Procedures for Dual Use Research of Concern
Dual Use Research of Concern is defined as a subset of life sciences research involving seven categories of experiments and 15 agents that poses the greatest risk of deliberate misuse with the most significant potential for mass casualties or devastating effects to the economy, critical infrastructure, or public confidence.
Principal Investigators are responsible for the identification and submission for review of research that meets any one of the following criteria:
- The PI’s research directly involves nonattenuated forms of one or more of the listed agents; or
- The PI’s research with nonattenuated forms of one or more of the listed agents also produces, aims to produce, or can be reasonably anticipated to produce one or more of the seven listed experimental effects; or
- The PI concludes that the PI's research with non-attenuated forms of one or more of the listed agents that also produces, aims to produce, or can be reasonably anticipated to produce one or more of the seven listed experimental effects may meet the definition of DURC and should be considered (or reconsidered) by the IRE for its DURC potential.
PIs are to notify the Institutional Biosafety Administration Office (IBC) if they are conducting research that directly uses nonattenuated forms of one or more of the following agents:
- Avian influenza virus (highly pathogenic)
- Bacillus anthracis
- Botulinum neurotoxin (in any quantity)
- Burkholderia mallei
- Burkholderia pseudomallei
- Ebola virus
- Foot-and-mouth disease virus
- Francisella tularensis
- Marburg virus
- Reconstructed 1918 influenza virus
- Rinderpest virus
- Toxin-producing strains of Clostridium botulinum
- Variola major virus
- Variola minor virus
- Yersinia pestis
When a PI determines that the PI's research does directly involve nonattenuated forms of one or more of these listed agents, the PI must also assess whether the research produces, aims to produce, or is reasonably anticipated to produce one or more of the experimental effects listed below. This assessment must be provided to the IBC for its consideration during the review of the research.
The categories of experimental effects are as follows:
- Enhances the harmful consequences of the agent or toxin;
- Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical and/or agricultural justification;
- Confers to the agent or toxin resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates their ability to evade detection methodologies;
- Increases the stability, transmissibility, or the ability to disseminate the agent or toxin;
- Alters the host range or tropism of the agent or toxin;
- Enhances the susceptibility of a host population to the agent or toxin; and
- Generates or reconstitutes an eradicated or extinct listed agent or toxin.
- Obtaining approval to conduct the research:
University faculty, staff, or researchers working at the University as well as those individuals at off campus sites must initiate review of their research by the IRE prior to initiation. Notification will be done via the IBC administrative office
Non-University entities renting, leasing or otherwise using University property, equipment or facilities, and that are using or storing any of these agents must notify the University Health and Safety (UHS) UHS has the authority to prohibit unacceptable use and storage of the materials.
- Reviewing activities involving potentially hazardous biological agents
The effective oversight of DURC is based on identifying DURC and its associated risks, then devising ways to mitigate these risks. Under both USG policies on DURC, this process begins with the identification of research that directly involves 1 or more of the 15 listed agents. Any such research that is identified must then be assessed for whether the research produces, aims to produce, or can be reasonably anticipated to produce one or more of seven listed experimental effects
Under the Policy for Institutional DURC Oversight, the identification of DURC-related risks and the management of those risks begin with the identification, by PIs, of research that directly involves nonattenuated forms of 1 or more of the 15 listed agents. As mentioned above, any such research that is identified must then be assessed for whether the research produces, aims to produce, or can be reasonably anticipated to produce one or more of seven listed experimental effects.
Use of potentially hazardous biological agents in human subjects
The use of any of the listed agents in humans is subject to review and approval by the University of Minnesota Institutional Review Board (IRB). In addition to review and approval by the IBC and the IRE . IBC approval must be obtained before approval for human activities involving hazardous biological agents will be granted by the IRB.
Use of potentially hazardous biological agents in animal subjects
The use of any of the listed 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 and the IRE . IBC approval must be obtained before approval for animal activities involving hazardous biological agents will be granted by the IACUC.
Under the Policy for Institutional DURC Oversight, the IRE is required to review all risk mitigation plans at least annually and to modify plans as warranted. Increased monitoring of the DURC may result in more frequent updates to risk mitigation plans.
- Determining the Risk Level
The Policy for Institutional DURC Oversight requires that IREs develop a draft risk mitigation plan for any DURC identified by the IRE. This plan should be based on the assessment of the risks and benefits, as described in Section C of the Companion Guide.
Once DURC has been identified, institutions should do the following:
Work with the USG funding agency (or, for nonfederally funded DURC, the NIH-designated USG agency) to develop the draft risk mitigation plan.
Submit a copy of the draft risk mitigation plan within 90 calendar days of an IRE’s determination that the research is DURC to the USG funding agency (or, for nonfederally funded DURC, the NIH-designated USG agency) for review and final approval. USG agencies are required to provide an initial response to institutions within 30 calendar days and should finalize the plan within 60 calendar days of receipt of the draft plan.
- Completing appropriate training
All researchers and staff involved in DURC research should receive training and education related to DURC and the DURC oversight policies. IREs may also consider whether additional training is required to address specific concerns about dual use raised by the research in question. The USG and individual Federal funding agencies have developed training and education resources, Training will be mandated via the risk mitigation plan and/or as determined by the IRE or IBC.
- Determining security needs
All biological material must be stored in a secure manner as outlined in the risk mitigation plan. Access to hazardous or potentially hazardous biological material must be limited to only those approved to use it per the risk mitigation plan. 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 the listed agents. 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 subject to the same requirements and inspection of their storage, security, and handling facilities as outlined above.
- Storing dual use research agents
All listed agents must be stored in an appropriate and safe manner. Access to materials should be limited to those with a legitimate need. All stored material must be claimed by an individual, who is a University employee (or an entity as described above) and who is responsible for the storage and use of the material. Investigators must label all materials so that contents can be properly identified. Unidentified material must be treated as potentially hazardous and disposed of in a proper manner.
- Transferring listed agents
Transfer of any of these DURC agents is not allowable.
- Disposing of biological materials
Disposal of agents must be included in the risk mitigation plan. Agents 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 or was created.
- Laboratory Close Out
The risk mitigation plan should include plans for laboratory close out which include final inspection by UHS and the BSO. In the event that a researcher leaves the University or moves their laboratory area, the researcher and the Department are responsible for ensuring that appropriate laboratory closeout procedures are followed, including disposal of any unwanted agents and inspection by the Biosafety Office.