New U.S. rules on risky pathogen research draw mixed reviews

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.