Activities Involving Potentially Hazardous Biological Agents

University faculty, staff, or researchers working at the University as well as those individuals using biological materials under grants and contracts to the University at off-campus sites 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
Non-University entities renting, leasing or otherwise using University property, equipment or facilities, and that are using or storing biological material must notify the Department of Environmental Health and Safety (DEHS). DEHS has the authority to prohibit unacceptable use and storage of the materials.

2. Reviewing activities involving potentially hazardous biological agents

The IBC reviews and approves (if appropriate) the use of all potentially hazardous biological agents: recombinant DNA, 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. IBC approval of the projects is required before IRB approval is granted.

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 final approval from the IACUC will be granted.

Continuing Review
IBC approvals for each project are valid for three years and are subject to 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 before initiation.

Biological material must be handled according to the practices and procedures defined by the appropriate Biosafety Level requirements. The Biosafety Level is determined by 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 will provide appropriate housing or will verify that appropriate housing is provided.

4. Completing appropriate training

All persons working with potentially hazardous biological agents should be appropriately trained for use of the agents with which they are working or to which they are potentially exposed. Personnel must also complete DEHS's Bloodborne and Other 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.research.umn.edu/ibc/training/index.cfm.

Custodial staff must also be appropriately trained when entering areas where infectious agents are used and when disposing of infectious waste.

5. 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, BSO, DEHS or ORA 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 DEHS website.

6. Conducting Inventories and Inspections

DEHS and ORA have 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, DEHS or ORA. 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.

7. 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.

8. Transferring biological materials

Transfer of material handled at Biosafety Level 2 or above must be approved by the BSO or IBC. 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.

9. 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 was housed.

10. 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 DEHS.