Research protocol approvals require the researcher to complete an application to be reviewed by UCUCA. Researchers are required to identify hazardous materials and operations that may be used in the protocol. If infectious or transmissible agents are specified, OSEH verifies the risk group of the agent and the containment level required for work with the agent(s). If recombinant and/or replication-defective agents are specified, the risk assessment considers the nature of the vector, its insert(s) and the potential for replication competent virus to be produced and shed. All rDNA and Select Agent projects must be registered and approved by the Institutional Biosafety Committee (IBC) prior to commencement of the experiment. The use of hazardous chemicals is reviewed by OSEH and requires the researcher to list the dose and route of administration of any potentially hazardous substance (including FDA approved or experimental pharmaceutical products, laboratory chemicals and inhalation anesthetics to live animals). OSEH will provide safe handling and use information, along with housing recommendations.
The University of Michigan Radiation Policy Committee (RPC) controls the use of radioactive substances and equipment emitting radiation. OSEH acts as the operational arm of the Committee and has implemented standard operating procedures University-wide governing the use of radioactive materials in animals. To get started the PI must complete the appropriate application form to use radioactive substances.
The PI/Supervisor will designate personnel responsible for preparing the Biosafety Manual, Chemical Hygiene Plan Supplement Documents, and Exposure Control Plan for the laboratory. The Chemical Hygiene Plan is required for all laboratories that handle hazardous chemicals for research purposes. A Biosafety Manual is also required when using infections agents or recombinant DNA at a Biosafety Level 2 or higher. The Exposure Control Plan is required for all labs using unfixed human derived materials (tissues, fluids, cell-lines). Guidelines and templates are available on the OSEH website. It is advised that one individual should be assigned for the laboratory to make sure the documents are maintained up to date. It is the PI/Supervisor that is ultimately responsible to devise effective occupational safety protocols in consultation with ULAM and OSEH.
Both UCUCA and OSEH must be notified by the PI/Supervisor whenever protocols change, or something occurs in the facility that creates a new hazard. The Chemical Hygiene Plan, Biosafety Manual, and Exposure Control Plan must be updated by the PI/Supervisor and all staff in the area briefed on new safety requirements.
Once the review process is completed the appropriate containment level will be assigned to the research by OSEH. It is then up to the unit sponsoring the research to obtain the appropriate equipment necessary to meet the level of protection. The researcher will acknowledge acceptance of the findings and recommendations provided by OSEH. If the procedures and hazardous materials involved in the research warrant a start-up inspection by OSEH, it will be scheduled upon notification the laboratory is ready. All personnel entering an animal room with potential exposure to a hazardous material are notified by signage on the entrance door of all hazardous materials that may be present in the room. The signs must be clearly marked with the biohazard symbol if applicable, the name of the hazardous materials, the Biosafety Level of the agent if applicable, the investigator’s name and phone number, the laboratory contact’s name and phone number, the animal husbandry supervisor’s name and phone number and any special requirements for entering that room including personal protective equipment.