Dual Use Research for Concern - Pathogens with Enhanced Pandemic Potential (DURC-PEPP)

"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 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, material, or national security.

Defined as a pathogen that is likely capable of wide and uncontrollable spread in a human population and would likely cause moderate to severe disease and/or mortality in humans. PPPs are often those with little to no pre-existing immunity in the human population.

"Pathogen with enhanced pandemic potential (PEPP)" is a type of pathogen with pandemic potential (PPP) resulting from experiments that enhance a pathogen’s transmissibility or virulence, or disrupt the effectiveness of pre-existing immunity, regardless of its progenitor agent, such that it may pose a significant threat to public health, the capacity of health systems to function, or national security. Wild-type pathogens that are circulating in or have been recovered from nature are not PEPPs but may be considered PPPs because of their pandemic potential.

Category 1 research involves biological agents and toxins that pose significant risks due to their inherent properties and potential for misuse. This category requires careful oversight to mitigate risks associated with biosafety and biosecurity.

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, material, or national security. Category 1 research may also have biosafety risks.

Category 1 research criteria:

1. Involves one or more biological agents and toxins from a predetermined list. See Appendix A.
2. Is reasonably anticipated to result, or does result, in one of nine experimental outcomes or actions outlined below:

• 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; or
• Enhance the susceptibility of a host population to a pathogen or toxin.

1. Involves, or is reasonably anticipated to result in, a Pathogen with Pandemic Potential (PPP) , the development, use, or transfer of a Pathogen with Enhanced Pandemic Potential (PEPP), or an eradicated or extinct PPP that may pose a significant public health threat.
2. Is reasonably anticipated to result in, or does result in, one or more experimental outcomes or actions. 

• 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 pre-existing immunity via immunization or natural infection;
• Generate, use, reconstitute, or transfer an eradicated or extinct PPP, or a previously identified PEPP.

The Institutional Review Entity (IRE) is charged with oversight of, and education on, life sciences research involving the use of potential DURC-PEPP biological agents.  The Committee advises and reports to the Associate Vice President for Research Integrity and Facilities.  

Complete PI Self-Assessment Form

Available on DURC-PEPP website or during proposal development in Cayuse under Biological Materials, when question is answered as "Yes".

PI Self Assessment reviewed by IRE administration for Category 1 or 2 confirmation.

Full IRE Committee review as needed.

Determination letter provided to Principal Investigator and to Federal Funding Agency (FFA) as required.

If Category 1 or 2 researcher, IRE will send letter to FFA. In coordination with PI and Sponsored Programs (SP) within 30 days.

If approved Category 1 or 2 research, prepare and submit IBC protocol in Cayuse.

All Principal Investigators and research staff on protocol required to take CITI Dual use of Concern (DURC) training.

Risk Mitigation Plan (RMP) for Category 1 and 2 research. 

1. RMP submitted to FFA for approval
2. No research can begin until RMP approved by FFA

1. Category 1 research subject to annual review.
2. Category 2 research subject to semiannual review
3. Principal Investigators (PIs) must report changes in research to the IRE.