There are a number of core facilities (e.g., animal breeding, flow cytometry, assay services, microscopy, imaging services, GMP facilities, etc.) at the University of Wisconsin–Madison that are engaged in activities covered by biosafety protocols, human subjects protocols, animal care and use protocols, and/or performed on a fee-for-service basis. These activities may involve biological materials and/or animals which have been exposed to pathogens, potentially infectious materials, biological toxins, or recombinant or synthetic nucleic acid molecules. This policy is intended to help ensure that the work is performed in a safe manner and is covered in a Biosafety protocol.
All work that is associated with a specific project must be accounted for on the Biosafety protocol corresponding to the Principle Investigator (PI) that is facilitating the work.
Core facilities incur inherent risks associated with the services they provide. The biological risks may include, but are not limited to, zoonotic diseases, aerosol generating activities, and exposure to infectious or potentially infectious agents. UW–Madison core facilities must account for risks associated with the activities performed in a Biosafety protocol that describes the work they do and hazards they may encounter through the service they provide. The biological materials requiring a Biosafety protocol are defined in the UW–Madison Researchers’ Biosafety Manual. The Biosafety protocol must describe the types of materials handled, the activities performed by core personnel, and specify the materials that are not permitted in the core facility. The Biosafety protocol must include steps taken to mitigate risks, including training, engineering controls (e.g., biosafety cabinets) and personal protective equipment. The Office of Biological Safety should be consulted to determine if a separate protocol needs to be submitted for PIs with research and core facility responsibilities.
Biosafety protocols provide a description of the research methods and materials so that risks associated with the work can be assessed and mitigated. A Biosafety protocol also provides a registration for recombinant or synthetic nucleic acid materials in accordance with the NIH Guidelines.
Because a core facility may not have detailed knowledge of the research activities to accurately assess risk associated with biologicals materials supplied to them by a PI or user, the PI or user must communicate any potential hazards associated with the materials and provide the appropriate biosafety training. For UW–Madison investigators, biological materials must be accounted for on the protocol of the PI for which the work is being performed. All work that is associated with a specific project must be accounted for on the Biosafety protocol corresponding to the PI that is facilitating the work.
An intake process is needed for sample submission for cores that are service oriented, accept samples/materials, or are overseeing equipment for people to use. This process must ensure that appropriate information is given to core personnel and should be documented by the core. The intake process needs to include contact information for the PI and/or user, a description of materials, occupational health considerations, and clearly define expectations for entry and/or use of equipment (e.g., training requirements, PPE, disposal of waste, disinfection/inactivation, emergency response, etc.). The process may include the use of an intake form that is completed by core facility personnel or by the user.
Training will need to be provided to persons using equipment or present in the facility while experiments are in progress. The training will need to include information about the biological agents potentially present, spill response procedures, and exposure response procedures. Training frequency and documentation needs to be specified in the Biosafety protocol.