ࡱ>  p bjbjVV 8(<<6p SSSggg8Kg>7(_uuu o=q=q=q=q=q=q=$@C=9S=uu[="""x8uSuo="o=""9;i;ugz X9[==0>9*D *D4i;i;&*DS;"==!>*D :  BIOLOGICAL AGENTS REGISTRATION PRINCIPAL INVESTIGATOR NAME:ALTERNATE CONTACT NAME: CAMPUSDEPARTMENT:OFFICE ADDRESS: (INCLUDE ROOM No.)MAILING ADDRESS (IF DIFFERENT)TELEPHONE No.FAX No.E-MAIL ADDRESSDocket No (IBC-Assigned) PROJECT TITLE:BSL (IBC assigned)( ) New Registration( ) Amendment( ) 3 Year Renewal Statement of Principal Investigator I attest that the information provided is accurate and complete to the best of my knowledge. I am familiar with and I agree to abide by the requirements of the current NIH Recombinant DNA Guidelines, and NIH, CDC, USDA or APHIS Biocontainment or Biosecurity Guidelines and other Federal, State and Local regulations pertaining to the proposed research. I am familiar with and I agree to comply with the requirements pertaining to shipment and transfer of biohazardous materials and / or recombinant DNA (rDNA). I also agree to treat and render non-infectious, all potentially-infectious materials using an IBC-approved method prior to disposal. Written reports will be submitted to the Institutional Biosafety Committee concerning: Any accident or illness as the result of inoculation, ingestion, and inhalation of biohazardous materials or recombinant DNA; any incident causing serious exposure of personnel or danger of environmental contamination. Any problems pertaining to operation and implementation of biological and physical containment safety procedures or equipment or facility failure. An amendment or a new registration will be submitted to the IBC if there are changes that alter the Biosafety levels or introduce new rDNA or biohazardous materials for any proposed research. Signatures: Principal Investigator ____________________________________Date______________ Additional Investigator ___________________________________Date______________ Reviewed and Approved ___________________________________Date______________ IBC Chair( ) Exempt : The work described in this application is exempt from NIH recombinant DNA guideline IBC Director /Biosafety Officer Date Top of Form Section A: Project summaryA1. List other institutional reviews / approvals required for this project: Animal subjects: IACUC Docket No _______ Human subjects: IRB Docket No _______A2. Declare the highest Biosafety level required for the project: (check appropriate response) ( ) BSL-1 ( ) BSL-2 ( ) BSL-3 A3. Goals/objectives of the project (not exceeding four or five sentences): A4. Briefly describe potential risks to researchers, environment, or public:A5. Briefly describe experimental approach and pertinent materials/methods: A6. Are you using Animals (check YES only if animals are directly exposed to any of the biohazard agents)? ( ) YES ( ) NO If YES, fill out Addendum for Animal Experimentation (form attached to the end of this registration) Section B: Recombinant DNA B1. Recent concerns about bioterrorism and potential dual use technologies have prompted a proposal to have the IBC perform more rigorous reviews of classes of experiments involving microbial agents that raise concern about their potential for misuse. Does your research involve any experiments that would: Demonstrate how to render a vaccine ineffective. ( ) Yes ( ) No Render a pathogen (e" risk group 2) resistant to antibiotics or antivirals ( ) Yes ( ) No Enhance a pathogen's virulence or render a non-pathogen virulent ( ) Yes ( ) No Increase a replication competent pathogen's transmissibility ( ) Yes ( ) No Alter a replication competent pathogen's host range ( ) Yes ( ) No Enable a pathogen to evade diagnostic tests ( ) Yes ( ) No Enable weaponization of pathogens and toxins ( ) Yes ( ) No B2. Declare the highest level of oversight required under the NIH Recombinant DNA Guidelines for this project (i.e. what section of the Guidelines applies to the rDNA of greatest biosafety concern): ( ) III-A ( ) III-B ( ) III-C ( ) III-D ( ) III-E ( ) III-F *Reference links: HYPERLINK "http://inside.umassmed.edu/subjects/Biosafety/IBCResources.aspx?linkidentifier=id&itemid=13644"http://inside.umassmed.edu/subjects/Biosafety/IBCResources.aspx?linkidentifier=id&itemid=13644 (HYPERLINK "http://inside.umassmed.edu/uploadedFiles/SummaryTable(UMMS%20-%204-2002).XLS"Summary of NIH Recombinant DNA Guidelines) http://oba.od.nih.gov/oba/ibc/FAQs/FAQs_about_Experiments_that_are_Exempt_from_the_NIH_Guidelines.pdfB2. Describe inserted / altered genetic element(s): Name: Origin: Biological function: The inserted genetic material is: (check all appropriate responses) ( ) Oncogene ( ) Immunomodulator ( ) Toxin B3. Types of vector(s) that will be used: (check all appropriate responses) ( ) Bacterial ( ) Retroviral ( ) Lentiviral ( ) Adenoviral ( ) Adeno-associated viral ( ) Poxviral ( ) Herpesviral (Amplicon) ( ) Herpesviral ( ) Other virus (specify) B4. List and briefly describe each vector below Attach an IBC vector checklist to this application if you are using viral vectors; checklist IBC website: B5. Biosafety level of each construct: Section C: Non-Vector-Derived Nucleic Acids (that regulate gene expression, excluding primers)C1. Describe the agent: Provide the following information (1) Agent type (e.g. shRNA, synthetic DNA, etc.) (2) Name of the agent, if applicable (3) Source (4) Expected biological function of the agent (e.g. gene silencing) C2. Genes regulated by the agent (specify if antioncogenes/tumor suppressors and immune function genes are suppressed) C3. Biosafety level of the agent: Section D: Material of human and non-human primates origin Does your research involve the use of any of the following material(s) from human and/or non-human primates origin, living or dead: (check all appropriate responses) ( ) Unfixed cells ( ) Organs ( ) Tissues ( ) Blood ( ) Blood products ( ) Other body fluids ( ) Cell lines [please list the lines that you are using] Biosafety level when working with materials of human origin: BSL-2. The investigator should use universal precautions described in the OSHA-bloodborne pathogens Standard, when handling any material of human origin. Research involving unfixed tissues, cells and body fluids of human and/or non-human primate origin needs to be registered with the IBC, and can generally receive expedited IBC approval, unless infectious agents, recombinant DNA, Biotoxins, or live animals are also involved.Section E: Infectious Agents (excluding Select Agents)E1. Name of agent(s) (including transforming agents shed by cell lines [e.g. HTLV-1, EBV]): E2. Source of agent(s): Section F: Biotoxins* *Poisonous substances that are specific products of the metabolic activities of living organisms (plant, animal, fungus, bacteria). Contact EH&S at x8176 with questions about safe storage, handling or disposal. F1. Name of the toxin(s): F2. Source of the toxin F3. LD50 for the toxin(s) if available F4. Biosafety level of the toxin(s): Section G: Select Agents (CDC/USDA list)G1. Name of the agent (s): G2. Source of the agent(s) G3. Biosafety level of the agent(s): G4. List all permit numbers: G5. Storage and security: G6. Plans for notification in case of accidental exposure: Section H: Management of BiohazardsH1. Describe the maximum anticipated titer/concentration of the agent preparations (e.g. virus): H2. Describe the maximum anticipated volume of the preparations (e.g. bacteria): H3. Describe the biohazard potential for the agent(s) (what would happen to a human with significant exposure to the agent?): H4. Describe how accidental exposure might occur (e.g. needlestick, splash, aerosol, eye exposure): H5. Describe plans for notifying and training personnel with potential for exposure to the agent(s): H6. Describe availability of vaccination and plans for administration: Section I: Plans for accidental exposuresI1. In the event of an accidental exposure to agents used in this project, or onset of an illness that is unexplained and potentially related to lab activities, should the UMD and / or SouthCoast Medical have Standard Operating Protocols (SOP) that will facilitate care delivery and/or prevent spread? ( ) YES ( ) NO ( ) UNSURE I2. If answered YES above (I1), list all agents that should have an SOP filed with UMD and / or SouthCoast Medical and attach copies to the registration form:I3. Should lab personnel have MSDS sheets on file that identify the biological agents to which they may be exposed? ( ) YES ( ) NO ( ) UNSURE I4. If answered YES above (I3), list all agents that should have MSDS on file:Section J: Biocontainment, and Biosafety PrecautionsJ1. Work location (building and room numbers): J2. Describe Biosafety equipment (e.g. Biosafety cabinets, sealed centrifuge containers): J3. Describe personal protective equipment (e.g. gloves, masks, gowns): J4. Describe procedures for storage, transport and disposal: J5: Indicate Engineering controls: ( ) BioSafety Cabinet; ( ) Fume Hood; ( ) Other: J6. Indicate PPE: ( ) Gloves; ( ) disposable lab gowns; ( ) lab coats; ( ) tyvek suits; ( ) surgical mask; ( ) safety glasses; ( ) face shield; ( ) disposable booties; ( ) N-95 respirator; ( ) PAPRs; ( ) other:Section K: List all personnel associated with the project (including PI and Co-PI)K1. Name of the personnelK2. Role in the project (please clarify what you do in the project, not your title)K3. Training/experience, and any other relevant information (e.g. vaccination against a particular agent; N95 fit test, etc.)Bottom of Form IBC Docket # (office use only): ___________________________________ Top of Form Addendum for Animal Experimentation: (use one Addendum-form for each biohazardous agent unless safety requirements are exactly the same)Name of Principal Investigator: Primary Contact Information: Name: Tele: Pager: IACUC Docket #: Animal SPECIES (use one form for each species, unless safety requirements are exactly the same): Name of the AGENT(s) (use one form for each agent, unless safety requirements are exactly the same) Animal Biosafety level of the agent(s): (check appropriate response) ( ) ABSL-1 ( ) ABSL-1+BBP* ( ) ABSL-2** ( ) ABSL-3** *Reference: Use of Human and Non-Human Primate Cells and other Material in Animals **NB: ABSL-2 and 3 laboratory space is restricted to the A-level Animal Medicine Facility at UMMSWith respect to animal experimentation, locations where the agent(s) will be encountered:In the animal facility: Building; Room number(s) In the laboratory: Building; Room number(s) Other area: Building; Room number(s) a. Describe routes the agent(s) will be administered to animals: (check appropriate responses) ( ) Intraperitoneal ( ) Intramuscular ( ) Intravenous ( ) Subcutaneous ( ) Intracerebral ( ) Per Os ( ) Intranasal ( ) Inhalation ( ) Gastric lavage ( ) other (list)  b. Does the agent occur naturally in the species used for the studies? ( ) YES ( ) NO Describe the expected time course of the experiments in animals: number of experiments duration of experiments duration of potential exposure to the agent Define the personnel with the potential for exposure to the agent(s) (check appropriate responses) ( ) investigators ( ) lab personnel ( ) animal medicine personnel ( ) other (list): Describe the personal protective equipment (PPE) that will be required for personnel working with animals that are exposed to the agent: (check appropriate responses) ( ) gloves ( ) jumpsuits ( ) masks ( ) eye protection ( ) other (list) Describe method of disposal and decontamination of PPE: (check appropriate response) ( ) standard for designated ABSL ( ) other (describe) Describe how accidental exposure might occur: (check appropriate responses) ( ) needle stick ( ) inhalation ( ) animal bite ( ) other (describe) If personnel handling animals are at risk for exposures to the agent(s), do they need to have an MSDS sheet on file: (check appropriate response) ( ) YES ( ) NO ( ) UNSURE If animal handlers or other animal medicine personnel are at risk for exposures to the agent(s), describe how they will be informed of the risk, and trained in the agent-specific SOP. Provide the best estimate of the length of time after animal inoculation that the animal may shed the inoculated agent in a form that is potentially hazardous to humans. Indicate the route of shedding (e.g. urine, feces, saliva, from skin). Please provide any available scientific data that supports your time estimate. 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