:
5. Transgenic Animals
Yes
No
Yes
No
6. Humans
If “YES” provide IRB approval number:
Yes
No
IBC Office (IBC@tulane.edu)
Internal address: Mail Box TW-5
Phone: (504) 988-0300; Fax: (504) 988-0370
Version March, 2013
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SECTION C: GENERAL INFORMATION
PERFORMANCE SITES
Research location(s)--check all that apply:
Tulane University- St. Charles Campus
Tulane University- School of Medicine
Tulane University- School of Public Health and Tropical Medicine
Tulane National Primate Research Center
Other location(s). Specify :
Building and Room Number(s) where research will be conducted (provide buildings/room numbers for
all experiments detailed in this application), and biocontainment level of that room.
Biocontainment
Building:
Room No:
level for this
Experiment (ie. in vitro work, animal infection)
laboratory
Does this project involve work to be done by collaborators at other institutions?
Name of the institution(s):
If ‘YES’, did the institution grant approvals for this project?
Don’t know
IBC
Don’t know
IACUC
Don’t know
IRB
Yes
No
Yes
Yes
Yes
No
No
No
SECTION C-2: PROJECT OVERVIEW
1. Provide a description of the work to be conducted in this project. Briefly explain in language
understandable to a layperson the objective of this research and its importance to human or
animal health, the advancement of knowledge, or the benefit to society.
2. Succinctly describe in logical and chronological order the experiments that will be conducted.
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SECTION D:
Recombinant DNA Research Questionnaire.
Check 'YES' or 'NO' to the following questions. For any items checked 'YES', include a thorough description
of the work in the following page .The relevant section of the NIH Guidelines is referenced for each question
(refer to the NIH Guidelines* for more information).
1. Does your project include deliberate transfer of a drug resistance trait to
microorganisms that are not known to acquire the trait naturally (Section IIIA*)?
1a. If “YES”, could such a transfer compromise the use of the drug to control
disease agents in humans, veterinary medicine, or agriculture?
2. Does your project include cloning toxin molecules with an LD50 of less than
100 nanograms per kilogram body weight (Section III-B*)?
3. Does your project include experiments using Risk Group 2, Risk Group 3,
Risk Group 4, or Select Agents as host-vector systems (Section III-D-1*)?
4. Does your project include experiments cloning DNA/RNA from Risk Group 2,
Risk Group 3, Risk Group 4 , or Restricted Agents into nonpathogenic
prokaryotic or lower eukaryotic host-vector systems (Section III-D-2*)?
5. Does your project include experiments involving the use of replicationcompetent recombinant DNA or RNA viruses or defective DNA or RNA
viruses in the presence of helper virus in tissue culture systems (Section III-D3*)?
6. Does your project include experiments involving genetically engineered plants
(Section III-D-5, III-E-2*)?
7. Does your project include experiments involving more than 10 liters of culture
of recombinant DNA organisms or constructs (Section III-D-6*)?
8. Does your project include experiments involving the formation of recombinant
DNA molecules containing two-thirds or less of the genome of any
eukaryotic virus (Section III-E-1*)?
9. Does your project include experiments involving viable rDNA-modified
microorganisms tested on animals (Section III-D-4, III-E-3*)? If “YES”
answer question 2 on the next page.
10. Does your project include experiments involving whole animals in which the
animal’s genome has been altered by introduction of DNA into the germ line
(i.e. transgenic animals) (Section III-D-4, III-E-3*) .If “YES” answer
questions 2 and 3 on the next page.
11. Does your project include experiments involving the deliberate transfer of
recombinant DNA, or DNA or RNA derived from recombinant DNA, into one
or more human research participants (Section III-C*)?*). If “YES”, answer
question 4 on the next page.
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
* The NIH Guidelines are found in this link: http://oba.od.nih.gov/rdna/nih_guidelines_oba.html
Updated information about required levels of Biosafety are found in the
CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL)
http://www.cdc.gov/biosafety/publications/bmbl5/
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Internal address: Mail Box TW-5
Phone: (504) 988-0300; Fax: (504) 988-0370
Version March, 2013
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SECTION D-2:
Recombinant DNA Research Information
1. Provide succinct explanations for items checked ‘YES’ in questions 1-8 of the Recombinant DNA
Research Questionnaire in the previous page (include the question number).
2. Describe the use of animals in your experiments. Briefly explain experiments in logical,
chronological order. The approval of this protocol will not be effective until IACUC approval is
received.
3. If using transgenic animals please answer the following questions:
 Are you acquiring or breeding rodents that can be safely housed under BSL1 containment?*
Yes
No
 Do these rodents contain more than 50 percent of the genome of an exogenous eukaryotic virus
from a single family?*
Yes
No
 Is the transgene in these rodents under the control of a gammaretroviral long terminal repeat
(LTR)?*
Yes
No
*You MUST fill appendix C and submit it with this application IF you are using transgenic animals other
than rodents OR your transgenic rodents need to be housed at BSL2 or higher containment OR you
answered YES to one or both of the last 2 questions.
4. Describe the use of humans in your experiments. Explain experiments in logical, chronological
order. The approval of this protocol will not be effective until IRB approval is received.
5. Identify the host(s) to be used (e.g., the target of gene transfer). Examples: E. coli, S. cerevisiae,
human/animal cells, whole animals, humans. Provide species designations for all organisms where
possible.
6. Identify the vector(s) to be used. Examples: Bacterial plasmids, yeast vectors, mammalian cell
vectors, baculoviruses, transforming viruses, etc. Provide name, source, and description of the vector,
and include description of antimicrobial resistance genes.
7. Identify the nature of the insert DNA sequence, including the species of origin (i.e., specific gene,
promoter, expressed product and function (if known). If available attach a vector and/or insert map.
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8. If foreign gene product(s) will be purified, indicate which foreign gene product will be purified
and briefly describe the procedures for purification, including volumes of culture
9. If replication-incompetent vectors will be used, include information about how incompetent
vectors are tested for reversion mutations (e.g., endpoint dilution analysis, plaque assay, commercially
obtained and tested by manufacturers).
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Phone: (504) 988-0300; Fax: (504) 988-0370
Version March, 2013
Page 5 of 12
SECTION E:
Hazardous Biological Research Questionnaire
Check 'YES' or 'NO' to the following questions. For any items checked 'YES', include a thorough description
of the work in the following page (question 1).
1. Is agent/material a potential human, animal or plant pathogen?
Yes
No
Human
Animal
Plant
N/A
2. Is agent/material a toxin?
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No


If “YES” name of the toxin (s):
Toxic to (animals/humans/plants):
LD50 :
3. Do you work with quantities (i.e. cultures) larger than 1 liter?
If “YES”, what is the largest volume (liters)?
4. Do you inactivate the agent/material prior to laboratory manipulation?
If “YES”, by what method?
Heat
Chemical
Radiation
Other
5. Do you concentrate the agent/material? If “YES”, specify method:
Centrifugation
Precipitation
Filtration
Other
6. Do you expose live animals or humans to the agent/material? If “YES”, specify
the animal species:
IACUC Approval #
IRB Approval:#
7. Does your project include experiments with Risk Group 2, Risk Group 3 or, Risk
Group 4 agents? *
If “YES”, which Risk Group?
RG-2
RG-3
RG-4
8. Does your experiment involve work with arthropods (i.e. insects, spiders.
others)? If “YES”, provide specific details in the next page (question 1)
Work with certain arthropods must conform to the guidelines set forth in the BMBL and those
established by the American Committee of Medical Entomology.
9. Does your work involve a SELECT AGENT? (see appendix H for list of select agents)
If “YES” name the organism (s):
10. Do you work with human blood, tissues, or body fluids?
If “YES” contact Tulane OEHS for guidelines on working with blood-borne
pathogens.
11. What is the recommended Biosafety Level for this agent/material? *
BSL-1
BSL-2
BSL-3
BSL-4
*To identify the risk group (RG) classification of the recombinant or etiologic agent(s) and the proposed biosafety levels ,
consult the NIH Guidelines at http://oba.od.nih.gov/rdna/nih_guidelines_oba.html
and the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories at:
http://www.cdc.gov/biosafety/publications/bmbl5/
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SECTION E-2:
Hazardous Biological Research Information
1. Provide succinct explanations for items checked ‘YES’ in the Hazardous Biological Research
Questionnaire in the previous page (include the question number).
2. Describe the key features of the agent/microorganism/toxin or material that you will use in this
project, particularly as it refers to biosafety considerations. Briefly describe the pathogenesis of the
disease caused by this agent in humans and/or animals.
3. What is the source or your biohazardous agent? (Be specific: i.e. ATCC, CDC, clinical isolate,
etc).
4. Do you work with microorganisms of unknown identity (such as those obtained from
environmental samples, animals/humans infected with unknown organisms)?
5. Does import of this agent into Tulane facilities require a USDA/CDC import/transport permit?
6. Will the agent be cultured/propagated at Tulane? If “YES” provide a synopsis of the procedures.
7. Will your work be performed in a BSL3 laboratory? If “YES” detail the procedures to be done in
the BSL3.
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Section F:
Select Agent Questionnaire


All work with Select Agents must be approved by IBC before initiation.
IBC protocols involving Select Agents will be subjected to yearly review.
1. List all the Select Agents that will be used in this project:
2. Is there a vaccine available and recommended for persons handling this
Select Agent?
If “YES” will personnel working in this project be offered the vaccine?
Expand the answer to this question under question 1 in the next page.
Yes
No
Yes
No
3. Do you plan on shipping, or transporting the select agent?
If “YES” be aware that a Select Agent must be transported under the
conditions described in specific Code of Federal Regulations (CFRs). Consult
the Office of Biosafety for guidelines.
Yes
No
4. If you are working with a toxin, indicate the largest amount that you will
have in your possession at any given time.
5. What is the largest volume of culture (bacterial/viral) and approximate
concentration that you will have at any given time? (i.e. 1 liter at 10x106
CFU/ml).
6. Will access to the Select Agent be meticulously controlled at all times?
mgs
Yes
No
Yes
No
Yes
No
Yes
No
10. Will a copy of the training certification and assessment evaluation for each
person working with the agent be filed with the Biosafety Office?
Yes
No
11. Are you and all the personnel involved in this project proficient in the
general BSL3 SOPs written by the Biosafety Office?
Yes
No
7. Have you submitted an agent-specific Standard Operating Procedure
(SOP) with this application? (This is a requirement for approval of your
protocol).
8. Does your SOP include specific instructions to handle accidental spills and
accidental personnel exposures?
9. Will personnel involved in this project receive agent-specific training, to
make them aware of the risk and hazards associated with this agent, and the
SOPs for accidental spills or exposures?
Who will provide the agent-specific training?
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Section F-2:
Select Agent Information
1. Provide relevant and detailed information to expand the answers to the questionnaire in the
previous page (provide item number).
2. What agent-specific SOPs will be used in the course of these experiments? Provide name and date
of the SOP (SOPs must accompany this application. The protocol will not be approved until agent
specific SOPs are submitted and approved by the Biosafety Office).
3. If working with animals indicate the final fate of all animals exposed to the select agent.
4. If necessary, add additional pertinent information on the Select Agent and/or experimental
procedures for this project (do not write decontamination or disposal practices in this section).
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SECTION G:
Biohazards, Decontamination and Training
1. Identify all known and potential hazards or risks associated with the specific biohazardous
agent or with the use of recombinant DNA materials described in this application.
Check all that apply and add additional information as needed.
Generation of aerosols
Potential spills or splashes
Exposure to blood borne pathogens
Splashes to mucosal surfaces
Others:
Contaminated needles or sharps
Exposure to infected animals
Insect bites
2. Describe the necessary facilities/equipment that will be used for all aspects of the work. (i.e.
use of biosafety cabinets, aerosol-proof centrifuges, aerosolization chambers, etc.)
3. Describe the practices for managing infectious/hazardous agent SPILLS and personnel
ACCIDENTAL EXPOSURES.
4. Indicate the personal protective equipment (PPE) required for personnel working in this
project. Check all that apply and add additional information as needed.
PPE required for bench work:
Lab coat
Gloves
Goggles
Face mask
Full face shield
N-95 mask
PAPR
Tyvek coverall
Shoe covers
Solid front gown
Head cover
PPE required for work with animals:
Lab coat
Full face shield
Shoe covers
Others:
Gloves
N-95 mask
Solid front gown
Goggles
PAPR
Head cover
Face mask
Tyvek coverall
5. Specifically describe the decontamination practices of the work area, equipment and
samples*. Check all that apply and add additional information as needed.
Surfaces/equipment and or samples are thoroughly treated or cleaned with:
70% ethanol
Aldehydes
10% Bleach
Lysol
Povidone/Iodine
Quaternary ammonium compounds
* Samples to be transported out of the lab will be treated as follows:
Additional decontamination practices:
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6. Describe the disposal practices of contaminated waste material. Provide specifics for each
type of material.
Contaminated liquid waste:
Contaminated solid waste:
Carcasses of infected/exposed animals:
Contaminated sharps:
Others disposal practices:
7. For Risk Group 3 agents and for agents that require BSL3 containment, briefly describe
YOUR prior training or experience in this type of work.
8. Describe how personnel will be trained in the handling of the biological agents described in
this application. Who is in charge of training? (The PI is responsible for keeping accurate
records of personnel training).
For projects involving rDNA molecules, it is required that investigators attend the “NIH Guidelines for
Research involving rDNA molecules Training Module offered by the Office of Biosafety. Please
indicate:
The PI has already attended the “NIH Guidelines for Research involving rDNA molecules Training
Module”.
The PI will attend the “NIH Guidelines for Research involving rDNA molecules Training Module”
9.
If your experiments involve animals, do animal handlers need to CHANGE their
normal/daily biosafety and animal handling routines? If so, please explain how.
10. Describe any specific biosafety considerations for this agent that have NOT been addressed
in the previous questions.
11. List other personnel in this project (not listed on page 1)
Name
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SECTION H:
Investigator’s Assurance
1. I confirm that all persons conducting this work at Tulane University (including students, fellows, technicians,
and collaborators) have been adequately trained in good laboratory/ microbiological practices and aseptic
techniques; have received instruction on the specific hazards associated with the work and are aware of the
specific safety equipment, practices, and behaviors required during the course of the work and use of these
facilities.
2. I will report to the Biological Safety Officer immediately any spill of biohazardous material, any equipment
or facility failure (e.g., ventilation failure), and/or any breakdown in procedure that could result in potential
exposure of laboratory personnel and/or the public to biohazardous material.
3. I confirm that any proposed changes to my work that would result in an increased level of biohazard will be
reported to the IBC before the change is implemented.
4. I confirm that no work requiring IBC approval will be initiated or modified until approval is received.
5. I have read and understand my responsibilities as Principal Investigator outlined in Section IV-B-7 of the
NIH Guidelines and the Tulane University Institutional Biosafety Committee (IBC) Policy Manual for the
Use of Recombinant DNA, and agree to comply with these responsibilities.
6. I certify that the information provided within this application is accurate to the best of my knowledge. I also
understand that, should I use the project described in this application as a basis for a funding proposal
(either intramural or extramural), it is my responsibility to ensure that the description of the work in the
funding proposal is identical in principle to that contained in this application.
Typed Name of Principal Investigator
Signature of Principal Investigator
Date
UPON APPROVAL, YOU MUST SEND A SIGNED COPY OF THIS LAST PAGE TO THE IBC OFFICE (by email
(scanned copy) to ibc@tulane.edu)
For IBC Use Only
Protocol Number:
BSL Level:
Protocol Title:
Date Received:
Date Approved:
Date Expiration:
Experiment Class Determination (check one)
III-A Requires IBC approval, RAC review, and NIH Director approval before initiation
III-B Requires NIH/OBA and IBC approval before initiation
III-C Requires IBC and IRB approvals and RAC review before research participant enrollment
III-D Requires IBC approval before initiation
III-E Requires IBC notice simultaneous with initiation
III-F Exempt
IBC Signature:
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Version March, 2013
Date:
Page 12 of 12