Expert Views on Biological Threat Characterization for the U.S. Government: A Delphi Study.

Biological threat characterization (BTC) involves laboratory research conducted for the purpose of biological defense. BTC research is important for improving biological risk assessment and informing resource prioritization. However, there are also risks involved in BTC work, including potential for escape from the laboratory or the misuse of research results. Using a modified Delphi study to gather opinions from U.S. experts in biosecurity and biodefense, this analysis explores what principles and safeguards can maximize the benefits of BTC research and ensure that it is conducted safely and securely. Delphi participants were asked to give their opinions about the need for BTC research by the U.S. government (USG); risks of conducting this research; rules or guidelines that should be in place to ensure that the work is safe and accurate; components of an effective review and prioritization process; rules for when characterization of a pathogen can be discontinued; and recommendations about who in the USG should be responsible for BTC prioritization decisions. The findings from this research reinforce the need for BTC research at the federal level as well as a need for continued review and oversight of this research to maximize its effectiveness and reduce the risks involved. It also demonstrates the need for further discussion of what would constitute a "red line" for biothreat characterization research-research that should not be performed for safety, ethical, or practical reasons-and guidelines for when there is sufficient research in a given topic area so that the research can be considered completed.