A new U.S. policy that aims to reduce the risks arising from federally funded research with dangerous pathogens is drawing mixed reviews from scientists, with even some who support tighter regulation fearing its vague wording could complicate, not clarify, the rules on what kinds of studies the government will support.
“The error bars for how [the policy] could be implemented range from too permissive to too restrictive,” says Marc Lipsitch, an epidemiologist at Harvard University who has advocated for stricter government controls on risky pathogen research.
Others are more critical. “I think it [is] intended to put a chill on all kinds of research that has anything to do with infectious diseases,” says Gigi Gronvall, an immunologist and biosecurity expert at the Johns Hopkins University School of Medicine.
The much-anticipated policy, released yesterday by the White House, marks the U.S. government’s latest attempt to address decades-old concerns that researchers could create or enhance a deadly biological agent—such as a virus or other microbe—that somehow escapes the laboratory and threatens people or agriculture. Those fears grew after the COVID-19 pandemic, which some believe was sparked by a virus that had been engineered or was under study at a research facility in China. (Others argue the evidence points to transmission from wild or farmed animals.)
Last year, in response to those concerns, President Donald Trump ordered the National Institutes of Health (NIH) and other research funding agencies to pause or review studies that potentially involved so-called dangerous gain-of-function (DGOF) research. Such experiments give pathogens new characteristics, such as the ability to more easily spread or cause death. The White House also tasked agencies with developing the new policy to stop other “high risk life sciences research.”
The 12-page policy—which broadly follows the language in Trump’s executive order—includes several departures from past U.S. attempts to govern similar work. It appears to cover all pathogens, rather than limiting regulation to a specific list, such as only those with “pandemic potential.” It requires researchers and universities to identify any study that might produce a biological agent that would “significantly endanger” people or agriculture. They must thoroughly evaluate its risks and benefits before submitting a funding proposal to the government.
In addition, the policy imposes an outright ban—rather than tighter review requirements—on funding for seven kinds of biological research that the policy defines as DGOF. That list of forbidden studies includes projects that could make a pathogen more transmissible, for instance, or better able to evade the human immune system. It also includes efforts to resurrect an extinct pathogen, such as the virus that caused the 1918 flu pandemic—a project completed in 2012 by a team led by one of NIH’s own scientists.
The policy also bars funding for studies in the nascent field of “mirror life”—engineered microorganisms with reversed molecular building blocks that could theoretically threaten all life on Earth. No governments have so far enacted bans on such research and the issue has divided scientists, with some calling such prohibitions premature.
If it is not clear whether a proposed study fits into one of the DGOF categories—or if the institution, scientist, or funding agency thinks it might eventually do so—the policy says the research must be reviewed by a new independent review board, rather than a specific agency. The members of that board, which the government will create by 26 October, will be publicly disclosed and will include experts on molecular biology, law enforcement, biosecurity, and other topics. “Under the new policy, the funding agencies will no longer be grading their own homework,” NIH Director Jay Bhattacharya wrote yesterday in The Wall Street Journal.
The policy also directs scientists and institutions to review and report to the government any ongoing research that might constitute DGOF—whether federally or privately funded. Violations of the rules could draw penalties that include withdrawal of federal funds and a 5-year ban on new federal funding for life sciences research. (In a footnote, the White House added that the government plans to explore ways to manage the risks of privately funded research as well, but that could require Congress to pass new legislation.)
The new policy also bans federal funds from going to researchers in countries of “concern,” including China, North Korea, Iran, and Cuba. And it directs U.S. agencies to review the research projects they fund in other countries to ensure that foreign institutions use adequate safety standards.
Some observers applaud the international safety review. “We should be seeking to bring those entities up to the U.S. standard,” says Allen Segal, spokesperson for the American Society for Microbiology.
But he and others worry the extensive domestic review and reporting requirements—and the potentially severe penalties for violating them—could drive scientists away from certain kinds of valuable research. “What we don’t want is a policy that suggests that the consequence of conducting research outweighs the public health benefit that that research could provide,” Segal says. One source of concern, he adds, is the policy’s broad and potentially confusing language on how researchers should weigh a study’s risks against its potential benefits.
Both Gronvall and Lipsitch fear the uncertainty created by the vague wording will impede research projects that have little to no risk of causing disease. One challenge, Gronvall says, is that “you cannot necessarily predict what is going to be the result of your experiment—that is why you do the experiment.”
Past administrations tried to avoid having controls on pathogen research harm efforts to study diseases and develop countermeasures, Gronvall says. But the Trump administration “sees scientists as the enemy, not the disease,” she says. “They are really betting on not needing to fight an infectious disease during their tenure.”
The policy instructs agencies to issue guidance on implementing the policy within 120 days. In the meantime, NIH says 40 projects it suspended last year because they were deemed to constitute DGOF will remain paused. About half of the suspended work involved experiments with tuberculosis, which is not usually considered to be a pathogen that could cause dangerous outbreaks as it can be treated with antibiotics and is slow to spread. Other halted grants confused scientists as they didn’t involve the direct use of pathogens, but studied antibodies that the immune system produces to fight deadly viruses. NIH has suspended at least several more studies since then.
NIH did not respond to questions about the suspended research and its plans for reviewing additional ongoing research by press time.
Facts Only
* A new U.S. policy was released by the White House regarding federally funded research with dangerous pathogens.
* Marc Lipsitch, an epidemiologist at Harvard University, noted error bars for implementation range from too permissive to too restrictive.
* Gigi Gronvall, an immunologist and biosecurity expert at Johns Hopkins University School of Medicine, suggested the policy intends to chill all infectious disease research.
* The policy addresses fears that researchers could create or enhance biological agents escaping the lab.
* The policy follows language from a previous executive order regarding DGOF research.
* The policy covers all pathogens rather than limiting regulation to specific lists, such as only those with "pandemic potential."
* Researchers must evaluate risks and benefits before submitting funding proposals.
* Funding is banned for seven types of biological research defined as DGOF, including projects that make pathogens more transmissible or attempt to resurrect extinct pathogens.
* Funding for studies in the field of “mirror life” (engineered microorganisms) is also banned.
* Research not clearly fitting DGOF categories must be reviewed by a new independent board.
* Violations can result in penalties including withdrawal of federal funds and a 5-year ban on new federal funding for life sciences research.
* Federal funds are banned for researchers in countries of "concern," including China, North Korea, Iran, and Cuba.
* NIH suspended 40 projects from last year due to DGOF concerns, including some involving tuberculosis.
Executive Summary
A new U.S. policy aims to reduce risks from federally funded research involving dangerous pathogens, which has drawn mixed reactions from scientists regarding its implementation and scope. Some experts, like Marc Lipsitch, suggest the policy's wording creates uncertainty about regulatory outcomes, ranging from overly permissive to restrictive. Others view it as an attempt to restrict all infectious disease research. The policy seeks to address concerns that researchers could create or enhance deadly biological agents escaping the laboratory. Previously, the Trump administration ordered pauses or reviews of studies involving dangerous gain-of-function (DGOF) research and tasked agencies with stopping other high-risk life sciences research.
The 12-page policy includes changes such as regulating all pathogens rather than limiting review to specific groups like those with "pandemic potential." It requires researchers to evaluate risks and benefits before submitting funding proposals. Furthermore, the policy imposes an outright ban on funding for seven categories of DGOF research, including efforts to enhance pathogen transmissibility or resurrect extinct pathogens. The policy also bans funding for research into engineered microorganisms, termed "mirror life." Researchers must now submit ongoing work for review by a new independent board if a study might involve DGOF. Finally, the policy restricts federal funding to countries deemed of "concern" and requires reviews of foreign research safety standards.
Full Take
The narrative balances a clear attempt at risk mitigation against profound scientific and practical uncertainty introduced by the policy's structure. The tension arises between the stated goal of safety and the practical reality of managing research complexity. Scientists express concern that vague language—the permitting mechanism versus outright bans—could impede legitimate inquiry, particularly in areas where risk assessment is inherently difficult, as Gronvall suggests prediction remains elusive. This creates a structural conflict: policy demands certainty for control, while scientific methodology demands acknowledgement of inherent uncertainty.
The pattern observable here relates to the tension between command structures and epistemic practice. The government seeks to impose a specific regulatory structure (bans, mandatory reviews) onto an inherently open-ended field of scientific exploration, which resists neat categorization. This mirrors historical friction where external control mechanisms clash with autonomous discovery. Furthermore, the explicit focus on funding restrictions targeting specific research modalities—like DGOF or mirror life—suggests an underlying political prioritization is shaping which forms of knowledge are deemed permissible, raising questions about whose definition of "dangerous" and "valuable" supersedes scientific consensus in policy formulation.
What follows this structure is not simply a regulatory update but a negotiation over the boundaries of legitimate scientific agency. If the framework punishes uncertainty as much as documented risk, it risks creating a self-fulfilling prophecy where valuable, low-risk research is sidelined simply due to the ambiguity inherent in any experimental outcome. The real implication lies in determining whether the process of imposing external constraints can enhance or erode the very pursuit of knowledge.
BRIDGE QUESTIONS:
How should independent review boards be structured to effectively adjudicate novel risk assessments without succumbing to political pressure?
What mechanisms exist to ensure that funding restrictions do not disproportionately stifle research into areas with high potential public health benefits, even if the risk profile is speculative?
If the definition of DGOF remains fluid, how can the system ensure that the focus on mitigating known threats does not inadvertently create new, unmonitored avenues for future biological risks?
Sentinel — Human
This analysis presents a complex policy dispute framed by specific scientific concerns and political history, showing signs of human-driven synthesis of expert viewpoints rather than purely mechanical generation.