ࡱ> = U$bjbj.. . LhLhN8L"Tv"   "1 $\!$=====  R=j  = <ڙ!h0%YB%%L================%=========X P: APPLICATION FOR INSTITUTIONAL BIOSAFETY COMMITTEE REVIEW AND APPROVAL Ͽ (Protocol Submission Form)This form must be submitted for ALL research or teaching activities involving recombinant DNA (rDNA), infectious agents, toxins, prions, and/or human tissue and fluids. Submit the original and two copies to: Dave Bergmann, Chair of the Ͽ Institutional Biosafety Committee, Life Science Laboratory Bldg, Rm 121. Phone 642-6465 e-mail  HYPERLINK "mailto:Dave.Bergmann@Ͽ.edu" Dave.Bergmann@Ͽ.edu SECTION IDEPT./CENTER:P.I./Faculty Name:Ͽ ID#:EMAIL:RANK (CIRCLE ONE): FACULTY / SCIENTIST / POST-DOC / STAFFCITIZENSHIP:CO P.I.:Ͽ ID#:EMAIL:RANK (CIRCLE ONE): FACULTY / SCIENTIST / POST-DOC / STAFFCITIZENSHIP:CAMPUS ADDRESS:OFFICE PHONE:LAB PHONE:HOME PHONE:SECTION IIPROJECT or COURSE TITLE:GRANT TITLE if applicable:FUNDING SOURCE if applicable:APPLICATION DEADLINE:PROPOSED START/RENEWAL DATE:LOCATION: (BUILDING AND ROOM #)PROJECT TYPE (CIRCLE ONE):PROJECT OR COURSE #:NEW OR RENEWAL?RESEARCH / TEACHINGLIST GRANT NUMBERS AND AGENCIES:PROJECT START DATE:PROJECT END DATE: If this application requires BL-2 or higher containment circle yes or no:YESThe facilities used in these activities have been previously inspected by the IBC and meet appropriate biological laboratory safety standards.NOCircle yes or no for the following agents or materials used and follow instructions:YESRecombinant DNA. Fill out sections even if exempt. Complete sections A, B, C, & D as required.NOYESInfectious agents, toxins, or prions (pathogenic to humans, animals or plants). Fill out section E.NOYESHuman tissues or fluids. Fill out section F.NOYESUse and/or possession of select agents according to the Patriot Act ( HYPERLINK "http://epic.org/privacy/terrorism/hr3162.html" http://epic.org/privacy/terrorism/hr3162.html). Contact the Institutional Biosafety Committee Chair for appropriate forms and information at Dave.Bergmann@Ͽ.edu or call 642-6465.NOCOMPLETION AND SIGNING OF THIS FORM ARE THE RESPONSIBILITY OF THE PRINCIPAL INVESTIGATOR OR FACULTY MEMBER IN CHARGE.In signing this form, I agree to abide by all university and federal guidelines and regulations regarding recombinant DNA, infectious agent and/or human tissues and fluids work.Principal Investigator is responsible for all liabilities related to use of his/her materials. ____________________________________________ Principal Investigator Signature _________________________ Date SECTION AExperiments that require RAC or ORDA review; NIH and IBC approval. Circle yes or no:YESDeliberate formation of rDNAs containing genes for biosynthesis of toxic molecules.NOYESDeliberate release into the environment of any organism containing rDNA.NOYESDeliberate transfer of drug resistance trait to microorganisms such that drug control might be compromised.NOYESDeliberate transfer of rDNA into human subjects.NOSECTION BExperiments that require IBC approval before initiation. Circle yes or no:YESUse of other than a Risk Group 1 agent as host-vector system (see Appendix B of NIH Guidelines, 2002).NOYESWill you use a Class 2, 3, or 4 viral vector? If so, will:NOYESGreater than 2/3s of the genome be used?NOYESHelper virus be used?NOYESYour experiment enhance pathogenicity (e.g. insertion of oncogene, extend host range)?NOYESWill whole animals or plants be used as hosts?NOYESWill experiments involve more than 10 liters of culture?NOYESWill a deliberate attempt be made to obtain expression of a foreign gene?NOIf so, what protein / RNA will be produced:YESWill a toxin be used?NOYESWill prions be used?NOALL YES ANSWERS ABOVE MUST BE EXPLAINED IN THE NEXT SECTION.SECTION CHost organism:List the vector(s) name and type (e.g., -gt11, retroviral pLNL), and append a DNA map of any novel vectors listing components with their sizes:Source organism of DNA to be cloned (e.g., human T-Cell cDNA library, HIV gag gene):If the DNA is microbial, circle the appropriate class as given in Appendix B [Current federal guidelines:  HYPERLINK "http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm" http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm :12345N/AFunction of products (protein or RNA) of the cloned DNA:For oncogenic viruses, circle appropriate level (Appendix B [and all federal guidelines and Biosafety Manual]):Low RiskModerate RiskN/ACircle containment level specified by the current Federal Guidelines ( HYPERLINK "http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm" http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm) and the Biosafety Manual:ExemptBL1BL2BL3BL4*All human tissue / body fluid samples require BL2.SECTION DInclude a succinct description of your project on a separate page and explain WHAT, WHY, and HOW rDNA will be used in your project. This CANNOT be replaced with a grant proposal or reprint.SECTION EDescription of proposed research involving infectious agents, toxins, or prions.Describe the purpose of this research project and the experimental procedures to be employed. Explain why and how infectious agent(s), toxins, or prions will be used and the biosafety practices that will be incorporated to minimize any risks. Specific issues to be addressed include: contamination control, spill response, waste management, use of protective apparel, and inventory control. List the infectious agent(s), toxins, or prions:Circle level of research according to the federal guidelines and Biosafety in Microbiological and Biomedical Laboratories ( HYPERLINK "http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmgl4toc.htm" h HYPERLINK "http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm" http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm). BL1BL2BL3BL4SECTION FHuman Tissues and Fluids UsageSubmit to the IBC a statement of that intent and include an outline (abstract) of the proposed activity, and sufficient information that will clarify to the reader that the guidelines involving human tissue and fluids are understood and that the submitting individual is able and intends to adhere to those guidelines.FOR BIOSAFETY COMMITTEE USE ONLYAPPROVEDDISAPPROVEDEXEMPT/BL1RESTRICTIONS:For BL2 Level Research or higher: FORMCHECKBOX The facilities used in this activity have been previously inspected and meet appropriate laboratory safety standards. 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