Approval Date: Expiration date: Protocol Number:

Institutional Biosafety Committee (IBC)

PROTOCOL SUBMISSION FORM

Submit the completed application by email to with“IBC-Application” in the subject line.

Section A: TITLE AND PERSONNEL
Title of the study:
Submission date: / Is this a new submission? YESNO
Principal investigator*: / Position/title:
Department: / School:
Email: / Phone: / Emergency phone:
Names of co-investigators or collaborators / Title: / 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 No
If “YES” complete SectionsA,B, C, D,G and Hof this application
  1. Infectious/Pathogenic microorganismsor toxinsYes No
If “YES” complete Sections A ,B,C,E, Gand Hof this application
  1. Select Agents (see appendix 1 in the IBC web page) Yes No
If “YES” complete SectionsA,B,C,E, F, G and Hof this application
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:
  1. AnimalsYes No
If “YES” Species: Non-human primatesRodentsRabbitsFerretsCatsDogsOther
IACUC approval number:
  1. Transgenic Animals Yes No

  1. HumansYes No
If “YES” provide IRB approval number:

IBC Office ()

Internal address: Mail Box TW-5

Phone: (504) 988-0300; Fax: (504) 988-0370

Version March, 2013 Page 1 of 12

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.
Building: / Room No: / Biocontainment level for this laboratory / Experiment (ie. in vitro work, animal infection)
BSL1BSL2BSL2-N (animals)BSL3BSL3-N (animals)
BSL1BSL2BSL2-N (animals)BSL3BSL3-N (animals)
BSL1BSL2BSL2-N (animals)BSL3BSL3-N (animals)
Does this project involve work to be done by collaborators at other institutions?
Name of the institution(s): / Yes / No
If ‘YES’, did the institution grant approvals for this project?
IBC
IACUC
IRB / Don’t know
Don’t know
Don’t know / 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 andchronological order the experiments that will be conducted.

IBC Office ()

Internal address: Mail Box TW-5

Phone: (504) 988-0300; Fax: (504) 988-0370

Version March, 2013 Page 1 of 12

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 adrug resistance trait to microorganisms that are not known to acquire the trait naturally (Section III-A*)?
1a. If “YES”,could such a transfer compromise the use of the drug to control disease agents in humans, veterinary medicine, or agriculture? / Yes
Yes / No
No
  1. Does your project include cloning toxin molecules with an LD50 of less than 100 nanograms per kilogram body weight (Section III-B*)?
/ Yes / No
  1. Does your project include experiments usingRisk Group 2, Risk Group 3, Risk Group 4, or Select Agents as host-vector systems (Section III-D-1*)?
/ Yes / No
  1. 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*)?
/ Yes / No
  1. Does your project include experiments involving the use of replication-competentrecombinant DNA or RNA viruses or defective DNA or RNA viruses in the presence of helper virus in tissue culture systems (Section III-D-3*)?
/ Yes / No
  1. Does your project include experiments involving genetically engineered plants (Section III-D-5, III-E-2*)?
/ Yes / No
  1. Does your project include experiments involving more than 10 liters of culture of recombinant DNA organisms or constructs (Section III-D-6*)?
/ Yes / No
  1. 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*)?
/ Yes / No
  1. 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.
/ Yes / No
  1. 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.
/ Yes / No
  1. 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

* The NIH Guidelines are found in this link:

Updated information about required levels of Biosafety are found in the

CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL)

IBC Office ()

Internal address: Mail Box TW-5

Phone: (504) 988-0300; Fax: (504) 988-0370

Version March, 2013 Page 1 of 12

SECTION D-2:

Recombinant DNA ResearchInformation

  1. Provide succinct explanations for items checked ‘YES’ in questions 1-8 of the Recombinant DNA Research Questionnairein the previous page (include the question number).
  1. Describe the use of animalsin your experiments. Briefly explain experiments in logical, chronological order.The approval of this protocol will not be effective untilIACUC approval is received.
  1. If using transgenic animals please answer the following questions:
  • Are you acquiring or breedingrodents that can be safely housed under BSL1 containment?*

YesNo

  • Do these rodentscontain more than 50 percent of the genome of an exogenous eukaryotic virus from a single family?* Yes No
  • Is thetransgene in these rodents under the control of a gammaretroviral long terminal repeat (LTR)? * Yes No

*YouMUST fill appendix C and submit it with this application IFyou are using transgenic animals other than rodentsOR your transgenic rodents need to be housed at BSL2 or higher containment ORyou answeredYES to one or both of the last 2 questions.

  1. Describe the use of humans in your experiments. Explain experiments in logical, chronological order. The approval of this protocol will not be effective untilIRBapproval is received.
  1. 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.
  1. 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.
  1. Identify the nature of the insertDNA 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.
  1. 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
  1. 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, commerciallyobtained and tested by manufacturers).

IBC Office ()

Internal address: Mail Box TW-5

Phone: (504) 988-0300; Fax: (504) 988-0370

Version March, 2013 Page 1 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?
Human Animal Plant N/A / Yes / No
  1. Is agent/material a toxin?
  • If “YES” name of the toxin (s):
  • Toxic to(animals/humans/plants): LD50 :
/ Yes / No
  1. Do you work with quantities (i.e. cultures) larger than 1 liter?
If “YES”, what is the largest volume (liters)? / Yes / No
  1. Do you inactivate the agent/material prior to laboratory manipulation?
If “YES”, by what method?
Heat Chemical Radiation Other / Yes / No
  1. Do you concentrate the agent/material? If “YES”, specify method:
Centrifugation Precipitation Filtration Other / Yes / No
  1. Do you expose live animals or humans to the agent/material? If “YES”, specify the animalspecies:

IACUC Approval # IRB Approval:# / Yes / No
  1. 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 / Yes / No
  1. 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. / Yes / No
  1. Does your work involve a SELECT AGENT? (see appendix H for list of select agents)
If “YES” name the organism (s): / Yes / No
  1. Do you work with human blood, tissues, or body fluids?
If “YES” contact Tulane OEHS for guidelines on working with blood-borne pathogens. / Yes / No
  1. What is the recommended Biosafety Level for this agent/material?*
BSL-1 BSL-2 BSL-3 BSL-4

*To identifythe risk group (RG) classification of the recombinant or etiologic agent(s) and theproposed biosafety levels , consult theNIH Guidelines at

and the CDC/NIH Biosafety in Microbiological and Biomedical Laboratoriesat:

IBC Office ()

Internal address: Mail Box TW-5

Phone: (504) 988-0300; Fax: (504) 988-0370

Version March, 2013 Page 1 of 12

SECTION E-2:

Hazardous Biological ResearchInformation

  1. Provide succinct explanations for items checked ‘YES’ in the Hazardous Biological Research Questionnairein the previous page (include the question number).
  1. Describe the key features of the agent/microorganism/toxinor 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.
  1. What is the source or your biohazardous agent? (Be specific: i.e. ATCC, CDC, clinical isolate,etc).
  1. Do you work with microorganisms of unknown identity(such as those obtained from environmental samples, animals/humans infected with unknown organisms)?
  1. Does import of this agent into Tulane facilities require a USDA/CDC import/transport permit?
  1. Will the agent be cultured/propagated at Tulane? If “YES” provide a synopsis of the procedures.
  1. Will your work be performed in aBSL3 laboratory? If “YES” detail the procedures to be done in the BSL3.

IBC Office ()

Internal address: Mail Box TW-5

Phone: (504) 988-0300; Fax: (504) 988-0370

Version March, 2013 Page 1 of 12

Section F:

Select Agent Questionnaire

  • All work with Select Agents must be approved by IBCbefore 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:

  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
Yes / No
No
  1. Do you plan onshipping, 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
  1. If you are working with a toxin, indicate the largest amount that you will have in your possession at any given time.
/ mgs
  1. 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).

  1. Willaccess to the Select Agent be meticulously controlled at all times?
/ Yes / No
  1. Have you submitted an agent-specific Standard Operating Procedure (SOP) with this application? (This is a requirement for approval of your protocol).
/ Yes / No
  1. Does your SOP include specific instructions to handle accidental spills and accidental personnel exposures?
/ Yes / No
  1. Will personnelinvolved in this project receiveagent-specific training, to make them aware of the riskand hazards associated with this agent, and the SOPs for accidental spills or exposures?
Who will provide the agent-specific training? / Yes / No
  1. 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
  1. Are you and all the personnel involved in this project proficient in the general BSL3 SOPs written by the Biosafety Office?
/ Yes / No

IBC Office ()

Internal address: Mail Box TW-5

Phone: (504) 988-0300; Fax: (504) 988-0370

Version March, 2013 Page 1 of 12

Section F-2:

Select Agent Information

  1. Provide relevant and detailed information to expand the answers to the questionnairein the previous page (provide item number).
  1. What agent-specific SOPswill 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).
  1. If working with animals indicate the final fate of all animals exposed to the select agent.
  1. 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 ()

Internal address: Mail Box TW-5

Phone: (504) 988-0300; Fax: (504) 988-0370

Version March, 2013 Page 1 of 12

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 Contaminated needles or sharps

Potential spills or splashes Exposure to infected animals

Exposure to blood borne pathogens Insect bites

Splashes to mucosal surfaces

Others:

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 coatGlovesGogglesFace mask

Full face shield N-95 mask PAPR Tyvek coverall

Shoe covers Solid front gown Head cover

PPE required for work with animals:

Lab coatGlovesGogglesFace mask

Full face shield N-95 mask PAPR Tyvek coverall

Shoe covers Solid front gown Head cover

Others:

5.Specifically describe the decontamination practicesof the work area, equipmentand samples*.Check all that apply and add additional information as needed.

Surfaces/equipment and or samples are thoroughly treated or cleaned with:

70% ethanol 10% BleachLysolPovidone/Iodine

Aldehydes Quaternary ammonium compounds

*Samples to be transported out of the lab will be treated as follows:

Additional decontamination practices:

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 YOURprior 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 toCHANGEtheir 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 / Title / E-mail

IBC Office ()

Internal address: Mail Box TW-5

Phone: (504) 988-0300; Fax: (504) 988-0370

Version March, 2013 Page 1 of 12

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/ microbiologicalpractices 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 (byemail (scanned copy) to )