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U.S. scientists brace for tighter scrutiny of potentially risky research

Federally funded scientists who work with potentially harmful bacteria, viruses, and other agents could soon face a major expansion of U.S. government oversight. An expert group last week recommended broadening rules that require universities and funding agencies to determine whether proposed studies count as dual-use research—work that carries the risk of intentionally or accidentally creating a bioweapon. Currently, such reviews are only required for experiments involving 15 dangerous agents. But the panel argues the reviews should now extend to work with all human, plant, and animal pathogens, even those causing only mild disease.

Coming from the National Science Advisory Board for Biosecurity (NSABB), the recommendation reflects the heightened concern about biosafety and biosecurity catalyzed by the COVID-19 pandemic, which some allege originated from a laboratory in Wuhan, China. But the proposal has drawn fierce pushback from many researchers and even one NSABB member. Extending dual-use reviews to all disease-causing viruses, bacteria, and fungi is “a potential for disaster” because it could hamstring even routine studies, warned NSABB panelist Mark Denison, a virologist at Vanderbilt University, at a 27 January meeting. The move and other policy changes could even hinder crucial work to fight pandemics, critics say.

NSABB’s chair, however, downplayed such concerns. “We … suspect this will be a very small subset of research that would ultimately require a full [dual-use] review,” said Gerald Parker, a biosecurity expert at Texas A&M University, College Station. If funding agencies adopt the policy, he said, they will need to clarify how they plan to prevent it from hampering research.

The rules for managing “dual-use research of concern” (DURC) emerged after letters holding anthrax killed five people in the United States in 2001. Under 2012 and 2014 federal policies, researchers working with any of 15 “select agents,” including anthrax and Ebola virus, must decide whether a planned study falls into any of seven problematic categories. For example, if they plan to modify an agent to make it drug-resistant or more transmissible, institutional biosafety committees (IBCs) must report it to federal officials and include a risk management plan. (In rare cases, institutions have decided the work won’t move forward.)

Such studies continued to stir concerns, however. In 2017, the Department of Health and Human Services (HHS) added review rules for a subset of DURC: “gain-of-function” studies that modify viruses such as severe acute respiratory syndrome and H5N1 avian influenza in ways that could make them more dangerous to humans. But HHS has only reviewed three experiments under this policy, known as Potential Pandemic Pathogen Care and Oversight (P3CO). Some scientists say these policies are too lax, and that the National Institutes of Health (NIH) has improperly exempted problematic studies, including some involving mpox and bat coronaviruses. In February 2022, NIH and the White House asked NSABB to revisit and harmonize the DURC and P3CO policies.

NSABB’s recommendation reflects long-standing concerns that limiting DURC reviews to any list of agents could miss high-risk studies. For example, the current policy does not cover reconstructing an extinct virus such as horsepox, a relative of smallpox. Some institutions already extend DURC reviews to all pathogen work.

Under the new proposal, local IBCs would review studies with any pathogen that involve any of the seven DURC experiments. They would also look for studies that fall under an expanded P3CO definition: any work that is “reasonably anticipated” to generate a pathogen that, even if only moderately transmissible or virulent, is likely to pose a “severe threat to public health.” The P3CO policy would no longer exempt studies done for disease surveillance or vaccine development, but promises expedited review of such studies.

Many virologists worry the new reviews could delay work with relatively benign agents such as cold viruses, herpesviruses, and viruses modified to treat cancer. They fear the rules also could complicate basic studies that manipulate viruses to understand protein function. Denison and others note that deliberately creating viruses resistant to drugs is essential to developing antiviral treatments. “At the moment it looks like this would significantly slow down science,” says influenza virologist Seema Lakdawala of Emory University.

If NIH and other agencies adopt the rules—and it’s not clear when that might happen—NSABB recommends the government create a special office to help researchers comply. The panel also wants the policy to apply to privately funded research, but that could require Congress to pass new laws.

Source: Science Mag