Dual Use Research: Research conducted for legitimate purposes that generates knowledge, information,
technologies, and/or products that could be utilized for both benevolent and harmful
Dual Use Research of Concern (DURC): Life sciences research that, based on current understanding, 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,
materiel, or national security.
Institutional Contract for Dual Use Research (ICDUR): An individual designated by the institution to serve as an institutional point of
contact for questions regarding compliance with the implementation of the requirements
for oversight of DURC as well as the liaison between the institution and relevant
federal funding agencies. At OSU, the Biosafety Officer (BSO) serves as the ICDUR.
Institutional Review Entity (IRE): A committee established by the institution to review all research with dual use potential.
At OSU, the Institutional Biosafety Committee (IBC) serves as the IRE.
Principal Investigator (PI): An individual who is designated by OSU to direct a project or program and who is
responsible for the scientific and technical direction of the project or program.
All research directly involving one or more of the biological agents listed below
is subject to additional review and oversight. Principal investigators (PI) are ultimately
responsible for ensuring that all research involving these agents is submitted to
the IBC for review.
Research Requiring Review and Oversight
Per the United States Government (USG) Policy for Oversight of Life Sciences Dual
Use Research of Concern, research that directly involves non-attenuated forms of one
or more of the following agents or toxins and falls into one of the listed experimental
categories must be evaluated for DURC potential.
Agents and Toxins
Avian influenza virus (highly pathogenic)
Botulinum neurotoxin (any quantity)
Foot-and-mouth disease virus
Reconstructed 1918 influenza virus
Toxin-producing strains of Clostridium botulinum
Variola major virus
Variola minor virus
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
Alters the host range or tropism of the agent or toxin
Enhances the susceptibility of a host population to the agent or toxin
Generates or reconstitutes an eradicated or extinct agent or toxin listed above
Process for Review of Life Sciences Research with DURC Potential
If the IRE determines that the research does not meet the definition of DURC, the research is not subject to additional institutional
oversight. However, if the IRE determines that the research does meet the definition of DURC, the PI will be notified and a draft risk mitigation
plan will be prepared.
Risk Mitigation Plan
If the IRE finds that the proposed research meets the definition of DURC, the committee
will work with the PI to develop a draft risk mitigation plan based on an assessment
of the risks and benefits associated with the research. The plan will be specifically
tailored to the research in question and will outline the strategies that will be
used to mitigate all identified risks. Possible risk mitigation measures may include
the application of additional biosafety or biosecurity measures, modification of the
experimental design or methodology, and/or the application of medical countermeasures.
Additionally, the plan may include information regarding the responsible communication
of DURC findings.
This draft plan will be submitted to the USG funding agency or NIH within 90 days
of the IRE’s determination that the research in question is DURC. The USG agency will
provide an initial response regarding the draft risk mitigation plan within 30 days
and will finalize the plan within 60 days. The project may not be initiated until an approved risk mitigation plan is received
form the USG funding agency or NIH.
The IRE will review all DURC protocol and associated risk mitigation plans on an annual
basis. The USG funding agency or NIH will be notified of any modification or updates
to DURC research protocols or risk mitigation plans within 30 days.
All PIs and laboratory personnel (i.e., those under the supervision of laboratory
leadership, including graduate students, postdoctoral fellows, research technicians,
laboratory staff, and visiting scientists) who will conduct research with one or more
of the listed agents or toxins must complete training on DURC at the time that the
indicated protocol is submitted for IBC review or when he or she is added to the protocol