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Biosafety - Dual Use Research of Concern
Dual Use Research of Concern
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 purposes.
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)
- Bacillus anthracis
- Botulinum neurotoxin (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
- 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
- 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 who will conduct research with one or more of the listed agents or toxins musts complete training on DURC before beginning work and every three years thereafter.
- United States Government Policy for Oversight of Life Sciences DURC
- United States Government Policy for Institutional Oversight of DURC
- Companion Guide to USG Policies for Oversight of DURC
- DURC Case Studies
- DURC FAQs
- Responsible Communication of DURC
- A Code of Conduct Tool Kit for DURC
- FAS Case Studies in Dual Use Biological Research