Activities Involving Potentially Hazardous Biological Agents
Obtaining approval to use the biological material:
University faculty, staff, or researchers working at the University as well as those individuals using biological materials at off campus sites under grants and contracts to the University must obtain Institutional Biosafety Committee (IBC) approval for their research projects or other activities prior to initiation. IBC Application forms are available at the IBC website.
Non-University entities renting, leasing or otherwise using University property, equipment or facilities, and that are using or storing biological material or agents identified as potential dual use agents in addition to review and approval of the IBC must notify University Health and Safety (UHS). UHS has the authority to prohibit unacceptable use and storage of materials.
Reviewing activities involving potentially hazardous biological agents
The IBC reviews and approves (if appropriate) the use of all potentially hazardous biological agents: recombinant or synthetic nucleic acid molecules, artificial gene transfer, biological agents (bacteria, viruses, protozoa, fungi, etc.) or biologically derived toxins.
Use of potentially hazardous biological agents in human subjects
Use of potentially hazardous biological agents in humans is subject to review and approval by the University of Minnesota Institutional Review Board (IRB). Gene transfer protocols involving human subjects require review by the NIH-Office of Biotechnology Activities (OBA) Recombinant DNA Advisory Committee (RAC), review and approval by the IRB and review and approval by the IBC.
Use of potentially hazardous biological agents in animal subjects
The use of potentially hazardous biological agents in animal subjects requires review and approval by the University of Minnesota Institutional Animal Care and Use Committee (IACUC), in addition to review and approval by the IBC. IBC approval must be obtained before approval for animal activities involving hazardous biological agents will be granted by the IACUC.
IBC approvals for each project are valid for three years and are subject to annual continuing review and approval. Approved protocols are also subject to the University of Minnesota's post approval verification and evaluation programs. Any changes to research protocols must be approved by the IBC (and IRE as appropriate) before initiation.
Determining the Biosafety Level
Biological material must be handled according to the practices and procedures defined by the appropriate Biosafety Level requirements as outlined in the current edition of Biosafety in Microbiological and Biomedical Laboratories. The Biosafety Level is determined by a thorough risk assessment which considers the risk group of the agent as well as other use characteristics. The investigator will determine the Biosafety Level to be used in the laboratory, in consultation with the BSO or IBC as necessary. The BSO and the IBC have the final authority to determine which Biosafety Level will be used when handling a particular agent.
If animals are used, an Animal Biosafety Level (ABSL) for containment of the agent will be assigned by the IBC in consultation with Research Animal Resources (RAR). RAR or the BSL-3 Program Management will provide appropriate housing or will verify that appropriate housing is provided.
Completing appropriate training
All persons working with or that may come into contact with potentially hazardous biological agents must be appropriately trained for use of the agents with which they are working or to which they are potentially exposed. Personnel must also complete OHS's Bloodborne Pathogen Training and be informed of potential risks posed by these agents. Training is also required by NIH for researchers using recombinant DNA. Training is available at http://www.ohs.umn.edu/programs/bbpe/training/home.html
Custodial, IT, mechanical, structural and other non-lab staff must also be appropriately trained before entering areas where infectious agents are used and when disposing of infectious waste.
Determining security needs
All biological material must be stored in a secure manner. Access to hazardous or potentially hazardous biological material must be limited. The IBC, or UHS will assist in the determination of security needs according to an assessment of risk and in accordance with federal and state regulations. Detailed information about security is available on the UHS website.
Conducting Inventories and Inspections
UHS has the authority to conduct inventories and inspections of all laboratories that use biological materials. Researchers are required to cooperate with inventories and inspections of their laboratories, which may be announced or unannounced and are conducted at intervals determined by the IBC, BSO or UHS. In addition, researchers may be required to maintain a list of the biological materials used or stored in their laboratories.
Non-University entities using University property are also subject to inspection of their storage, security, and handling facilities.
Storing potentially hazardous biological materials
All biological material must be stored in an appropriate and safe manner. Access to materials should be limited to those with a legitimate need. All stored biological material must be claimed by an individual, who is a University employee (or an entity as described above) and who are responsible for the storage and use of the material. Investigators must label all materials so that contents can be properly identified. Unidentified biological material must be treated as potentially hazardous and disposed of in a proper manner.
Transferring biological materials
Transfer of material handled at Biosafety Level 2 or above must be carried out in accordance with approved University procedures (http://www.dehs.umn.edu/bio_pracprin_std_ship.htm). This refers to transfer of agents within the University as well as transfers outside the University. All applicable regulations for shipping of hazardous materials must be followed (see http://www.dehs.umn.edu/hazwaste_shiphazwaste.htm). A Material Transfer Agreement (MTA) is used when appropriate. Information regarding MTAs may be located at http://www.ospa.umn.edu/policiesandprocedures/MTAs/index.html.
Disposing of biological materials
Biological material must be appropriately decontaminated before disposal. The IBC and BSO will determine appropriate decontamination procedures and disposal requirements for specific biological agents. There may be costs associated with decontamination and disposal will be borne by the laboratory/department/college in which the material originated.
Laboratory Close Out
In the event that a researcher leaves the University or moves his or her laboratory area, the researcher and the Department are responsible for ensuring that appropriate laboratory closeout procedures are followed, including disposal of any unwanted material. A laboratory closeout policy is available from UHS.