Advances in life science research can provide information that will benefit humankind. However, some advances also have the potential to be misused for harm.
Dual Use Research of Concern is defined as:
Research that, based on current understanding, can be reasonably anticipated to provide knowledge, products or technologies that could be directly misapplied by others to pose a threat to public health and safety, agricultural crops and other plants, animals, the environment or materiel.
The National Institutes of Health’s Office of Science Policy has provided a short video on DURC to raise awareness of the potential for DURC in research.
The United States government has issued two policies for oversight of DURC:
The policies govern research involving non-attenuated forms of one or more of the following agents:
| avian influenza virus (highly pathogenic) | Marburg virus |
| Bacillus anthracis | reconstructed 1918 influenza virus |
| botulinum neurotoxin (in any quantity) | rinderpest virus |
| Burkholderia mallei | toxin-producing strains of Clostridium botulinum |
| Burkholderia pseudomallei | variola major virus |
| Ebola virus | variola minor virus |
| foot-and-mouth disease virus | Yersinia pestis |
| Francisella tularensis |
The research must also aim to produce, or be reasonably anticipated to produce, one or more of the effects below:
- 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 listed agent or toxin.
Investigators are responsible for being aware of the potential for misuse of their research and to mitigate the risk of misuse whenever possible. The Institutional Biosafety Committee reviews for DURC in consultation with experts in the agent being used. For more information on DURC, contact us.
On May 6, 2025, the new Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential policy will go into effect. This policy will supersede the existing 2012 US Government Policy for Oversight of Life Sciences Dual Use Research of Concern (Federal DURC Policy), the 2014 United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (Institutional DURC Policy), and the Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO Framework). The full policy can be found here.
Category 1
Material List
- All Select Agents and Toxins listed in 9 CFR 121.3 – 121.4, 42 CFR 73.3 – 73.4, and 7 CFR 331.3 and regulated by USDA and/or HHS.
- All Risk Group 4 pathogens in NIH Guidelines.
- All Risk Group 3 pathogens except HIV, HTLV, SIV, Mtb (including mycobacterium bovis), Clade II of MPVX viruses unless containing nucleic acids coding for clade I MPVX virus virulence factors, vesicular stomatitis virus, Coccidioides immitis, C. posadasii, Histoplasma capsulatum, and H. capsulatum var. duboisii.
- Biological agents affecting humans that have not been assigned a Risk Group in NIH Guidelines, refer to BMBL — in general, agents that are recommended to be handled at BSL3 or BSL4.
- Others as added.
Experimental Outcomes
- Increase transmissibility of a pathogen within or between host species.
- Increase the virulence of a pathogen or convey virulence to a non-pathogen.
- Increase the toxicity of a known toxin or produce a novel toxin.
- Increase the stability of a pathogen or toxin in the environment, or increase the ability to disseminate a pathogen or toxin.
- Alter the host range or tropism of a pathogen or toxin.
- Decrease the ability for a human or veterinary pathogen or toxin to be detected using standard diagnostic or analytical methods.
- Increase resistance of a pathogen or toxin to clinical and/or veterinary prophylactic or therapeutic interventions.
- Alter a human or veterinary pathogen or toxin to disrupt the effectiveness of preexisting immunity, via immunization or natural infection, against the pathogen or toxin.
- Enhance susceptibility of a host population to a pathogen or toxin.
Risk Assessment
Based on current understanding, the research can be reasonably anticipated to provide, or does provide, knowledge, information, products, or technologies that could be misapplied to do harm with no — or only minor — modification to pose a significant threat with potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.
Category 2
Material List
- A PPP, or any pathogen that will be modified in such a way that is reasonably anticipated to result in a PPP. (This includes the development of new PPPs from non-PPPs as well as the enhancement of existing PPPs.)
- Eradicated or extinct PPPs that may pose significant threat to public health, the capacity of health systems to function, or national security (Current eradicated and extinct pathogens include Variola major, Variola minor, and 1918 H1N1 Influenza virus.)
Experimental Outcomes
- Enhance transmissibility of the pathogen in humans.
- Enhance the virulence of the pathogen in humans.
- Enhance the immune evasion of the pathogen in humans such as by modifying the pathogen to disrupt the effectiveness of preexisting immunity via immunization or natural infection.
- Generate, use, reconstitute, or transfer an eradicated or extinct PPP or previously identified PEPP.
Risk Assessment
The research can be reasonably anticipated to result in the development, use, or transfer of a PEPP or an eradicated or extinct PPP that may pose a significant threat to public health, the capacity of health systems to function, or national security.
NOTE: Any research that meets the definition of both Category 1 and Category 2 research designated as Category 2 research.
Research under this policy will be reviewed by the Institutional Review Entity (IRE). The membership, roles and responsibilities of the IRE are:
- Composed of at least 5 members
- Sufficiently empowered to ensure policies are followed
- Have sufficient breadth of expertise, including biosafety & biocontainment expertise, to assess applicability of Category 1 or Category 2 designation
- Have knowledge of PPPs, PEPPs, dual use concerns and related institutional and US government policies
- Make procedures for reviewing research for Category 1 or Category 2 designation accessible to the public
If you are interested in joining the IRE, or would like to recommend someone, please reach out to [email protected].