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Handbook for Principal InvestigatorsREGULATORY REVIEWExport Control Hazardous Materials Hazardous Chemicals General Biohazards Contacts: Risk Management and Safety Institutional Biosafety Committee Recombinant DNA/Microbial Pathogens/Human Tissues Prior to initiating newly funded or unfunded research involving recombinant DNA or microbial pathogens, principal investigators must complete a Memorandum of Understanding and Agreement (MUA) form and receive IBC approval. This form is available from the Institutional Biosafely Committee office, biosafety committee members, department offices, and the Office of the Vice President for Research. A completed MUA form must also be filed when resubmitting research related revisions to a granting agency and when submitting continuations involving changes or additions to the original research that affect biosafety procedures used in the research. When submitting continuations without changes in the research, the original MUA on file will be used as a basis for signing the Proposal Routing Sheet. An MUA form must be filed when submitting proposals for local funds, such as Hatch and VP for Research Small Grants. The IBC will review the proposed research as described in the MUA, and, if it is in compliance with federal, state, and local guidelines and regulations, the MUA will be signed and a copy returned to the principal investigator. Note: A copy of the signed MUA should be sent to the sponsor if required or requested. Each MUA form must contain the following information: 1) an assurance that the principal investigator is familiar with the current NIH Guidelines and with other federal guidelines (e.g., USDA, EPA, Centers for Disease Control Handbook) appropriate to the proposed research; 2) a short description of the experiments which involve recombinant DNA and/or microbial pathogens; 3) an indication of whether or not human tissue or fluids will be used and a description of the Biosafety Level 2 or higher practices that will be employed; 4) a description of the nature of the recombinant organisms and microbial pathogens used in the research to ensure that the IBC that the principal investigator is aware of the risks and the necessary safety precautions; 5) A description of cell lines used, including source and special safety practices necessary; 6) A description of the physical and biological containment practices required by current NIH Guidelines and/or CDC/NIH publication, "Biosafety in Microbiological and Biomedical Laboratories," to prevent accidental exposure or environmental releases; and, 7) the signature of the principal investigator. Principal investigators submitting proposals involving any recombinant DNA research and microbial pathogens must check "Yes" after the Recombinant DNA/Microbial Pathogens on the Proposal Routing Sheet whether or not the research falls within the NIH Guidelines. The Proposal Routing Sheet must be signed on the "Special Approvals" line by a member of the Institutional Biosafety Committee or its staff. No work with plant, animal, or human pathogens may be initiated without prior approval of the Institutional Biosafely Committee. As part of the 1996 Anti-terrorism and Effective Death Penalty Act (PL 104-132), the Centers for Disease Control and Prevention (CDC) and Department of Health and Human Services issued a final rule regarding the transfer of select biological agents that could be used in terrorist activities. Researchers who plan to ship or receive any of the listed agents must contact the IBC Office so that the University is properly registered prior to shipment or receipt of the listed agent(s). A current list of select agents is available on the IBC web site. The final rule carries with it one to five years in jail and/or $250,000 to $500,000 in fines for individuals or organizations who violate it. Contact: Institutional Biosafety Committee Animal Subjects Principal investigators proposing to conduct research involving the use of animal subjects must complete an Animal Protocol Review Form, available from the offices of University Animal Care. The Animal Protocol Review Form is to be submitted directly to the IACUC office (c/o IACUC Coordinator, Central Animal Facility, P.O. Box 210101). The IACUC will then evaluate the protocol to determine whether it conforms to all applicable laws, regulations, and policies. Approval by the IACUC must be obtained before an animal research project can be conducted at the University. Most granting agencies also require IACUC approval prior to their review, approval, and funding of a project. As completion of review by the IACUC generally takes four to six weeks, it behooves the investigator to complete and submit the Animal Protocol Review Form as early as possible. If the protocol is part of a proposal for external funding, the Animal Subjects item of the Proposal Routing Sheet must be checked "Yes." Signature approval by the IACUC is not required on the routing sheet. The Sponsored Projects Services office will inform the IACUC of all proposals involving animal subjects. The IACUC publishes its policies and procedures in handbook form, which can be obtained by contacting the IACUC coordinator at 621-9305. The University of Arizona Animal Care and Use Program User's Handbook can be obtained by contacting either the Arizona Health Sciences Center Animal Facility (room 1126 Basic Sciences, 626-6702) or the Central Animal Facility (Building 101, 621-1330). Contact: University Animal Care Human Subjects In compliance with federal regulations, the review shall ensure: (1) that the rights and welfare of the subjects involved are adequately protected; (2) that the risks to an individual (whether physical, psychological, or social) in any activity which goes beyond the application of accepted procedures are outweighed by potential benefits; and (3) subject selection is fair; and (4) that legal, informed consent of participants is obtained by methods that are appropriate and adequate. Approval of the IRB or HSPP must be obtained before the project is initiated. Forms and instructions for securing approval for research involving human subjects may be obtained from the Human Subjects Protection Program website (listed below). Information concerning the membership of the IRB may also be found at the website. Human Subjects Protection Program 1350 N. Vine Ave. Contact: David Johnson, M.D., Chair Radiation Safety Contact: Radiation Control Office http://www.radcon.arizona.edu/main.asp
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