President Donald Trump on May 5 issued a formal directive pausing all federal funding for dangerous gain-of-function (GoF) research involving enhanced pathogens of pandemic potential, particularly in adversarial nations such as China and Iran.
In an Executive Order called “Improving the Safety and Security of Biological Research,” Trump said GoF research on biological agents has “the potential to significantly endanger the lives of American citizens” and if left unrestricted, have the potential to cause “widespread mortality, an impaired public health system, disrupted American livelihoods, and diminished economic and national security.”
“The Biden Administration allowed dangerous gain-of-function research within the United States with insufficient levels of oversight. It also actively approved, through the National Institutes of Health [NIH], Federal life-science research funding in China and other countries where there is limited United States oversight or reasonable expectation of biosafety enforcement,” the executive order states.
“This recklessness, if unaddressed, may lead to the proliferation of research on pathogens (and potential pathogens) in settings without adequate safeguards, even after COVID-19 revealed the risk of such practices.”
The order was accompanied by a notice from the NIH formally suspending the acceptance of new proposals for high-risk pathogen research and signaling a temporary halt to ongoing projects that fall under the same category.
Trump’s action is the most consequential federal intervention in biological research since the post-Ebola era policy review under President Obama in 2014, and it is being hailed by supporters as long overdue in the wake of renewed concerns over the origins of COVID-19 and the global proliferation of bio-research programs operating with minimal oversight. The decision has sent ripples across the research community, drawing sharp praise from public health reformers and sharp criticism from virologists who fear the move may hinder global preparedness against future pandemics.
Gain-of-function research broadly refers to experiments that enhance the transmissibility, virulence, or host range of pathogens—particularly viruses—to better understand how they might evolve to cause pandemics in humans. Proponents argue that GoF studies are essential to staying ahead of viral threats, giving scientists a head start on vaccine development and emergency countermeasures. But critics, including an increasing number of former federal officials and whistleblowers, warn that such research carries unacceptable biosecurity risks and is often conducted without transparent risk assessments or adequate containment.
Trump’s executive order takes direct aim at foreign gain-of-function collaborations, stating unequivocally that federal funds shall not be awarded, directly or indirectly, to any foreign institution or entity located in a country of concern where gain-of-function research may be conducted without adequate oversight, to “ensure that the countries are compliant with United States oversight standards and policies.”
The order mandates that all current federal grant recipients review their projects for compliance and imposes a pause on any new or continuing funding until the Office of Science and Technology Policy and the Director of the Office of Management and Budget and the Assistant to the President for National Security Affairs, in coordination with the Department of Health and Human Services (HHS), develops a new oversight policy.
The NIH followed swiftly with Notice Number NOT-OD-25-112, which instructed potential applicants that any new proposals involving enhanced pathogens will be held and that existing grants involving GoF work may be suspended pending review. The agency further instructed researchers to proactively evaluate ongoing studies to determine whether they meet the revised criteria and to halt any experiments that could fall under the definition of “enhanced potential pandemic pathogens.”
Reaction to the move has been mixed and predictably polarized. Public figures such as HHS Secretary Robert F. Kennedy Jr. and NIH Director Dr. Jay Bhattacharya praised the order as a long-overdue course correction. In a statement issued the day of the announcement, Bhattacharya said, “The conduct of this dangerous gain-of-function research, which aims at taking pathogens and making them more virulent, more transmissible in humans, many scientists believe is responsible for the COVID pandemic.”
“Any nation that engages in this research endangers their own population as well as the world, as we saw during the COVID pandemic,” he added.
Dr. Marty Makary, the new commission of the U.S. Food and Drug Administration) agreed. “It’s crazy to think that this entire nightmare was probably the result of some scientists messing with Mother Nature in a laboratory with technology exported from the United States,” Makary said.
Supporters have pointed to the still-unresolved debate over the origins of COVID-19, including the possibility that the virus emerged from a lab in Wuhan, China, as a compelling reason to reevaluate federal funding of GoF studies. Trump himself has long criticized U.S. involvement in controversial overseas research, particularly the now-infamous grant to EcoHealth Alliance, which funneled money from the NIH to the Wuhan Institute of Virology prior to the pandemic. In campaign speeches and media interviews, Trump has consistently referenced this funding as a major failure of U.S. oversight and a lesson in the dangers of unaccountable scientific adventurism.
“This never should have happened,” Trump said in a statement shared on Truth Social. “We gave money to the Wuhan lab, and we got a pandemic. Now we’re putting America first, and putting an end to these dangerous experiments—especially in places that hate us.”
The policy comes at a time when gain-of-function research is under growing scrutiny from both sides of the political aisle. While many Democrats remain cautious about appearing to validate lab-origin theories, a handful of bipartisan investigations—including those by the House Select Subcommittee on the Coronavirus Pandemic—have criticized federal health agencies for failing to adequately monitor high-risk research. A 2023 report from the Government Accountability Office found significant gaps in HHS’s oversight mechanisms, including unclear definitions, insufficient enforcement tools, and a lack of inter-agency coordination.
The Trump directive aims to address these weaknesses head-on. Among its key provisions is a requirement that HHS, the National Security Council, and the Office of Management and Budget jointly develop within 120 days a comprehensive framework for identifying, overseeing, and regulating research involving dangerous pathogens. It also directs federal agencies to update gene synthesis screening requirements—an area of growing concern given the advent of synthetic biology and the potential for homegrown bioterrorism.
Perhaps most notably, the order calls for the expansion of federal oversight to include non-federally funded pathogen research—a provision likely aimed at closing the so-called “EcoHealth loophole,” through which organizations operating as pass-throughs have funneled funds to foreign labs with limited accountability. Critics of the existing policy framework have long argued that the U.S. lacks visibility into what happens after money leaves the hands of NIH or USAID grantees, especially when those grantees subaward funds to international partners in countries with opaque research practices.
Still, some researchers warn that the order may have unintended consequences. A number of scientists have expressed concern that the pause could interrupt critical studies into influenza, coronaviruses, and other pathogens with real-world pandemic potential. “We understand the need for caution,” said Dr. Angela Rasmussen, a virologist at the Vaccine and Infectious Disease Organization in Canada. “But a broad suspension of GoF research—even temporarily—could hamper our ability to respond effectively to emerging threats.”
Others have noted the ambiguity in the term “gain-of-function” itself, which can apply to a wide range of experiments—from those that merely swap viral proteins for better detection in lab models to those that create entirely new viral strains with increased virulence. As such, there is concern within the academic community that the order may cast too wide a net, pulling in low-risk research alongside high-risk studies that legitimately warrant pause or prohibition.
Looking ahead, much will depend on how the forthcoming policies are crafted, interpreted, and enforced. Biosecurity experts warn that crafting a nuanced framework that balances innovation and safety will be no small task. Some are calling for a new federal agency or commission to regulate high-risk life sciences, independent of both the NIH and the Department of Defense. Others urge Congress to codify the executive order into law to ensure its durability beyond the Trump administration.
What is clear, however, is that the landscape for pathogen research in the United States has shifted and gain-of-function research will never again be the quiet domain of obscure grant applications and peer-reviewed journals. It is now, unmistakably, a matter of public policy—and political will.
