The President of the United States has issued an executive order aimed at enhancing the safety and security of biological research, particularly focusing on gain-of-function studies. The order outlines measures to prevent potential threats posed by such research to public health and national security.
"Dangerous gain-of-function research on biological agents and pathogens has the potential to significantly endanger the lives of American citizens," states the order. It emphasizes that "if left unrestricted, its effects can include widespread mortality, an impaired public health system, disrupted American livelihoods, and diminished economic and national security."
The order criticizes previous administration policies for permitting gain-of-function research with inadequate oversight. "The Biden Administration allowed dangerous gain-of-function research within the United States with insufficient levels of oversight," it notes. Concerns are raised about federal funding directed through the National Institutes of Health for life-science research in countries like China, where U.S. oversight is limited.
To address these issues, the order mandates several actions:
1. Immediate cessation of federal funding for dangerous gain-of-function research conducted by foreign entities in countries deemed as concerns.
2. Development of guidance to suspend federally funded dangerous gain-of-function research until a comprehensive policy is established.
3. Revision or replacement of existing policies to enhance independent oversight and accountability.
4. Implementation of strategies to govern non-federally funded gain-of-function research within the U.S.
5. Increased transparency requirements for institutions receiving federal funding.
Further enforcement terms require compliance certification from recipients of life-science research grants, ensuring they do not engage in prohibited activities abroad.
The President's directive concludes with definitions pertinent to "dangerous gain-of-function research" and stipulates that nothing in this order should impair existing legal authorities or budgetary functions.