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

Policy Documents
DURC-PEPP Policy
DURC-PEPP Implementation Guidance
NIH Implementation of DURC-PEPP

The U.S. Government’s new policy for research involving Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP) in effective beginning on May 6, 2025. This new policy involving DURC-PEPP is a unified federal oversight framework for the federally funded life sciences research on broad range of biological agents, select toxins that may pose a significant threat with potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.

Purpose

The purpose of the United States Government Policy (USG) for Oversight of DURC and PEPP is to establish a unified federal oversight framework for conducting and managing certain types of federally funded life sciences research on biological agents and toxins that may pose risks to public health, agriculture, food security, economic security, or national security.

This DURC-PEPP Policy is Effective from May 6, 2025 and supersedes the following previous polices:
  • 2012 United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (Federal DURC Policy).
  • 2014 United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (Institutional DURC Policy).
  • 2017 Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO Framework).

Scope

The scope of The USG Policy for DURC-PEPP applies to federally funded life sciences research involving biological agents and toxins or pandemic risks from enhanced/extinct pathogens. Research should be evaluated by PIs and research institutions to determine whether it meets the policy oversight at the proposal stage, and throughout the full funding cycle of the research.

Definitions

Dual use research: Research conducted for legitimate purposes that generates knowledge, information, technologies, and/or products that can be utilized for benevolent or harmful purposes. 

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. 

Pathogen with enhanced pandemic potential (PEPP): 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. 

Pathogen with pandemic potential (PPP): 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. 

Institutional review entity (IRE): Entity established by the research institution to execute the institutional oversight responsibilities ensuring that research is conducted responsibly, with appropriate safeguards to minimize risks involving PEPPs and PPPs. 

Institutional Contact for Dual Use Research (ICDUR): Official designated by the research institution to serve as a subject matter expert for application of this policy as well as the liaison (as necessary) between the Principal Investigator, the IRE and the Authorized Organizational Representative and/or funding agency on matters of qualifying research and risk mitigation. 

Categories of Research

The United States government's framework for overseeing life sciences research that could potentially pose significant risk is classified into two categories, Category 1 for DURC and Category 2 for PEPP and PPP. Research should be assessed for Category 1 or Category 2 oversight at the proposal stage and throughout the full life cycle of the research.

Category 1 Research

Category 1 Research is research that 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 must meet all three criteria listed below: 

  1. Biological Agents: Involves any of the following biological agents or toxins within the scope of Section 4.1.1 of the policy.
    1. Biological Select Agents and Toxins# Listed by the Federal Select Agent Program 
    2. All Risk Group 4† pathogens listed in Appendix B of the NIH Guidelines. 
    3. A subset of Risk Group 3 (RG-3) pathogens listed in Appendix B of the NIH Guidelines except the following:
      • HIV (Human Immunodeficiency Virus), HTLV (Human T-cell Lymphotropic Virus), SIV (Simian Immunodeficiency Virus), 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, Coccidioides Posadasii, Histoplasma Capsulatum, Histoplasma Capsulatum var. Duboisii. 
      • Biological agents affecting humans that have not been assigned a risk group in NIH guidelines but are recommended to be handled at Biosafety Level 3 (BSL-3) or BSL-4*, Examples: Newly emerging pathogen or chimeric agent etc.

      †Risk group 4 pathogens, or those requiring Biosafety Level 4 (BSL-4*) containment are not allowed at UAB. 

      #Category 1 oversight considers the anticipated experimental outcomes, regardless of the amount of toxin involved. 

  1. Experimental outcomes: Is reasonably anticipated to result, or does result, in one or more of the following experimental outcomes listed in Section 4.1.2 of the policy. 
    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 pre-existing immunity, via immunization or natural infection, against the pathogen or toxin 
    9. Enhance the susceptibility of a host population to a pathogen or toxin 
  1. DURC Risk Assessment: A DURC risk assessment is performed by Principal Investigator, research institute and Federal agency as mentioned in Section 4.1.3 of the policy. 

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. 

Category 2 Research

Category 2 research is research that 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.
Category 2 research must meet all three criteria listed below:

  1. Biological Agents: Involves a PPP, or is reasonably anticipated to result in a PPP, as mentioned in Section 4.2.1 of the policy.  
    1. A PPP, or any pathogen that will be modified in such a way that is reasonably anticipated to result in development, use or transfer of a PEPP. This includes development of new PPPs from non-PPPs as well as the enhancement of existing PPPs.
    2. Transfers, generation, uses, or reconstitution of an extinct or eradicated PPP, regardless of whether the extinct or eradicated pathogen will be enhanced relative to its wild-type form. 
  1. Experimental outcomes: Is reasonably anticipated to result, or does result, in one or more of the following experimental outcomes listed in Section 4.2.2 of the policy. 
    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.
  1. A Risk Assessment: A risk assessment is performed by the Principal Investigator, research institute and Federal agency, as mentioned in Section 4.2.3 of the policy. The risk assessment determines if 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. The risk assessment should also assess whether the research poses potential DURC risks. 
Responsibilities
Principle Investigator

PIs must assess proposed and ongoing research to determine if it falls under Category 1 (involving specified biological agents/toxins with dual-use risks) or Category 2 (involving pathogens with enhanced pandemic potential) criteria. PIs must contact biosafety office at UAB of such research and collaborate with the Institutional Review Entity (IRE) to develop risk-benefit assessments and mitigation plans. PIs are required to submit these plans for federal approval before initiating or continuing in-scope experiments, adhere to approved mitigation measures during research, and provide annual (Category 1) or semiannual (Category 2) progress reports. Additionally, PIs must ensure laboratory personnel receive training on oversight policies and communicate research findings responsibly. 

University of Alabama at Birmingham

UAB, as a research institute, is responsible for establishing a robust oversight process for Category 1 and Category 2 research. UAB creates and implements internal policies to identify and manage such research. UAB will follow this policy when seeking federal funding, ensure personnel receive training on oversight requirements, and maintain records of reviews and mitigation plans for at least three years post-project completion. Additionally, UAB notify federal agencies of Category 1 or 2 determinations within 30 days and provide finalized risk benefit assessment and risk mitigation plans within 90 days of notification. UAB IBC establish Institutional Review Entities (IREs) composed of at least five members with expertise in biosafety, biosecurity, and dual-use risks. IRE is responsible for evaluating proposed or ongoing research to determine if it meets Category 1 (DURC risks) or Category 2 (PEPP risks) criteria. The IRE collaborates with principal investigators (PIs) to conduct risk-benefit assessments and develop risk mitigation plans. The IRE ensures ongoing compliance by reviewing and updating risk mitigation plans at least annually. Additionally, UAB designate an Institutional Contact for Dual Use Research (ICDUR) to liaise with federal agencies and oversee appeals for institutional decisions. 

The DURC-PEPP Review Process at UAB

The DURC-PEPP Policy oversight framework at UAB involves the following steps shown below. 



  1. The Principal Investigator (PI) makes initial assessment if their research (at proposal stage or ongoing research or renewal stage of grant application) may be within the scope of Category 1 research (DURC, as specified in Section 4.1.1, 4.1.2 and 4.1.3 of policy) or Category 2 research (PEPP-PPP as specified in Section 4.2.1, 4.2.2 and 4.2.3 of policy).
  2. The PI designates the determination of DURC or PEPP-PPP information on the PH 398 Form (Grant Application), if their research falls under Category 1 or Category 2 based on the biological agent or toxin and the experimental outcomes. PIs should declare even if their research does not fall under these two categories on the PH 398 Form. For ongoing research PIs should make a determination on the DURC-PEPP Research Declaration Form. The PI sends the grant application with DURC-PEPP determination to Office of Sponsored Program, that the research may be within scope of Category 1 or Category 2. The Office of Sponsored Programs reviews the grant application and submit the application to funding agency (FA). The research institution is responsible for providing training and ensuring that PIs are aware of the policy and executing their responsibilities promptly.
  3. The Federal funding agency reviews the research proposal and upon identifying potential funding eligibility, finding agency notifies the research institution through Institutional Contact for Dual Use Research (ICDUR).
  4. The Institutional Biosafety Committee (IBC) reviews all research proposals involving Risk Group 2 or higher agents, regardless of whether the work involves recombinant material. This ensures the UAB IBC is operating as the Initial Institutional Review Entity (IRE) to determine if research funded through any source is within the scope of Category 1 or Category 2 research. If the IBC determines that the research meets 2 of the 3 requirements for designation as Category 1 or Category 2, then the IBC informs the IRE (Institutional Review Entity) to make a formal determination. If the IRE determines the work to fall within the scope of Category 1 or 2 research, the PI and the IRE collaboratively conduct a risk-benefit assessment and develop a risk mitigation plan. For NIH grants, these documents are submitted to the federal funding agency through the ICDUR. For all other funding sources, the IRE maintains records and internal oversight together with the ICDUR.
  5. The federal agency reviews the risk mitigation plan and risk-benefit assessment as follows: For Category 1 research: The Federal Funding Agency evaluates risk-benefit assessment and risk mitigation plan to determine whether the potential benefits justify the potential risks prior to the funding decision. For Category 2 research: Federal agency refers the proposed research for department-level review. Department convenes a multidisciplinary review entity to evaluate the research institution’s risk-benefit assessments and risk mitigation plan. The multidisciplinary review entity will make recommendations to the federal funding agency regarding the risk-benefit assessments, risk mitigation plan, prior to the federal funding agency making a funding decision on the research proposal. 
  6. Upon federal agency funding approval and IBC authorization, research commences at UAB. It is the responsibility of PI and research institute to make sure research is conducted as mentioned in the approved risk-benefit assessments and risk mitigation plan.
  7. If new information emerges during experimentation that alters risk profiles, the PI must stop the ongoing research and report it to research institute and funding agency through ICDUR using the DURC-PEPP Declaration Form. The PI should contact biosafety@uab.edu to reach the ICDUR for consultations on the required assessments as mentioned in the policy and Implementation Guidance. It is the responsibility of PIs and research institution to comply with the regulation as mentioned in policy. 

NIH Implementation

The DURC-PEPP Policy requirements apply to all UAB research, including grants and cooperative agreements, Research and Development (R&D) contracts, NIH intramural research projects, and other funding agreements (e.g., Other Transactions). All research funded by NIH-based sources will have federal oversight under this policy, whereas all other funded research will receive internal oversight to ensure compliance. 

For competing grant and cooperative agreement applications, NIH will request applicable DURC-PEPP materials to be provided as part of Just-in-Time (JIT) materials submitted on or after May 6, 2025. DURC-PEPP materials must be submitted by the Authorized Organizational Representative (AOR). 

For active grants and cooperative agreements, NIH will request applicable DURC-PEPP materials to be provided as part of any non-competing applications, including Research Performance Progress Reports (RPPRs), due on or after May 6, 2025. Non-competing applications that include DURC-PEPP materials must be submitted by an AOR. 

Resources

UAB Contact Information

Insitutional Contact for Dual Use Research (ICDUR):

References