Approval Date: 1/10/12
Expiration date: 2/15/15
Protocol Number: 1202-70118
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: Development of Attenuated Shigella Vaccines
Submission date: 1/10/2012
Is this a new submission? YES
Principal investigator*: Joe Smith
Department: Microbiology and Immunology
Position/title: Assistant Professor
School: School of Medicine
Email: Jsmithxx@tulane.edu
Phone: 988-0000
Emergency phone: 504-123-4567
Names of co-investigators or collaborators
Title:
Email:
Phone:
Bunsen Honeydew
Associate Professor
Honeydew@tulane.edu
8-0000
Laboratory technician
beakerxx@tulane.edu
8-0000
Name other personnel under your
supervision working on this project **
Assistant Beaker
*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: Rodents
IACUC approval number:10000099
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 December 2011
Page 1 of 13
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
SOM
43009
SOM
vivarium
BSL2
BSL2-N (animals)
In vitro work
In vivo work: animal immunization & euthanasia
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 aim of this research and its importance to human or animal
health, the advancement of knowledge, or the benefit to society.
Members of the genus Shigella are bacterial enteropathogens which cause bacillary dysentery and bloody diarrhea. The
incidence of shigellosis in the US is between 15000-25000 infected people a year. The infections are usually self-limited but they
can cause serious consequences in children and malnourished individuals. Effective vaccines against Shigella are not currently
available. The aim of this research is to develop potential vaccines against shigellosis, based on attenuated Shigella flexneri
mutants. Our hypothesis is that Shigella attenuated mutants can induce long-lasting immunological protection without causing
disease. Mutated strains of S. flexneri will be constructed as described below and will be tested for immunogenicity in mice.
2. Succinctly describe in logical and chronological order the experiments that will be conducted.
We will develop between 3-5 attenuated mutants of Shigella as explained in Section D-2. The mutations will be confirmed by
DNA sequencing and Western Blot analysis (by testing for lack of expression of the proteins encoded by the mutated genes).
These bacterial mutants will be grown in the laboratory, centrifuged and adjusted for concentration; mice will be orally
vaccinated with 2 doses (between 1x10^(3) and 1x10^(6)). We will vaccinate animals 2 times at monthly intervals. Four weeks
after the final immunization animals are euthanized and samples collected for immunological analysis.
IBC Office (IBC@tulane.edu)
Internal address: Mail Box TW-5
Phone: (504) 988-0300; Fax: (504) 988-0370
Version December 2011
Page 2 of 13
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 in which DNA from Risk Group 2, Risk
Group 3, Risk Group 4 , or Restricted Agents is cloned into nonpathogenic
prokaryotic or lower eukaryotic host-vector systems (Section III-D-2*)?
5. Does your project include experiments involving the use of infectious DNA or
RNA viruses or defective DNA or RNA viruses in the presence of helper
virus in tissue culture systems (Section III-D-3*)?
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
(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/
IBC Office (IBC@tulane.edu)
Internal address: Mail Box TW-5
Phone: (504) 988-0300; Fax: (504) 988-0370
Version December 2011
Page 3 of 13
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).
Question 1.To develop attenuated mutants of S. flexneri we will insert a Kanamycin containing casette into specific loci in
the Shigella bacterial chromosome. We have received (from Dr. R. Toodtoo, Emory University) three recombinant suicide
plasmids derived from pXZTY. The plasmids carry the Shigella genes xxx1, xxx2, and xxx3 with a Kan casette inserted in
the middle of the gene. We will create at least three mutated Shigella strains by transforming wild type S. flexneri with these
plasmids.
Question 1a. Kanamycin is not used in the clinic to treat shigellosis (neither in the US nor in other countries); therefore,
transfer of a Kan. gene into Shigella does not compromise the way Shigella infections are controlled. Unintended
dissemination of Kanamycin-resistant Shigella strains will be avoided by handling the strains under strict BSL2 containment.
Question 3. Shigella is a RG2 organisms and will be used as a host of plasmids pXZTY1, pXZTY2 and pXZTY3,which carry
the mutated genes and Kan cassettes.
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.
Groups of Balb/c male mice will be orally immunized, twice (day 0 and 30), with 1x10^5 or 1x10^3 attenuated Shigella
CFUs; control groups will receive the same dose of non-recombinant E. coli K-12 or saline. Four weeks after the final
immunization, the mice will be euthanized and blood and tissue samples will be harvested for immunological analysis.
3. If using transgenic animals please answer the following questions:
a. Are you acquiring or breeding rodents that can be safely housed under BSL1 containment?*
Yes
No
b. Do these rodents (parents or progeny) contain more than 50 percent of the genome of an
exogenous eukaryotic virus from a single family?*
Yes
No
c. Is the transgene in these rodents (parents or progeny) 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.
N/A
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.
The host will be Shigella flexneri
IBC Office (IBC@tulane.edu)
Internal address: Mail Box TW-5
Phone: (504) 988-0300; Fax: (504) 988-0370
Version December 2011
Page 4 of 13
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.
The vector is a modified plasmid pXZTY . This vector was obtained from Dr. R. Toodtoo (Emory University). The vector was
originally derived from pBR322 but it does not carry the gene encoding for resistance to ampicillin. It is a low copy number
plasmid with the ColE1 origin of replication. pXZTY has 2 multiple cloning sites located upstream and downstream of the
LacZ gene. It carries a Kanamycin resistance gene flanked by two FRP (recombination) sites.
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.
The insert DNA sequences are the mutated Shigella genes xx1, xxx2 and xxx3. These genes encode the X1, X2, and X3
proteins respectively. These are outer membrane proteins (porins) that allow diffusion of macromolecules into the bacterial
cytoplasm. These proteins are not toxic for animals or humans. When any of these 3 proteins is not functional, the resultant
mutants cannot survive in the murine hosts for more than 96 hours. A map of the plasmid+insert is provided as an
attachment at the end of this application.
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
N/A
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).
N/A
IBC Office (IBC@tulane.edu)
Internal address: Mail Box TW-5
Phone: (504) 988-0300; Fax: (504) 988-0370
Version December 2011
Page 5 of 13
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: Mice
IACUC Approval # 10000099
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 level
(See 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/
IBC Office (IBC@tulane.edu)
Internal address: Mail Box TW-5
Phone: (504) 988-0300; Fax: (504) 988-0370
Version December 2011
Page 6 of 13
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).
Question 1. Shigella species are pathogenic in humans and are the etiological agents of bacillary dysentery.
Question 5. Overnight cultures of Shigella will be centrifuged and resuspended in saline. The right concentration will be
determined by spectrophotometer reading at O.D. 650 (based in pre-established growth curves).
Question 6. animals will be orally immunized twice with 1x10^6 organisms
Question 7. Shigella is a RG2 pathogen
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.
Shigella are Gram-negative bacterial enteropathogens which are transmitted to humans by the fecal-oral route. The
infectious dose can be as little as 10 organisms . Once the organisms reach the large intestine they invade epithelial cells,
and kill the resident macrophages inducing a severe inflammatory reaction characterized by influx of neutrophills and
intestinal tissue destruction. This tissue destruction results in cramps, and bloody diarrhea.
Personnel working in this project will be instructed about the high communicability of this disease and the strikingly low
infectious dose.
3. What is the source or your biohazardous agent? (Be specific: i.e. ATCC, CDC, clinical isolate,
etc).
S. flexneri will be obtained obtained from ATCC (strain V9089)
4. Do you work with microorganisms of unknown identity (such as those obtained from
environmental samples, animals/humans infected with unknown organisms)?
NO
5. Does import of this agent into Tulane facilities require a USDA/CDC import/transport permit?
NO
6. Will the agent be cultured/propagated at Tulane? If “YES” provide a synopsis of the procedures.
Yes, it will be propagated at Tulane. Shigella strains will be grown overnight in 10 mls of Trypticase Soy broth. Bacterial
cultures will be centrifuged; bacterial pellets will be washed twice in PBS and resuspended in the amount of saline
necessary to give the desired concentration. These manipulations are done at BSL2 containment.
7. Will your work be performed in a BSL3 laboratory? If “YES” detail the procedures to be done in
the BSL3.
NO
IBC Office (IBC@tulane.edu)
Internal address: Mail Box TW-5
Phone: (504) 988-0300; Fax: (504) 988-0370
Version December 2011
Page 7 of 13
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. 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
2. 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
3. If you are working with a toxin, indicate the largest amount that you will
have in your possession at any given time.
mgs
4. 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).
5. Will access to the Select Agent be meticulously controlled at all times?
Yes
No
6. Have you submitted an agent-specific Standard Operating Procedure
(SOP) with this application? (This is a requirement for approval of your
protocol).
Yes
No
Yes
No
Yes
No
9. 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
10. Are you and all the personnel involved in this project proficient in the
general BSL3 SOPs written by the Biosafety Office?
Yes
No
7. Does your SOP include specific instructions to handle accidental spills and
accidental personnel exposures?
8. 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?
IBC Office (IBC@tulane.edu)
Internal address: Mail Box TW-5
Phone: (504) 988-0300; Fax: (504) 988-0370
Version December 2011
Page 8 of 13
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).
IBC Office (IBC@tulane.edu)
Internal address: Mail Box TW-5
Phone: (504) 988-0300; Fax: (504) 988-0370
Version December 2011
Page 9 of 13
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: Accidental ingestion.
Contaminated needles or sharps
Exposure to infected animals
Insect bites
Unintended dissemination of new Shigella strains (the mutated strains cannot survive outside
mammalian hosts for more than 2-3 hours, therefore the risk of dissemination of new strains is very low).
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.)
The bacterial cultures will be centrifuged in aerosol-proof tubes and rotors
Dilutions of bacteria will be done in a Biosafety cabinet
Immunization of animals will be done in the vivarium in biosafety cabinets
BSL2 guidelines will be strictly followed
3. Describe the practices for managing infectious/hazardous agent SPILLS and personnel
ACCIDENTAL EXPOSURES.
Spills will be handled as per instructions in the Biosafety Office SOP Biohazard Spill Clean up
Briefly, spill will be covered with paper towels andthe towels are soaked with a 70% ethanol.. Spill is allowed
to soak for approximately 20 minutes before discarding materials in biohazard bag/box. Surfaces will be
decontaminated with 70% ethanol. All disposable materials used for the clean up (paper towls, gloves, etc)
will be discarded in a biohazard bag
All personell accidental exposures will be inmediately reported to supervisor (principal Investigator Dr. Joe
Smith.
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:
IBC Office (IBC@tulane.edu)
Internal address: Mail Box TW-5
Phone: (504) 988-0300; Fax: (504) 988-0370
Version December 2011
Gloves
N-95 mask
Solid front gown
Goggles
PAPR
Head cover
Face mask
Tyvek coverall
Page 10 of 13
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
Autoclave
*Samples to be transported out of the lab will be treated as follows: Samples will be transported from
the vivarium to room 4300 in a primary leak-proof container inside a secondary leak-proof container ( i.e.closed
polypropylene tubes, placed inside a plastic tray with a lid).
Additional decontamination practices: Non disposable equipment will be autoclaved.
6. Describe the disposal practices of contaminated waste material. Provide specifics for each
type of material.
Contaminated liquid waste: Will be either autoclaved or diluted to 10% bleach before disposal.
Contaminated solid waste: Disposable solid waste will be placed in the biohazard autoclavable bags/boxes
provided by Tulane.
Carcasses of infected/exposed animals: Infected carcasses/tissues will be double bagged and placed in the
JBJ vivarium carcass cold room, where vivarium personnel will decontaminate and dispose as per their standard SOPs.
Contaminated sharps: Contaminated sharps will be placed in a "sharp containers" which will be securely closed
before placing it in the autoclavable boxes provided by Tulane.
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.
N/A
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).
The PI (Dr. Joe Smith) will train all personnel working in this project. Personnel will be instructed on the risks of working
with infectious (wild type or mutant) Shigella strains and with recombinant DNA materials. Personnel will be trained to
follow BSL2 guidelines and wear the required PPE at all times while handling Shigella strains and/or rDNA. The PI will
keep records of this training.
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.
No changes to routine veterinary care are necessary.
Cages with infected animals will be properly labelled (with biohazard stickers identifying wild type Shigella or rDNA
carrying Shigella as the biohazardous agents).
IBC Office (IBC@tulane.edu)
Internal address: Mail Box TW-5
Phone: (504) 988-0300; Fax: (504) 988-0370
Version December 2011
Page 11 of 13
10. Describe any specific biosafety considerations for this agent that have NOT been addressed
in the previous questions.
N/A
11. List other personnel in this project (not listed on page 1)
Name
IBC Office (IBC@tulane.edu)
Internal address: Mail Box TW-5
Phone: (504) 988-0300; Fax: (504) 988-0370
Version December 2011
Title
E-mail
Page 12 of 13
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. I also confirm that I will keep records of training my personnel.
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.
1/10/12
Joe Smith
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 Campus
mail Box TW-5; Fax 8-0370; or email (scanned copy) to ibc@tulane.edu)
For IBC Use Only
Protocol Number: 1202-70118
BSL Level: BSL2
Protocol Title: Development of Attenuated Shigella vaccines
Date Received: 1/10/2012
Date Approved: 2/15/12
Date Expiration: 2/15/15
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:
IBC Office (IBC@tulane.edu)
Internal address: Mail Box TW-5
Phone: (504) 988-0300; Fax: (504) 988-0370
Version December 2011
Date:
2/15/2012
Page 13 of 13