Dual-Use Research

Dual Use Research of Concern (DURC) is 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. The United States Government’s oversight of DURC is aimed at preserving the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research. For additional information, please visit the NIH Office of Science Policy, Dual Use Research of Concern.

Please be aware that there are select agents that overlap with or are not considered human pathogens, including animal and plant pathogens. However, it is very possible that a non-select agent may fall under dual use concerns. Please visit the Federal Select Agent Program Website for additional information.

Oversight Related to Dual Use Research within the Intramural Research Program

Education

Sensitivity regarding the potential dual use of any research should be reviewed in the context of the proper conduct of research. The Office of Biotechnology Activities (OBA) has an online Educational Tool, developed by the National Science Advisory Board for Biosecurity that is recommend for all new scientific staff.

Oversight and Review of DURC

Registration of Work on Select Agents - All PIs working on human pathogens are required to register with the Division of Occupational Health and Safety's Human Pathogen Registration Program.

Principal Investigators (PIs) registering agents and toxins that are regulated by the Select Agent Program under Federal law (7 C.F.R. part 331,9 C.F.R. part 121,42 C.F.R. part 73), as having the potential to pose a severe threat to human, animal, or plant health, or to animal and plant products are subject to having their proposed research subject to the following review: http://www.ors.od.nih.gov/sr/dohs/Documents/FD-61%20FORM%20Revised%20January%202013.pdf.

Can the research be reasonably anticipated to produce one or more of the seven experimental effects/categories listed below?

1. Will an intermediate or final product of your research make a vaccine less effective or ineffective? YES / NO
2. Will the final or intermediate product of your research confer resistance to antibiotics or antivirals in ways that are inherently different than those published previously? YES / NO
3. Will your work enhance the virulence of a pathogen or render a non-pathogen virulent? YES / NO
4. Will the results of your work increase the transmissibility of any pathogen? YES / NO
5. Will your research result in alteration of the host range of a pathogen? YES / NO
6. Will your research result in a product or intermediate that that may prevent or interfere with diagnosis of infection or disease? YES / NO
7. Does your research enable “weaponization” of an agent or toxin? YES / NO
8. Even though your research did not involve any of the aforementioned seven criteria, and recognizing that your work product or results of your research could conceivably be misused, is there the potential for your results/product to be readily utilized to cause public harm? YES / NO

• If the answer is "No", no further action is required, but the PI should conduct an ongoing assessment that this continues to be the case and must file an annual report of that assessment.
• If one or more of the seven experimental effects/categories listed above can potentially occur, the Institutional Biosafety Committee (IBC) working with the Pl assesses if the criteria defining DURC would potentially be met. Again if the answer is "No", no further action is required, but the PI should conduct an ongoing assessment that this continues to be the case, and must file an annual report of that assessment.
• If the criteria defining DURC would potentially be met, the IBC working with the PI must develop and implement a risk management plan based on the risk assessment. The conduct and or communication of the research findings must adhere to the risk management plan with ongoing oversight by the IBC with respect to DURC and in consultation with the Intramural Research's Dual Use Committee as appropriate.

Manuscript Clearance

Prior to submitting a manuscript for publication, the Principal Investigator (PI) must submit a Manuscript Clearance Form through the Scientific Director, which specifically monitors for potential dual use issues. If there is concern about dual use issues, the matter is referred to the NIH Deputy Director for Intramural Research's Dual Use Committee