• Dual-Use Research is 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) 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.
• Institutional Review Entity (IRE) is the entity established by the research institution to execute the institutional oversight responsibilities described in Section 5.2, with the attributes described in Section 5.2.B
• Pathogen with Enhanced Pandemic Potential (PEPP) is a type of pathogen with pandemic potential (PPP) resulting from experiments that enhance a pathogen’s transmissibility10 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. K. “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.
• Reasonably Anticipated describes an assessment of an outcome such that, generally, individuals with scientific expertise relevant to the research in question would expect this outcome to occur with a non-trivial likelihood. It does not require high confidence that the outcome will definitely occur but excludes experiments in which experts would anticipate the outcome to be technically possible, but highly unlikely.

This policy categorizes the research into Category 1 and Category 2 research and expands the scope of research. Category 1 research is subject to oversight by research institutions and federal funding agencies, and Category 2 research is subject to oversight by research institutions, federal funding agencies, and their federal department if applicable12 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.

• Category 1 Research: Category 1 DURC (Dual Use Research of Concern) refers to research involving biological agents and toxins that, if misused, could pose significant risks to public health, agriculture, or national security. These agents are expected to produce risky experimental outcomes, such as increasing a pathogen's transmissibility or virulence. These agents include all Select Agents & Toxins (in any quantity), all Risk Group 4 pathogens listed in Appendix B-IV of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, a subset of Risk Group 3 pathogens listed in Appendix B-III of the NIH Guidelines, and other agents that have not been assigned a Risk Group in the NIH Guidelines but are recommended to be handled in BSL-3 or BSL-4 in the Biosafety In Microbiological and Biomedical Laboratories (BMBL).
• Category 2 Research: Category 2 DURC-PEPP research involves experiments that enhance a pathogen’s transmissibility, virulence, or ability to evade detection or immunity, posing a significant threat to public health, agricultural crops, animals, the environment, or national security.

It is the responsibility of all NIH applicants and recipients, through their Principal Investigators (PD/PIs) and other Senior/Key Personnel (“researchers”) named in the application, to assess whether or not their research, for which NIH funding is received or sought, falls under the scope of Category 1 and/or Category 2 research. Applicants and recipients seeking to conduct research within the scope of this policy will be required to have an Institutional Review Entity (IRE) and an Institutional Contact for Dual Use Research (ICDUR). Composition and responsibilities of the IRE and ICDUR are outlined in the DURC/PEPP Policy. Researchers must work with their IRE to develop a risk-benefit assessment and risk mitigation plan, as needed, that must be approved by NIH before this work can begin or continue. Once awarded, recipients, through their PD/PIs, must carry out and oversee research according to the approved plan. Recipients and applicants are expected to develop necessary infrastructure and personnel to comply with the DURC/PEPP Policy. NIH strongly recommends institutions begin training relevant staff on the DURC/PEPP Policy.

PIs Should:

• Be knowledgeable about and comply with or follow all applicable institutional and U.S. government policies, requirements, and regulations for oversight of biological agent and toxin research.
• Assess their research at the proposal stage, and continuously throughout the research lifecycle, to identify whether there is research reasonably anticipated to be within scope of Category 1 or within scope of Category 2. Following identification of potential Category 1 or Category 2 research, notify the federal funding agency and research institution, refer the research to an appropriate IRE, and be prepared to develop a risk-benefit assessment and a risk mitigation plan.
• Work with the IRE to assess the risks and benefits of the proposed research and submit the risk-benefit assessments and draft risk mitigation plan for Category 1 or Category 2 research to the federal funding agency for review and approval when appropriate:
• Conduct Category 1 and Category 2 research in accordance with the provisions identified in the risk mitigation plan approved by the federal funding agency.
• Provide annual progress reports for Category 1 research and semiannual progress reports for Category 2 research, and as requested by the federal funding agency
• Ensure that laboratory personnel conducting life sciences research within the scope of this Policy (i.e., those under the supervision of laboratory leadership including graduate students, postdoctoral fellows, research technicians, laboratory staff, and visiting scientists) have received and maintain education and training on all research oversight policies and processes and demonstrated competency.
• Communicate Category 1 and Category 2 research in a responsible manner.