Key Insights
- Federal funds will no longer support any research in which a pathogen is altered in such a way that may make it more dangerous.
- Debate about oversight of such work has gone on for over a decade but intensified due to the COVID-19 pandemic.
- The new policy may affect work on vaccines and treatments for emerging pathogens.
The White House on Tuesday released a new policy that prevents the federal government from funding research that intentionally makes a pathogen more dangerous in order to study it.
The policy also blocks US agencies from funding such research (PDF)—termed “dangerous gain of function” (DGOF)—in certain countries, tasks agencies with setting up new approval policies and an independent oversight board to evaluate research that is potentially dangerous, and requires scientists to attest whether their research has the potential to become DGOF work.
The policy is the latest development in a decade-plus-long debate over an arm of infectious disease research in which researchers manipulate biological agents such as viruses with the aim of protecting people against them—a debate that intensified due to the COVID-19 pandemic. Such research might involve editing a pathogen’s genome to understand how it spreads or causes disease, says Gigi Gronvall, an immunologist at Johns Hopkins University who researches biosecurity and pandemic preparedness.
Such work might—intentionally or otherwise—make a pathogen more easily transmissible or harmful or otherwise make it more dangerous. The broad term “gain of function” is not new, and only a small subset of it is of concern, says Mary Denigan-Macauley, director of health care at the US Government Accountability Office (GAO). In 2014, the Barack Obama administration temporarily suspended gain-of-function research with influenza viruses and the viruses that cause Middle East respiratory syndrome and severe acute respiratory syndrome (SARS).
At the time, the pause affected 21 grants.
Previous policies in this area have tried to balance the potential risks and benefits of this work, Gronvall says, without which it’s difficult to develop vaccines and treatments. The new policy, though, seems to abandon any recognition of its importance, she says.
“This is all part of stopping infectious disease research,” Gronvall says. “I don’t know how else you could interpret this. It’s just another way that it’s making it very difficult for universities to do research on diseases that kill people.”
Policy comes amid years of questions and attacks regarding the COVID-19 pandemic
“Gain of function” as a term has been used in different ways, Denigan-Macauley says. The new policy defines DGOF research as any research with a biological agent that “could result in significant negative societal consequences” via outcomes such as altering its host range, making it more harmful, or giving it resistance to current medical interventions.
Such research had already been under a moratorium since May 2025, when President Donald J. Trump issued an executive order to ban it until a new policy could be established. The order gave the Office of Science and Technology Policy 120 days to do so; it’s unclear why it took longer.
“For decades, federal policies overseeing gain-of-function research on pathogens and toxins have lacked adequate oversight and transparency both at home and in foreign countries, endangering the lives of Americans and people around the world,” White House spokesperson Kush Desai writes in an email to C&EN. “President Trump pledged to crack down on dangerous gain-of-function research while cementing America’s innovative dominance in biotech and other cutting-edge industries.”
Desai did not answer specific questions about the policy.
In the executive order, Trump referenced theories—contested by many scientists—that the National Institutes of Health approved research in China that led to the COVID-19 pandemic. That theory has largely pinned the blame on Anthony Fauci, a now-retired immunologist who served as the director of the National Institute of Allergy and Infectious Diseases from 1984 to 2022. Kennedy in 2021 released a book called The Real Anthony Fauci, which accuses Fauci of intentionally mishandling and hiding information about the pandemic.
In a Senate hearing on Wednesday, Fauci, saying he was speaking on the advice of his lawyers, invoked his Fifth Amendment rights more than 100 times as Sen. Rand Paul (R-KY) and other Republicans pressed him about his oversight of DGOF research and the origins of COVID-19. Many of their points have been debunked.
“Clearly the focus of the discussions between Rand Paul and Fauci are directly at the heart of this policy,” says Denigan-Macauley.
Rule could broadly affect infectious disease research
In a January report on pathogen-altering research, the GAO urged the HHS to disclose more information to researchers, Congress, and the public about how it mitigates risks from pathogen research and the number of such research projects federal agencies support.
Denigan-Macauley and the GAO have not fully analyzed the new policy yet and spoke to C&EN based on a brief review.
The independent oversight board that is part of the policy announced Tuesday may in part fulfill the GAO’s recommendations, Denigan-Macauley says, but whatever process is established needs to be able to move quickly in the event of an emergency, such as a new pandemic. The new policy appears to take this into account, she says.
The policy instructs agencies to issue oversight guidance to research institutions within 120 days, and it’s difficult to evaluate the policy’s true impact on research until agencies spell out how they will implement it, Denigan-Macauley says. It also gives agencies 120 days to publish a list—to be updated annually—of foreign “entities of concern” that would be banned from US-supported DGOF work and could include countries, institutions, or people.
The policy also creates a new category of “potentially dangerous gain of function research,” which is permissible only if approved by an independent review board. That broad scope could deter researchers and their institutions from doing any infectious disease work, Gronvall says.
“It’s really hard to say whether it would have societal consequences when you’re talking about very reductive experiments in a laboratory,” she says.