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Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PePP)
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Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential |
Biosafety Manual |
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Effective: 05/06/25 |
Version 1.0 |
The United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (Policy) is a unified federal oversight framework for conducting and managing certain types of federally funded life sciences research on biological agents and toxins. This Policy oversees research previously covered by the 2012 Federal DURC, 2014 Institutional DURC and the 2017 P3CO Framework policies. It is effective on May 6, 2025.
- DEFINITIONS:
Dual Use Research of Concern (DURC)- 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.
Institutional Contact for Dual Use Research (ICDUR)- the official designated by the research institution to serve as an internal resource for application of this Policy as well as the liaison (as necessary) between the institution and the relevant federal funding agency.
Institutional Review Entity (IRE)- the entity established by the research institution to execute the institutional oversight responsibilities described in the Policy.
Pathogen with Pandemic Potential (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.
Pathogen with Enhanced Pandemic Potential (PePP)- a type of pathogen with pandemic potential (PPP) resulting from experiments that enhance a pathogen’s transmissibility or virulence, or disrupt he 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.
Reasonably anticipated- describes an assessment of an outcome such that, generally, individuals with scientific expertise relevant to the research in question would expect this outcome to occur with a non-trivial likelihood. It does not require high confidence that the outcome will definitely occur but excludes experiments in which experts would anticipate the outcome to be technically possible, but highly unlikely.
2.SCOPE:
The Policy applies to all research, regardless of funding source on any of WVU’s campuses.
3.RESPONSIBILITIES:
The Institutional Biosafety Officer (BSO) and the Institutional Biosafety Committee (IBC) is charged with ensuring the University is in compliance with the Policy. The BSO will serve as the ICDUR while the IBC will serve as the IRE.
Principal Investigators (PI) is responsible for making an initial assessment to whether their proposed or ongoing research may be within the scope of the Policy based upon the biological agent or toxin and the experimental outcome or actions. The PI is responsible for being knowledgeable and complying with the Policy.
4. PROCEDURE:
4.1. The PI makes an initial assessment of whether their proposed or ongoing research may be within the scope of Section 4 of the Policy, which is detailed in Appendix A and B, based upon the biological agent or toxin and the experimental outcome or actions.
4.2. The PI will contact the ICDUR to discuss the proposed research and collaborate on the initial assessment and risk assessment plans.
4.3. The PI submits the research proposal to the federal funding agency including notification that the research may be within scope of Category 1 or Category 2 based on the biological agent or toxin and the experiment.
4.4. When the federal funding agency has completed merit review of the proposed research and if it is considering funding the proposed research, the federal funding agency notifies the research institution.
4.5. The research institution, through an IRE, reviews the PI’s initial assessment and confirms whether proposed or ongoing research is within the scope of Category 1 or Category 2 research. If so, the IRE determines whether the research is Category 1 or Category 2, including based on a risk assessment under Appendix A and B. The research institution notifies the federal funding agency of the results of its Category 1 or Category 2 research determination, and the federal funding agency evaluates and verifies the research institution’s assessment.
4.6. If the research is assessed to be within scope of Category 1 or Category 2, the research institution, through an IRE, conducts risk-benefit assessments and develops a draft risk mitigation plan for the conduct and communication of research. The PI or research institution submits the risk-benefit assessment and a draft risk mitigation plan to the federal funding agency.
4.6.1. The risk mitigation plan is submitted to the IBC as an IBC protocol.
4.6.1.1. As part of the risk mitigation plan is to include a mechanism to ensure that the resulting biological agent or toxin from Category 1 and Category 2 research are properly accounted for and destroyed when no longer needed if not already required to do so by existing law and regulation.
4.7. The federal funding agency reviews the risk-benefit assessment and draft risk mitigation plan as follows:
4.7.1. For specific experiments within the research proposal determined to be within scope of Category 1, the federal funding agency evaluates the research institution’s risk benefit assessments and determines whether the potential benefits justify the potential risks prior to the funding decision. These specific experiments will not proceed until the federal funding agency approves the risk mitigation plan.
4.7.2. For specific experiments within the research proposal determined to be within scope of Category 2, the federal funding agency refers the proposed research for department-level review. Upon receipt of the Category 2 research proposal, the department convenes a multidisciplinary review entity to evaluate the research institution’s risk-benefit assessments and risk mitigation plan prior to the federal funding agency making a funding decision on the research proposal. The multidisciplinary review entity will make recommendations to the federal funding agency regarding the risk-benefit assessments, risk mitigation plan, and research proposal funding. The specific experiments within the research proposal determined to be within scope of Category 2 will not proceed until the federal funding agency determines that the potential benefits justify the potential risks and approves the risk mitigation plan.
4.8. If research is identified as potentially within the scope of Category 1 or Category 2 research during the course of experimentation, the PI halts further work, notifies the federal funding agency and research institution, and contacts their IRE to conduct the required assessments consistent with the procedures in this Policy for assessing Category 1 or Category 2 research.
4.9. Establish a mechanism to ensure that the resulting biological agent or toxin from Category 1 and Category 2 research are properly accounted for and destroyed when no longer needed if not already required to do so by existing law and regulation
5. REFERENCES:
“NIH Implementation of the U.S. Government Policy for Oversight of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP)” National Institutes of Health Office of Extramural Research.
“United States Government Policy for Oversight of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP)” US Government Health and Human Services. May 2024.
https://aspr.hhs.gov/S3/Documents/USG-Policy-for-Oversight-of-DURC-and-PEPP-May2024-508.pdf
6. APPENDICES:
6.1. Appendix A: Category 1 Research
Category 1 research meets three criteria:
it involves one or more of the biological agents and toxins specified in Appendix A,
it is reasonably anticipated to result, or does result, in one of the experimental outcomes specified in Appendix A; and
based on current understanding, the research institution and/or federal funding agency assesses that the research constitutes DURC as specified in Appendix A.
Biological Agents and Toxins within Scope of Category 1 Research
- 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.
- Current 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
- 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.
Category 1 Research Experimental Outcomes- Research within the scope of Category 1 are those experimental outcomes with a biological agent or toxin outlined in Appendix A that are reasonably anticipated to:
1. Increase transmissibility of a pathogen within or between host species
2. Increase the virulence of a pathogen or convey virulence to a non-pathogen
3. Increase the toxicity of a known toxin or produce a novel toxin
4. Increase the stability of a pathogen or toxin in the environment, or increase the ability to disseminate a pathogen or toxin
5. Alter the host range or tropism of a pathogen or toxin
6. Decrease the ability for a human or veterinary pathogen or toxin to be detected using standard diagnostic or analytical methods
7. Increase resistance of a pathogen or toxin to clinical and/or veterinary prophylactic or therapeutic interventions
8. 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
9. Enhance the susceptibility of a host population to a pathogen or toxin.
Category 1 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, material, or national security.
6.2. Appendix B: Category 2 Research
Category 2 research meets three criteria:
1. it involves, or is reasonably anticipated to result in, a PPP as specified in Appendix B;
2. it is reasonably anticipated to result in, or does result in, one or more of the experimental outcomes or actions specified in Appendix B; and
3. 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 Appendix B.
Biological Agents within Scope of Category 2 Research
- A PPP, or any pathogen that will be modified in such a way that is reasonably anticipated to result in a PPP
1. Enhance transmissibility of the pathogen in humans
2. Enhance the virulence of the pathogen in humans
3. 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
4. Generate, use, reconstitute, or transfer an eradicated or extinct PPP, or a previously identified PEPP.
Category 2 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
Version History:
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1.0 |
Initial version |
Matt Stinoski |
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