University of Florida Policy on Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential

Introduction

In May 2024, the United States Government (USG) issued its “Policy for Oversight of Dual Research of Concern and Pathogens with Enhanced Pandemic Potential” (the “Policy”) which superseded the 2014 USG “Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern” (Institutional DURC Policy) and the “Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight” (P3CO Framework).  The updated, combined policy document defines an expanded scope of biological agent and toxin research subject to oversight, provides a unified framework for oversight of research involving DURC and potential pandemic pathogens (PPPs), and delineates updated roles and responsibilities of stakeholders within scope of the Policy.

The Policy applies to federal departments and agencies that fund or sponsor intramural or extramural research at research institutions in the United States and internationally, including research funded or sponsored by grants, contracts, cooperative agreements, and other agreements and transactions.  For federal departments or agencies with authorization to establish oversight requirements on non-federally funded life sciences research, the Policy recommends that those departments and agencies require attestation by U.S. research institutions that they are implementing oversight of non-federally funded research in scope of the Policy.

The Policy was effective on May 6, 2025.  Simultaneous with publishing the Policy in May 2024, the USG published the “Implementation Guidance for the United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential.”

Dual Use Research of Concern

Dual use research (DUR) is research conducted for legitimate purposes that generates knowledge, information, technologies, and or products that can be utilized both for benevolent and harmful purposes. A limited subset of this research is termed Dual Use Research of Concern (DURC), defined as:

“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 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.”

DURC is considered Category 1 research by the Policy.

Research Involving Pathogens with Enhanced Pandemic Potential

A pathogen with pandemic potential (PPP) is 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.  In addition to research involving extinct or eradicated PPPs, the Policy requires oversight of research involving pathogens with enhanced pandemic potential (PEPPs).  A PEPP is defined as:

“A type of pathogen with pandemic potential 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.”

PEPP is considered Category 2 research by the Policy.

Applicability

The University of Florida, as an institution that receives USG funding for life sciences research, must adhere to the oversight requirements specified in the Policy, even for research that is not funded by the USG in anticipation of federal department and agency requirements for such oversight.

Timing of Review

The following review timepoints are required based on the Policy:

• At the time of proposal: The Principal Investigator (PI) assesses whether proposed or ongoing research may be within the scope of Category 1 or Category 2 based on the biological agent or toxin and experiment.  If so, the the PI notifies the federal funding agency and the UF Institutional Review Entity (IRE).
• Upon notification by federal funding agency: If the federal funding agency is considering funding the proposed research, they will notify UF and the PI of their initial assessment.  The IRE will assess whether the research meets the criteria for Category 1 or Category 2 oversight and notify the federal funding agency of its assessment.
• Upon verification by federal funding agency: The federal funding agency will evaluate and verify the UF IRE’s assessment.  After verification, the UF IRE and PI will develop and submit a risk-benefit assessment and risk mitigation plan.  Research may not begin or continue until the federal funding agency has approved the risk mitigation plan

Certification and Annual Assurance

In addition to certification at the time of application, an annual assurance of compliance to the funding agency by the institution is also required. Each USG funding agency will implement the certification requirement for applications and grantees according to their own agency policies.

Compliance

The university must report instances of noncompliance with the federal policy, as well as mitigation measures undertaken by the institution to prevent recurrences of similar noncompliance, within 30 calendar days to the federal funding agency (or to the NIH in the case of non-USG funded research). Non-compliance with the policy may result in suspension, limitation, or termination of USG funding, or loss of future USG funding opportunities for the non-compliant USG-funded research project and of USG funds for other life sciences research at the institution, consistent with existing regulations and policies governing USG funded research, and may subject the institution to other potential penalties under applicable laws and regulations.

Institutional Responsibilities

Risk Assessment for Category 1 Research

Research determined to be subject to Category 1 oversight should not be conducted until an approved risk mitigation plan has been implemented. The PI is required to notify the institution through its IRE if their research directly involves use of one or more of the biological agents or toxins listed below.

Biological agents and toxins relevant to Category 1 research:

1. All Biological Select Agents and Toxins as listed on the Federal Select Agents Program (FSAP) website, regulated by USDA and/or HHS.
2. All Risk Group 4 pathogens listed in Appendix B of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines).
3. All Risk Group 3 pathogens, also listed in Appendix B of the NIH Guidelines, except for the following: Human immunodeficiency virus, human T-lymphotrophic virus, simian immunodeficiency virus, Mycobacterium tuberculosis or bovis, clade II of MPVX viruses unless containing nucleic acids coding for clade I virulence factors, vesicular stomatitis virus, Coccidioides immitis or posadasii, Histoplasma capsulatum or capsulatum var. duboisii.
4. For biological agents affecting humans that have not been assigned a Risk Group in the NIH Guidelines, all agents affecting humans that are recommended to be handled at Biosafety Level 3 or 4 per the current edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL).

Select agents and toxins are regulated by HHS/USDA Select Agents Regulations for security and safety to avoid accidents or deliberate misuse. The Policy directly addresses the potential risk of the misuse of the research results – its dual uses – and provides for oversight of the agents and toxins that complements, but is different from, current regulations.

Further, the PI will provide an assessment of whether s/he feels the research meets the definition of Category 1 research and produces, aims to produce, or can be reasonably anticipated to produce one or more of the nine experimental outcomes of concern listed below:

Category 1 research experimental outcomes:

1. Increased transmissibility of a pathogen within or between host species;
2. Increased virulence of a pathogen or conveyance of virulence to a non-pathogen;
3. Increased toxicity of a known toxin or production of a novel toxin;
4. Increased stability of a pathogen or toxin in the environment, or increase in the ability disseminate a pathogen or toxin;
5. Alteration of the host rage or tropism of a pathogen or toxin;
6. Decrease in the ability for a human or veterinary pathogen or toxin to be detected using standard diagnostic or analytical methods;
7. Increased resistance of a pathogen or toxin to clinical and/or veterinary prophylactic or therapeutic interventions;
8. Alteration of 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. Enhancement in the susceptibility of a host population to a pathogen or toxin.

Risk Assessment for Category 2 Research

As with Category 1 research, research determined to be subject to Category 2 oversight should not be conducted until an approved risk mitigation plan has been implemented. The PI is required to notify the institution through its IRE if their research:

1. Involves, or is reasonably anticipated to result in, a PPP;
2. Is reasonably anticipated to result in, or does result in, one or more of the experimental outcomes or actions listed below; and
3. Based on current understanding, 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.

Category 2 research experimental outcomes or actions:

1. Enhancement in the transmissibility of the pathogen in humans;
2. Enhancement of the virulence of the pathogen in humans;
3. Enhancement of 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. *Generation, use, reconstitution, or transfer of an eradicated or extinct PPP, or a previously identified PEPP.

* The following eradicated or extinct PPPs could be used at UF given current capability of facilities and infrastructure: influenza A virus sybtypes H1N1 (1918) and H2N2 (1957-1968).

Risk Assessment for Determining a Pathogen with Pandemic Potential

A pathogen with pandemic potential (PPP) is 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.”  The following characteristics are relevant for determining whether a pathogen meets the definition of a PPP:

• Ability of a pathogen to exhibit sustained human-to-human transmission in a population under specific conditions, e.g., an effective reproductive number (R_t) of greater than one;
• Lack of pre-existing population immunity to the pathogen;
• Environmental stability of the pathogen (e.g., in air or on surfaces);
• Respiratory route of transmission;
• Lack of availability or of access to non-medical and medical countermeasures;
• Case hospitalization rate and case fatality rate; and
• Types of symptoms, duration of disease, or long-term symptoms that persist after infection.

Note that a non-PPP may result in a PEPP if it meets the definition provided above, e.g., by genetic modification increasing transmissibility and/or virulence such that it is capable of wide and uncontrollable spread in a human population while causing moderate to severe disease.

Institutional Review Entity Review

Upon initial notification by the PI for new Category 1 or Category 2 research, the UF IRE and Environmental Health and Safety (EH&S) Biosafety Office will log the PI’s notification and await a funding decision from the federal funding agency.  If the funding agency notifies the PI and/or UF that it intends to fund the research, the IRE will convene to review the PI’s Category 1 or Category 2 determination and make an independent determination as to whether the research meets the criteria for oversight.  This decision will then be communicated to the federal funding agency within 30 calendar days.  In the event that the research is not funded through a USG sponsor, the results of this review process will be communicated per funding agency and NIH policy.

Note that all Category 2 research must also be assessed for applicability of Category 1 oversight according to the list of applicable agents and experimental outcomes.

Risk-Benefit Assessments and Risk Mitigation Plans

Upon federal funding agency concurrence with the UF IRE’s Category 1 or Category 2 oversight determination, a risk-benefit assessment and risk mitigation plan for the conduct and communication of the research must be completed and submitted to the USG (or for non-federally funded research, the appropriate party per USG and NIH policy) within 90 days of the IRE determination.

The risk-benefit assessment will assess the potential benefits of the research in light of the risks as an introduction to the risk mitigation plan.  The risk mitigation plan will indicate the Category 1 or Category 2 risks associated with the research, the specific risk mitigation measures to be employed, and how these measures address the identified risks.  The federal funding agency will review the risk-benefit assessment and risk mitigation plan in concert with funding decisions and, to the extent practicable, complete the review process within 90 calendar days of submission by the IRE.

Training

Education and training on Category 1 and Category 2 research is required for all individuals conducting life sciences research with Risk Group 2 or higher biological agents, or biological toxins. All individuals with access to select agents are provided with such training as part of introductory training for access to select agents.  Note: As of April 2025, a DURC/PEPP training course is being developed for deployment to impacted faculty and staff.

Record Retention and Access

Records regarding IRE review, risk-benefit assessments, and risk mitigation plans must be kept for the duration of the project plus three years, but not less than eight years, unless a shorter period is required by law or regulation. Records of education and training must be kept for the term of the research grant or contract plus three years after its completion.

Principal Investigator Responsibilities

1. Be knowledgeable about and comply with all UF and USG policies and requirements for the oversight of biological agent and toxin research.
2. Make appropriate attestations in funding proposals and UF proposal management systems (UFIRST) regarding the applicability of USG DURC/PEPP policy.
3. Submit the appropriate registration form to the EH&S Biological Safety Office. As part of the normal registration process for biohazards, all registration submissions are reviewed for DURC/PEPP policy applicability.
4. Document an assessment for DURC/PEPP, if required. A form will be provided to the PI for this purpose.
5. If Category 1 or Category 2 research is identified, work with the IRE to conduct a risk-benefit assessment and develop a risk mitigation plan.
6. Conduct DURC/PEPP research in accordance with the provisions in the approved risk mitigation plan.
7. Communicate results from Category 1 or Category 2 research in a responsible manner. Communication of research and research findings is an essential activity for all researchers, and occurs throughout the research process, not only at the point of publication. Researchers planning to communicate such research should do so in compliance with the approved risk mitigation plan.
8. Remain vigilant for changes in the DURC/PEPP status of ongoing research projects and communicate with the IRE (DURC@research.ufl.edu) when a change occurs.
9. If changes need to be made to an approved risk mitigation plan, work with the IRE to revise the plan (which then needs to be reviewed and approved by the USG funding agency or NIH prior to implementation of any changes).
10. Ensure that all project personnel, including graduate students, postdoctoral fellows, research technicians, laboratory staff, and visiting scientists, conducting life sciences research at Biosafety Level 2 or above have completed DURC/PEPP training (as available).

Note that more details regarding PI responsibilities under the USG DURC/PEPP policy may be found in section 5.1 of the policy document.

Other Institutional Responsibilities

The IRE must also notify, within 30 calendar days, the USG sponsor or NIH of any change in the status of a project subject to Category 1 or Category 2 oversight at the institution (e.g. unexpected experimental outcomes) and/or the details of any changes to risk mitigation plans.

An Institutional Contact for Dual Use Research (ICDUR) will serve as the institutional point of contact for questions regarding compliance with, and implementation of, requirements that apply to Category 1 or Category 2 research. The ICDUR serves as the liaison (as necessary) between the institution and the relevant program officers at the USG funding agencies, or for non-USG funded research, between the institution and NIH. At this institution, the ICDUR sits within the UF Research Integrity, Security & Compliance Office.

In cases of collaborations involving multiple institutions via a subaward, the primary institution is considered the research institution under the USG DURC/PEPP policy and is responsible for all activities related to this policy, including federal funding agency notifications, development of risk mitigation plans, and ensuring that sub awardees apply consistent Category 1 or Category 2 research oversight, e.g., through inclusion of appropriate requirements in the terms of the subaward.

Information about the process for reviewing life sciences research for DURC/PEPP will be made available upon request as consistent with applicable law.

Funding Agency Review

Federal agencies can notify an institution when they believe research meets the definition of Category 1 or Category 2 research or when they don’t agree with an institution’s assertion that it is. Open communication between PIs, UF’s IRE, and federal agencies on what constitutes regulated research is important, especially when:

1. The IRE requires guidance on developing an adequate risk mitigation plan in cases where the potential risks are perceived as particularly high;
2. The IRE considers the only viable risk mitigation measure to be not conducting or not communicating the research in question;
3. The PI does not agree with the finding of the IRE and so the institution would like to request outside advice;
4. The research in question represents a particularly complex case or appears to fall outside the scope of the USG policy, but still seems to present significant concerns; or
5. Guidance is required to ensure a clear understanding of how the USG interprets the definition of Category 1 or Category 2 research and related terms.

Federal agencies may opt to terminate funding or future funding opportunities for USG-funded research projects and USG funds for other life sciences research at an institution if they believe institutions are not in compliance with the USG DURC/PEPP Policy. Questions about the nature of a particular project with regards to the DURC/PEPP policy should be addressed to the program official at the pertinent funding agency, unless the project is not federally funded, in which case questions can be sent to: DURC@od.nih.gov.

Additional Information and Resources

• USG Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (DURC/PEPP)
• Implementation Guidance for the USG Policy for Oversight of DURC/PEPP
• ASPR FAQs on USG Policy for Oversight of DURC/PEPP
• US Dept of Health & Human Services High-Consequence Research Oversight webpage
• NIH Implementation of the USG Policy for Oversight of DURC/PEPP
• NIH Office of Science Policy – Biosafety and Biosecurity Policy
• National Science Advisory Board for Biosecurity (NSABB)

For questions, contact DURC@research.ufl.edu or the EH&S Biosafety Office (bso@ehs.ufl.edu).