The Trump administration released a government-wide policy Tuesday prohibiting federal support for dangerous gain-of-function (DGOF) research in the United States and abroad while imposing new reviews and reporting requirements on other high-risk life sciences studies.
The U.S. Department of Health and Human Services announced the policy on July 28. The 12-page document carries a July 20 date and implements Executive Order 14292, which President Donald Trump signed on May 5, 2025.
As previously reported by The Dallas Express, the executive order directed agencies to suspend federally funded DGOF research while officials replaced the previous oversight framework. The new policy keeps the order’s provisions in force until agencies issue implementation guidance and establish the required review system.
What the policy prohibits
The framework creates four funding categories and prohibits DGOF research. An independent review body must recommend research with the potential to become DGOF and determine that the project will not meet the prohibited definition before a federal agency may fund it.
The framework also bars federal funding for life sciences research conducted in a country of concern, or outside the United States by an institution or individual of concern. Other risky international research may proceed only after officials assess the possible threat and the institution’s ability to provide adequate oversight.
The policy defines DGOF as research with a biological agent that seeks, achieves or has a substantial risk of producing listed outcomes and could cause significant societal harm. Those outcomes include increasing an agent’s harmful effects, transmissibility or resistance to medical interventions; changing its host range; or reconstituting an eradicated or extinct agent.
“The federal government has a duty to protect the American people—not fund research that could put them at risk,” HHS Secretary Robert F. Kennedy Jr. said.
Independent reviews and penalties
Institutions receiving federal research funds must evaluate all proposed or ongoing life sciences research under the new definitions. Researchers must attest in writing whether a project involves DGOF, potential DGOF or international research of concern. Researchers must immediately stop a project that may cross into the prohibited category and notify institutional and federal officials within 24 hours.
Federal agencies have 90 days from the policy’s issuance to establish a single independent review body and 120 days to issue implementation guidance. Federally funded research institutions have 180 days to establish internal review entities, designate institutional contacts and begin annual training.
Violations may lead to immediate revocation of ongoing federal funding, up to five years of ineligibility for federal life sciences funds and other penalties under federal law.
The policy governs federal support rather than imposing a direct nationwide ban on privately financed research. It states that additional statutory action is required to stop all DGOF research and funding by U.S. entities, while an interagency group will explore regulatory, legislative or other steps.
Medical research remains eligible
The policy says it does not prohibit the development of essential medical products or medical countermeasures. Federally supported work on vaccines, therapeutics, diagnostics and other medical countermeasures may continue under the new safeguards.
“The overwhelming majority of biomedical research provides enormous benefits to society,” National Institutes of Health Director Jay Bhattacharya said. He said research that could create extraordinary biological risks should receive the highest level of scrutiny.
The framework replaces the 2024 federal policy and earlier oversight systems dating to 2012. A separate joint statement described it as an “America First approach” and urged international partners to adopt stronger biosafety and biosecurity standards and end DGOF research.
Provided by Dallas Express
