Activities Involving Potentially Hazardous Biological Agents
Responsible University Officer(s):
- Vice President for Research
- Vice President for University Services
- Assistant Vice President for University Health and Safety
- Executive Director, Human Research Protection Program
- Betty Kupskay, Debra Dykhuis
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.
|Primary Contacts||Debra Dykhuis
- Biosafety Levels
- Standard and special microbiological practices, safety equipment, and facilities recommended for work with a variety of infectious agents in various laboratory settings. These levels are defined by the U.S. Department of Health and Human Services in the latest edition of Biosafety in Microbiological and Biomedical Laboratories. Biosafety Level 1 (BSL-1) has the least restrictive containment requirements, Biosafety Level 2 (BSL-2) and Biosafety Level 3 (BSL-3) have increasingly more stringent containment requirements and Biosafety Level 4 (BSL-4) requires a dedicated facility. Four Animal Biosafety Levels (ABSL 1-4) describe the practices, safety equipment, and facilities for work with infected research animals.
- Placing of biological agents and other items used in the manipulation of these agents in the laboratory that are no longer intended for use into the waste stream.
- Dual Use Research of Concern (DURC)
- A subset of life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that have the potential to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.
- Handling Biological Agents
- Manipulation of biological material. Can also refer to manipulation of material at a specific Biosafety Level.
- Institutional Animal Care and Use Committee (IACUC)
- The committee established by the president or delegate in accordance with federal regulations to review University activities involving the use of animals. firstname.lastname@example.org
- Institutional Biosafety Committee (IBC)
- The committee established by the president or delegate in accordance with federal regulations to review University activities involving recombinant or synthetic nucleic acid molecules and potentially hazardous biological agents or. email@example.com">firstname.lastname@example.org
- Institutional Contact for Dual Use Research (ICDUR)
- The institutional point of contact for questions regarding compliance with and implementation of the requirements for the DURC oversight policies
- Institutional Review Board (IRB)
- The committee established by the president or delegate in accordance with federal regulations to review University research involving human subjects. email@example.com">firstname.lastname@example.org
- Institutional Official
- The official appointed by the president or delegate who ensures compliance with ethical standards, laws, regulatory requirements, institutional policies, and mandatory reporting requirements.
- Institutional Review Entity (IRE)
- Composed of at least 5 members, including persons with knowledge of US government policies and sufficient range of expertise to assess the dual use potential of research conducted at that institution
- NIH Guidelines
- The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
- Non-University Entity
- A group or individual not a part of the University, as well as University employees using University real estate for personal use and student organizations not covered by the University's liability insurance
- Potentially Hazardous Biological Agent
- Recombinant or synthetic nucleic acid (e.g., rDNA), biologically derived toxins (including mutated, truncated, or inactivated toxins), and infectious agents (including non-virulent and vaccine strains) that require handling at Biosafety Level 2 (BSL2) or above.
- Principal Investigator (PI)
- A University employee who serves as the lead investigator for their life sciences research or who is in charge of a teaching laboratory and who is responsible for all aspects of their research projects at the University, including the actions of their staff. The DURC policy requires the PI to notify the IRE as soon as they propose any work that may fall under the DURC policy (see Dual Use Research of Concern – A Companion Guide).
- Recombinant or Synthetic Nucleic Acid Molecule Research
- This includes all research involving the joining of natural or synthetic DNA segments to other DNA molecules, as well as all synthetic or natural DNA segments that are being used for gene transfer into an in vivo system. All research must be conducted in accordance with the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines).
- Systematic investigation, including development, testing and evaluation designed to develop or contribute to generalizable knowledge.
- Research Animal Resources (RAR)
- The program established by the president or delegate to provide veterinary services and support for activities covered under Board of Regents Policy: Animal Care and Use.
- Research Compliance Office (RCO)
- RCO provides independent oversight and monitoring of research activities both internally and across the University system.
- Responsible Official (RO)
- The University of Minnesota official designated to act on behalf of the University regarding the possession, receipt or transfer of Select Agents.
- Policies, procedures, or devices intended to control access to biological materials
- Select Agent
- Refers to the HHS Select Agent and Toxin list (42CFR part 73), the Overlap Select Agent and Toxin list (42CFR Part 73 and 9CFR Part 121), the plant pathogens (7CFR Part 331) and the High Consequence Livestock Pathogens and Toxins (9CFR Part 121) as amended or revised.
- Retention of biological materials by University employees or on University property, including materials kept in open laboratory space, incubators, refrigerators, or freezers.
- Activities that include classroom demonstrations, laboratory exercises and research projects that are required for completion of a course at the undergraduate, graduate, or professional level.
- Biological Safety Officer (BSO)
- Oversee the inspection of research facilities. Serve as a member of the IBC. Take such actions that are necessary, including the suspension of research activities in the event of an unresolved safety hazard.
- University Health and Safety (UHS)
- Manage the Select Agent Program. Conduct inspections of laboratories where biological agents are used and/or stored. Assess risks and provide information and training to the University community on the safe handling, storage, security, or disposal of biological agents.
- Institutional Biosafety Committee (IBC)
- Review and grant approval for research proposals involving the use of biological agents. Mandate practices or procedures for the handling, storage, security and disposal of biological agents used in research or teaching. Inspect research facilities or delegate inspections and disapprove research in the event of noncompliance or an unresolved safety hazard.
- Institutional Contact for Dual Use Research (ICDUR)
- Serve as institutional point of contact for questions regarding compliance with and implementation of the requirements for the DURC oversight policies; serve as liaison between the institution and the relevant USG funding agency; and consult with the relevant USG funding agency when the institution seeks advice on matters related to DURC
- Institutional Official (IO)
- Responsible for taking steps to ensure compliance with ethical standards, laws, regulatory requirements, institutional policies, and mandatory reporting requirements. The IO appoints the RO. The IO also ensures adequate resources are available for proper functioning of the IBC and HRPP.
- Institutional Review Entity (IRE)
- Review of life sciences dual use research of concern as identified by PIs: verification that the research involves one or more of the agents listed in the United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (Sept 2014) or subsequent amendments; review of the PIs assessment and final determination of whether the research meets any of the seven experimental effects; when appropriate, make a determination of whether the research meets the definition of DURC. For research determined to be DURC, the IRE: consider the risks and benefits of conducting the research; works with the appropriate Federal funding agency to develop a risk mitigation plan; reviews the risk mitigation plan at least annually and modifies the plan, as warranted
- Register any projects or activities involving potentially hazardous biological materials with the IBC. Inform the IBC of any modifications to activities or storage locations and any incidents incurred during work with same. Ensure the safe use and storage of biological agents in the laboratory. When requested, inventory biological agents in the laboratory. Ensure the proper disposition of biological agents when the project is terminated. Abide by the policies and decisions of the University and the IBC.
- Human Research Protection Program (HRPP)
- Provide administrative support for the IBC
- Responsible Official (RO)
- Ensure compliance with regulations governing the possession, receipt or transfer of Select Agents. Report to appropriate federal agencies as required. Appoint alternate ROs (AROs).
- Sponsored Projects Administration (SPA)
- Verify IBC and IRE approval before setting up new awards.
- Vice President for Research (VPR)
- Provide oversight for the regulatory committees or offices involved with this policy.
Related Board of Regents Policies:
- Activities Involving Recombinant or Synthetic Nucleic Acid Molecules or Other Potentially Hazardous Biological Agents
- Research Involving Human Subjects
- Animal Care and Use
- NIH - Guidelines for Research Involving Recombinant DNA Molecules
- Antiterrorism and Effective Death Penalty Act of 1996
- 42 CFR Part 73 - Possession, Use and Transfer of Select Agents and Toxins
- 7 CFR Part 331 - Possession, Use and Transfer of Biological Agents and Toxins (plant pathogens)
- 9 CFR Part 121 - Possession, Use and Transfer of Biological Agents and Toxins (animal agents)
- Uniting and Strengthening America Act by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA Patriot Act) of 2001
- Public Health Security and Bioterrorism Preparedness and Response Act of 2002
- Biosafety in Microbiological and Biomedical Laboratories (CDC/NIH)
- Dual Use Research of Concern A Companion Guide
- Institutional Biosafety Committee
- University Health and Safety
- September 2015 – Comprehensive Review, Minor Revision. Added information on Dual Use Research of Concern. Removed outdated language, updated UMN departments, added contacts, and revised definitions. Responsibilities and Procedures updated.
- June 2012 - Comprehensive Review, Minor Revision. Removed outdated language, updated UMN departments, added contacts, and revised definitions. All minor updates with no substantive change to policy statement. Title of this policy should be changed to read "Potentially" rather than "Potential" in order to align with other Board of Regents policies and NIH Guidelines. Responsibilities and Procedures updated.
- January 2004