Texas Tech University Health Sciences Center Institutional Biosafety Committee (IBC) PROTOCOL APPLICATION All of the Following Questions Must Be Answered. 1. Protocol Number: 2. Principal Investigator: 3. Title: 4. Campus: 5. Department: 6. Office room number: 7. Phone (Office): 8. FAX: 9. E-mail: (Laboratory): I. INITIAL RISK ASSESSMENT: What categories of hazardous materials are to be used in your lab? (Type “X” in boxes that apply) Biological Materials (BSL2 or higher): Please specify vectors and generation, as appropriate Bacteria (including Rickettsiae), viruses, fungi, parasites, and prions that can cause disease in humans or cause significant environmental or agricultural impact ▪ Complete an Addendum A for each genus and species of bacteria; or for each genus of fungi, viruses (virus FAMILY may be sufficient for some) and parasites *Example pre-filled addendum available Viral vectors: replication competent replication incompetent Human and/or nonhuman primate blood and blood products* Human and/or nonhuman primate body fluids* Human and/or nonhuman primate tissues* All human and/or nonhuman primate cell lines and/or any other cell lines requiring BSL2* ▪Complete one Addendum A for the entire group *Pre-filled addendum available for these agents; list specific types of blood products, body fluids, tissues, or cell lines used in appendix in addendum Biological Toxins: ▪Complete an Addendum A for each toxin Highly Hazardous Chemicals & chemical toxicants: LD50 ≤ 50 mg/kg or, if LD50 not available, a GHS rating of 1 or 2 oral, 1 dermal, or 1 inhalation; or HMIS rating of 4 ▪Complete an Addendum B for each chemical and toxicant *Pre-filled addenda are available for silver nitrate, sodium azide, and sodium fluoride Proprietary compounds of unknown toxicity ▪Complete an Addendum B for the GROUP *Pre-filled addendum available for these agents Select Agents in exempt quantities ▪Complete an Addendum B for each agent. Page 1 of 3 http://www.ttuhsc.edu/admin/safety/ http://www.ttuhsc.edu/sponsoredprograms/ibc/ Rev. 4/30/14 IBC Initial Protocol Application NOTE: Work with any of the following requires separate approval from the appropriate review committee: Recombinant DNA molecules → Recombinant DNA Committee Forms may be found at http://www.ttuhsc.edu/sponsoredPrograms/rdbc/. Contact the Research Integrity Office at 743-2027 for more information. Radioactive materials or radiation producing devices → Radiation Safety Committee To apply for a sub-license or for more information, contact radiation safety at 743-2597. Human subjects* → Institutional Review Board (IRB) Information may be found at the following site: http://www.ttuhsc.edu/research/hrpo/irb/. Animals* → Animal Care and Use Committee (ACUC) Information may be obtained at: http://www.ttuhsc.edu/sponsoredPrograms/ACUC/ *These committees require IBC approval first if agents to be collected from or used with human subjects and/or animals II. DESCRIPTION OF RESEARCH AND AGENTS 1. List ALL of your laboratory room numbers; indicate shared spaces with an “s” after the room #: 2. List each co-investigator with their name, title and department: 3a. Please list ALL persons who work in your laboratory, with their name, position/title, and training dates (please copy lines for additional personnel): Name Position/title Training Date for LSE* *Laboratory Safety Essentials 3b. List any constraints on personnel (e.g., “only PI and John Doe may work with Shigella isolates): 4. List all hazardous chemical or biological materials being registered on this application: Biologicals: Chemicals: NOTE: Register ONLY: (If you are unsure of what to register, call Laboratory Safety: 806-743-2597) Biosafety level 2 or higher biological materials: Infectious organisms that can cause disease in humans or cause significant environmental or agricultural impact; and/or all human or non-human primate tissues, fluids, and cell lines; and any cell lines, human or animal, that express human genes or substances pathogenic to humans. Other cell lines are exempt from registration. Page 2 of 3 http://www.ttuhsc.edu/admin/safety/ http://www.ttuhsc.edu/sponsoredprograms/ibc/ Rev. 4/30/14 IBC Initial Protocol Application Chemicals or toxins with an animal LD50 ≤ 50 mg/kg or, if LD50 not available, a SDS rating of 1 or 2 oral, 1 dermal, or 1 inhalation; or a HMIS rating of 4 (SDS sheets can be found at: http://www.sigmaaldrich.com/safety-center.html) Proprietary compounds of unknown toxicity. If you do not possess any that meet those cut-off values, and if you have submitted a chemical inventory to safety services, then your chemical inventory will serve. 5. Give a brief general summary of your research sufficient to allow assessment of risks from agents being registered: 6a. Do you plan to ship any hazardous chemicals or biological materials to other users? Yes No If you answered “Yes” please contact Safety Services at 806-743-2597 for information on training requirements. Any person who is involved in any way with putting hazardous materials into commerce is considered a hazmat shipper according to 49CFR, and must be accordingly trained. If you are unsure of the requirements of this law, please contact Safety Services for more information. 6b. Name of trained shipper: 7. Do you have any reason to believe that any of the materials used in the laboratory will support the design, development, production, stockpiling or use of chemical or biological weapons? Yes No ▪ PLEASE BE SURE TO INCLUDE APPROPRIATE ADDENDA WITH YOUR SUBMISSION. Signature of PI Date Submit completed form and Addenda to IBC.submissions@ttuhsc.edu In the space provided, type your name and the date to certify the above information is accurate. Page 3 of 3 http://www.ttuhsc.edu/admin/safety/ http://www.ttuhsc.edu/sponsoredprograms/ibc/ Rev. 4/30/14