PI Self-Assessment Form for Category 1 (DURC) or Category 2 (PEPP) Research

PI Self-Assessment Form for Category 1 (DURC) or Category 2 (PEPP) Research


Please complete a separate form for each grant or project proposal.

The US Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (USG Policy) identifies two Categories of research that must be proactively assessed by the PI when described as part of a federal grant application:

Category 1 Research
(1) Involves one or more biological agents and toxins from a pre-determined list.
(2) Is reasonably anticipated to result, or does result, in one or more experimental outcomes.

Category 2 Research
(1) Involves, or is reasonably anticipated to result in, a Pathogen with Pandemic Potential (PPP) , the development, use, or transfer of a Pathogen with Enhanced Pandemic Potential (PEPP), or an eradicated or extinct PPP that may pose a significant public health threat.
(2) Is reasonably anticipated to result in, or does result in, one or more experimental outcomes or actions.

Complete this self-assessment tool to determine whether your proposal involves research that is potentially within scope of Category 1 or Category 2.
You will receive a copy of this completed form to your email.

Please note:

• You will be required to declare the results of your assessment in your funding proposal.
• If the federal funding agency is considering your proposal for award, the FIU Institutional Review Entity (IRE) will be required to review this assessment and make their own determination of whether the proposed research in within the scope of Category 1 or Category 2.

For questions or assistance completing this form: ori@fiu.edu