ASM supports a robust oversight process for pathogen research to make sure work is conducted safely and addresses public health challenges without hindering national security. The new policy from the U.S. Department of Health and Human Services, "United States Government Policy for Stopping High-Risk Life Sciences Research," broadly defines several categories of research that, if shut down, will impede our ability as a nation to address infectious disease threats and respond to future outbreaks.
State, federal, international and institutional oversight ensures that pathogen research is conducted by trained professionals in compliance with strict safety, security and ethical guidance. The new policy suggests that some research that has been performed in adherence to this guidance is now considered "dangerous" and includes broad definitions of "Dangerous Gain of Function Research (DGOF)," "Potential Dangerous Gain of Function Research (Potential DGOF)" and "International Research of Concern (IROC)." The differentiation between DGOF and Potential DGOF is ambiguous as written, and the disruptive and confusing impact on the research community will hinder work at the forefront of addressing threats to the health and well-being of Americans.
This policy requires clarification in several areas. The definitions are broad, the penalty for violation is high, and the resulting ban on swaths of research will inhibit national preparedness to combat infectious disease threats.
ASM is ready to work with the Administration on a clear and detailed oversight process for pathogen research that ensures research is conducted safely and addresses urgent public health threats without weakening our ability to maintain the health and security of the nation.
