Research protocol approvals require the researcher to complete the eSirius Online Application for UCUCA. Researchers are required to identify hazardous operations and biological, chemical or radioactive materials that may be used in the protocol. If infectious or transmissible agents are specified, OSEH and the Faculty Veterinarian verify the risk group of the agent and the containment level required for work with the agent(s).
To facilitate the risk assessment, the researcher will complete an on-line form for OSEH - Use of Hazardous Materials in Animal Research: Safety and Health Disclosure for OSEH Review. Once the on-line form is completed and the individual hits the send button, a copy of the disclosure information will automatically be sent to an OSEH representative and the Faculty Veterinarian for risk assessment for specific hazards associated with the research. The OSEH representative will review the information and notify the researcher on a) outcomes of the review process including potential concerns, and b) an approximate timeframe the researcher can expect a site visit from OSEH, based upon the apparent risk of the research protocol.
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 projects must be registered and approved by the Institutional Biosafety Committee (IBC) prior to commencement of the experiment using the on-line IBC Registration forms.
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 and Chemical Hygiene Plan for the laboratory. The Chemical Hygiene Plan is required of all laboratories that handle hazardous chemicals for research purposes. A Biosafety Manual is also required when using infectious agents or recombinant DNA at a Biosafety Level 2 or higher. Guidelines and templates are available on the OSEH website. 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 and Biosafety Manuals must be updated by the PI/Supervisor and all staff in the area briefed on new safety requirements.
Once the risk review process is completed an appropriate containment level will be assigned to the research by OSEH and ULAM. It is then up to the unit sponsoring the research to obtain the appropriate equipment necessary to meet the level of protection. An e-mail notification with links to the appropriate guidance and requirements will be sent to the researcher from OSEH. The researcher will reply to the e-mail when the laboratory operation is ready, notifying OSEH they understand the requirements and have complied. OSEH will follow up with the researcher quarterly to review status of the setup until the e-mail notification is received. 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.