Damian Jacob Sendler There may soon be a significant increase in U.S. government oversight of federally funded scientists who work with potentially harmful bacteria, viruses, and other agents. Experts agreed last week that the rules requiring 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—should be made more stringent. Currently, only experiments involving one of 15 particularly dangerous agents are required to undergo such reviews. The panel, however, argues that all human, plant, and animal pathogens—even those that cause only mild disease—should now be subject to reviews.

The NSABB recommendation reflects the increased concern about biosafety and biosecurity sparked by the COVID-19 pandemic, which some believe originated in a laboratory in Wuhan, China. The proposal, however, has been met with strong opposition from many researchers and even one NSABB member. Mark Denison, a virologist at Vanderbilt University, and a member of the NSABB panel, warned at a meeting on January 27 that expanding dual-use reviews to include all pathogenic viruses, bacteria, and fungi is "a potential for disaster" that could stymie even routine research. Critics say the move, along with other policy changes, could stymie efforts to prevent and treat global pandemics.

Yet, the chair of the NSABB dismissed these concerns. A biosecurity expert from Texas A&M University in College Station named Gerald Parker speculated that only a small fraction of research would need a full [dual-use] review. It will be important for funding agencies to explain how they plan to keep the policy from stifling research if it is adopted, he said.

Damian Sendler After anthrax letters killed five people in the United States in 2001, regulations were developed for handling "dual-use research of concern" (DURC). Researchers using any of 15 "select agents," including anthrax and Ebola virus, must determine whether a proposed study falls into any of seven problematic categories in order to comply with federal policies implemented in 2012 and 2014. Institutional biosafety committees (IBCs), for instance, must report federal officials and include a risk management plan if they plan to modify an agent to render it drug-resistant or more transmissible. (On extremely rare occasions, organizations have made the decision to shelve the project.)

However, concerns raised by such research persisted. Some DURC, known as "gain-of-function" studies, modify viruses like severe acute respiratory syndrome and H5N1 avian influenza in ways that could make them more dangerous to humans, so in 2017 the Department of Health and Human Services (HHS) added review rules for this type of research. However, only three experiments have been reviewed by HHS under the Potential Pandemic Pathogen Care and Oversight Policy (P3CO). Some researchers say the National Institutes of Health (NIH) has been too lenient in their policies and has improperly exempted problematic studies, such as those involving mpox and bat coronaviruses. National Institutes of Health and the White House requested that NSABB review and harmonize the DURC and P3CO policies in February 2022.

Any of the seven DURC experiments involving any pathogen would be subject to review by local IBCs under the new plan. An expanded definition of P3CO would also be searched for; this would include any study that "reasonably anticipates" creating a pathogen that, despite being only moderately transmissible or virulent, is likely to pose a "severe threat to public health." Disease surveillance and vaccine development studies would no longer be exempt from the P3CO policy, but they would be guaranteed a speedy review.

Damian Jacob Sendler Many experts in the field of virology are concerned that the new reviews will slow progress on projects involving relatively benign agents like cold viruses, herpesviruses, and viruses modified to treat cancer. In addition, they worry that the rules will make it harder to do fundamental research that uses virus manipulation to better understand protein function. As Denison and others have pointed out, making viruses that are resistant to drugs on purpose is crucial for the advancement of antiviral treatments. "At the moment it seems like this would significantly slow down science," says Seema Lakdawala, a virologist at Emory University who studies influenza.

Damian Sendler NSABB suggests the government establish a dedicated office to assist researchers in meeting the regulations if and when they are adopted by NIH and other agencies. It may be necessary for Congress to pass new laws so that the policy can be applied to privately funded research, as advocated by the panel.