Gain-off-function research, biothreats, labs, epidemics

Trump Administration Issues Restrictive Executive Order to Govern Gain-of-Function Research

Similarly, studies on SARS-like coronaviruses at the University of North Carolina and the University of Wisconsin-Madison have provided invaluable insight into viral spillover potential and immune escape mechanisms, informing our response to threats like COVID-19 and SARS.

The new restrictions not only risk stalling current research but may also deter future investigations into dangerous pathogens, leaving the U.S. less prepared to respond to the next pandemic threat. Rather than strengthening biosecurity, the executive order risks dismantling the very research infrastructure that protects public health and national security.

The American Society for Microbiology writes:

Pausing Research Not a Path to Better Biosafety & Biosecurity

The American Society for Microbiology is committed to ensuring that scientific research is conducted adhering to strict standards for biosafety and biosecurity. The Trump Administration has an opportunity to work closely with the scientific community to develop guidance that enables U.S. researchers to detect, prevent and treat infectious diseases. Implementation of the Executive Order “Improving the Safety and Security of Biological Research” should enable—not impede—this work.

To be clear, scientists seeking to better understand infectious diseases do so with the highest regard for biosafety and biosecurity, and do not seek ways to evade regulatory oversight. Institutional, state, federal and global policies help ensure that pathogen research is conducted ethically, safely and securely by trained professionals at facilities that comply with strict guidance. Unfortunately, this Executive Order raises more questions than it answers regarding implementation deadlines, definitions and coordination with existing guidelines.

Of particular concern in the Executive Order is the pausing of research while new policies are developed. This will have an impact that is disproportionate to the challenges we are trying to address. Such a pause is also part of a disturbing pattern suggesting that research can be stopped and restarted without serious consequences to our ability to address major health challenges. Make no mistake, this approach will unnecessarily hinder scientific progress and will drive the “best and brightest” away from the field at a time when our public health challenges are more complex than ever before.

This Executive Order cannot be separated from the environment in which it was introduced. Strong biosafety and biosecurity measures require state-of-the-art facilities and a highly trained workforce. This Executive Order was introduced at a time when the President is proposing to cut the National Institutes of Health (NIH) budget by 44%, making it virtually impossible to make such investments. This is what is at stake, not only regarding biosafety and biosecurity, but the U.S.’s role as a global leader in biomedical research.

The Executive Order still requires clarification in several areas. ASM stands ready to work with the Administration on a robust research oversight process for pathogen research to ensure work is conducted safely and addresses urgent public health needs without adversely impacting our ability to maintain national security.

Further Reading

· The White House: Fact Sheet: President Donald J. Trump Achieves Improved Safety and Security of Biological Research

· Global Biodefense. How the Trump Administration’s Ban on Gain-of-Function Research Undermines Pandemic Preparedness

· NPR: Trump restricts funding for ‘gain-of-function’ research — calling it dangerous

· New York Times: Trump Executive Order Restricts ‘Gain of Function’ Research on Pathogens

· The Hill: Trump signs orders on gain of function research, drug manufacturing

· American Society for Microbiology: Gain of Function Research Fact Sheet

· The Conversation: Gain-of-function research is more than just tweaking risky viruses

· RAND: The evolution of United States governance policies for research using pathogens with enhanced pandemic potential

· MSNBC: Trump just took a sledgehammer to our pandemic preparedness

· CIDRAP: New executive order targets certain pathogen research; states sue HHS over restructuring

· Science: Trump moves to tighten rules on risky research on viruses, bacteria, and toxins