All University faculty, staff and students must comply with federal and state regulations and University policies and procedures when conducting research and teaching activities with potentially hazardous biological agents or conducting life sciences dual use research of concern. This includes review and approval by the Institutional Biosafety Committee (IBC), and/or the Institutional Review Entity (IRE) and compliance with inventory, reporting, storage, transport, security, handling and disposal procedures as specified in University, state and federal regulations.
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.
This policy as it pertains to the review and approval by the IBC, and/or the IRE includes all University of Minnesota entities involved in life sciences research or teaching activities including all hospitals owned by Fairview Health Services.
University as well as non-University entities using University property are subject to internal and external inspection of their storage, security, and handling facilities.
Recombinant DNA and Other Potentially Biohazardous Agents
Research involving the use of recombinant or synthetic nucleic acid molecules and other potentially biohazardous agents is regulated by federal guidelines, as well as state and University requirements. All recombinant or synthetic nucleic acid molecule research must be conducted in accordance with the “NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules”. All research on potentially biohazardous agents must be done according to the NIH-CDC publication, “Biosafety in Microbiological and Biomedical Laboratories” (BMBL). Such research is also subject to Administrative Procedure: Activities Involving Potentially Hazardous Biological Agents, including review and approval by the IBC.
All University faculty, staff or students must obtain Institutional Biosafety Committee (IBC) approval for their research projects or other activities, such as those taking place in teaching laboratories, involving biohazardous agents or potential products prior to initiation.
IBC and IRE 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, evaluation and inspection programs. Any changes to research protocols must be approved by the IBC and/or the IRE before initiation.
Biological material must be handled and stored according to the practices and procedures defined by the current edition of the Biosafety in Microbiological and Biomedical Laboratories (BMBL).
All persons working with potentially hazardous biological agents must be appropriately trained for use of the agents with which they are working or to which they could be exposed.
Select Agents are potentially hazardous biological materials and as such are subject to University Procedure and must be approved by the IBC. Persons using, storing, or transferring Select Agents must follow additional procedures described in Administrative Procedure: Additional Procedures for Storing and Using Select Agents.
Dual Use Research of Concern (DURC)
Life sciences research that can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, material, or national security must be done according the US Government (USG) Policy for DURC Oversight and is subject to review by the Institutional Review Entity (IRE) as well as review and approval by the IBC.
Reason for Policy
This administrative policy implements Board of Regents' Policy: Activities Involving Recombinant DNA or Other Potentially Hazardous Biological Agents. In addition, the University has the responsibility to protect researchers, the University community and its assets, and the environment, by assuring the safe use and storage of potentially hazardous biological material in research or teaching at the University. The University also has the responsibility to assure compliance with all federal, state, and internal requirements to prevent the theft, diversion, or misuse of potentially hazardous biological agents.