Touro University of California Mare Island, Vallejo

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1 Touro University of California Mare Island, Vallejo Institutional Biosafety Committee INITIAL REVIEW FORM Date Received: For IBC use only: Exempt Approved Approved with contingency(ies) Revisions required Tabled Rejected Who should complete and submit this form? All Principal Investigators (PIs) who propose to use real or potential chemical or biological hazards in their research. Potential biological hazards include toxins, cells or cell lines, human or veterinary pathogens (viruses, bacteria, parasites or fungi), packaged expression vectors capable of infecting cells, animals or animal tissues harboring potentially infectious agents or recombinant DNA, and human specimens (blood, urine, and other bodily fluids or tissues). Submit one (1) original hardcopy with all the signatures and one (1) electronic copy in PDF-format to the Chair of the Institutional Biosafety Committee (IBC) at least fourteen (14) days prior to the next IBC meeting (IBC meetings are usually held on the third Tuesday of every month). Note: Forms must be completed electronically. Incomplete forms or forms that are not properly signed will be returned. Prior to approval of the Biosafety Protocol, the IBC Chair will ensure compliance with other institutional committees (IRB & IACUC) in effect at Touro University of California (TUC). In order to get further guidelines, please feel free to call or the IBC Chair BEFORE preparing your Biosafety Protocol. The deadline for this review is (date): Title of Project: Principal Investigator: Degree: Protocol Number: Office Telephone: Period of IBC Protocol Approval: Emergency Telephone: Lab Room Number(s): Biosafety Level: Lab Contact Person: If you are not the investigator to whom the above laboratory space has been assigned to, please submit a letter of collaboration or cooperation from the assigned principal investigator. Table of Content: I. ABSTRACT II. TYPES OF AGENTS AND HAZARDS POSED BY THEIR USE III. AGENT USE AND STORAGE IV. TRAINING/EXPERIENCE IN AGENT USE (of PI) V. TUC POLICY COMPLIANCE VI. LABORATORY PERSONNEL VII. SIGNATURES (PI & Department/Division Chair/Director) Page 1

2 I. ABSTRACT OF RESEARCH Include a general description of the experimental methods and overall research goals (750 words or less). This section provides an overview of the detailed information documented in this application. Please include: i) general description of experiments, ii) description of activities which might pose biohazards (chemical or biological) and iii) possible effects of biohazards on exposed humans. Chemical agents should be described only if they pose an unusual hazard (not normally found in academic laboratories) or if they are used in unusually large quantities, (for questions, please call the IBC Chair), or in methods that pose exceptional hazards, (e.g., aerosol formation outside the hood or used for injection). II. TYPES OF AGENTS AND HAZARDS POSED BY THEIR USE II-1. Is your research exempt of TUC Biosafety review procedures? (Double-click on boxes below to check or uncheck) (if answer is No, then proceed to Section II-2) II-1A. Explain in the space below why your research is exempt of TUC Biosafety review procedures, e.g., research does not involve any biohazards (chemical or biological); research is performed partly or fully at another site (list the contact person and address at the other site) II-1B. Will biohazards (chemical or biological) be used at the other site? What is the status of the research protocol at the other site? Approved Protocol Number(s): Submitted Not Submitted II-2. Does this research involve Recombinant DNA? (if answer is No, then proceed to Section II-3) II-2A. If your research involves recombinant DNA, mark the statement below that applies to this work, according to the latest NIH Guidelines for Research involving Recombinant DNA Molecules ( and U.S. Department of Health & Human Services guidelines on Biosafety in Microbiological and Biomedical Laboratories (BMBL) ( The proposed experiments require specific RAC (Recombinant Advisory Committee) review and NIH or IBC approval before initiation of the experiments. The proposed experiments require IBC approval before initiation of the experiment. The proposed experiments require IBC notification at the initiation of the experiment. The proposed experiments are exempt from the procedures detailed in the Federal Register. Please cite the page number for this reference. Page 2

3 II-2B. To avoid consequences of unintended expression in humans, provide a table listing all vector and host systems that will be employed in the proposed studies, listed in categories according to intent. This should include any recombinant nucleic acid elements such as bacterial plasmids, eukaryotic expression vectors or virus vectors and prokaryotic or eukaryotic cells used for propagation or expression. List all types of recombinant protein coding or regulatory DNA sequences to be expressed. Indicate whether or not vectors are self-replicating or selftransmissible. Describe any helper systems used to produce infectious forms of the vectors. Vector name System Host for propagation Host for assays Potential hazard (risk group 1, 2) Additional explanations: II-2C. Describe the potential consequences of human exposure to recombinant DNA elements, including expressed sequences (unintended expression in humans). Please, cite references to support these statements if possible. II-2D. What is the level of containment recommended/required for the recombinant DNA materials? Please, cite a reference including page number (e.g., NIH Guidelines for Research involving Recombinant DNA Molecules at and U.S. Department of Health and Human Services guidelines for Biosafety in Microbiological and Biomedical Laboratories at II-3. Does this research involve Biological Agents (e.g., toxins, cells or cell lines, human or veterinary pathogens (viruses, bacteria, parasites or fungi), packaged expression vectors capable of infecting cells, animals or animal tissues harboring potentially infectious agents or recombinant DNA, or human specimens (blood, urine, and other bodily fluids or tissues)? (If the answer is No, proceed to Section II-4) II-3A. Provide a table listing potentially hazardous biological agents, e.g., toxins, cells or cell lines, human or veterinary pathogens (viruses, bacteria, parasites or fungi), packaged expression vectors capable of infecting cells, animals or animal tissues harboring potentially infectious agents or recombinant DNA, and human specimens (blood, urine, and other bodily fluids or tissues) (expand table below if necessary): Cells & Cell Lines, Pathogens, Infectious Agents & Toxins Risk Group (1, 2) _ Page 3

4 II-3B. Describe the potential consequences of human exposure to these biological agents (include vectors expressing heterologous genetic elements). Cite references to support these statements if possible. II-3C. What is the level of containment recommended/required for the biological materials? Please cite a reference including page number (e.g., U.S. Department of Health and Human Services guidelines for Biosafety in Microbiological and Biomedical Laboratories at II-4. Does this research involve Chemical Agents that pose extraordinary risk to humans? Only fill out this section if chemicals used are unusually hazardous, used in unusually large quantities or used with techniques that pose exceptional hazards. If you are not sure whether this applies, contact the IBC Chair. II-4A. Provide a table listing unusually hazardous chemical agents and describe consequences of human exposure to these chemicals via techniques used in the laboratory. Cite references to support these statements if possible. Unusually Hazardous, Chemical Agents or Carcinogens Risk Group (1, 2) _ II-5. Does the research involve Human Clinical Samples? Check appropriate sample type(s): Blood Tissue Serum II-5A. If the sample will be processed in a manner that is expected to inactivate any or all infectious agents, describe this process and proceed to Section III. II-5B. By initialing below, you certify that you have received the appropriate Blood-Borne Pathogen Exposure Control Plan (if you have not yet received the manual, pick up a copy with the TUC- Biological Safety Officer, x ). initial here Reminder: All samples are to be treated with Standard Universal Procedures II-5C. If IRB approval is necessary for the research, supply the IRB number: III. AGENT USE AND STORAGE Page 4

5 Briefly describe the following aspects as they relate to individual biological or chemical agents. Please include TUC room numbers for storage and experimental procedures. III-1. Methods of physical containment and security, for example, how will access to BL2 agents or select agents be limited? III-2. Physical handling of the agent III-2A. Safety procedures for individuals working with the agent(s). Descriptions should be specific to agents and procedures used in your laboratory. Please cite references for these procedures if possible. III-2B. Procedures associated with use of agents in animals, if applicable. III-2C. Disposal and decontamination procedures for contaminated material and laboratory equipment. a. How will contaminated equipment or surfaces be treated? State the disinfectants to be used. b. How will disposable items be treated and stored prior to disposal? c. How will non-disposable items be treated and stored before re-use? d. If research involves animals, how will animals or tissue be disposed following each experiment? IV. TRAINING/EXPERIENCE IN AGENT USE Describe any prior training and experience you (the PI) have had in handling agent(s) listed in Section II or any similar materials. Include references to any manuscripts you have published employing these agents. V. TUC POLICY COMPLIANCE V-1. V-2. V-3. All laboratory personnel who might have direct contact with human clinical samples MUST complete online training sessions at This protocol cannot be approved unless training has occurred. All laboratory personnel MUST complete online training sessions at Contact the BSO for compliance guidelines. What is the status of your online training? Completed Scheduled Not Completed nor scheduled If this research project is designated Biosafety Level BSL-2 or BSL-3, provide the most recent inspection date of the required Biosafety cabinet: _ Page 5

6 V-4. V-5. Will animals be used for this research? What is the Status of the IACUC Protocol? Approved Protocol Number(s): Submitted Not Submitted Will radioisotopes be used in this research? What is the status of the Radiation Safety Protocol? Approved Protocol Number(s): Submitted Not Submitted VI. LABORATORY PERSONNEL For all persons (including intramural collaborators) who are currently or will be working with potentially hazardous agents, provide name, position, signature and date. Persons should sign this form only after reading it and becoming familiar with its contents. Signatures will document that these individuals have been informed of the identity and nature of biological hazards present in the laboratory and have been trained in proper safety procedures for their use. (Expand section if necessary) (The PI of the project signs under Section VII) Name Position Signature & Date VII. SIGNATURES By signing below, I certify that I have read the following statements and agree that I and all listed participants will abide by those statements and all TUC policies and procedures governing the use of recombinant DNA materials and technologies, infectious agents, toxins and other biological materials as outlined in this application and in the TUC Laboratory Safety Manual (copy with BSO). I will: Ensure that listed personnel have received or will receive appropriate training in safe practices and the procedures for the protocols performed in my laboratory before they begin any work. In addition, all listed personnel who have occupational exposure to blood-borne pathogens will attend annual blood-borne pathogen training sessions. Follow the health surveillance practices as approved for this laboratory and inform those working in the laboratory about how to obtain emergency assistance in their work locations. Page 6

7 Inform the IBC Chair of any significant research-related incident, accident, or illness as soon as possible after its occurrence or discovery. Submit in writing a request for approval from IBC of any significant modifications to the procedures, equipment, or materials used in my laboratory. The most recently revised protocol and MSDSs, must be available in the Principal Investigator's laboratory. Signature of Principal Investigator Date Signature of Department Chair Date Page 7