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

Overview

As a federally funded research institution, Texas A&M University is required to establish and implement policies to identify and oversee dual use research of concern (DURC) and pathogens with enhanced pandemic potential (PEPP), in accordance with the 2024 US Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (“Policy”).

Definitions

Dual Use Research of Concern, or DURC

Dual Use Research of Concern, or DURC, is defined as 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.

Pathogens Pandemic Potential, or PPP

Pathogens with Pandemic Potential, or PPP, are pathogens that are likely capable of wide and uncontrollable spread in a human population and would likely cause moderate to severe disease and/or mortality in humans.

Pathogens with Enhanced Pandemic Potential, or PEPP

Pathogens with Enhanced Pandemic Potential, or PEPP, are a type of 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.

Category 1 Research

Category 1 Research meets 3 criteria: (1) involves one or more of the biological agents and toxins specified in Section 4.1.1 of the Policy; (2) it is reasonably anticipated to result, or does result, in one of the experimental outcomes specified in Section 4.1.2 of the Policy; and (3) based on current understanding, the research institution and/or federal funding agency assesses that the research constitutes DURC as specified in Section 4.1.3 of the Policy.

• Category 1 research is subject to oversight by research institutions and federal funding agencies.

Category 2 Research

Category 2 Research meets 3 criteria: (1) it involves, or is reasonably anticipated to result in, a PPP as specified in Section 4.2.1 of the Policy; (2) 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; 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[1] 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.

• Category 2 research is subject to oversight by research institutions, federal funding agencies, and their federal department if applicable, due to heightened potential for biosafety and biosecurity risks.
• Any research that meets the definition of both Category 1 and Category 2 research is designated as Category 2 research.

[1] Current eradicated and extinct pathogens include Variola major, Variola minor, and 1918 H1N1 Influenza virus

What is Texas A&M University’s review and approval process for DURC and PEPP?

Texas A&M is committed to the shared responsibility of upholding the integrity of science and to reducing the risk of its misuse. Review and oversight of DURC are outlined in Texas A&M Rule 15.99.06.M1 Use of Biohazards, Biological Toxins and Recombinant DNA and Dual Use Research of Concern and IRE SOP 019 “Institutional Review of Research with Dual Use Potential”. Per Texas A&M Rule 15.99.06.M1, Texas A&M’s Institutional Biosafety Committee (IBC) serves as Texas A&M’s Institutional Review Entity (IRE) and is responsible for reviewing potential DURC and executing the requirements in the 2024 US Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (“Policy”).

Who do I contact regarding DURC and PEPP? 

The Texas A&M University IRE is administratively managed and supported by the Office of Biosafety. For questions related to the institutional review of DURC,  contact ire@tamu.edu. TAMU’s Vice President for Research designated the Responsible Official and Associate Director of Biosafety to serve as the Institutional Contact for Dual Use Research (ICDUR).  The ICDUR serves as TAMU’s internal resource for issues regarding compliance with and implementation of the requirements for oversight of DURC. The ICDUR shall also serve as the point of contact for Authorized Organizational Representatives, who are responsible for liaising between the University and relevant funding agencies. 

What research must be reviewed by Texas A&M’s IRE?

Research that falls within the scope of Category 1 or Category 2 of the  Policy  must be evaluated by the IRE to determine whether it has DURC or PEPP potential. Additionally, if the USG has notified Texas A&M that specific research requires IRE review, the research must be reviewed by the IRE. 

What do Principal Investigators need to do? 

• Complete DURC/PEPP training in CITI.
• Be knowledgeable about, and comply with, all institutional and Federal policies and requirements for oversight of DURC and PEPP; 

• Assess your research for potential DURC (Category 1) or PEPP (Category 2) at the proposal stage and continuously throughout the research lifecycle. 

• If you identify potential Category 1 or Category 2 research, contact the ICDUR for guidance.  
  • If you determine that your ongoing research is potentially within the scope of Category 1 or Category 2, halt further work and contact the ICDUR immediately. 

What are the responsibilities of Principal Investigators who propose research or are conducting DURC/PEPP?

• Work with the IRE to assess the risks and benefits of the proposed research, submit risk-benefit assessments and draft risk mitigation plan for funding agency review and approval, as appropriate; 

• Conduct Category 1 and Category 2 research in accordance with the provisions of the risk mitigation plan; 

• Provide annual reports for Category 1 research and semiannual reports for Category 2 research. Submit reports, as requested by the funding agency, for review and clarification. 

• Make sure all lab personnel, including students, fellows, technicians, staff, and visiting scientists, are trained and competent in DURC for life sciences research covered by the Policy.  

• Communicate Category 1 and Category 2 research responsibly, adhering to the risk mitigation plan approved by the federal funding agency. 

What if research meets the definition of DURC?

If the IRE determines that a research project meets the definition of DURC/PEPP, the ICDUR will notify the funding agency in accordance with the Policy and work together with the IRE and the researcher to develop a draft risk mitigation plan for final approval by the funding agency. Once the draft risk mitigation plan is approved, the IRE will continue to monitor the research project and provide compliance oversight until the project has been completed. Any changes in the status of a DURC project or proposed changes to the risk mitigation plan must be communicated to the funding agency. Changes in the risk mitigation plan require funding agency approval. 

What is not DURC? 

The review and oversight requirements presented in the USG Policy do not apply to research that involves the use of the genes from any of the listed agents, in silico experiments (e.g., modeling experiments, bioinformatics approaches) involving the biology of the listed agents, or research related to the public, animal, or agricultural health impact of the listed agents (e.g., modeling the effects of a toxin, developing new vaccine delivery methods, developing surveillance mechanisms for a listed agent). 

Does IBC approval for research involving use of select agents satisfy the IRE’s requirement to review the research? 

No. IBC review and approval, prior to initiation of any research project involving the use of pathogens, materials potentially containing human pathogens (human blood, tissues or cell lines), rDNA (or rRNA) including the creation of transgenic plants and animals, and select agents and toxins, remains a separate institutional requirement, distinct from the IRE review process. Furthermore, experiments with select agents and toxins (excluding attenuated strains or permissible toxin amounts) also require review by and approval from the Federal Select Agents Program.