Your Federal Quarterly Tax Payments are due April 15th Get Help Now >>

Louisiana State University Health Sciences Center - NO by 9PW3wT

VIEWS: 2 PAGES: 14

									                                                 Institutional Biosafety Committee (IBC)
                                                         Protocol Submittal Form
                     INSTRUCTIONS: ALWAYS download latest version, then save this form before completing applicable parts.
                     ► Submit the application only in WORD format by email to IBCoffice@lsuhsc.edu (If submitting in
                     behalf of the PI, you must cc the PI on the email and enter PI’s name in the subject line.) AND
                     ► Send ONLY the last page with PI’s original signature to the IBC Office, RCB 206 (433 Bolivar Street,
                         New Orleans, LA 70112). For questions, email IBCoffice@lsuhsc.edu .

All research conducted at this institution must conform to regulations and guidelines for biosafety that have been
established by various authorities. This form will document and confirm that Biosafety concerns have been addressed or
determined non-applicable for your protocol. The Center for Disease Control has a manual that is particularly informative
on their website http://www.cdc.gov/biosafety/. IBC approval will be contingent upon concurrent IRB or IACUC
approval. Note that some sections may be copied from your IRB or IACUC application.

 Submission Date:
 Application Type:             Initial Protocol                      Amendment for IBC #
 Check ALL categories that the proposed research will involve:
      1. Research with Animal Usage under IACUC Protocol #                                  and/or
         Research with Human Contact under IRB Protocol #                                (any interaction where the investigator "touches" the subject,
          e.g. physical examination, surgery, or "instrumenting" the subject as in auditory testing, providing inhalers, etc)
                    Complete Part A and F1 and where applicable, Part B. C, D, or E
      2. Research NOT requiring IRB or IACUC review/approval (e.g. cell lines, fungi, bacteria) – Complete Part A and F1
      3. Animal Research - Complete Part B
      4. Potentially Infectious Agents or Biological Toxins – Complete Part C
      5. Blood or Body Matierals from Human or Non-Human Primate – Complete Part D
      6. Use of Recombinant DNA or Transgenic Animals – Complete Part E
      7. None of the above categories – Complete only Parts A1, A2, A3, F1 (Includes Human Subject Research without
            human contact under IRB Protocol #                       (e.g. chart reviews, surveys and human studies with no face-to-face interaction or
            no physical contact with, or instrumentation of, the person)


General Information (all categories)
 Principal                                                                 Project Supervisor
 Investigator: (must be                                                    or Coordinator: (if
 faculty or staff)                                                         different from PI)
 Email:                                                                    Email:
 Bldg/Room:                                                                Bldg/Room:
 Department:                                                               Department:
 Phone:                                                                    Phone:

 Project Title:


Funding Information:
 Source of Funds:                                                                 Grant Number:
 Grant Title:
 PI on Grant if different:




IBC Protocol Submittal Form Revised 8/01//2012
                                                 Institutional Biosafety Committee (IBC)


 Part A: Human, Animal or Other Research
 A1      Describe, in NON-TECHNICAL LANGUAGE, the objective of the protocol for research. If amending a previously
         approved IBC application, describe the changes requested and complete the applicable sections including
         section F.



 A2      Estimate the start date and expected duration of the study:



 A3      Is this project classified under Category 7: None of the Above?
         (i.e., DOES NOT: have human or non-human primate physical interaction/contact, use human or non-human
         primate materials, use recombinant DNA, infectious agents or biological toxins, or involve animal research)
              No, continue to A4.
              Yes; this study does NOT require IBC oversight for the following reasons.
                   This is a chart review or data collection/analysis with no physical human contact.
                   This is a telephone, mail or web survey with no physical human contact.
                   Other: Provide Explanation:
               Complete Items A1, A2. A3 and F1. Submit the application to the IBC Office as per the above instructions.
               Annual reviews are not required; however, the investigator agrees to report to the IBC Committee any
               changes that may affect the exempt status of the study, and that no such change will be implemented
               without IBC Committee review. GO TO Section F1.

 A4      Describe sequentially all experimental procedures and techniques in this protocol:


 A5      Identify the Biosafety Level(s) and thoroughly address all potential hazards associated with this protocol to the
         personnel, clinic, and/or the animal facility.


 A6      Do all laboratories, clinical facilities and equipment that will be used to conduct this protocol meet the applicable
         standards set forth by this institution and federal or state regulations? (e.g., proper ventilation, flooring, radiation
         protective barrier, wash station, current hood inspection)
            Yes    No If No, list the area or items that require attention. Contact the LSUHSC Environment Health &
         Safety Department for guidance to attain safe practices standards.



 A7      Describe the equipment and procedures used to safely conduct this work. (e.g., universal precautions, spill
         procedures, biomedical waste disposal, decontaminants/disinfectants, sharps handling, etc.)


 A8      Describe the source(s) of the research material(s) used in this protocol:


 A9      Do you intend to transport research material?  Yes               No If Yes, complete A8a and A8b below.
         A9a        Transporting within the LSUHSC Campus?
                       Transporting outside the LSUHSC Campus?
         A9b        Describe the equipment and procedures used to ensure the material is transported safely and in
                    accordance with all applicable regulations and requirements:


A10      Beyond the standard LSUHSC-NO Biosafety Training required, have all personnel associated with this protocol

IBC Protocol Submittal Form Revised 8/01//2012
                                                 Institutional Biosafety Committee (IBC)

         (including animal caretakers) been instructed and trained in the specific practices and techniques required to
         ensure safety in the conduct of this protocol and the safety procedures for dealing with accidents related to this
         protocol?
              Yes; describe training provided:
              No; explain why no training was provided:




IBC Protocol Submittal Form Revised 8/01//2012
                                                       Institutional Biosafety Committee (IBC)


 A11     Indicate the date of your last On Site Bioinventory Update:
         [Enter “N/A” if you do not maintain a laboratory subject to LSUHSC policy*.]
            Biological Materials Inventory and Control is required to ensure compliance with federal regulations;
            investigators must maintain an accurate inventory detailing the type, amount, and location of ALL biological
            materials under their supervision via the On Site database. To access the On Site inventory database, click
            on: http://172.20.240.20:1568/.*1

           *NOTE: The inventory must be updated when new biological materials are added or materials are removed
           from the laboratory, when there is a significant change in quantity of biological materials or a change in location
           of the storage or use of biological materials, and must be updated at least annually. To review the complete
           LSUHSC policy, click on: Biological Materials Inventory and Control Policy.

           List all agents and/or organisms that are specifically associated with this protocol. List the species of
           animals/animal parts that are used in the laboratory or in Animal Care.

             Agents/Organisms                           RISK GROUP /   Place “X” if    Place “X” if       Building and Room #
                                                                       Agent or         bioagents        Where stored       Where        Place
             (by GENUS species for bacteria, virus,      BIOSAFETY
             parasites, etc.; i.e. Escherichia Coli)                   Organism is     have been      (if not on LSUHSC     used         “X” if
                                                           LEVEL*2     Dual Use       received and                                      room is
             Species                                                                                    campus, include
                                                        (RG/BSL-                        input into     physical address)                shared
             (by common name, i.e. mice, rats)          1,2,3,4)                         On Site*3




         *Note 1: To login to On Site, use your LSUHSC-NO user name and password. Instructions for entering the biological
         inventory are available here or at the login screen. For additional assistance (i.e., granting PI designate access to manage
         inventory, adding labs/materials, or login assistance) contact the Biosafety Officer at 504-568-6585.
         *Note 2: For assistance selecting biological material(s) risk group and biosafety level, visit the on line American Biological
         Safety Association (ABSA) resource page at http://www.absa.org/riskgroups/index.html
              CDC/NIH Guidelines (1999)
              BSL 1: well characterized agents not consistently known to cause disease in healthy adult humans of minimal potential hazard to
                     laboratory personnel and the environment
              BSL 2: agents of moderate potential hazard to personnel and the environment
              BSL 3: indigenous or exotic agents which may cause serious or potentially lethal disease as a result of exposure by the inhalation
                      route (applicable to clinical, diagnostic, teaching, research or production facilities)
              BSL 4: dangerous and exotic agents which pose a high individual risk of aerosol-transmitted laboratory infections and life-
                      threatening disease
              NIH Recombinant DNA Guidelines (USA, 2002)
              RG1: Agents that are not associated with disease in healthy adult humans. Includes a list of animal viral etiologic agents in
                    common use.
              RG2: Agents that are associated with human disease which is rarely serious and for which preventive or therapeutic interventions
                    are often available.
              RG3: Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be
                    available (high individual risk but low community risk).
              RG4: Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not
                    usually available (high individual risk and high community risk).
         *Note 3: If biological materials for this research protocol are not yet in PI possession, ensure they are input into On
         Site as soon as they are received in the laboratory.




IBC Protocol Submittal Form Revised 8/01//2012
                                                  Institutional Biosafety Committee (IBC)


A 12      List personnel who will have physical contact with humans or animals or who will physically handle blood/body
          fluids/materials, biological materials, biohazardous agents or recombinant DNA molecules and are conceivably at
          risk from research procedures involving the use of these biological materials.
          Approval of the proposed experiment(s) is given only for the identified personnel listed below. Once approved,
          submit the IBC Update Form to add personnel to this project. All training must be completed prior to participation.
          The Principal Investigator is responsible for informing all personnel of potential hazards, safe work
          practices, availability of medical surveillance, and that they understand and will follow all approved
          laboratory practices and procedures. The Principal Investigator assures that all personnel complete all
          safety, biological, animal and/or human research training requirements.


                                                                                        If working with blood or     Date of               Date of
            First & Last Name, Degree            Role in study   If not an LSUHSC       body fluids, indicate if     Biological            Bloodborne
                                                                 employee or student,   individual received or       Safety/IBC            Pathogens
                                                                 list institution or    declined the Hepatitis B
                                                                                                                     Training
                                                                                                                              2
                                                                                                                                           Training
                                                                                                                                                    2
                                                                 employer               vaccine series or if         Verification by IBC   Verification by IBC
                                                                                                                 1
                                                                                        vaccine was not offered




                                                                                                                                           Use TAB key
                                                                                                                                           to add lines
                                                                                                                                           as needed

1
 Although highly recommended, Hepatitis B vaccine may be declined, but individuals must sign the declination form. If declined, the
vaccine may be obtained at future date. Contact your Department Business Manager about receiving the Hepatitis B vaccine at no
charge. For more information, refer to the Bloodborne Pathogens Exposure Control Policy #EHS-300.04, Section 9.0 and Appendix A:
http://www.is.lsuhsc.edu/safety/bio_policies.aspx.
2
    Bloodborne Pathogens Training (Initial or Refresher) is mandatory for ALL employees, students and gratis appointments.
    Biological Safety Training is required for personnel who will have physical contact with humans or animals and/or who will
    physically handle biological materials, biohazardous agents or recombinant DNA molecules. For information on safety requirements,
    go to the EH&S Safety Training website: http://www.is.lsuhsc.edu/safety/training.aspx. (Note: Equivalent IBC, BST (Biosafety
    Training) and BBP (Bloodborne Pathogen) from other institutions or hospitals will be accepted by LSUHSC IBC by providing
    documentation of completion.) Principal and key investigators must complete IBC Compliance training.
    IBC, Biological Safety and Bloodborne Pathogens training courses are available through the online LSUHSC Compliance Office
    training system, KDS: https://intranet.lsuhsc.edu/ctms/kds/ViewTrainings.aspx.




IBC Protocol Submittal Form Revised 8/01//2012
                                                 Institutional Biosafety Committee (IBC)

Part B: Animal Research
B1 Specify Animal Species:                  Mice           Rats        Rabbits      Non-Human Primates
                                            Cats           Dogs        Frogs        Other
B2 Identify the source(s) of animals used in this project:


B3 Do you expose animals to live organism(s) or viruses?                     Yes   No
     B3a If Yes, what organisms/viruses? (For potentially infectious agents or biological toxins, complete Part C)


     B3b If Yes, by what route(s) of administration:
                 Subcutaneous            Intraperitoneal      Intracranial
                 Intramuscular           Intravenous          Other


B4 Will transgenic animals be used?                 Yes    No If Yes, complete Recombinant DNA/Transgenic – Part E
B5 Is any rDNA being introduced into the animal model, and/or has the genome of the animal been modified by rDNA?
          Yes       No               If Yes, complete Recombinant DNA/Transgenic – Part E

B6 Is there any possibility that the research material introduced to the animal(s) (recombinant molecule, vector, toxin, or
   pathogen) could remain a viable hazard in the animal secreta, excreta and/or soiled bedding?         Yes       No
   B6a If Yes, describe the practices and procedures used to minimize occupational exposures:



B7 List all LSUHSC-NO Animal Care’s Standard Operating Procedures (SOP) relevant to this application (copies of
   standing SOPs are not required). Depending upon the IBC risk assessment of this application, new SOPs may be
   required whereby you must consult with the Animal Care Facility Veterinarians to modify or develop new SOPs
   specific to the procedures and/or the biosafety hazards of the study. You will be notified of this requirement if
   necessary. While the new SOPs are being developed, contingent approval of this application can be given; however,
   final approval will not be given until the new SOPs are submitted for IBC review.




IBC Protocol Submittal Form Revised 8/01//2012
                                                 Institutional Biosafety Committee (IBC)


PART C: Pathogen and Toxin Registration
To be completed by laboratories handling biological agents (actual or potential human pathogens, oncogenic viruses) or
toxins. Regulatory websites are listed below for reference. Contact the IBC or EH&S office is you need further assistance.

1
 NIH Guidelines Appendix B: http://oba.od.nih.gov/oba/rac/guidelines_02/Appendix_B.htm#_Toc3023181
2
 CAS Registry Number: http://www.cas.org/expertise/cascontent/registry/regsys.html
3
 CDC/APHIS List of Select Agents:
http://www.selectagents.gov/resources/List%20of%20Select%20Agents%20and%20Toxins_111708.pdf
4
 EAR - CCL Database: Part 774 (In particular, see Category 1, pages 58 -73)
http://www.access.gpo.gov/bis/ear/pdf/ccl1.pdf
5
 National Select Agent Registry (NSAR): http://www.selectagents.gov/
       Select Agents and Toxins List
       Select Agents and Toxins Exclusions
       Select Agents and Toxins Restricted Experiments
       Permissible Toxin Amounts


C1     Name(s) of Biological Agent(s) or Toxin(s)

                                                                      1
       C1a        Identify Specific Strain, Genotype, and risk group.


                                                                           2
                  or Chemical Abstracts Service (CAS) Registry Number.


C2     Select Agents Classification
                                                                                3
       C2a        Is the agent(s) listed in the CDC/APHIS List of Select Agents ?
                       Yes*         No
       C2b        Is the agent(s) listed in the Export Administration Regulations (EAR) - CCL Database, Part 774
                                                                 4
                  (In particular, see Category 1, pages 58 -73) ?
                       Yes*         No

       *If you answer “Yes” to C2a or C2b, contact the LSUHSC-NO Office of Research Services and the Office of
       Environmental Health & Safety for additional requirements.



Complete C3 – C8 for Each Pathogen
C3     Is antimicrobial resistance expressed?                                   Yes        No
       C3a     If Yes, provide details:


C4     Are other markers expressed?                                             Yes        No

       C4a        If Yes, provide details:

C5     Is there a possibility of new strains being created?                     Yes        No

       C5a        If Yes, provide details:




IBC Protocol Submittal Form Revised 8/01//2012
                                                 Institutional Biosafety Committee (IBC)

C6     Is the organism inactivated prior to other manipulations?                     Yes        No

       C6a        If Yes, specify methods:                  Heat                     Chemical
                                                            Radiation                Other:
       C6b        How do you verify inactivation?

C7     Do you culture the organism?                                                  Yes        No
       C7a        If Yes, specify the amount:

C8     Do you concentrate the organism?                                              Yes        No

       C8a        If Yes, specify methods:              Centrifugation      Precipitation
                                                        Filtration          Other:


Complete C9 – C13 for Each Toxin
C9    Is a toxin produced as a result of or for this project?                        Yes        No
C10 If you are working with a toxin, identify the amount of toxin & how it will be aliquotted. (See NSAR5 links in
    beginning of Section “C”)


      C10a      If you are working with a toxin, does the toxin have an LD50 more than 100 nanograms per
                kilogram body weight?              Yes          No
C11 The largest volume used is:                           Liters
      The usual volume used is:                           Liters

C12 If dilutions will be prepared, identify the method & how they will be aliquotted:


C13 Containment equipment available:                   Biological Safety Cabinet       Chemical Fume Hood
                                                       Containment Centrifuge          Other:




IBC Protocol Submittal Form Revised 8/01//2012
                                                  Institutional Biosafety Committee (IBC)


Part D: Research Involving Human or Non-Human Primate Blood, Blood Components, Cell
        Lines and/or Other Potentially Infectious Materials (OPIM)
D1     Identify the type of samples to be manipulated:
          Whole Blood/Serum             Blood Component                       Cell Lines or Repository Cells infected with HIV or HBV
          Established Cell Lines        Unfixed Tissue                        Tissue from animals infected with HIV or HBV
          Cell "strains"                Other:

D2.    List specific samples below:
Sample Type                                             Sample Name                              Source (Vendor, Lab Group, etc.)




D3     Is work being conducted with clinical specimens?                             Yes              No
D4     Has material been prescreened for pathogens?                Yes                               No
       D4a   If YES, what pathogens was the material screened for:


       D4b       Identify any positive tests

D5     Has the material been intentionally infected or is it suspected of being infected, with                   Yes            No
       any pathogens?
       D5a    If Yes, what pathogens?
       D5b       Will the material be infected with any pathogens as part of this protocol?                      Yes            No
       D5c       If Yes, what pathogen(s)?


D6     Frequency of manipulations:                      Daily          Weekly                Other

D7     Types of manipulations:                   Centifugration        Sonification          Dissection
                                                 Blending/Mixing       Pipetting             Other
D8     Containment equipment                     Biological Safety Cabinets            Chemical Fume Hood
       available:                                Containment Centrifuge                Other




IBC Protocol Submittal Form Revised 8/01//2012
                                                 Institutional Biosafety Committee (IBC)


PART E: Use of Recombinant DNA or Transgenic Animals in Research
                   Websites for additional information on NIH Guidelines for Research Involving rDNA Molecules:
                         [http://oba.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm ] and
                              Office of Biotechnology Activities (OBA) [http://oba.od.nih.gov/oba/index.html]


E1     Indicate by placing an “X” for each Section III Experiments Covered by the NIH Guidelines that covers the
       experiments described in this application.

                              Section III. Experiments Covered by NIH Guidelines
                              [http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm ]
Section III-A Experiments that Require Institutional Biosafety Committee Approval (IBC), RAC Review, and NIH
Director Approval Before Initiation
       Section III-A-1       Major Actions under the NIH Guidelines

Section III-B       Experiments That Require NIH/OBA and IBC Approval Before Initiation
       Section III-B-1       Experiments Involving the Cloning of Toxin Molecules with LD50 of Less than 100 Nanograms per Kilogram
                             Body Weight
Section III-C       Experiments that Require IBC and Institutional Review Board Approvals (IRB) and RAC Review Before
                    Research Participant Enrollment
       Section III-C-1       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-D       Experiments that Require IBC Approval Before Initiation
       Section III-D-1       Experiments Using Risk Group (RG) 2, RG 3, RG 4, or Restricted Agents as Host-Vector Systems
       Section III-D-2       Experiments in Which DNA From RG 2, RG 3, RG 4, or Restricted Agents is Cloned into Nonpathogenic
                             Prokaryotic or Lower Eukaryotic Host-Vector Systems
       Section III-D-3       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-4       Experiments Involving Whole Animals
       Section III-D-5       Experiments Involving Whole Plants
       Section III-D-6       Experiments Involving More than 10 Liters of Culture

Section III-E       Experiments that Require IBC Notice Simultaneous with Initiation
       Section III-E-1       Experiments Involving the Formation of Recombinant DNA Molecules Containing No More than Two-Thirds
                             of the Genome of any Eukaryotic Virus
       Section III-E-2       Experiments Involving Whole Plants
       Section III-E-3       Experiments Involving Transgenic Rodents

Section III-F       Exempt Experiments
        Section III-F- ___     (Enter which of the 6 category exemptions under the NIH Guidelines is applicable)


E2     Is the use of rDNA in this project EXEMPT according to NIH Guidelines?                 No       Yes
       If “Yes”, explain why this is “EXEMPT”.




E3     Describe the gene sequences used to make the recombinant (If obtained commercially, give a detailed description
       and attach catalog description).


IBC Protocol Submittal Form Revised 8/01//2012
                                                 Institutional Biosafety Committee (IBC)




E4     Explain the function of the foreign genetic material in this experiment:


E5     Is a deliberate attempt made to obtain expression of foreign gene(s) in the cloning vehicle? If yes, list what proteins
       and indicate any hazards associated with expression of the foreign proteins?


E6     Name the organism(s) used as the host/cloning vehicle (Check all that apply):
          Prokaryotes (e.g., E. coli K12):
             Eukaryotes (e.g., mammalian cell lines)
             Higher Animals (e.g., insects, amphibians,
             mice, non- human primates, etc.)

E7     Are plant or animal cells to be exposed to the recombinant?              No     Yes
       E7a If YES, list the cells or cell lines to be used:


       E7b Will infectious virus, oncogenic agents or toxins be produced during this work?         No     Yes
               If Yes, describe:

       E7c Describe the potential hazards and the planned mitigation measures:


E8     Are viruses or viral-based promoters used in this work?             No        Yes
       If Yes, please explain and then answer questions E8a-E8k.


       E8a      Name of virus or viral promoter:
       E8b      Amount of viral genomic material used:
                  Whole virus       <2/3 viral genome           <1/2 viral genome
       E8c      How is the virus used?             Vector     Donor of genetic information
                If used as vector:
                E8c1      List specific phage, virus or plasmid and the function of each:


                E8c2      If you are using a mammalian expression system, please provide a comprehensive description of the
                          system:


                E8c3      Will human or amphotropic viral vectors be utilized?         No    Yes
                          If Yes, please provide a detailed description.



       E8d      Is virus replication competent or mobilizable?        No      Yes
                E8d1      If YES, what is the host range?


       E8e      Is the virus capable of infecting human cells?        No     Yes

IBC Protocol Submittal Form Revised 8/01//2012
                                                 Institutional Biosafety Committee (IBC)

       E8f      Is the strain attenuated?           No      Yes
       E8g      Provide detailed information on the specific strain being used:


       E8h      Is a less virulent strain available?             No   Yes
       E8i      Is there a potential for producing aerosols?           No   Yes
                E8i1 If YES, how will the generation of aerosols be minimized or eliminated?


       E8j      Virus Classification (check all that apply)
                E8j1          Prokaryotic Virus          Name:
                E8j2          Eukaryotic Virus           Name:
                B8j3          Oncogenic Virus            Name:
       E8k      Organism Risk Group (Check one). Refer to the NIH Guidelines Appendix B to determine risk group:
                [http://oba.od.nih.gov/oba/rac/guidelines_02/Appendix_B.htm#_Toc3023181]
                     Risk Group 1              Risk Group 3
                    Risk Group 2                     Risk Group 4

E9       If rDNA is being introduced into animal models, and/or has the genome of the animal been modified by rDNA:
         E9a      Would it pose any threat to other animals or humans?            No       Yes

         E9b      Are cells permissive to further infection?                      No       Yes
                  E6b1. If Yes, please explain:
         E9c      Is rDNA used to make a transgenic animal model?                 No       Yes
                  E6b1. If Yes, please explain:
         E9d      Is any of the rDNA in the transgene from a virus?               No       Yes

         E9e      Is there any reasonable expectation that this viral segment could help mobilize part or all of the transgene,
                  either by itself or by interaction with other viruses (including endogenous viruses)?
                               No       Yes
         E9f      If part or all of the transgene was mobilized, would it carry any particular risk (is part or all of the transgene
                  known oncogene/anti-oncogene, toxin, immunosuppressant, or could it reasonably be expected to confer
                  pathogenic properties on a virus that carried it?
                                No         Yes
         E9g      If there is a possibility of viral vector sequences recombining with endogenous or exogenous helper viruses to
                  produce new and unpredictable forms of infectious viruses, please explain:



E10    Are the recombinant organisms/molecules:
       E10a Genetically modified microorganisms or genetic elements from organisms                       No            Yes
            listed on the CDC List of Select Agents shown to produce or encode for a
            factor associated with a disease?

       E10b Genetically modified microorganisms or genetic elements that contain                         No            Yes
            nucleic acid sequences coding for any of the toxins listed on the CDC List
            of Select Agents or their toxin subunits?

          Select Agent List: http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html
          CDC Requirements for transferring or receiving Select Agents (42 CFR 72.6 (Listing in Appendix A)

IBC Protocol Submittal Form Revised 8/01//2012
                                                 Institutional Biosafety Committee (IBC)

          http://grants.nih.gov/grants/policy/select_agent/42CFR_Additional_Requirements.pdf
          PI responsibility for the conduct of this research in accordance with Section IV-B-7 of the NIH Guidelines:
          http://oba.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm#_Section_IV-B-7._Principal




IBC Protocol Submittal Form Revised 8/01//2012
                                                 Institutional Biosafety Committee (IBC)


PART F: IBC APPROVAL STATUS
F1      Principal Investigator:                                                                 Email:
                                                                                                cc email:
Project Title:
(Must match title listed on page 1)
If applicable, IACUC Protocol #                       IRB Protocol #
I attest that the information contained in this application is accurate and complete. I accept the responsibility for the safe conduct of work with this study
at the Biological Safety Level practices and procedures assigned by the IBC. I will inform all personnel, who may be at risk of potential exposure of the
conditions of this work. I assure that all personnel will receive adequate training to perform all activities safely and proficiently.
I will not carry out the work described in the attached application until it has been approved by the IBC and all requirements have been met.
Where applicable, I agree to comply with the NIH requirements pertaining to shipment and transfer of recombinant DNA materials. I acknowledge my
responsibility for the conduct of this research in accordance with Section IV-B-7 of the NIH Guidelines:
http://oba.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm#_Section_IV-B-7._Principal

Principal Investigator (signature): _______________________________________ Date: _________________
               Print, sign and submit only this page to the IBC Office - RBC 206 (433 Bolivar Street, New Orleans, LA 70112).
                                          Email the application to IBCoffice@lsuhsc.edu.


F2      This section is to be completed by the LSUHSC Biological Safety Officer and/or EHS Representative.
        (Note: A copy of this page will be forward to the IRB or IACUC).

     Modifications Required to Secure Approval (Refer to separate notification for IBC recommendations.)

     Approval Withheld (Refer to separate notification for IBC recommendations.)

      This protocol application was determined exempted from LSUHSC IBC coverage. Annual re-approval is not
      required; however, you must submit an amendment prior to implementing any changes that may alter this exemption.

      This protocol application is approved by the LSUHSC IBC. Annual re-approval will be required and routine inspections
      should be expected. You must submit an amendment prior to implementing any changes.

      This amendment is approved by the LSUHSC IBC. Annual re-approval will be bound to the approved date of the
      application which this amends.

IBC Application #: ____________ Amendment # ______

Other requirements: ______________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________


IBC Chairman Signature: _________________________________                                      Date of IBC Approval: _______________


F3      This section is to be completed by Principal Investigator upon project termination.

The date of completion of all activities covered under this protocol was ________________________
Email a copy of this page to the IBCoffice@lushsc.edu or mail to IBC Office, RCB 206 (433 Bolivar Street, New Orleans, LA 70112)


F4      This section is to be completed by LSUSHC IBC upon project termination.

Date Protocol Inactivated: ________________ IBC/Biological Safety Representative: __________________________



IBC Protocol Submittal Form Revised 8/01//2012

								
To top