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

A: Dual Use Research of Concern (DURC) is 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.
 

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. Pathogens with pandemic potential are often those with little to no pre-existing immunity in the human population.
 

A: A 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.

* "Experiments that enhance a pathogen’s transmissibility" include those that enhance environmental stability of the pathogen or toxin or change the tropism or host range of the pathogen or toxin in a way that enables an increased ability to infect and transmit between humans, among others.
 

A: The U.S. Government's DURC and PEPP Policies establish a national framework to ensure that certain types of life sciences research are conducted responsibly. These policies apply to research involving specific biological agents, toxins, or experiments that could be misused to pose significant threats to public health, agriculture, food security, the environment, economic stability, or national security.

As of May 6, 2025, all federally funded life sciences research must be assessed for its potential to pose such risks. This includes research funded through grants, contracts, cooperative agreements, and other agreements and transactions issued on or after the policy’s effective date. The policies require risk assessments not only at the proposal stage but throughout the entire life cycle of the research project.

Organizations are also encouraged to assess all research that may present biosafety or biosecurity risks, regardless of funding source. This includes in silico studies and the use of computational technologies, such as artificial intelligence, that model or manipulate biological systems.

At UMD, these policies guide institutional oversight efforts to maximize the benefits of scientific advancement while minimizing potential risks to society.

Principal Investigators (PIs) conducting life sciences research must fulfill the following responsibilities to comply with UMD and U.S. Government DURC-PEPP oversight requirements:

1. Understand and Comply:
   Be knowledgeable about and comply with all UMD and U.S. Government policies, requirements, and regulations governing research involving biological agents, toxins, and dual use research concerns.
2. Assess Research Throughout the Lifecycle:
   Evaluate your research at the proposal stage and continuously throughout the research lifecycle to determine whether it is reasonably anticipated to fall within the scope of Category 1 or Category 2 Research. If such research is identified, promptly notify the federal funding agency (if applicable) and the UMD Biosafety Office.
3. Submit Required Protocols:
   Submit an Institutional Biosafety Committee (IBC) protocol for any research involving recombinant or synthetic nucleic acid molecules, infectious agents, select toxins (at any quantity), and/or human materials. All IBC protocols are reviewed for potential Category 1 or Category 2 Research and referred to the Institutional Review Entity (IRE) as needed.
4. Collaborate on Risk Assessment and Mitigation:
   For research identified as Category 1 or Category 2, work with the IRE to assess the risks and benefits and to develop a draft risk mitigation plan. Submit progress reports for Category 1 and/or Category 2 Research to the federal funding agency for ongoing review and evaluation.
5. Follow Approved Mitigation Measures:
   Conduct all Category 1 and Category 2 Research strictly in accordance with the provisions outlined in the approved risk mitigation plan.
6. Ensure Training and Competency:
   Ensure that all laboratory personnel involved in life sciences research under your supervision receive and maintain appropriate education, training, and demonstrated competency regarding DURC-PEPP oversight policies and procedures.
7. Communicate Research Responsibly:
   Communicate findings from Category 1 and Category 2 Research responsibly throughout the research process, not just at publication. All communications must align with the risk mitigation measures approved by the IRE and, if applicable, by the federal funding agency.

A: The IRE is the Institutional Review Entity responsible for reviewing research with DURC-PEPP potential, as well as working with the PI to assess the risks and benefits of the DURC-PEPP and to develop risk mitigation measures where appropriate. At UMD, the IBC serves as IRE.
 

A: SciShield has updated its DURC questionnaire to align with the U.S. Government DURC-PEPP Policy. All biological laboratories must complete the DURC-PEPP survey when submitting their IBC projects.

A: The ICDUR is the Institutional Contact for Dual Use Research and serves as an institutional point of contact for questions regarding compliance with and implementation of the requirements for the oversight of DURC as well as the liaison (as necessary) between the institution and the relevant USG funding agency.

Hong Yang, Assistant Director of Biosafety and the Biological Safety Officer, serves as UMD’s ICDUR.