DURC-PEPP Policy

On May 6, 2025, a new US Government Policy for Oversight of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP) (the USG DURC-PEPP Policy) will go into effect. The Policy applies to all federally funded research. The Policy supersedes the 2012 Federal DURC Policy, 2014 Institutional DURC Policy, and 2017 P3CO Framework. The Policy does not supersede, but complements, other existing federal regulations, including the Select Agent Regulations.

Purpose of the USG DURC-PEPP Policy
The intent of the DURC-PEPP Policy is to strengthen oversight of life sciences research with biological agents and toxins throughout the research lifecycle by:
- Defining an expanded scope of biological agent and toxin research subject to additional oversight by the U.S. government;
- Providing a unified framework to support the consistent identification and oversight of research proposals subject to the DURC-PEPP Policy that accounts for safety, security, and ethical considerations; and
- Delineating the roles and responsibilities of principal investigators, research institutions, and federal departments and agencies that conduct, fund, or oversee research within the scope of the DURC-PEPP Policy, with an emphasis on institutional oversight and management of this research.
USG DURC-PEPP Policy Statement
It is the policy of the U.S. Government that federally funded intramural or extramural research that meets the scope of Category 1 or Category 2 research within this Policy is subject to federal and institutional oversight. The purpose of this oversight is to preserve the benefits of such research while minimizing the biosafety and biosecurity risks, including risks that the knowledge, information, products, or technologies generated by the research could be used in a manner that results in harm to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.
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UTMB adopts the USG DURC-PEPP Policy and follows the Implementation Guidance for identification, review, and oversight of life sciences research that is within Category 1 and Category 2 as defined by that policy.
At UTMB, the DURC-PEPP Policy applies to all research, regardless of funding source, that meets the criteria for DURC-PEPP research. Federal sponsors may delay release of funds if a project identified as DURC-PEPP research does not fulfill all requirements for compliance with the DURC-PEPP Policy – this includes research that is funded or sponsored by federal grants, contracts, cooperative agreements, and other agreements.
Responsibilities of Principal Investigators (PIs)
- Initial and Ongoing Assessment: PIs must assess their research at the proposal stage and continuously throughout the research lifecycle to:
  - Identify if the research involves a biological agent/toxin within scope
  - Determine if the research is reasonably anticipated to lead to a Category 1 or 2 experimental outcome/action
- Notification: If research is assessed as potentially within scope of Category 1 and/or Category 2, the PI must notify the federal funding agency and the research institution
- Referral: Refer the research to the Institutional Review Entity (IRE)
- Halting Work: If potential Category 1 or 2 research is identified during experimentation, the PI should halt further work pending review
- Risk-Benefit Assessment: Work with the IRE to assess the risks and benefits of Category 1 or 2 research
- Risk Mitigation Plan: Collaborate with the IRE to draft a risk mitigation plan
- Submission: Submit the risk-benefit assessment and draft risk mitigation plan to the federal funding agency for review and approval (when appropriate)
- For projects that have been identified as DURC or PEPP, reviewed by the IRE and funding agency, and received approval for risk mitigation plan, the PI must:
- Conduct of Research: Conduct research in accordance with the approved risk mitigation plan
- Training: Ensure all laboratory personnel under their supervision receive and maintain education and training on research oversight policies and processes
- Progress Reports: Provide the federal funding agency annual progress reports for Category 1 research and semiannual reports for Category 2 research (and as requested)
- Responsible Communication: Communicate Category 1 and Category 2 research in a responsible manner, following the risk mitigation plan
All PIs conducting research involving biological agents and toxins must continuously assess their work for DURC-PEPP elements throughout the research lifecycle (even if the work was not initially considered DURC-PEPP) and notify the Institutional Contact for Dual Use Research (ICDUR) if at any time before or during a project they identify potential DURC-PEPP research.
Responsibilities of the Institution
- Establish an IRE: Create an Institutional Review Entity (IRE) with appropriate expertise to oversee Category 1 and 2 research
  - IRE members should have knowledge of biosafety, biosecurity, DURC/PEPP concepts, and relevant policies
  - At UTMB, the Institutional Biosafety Committee (IBC), with additional experts, serves as the IRE
- Review PI Assessments: Review and confirm whether research falls within scope of Category 1 or 2 research
- Risk Assessment: Conduct a risk assessment to determine if research meets the criteria for Category 1 (DURC) or Category 2 (PEPP potential)
- Risk Mitigation Plans: Work with PIs to develop risk-benefit assessments and risk mitigation plans
- Notification to Funding Agency: Notify the federal funding agency of Category 1 or 2 determinations and provide risk mitigation plans
- Oversight: Assist with and oversee the implementation of the risk mitigation plan and review/modify it at least annually
- Training: Provide education and training on research oversight for individuals conducting life sciences research that may be within scope of Category 1 or 2
- Record Keeping: Maintain records of reviews, risk mitigation plans, and personnel training
If a project could fall under the USG DURC-PEPP Policy, PIs will be required to complete a DURC-PEPP Self-Assessment when seeking funding for this research.
- If identification occurs at the proposal stage, the PI must:
  - Notify the federal funding agency when they submit the proposal
  - Refer the research to the UTMB IRE to assess whether the research meets the definition of Category 1 or Category 2 research
  - Be prepared to develop a risk-benefit assessment and a risk mitigation plan
- If identification occurs during the course of experimentation, the PI must:
  - Halt further work
  - Notify the federal funding agency
  - Refer the research to the IRE
  - Work with the IRE to develop a risk-benefit assessment and a risk mitigation plan
    The IRE will determine whether the research is within scope of Category 1 or Category 2 using the processes outlined in the Implementation Guidance. This includes:
    Confirm that the research involves a PPP or is reasonably anticipated to result in a PPP.
    Confirm that the research is reasonably anticipated to result in, or does result in, one or more of a listed experimental outcomes or actions in scope of Category 2 research.
    Perform a risk assessment to determine 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.
    Confirm that the research involves one or more of the biological agents or toxins listed in Section 4.1.1 of the UGS DURC-PEPP Policy.
    Confirm that the research is reasonably anticipated to result, or does result, in one or more of the listed experimental outcomes in scope of Category 1 research.
    Perform a risk assessment to determine if 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.
The IRE is responsible for communicating the determination to the federal funding agency. Federal funding agencies have the discretion to request additional information or review of individual research proposals or projects to determine whether they may fall within scope of Category 1 or Category 2 research.
For projects that are identified as DURC-PEPP
The PI and IRE will work together to conduct a risk-benefit assessment and develop a draft risk mitigation plan. The PI will submit the risk-benefit assessment and draft risk mitigation plan to the federal funding agency for review and approval.
For funded projects with approved risk mitigation plans
The PI is responsible for:
- Conducting the Category 1 or Category 2 research in accordance with the approved risk mitigation plan
- Providing annual (for Category 1) or semiannual (for Category 2) progress reports, and as requested by the federal funding agency
- Ensuring that laboratory personnel conducting life sciences research within the scope of this Policy have received and maintain education and training on all research oversight policies and processes and demonstrated competency
- Communicating Category 1 and 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
  - When researchers are planning to communicate Category 1 and Category 2 research results, it is their duty to ensure that it is done in a responsible manner, and follows any measures outlined in the risk mitigation plan approved by the federal funding agency.
The IRE is responsible for:
- Assisting with and overseeing the implementation of the risk mitigation plan.
  - The research should be conducted in accordance with the approved risk mitigation plan and should be periodically reviewed by the research institution to determine if additional modifications to the risk mitigation plan are appropriate
- Evaluating risk mitigation plans at least annually and modifying them as necessary for the duration of the research
  - Institutions are responsible for ensuring that the research is conducted in accordance with the risk mitigation plan
- US Government Policy for Oversight of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP)
- Implementation Guidance for the USG Government Policy for Oversight of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP)

Compliance

It is the responsibility of all UTMB Principal Investigators to be knowledgeable about and comply with or follow all applicable institutional and USG policies, requirements, and regulations for oversight of biological agent and toxin research.

For PIs and research institutions, failure to follow the DURC-PEPP Policy may result in suspension, limitation, or termination of federal funding and loss of future federal funding opportunities for the research proposal and for other life sciences research at the research institution, as imposed by the federal funding agency. Federal funding agencies will consider relevant statutory and regulatory authorities when considering appropriate actions.

DURC-PEPP Policy

Purpose of the USG DURC-PEPP Policy

USG DURC-PEPP Policy Statement

Responsibilities of Principal Investigators (PIs)

Responsibilities of the Institution

Compliance