Tighter rules on US virus research
Comes years after COVID debate
the white house has unveiled tighter rules for research on potentially dangerous microbes and toxins, in an effort to stave off laboratory accidents that could unleash a pandemic.
the new policy, published monday evening, arrives after years of deliberations by an expert panel and a charged public debate over whether coviD arose from an animal market or a laboratory in china.
a number of researchers worried that the government had been too lax about lab safety, with some even calling for the creation of an independent agency to make decisions about risky experiments that could allow viruses, bacteria, or fungi to spread quickly among people or become deadlier. But others warned against creating restrictive rules that would stifle valuable research without making people safer.
the debate grew sharper during the pandemic as politicians raised questions about the origin of coviD. those who suggested it came from a lab raised concerns about studies that tweaked pathogens to make them more dangerous — sometimes known as “gain of function” research.
the new policy, which applies to research funded by the federal government, strengthens the government’s oversight by replacing a short list of dangerous pathogens, using instead broad categories into which more pathogens might fall. the policy pays attention not only to human pathogens but also those that could threaten crops and livestock. and it provides more details about the kinds of experiments that would draw the attention of government regulators.
the rules will take effect in a year, giving government agencies and departments time to update their guidance to meet the requirements.
“it’s a big and important step forward,” said Dr. tom inglesby, the director of the Johns hopkins center for health Security and a longtime proponent of stricter safety regulations. “i think this policy is what any reasonable member of the public would expect is in place in terms of oversight of the world’s most transmissible and lethal organisms.”
Still, the policy does not embrace the most aggressive proposals made by lab safety proponents, such as creating an independent regulatory agency. it also exempts certain types of research, including disease surveillance and vaccine development. and some parts of the policy are recommendations rather than government-enforced requirements.
“it’s a moderate shift in policy, with a number of more significant signals about how the white house expects the issue to be treated moving forward,” said Nicholas Evans, an ethicist at the university of massachusetts lowell.
Experts have been waiting for the policy for more than a year. Still, some said they were surprised that it came out at such a politically fraught moment. “i wasn’t expecting anything, especially in an election year,” Evans said. “i’m pleasantly surprised.”
under the new policy, scientists who want to carry out experiments would need to run their proposals past their universities or research institutions, which would determine if the work poses a risk. Potentially dangerous proposals would then be reviewed by government agencies. the most scrutiny would go to experiments that could result in the most dangerous outcomes, such as those tweaking pathogens that could start a pandemic.