Division of Research

Category 2 Research

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Category 2 Research

Research that is subject to Category 2 oversight must meet the following criteria:

  • Involves, or is reasonably anticipated to result in, a pathogen with pandemic potential (PPP) as specified in Section D; and
  • Is reasonably anticipated to result in, or does result in, one or more of the experimental outcomes or actions specified in Section E; and
  • Based on current understanding, the research institution, federal funding agency, and/or Department multidisciplinary review entity assesses that the research is reasonably anticipated to result in the development, use, or transfer of the 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 as specified in Section F.

Section D: Biological Agents within Scope of Category 2 Research

A pathogen with pandemic potential (PPP), or any pathogen that will be modified in such a way that is reasonably anticipated to result in a PPP. 

Section E: Category 2 Research Experimental Outcomes or Actions

Research within the scope of Category 2 is experimental outcomes or actions with a pathogen outlined in Section D that are reasonably anticipated to:  

  1. Enhance the transmissibility of the pathogen in humans;
  2. Enhance the virulence of the pathogen in humans;
  3. Enhance 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. Generate, use, reconstitute, or transfer an eradicated or extinct PPP, or a previously identified PEPP. 

Section F: Category 2 Risk Assessment

The research can reasonably be expected to lead to the development, use, or transfer of a PEPP or an eradicated or extinct PPP that may pose a significant threat to public health, the ability of health systems to function, or national security. Refer to the Implementation Guidance [PDF] for additional information, including illustrative examples