ࡱ> c fbjbjZWZW 48=`\8=`\(4@@!!!!!!!!8"#d!|$x(pd)d)|)*B,<..-//////$̌S!.**..S!!d)|)4@111.v!d)!|)-1.-11vi~d)08*9.cD/R1{^V0{R/D~~!T..1.....SS1................@> ~ :  IBC Research Application Project Title:  FORMTEXT      Anticipated Start date: FORMTEXT      Application type: FORMCHECKBOX  Initial submission  FORMCHECKBOX  Revised submission For IBC use only ReceivedBy:Date:ReviewedBy:Date:Action taken FORMCHECKBOX  Approved  FORMCHECKBOX Approved contingent upon recommended changes  FORMCHECKBOX  Not approved. Date: Principal investigator: FORMTEXT       FORMTEXT  Title: FORMTEXT   FORMTEXT      Department: FORMTEXT   FORMTEXT      Building: FORMTEXT   FORMTEXT      Room: FORMTEXT      Phone: FORMTEXT   FORMTEXT      E-mail address: FORMTEXT   FORMTEXT       Co-investigator: FORMTEXT   FORMTEXT      Title: FORMTEXT   FORMTEXT      Department: FORMTEXT   FORMTEXT      Building: FORMTEXT   FORMTEXT      Room: FORMTEXT      Phone: FORMTEXT      E-mail address: FORMTEXT       Part A: Research Project Summary Please describe the purpose and nature of your project in lay terms.  FORMTEXT        Part B: Experiment Details Provide a concise description of your laboratory procedures involving recombinant and synthetic DNA/RNA. Be concise but use non-technical terms as much as reasonably possible. Please include the following: Enough information so that the techniques used with the biohazardous materials are clear. Provide a description of the genes used (including function). Indicate the culture volumes, maximum concentrations and other agent specific information. Identify at what stage the agent is inactivated and by what means.  FORMTEXT        Part C: Recombinant DNA Host, vector and gene information Host (organism or common name) Plasmid Strain # or NameSource*  Commercial or Laboratory (Name & Location)Host(s):  FORMTEXT       FORMTEXT       FORMTEXT      Vector, plasmids(s):  FORMTEXT       FORMTEXT      Inserted DNA/Gene(s) to be cloned: FORMTEXT       FORMTEXT       FORMTEXT      Will there be an attempt made to express the foreign gene?  FORMTEXT       If so, indicate what protein will be produced?  FORMTEXT       Is the source of these agents a non-commercial laboratory?  FORMTEXT      If yes, a copy of the fully executed Material Transfer Agreement is required for IBC approval. Part D: Risk Assessment Indicate the risk group of the agent to be used. If more than one agent will be used, indicate the highest risk group among all the agents. Risk GroupBiosafety Level FORMCHECKBOX Risk group 1 (RG 1) agents not associated with disease in healthy adults.BSL1: Lab space is not separated from general building traffic. Work is generally done on open bench tops. Special containment is not generally required. Lab personnel have specific training in procedures and is supervised by a scientist with training in microbiology. FORMCHECKBOX Risk group 2 (RG 2) agents associated with human disease but for which preventative or therapeutic interventions are often available.BSL2: Differs from BSL1 in that lab personnel have specific training in handling pathogenic agents. Access to the laboratory is limited. Procedures that produce infectious aerosols are conducted in biological safety cabinets or similar equipment. FORMCHECKBOX Risk group 3 (RG 3) agents associated with serious or lethal human disease for which preventive or therapeutic interventions may be availableBSL3: Not allowed at WU. Applicable to clinical, diagnostic, teaching, research or production facilities. Lab personnel have specific training in handling pathogenic and potentially lethal agents. All procedures are conducted in a BSC and other safety measures such as access zones, sealed penetrations and specialized PPE are employed. FORMCHECKBOX Risk group 4 (RG 4) agents likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually availableBSL4: Not allowed at WU. Based on the risk group designation, is the corresponding biosafety level appropriate?  FORMTEXT       (Y/N) If yes, proceed to Part E. If no, complete this section. Based on any of the criteria listed below, please provide a rationale for the proposed adjustment (increase or decrease) in biosafety containment levels. Be sure to consider both the source of the nucleic acid sequence and the function that sequence codes for as well as potential increased risk due to synergistic functions when sequences from multiple organisms are combined. VirulenceChange of virulence PathogenicityInfectious doseEnvironmental stabilityRoute of spreadCommunicabilityOperationsQualityGene product effectsAvailability of vaccine or treatment Change biosafety containment to:  FORMTEXT       Rationale:  FORMTEXT       Part E: Controls that will be used to protect workers and the environment from exposure. Select all that apply. Latex or nitrile glovesLab coatGogglesFace shieldBiological Safety CabinetFume hoodControl access to laboratoryChemical degradation of samplesAutoclaveOther: (Please specify) Part F: Decontamination of Work Areas and Equipment /Waste Disposal  FORMTEXT       I acknowledge that all decontamination and disposal will be conducted according to Whitworth s established biosafety decontamination protocols. In general, solids are decontaminated by autoclave and liquids are decontaminated chemically with bleach or similar chemical. List any additional or specialized decontamination and waste disposal for this particular procedure below.  FORMTEXT       Part G: Transportation of Biological Materials Do you plan on shipping any form of the material from Whitworth University to another location or lab?  FORMCHECKBOX  YES  FORMCHECKBOX  NO If yes, please provide written procedure on how the biological material will be transported away from 鶹ԭ University. We are required to meet all State, U.S. Department of Transportation (DOT) and United Nations International Civil Aviation Organization (ICAO), and International Air Transport Association (IATA) regulation.  FORMTEXT        Part H: Training All individuals participating in this research project must be adequately trained in general chemical hygiene and biosafety techniques prior to the start of work. As stated in the Policy on Research Involving Recombinant or Synthetic Nucleic Acid Molecules IBC approval may be suspended if training documentation is not submitted for project participants. Part I: Types of research currently prohibited at Whitworth University. 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A Major Action is the deliberate transfer of a drug resistance trait to a microorganism when such resistance could compromise the ability to control the disease agent in humans, veterinary medicine, or agriculture. Click  HYPERLINK "http://osp.od.nih.gov/sites/default/files/resources/Major_Action_FAQs_March_2013.pdf" here for more information.  FORMTEXT       I am not conducting research that involves the cloning of toxin molecules lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight. Examples include: microbial toxics such as the botulinum toxins, tetanus toxin, diphtheria toxin and Shigella dysenteriae neurotoxin. Specific approval has been given for the cloning in E.coli K-12 of DNA containing genes coding for certain toxins. For more information about approval a specific request must be sent to  HYPERLINK "mailto:NIHGuidelines@od.nih.gov" NIHGuidelines@od.nih.gov.  FORMTEXT       I am not conducting research that involves the use of  select agents or any DNA from select agents. For a list of select agents, click  HYPERLINK "http://www.selectagents.gov/SelectAgentsandToxinsList.html" here.  FORMTEXT       I am not conducting research that involves the transfer of nucleic acid molecules into humans. Principal Investigator s Certification: By signing below, I certify that I have read the following statements and agree that all participants and I will abide by these statements as well as all Whitworth University policies and procedures governing the use of recombinant DNA, infectious agents and other biological materials as outline in this application and in the NIH Guidelines. I will: Ensure that listed personnel have or will receive appropriate training in safe laboratory practices and procedures for this protocol before any work begins on this project and will receive required annual refresher training thereafter. Also, all listed personnel who have potential occupational exposure to blood borne pathogens will file a declaration form with Human Resources and be trained annually; Follow the health surveillance practices as approved for this protocol and inform those working on the protocol about appropriate emergency assistance information for their location(s); Inform the IBC of any research-related accident or illness as soon as possible after its occurrence. Submit in writing a request for approval from the IBC of any significant modifications to the study, facilities or procedures; Submit in writing an updated proposal annually to the IBC. Abide by all Federal, State and local regulations governing research including the NIH guidelines on recombinant DNA and OSHA on Blood Borne Pathogens; and Report potentially toxic exposure to recombinant DNA materials, any incident releasing recombinant DNA materials into the environment, any problem with physical or biological containment and new information related to my research on the safety and biological hazard of the recombinant DNA molecules being studied to the IBC. Signatures:Principal investigator FORMTEXT      Date: FORMTEXT      Shared space principal investigator: FORMTEXT      Date: FORMTEXT       It is agreed upon that this form may be electronically initialed and signed. It is agreed upon that the electronic signatures appearing on this documents are the same as handwritten signatures for the purposes of validity, enforceability and admissibility.     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