Handbook for Principal Investigators

REGULATORY REVIEW

Export Control
Federal regulations and sanctions promulgated and enforced by various federal agencies including the Department of Commerce - Export Administration Regulations (EAR), the Department of State - International Traffic in Arms Regulations (ITAR) and the Department of Treasury - Office of Foreign Assets Control (OFAC) prohibit the unlicensed export of specific technologies and items and payments to certain entities and individuals for reasons of national security or protection of trade.

While most research conducted on U.S. college and university campuses is excluded from these regulations under the Fundamental Research Exclusion, university research involving specified technologies controlled under the EAR and/or ITAR, or transactions and exchanges with designated countries, individuals and entities may require the University to obtain prior approval in the form of a license from the appropriate agency before allowing foreign nationals to participate in controlled research, collaborate with a foreign company and/or share research - verbally or in writing - with persons who are not United States citizens or permanent residents. The consequences of violating these regulations can be quite severe, ranging from loss of research contracts to monetary and criminal penalties for the individual and/or organization violating these regulations.

Work on an export controlled project cannot begin until a Technology Control Plan (TCP) is in place. Expenditure of funds on the sponsored program account will be restricted until the TCP is finalized. Additional information concerning export controls can be found at: http://orcr.vpr.arizona.edu/export-control and/or by contacting the UA Export Control Officer at 520-626-5338.

Hazardous Materials
Hazardous materials are any chemical or biological agent that may cause a physical or health hazard to persons exposed to them. Use and disposal of hazardous materials are governed by many Federal, State and local agencies. Regulations promulgated by the Federal Environmental Protection Agency, the Occupational Health and Safety Administration, the Arizona Department of Environmental Quality, the Arizona Department of Health Services, and the Pima County Wastewater Department must be adhered to by all laboratory personnel.

Hazardous Chemicals
Hazardous chemicals are defined as any chemicals that exhibit a physical or health hazard. Examples of such chemicals are flammable liquids and solids, corrosives, oxidizers, and any chemicals that are considered toxic such as heavy metals. The University of Arizona Department of Risk Management and Safety has developed a Chemical Hygiene Plan (CHP) that all laboratories must follow. The CHP has incorporated all the above regulatory requirements regarding use and disposal of hazardous chemicals. All laboratory personnel (employees, students, and volunteers) who manipulate chemicals must attend an OSHA mandated Laboratory Safety Training offered by Risk Management and Safety. Previous training at other institutions does not preclude any laboratory personnel from this requirement.

General Biohazards
The term "biohazards" generally refers to carcinogens, mutagens, teratogens, all microbiological agents and radiological hazards. Examples of materials that fall into the biohazard classification are viral, bacterial, and fungal agents, and chemical toxins. Any work involving human blood, blood products, and body fluids must follow the procedures outlined in The University of Arizona’s Bloodborne Pathogen Exposure Control Plan. Principal investigators proposing to conduct research involving biological agents or certain toxins must complete a required Memorandum of Understanding and Agreement (MUA) with the Institutional Biosafety Committee (IBC). More information of the MUA is included in the following section regarding Recombinant DNA/Microbial Pathogens/Human Tissues. Sponsored Projects will notify Risk Management and the IBC when "Gen Biohazards/Hazardous Waste" is checked on the Proposal Routing Sheet. Any laboratory personnel who work with human blood, body fluids, or human bloodborne pathogens must attend an OSHA mandated Bloodborne Pathogen Exposure Control Training offered by Risk Management and Safety. Previous training at other institutions does not excuse any laboratory personnel from this requirement.

Contacts:

Risk Management and Safety
Campus Mail Box 210460
520-621-1790

The Office of Radiation, Chemical & Biological Safety
Campus Mail Box 245101
Phone: 520-626-6850, Fax 520-626-2583

Recombinant DNA/Microbial Pathogens/Human Tissues
The Institutional Biosafety Committee (IBC) established local policy for review of ALL projects involving the use of recombinant DNA and microbial pathogens to assure compliance with current guidelines from regulatory agencies. Principal investigators at The University of Arizona who conduct experiments involving recombinant DNA and microbial pathogens must inform the Institutional Biosafety Committee as stipulated below.

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:

The Office of Radiation, Chemical & Biological Safety
Campus Mail Box 245101
Phone: 520-626-6850, Fax 520-626-2583

Animal Subjects
The Institutional Animal Care and Use Committee (IACUC) and University Animal Care (UAC) oversee campus-wide animal care and use. The IACUC reviews all use of animals (research, testing, or educational) to assure adherence to humane and ethical principles, as outlined in the Animal Welfare Act, ILAR "Guide for Care and Use of Laboratory Animals," and all other applicable public laws and local policies. Investigators who plan to use animal subjects as part of their research should become familiar with these laws and policies, copies of which are available from the offices of UAC. Federal laws and regulations define and prescribe rules for obtaining, maintaining, transporting, and using animals for research purposes. Failure to comply with these rules and regulations can result in significant monetary fines and penalties, including the loss of federal funding for the University.

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
Arizona Health Sciences Center, Room 1126
621-9305

Human Subjects
The University is required to safeguard the rights and welfare of human subjects involved in research. Any project originating at the University of Arizona, University Medical Center, University Physicians, or the Southern Arizona VA Health Care System (SAVAHCS) which uses human subjects must be submitted for review and receive approval by the University’s Institutional Review Board (IRB) prior to initiation of research. 

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. Please contact the Human Subjects Protection Program office if you have any questions.

Human Subjects Protection Program
http://orcr.vpr.arizona.edu/irb

1618 E. Helen St.
PO Box 245137
626-6721

Contact:  Sheryl Wurl, Ph.D., Director
                Wendy Tate, PSM, CIP, Assistant Director, Compliance
                Mariette Marsh, MPA, CIP, Assistant Director, Education and Outreach

Radiation Safety
All projects involving radioactive materials or radiation-generating equipment must be coordinated with the Radiation Control Office. All uses of radioactive material within the University must have the prior approval of the University Radiation Safety Committee or the Clinical Radioisotope Committee (AHSC). Application forms for "Radioactive Materials Approval" are available at the Radiation Control Office. Signature of the Committee is not required on the Proposal Routing Sheet.

Contact:

The Office of Radiation, Chemical & Biological Safety
Campus Mail Box 245101
Phone: 520-626-6850, Fax 520-626-2583