The Department of Health and Human Services, the White House, and multiple federal departments issued a joint policy halting all federally funded high-risk life sciences research on July 28, including gain-of-function experiments that enhance the transmissibility or lethality of pathogens.
The government-wide policy marks the most significant federal action on research biosafety governance in decades and has sweeping implications for National Institutes of Health grantees, universities, and the broader biodefense research community, according to HHS.
Gain-of-function research involves deliberately modifying pathogens to make them more dangerous in order to study pandemic preparedness and develop countermeasures. The practice became the subject of intense public scrutiny following the COVID-19 pandemic, with ongoing debate over whether U.S.-funded research at the Wuhan Institute of Virology may have contributed to the outbreak.
The policy affects hundreds of federally funded research institutions that have relied on government grants to conduct this category of work. Researchers studying potential pandemic pathogens will now face new prohibitions on experiments that could enhance a pathogen’s ability to spread among or kill humans.
HHS described the action as a necessary step to protect public health and ensure that taxpayer-funded research does not create the very risks it seeks to prevent.
Previous administrations had imposed and then lifted moratoriums on certain categories of gain-of-function research, but the new policy goes further in scope, applying across multiple federal departments simultaneously.