Lab manipulations of COVID virus fall under murky government rules

Scientists at Boston University came under fire this past week for an experiment in which they tinkered with the COVID-19 virus. Breathless headlines claimed they had created a deadly new strain, and the National Institutes of Health rebuked the university for not seeking the government’s permission.

As it turned out, the experiments, performed on mice, were not what the inflammatory media coverage suggested. The manipulated virus strain was actually less lethal than the original.

But the uproar highlighted shortcomings in how the U.S. government regulates research on pathogens that pose a risk, however small, of setting off a pandemic. It revealed loopholes that allow experiments to go unnoticed, a lack of transparency about how the risk of experiments is judged and a seemingly haphazard pattern in the federal government’s oversight policy, known as the Potential Pandemic Pathogen Care and Oversight, or P3CO framework.

Even as the government publicly reprimanded Boston University, it raised no red flags publicly about several other experiments it funded in which researchers manipulated coronaviruses in similar ways. One of them was carried out by the government’s own scientists.

The Boston episode “certainly tells us the P3CO framework needs to be overhauled pretty dramatically,” said Angela Rasmussen, a virus expert at the Vaccine and Infectious Disease Organization at the University of Saskatchewan in Canada. “The whole process is kind of a black box that makes it really difficult for researchers.”

Under the P3CO framework, the NIH and other agencies are supposed to flag grant applications for experiments that could potentially produce a new pandemic. Risky research may not be funded or may require extra safety measures.

The NIH said that every study it considers for funding is vetted for safety concerns by agency experts, who decide whether to escalate it to a higher-level dangerous pathogen committee.

Critics of P3CO have complained that this evaluation happens largely in secret and ignores projects that aren’t funded by the U.S. government. Biosafety experts said some experiments end up falling outside the scope of the process, leading to confusion.

The rules could be overhauled. A committee of government advisers is expected to deliver updated recommendations for such research by December or January.