Trump administration bans dangerous gain-of-function funding amid renewed COVID scrutiny

The Trump administration released a sweeping government-wide policy July 28 prohibiting federal support for dangerous gain-of-function research, citing the potentially catastrophic consequences of experiments that make biological agents more harmful or transmissible.

The 12-page “United States Government Policy for Stopping High-Risk Life Sciences Research” applies to federal agencies, federally funded research institutions, and investigators seeking taxpayer support for life-sciences work in the U.S. or abroad.

The policy fulfills an executive order President Donald Trump signed in May 2025 after years of controversy over U.S.-funded coronavirus research in China and the unresolved origins of COVID-19.

“The federal government has a duty to protect the American people — not fund research that could put them at risk,” Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. said in a July 28 press release announcing the policy.

“Today, we are ending federal support for dangerous gain-of-function research and replacing weak oversight with clear, enforceable safeguards,” Kennedy added. “This policy delivers on President Trump’s commitment to put safety first while ensuring America remains the global leader in ethical, responsible, and lifesaving biomedical research.”

The policy defines dangerous gain-of-function research as work involving a biological agent that seeks, achieves, or carries a substantial risk of making that agent more lethal while potentially producing “significant negative societal consequences.”

Covered outcomes include making a biological agent more harmful or transmissible, enabling it to evade vaccines or detection methods, expanding its host range, increasing a population’s susceptibility to it, making it resistant to medical treatments, or recreating an eradicated or extinct pathogen.

Projects that could potentially produce such outcomes — but do not yet qualify as dangerous gain-of-function research — must undergo a risk-benefit assessment and review by a new independent third-party review body before receiving federal support under the new policy. Researchers must also develop safeguards and modify experiments to prevent them from crossing the prohibited line.

According to the policy, the new review body will include specialists in molecular biology, microbiology, clinical medicine, biosafety, cybersecurity, ethics, public health, biodefense, law enforcement, and national security. Federal intelligence, defense, law-enforcement, and diplomatic agencies will have an opportunity to provide information that could inform assessments of proposed projects.

The review body may also audit up to 25% of proposals submitted annually by researchers who determined their proposed work did not present a dangerous gain-of-function risk.

Researchers must continually evaluate their experiments. If a project unexpectedly begins to present a substantial risk of producing a prohibited outcome, the investigator must stop the work immediately and notify the research institution and funding agency within 24 hours.

Violations could result in the immediate loss of federal support, additional penalties under federal law, and up to five years of ineligibility for federal life-sciences funding.

Research institutions receiving federal life-sciences money must establish internal review panels of at least five members, designate an official responsible for dangerous gain-of-function compliance, and institute annual training for researchers. Institutions must also report both potential and actual dangerous gain-of-function work being conducted with private money, even though the new policy does not directly prohibit all privately funded research.

The document acknowledges that additional legislation or regulation will be required to stop dangerous gain-of-function work funded entirely outside the federal system. An interagency group will consider further action under Trump’s executive order.

The policy also creates a category known as “international research of concern.” Federal agencies may not fund life-sciences research conducted in countries of concern or involving designated foreign institutions or individuals of concern. Other foreign research conducted under inadequate biosafety or biosecurity rules will require a separate risk assessment before it can receive federal support.

Federal agencies have 90 days to establish the independent review body and 120 days to publish implementation rules. Research institutions will have 180 days to establish their internal review systems.

HHS emphasized in its release that the policy does not prohibit ordinary biomedical research or the development of vaccines, therapeutics, diagnostic tools, and countermeasures against biological weapons. Purely computational research is also generally excluded, although the White House Office of Science and Technology Policy will monitor the growing intersection of artificial intelligence and biological research.

National Institutes of Health (NIH) Director Dr. Jay Bhattacharya said in a July 28 statement that the policy marked a “paradigm shift” by establishing the government’s first explicit prohibition on dangerous gain-of-function research.

“The pursuit of knowledge must be matched by a commitment to responsibility,” Bhattacharya said. “The overwhelming majority of biomedical research provides enormous benefits to society, and this framework helps ensure that research with the potential to create extraordinary biological risks receives the highest level of scrutiny.”

COVID controversy looms over new policy

Although the framework applies broadly to life-sciences research, its origins are inseparable from the questions surrounding the origin of COVID-19.

Trump’s 2025 executive order said dangerous research could lead to catastrophic consequences “even after COVID-19 revealed the risk of such practices.” The order also accused the Biden administration of permitting insufficiently supervised domestic research and approving NIH funding in China and other countries where U.S. officials could not ensure compliance with American safety standards.

The final policy was released one day before former National Institute of Allergy and Infectious Diseases Director Anthony Fauci appeared before the Senate Homeland Security and Governmental Affairs Committee to face renewed questions about COVID-19, the Wuhan Institute of Virology, and federal support for gain-of-function research. 

Fauci invoked his Fifth Amendment right against self-incrimination and declined to answer the committee’s questions during the July 29 hearing.

As Zeale News recently reported, committee Chairman Rand Paul, R-Ky., released 1,141 pages of Fauci’s pandemic-era journal entries ahead of the hearing. Paul argued that the documents reveal a divide between Fauci’s private concerns about a possible laboratory origin and the public account he presented during the pandemic.

Fauci has denied concealing COVID-19’s origins or lying about federal research funding. He has maintained that the experiments supported by NIH in Wuhan did not meet the government’s regulatory definition of gain-of-function research and that the available evidence favors natural transmission.

That dispute has repeatedly turned on competing definitions. Former NIH Principal Deputy Director Lawrence Tabak said in 2024 that NIH-funded work at the Wuhan laboratory qualified as gain-of-function research under the term’s broad scientific meaning, while arguing that it did not meet the narrower definition governing particularly dangerous experiments.

The current scrutiny has also extended beyond Fauci. Federal prosecutors indicted his former senior adviser David Morens in April for allegedly participating in a scheme to conceal, remove, destroy, or falsify federal records related to COVID-19 research grants, as Zeale News previously reported. The investigation into Morens is ongoing, and Fauci has not been charged in connection with that case.

The Trump administration is now urging foreign governments to adopt similar restrictions, arguing that ending federal support in the U.S. will not eliminate the danger if high-risk biological experiments continue under weaker safeguards elsewhere.