Biosafety Office

Dual Use Research of Concern

Definitions

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.

Scope

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

Experimental Effects

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

durc workflow

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.

Training

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 via modification.