Login
The Trump administration on Tuesday released a policy restricting high-risk life sciences research, including a ban on federal support for “dangerous gain-of-function research,” the U.S. Department of Health and Human Services (HHS) announced in a press release.
The policy follows President Donald Trump’s May 2025 executive order directing the U.S. government to temporarily suspend dangerous gain-of-function research. At the time, the National Institutes of Health (NIH) and other agencies paused research projects that may have fallen under that definition.
The policy was released as the U.S. Senate Homeland Security and Governmental Affairs Committee prepared to question Dr. Anthony Fauci, former head of the National Institute of Allergy and Infectious Diseases (NIAID), today about his possible role in the origins of COVID-19.
Gain-of-function research, which increases the transmissibility or virulence of viruses, is often used in vaccine development. It’s the type of research conducted at the Wuhan Institute of Virology in Wuhan, China, that led to the theory that the virus that causes COVID-19 was developed at the lab and subsequently leaked.
The research at the Wuhan lab, involving both U.S. and Chinese scientists, was partially funded by NIAID under Fauci.
The administration’s new policy prohibits federal support for such research both domestically and abroad and establishes independent review for some types of high-risk life sciences research.
It also restricts federal funding for research conducted in countries and institutions that don’t have appropriate biosafety and biosecurity standards, according to the press release.
The policy still allows “critical biomedical research,” including the development of medical countermeasures, such as vaccines, therapeutics and diagnostics “under strong safety and security safeguards,” according to the press release.
“The federal government has a duty to protect the American people — not fund research that could put them at risk,” said U.S. Health Secretary Robert F. Kennedy Jr., whose book, “The Wuhan Cover-up,” included evidence that Fauci pursued and funded dangerous gain-of-function research, which led to the COVID-19 lab leak.
“Today, we are ending federal support for dangerous gain-of-function research and replacing weak oversight with clear, enforceable safeguards,” Kennedy said.
New oversight framework targets two types of research
Writing in The Wall Street Journal, NIH Director Jay Bhattacharya said the new policy fosters life sciences research, but minimizes the risk of another pandemic.
“The new policy preserves the benefits of life-sciences research while defining the areas of greatest risk, including prevention of accidental or intentional lab leaks, and penalties for irresponsible practices,” he wrote.
The policy does not ban gain-of-function research altogether and does not end federally funded biological health research in other countries. Instead, it defines two categories of research “posing the highest risk.”
These include “dangerous gain-of-function research (DGOF)” and “international research of concern (IROC).”
DGOF is research that enhances biological agents “in ways that make it more dangerous.” IROC is federally funded life sciences research that happens in other countries, which under the new policy must be conducted by trusted entities under U.S. oversight.
DGOF is prohibited, but research that has the potential to be DGOF is allowed after review by an independent third-party review.
IROC is prohibited, but IROC that could reasonably pose a threat to public health and safety or national security is allowed, after it is assessed for the research institution’s ability to provide oversight.
The policy mandates that principal investigators must evaluate whether their research meets these definitions and, if it does, they must complete a risk assessment and create a risk mitigation plan.
The research institutions proposing or funding such research must also assess the risks of that work and provide appropriate oversight. They will be required to have a special risk-benefit assessment infrastructure. If they don’t report the risks, they will be subject to penalties.
Federal funding agencies will also be required to review proposals for potentially risky research. That research must be reviewed by an independent review board that will conduct assessments, make funding recommendations and complete a mitigation plan.
The director of national intelligence and the secretaries of agriculture, state, and HHS will oversee the implementation process. Institutions that receive federal life sciences funding will establish Institutional Review Entities to carry out the work.
A decade of controversy over risky research
Gain-of-function research has long been controversial. Proponents argue the research allows scientists to reduce the risks of pandemics caused by new pathogens by manipulating viruses to better understand them, to evaluate their potential dangers and transmissibility, and to develop vaccines to protect against them.
Critics argue that the new pathogens can leak from labs and cause public health emergencies or pandemics — such as the COVID-19 pandemic — and that no oversight or mitigation can outweigh that risk.
They also warn that gain-of-function research has a “dual-use” potential — the pathogens can be used for bioweapons research and development.
Controversy ensued in 2011 when the National Science Advisory Board for Biosecurity suppressed two studies involving H5N1 viruses that had been modified to be more transmissible, worried that bad actors could replicate the work to cause an outbreak among humans, according to a study published in The Lancet Infectious Diseases.
In 2014, several breaches at U.S. government laboratories — including possible anthrax exposures for Centers for Disease Control and Prevention (CDC) workers, carelessness with smallpox vials at NIH and the accidental distribution by the CDC of manipulated flu virus — sparked an outcry among scientists and led to policy change.
The Obama administration paused gain-of-function experiments until the potential benefits and risks could be better evaluated.
The pause was lifted in 2017, when the NIH announced it would resume funding some gain-of-function research. HHS released the “Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens,” which provided standards for overseeing the research.
Public concern over gain-of-function research exploded with the onset of the COVID-19 pandemic, which many scientists and U.S. government investigators believe began with a gain-of-function virus lab leak at the U.S.-funded Wuhan Institute of Virology.
This article was funded by critical thinkers like you.
The Defender is 100% reader-supported. No corporate sponsors. No paywalls. Our writers and editors rely on you to fund stories like this that mainstream media won’t write.
However, Fauci and Dr. Francis Collins, then head of the NIH, maintained that the virus had “natural origins” — spilling over from animals to humans.
Documents obtained through Freedom of Information Act requests, along with findings from a congressional investigation, revealed that Fauci and others colluded to push the “natural origins” theory and to cover up U.S. government funding of risky gain-of-function research.
The substantial amount of evidence since released, which points to a lab origin, led the congressional committee, along with the FBI, the U.S. Department of Energy, the Defense Intelligence Agency and the CIA to conclude that the virus most likely escaped from a lab.
Mounting evidence eventually prompted mainstream publications, including The New York Times and Vanity Fair and ProPublica, to publish investigations supporting the theory.
In today’s hearing with Fauci, Sen. Rand Paul said, “The decision to fund dangerous gain-of-function research in Wuhan, China, will likely go down in history as perhaps one of the worst public health decisions.”
“Frankly, the American people deserve an apology,” he said.
The Trump administration suspended gain-of-function research with its May 2025 executive order, and made cuts to gain-of-function research funding.
However, an investigation by Paul Thacker showed that Congress continued funding a federal program established by Fauci to support emerging infectious disease research, despite cuts to the program.
Related articles in The Defender
- Congress Restores Funding to Fauci-Linked Research — Is It Gain-of-Function?
- Trump Pauses Federally Funded Gain-of-Function Research in U.S., But for Only 120 Days
- ‘No Doubt’ Fauci Funded Gain-of-Function Research That Likely Led to Pandemic, Former CDC Director Tells Lawmakers
- Fauci Knew NIH Funded Gain-of-Function Research at Wuhan Lab, Pressured Scientists to Push ‘Natural’ COVID Origins, Leaked Messages Reveal
