Dual Use Research of Concern

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Review Process

Figure 1. Overview of Review Process for Category 1 or Category 2 Research. Depicts the general workflow for review and assessment of research under to the Policy involving PIs (green boxes), research institutions (peach boxes), federal funding agencies (blue boxes), and federal departments (gray box).

 

PIs proposing to work with and/or generate any agents that fall under the scope of Category 1 or Category 2 as described above must complete the initial DURC-PEPP Self-Assessment questionnaire at the proposal stage when seeking funding and/or in OneAegis during their initial IBC protocol submission.

 

This review process will allow the IRE to assess the potential that the information, technology, or products generated by the proposed research could be misused to harm public health, agriculture, or national security.  In making a determination, the IRE will consider the following.

• The types of knowledge, information, technology, or products anticipated to be generated through the research.
• How the results or product of the research will be shared or distributed.
• The novelty of the information provided by the research or of the research methods.
• Whether the products of the research are applicable to other pathogenic organisms or agents.
• Whether the research highlights vulnerabilities in existing public health or agricultural infrastructure.
• The expertise and/or resources that would be required to apply the knowledge, information, technology, or product for malevolent purposes.
• Whether the products of the research could be directly misused to pose a threat to public health and safety, agriculture, plants, animals, the environment, materiel, or national security.
• How readily the knowledge, information, technology, or products from the research could be used to threaten public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.

The nature of the potential consequences (e.g., harm to the economy, the environment, agriculture, or public health) that could result from misuse of the research results.

 

If the IRE determines that the research does not meet the definition of DURC-PEPP, the research is not subject to additional institutional DURC-PEPP oversight.  However, if the IRE determines that the research does meet the definition of DURC-PEPP, the PI will be notified, and a draft risk mitigation plan will be prepared. 

 

The ICDUR will inform the appropriate federal funding agency of the IRE’s assessment of the DURC potential of the project within 30 days of the determination.