ࡱ> c HbjbjԚ 2^Z\Z\@> JJJJJ^^^8T^6 :> > > %%%O6Q6Q6Q6Q6Q6Q6$8;u6J%!$%%%u6JJ> > 6s's's'%J> J> O6s'%O6s's'4|5> ,æ &6K5;6606]5f<9':f<$5f<J5<s'%%%u6u6s'%%%6%%%%f<%%%%%%%%% > : 51 Institutional Biosafety Committee Biosafety Registration Form Principal Investigator: Dept: Phone: Alternate Contact: Phone: Please review the entire form prior to completion and provide information as requested and relevant to the biologicals in use and currently possessed by your laboratory. Registration of all your non-exempt (see NIH Guidelines) recombinant DNA constructs and your biohazardous materials with the IBC is required by the NIH. Be sure to save a copy on your computer for future modifications. Useful references are the NIH Guidelines http://osp.od.nih.gov/sites/default/files/resources/NIH_Guidelines.pdf, and the 5th edition of CDC/NIH Biosafety in Microbiological and Biomedical Laboratories  HYPERLINK "http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm" http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm, Questions can be referred to Harold Hoops (Hoops@geneseo.edu) or Kevin Militello (Miltello@geneseo.edu) Sign and submit this document with any supporting attachments to the IBC in the Dept of Biological Sciences and as a PDF or Word e-mail attachment (Hoops@geneseo.edu).  Section Zero 1. Activities listed below are considerations listed under the Fink report. Would this experiment demonstrate how to render a vaccine ineffective? This would apply to both human and animal vaccines. Creation of a vaccine-resistant smallpox virus would fall into this class of experiments. YESNO Would this experiment confer resistance to therapeutically useful antibiotics or antiviral agents? This would apply to therapeutic agents that are used to control disease agents in humans, animals, or crops. Introduction of ciprofloxacin resistance in Bacillus anthracis would fall in this class. YESNO Would this experiment enhance the virulence of a pathogen or render a nonpathogen virulent? This would apply to plant, animal, and human pathogens. Introduction of cereolysin toxin gene into Bacillus anthracis would fall into this class. YESNO Would this experiment increase transmissibility of a pathogen? This would include enhancing transmission within or between species. Altering vector competence to enhance disease transmission would also fall into this class. YESNO Would this experiment alter the host range of a pathogen? This would include making nonzoonotics into zoonotic agents. Altering the tropism of viruses would fit into this class. YESNO Would this experiment enable the evasion of diagnostic/detection modalities? This could include microencapsulation to avoid antibody-based detection and/or the alteration of gene sequences to avoid detection by established molecular methods. YESNO Would this experiment enable the weaponization of a biological agent or toxin? This would include the environmental stabilization of pathogens. Synthesis of smallpox virus would fall into this class of experiments. YESNO 2. Other activities of concern Will you use a recombinant mammalian virus as a vector? (Note: this does not include use of cells that have been transformed with rDNA derived from less than 1/2 of a viral genome). YESNO Will you deliberately form rDNAs containing genes for biosynthesis of toxic molecules? (Sec III-B-1of NIH Guidelines.) YESNO Will you deliberately transfer drug resistance to microorganisms that could compromise the use of the drug to control disease agents in humans, animals, or plants (Sec III-A-1-a)? YESNO Will you use an organism from Risk Group 3 or 4 as a host? YESNO Will you deliberately attempt to obtain expression of a cloned (inserted) gene from a restricted or regulated organism? (e.g. USDA restricted pathogen, Select Agent). YESNO Will you use greater than 1/2 of a Risk Group 2, 3, or 4 virus as an INSERT? YESNO Will you use deliberately release into the environment any organism containing rDNA? YESNO Will your deliberately introduce rDNA or synthetic nucleic acids to humans? YESNO Do you anticipate adding projects that involve biological toxins? YESNO If you have checked yes in any of the boxes in section zero, STOP. Please contact the chair of the Institutional Biosafety Committee. SUNY-Geneseo does not presently have the expertise and infrastructure to support these activities and carrying out these activities without such support is prohibited. 3) Does your proposal require simultaneous submission or prior approval? In certain cases, NIH allows for the submission of the registration form or update simultaneously with the initiation of experiments (see section III-E of the NIH guidelines). These must use only Risk group 1 or exempt organisms as the sources of DNA and as the vector. They also must be able to be conducted at BSL-1 level containment. If the conditions of section III-E are not met, the investigator must wait until the IBC has approved the registration form or update before starting the experiments. Please check the appropriate box. If there are any questions please select the prior approval box or check with the chair of the IBC. Simultaneous submission Prior approval If you selected Prior approval, you MUST wait for the IBC approval before initiating any part of your project that requires IBC approval. The IBC meets semiannually and expedited review is specifically prohibited. Therefore it is essential that any research group planning such experiments to submit these Biosafety forms well before planning to start these experiments. Section I: Recombinant DNA (rDNA) 1. NIH requires that all research labs that carry out research involving possession and/or use recombinant DNA that will be replicated in organisms (including bacteria) and are not specifically exempt register their research plans with our IBC. NIH also requires the IBC to specify how the exemptions are determined. Thus, it is SUNY-Geneseo policy that all labs that carry out research involving possession and/or use recombinant DNA fill out the following registration form and be approved by the Geneseo Biological Safety Committee (IBC). Do you intend to express any known oncogenes in a eukaryotic expression vector? YESNOIf yes: explain, describing the oncogene. Do you intend to administer rDNA or synthetic nucleic acids to plants or animals (including transgenics)? YESNO If yes: What is the species? Will experiments ever involve more than 10 liters of culture at a time? YESNO 2. Origin and nature of rDNA or synthetic nucleic acids inserts (check all that apply, complete blanks next to checked boxes): Genomic Identity of sequences(s): Sequence derived from which species? cDNAIdentity of sequences(s): Sequence derived from which species? AntisenseIdentity of sequences(s): Sequence derived from which species? Other(e.g. synthetic): Derivation? 3. Gene transfer vectors (check all that apply, complete blanks next to checked boxes):  Plasmids, cosmids, BACs, YACs, etc. Name or Derivation of (i.e. pBR322, pCINeo): a. Commercial source? YESNO If yes, specify vendor: b. Antibiotic resistance in bacteria: AmpicillinKanamycinOther: c. Stable selection in eukaryotic cells? YESNO If yes, applicable selection method(s): Limiting DilutionAntibiotic selection:NeomycinHygromycinPuromycinBleomycinOther:Other selection method: d. Is the plasmid replication competent in eukaryotic cells? (e.g., yeast or SV40 minichromosomes, EBNA/oriP plasmid episomes) YESNO  Bacteriophage Name or Derivation of: a. Commercial source? YESNOIf yes, specify vendor: b. In vitro packaging system: Phage library: cDNAGenomicOther: Species? Phage display? YESNO If yes, proteins/peptides to be displayed: Baculovirus Name or Derivation of: a. Commercial source? YESNOIf yes, specify vendor: b. Packaging system: c. List host cells: Sf9Sf21Other: Species? 3. Is the rDNA to be used for transgene expression in cells? YESNO Check all that apply, complete blanks next to checked boxes: If yes: Bacterial expressionSpecies/Strain:Yeast expressionSpecies/Strain:Insect cell expressionSpecies/Strain:Non-mammalian vertebrate species cell expressionSpecies/Strain:Mammalian cell expressionCell or tissue type (check all that apply)HumanNon-human primateOther species; specify:Primary cellsEstablished cell lineTransformed cell lineCell name:Source or vendor & vendor item number:Other cells: Section II: Pathogens 1. Do you possess, use or plan on using pathogens affecting human, animal, or plants? YESNO If NO, proceed to Section III. If YES, complete Section II. a. Pathogen(s) (genus, species, and strain): b. Agent is pathogenic for: (check all that apply) HumanAnimalPlant c. Maximum quantity cultured at any one time: < 1 liter1-10 liters Section III: Mammalian Cells, Cell lines, and Unfixed Tissues 1. Do you possess, use or plan on using mammalian cells, mammalian cell lines, or mammalian unfixed tissues? YESNO If NO, proceed to Section IV. If YES, complete Section III. 2. Complete the table below: (NOTE: Alternatively, you may provide the requested information in a non-tabular form as an attachment to this document.) Cell(s)Cell Line(s)Unfixed tissuesName:Species of origin:Primary human or primary non-human primate materials?Source or Vendor (& vendor number)Harbor any pathogens? (Answer YES/NO/UNKNOWN) If YES, specify pathogens harbored:BSL Level 3. Maximum quantity cultured at any one time: < 1 liter1-10 liters> 10 liters  Section IV: Employee Medical Surveillance (Check all that apply) Hepatitis B Vaccine Series: This vaccine series must be offered to all lab workers who have contact with human blood, body fluids, and tissues; primary human cells; and human cell lines (including established lines), unless all cells are certified free of Hepatitis B virus by the vendor. Contact Student Health Services for more information.All individuals must receive information about factors that might put them at increased risk of susceptibility to agent(s) (e.g. pre-existing disease, medication, compromised immunity, pregnancy or breastfeeding) and have been counseled by the head of the laboratory. Further, any worker may obtain confidential counseling by Student Health Services. *This is a requirement for all laboratories working at BSL2.Not Applicable. Please note that if you check this box and are using human cell lines, you will be asked to provide certification that the lines have been found to be free of human pathogens. Section V: Additional Questions (Answer each question) 1. Will a Class II biosafety cabinet be used? YESNONAIf yes, provide last certification date and certifier: 2. Will your experiments involve centrifugation? YESNO If yes, is either of the items below available for use? Sealed rotors *YESNOSealed Centrifuge Safety caps YES NO (* Sealed rotors means the rotor can be removed from the spindle without taking off the lid, to be opened in a biosafety cabinet for aerosol containment in the event of a tube failure or spill.) These are available for many newer centrifuges but may not be available for older ultracentrifuges.) 3. Will your experiments involve blending, grinding, sonicating, shaking, opening containers whose internal pressures may be different from ambient pressure? YESNO If yes, how are resulting aerosols controlled? Please describe briefly: 4. Has the use of sharps (e.g. needles, scalpels, and glass) for this project been evaluated and minimized wherever possible? YESNO 5. Are safety sharps (e.g. retractable scalpels, safety needles, plastic pipettes) in use for all work with human materials and human pathogens? YESNONAIf no: explain why not? 6. Will personal protective equipment be used? YESNOIf yes, list:  Section VI: Waste Handling and Disinfection (Check all that apply) Laboratory waste generated as a result of these experiments must be segregated and treated separately from regular garbage. Sharps (e.g. needles, blades, contaminated glass, etc.) are disposed of in a sharps container.Solid laboratory waste, EXCLUDING sharps, is disposed of in a red bag. Required for biosafety level 2 and higher.Liquid waste contaminated with biologicals only (NO hazardous chemicals or radiologicals) is decontaminated and disposed of down the drain after an appropriate contact time. If you checked this box, what is your disinfectant, its final concentration, and contact time? Alternatively, liquid waste contaminated with BSL-1 or exempt biologicals only (NO hazardous chemicals or radiologicals) can be autoclaved and disposed in regular trash. Other. Please describe:  Surface decontamination of equipment and work surfaces is required periodically and following spills. 1. What disinfectant and its working concentration do you use for surface disinfection?  Section VII: Petition for Modification of Biosafety Levels In certain cases, the NIH guidelines allow the IBC to permit work ordinarily done at BSL-2 to be done in BSL-1 instead. For example, inserting DNA from a risk group 2 organism into non-pathogenic prokaryotic or lower eukaryotic host if the DNA/protein is presumed non-hazardous (See section III-D-2-a of the NIH guidelines.) Do you wish the IBC to consider such a request for your experiments? YESNO If you chose yes, please include your justification here. Section VIII: Research Location and Biosafety Levels Correlate the information declared in each section with the agent, a location, and your assessment of the necessary biological containment. An example is provided in shaded area. Use additional Sheets if necessary Biological Used or Stored (e.g. rDNA, pathogen, human tissue, virus vector, etc.)Building, Room Number, Lab Type (e.g. main lab, tissue culture, freezer storage, etc.)General Tasks Performed with Agent in Room (e.g. tissue culture, centrifugation, sonication, animal administration, animal necropsy, vector construction, etc.)Biosafety LevelExample: Human cell linesISC, 305F, tissue culturecentrifugation2  Section IX: Personnel and Lab Description List of all laboratory personnel, including PI. Please use full name. Please provide a summary outlining experiments done with each agent declared above. Include the aims of these experiments. You may paste it into this space or provide as a separate document. A grant abstract or list of specific aims can be very helpful here, but please consider that reviewers need to understand how you plan to use rDNA materials, infectious pathogens and viral vectors. Thus, you may need to provide some extra details. Section X: Principal Investigator Affirmation By signing below, I certify that I have read the following statements and agree that all the listed participants and I will abide by them. All research involving rDNA performed in my laboratory will comply with the NIH Guidelines for Research Involving Recombinant DNA. All research involving non-recombinant infectious agents performed in my laboratory will comply with the 5th edition CDC/NIH Biosafety in Microbiological and Biomedical Laboratories. All research performed in my laboratory involving materials that may contain pathogens such as human cells will comply with the OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030). All personnel have completed the Colleges Laboratory Safety Training Program. Required annually. All personnel have received training regarding your laboratory and agent specific guidelines prior to working at the bench. Annual refresher biosafety training that is research specific is required at least annually for lab personnel working at BSL-2 & higher. This training is documented including date of training, summary of training, signature of trainee, initials or signature of trainer. All significant laboratory-related accidents and illnesses will be reported to the IBC immediately. 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