IBC Research Submission 1General Information2NIH Research Categories3r/s Nucleic Acids4GMO5Infectious Materials6Toxins7Humans or Non-human Primates8Zoonotic Diseases9Risk Assessment10Declarations General InformationPrincipal Investigator Name* First Last EWU ID# Email* PhoneName of the department's chair* First Last Department Chair's Email* Project Title* Anticipated Research Start Date MM slash DD slash YYYY Anticipated Research End Date MM slash DD slash YYYY Laboratory Location(s)Please list all locations where experiments will take place. Is this project part of a class?* No Yes Which class is this project for?* Other Approvals*Does the project requires Institutional Animal Care and Use Committee (IACUC) or Institutional Review Board (IRB) approval. AICUC IRB No other approvals needed AICUC approval number or status* IRB approval number or status* Research PersonnelList all personnel who will work on this projectNamePosition (student/faculty/staff)EWU ID# Please complete the rest of this form using language directed to a general audience with limited scientific background. Please define any technical terms. Research DescriptionResearch Goals*Provide a brief description of the goals of this project and why the materials in this registration are used.Research will take place under:*Select all that apply Biosafety Level 1 (BSL1) Animal Biosafety Level 1 (ABSL1) Plant Biosafety Level 1 (PBSL1) Biosafety Level 2 (BSL2) Animal Biosafety Level 2 (ABSL2) Plant Biosafety Level 2 (PBSL2) PI Experience*Please describe the experience and qualifications you have for working with the agent(s) or using the proposed protocols.Research Involves Does this project involve any of the following: Select all that applyRecombinant DNA molecules (e.g. plasmids, viral vectors) or synthetic nucleic acids* No Yes Genetically modified organisms (e.g. plants, animals, eukaryotes, bacteria, archaea)* No Yes Potentially infectious material*Select "yes" if material to be used can infect humans, animals, or plants No Yes Biotoxins* No Yes Material from humans or nonhuman primates (e.g. blood, tissues, cell lines)* No Yes Field research involving animals/animal tissues (vertebrate and invertebrate) known to be reservoirs of zoonotic disease* No Yes Your research does not appear to be covered by the Institutional Biosafety Committee. You do not need to submit this form. If you have questions, please contact the Biosafety Officer to discuss your research project. NIH Research Categories The IBC follows the NIH Guidelines. The NIH Guidelines divide research into six categories, found in section III. Answer the questions below to determine which category or categories your project falls into. EWU does not have facilities to safely perform experiments that fall into Sections III-A, III-B, or III-C For all NIH Guideline questions r/sNA means recombinant or synthetic nucleic acidsSection III-D Experiments Please indicate if the project will involve any of the following:Introducing r/sNA into Risk Group 2 agents* No Yes Transferring DNA from Risk Group 2 or 3 agents into nonpathogenic prokaryotes or lower eukaryotes* No Yes Use of infectious or defective Risk Group 2 viruses in the presence of helper virus in tissue culture systems* No Yes Use of infectious or defective Risk Group 1 viruses (or viruses that do not infect humans) in tissue culture systems* No Yes Transfer of r/sNA, or DNA or RNA molecules derived therefrom into ANY animal* No Yes Does the r/sNA, DNA or RNA mentioned above contain more than 2/3 of any eukaryotic viral genome?* No Yes What is the virus?* Transfer of r/sNA from Risk Group 2 human or animal pathogens into ANY animal* No Yes Genetically engineering plants by r/sNA methods, use of such plants for propagation or in other experiments, or use of plants together with microorganisms or insects containing r/sNA* No Yes Experiments involving more than 10 liters of culture* No Yes Experiments with influenza viruses generated by recombinant or synthetic methods* No Yes HiddenIII-D CheckIf no III-D options were selected this value is 9Section III-E Experiments Please indicate if the project will involve any of the following:Tissue culture experiments involving the formation of r/sNA containing no more than 2/3 of the genome of any eukaryotic virus* No Yes Experiments involving whole plants or r/sNA modified organisms associated with whole plants not already covered* No Yes Generation of transgenic rodents in which the animal's genome has been altered by stable introduction of r/sNA*This only applies to animals that are housed under ABSL1 conditions. No Yes HiddenNon-Exempt Research CheckNumber will be 12 if no III-D or III-E selections were madeSection III-F Experiments Please indicate if the project will involve any of the following:r/sNA that: (1) can neither replicate nor generate nucleic acids that can replicate in any living cell (e.g., oligonucleotides or other synthetic nucleic acids that do not contain an origin of replication or contain elements known to interact with either DNA or RNA polymerase), and (2) are not designed to integrate into DNA, and (3) do not produce a toxin that is lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight.* No Yes r/sNA that are not in organisms, cells, or viruses and that have not been modified or manipulated (e.g., encapsulated into synthetic or natural vehicles) to render them capable of penetrating cellular membranes.* No Yes r/sNA that consist solely of the exact recombinant or synthetic nucleic acid sequence from a single source that exists contemporaneously in nature.* No Yes r/sNA that consist entirely of nucleic acids from a prokaryotic host, including its indigenous plasmids or viruses when propagated only in that host (or a closely related strain of the same species), or when transferred to another host by well established physiological means.* No Yes r/sNA that consist entirely of nucleic acids from a eukaryotic host including its chloroplasts, mitochondria, or plasmids (but excluding viruses) when propagated only in that host (or a closely related strain of the same species).* No Yes r/sNA that consist entirely of DNA segments from different species that exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent.*The list of exchangers can be found in the NIH Guidelines Appendix A No Yes r/sNA genomic DNA molecules that have acquired a transposable element, provided the transposable element does not contain any r/sNA* No Yes Tissue culture experiments involving r/sNA containing less than 1/2 any eukaryotic viral genome from Risk Group 2 or lower organisms and that do not code for molecules that are toxic to vertebrates* No Yes Experiments involving the following strains: Escherichia coli K-12, Saccharomyces cerevisiae, Saccharomyces uvarum, Kluyveromyces lactis, Bacillus subtilis, and Bacillus licheniformis* No Yes Do any experiments involving the above strains also involve Risk Group 3 or 4 organisms or nucliec acids from them?* No Yes Do any of the experiments involving the above strains introduce genes coding for molecules that are toxic to vertebrates?* No Yes The purchase or transfer of transgenic rodents that require ABSL-1 containment.* No Yes Breeding of two different transgenic rodents, or the breeding of a transgenic rodent and a non-transgenic rodent, with the intent of creating a new strain of transgenic rodent that can be housed at ABL1 containment for which:*(1) Both parental rodents can be housed under BL1 containment; and (2) neither parental transgenic rodent contains the following genetic modifications: (i) incorporation of more than one-half of the genome of an exogenous eukaryotic virus from a single family of viruses; or (ii) incorporation of a transgene that is under the control of a gammaretroviral long terminal repeat (LTR); and (3) the transgenic rodent that results from this breeding is not expected to contain more than one-half of an exogenous viral genome from a single family of viruses. No Yes HiddenIII-F CheckNumber will be 11 if no III-F selections are made Category III-F Recombinant and Synthetic Nucleic Acids Research category III-F is exempt under NIH regulations. Please answer the questions below for r/s DNA molecules in the III-F category.Which host cells will be used?* Which vectors will be used?* What DNA is being inserted?* What proteins will be produced?*Answer if applicable. Please provide a brief description of research protocols*Non-exempt Recombinant and Synthetic Nucleic Acids Please answer the questions below for r/s DNA molecules that do NOT fall into the III-F category.Which vector systems will be used*Select all that apply; a section of questions will open for each vector selected. Bacterial Plasmid Adeno-Associated Virus Adenovirus Simple Retrovirus Lentivirus Other Viruses Bacterial Plasmids Answer the questions in this section for experiments involving bacterial plasmids as the vector system.Provide a brief description of the type of plasmids that will be used. Describe the gene sequence(s) that will be inserted into the recombinant vector*Source of the gene(s) (genus/species) Do any of the gene sequences increase oncogenic potential, transfer a drug resistance trait that has the potential to compromise the use of the drug to control disease or have the potential to increase pathogenicity or virulence of a vector system?*Do any of the gene sequences increase oncogenic potential, transfer a drug resistance trait that has the potential to compromise the use of the drug to control disease or have the potential to increase pathogenicity or virulence of a vector system? No Yes Please explain.Please explain.Describe the function and activity of the transgene(s)*List classes if a large number of transgenes will be used. Indicate the components of the constructs in the library or libraries if a genome-wide approach will be used.Do any of the genes above compromise more than 2/3 of a viral genome?* No Yes Specify* Will the gene encoded in the recombinant DNA or RNA be expressed?* No Yes What protein(s) will be produced? Which cell lines or packaging cells will be used for vector propagation? What % of the viral genome remains?* What are the recipients of the DNA?Select all that apply. Bacterial cells Animal cells in culture Animals Modified tissue culture lines into animals Plant cells Plants DNA Vaccine For animal recipients, what is the animal species and where are they housed? For modified tissue culture into animals, specify the:Cell line nameCell line sourceAnimal species/strain For DNA vaccine, specify the target recipient(s) Please provide a brief description of research protocols using bacterial plasmids*Adeno-Associated Virus Answer the questions in this section for experiments involving adeno-associated viruses as the vector system.Is the virus replication competent?* No Yes What is the source of the virus?* PI's lab Commercial vendor Other Who and where will the virus come from?* Describe the gene sequence(s) that will be inserted into the recombinant vector*Source of the gene(s) (genus/species) Do any of the gene sequences increase oncogenic potential, transfer a drug resistance trait that has the potential to compromise the use of the drug to control disease or have the potential to increase pathogenicity or virulence of a vector system?*Do any of the gene sequences increase oncogenic potential, transfer a drug resistance trait that has the potential to compromise the use of the drug to control disease or have the potential to increase pathogenicity or virulence of a vector system? No Yes Please explain.Please explain.Describe the function and activity of the transgene(s)*List classes if a large number of transgenes will be used. Indicate the components of the constructs in the library or libraries if a genome-wide approach will be used.Do any of the genes above compromise more than 2/3 of a viral genome?* No Yes Specify* Will the gene encoded in the recombinant DNA or RNA be expressed?* No Yes What protein(s) will be produced? Which cell lines or packaging cells will be used for vector propagation?* What % of the viral genome remains?* What are the recipients of the DNA?*Select all that apply. Bacterial cells Animal cells in culture Animals Modified tissue culture lines into animals Plant cells Plants DNA Vaccine For animal recipients, what is the animal species and where are they housed? For modified tissue culture into animals, specify the:Cell line nameCell line sourceAnimal species/strain For DNA vaccine, specify the target recipient(s) Please provide a brief description of research protocols using adeno-associated viruses*Adenovirus Answer the questions in this section for experiments involving adenoviruses as the vector system.Describe wild-type deletions Is the virus replication competent?* No Yes What is the source of the virus?* PI's lab Commercial vendor Other Who and where will the virus come from?* Describe the gene sequence(s) that will be inserted into the recombinant vector*Source of the gene(s) (genus/species) Do any of the gene sequences increase oncogenic potential, transfer a drug resistance trait that has the potential to compromise the use of the drug to control disease or have the potential to increase pathogenicity or virulence of a vector system?*Do any of the gene sequences increase oncogenic potential, transfer a drug resistance trait that has the potential to compromise the use of the drug to control disease or have the potential to increase pathogenicity or virulence of a vector system? No Yes Please explain.Please explain.Describe the function and activity of the transgene(s)*List classes if a large number of transgenes will be used. Indicate the components of the constructs in the library or libraries if a genome-wide approach will be used.Do any of the genes above compromise more than 2/3 of a viral genome?* No Yes Specify* Will the gene encoded in the recombinant DNA or RNA be expressed?* No Yes What protein(s) will be produced? Which cell lines or packaging cells will be used for vector propagation?* What % of the viral genome remains?* What are the recipients of the DNA?*Select all that apply. Bacterial cells Animal cells in culture Animals Modified tissue culture lines into animals Plant cells Plants DNA Vaccine For animal recipients, what is the animal species and where are they housed? For modified tissue culture into animals, specify the:Cell line nameCell line sourceAnimal species/strain For DNA vaccine, specify the target recipient(s) Please provide a brief description of research protocols using adenoviruses*Simple Retroviruses Answer the questions in this section for experiments involving simple retroviruses as the vector system.What is the vector backbone?* What is the host range?* Amphotropic Ecotropic Is the virus replication competent?* No Yes What is the source of the virus?* PI's lab Commercial vendor Other Who and where will the virus come from?* Describe the gene sequence(s) that will be inserted into the recombinant vector*Source of the gene(s) (genus/species) Do any of the gene sequences increase oncogenic potential, transfer a drug resistance trait that has the potential to compromise the use of the drug to control disease or have the potential to increase pathogenicity or virulence of a vector system?*Do any of the gene sequences increase oncogenic potential, transfer a drug resistance trait that has the potential to compromise the use of the drug to control disease or have the potential to increase pathogenicity or virulence of a vector system? No Yes Please explain.Please explain.Describe the function and activity of the transgene(s)*List classes if a large number of transgenes will be used. Indicate the components of the constructs in the library or libraries if a genome-wide approach will be used.Do any of the genes above compromise more than 2/3 of a viral genome?* No Yes Specify* Will the gene encoded in the recombinant DNA or RNA be expressed?* No Yes What protein(s) will be produced? Which cell lines or packaging cells will be used for vector propagation?* What % of the viral genome remains?* What are the recipients of the DNA?*Select all that apply. Bacterial cells Animal cells in culture Animals Modified tissue culture lines into animals Plant cells Plants DNA Vaccine For animal recipients, what is the animal species and where are they housed? For modified tissue culture into animals, specify the:Cell line nameCell line sourceAnimal species/strain For DNA vaccine, specify the target recipient(s) Please provide a brief description of research protocols using simple retroviruses*Lentiviruses Answer the questions in this section for experiments involving lentiviruses as the vector system.Is the lentiviral vector HIV-1 based?* No Yes Do any of the transgenes have oncogenic properties or the potential to increase pathogenicity of the vector?* No Yes, explain below How many plasmids are used in the packaging system? Is the lentivirus replication defective? No Yes Does the packaging system contain the viral envelope gene? No Yes Does the coat protein broaden the host cell and tissue tropism of the lentivirus? No Yes What is the source of the virus?* PI's lab Commercial vendor Other Who and where will the virus come from?* Describe the gene sequence(s) that will be inserted into the recombinant vector*Source of the gene(s) (genus/species) Do any of the gene sequences increase oncogenic potential, transfer a drug resistance trait that has the potential to compromise the use of the drug to control disease or have the potential to increase pathogenicity or virulence of a vector system?*Do any of the gene sequences increase oncogenic potential, transfer a drug resistance trait that has the potential to compromise the use of the drug to control disease or have the potential to increase pathogenicity or virulence of a vector system? No Yes Please explain.Please explain.Describe the function and activity of the transgene(s)*List classes if a large number of transgenes will be used. Indicate the components of the constructs in the library or libraries if a genome-wide approach will be used.Do any of the genes above compromise more than 2/3 of a viral genome?* No Yes Specify* Will the gene encoded in the recombinant DNA or RNA be expressed?* No Yes What protein(s) will be produced? Which cell lines or packaging cells will be used for vector propagation?* What % of the viral genome remains?* What are the recipients of the DNA?*Select all that apply. Bacterial cells Animal cells in culture Animals Modified tissue culture lines into animals Plant cells Plants DNA Vaccine For animal recipients, what is the animal species and where are they housed? For modified tissue culture into animals, specify the:Cell line nameCell line sourceAnimal species/strain For DNA vaccine, specify the target recipient(s) Please provide a brief description of research protocols using lentiviruses*Other Viruses Answer the questions in this section for experiments involving other viruses as the vector system.Which viruses will be used?* Is a helper virus required for replication* No Yes Describe the gene sequence(s) that will be inserted into the recombinant vector*Source of the gene(s) (genus/species) Do any of the gene sequences increase oncogenic potential, transfer a drug resistance trait that has the potential to compromise the use of the drug to control disease or have the potential to increase pathogenicity or virulence of a vector system?*Do any of the gene sequences increase oncogenic potential, transfer a drug resistance trait that has the potential to compromise the use of the drug to control disease or have the potential to increase pathogenicity or virulence of a vector system? No Yes Please explain.Please explain.Describe the function and activity of the transgene(s)*List classes if a large number of transgenes will be used. Indicate the components of the constructs in the library or libraries if a genome-wide approach will be used.Do any of the genes above compromise more than 2/3 of a viral genome?* No Yes Specify* Will the gene encoded in the recombinant DNA or RNA be expressed?* No Yes What protein(s) will be produced? Which cell lines or packaging cells will be used for vector propagation?* What % of the viral genome remains?* What are the recipients of the DNA?*Select all that apply. Bacterial cells Animal cells in culture Animals Modified tissue culture lines into animals Plant cells Plants DNA Vaccine For animal recipients, what is the animal species and where are they housed? For modified tissue culture into animals, specify the:Cell line nameCell line sourceAnimal species/strain For DNA vaccine, specify the target recipient(s) Please provide a brief description of research protocols using other viruses* Genetically Modified Organisms Use this section to describe experiments that will involve the modification of an organism's genome. If the experiment involving the genetically modified organism is detailed above, answer "no" on the question belowHave your genetically modified organisms been described in any of the sections above?* No Yes What type(s) of genetically modified organisms will be used?*Select all that apply Vertebrate animals Invertebrate animals Plants Fungus Eukaryotes Prokaryotes Other Describe genetically modified organisms For each organism, describe: The organism to be modified The method used to alter the host genetic material The type of genetic modification The anticipated results Any housing or containment requirements The methods that will be used for disposal of genetically modified materials Describe vertebrate animals to be genetically modified*Describe invertebrate animals to be genetically modified*Describe plants to be genetically modified*Describe fungus to be genetically modified*Describe eukaryotes to be genetically modified*Describe prokaryotes to be genetically modified*Describe other organisms to be genetically modified* Potentially Infectious MaterialsWill research involve any potentially infectious material that has not already been discussed?* No Yes Potentially Infectious MaterialPlease add information about each potentially infectious material used in this project that has NOT been described earlier in this form.Configuration RequiredUse the Nested Form and Summary Fields settings to choose the form and fields to display in this Nested Form field. BiotoxinsWill the experiments produce biotoxins?* No Yes Will you work with the toxins?* No Yes Will you acquire biotoxins from another source?* No Yes Where are the toxins coming from?* Who/what do the toxins affect?* Largest quantity in use and stored* Do any toxins used in the experiment have an LD50 less than 100 nonograms per Kg body weight?* No Yes Will the toxins be introduced to animals?* no Yes What animals will be used? Will the toxins be introduced to plants?* no Yes What plants will be used? How will the toxin be stored and contained?*Where will the toxin be stored? How will the toxin be contained and people protected from exposure?How will materials be disposed of?* Materials from Humans or Non-human PrimatesWhat samples will be usedPlease indicate what materials will be used in the research and the species each material comes from. If cell lines are being used, please indicate if the lines are established or primary.Material typeMaterial sourceEstablished or Primary Have personnel received bloodborne pathogen training?*All individuals working with materials from humans* and non-human primates are required to receive bloodborne pathogen training. *Established cell lines that are certified free of pathogens do not require bloodborne pathogen training. No Yes Have EWU employees been offered HepB vaccinations?Anyone employed by EWU and working with materials potentially containing bloodborne pathogens must be offered the HepB vaccination series. No Yes Unknown List any information about potential infectious risk of the material*e.g. "material tested negative for pathogens", or "material know to be infected with _________(specific agent)"Describe disposal procedures* Field research involving animals known to be reservoirs of zoonotic disease This section is for field research only, please do not use it for animals housed in EWU facilities.Animal that are Reservoirs for Zoonotic DiseasePlease provide information about each animal species that is a reservoir for zoonotic disease that will be encountered or collected during field research.Configuration RequiredUse the Nested Form and Summary Fields settings to choose the form and fields to display in this Nested Form field. Risk Assessment Please complete the following section as a risk assessment for your experiment. Research Biosafety LevelsWill a biosafety cabinet be used for containment?* No Yes Date of last certification: Which procedures will take place in the biosafety cabinet?Lab Emergency EquipmentIs there an eyewash in the lab?* No Yes Where is the nearest eyewash or safety shower?* How frequently is the eyewash tested?* Is there a first aid kit in the lab No Yes Where is the nearest first aid kit Will fire be used for any part of this research? No Yes Is there a fire extinguisher in the lab? No Yes Hazards For questions below, if the answer to a question is yes please describe how the hazard will be controlled. Reference any lab protocols or procedures that address the question.Will materials be transported between rooms or buildings on campus?* No Yes How will materials be transported?Will materials be shipped off campus?* No Yes Shipping biohazardous material requires DOT training; email a copy of the completion certificate for the CITI course Shipping and Transport of Regulated Biological Materials to Environmental Health & Safety. Where will materials be stored and how will they be kept secure?Will any toxic or infectious materials be used in procedures that could create aerosols or droplets?* No Yes What will be done to minimize exposure?*Will infectious or toxic material be centrifuged?* No Yes Will sealed rotor buckets be used?* No Yes Where will rotor buckets be opened?* Will materials be cultured in an incubator?* No Yes What type of incubator will be used?*e.g. shaking or static shelf Describe measures to prevent and contain any spills and procedures for spill clean-up*Will sharps be used in this experiment?* No Yes Describe measures to protect users and others from injury*What is the lab procedure for sharps injuries?*Personal Protective EquipmentPersonal protective equipment use and disposal*List the personal protective equipment that will be used and how it will be disposed of or decontaminated.Personal protective equipmentDisposal or decontamination method Emergency ProceduresIn the event of a release of materials, what is the worst-case scenario for humans and/or the environment*Briefly describe the procedures for dealing with spills in the following locations. Put "NA" if it is not relevant.Inside a biosafety cabinet:*Inside a centrifuge*In the general lab area*Outside of the lab*e.g in the hallway during transport between roomsDescribe any other emergency related procedures in place.Upload additional informationIf there is any information you would like to add to this submission, please attach it here. The maximum file size is 16MB. Drop files here or Select files Max. file size: 63 MB. PI Declarations Read through each statement and indicate if you consent.PI Declarations*To the best of my knowledge, the information provided in this form and all attached documents is complete and accurate. If applicable, the information I have provided accurately reflects the research described in any associated grant applications. I have read the EWU Biosafety Manual and am familiar with the NIH Guidelines and the Biosafety in Microbiological and Biomedical Laboratories (BMBL). I will conduct all research in compliance with these documents. I understand that failure to comply with the NIH Guidelines may jeopardize my research grants and those of other researchers at Eastern, regardless of the funding source for my research. I have completed, or will complete, the CITI courses Training for Investigators, Staff, and Students Handling Biohazards, and NIH Recombinant DNA (rDNA) Guidelines and have included a copy of the completion certificates with this application, or I will send them to the IBC as soon as they are complete. I will ensure that any additional people involved in this project also complete these courses and submit their completion certificates to the IBC. I am trained in good microbiological techniques and I will ensure that all members of my laboratory receive appropriate training to conduct research safely. I understand that I am responsible for immediately reporting any violations of the NIH Guidelines, problems with containment, or significant research-related accidents or illnesses to the IBC. I will notify the IBC of changes to the described research and will submit a revised IBC registration form should such changes occur. I have read and agree with the declarations above HiddenIBC Submission Number HiddenDoes this proposal require review by the department chair and the dean? No Yes HiddenDoes this proposal require IBC review? No Yes Departmental Review The department chair or an appointed designee is required to review some research proposals. Please read through the entire proposal and determine if: The research being proposed can be safely completed with the facilities and resources available. The protocols and procedures minimize the research hazards. Department Department Reviewer Name* First Last Department Reviewer EWU ID #* Department Reviewer NotesUse this space to add comments or questions you would like the IBC to consider or address during their review.Department Declarations*I am the chair of the department or their representative. I have read the research submission. I believe the department possesses the appropriate facilities to control the biohazardous material proposed. I believe the protocols and emergency procedures are appropriate for the hazards involved in the research I have read and agree with the declarations above HiddenCollege Review The dean of the college or an appointed designee is required to review some research proposals. Please read through the entire proposal and determine if: The research being proposed can be safely completed with the facilities and resources available. The protocols and procedures minimize the research hazards. HiddenCollege Reviewer's Email HiddenCollege Reviewer Name* First Last HiddenCollege Reviewer EWU ID #* HiddenCollege Reviewer NotesUse this space to add comments or questions you would like the IBC to consider or address during their review.HiddenCollege Declarations*I am the Dean of the college or their representative. I have read the research submission. I believe the department possesses the appropriate facilities to control the biohazardous material proposed. I believe the protocols and emergency procedures are appropriate for the hazards involved in the research I have read and agree with the declarations above Δ
