Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP)

The United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential requires Principal Investigators (PIs) to make an initial assessment of whether their proposed or on-going research is subject to the Policy and to notify the Institutional Review Entity (IRE) if their research meets the following criteria:


Category 1 Research


Meets the following criteria:


  • Involves one or more of the following biological agents or toxins:
  • 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 listed in Appendix B of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) - Classification of Human Etiologic Agents on the Basis of Hazard.



  • For biological agents affecting humans that have not been assigned a Risk Group in the NIH Guidelines, refer to the current edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL). In such cases, agents affecting humans that are recommended to be handled at Biosafety Level 3 (BSL-3) or Biosafety Level 4 (BSL-4) per the BMBL guidance are subject to this Policy.


*Note: As of the time of release of this Policy, this subset consists of all RG3 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. This list may be updated in the Implementation Guidance on a periodic basis.


  • It is reasonably anticipated to result in, or does result in, one or more of the following experimental outcomes as specified in Section 4.1.2 of the Policy:


  • 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.


  • Meets the definition of Dual Use Research of Concern (DURC)


  • 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 Research


Meets the following criteria:


  • It involves, or is reasonably anticipated to result in, a Pathogen with Pandemic Potential (PPP) as specified in Section 4.2.1 of the Policy.


  • It is reasonably anticipated to result in, or does result in, one or more of the experimental outcomes or actions specified in Section 4.2.2 of the Policy:


  • 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; or


  • Generate, use, reconstitute, or transfer an eradicated or extinct PPP, or a previously identified PEPP


  • Meets the definition of Pathogen with Enhanced Pandemic Potential (PEPP)


  • Based on current understanding, the research institution and/or federal funding agency assesses that the research is 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 as specified in Section 4.2.3 of the Policy.

Self-Assessment Form

If you believe that your research may fall within scope of Category 1 or Category 2 research, please complete this Self-Assessment Form to notify the University of Kentucky (UK) Institutional Review Entity (IRE).

Instructions

All research activities that meet the criteria above should complete the self-assessment questionnaire below and submit to the Office of Biological Safety at University of Kentucky for review by the IRE. Upon review, the Office of Biological Safety will notify you of the IREs review of your assessment and coordinate with you regarding next steps (i.e. risk-benefit assessment, risk mitigation plan, federal funding agency notification, etc.).


Note: Federal sponsors may delay release of funds if a project identified as DURC-PEPP research does not fulfill all requirements for compliance with the USG DURC-PEPP Policy.


Please list your name (Last, First).

Please list your UKY email address.

Please select your department from the dropdown list.

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Please enter the Project Title here.

Please select from the dropdown list the source of funding for this project.

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Please specify.

Please enter the IBC protocol # associated with this project. If pending, please indicate "Pending".

Please enter the IACUC protocol # associated with this project. If pending, please indicate "Pending". If animals are not used in this project, please indicate "N/A".

Please provide a description of this project.

Does your research involve one or more of the following biological agents or toxins listed in Section 4.1.1 of the Policy?


  • 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 listed in Appendix B of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) - Classification of Human Etiologic Agents on the Basis of Hazard.
  • A subset of Risk Group 3 pathogens listed in Appendix B of the NIH Guidelines - Classification of Human Etiologic Agents on the Basis of Hazard.*
  • For biological agents affecting humans that have not been assigned a Risk Group in the NIH Guidelines, refer to the current edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL). In such cases, agents affecting humans that are recommended to be handled at Biosafety Level 3 (BSL-3) or Biosafety Level 4 (BSL-4) per the BMBL guidance are subject to this Policy.
  • Biological agents added during future updates to the Implementation Guidance as specified in Sections 7 and 8.


*Note: As of the time of release of this Policy, this subset consists of all RG3 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. This list may be updated in the Implementation Guidance on a periodic basis.

Select
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Is your research reasonably anticipated to result in (or does result in) one or more of the experimental outcomes or actions?


  • 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.


Select
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Considering the definition of DURC below, please indicate why or why not the project meets this definition.


“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, materiel, or national security.

Does your research involve a PPP, or is your research reasonably anticipated to result in a PPP, including the generation, use, reconstitution, or transfer of an eradicated, extinct, or existing PPP?


PPP – 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.


Consider the following…


  • Pathogens with an effective reproductive number (Rt) > 1 are expected to exhibit sustained human-to-human transmission in a population under specific conditions (i.e. lack of pre-existing population immunity, environmental stability, respiratory route of transmission, lack of availability of or access to non-medical and medical countermeasures (MCMs).


  • A pathogen’s capability to cause “moderate to severe disease and/or mortality in humans” may be estimated by comparing case hospitalization rate (CHR) and/or case fatality rates (CFR).


  • Pathogen characteristics including symptoms, duration of disease, or long-term symptoms.


  • Classification can evolve over time due to several factors (changing levels of populations immunity, development of MCMs, emergence of different variants, etc.)


Pathogen with Enhanced Pandemic Potential (PEPP) – type of PPP resulting from experiments that enhance a pathogen’s transmissibility or virulence, or disrupt effectiveness of pre-existing immunity…such that it may pose a significant threat…


Eradicated or Extinct PPP - Current eradicated and extinct PPPs include Variola major and minor, and Influenza A virus subtypes H1N1 (1918) and H2N2 (1957-1968).




Select
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Is your research reasonably anticipated to result in (or does result in) one or more of the following 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; or


  • Generate, use, reconstitute, or transfer an eradicated or extinct PPP, or a previously identified PEPP
Select
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Considering the definition of PEPP below, please indicate why or why not the project meets this definition.


“Pathogen with enhanced pandemic potential (PEPP)” is a type of pathogen with pandemic potential (PPP) resulting from experiments that enhance a pathogen’s transmissibility10 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.

Please attach any supplementary information or other documentation that you believe will be beneficial to the UKY IREs review here.

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