Life science research involving “high consequence pathogens and toxins” will require federal agencies to systematically review the potential risks associated with federally funded studies of 15 “high consequence” pathogens and toxins, according to new U.S. government policy issued by the National Institutes of Health.
The reviews are designed to reduce the risks associated with “dual use research of concern” (DURC) that could be used for good or ill. The 15 specified biological agents and toxins identified “pose the greatest risks of deliberate misuse with most significant potential for mass casualties or devastating effects to the economy, critical infrastructure or public confidence.” These include the Avian influenza virus, or “bird flu” and Bacillus anthracis, the pathogen of anthrax.
The DURC policy will expand upon the current reviews already conducted by the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). While both agencies already conduct reviews for studies proposed by staff scientists for dual-use potential, now these reviews will extend to projects conducted by scientists at universities and other institutions. The new rules will also apply to any other federal agency conducting unclassified biological research, such as the U.S. Department of Agriculture and the Department of Defense.
If a review under the current guidelines identifies DURC potential, the funding agency, institution and lead scientist are required to develop a “risk mitigation plan.” It could include efforts to modify how the research is conducted, move it to a more secure laboratory, and communicate it to the public and other scientists responsibly. For especially problematic studies, agencies will determine whether to “request voluntary redaction of the research publications or communications,” or to classify the findings.
The policy requires agencies to report within 60 days how many proposed or ongoing studies involve the 15 agents, as well as report within 90 days how many DURC projects have been identified.
