Identifying and Addressing Dual Use Research of Concern
What are the differences between Biosafety and Biosecurity
Biosafety – Ensuring safe handling of pathogens to limit accidental exposure to laboratory workers, the community and the environment
Biosecurity – Ensuring that pathogens or new technologies in the biological sciences are not used for nefarious reasons
Dual Use Research of Concern (DURC) is a Biosecurity Issue
Definition of 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.”
*Source: United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern
Examples of DURC:
Reconstruction of 1918 influenza virus (killed 20-100 million people)
Genetic sequence of virus determined from autopsy samples
Common laboratory techniques used to reconstruct virus
Risk: Publication of genetic sequence may allow others to also reconstruct virus for use as bio-weapon
Benefit: Genetic sequence may provide insights into new vaccines/therapies
Characterization of the Reconstructed 1918 Spanish Influenza Pandemic Virus. Science 07 Oct 2005: Vol. 310, Issue 5745, pp. 77-80
Characterization of the 1918 influenza virus polymerase genes Nature 437, 889-893 (6 October 2005)
Non-biological Research May be DURC
Aerosol Drug Delivery
Older generation methods for aerosol delivery of drugs to the lung were inefficient
Engineered large porous microcarriers (“wiffle balls”) that can deliver larger amounts of drugs deeper into lung
Risk: Publication of method may allow others to use approach for efficient delivery of anthrax or other agents as bio-weapons
Benefit: Better treatment methods for 20 million Americans with asthma
Large porous biodegradable particles for pulmonary drug delivery. Science. 1997;276:1868–1871.
Federal Policy on DURC Effective Sept 24, 2015
Institutions are required to:
Review research for DURC
Carry out a risk/benefit analysis,
Recommend risk mitigation plan
Report to appropriate US government agency
Provide for a means of appeal
The federal policy currently applies to the following 15 agents
Avian Influenza virus (highly pathogenic)
Bacillus anthracis
Botulinum neurotoxin
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
7 Categories of Research that may be DURC
Enhances the harmful consequences of a biological agent or toxin;
Disrupts the immunity or the effectiveness of an immunization without clinical and/or agricultural justification;
Confers to a biological agent or toxin, resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitate their ability to evade detection methodologies;
Increases the stability, transmissibility, or the ability to disseminate a biological agent or toxin;
Alters the host range or tropism of a biological agent or toxin;
Enhances the susceptibility of a host population; or
Generates a novel pathogenic agent or toxin or reconstitute an eradicated or extinct biological agent included in the list of tier 1 agents.
Allow the study to continue and be published with constraints
Do not allow the research to move forward
The PI may appeal decisions of the DURRC to the Institutional Contact for Dual Use Research (ICDUR)
Projects that are deemed DURC may evolve over time so that they are no longer DURC.
It is therefore important for the PI and the DURRC to maintain active communication and to continuously reevaluate the project.
Non-Reportable DURC
Research that does not involve any of the 15 listed agents or toxins does not need to be reported to US government agencies even if it meets the definition of DURC.
However, a risk mitigation plan will still be developed by the DURRC and approved by the ICDUR if the research meets the definition of DURC. The DURRC will implement the approved risk mitigation plan and provide ongoing oversight of the DURC.
